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Sample records for adults newly diagnosed

  1. Newly Diagnosed?

    MedlinePlus

    ... Suggestions Examine Your Skin Newly Diagnosed? Understanding Your Pathology Biopsy: The First Step Sentinel Node Biopsy Melanoma ... start this journey: Get a copy of your pathology report. We can help you understand the report ...

  2. Prevalence of hyperglycemia among adults with newly diagnosed HIV/AIDS in China

    PubMed Central

    2013-01-01

    Background The prevalence of hyperglycemia among HIV-infected persons who are not receiving antiretroviral therapy is unknown. We conducted a cross-sectional survey to estimate the prevalence of hyperglycemia among Chinese adults with newly diagnosed HIV/AIDS. Methods Two thousand and six newly diagnosed HIV/AIDS patients from 10 provinces and municipalities in China were selected during 2009 to 2010. After an overnight fast, serum samples were collected to measure glucose concentrations. Demographics and medical histories were recorded. Factors associated with the presence of diabetes were analysed by logistic regression. Results Among the 2006 patients, 75.67% were male. Median age was 40 years (range: 18–86 years). 19.99% had hyperglycemia, 9.47% had impaired fasting glucose (IFG) and 10.52% had diabetes. The prevalences of hyperglycemia, of IFG and of diabetes were 21.54%, 10.28% and 11.27% among men and 15.16%, 6.97% and 8.20% among women, respectively. The prevalence of diabetes increased with increasing age (7.00%, 13.36% and 21.21% among patients who were 18–40, 40–60, and ≥60 years of age respectively) and with decreasing CD4 count (6.74%, 8.45%, 9.69%, and 12.66% among patients with CD4 count of ≥350, 200–350, 50–200, and < 50/mm3 respectively). The prevalence of diabetes was higher among ethnic minority patients than among the Han patients (14.37% versus 9.24%). The logistic analysis showed that older age, lower CD4 count and minority ethnicity were significantly associated with an increased risk of diabetes. Conclusions Hyperglycemia is highly prevalent among Chinese adults with newly diagnosed HIV/AIDS. Older age, lower CD4 count and minority ethnicity are associated with increased risk of diabetes. All newly diagnosed HIV/AIDS individuals should be routinely evaluated for hyperglycemia. PMID:23394285

  3. Understanding Prostate Cancer: Newly Diagnosed

    MedlinePlus

    ... Wellness PCF Spotlight Glossary African American Men Understanding Prostate Cancer Newly Diagnosed Newly Diagnosed Staging the Disease Issues ... you care about has recently been diagnosed with prostate cancer, this section will help guide you through the ...

  4. Information needs of adult patients 50 or older with newly diagnosed acute myeloid leukemia.

    PubMed

    Yogaparan, T; Panju, A; Minden, M; Brandwein, J; Mohamedali, H Z; Alibhai, S M H

    2009-09-01

    When faced with a life-threatening illness such as acute myeloid leukemia (AML), patients may feel overwhelmed with making treatment decisions. We recruited 31 consecutive English-speaking patients aged > or = 50 with newly diagnosed AML. We explored patient information needs, decision-making roles, and perceptions about prognosis. Most patients felt that they had enough information about the diagnosis and treatment options and that the doctor spent the right amount of time with them. The majority of patients preferred a passive or collaborative decision-making role. Almost half the patients did not know their estimated 6-month prognosis, and 17% felt it was 90% or better.

  5. NRSF and BDNF polymorphisms as biomarkers of cognitive dysfunction in adults with newly diagnosed epilepsy

    PubMed Central

    Warburton, Alix; Miyajima, Fabio; Shazadi, Kanvel; Crossley, Joanne; Johnson, Michael R.; Marson, Anthony G.; Baker, Gus A.; Quinn, John P.; Sills, Graeme J.

    2016-01-01

    Cognitive dysfunction is a common comorbidity in people with epilepsy, but its causes remain unclear. It may be related to the etiology of the disorder, the consequences of seizures, or the effects of antiepileptic drug treatment. Genetics may also play a contributory role. We investigated the influence of variants in the genes encoding neuron-restrictive silencer factor (NRSF) and brain-derived neurotrophic factor (BDNF), proteins previously associated with cognition and epilepsy, on cognitive function in people with newly diagnosed epilepsy. A total of 82 patients who had previously undergone detailed neuropsychological assessment were genotyped for single nucleotide polymorphisms (SNPs) across the NRSF and BDNF genes. Putatively functional SNPs were included in a genetic association analysis with specific cognitive domains, including memory, psychomotor speed, and information processing. Cross-sectional and longitudinal designs were used to explore genetic influences on baseline cognition at diagnosis and change from baseline over the first year since diagnosis, respectively. We found a statistically significant association between genotypic variation and memory function at both baseline (NRSF: rs1105434, rs2227902 and BDNF: rs1491850, rs2030324, rs11030094) and in our longitudinal analysis (NRSF: rs2227902 and BDNF: rs12273363). Psychomotor speed was also associated with genotype (NRSF rs3796529) in the longitudinal assessment. In line with our previous work on general cognitive function in the healthy aging population, we observed an additive interaction between risk alleles for the NRSF rs2227902 (G) and BDNF rs6265 (A) polymorphisms which was again consistent with a significantly greater decline in delayed recall over the first year since diagnosis. These findings support a role for the NRSF–BDNF pathway in the modulation of cognitive function in patients with newly diagnosed epilepsy. PMID:26708060

  6. NRSF and BDNF polymorphisms as biomarkers of cognitive dysfunction in adults with newly diagnosed epilepsy.

    PubMed

    Warburton, Alix; Miyajima, Fabio; Shazadi, Kanvel; Crossley, Joanne; Johnson, Michael R; Marson, Anthony G; Baker, Gus A; Quinn, John P; Sills, Graeme J

    2016-01-01

    Cognitive dysfunction is a common comorbidity in people with epilepsy, but its causes remain unclear. It may be related to the etiology of the disorder, the consequences of seizures, or the effects of antiepileptic drug treatment. Genetics may also play a contributory role. We investigated the influence of variants in the genes encoding neuron-restrictive silencer factor (NRSF) and brain-derived neurotrophic factor (BDNF), proteins previously associated with cognition and epilepsy, on cognitive function in people with newly diagnosed epilepsy. A total of 82 patients who had previously undergone detailed neuropsychological assessment were genotyped for single nucleotide polymorphisms (SNPs) across the NRSF and BDNF genes. Putatively functional SNPs were included in a genetic association analysis with specific cognitive domains, including memory, psychomotor speed, and information processing. Cross-sectional and longitudinal designs were used to explore genetic influences on baseline cognition at diagnosis and change from baseline over the first year since diagnosis, respectively. We found a statistically significant association between genotypic variation and memory function at both baseline (NRSF: rs1105434, rs2227902 and BDNF: rs1491850, rs2030324, rs11030094) and in our longitudinal analysis (NRSF: rs2227902 and BDNF: rs12273363). Psychomotor speed was also associated with genotype (NRSF rs3796529) in the longitudinal assessment. In line with our previous work on general cognitive function in the healthy aging population, we observed an additive interaction between risk alleles for the NRSF rs2227902 (G) and BDNF rs6265 (A) polymorphisms which was again consistent with a significantly greater decline in delayed recall over the first year since diagnosis. These findings support a role for the NRSF-BDNF pathway in the modulation of cognitive function in patients with newly diagnosed epilepsy. PMID:26708060

  7. NRSF and BDNF polymorphisms as biomarkers of cognitive dysfunction in adults with newly diagnosed epilepsy.

    PubMed

    Warburton, Alix; Miyajima, Fabio; Shazadi, Kanvel; Crossley, Joanne; Johnson, Michael R; Marson, Anthony G; Baker, Gus A; Quinn, John P; Sills, Graeme J

    2016-01-01

    Cognitive dysfunction is a common comorbidity in people with epilepsy, but its causes remain unclear. It may be related to the etiology of the disorder, the consequences of seizures, or the effects of antiepileptic drug treatment. Genetics may also play a contributory role. We investigated the influence of variants in the genes encoding neuron-restrictive silencer factor (NRSF) and brain-derived neurotrophic factor (BDNF), proteins previously associated with cognition and epilepsy, on cognitive function in people with newly diagnosed epilepsy. A total of 82 patients who had previously undergone detailed neuropsychological assessment were genotyped for single nucleotide polymorphisms (SNPs) across the NRSF and BDNF genes. Putatively functional SNPs were included in a genetic association analysis with specific cognitive domains, including memory, psychomotor speed, and information processing. Cross-sectional and longitudinal designs were used to explore genetic influences on baseline cognition at diagnosis and change from baseline over the first year since diagnosis, respectively. We found a statistically significant association between genotypic variation and memory function at both baseline (NRSF: rs1105434, rs2227902 and BDNF: rs1491850, rs2030324, rs11030094) and in our longitudinal analysis (NRSF: rs2227902 and BDNF: rs12273363). Psychomotor speed was also associated with genotype (NRSF rs3796529) in the longitudinal assessment. In line with our previous work on general cognitive function in the healthy aging population, we observed an additive interaction between risk alleles for the NRSF rs2227902 (G) and BDNF rs6265 (A) polymorphisms which was again consistent with a significantly greater decline in delayed recall over the first year since diagnosis. These findings support a role for the NRSF-BDNF pathway in the modulation of cognitive function in patients with newly diagnosed epilepsy.

  8. ICU intervention during induction chemotherapy for adult patients with newly diagnosed acute myeloid leukemia.

    PubMed

    Hartsock, Bobbi; Lim, Matthew J; Roth, Christine Garcia; Raptis, Nepheli; Weber, David; Sehgal, Alison; Boyiadzis, Michael; Raptis, Anastasios; Hou, Jing-Zhou; Im, Annie; Dorritie, Kathleen; Marks, Stanley; Agha, Mounzer; Lim, Seah H

    2016-09-01

    We carried out a retrospective study on newly diagnosed AML patients to identify the risk factors associated with intensive care unit (ICU) intervention. One hundred and twenty consecutive AML patients were included. The median cycle of induction therapy (IT) was 2 (range 1-4). Ten patients (8%) needed ICU intervention during IT. The median time from first IT to ICU transfer was 16days (range 2-88days). Three patients required vasopressor/s, three mechanical ventilation, and four both. The cumulative probability for ICU intervention rose progressively with increasing cycles of IT received, from 2.5% during first induction to 27.5% at fourth induction. Age, sex, presentation white cell counts and coagulation profiles, cytogenetics, pre-chemotherapy ventricular ejection fractions, and prior chemoradiation were not risk factors. Univariate analysis identified a history of inflammatory bowel disease (IBD) (p=0.004) (RR=5.7; p=0.03) and positive blood cultures (BC) (p=0.03) (RR=3; p=0.06) as significant risks. Multivariate analysis found a history of IBD as the only significant factor (p=0.03), while positive BC (p=0.1) trending towards significance. AML patients with a history of IBD and positive BC are at increased risks for ICU intervention during IT.

  9. Stigma Reduction in Adolescents and Young Adults Newly Diagnosed with HIV: Findings from the Project ACCEPT Intervention

    PubMed Central

    Lemos, Diana; Hosek, Sybil G.

    2014-01-01

    Abstract This article describes the influence of a group-based behavioral intervention for adolescents and young adults newly diagnosed with HIV (Project ACCEPT) on four dimensions of HIV-related stigma—personalized stigma, disclosure concerns, negative self-image, and concern with public attitudes about people with HIV—as measured by the Berger HIV Stigma Scale. Stigma was addressed in a holistic manner during the intervention by providing HIV/AIDS-related information, facilitating the acquisition of coping skills, and providing contact with other youth living with HIV in order to improve social support. Fifty youth (28 male, 22 female; mean age=19.24 years) newly diagnosed with HIV from four geographically diverse clinics participated in a one-group pretest-posttest design study whereby they received the intervention over a 12-week period, and completed assessments at baseline, post-intervention, and 3-month follow-up. Results from the combined sample (males and females) revealed overall reductions in stigma in three dimensions: personalized stigma, disclosure concerns, and negative self-image, although only the combined-sample effects for negative self-image were maintained at 3-month follow-up. Gender-specific analyses revealed that the intervention reduced stigma for males across all four dimensions of stigma, with all effects being maintained to some degree at the 3-month follow-up. Only personalized stigma demonstrated a decrease for females, although this effect was not maintained at the 3-month follow-up; while the other three types of stigma increased at post-intervention and 3-month follow-up. Findings are discussed in terms of gender specific outcomes and the need for a different type of intervention to reduce stigma for young women. PMID:25216106

  10. Stigma reduction in adolescents and young adults newly diagnosed with HIV: findings from the Project ACCEPT intervention.

    PubMed

    Harper, Gary W; Lemos, Diana; Hosek, Sybil G

    2014-10-01

    This article describes the influence of a group-based behavioral intervention for adolescents and young adults newly diagnosed with HIV (Project ACCEPT) on four dimensions of HIV-related stigma-personalized stigma, disclosure concerns, negative self-image, and concern with public attitudes about people with HIV-as measured by the Berger HIV Stigma Scale. Stigma was addressed in a holistic manner during the intervention by providing HIV/AIDS-related information, facilitating the acquisition of coping skills, and providing contact with other youth living with HIV in order to improve social support. Fifty youth (28 male, 22 female; mean age=19.24 years) newly diagnosed with HIV from four geographically diverse clinics participated in a one-group pretest-posttest design study whereby they received the intervention over a 12-week period, and completed assessments at baseline, post-intervention, and 3-month follow-up. Results from the combined sample (males and females) revealed overall reductions in stigma in three dimensions: personalized stigma, disclosure concerns, and negative self-image, although only the combined-sample effects for negative self-image were maintained at 3-month follow-up. Gender-specific analyses revealed that the intervention reduced stigma for males across all four dimensions of stigma, with all effects being maintained to some degree at the 3-month follow-up. Only personalized stigma demonstrated a decrease for females, although this effect was not maintained at the 3-month follow-up; while the other three types of stigma increased at post-intervention and 3-month follow-up. Findings are discussed in terms of gender specific outcomes and the need for a different type of intervention to reduce stigma for young women.

  11. Newly Diagnosed: Older Adults

    MedlinePlus

    ... Video Games Video Sharing Sites Webcasts/ Webinars Widgets Wikis Follow Us on New Media Virtual Office Hours ... as you age because you may have other medical problems that require medication and treatment. You will ...

  12. Clinical activity of sequential flavopiridol, cytosine arabinoside, and mitoxantrone for adults with newly diagnosed, poor-risk acute myelogenous leukemia.

    PubMed

    Karp, Judith E; Blackford, Amanda; Smith, B Douglas; Alino, Katrina; Seung, Amy Hatfield; Bolaños-Meade, Javier; Greer, Jacqueline M; Carraway, Hetty E; Gore, Steven D; Jones, Richard J; Levis, Mark J; McDevitt, Michael A; Doyle, L Austin; Wright, John J

    2010-07-01

    Flavopiridol, a cyclin-dependent kinase inhibitor, is cytotoxic to leukemic blasts. In a Phase II study, flavopiridol 50 mg/m(2) was given by 1-h infusion daily x 3 beginning day 1 followed by 2 g/m(2)/72 h ara-C beginning day 6 and 40 mg/m(2) mitoxantrone on day 9 (FLAM) to 45 adults with newly diagnosed acute myelogenous leukemia (AML) with multiple poor-risk features. Thirty patients (67%) achieved complete remission (CR) and 4 (9%) died. Twelve (40%) received myeloablative allogeneic bone marrow transplant (BMT) in first CR. Median OS and DFS are not reached (67% alive 12.5-31 months, 58% in CR 11.4-30 months), with median follow-up 22 months. Sixteen received FLAM in CR, with median OS and DFS 9 and 13.1 months, and 36% alive at 21-31 months. Short OS and DFS correlated with adverse cytogenetics, regardless of age or treatment in CR. The addition of allogeneic BMT in CR translates into long OS and DFS in the majority of eligible patients.

  13. Efficacy of Compound Kushen Injection in Combination with Induction Chemotherapy for Treating Adult Patients Newly Diagnosed with Acute Leukemia

    PubMed Central

    Tu, Honglei; Lei, Bo; Meng, Shan; Liu, Hailing; Wei, Yongchang; He, Aili; Zhang, Wanggang

    2016-01-01

    We assessed the clinical effectiveness and safety of CKI (compound Kushen injection) plus standard induction chemotherapy for treating adult acute leukemia (AL). We randomly assigned 332 patients with newly diagnosed AL to control (n = 165, receiving DA (daunorubicin and cytarabine) or hyper-CVAD (fractionated cyclophosphamide, doxorubicin, vincristine, and dexamethasone)) or treatment (n = 167, receiving CKI and DA or hyper-CVAD) groups. Posttreatment, treatment group CD3+, CD4+, CD4+/CD8+, natural killer (NK) cell, and immunoglobulin (IgG, IgA, and IgM) levels were significantly higher than those of the control group (p < 0.05), and CD8+ levels were lower in the treatment group than in the control group (p < 0.05). Treatment group interleukin- (IL-) 4 and IL-10 levels were significantly higher compared to the control posttreatment (both p < 0.05) as were complete remission, overall response, and quality of life (QoL) improvement rates (p < 0.05). The control group had more incidences of grade 3/4 hematologic and nonhematologic toxicity (p < 0.05). Responses to induction chemotherapy, QoL improvement, and adverse events incidence between control group patients with acute myeloid leukemia and acute lymphocytic leukemia were not significantly different. CKI plus standard induction chemotherapy is effective and safe for treating AL, possibly by increasing immunologic function. PMID:27738441

  14. Screening for tuberculosis among adults newly diagnosed with HIV in sub-Saharan Africa: a cost-effectiveness analysis

    PubMed Central

    Zwerling, Alice A.; Sahu, Maitreyi; Ngwira, Lucky G.; Khundi, McEwen; Harawa, Tina; Corbett, Elizabeth L.; Chaisson, Richard E.; Dowdy, David W.

    2015-01-01

    Objective New tools, including light emitting diode (LED) fluorescence microscopy and the molecular assay Xpert MTB/RIF® offer increased sensitivity for TB in persons with HIV but come with higher costs. Using operational data from rural Malawi we explored the potential cost-effectiveness of on-demand screening for TB in low-income countries of sub-Saharan Africa. Design & Methods Costs were empirically collected in four clinics and one hospital using a micro-costing approach, through direct interview and observation from the national TB program perspective. Using decision analysis newly diagnosed persons with HIV were modeled as being screened by one of three strategies: Xpert, LED or standard of care (i.e., at the discretion of the treating physician). Results Cost-effectiveness of TB screening among persons newly diagnosed with HIV was largely determined by two factors: prevalence of active TB among patients newly diagnosed with HIV and volume of testing. In facilities screening at least 50 people with a 6.5% prevalence of TB, or at least 500 people with a 2.5% TB prevalence, screening with Xpert is likely to be cost-effective. At lower prevalence – including that observed in Malawi – LED microscopy may be the preferred strategy, whereas in settings of lower TB prevalence or small numbers of eligible patients, no screening may be reasonable (such that resources can be deployed elsewhere). Conclusions TB screening at the point of HIV diagnosis may be cost-effective in low-income countries of sub-Saharan Africa, but only if a relatively large population with high prevalence of TB can be identified for screening. PMID:26049281

  15. Valproic Acid versus Lamotrigine as First-line Monotherapy in Newly Diagnosed Idiopathic Generalized Tonic –Clonic Seizures in Adults – A Randomized Controlled Trial

    PubMed Central

    Giri, Om Prakash; Khan, Farhan Ahmad; Kumar, Narendra; Kumar, Ajay; Haque, Ataul

    2016-01-01

    Introduction Idiopathic Generalized Tonic-Clonic Seizures (GTCS) are frequently encountered in adults. Their successful control is necessary to improve the quality of life of these patients. Valproic acid is a simple branched-chain carboxylic acid and lamotrigine is a phenyltriazine derivative. Opinions differ in regards to their effectiveness in idiopathic GTCS. Aim To compare the effectiveness of valproic acid and lamotrigine in newly diagnosed adults with idiopathic generalized tonic-clonic seizures. Materials and Methods The present prospective randomized study was conducted on 60 patients suffering from idiopathic GTCS. Thirty patients received valproic acid and rest 30 patients received lamotrigine. All patients were followed regularly monthly for one year for treatment response and adverse effects. Results After 12 months follow-up, 76.67% patients taking valproic acid and 56.67% patients taking lamotrigine were seizure-free. Common adverse effects recorded were nausea, dyspepsia, headache and skin rash. Conclusion Valproic acid is more effective than lamotrigine as first-line drug in the treatment of adults with newly diagnosed idiopathic generalized tonic-clonic seizures.

  16. Valproic Acid versus Lamotrigine as First-line Monotherapy in Newly Diagnosed Idiopathic Generalized Tonic –Clonic Seizures in Adults – A Randomized Controlled Trial

    PubMed Central

    Giri, Om Prakash; Khan, Farhan Ahmad; Kumar, Narendra; Kumar, Ajay; Haque, Ataul

    2016-01-01

    Introduction Idiopathic Generalized Tonic-Clonic Seizures (GTCS) are frequently encountered in adults. Their successful control is necessary to improve the quality of life of these patients. Valproic acid is a simple branched-chain carboxylic acid and lamotrigine is a phenyltriazine derivative. Opinions differ in regards to their effectiveness in idiopathic GTCS. Aim To compare the effectiveness of valproic acid and lamotrigine in newly diagnosed adults with idiopathic generalized tonic-clonic seizures. Materials and Methods The present prospective randomized study was conducted on 60 patients suffering from idiopathic GTCS. Thirty patients received valproic acid and rest 30 patients received lamotrigine. All patients were followed regularly monthly for one year for treatment response and adverse effects. Results After 12 months follow-up, 76.67% patients taking valproic acid and 56.67% patients taking lamotrigine were seizure-free. Common adverse effects recorded were nausea, dyspepsia, headache and skin rash. Conclusion Valproic acid is more effective than lamotrigine as first-line drug in the treatment of adults with newly diagnosed idiopathic generalized tonic-clonic seizures. PMID:27630862

  17. Relationship between grip strength and newly diagnosed nonalcoholic fatty liver disease in a large-scale adult population

    PubMed Central

    Meng, Ge; Wu, Hongmei; Fang, Liyun; Li, Chunlei; Yu, Fei; Zhang, Qing; Liu, Li; Du, Huanmin; Shi, Hongbin; Xia, Yang; Guo, Xiaoyan; Liu, Xing; Bao, Xue; Su, Qian; Gu, Yeqing; Yang, Huijun; Bin Yu; Wu, Yuntang; Sun, Zhong; Niu, Kaijun

    2016-01-01

    Enhanced muscle strength is often related to improved insulin sensitivity and secretion, control of lipid metabolism, and increased secretion of myokines. These factors have emerged as important mechanisms involved in the development and progression of nonalcoholic fatty liver disease (NAFLD), implying that muscle strength may be a useful predictor for NAFLD. We aimed to assess the relationship between grip strength (GS) and NAFLD in a large-scale adult population. GS was assessed using an electronic hand-grip dynamometer, and NAFLD was diagnosed by the liver ultrasonography. Multiple logistic regression analysis was used to assess the relationship between the quartiles of GS per body weight and the prevalence of NAFLD. After adjusting for potentially confounding factors, the odds ratios (95% confidence interval) for overall NAFLD, NAFLD with normal alanine aminotransferase levels, and NAFLD with elevated alanine aminotransferase levels across the quartiles of GS were 1.00 (reference), 0.89 (0.78, 1.01), 0.77 (0.67, 0.89), and 0.67 (0.57, 0.79); 1.00 (reference), 0.91 (0.80, 1.04), 0.79 (0.68, 0.92), and 0.72 (0.61, 0.85); 1.00 (reference), 0.77 (0.61, 0.98), 0.67 (0.51, 0.86), and 0.53 (0.40, 0.71) (all P for trend < 0.01), respectively. This is the first study shows that increased GS is independently associated with lower prevalence of NAFLD. PMID:27616599

  18. Relationship between grip strength and newly diagnosed nonalcoholic fatty liver disease in a large-scale adult population.

    PubMed

    Meng, Ge; Wu, Hongmei; Fang, Liyun; Li, Chunlei; Yu, Fei; Zhang, Qing; Liu, Li; Du, Huanmin; Shi, Hongbin; Xia, Yang; Guo, Xiaoyan; Liu, Xing; Bao, Xue; Su, Qian; Gu, Yeqing; Yang, Huijun; Bin Yu; Wu, Yuntang; Sun, Zhong; Niu, Kaijun

    2016-01-01

    Enhanced muscle strength is often related to improved insulin sensitivity and secretion, control of lipid metabolism, and increased secretion of myokines. These factors have emerged as important mechanisms involved in the development and progression of nonalcoholic fatty liver disease (NAFLD), implying that muscle strength may be a useful predictor for NAFLD. We aimed to assess the relationship between grip strength (GS) and NAFLD in a large-scale adult population. GS was assessed using an electronic hand-grip dynamometer, and NAFLD was diagnosed by the liver ultrasonography. Multiple logistic regression analysis was used to assess the relationship between the quartiles of GS per body weight and the prevalence of NAFLD. After adjusting for potentially confounding factors, the odds ratios (95% confidence interval) for overall NAFLD, NAFLD with normal alanine aminotransferase levels, and NAFLD with elevated alanine aminotransferase levels across the quartiles of GS were 1.00 (reference), 0.89 (0.78, 1.01), 0.77 (0.67, 0.89), and 0.67 (0.57, 0.79); 1.00 (reference), 0.91 (0.80, 1.04), 0.79 (0.68, 0.92), and 0.72 (0.61, 0.85); 1.00 (reference), 0.77 (0.61, 0.98), 0.67 (0.51, 0.86), and 0.53 (0.40, 0.71) (all P for trend < 0.01), respectively. This is the first study shows that increased GS is independently associated with lower prevalence of NAFLD. PMID:27616599

  19. Diagnostic accuracy of a point-of-care urine test for tuberculosis screening among newly-diagnosed hiv-infected adults: a prospective, clinic-based study

    PubMed Central

    2014-01-01

    Background A rapid diagnostic test for active tuberculosis (TB) at the clinical point-of-care could expedite case detection and accelerate TB treatment initiation. We assessed the diagnostic accuracy of a rapid urine lipoarabinomannan (LAM) test for TB screening among HIV-infected adults in a TB-endemic setting. Methods We prospectively enrolled newly-diagnosed HIV-infected adults (≥18 years) at 4 outpatient clinics in Durban from Oct 2011-May 2012, excluding those on TB therapy. A physician evaluated all participants and offered CD4 cell count testing. Trained study nurses collected a sputum sample for acid-fast bacilli smear microscopy (AFB) and mycobacterial culture, and performed urine LAM testing using Determine™ TB LAM in the clinic. The presence of a band regardless of intensity on the urine LAM test was considered positive. We defined as the gold standard for active pulmonary TB a positive sputum culture for Mycobacterium tuberculosis. Diagnostic accuracy of urine LAM was assessed, alone and in combination with smear microscopy, and stratified by CD4 cell count. Results Among 342 newly-diagnosed HIV-infected participants, 190 (56%) were male, mean age was 35.6 years, and median CD4 was 182/mm3. Sixty participants had culture-positive pulmonary TB, resulting in an estimated prevalence of 17.5% (95% CI 13.7-22.0%). Forty-five (13.2%) participants were urine LAM positive. Mean time from urine specimen collection to LAM test result was 40 minutes (95% CI 34–46 minutes). Urine LAM test sensitivity was 28.3% (95% CI 17.5-41.4) overall, and 37.5% (95% CI 21.1-56.3) for those with CD4 count <100/mm3, while specificity was 90.1% (95% CI 86.0-93.3) overall, and 86.9% (95% CI 75.8-94.2) for those with CD4 < 100/mm3. When combined with sputum AFB (either test positive), sensitivity increased to 38.3% (95% CI 26.0-51.8), but specificity decreased to 85.8% (95% CI 81.1-89.7). Conclusions In this prospective, clinic-based study with trained nurses, a rapid

  20. Coffee Consumption, Newly Diagnosed Diabetes, and Other Alterations in Glucose Homeostasis: A Cross-Sectional Analysis of the Longitudinal Study of Adult Health (ELSA-Brasil)

    PubMed Central

    Yarmolinsky, James; Mueller, Noel T.; Duncan, Bruce B.; Bisi Molina, Maria del Carmen; Goulart, Alessandra C.; Schmidt, Maria Inês

    2015-01-01

    Introduction Observational studies have reported fairly consistent inverse associations between coffee consumption and risk of type 2 diabetes, but this association has been little investigated with regard to lesser degrees of hyperglycemia and other alterations in glucose homeostasis. Additionally, the association between coffee consumption and diabetes has been rarely investigated in South American populations. We examined the cross-sectional relationships of coffee intake with newly diagnosed diabetes and measures of glucose homeostasis, insulin sensitivity, and insulin secretion, in a large Brazilian cohort of middle-aged and elderly individuals. Methods We used baseline data from 12,586 participants of the Longitudinal Study of Adult Health (ELSA-Brasil). Logistic regression analyses were performed to examine associations between coffee consumption and newly diagnosed diabetes. Analysis of covariance was used to assess coffee intake in relation to two-hour glucose from an oral glucose tolerance test, fasting glucose, glycated hemoglobin, fasting and –2-hour postload insulin and measures of insulin sensitivity. Results We found an inverse association between coffee consumption and newly diagnosed diabetes, after adjusting for multiple covariates [23% and 26% lower odds of diabetes for those consuming coffee 2–3 and >3 times per day, respectively, compared to those reporting never or almost never consuming coffee, (p = .02)]. An inverse association was also found for 2-hour postload glucose [Never/almost never: 7.57 mmol/L, ≤1 time/day: 7.48 mmol/L, 2-3 times/day: 7.22 mmol/L, >3 times/day: 7.12 mol/L, p<0.0001] but not with fasting glucose concentrations (p = 0.07). Coffee was additionally associated with 2-hour postload insulin [Never/almost never: 287.2 pmol/L, ≤1 time/day: 280.1 pmol/L, 2–3 times/day: 275.3 pmol/L, >3 times/day: 262.2 pmol/L, p = 0.0005) but not with fasting insulin concentrations (p = .58). Conclusion Our present study provides

  1. CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL

    ClinicalTrials.gov

    2016-04-18

    Peripheral T-Cell Lymphoma; Angioimmunoblastic T Cell Lymphoma; ALK-negative Anaplastic Large Cell Lymphoma; Enteropathy Associated T Cell Lymphoma; Subcutaneous Panniculitis Like T Cell Lymphoma; Acute Adult T-Cell Leukemia/Lymphoma

  2. Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study.

    PubMed

    Ishida, Takashi; Jo, Tatsuro; Takemoto, Shigeki; Suzushima, Hitoshi; Uozumi, Kimiharu; Yamamoto, Kazuhito; Uike, Naokuni; Saburi, Yoshio; Nosaka, Kisato; Utsunomiya, Atae; Tobinai, Kensei; Fujiwara, Hiroshi; Ishitsuka, Kenji; Yoshida, Shinichiro; Taira, Naoya; Moriuchi, Yukiyoshi; Imada, Kazunori; Miyamoto, Toshihiro; Akinaga, Shiro; Tomonaga, Masao; Ueda, Ryuzo

    2015-06-01

    This multicentre, randomized, phase II study was conducted to examine whether the addition of mogamulizumab, a humanized anti-CC chemokine receptor 4 antibody, to mLSG15, a dose-intensified chemotherapy, further increases efficacy without compromising safety of patients with newly diagnosed aggressive adult T-cell leukaemia-lymphoma (ATL). Patients were assigned 1:1 to receive mLSG15 plus mogamulizumab or mLSG15 alone. The primary endpoint was the complete response rate (%CR); secondary endpoints included the overall response rate (ORR) and safety. The %CR and ORR in the mLSG15-plus-mogamulizumab arm (n = 29) were 52% [95% confidence interval (CI), 33-71%] and 86%, respectively; the corresponding values in the mLSG15 arm (n = 24) were 33% (95% CI, 16-55%) and 75%, respectively. Grade ≥ 3 treatment-emergent adverse events, including anaemia, thrombocytopenia, lymphopenia, leucopenia and decreased appetite, were observed more frequently (≥10% difference) in the mLSG15-plus-mogamulizumab arm. Several adverse events, including skin disorders, cytomegalovirus infection, pyrexia, hyperglycaemia and interstitial lung disease, were observed only in the mLSG15-plus-mogamulizumab arm. Although the combination strategy showed a potentially less favourable safety profile, a higher %CR was achieved, providing the basis for further investigation of this novel treatment for newly diagnosed aggressive ATL. This study was registered at ClinicalTrials.gov, identifier: NCT01173887. PMID:25733162

  3. Multi-institutional phase 2 clinical and pharmacogenomic trial of tipifarnib plus etoposide for elderly adults with newly diagnosed acute myelogenous leukemia.

    PubMed

    Karp, Judith E; Vener, Tatiana I; Raponi, Mitch; Ritchie, Ellen K; Smith, B Douglas; Gore, Steven D; Morris, Lawrence E; Feldman, Eric J; Greer, Jacqueline M; Malek, Sami; Carraway, Hetty E; Ironside, Valerie; Galkin, Steven; Levis, Mark J; McDevitt, Michael A; Roboz, Gail R; Gocke, Christopher D; Derecho, Carlo; Palma, John; Wang, Yixin; Kaufmann, Scott H; Wright, John J; Garret-Mayer, Elizabeth

    2012-01-01

    Tipifarnib (T) exhibits modest activity in elderly adults with newly diagnosed acute myelogenous leukemia (AML). Based on preclinical synergy, a phase 1 trial of T plus etoposide (E) yielded 25% complete remission (CR). We selected 2 comparable dose levels for a randomized phase 2 trial in 84 adults (age range, 70-90 years; median, 76 years) who were not candidates for conventional chemotherapy. Arm A (T 600 mg twice a day × 14 days, E 100 mg days 1-3 and 8-10) and arm B (T 400 mg twice a day × 14 days, E 200 mg days 1-3 and 8-10) yielded similar CR, but arm B had greater toxicity. Total CR was 25%, day 30 death rate 7%. A 2-gene signature of high RASGRP1 and low aprataxin (APTX) expression previously predicted for T response. Assays using blasts from a subset of 40 patients treated with T plus E on this study showed that AMLs with a RASGRP1/APTX ratio of more than 5.2 had a 78% CR rate and negative predictive value 87%. This ratio did not correlate with outcome in 41 patients treated with conventional chemotherapies. The next T-based clinical trials will test the ability of the 2-gene signature to enrich for T responders prospectively. This study is registered at www.clinicaltrials.gov as #NCT00602771.

  4. Multi-institutional phase 2 clinical and pharmacogenomic trial of tipifarnib plus etoposide for elderly adults with newly diagnosed acute myelogenous leukemia

    PubMed Central

    Vener, Tatiana I.; Raponi, Mitch; Ritchie, Ellen K.; Smith, B. Douglas; Gore, Steven D.; Morris, Lawrence E.; Feldman, Eric J.; Greer, Jacqueline M.; Malek, Sami; Carraway, Hetty E.; Ironside, Valerie; Galkin, Steven; Levis, Mark J.; McDevitt, Michael A.; Roboz, Gail R.; Gocke, Christopher D.; Derecho, Carlo; Palma, John; Wang, Yixin; Kaufmann, Scott H.; Wright, John J.; Garret-Mayer, Elizabeth

    2012-01-01

    Tipifarnib (T) exhibits modest activity in elderly adults with newly diagnosed acute myelogenous leukemia (AML). Based on preclinical synergy, a phase 1 trial of T plus etoposide (E) yielded 25% complete remission (CR). We selected 2 comparable dose levels for a randomized phase 2 trial in 84 adults (age range, 70-90 years; median, 76 years) who were not candidates for conventional chemotherapy. Arm A (T 600 mg twice a day × 14 days, E 100 mg days 1-3 and 8-10) and arm B (T 400 mg twice a day × 14 days, E 200 mg days 1-3 and 8-10) yielded similar CR, but arm B had greater toxicity. Total CR was 25%, day 30 death rate 7%. A 2-gene signature of high RASGRP1 and low aprataxin (APTX) expression previously predicted for T response. Assays using blasts from a subset of 40 patients treated with T plus E on this study showed that AMLs with a RASGRP1/APTX ratio of more than 5.2 had a 78% CR rate and negative predictive value 87%. This ratio did not correlate with outcome in 41 patients treated with conventional chemotherapies. The next T-based clinical trials will test the ability of the 2-gene signature to enrich for T responders prospectively. This study is registered at www.clinicaltrials.gov as #NCT00602771. PMID:22001391

  5. Children in an adult world: a phenomenological study of adults and their childhood experiences of being hospitalised with newly diagnosed type 1 diabetes.

    PubMed

    Ekra, Else Mari Ruberg; Blaaka, Gunnhild; Korsvold, Tora; Gjengedal, Eva

    2012-12-01

    Hospital conditions for children have changed dramatically over the last decades. Until recently, hospitalised children were left without their parents in an environment that was not adapted to children. In the period 1950-1980, hospitalised children did not have a voice. The aim of this Norwegian study was to use adult memories of childhood hospitalisation to investigate the influences of the hospital environment on the experiences of children. The study had a qualitative design and used a hermeneutic phenomenological approach. Twelve adults who were 5½ to 12 years old when they were first hospitalised with type 1 diabetes were interviewed. The participants described their hospital stays as representing a life in an adult world. They encountered an unfamiliar place where it was challenging to be abandoned in an adult hospital community with a serious and exhausting illness. The results underscore the need to incorporate children's perspectives to achieve a 'child friendly' environment in the hospital. Thirty years later there still may be a tension between the adults' responsibility to protect children and the children's own right to participation in decision-making. To understand current practices, it is important to know our historical past.

  6. Disseminated cutaneous histoplasmosis in newly diagnosed HIV

    PubMed Central

    Soza, Gabriela M.; Patel, Mahir; Readinger, Allison

    2016-01-01

    We present a woman with a widespread severe papulopustular eruption, fever, and fatigue of 5 weeks' duration. HIV infection was diagnosed, with an absolute CD4+ count of 3 cells/µL. The eruption was consistent with disseminated cutaneous histoplasmosis. The clinical manifestations and management of cutaneous histoplasmosis are reviewed. PMID:26722169

  7. Prevalence of thyroid dysfunction and its correlation with CD4 count in newly-diagnosed HIV-positive adults--a cross-sectional study.

    PubMed

    Dev, Nishanth; Sahoo, Ratnakar; Kulshreshtha, Bindu; Gadpayle, A K; Sharma, S C

    2015-11-01

    Prevalence of subclinical hypothyroidism in HIV-positive patients is reported to be high in those with severe immune deficiency. However, there is paucity of literature in newly-diagnosed HIV-positive population. Our aim was to estimate the prevalence of thyroid dysfunction and study its correlation with CD4 count in this population. In this cross-sectional study, patients presenting to the antiretroviral therapy clinic were screened with thyroid function tests, including thyroid stimulating hormone, free triiodothyronine, free thyroxine, and anti-thyroid peroxidase antibody levels at the time of diagnosis. Two hundred and twenty-five HIV-positive and an equal number of healthy volunteers were enrolled. The mean (SD) CD4 count in the study group was 147.1 (84) and 70.7% had advanced immune deficiency with CD4 count <200 cells/µL. The overall prevalence of thyroid dysfunction was 75.5% in the study group and 16% in the control group. Subclinical hypothyroidism was the commonest abnormality noted in almost 53%. Significant correlation was observed between CD4 count and thyroid stimulating hormone, free triiodothyronine, and free thyroxine levels (r = -0.86, r = 0.77, and r = 0.84, respectively, p < 0.0001 for all). The present study demonstrated high prevalence of thyroid dysfunction in HIV-positive patients. The dysfunction is subclinical in most cases and correlates well with declining CD4 counts.

  8. Prevalence of thyroid dysfunction and its correlation with CD4 count in newly-diagnosed HIV-positive adults--a cross-sectional study.

    PubMed

    Dev, Nishanth; Sahoo, Ratnakar; Kulshreshtha, Bindu; Gadpayle, A K; Sharma, S C

    2015-11-01

    Prevalence of subclinical hypothyroidism in HIV-positive patients is reported to be high in those with severe immune deficiency. However, there is paucity of literature in newly-diagnosed HIV-positive population. Our aim was to estimate the prevalence of thyroid dysfunction and study its correlation with CD4 count in this population. In this cross-sectional study, patients presenting to the antiretroviral therapy clinic were screened with thyroid function tests, including thyroid stimulating hormone, free triiodothyronine, free thyroxine, and anti-thyroid peroxidase antibody levels at the time of diagnosis. Two hundred and twenty-five HIV-positive and an equal number of healthy volunteers were enrolled. The mean (SD) CD4 count in the study group was 147.1 (84) and 70.7% had advanced immune deficiency with CD4 count <200 cells/µL. The overall prevalence of thyroid dysfunction was 75.5% in the study group and 16% in the control group. Subclinical hypothyroidism was the commonest abnormality noted in almost 53%. Significant correlation was observed between CD4 count and thyroid stimulating hormone, free triiodothyronine, and free thyroxine levels (r = -0.86, r = 0.77, and r = 0.84, respectively, p < 0.0001 for all). The present study demonstrated high prevalence of thyroid dysfunction in HIV-positive patients. The dysfunction is subclinical in most cases and correlates well with declining CD4 counts. PMID:25505045

  9. Low 25(OH) Vitamin D3 Levels Are Associated with Adverse Outcome in Newly-Diagnosed Intensively-Treated Adult Acute Myeloid Leukemia Patients

    PubMed Central

    Lee, Hun Ju; Muindi, Josephia R.; Tan, Wei; Hu, Qiang; Wang, Dan; Liu, Song; Wilding, Gregory E.; Ford, Laurie A.; Sait, Sheila N.J.; Block, Annemarie W.; Adjei, Araba A.; Barcos, Maurice; Griffiths, Elizabeth A; Thompson, James E.; Wang, Eunice S.; Johnson, Candace S; Trump, Donald L.; Wetzler, Meir

    2013-01-01

    Background Several studies suggest that low 25(OH) vitamin D3 levels may be prognostic in some malignancies, but no studies have evaluated their impact on treatment outcome in acute myeloid leukemia (AML). Methods VD levels were evaluated in 97 consecutive newly diagnosed, intensively-treated AML patients. MicroRNA-expression profiles and single nucleotide polymorphisms (SNPs) in the 25(OH) vitamin D3 pathway genes were evaluated and correlated with 25(OH) vitamin D3 levels and treatment outcome. Results Thirty-four (35%) patients had normal 25(OH) vitamin D3 levels (32–100 ng/ml), 34 (35%) insufficient (20–31.9 ng/ml) and 29 (30%) deficient levels (<20 ng/ml). Insufficient/deficient 25(OH) vitamin D3 levels were associated with worse relapse-free survival (RFS) compared to normal vitamin D3 levels. In multivariate analyses, deficient 25(OH) vitamin D3, smoking, European LeukemiaNet Genetic Groups and white blood cell count retained their statistical significance for RFS. A number of microRNAs and SNPs were found to be associated with 25(OH) vitamin D3 level, although none remained significant after multiple test corrections; one 25(OH) vitamin D3 receptor SNP, rs10783219, was associated with lower complete remission rate (p=0.0442), shorter RFS (p=0.0058) and overall survival (p=0.0011). Conclusions It remains to be determined what role microRNA and SNP profiles play in contributing to low 25(OH) vitamin D3 level and/or outcome and whether supplementation will improve AML outcome. PMID:24166051

  10. Outcome and molecular characteristics of adolescent and young adult patients with newly diagnosed primary glioblastoma: a study of the Society of Austrian Neurooncology (SANO)

    PubMed Central

    Leibetseder, Annette; Ackerl, Michael; Flechl, Birgit; Wöhrer, Adelheid; Widhalm, Georg; Dieckmann, Karin; Kreinecker, Sabine-Spiegl; Pichler, Josef; Hainfellner, Johannes; Preusser, Matthias; Marosi, Christine

    2013-01-01

    Background Young age is a favorable prognostic factor for patients with glioblastoma multiforme (GBM). We reviewed the outcomes and molecular tumor characteristics of adolescent and young adult patients with GBM treated in 2 Austrian centers. Patients and Methods Data on patients with histologically proven primary GBM diagnosed from 18 through 40 years of age were retrospectively analyzed. All patients were treated with standard first-line therapy. The primary end points were overall survival (OS) and time to progression (TTP). IDH1-R132H mutation status was analyzed using immunohistochemistry, and MGMT promoter methylation was assessed using methylation-specific polymerase chain reaction. Results We included 70 patients (36 men and 34 women) with a median age of 33 years. IDH1-R132H mutations were detected in 22 (39.3%) of 56 cases and MGMT promoter methylation in 33 (61.1%) of 54 cases with available tissue samples. In patients with wild-type IDH, median TTP was 8.2 months and median OS was 24 months, compared with 18 months and 44 months, respectively, observed in patients with mutated IDH. Neither IDH1 nor MGMT status showed a statistically significant association with TTP or OS. Of note, the social and economical situation of the young patients with GBM was alarming, because only 17% succeeded in staying employed after receiving the diagnosis. Conclusions We found a high frequency of IDH1 mutations and MGMT promoter methylation among young adult patients with primary GBM that may contribute to the generally favorable outcome associated with young age. The social and economic coverage of patients with glioma remains an unsolved socio-ethical problem. PMID:23223340

  11. Death Concerns among Individuals Newly Diagnosed with Lung Cancer

    ERIC Educational Resources Information Center

    Lehto, Rebecca; Therrien, Barbara

    2010-01-01

    Confronting the reality of death is an important challenge for individuals facing life-threatening illness such as lung cancer, the leading cause of cancer death. Few studies, however, document the nature of death-related concerns in individuals newly diagnosed with lung cancer. The aims of this exploratory study were to examine unsolicited…

  12. Increased gluconeogenesis in youth with newly diagnosed type 2 diabetes

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The role of increased gluconeogenesis as an important contributor to fasting hyperglycaemia at diabetes onset is not known. We evaluated the contribution of gluconeogenesis and glycogenolysis to fasting hyperglycaemia in newly diagnosed youths with type 2 diabetes following an overnight fast. Basal ...

  13. Chemoradiotherapy of Newly Diagnosed Glioblastoma With Intensified Temozolomide

    SciTech Connect

    Weiler, Markus; Hartmann, Christian; Wiewrodt, Dorothee; Herrlinger, Ulrich

    2010-07-01

    Purpose: To evaluate the toxicity and efficacy of chemoradiotherapy with temozolomide (TMZ) administered in an intensified 1-week on/1-week off schedule plus indomethacin in patients with newly diagnosed glioblastoma. Patients and Methods: A total of 41 adult patients (median Karnofsky performance status, 90%; median age, 56 years) were treated with preirradiation TMZ at 150 mg/m{sup 2} (1 week on/1 week off), involved-field radiotherapy combined with concomitant low-dose TMZ (50 mg/m{sup 2}), maintenance TMZ starting at 150 mg/m{sup 2} using a 1-week on/1-week off schedule, plus maintenance indomethacin (25 mg twice daily). Results: The median follow-up interval was 21.7 months. Grade 4 hematologic toxicity was observed in 15 patients (36.6%). Treatment-related nonhematologic Grade 4-5 toxicity was reported for 2 patients (4.9%). The median progression-free survival was 7.6 months (95% confidence interval, 6.2-10.4). The 1-year survival rate was 73.2% (95% confidence interval, 56.8-84.2%). The presence of O{sup 6}-methylguanine-DNA methyltransferase (MGMT) gene promoter methylation in the tumor tissue was associated with significantly superior progression-free survival. Conclusion: The dose-dense regimen of TMZ administered in a 1-week on/1-week off schedule resulted in acceptable nonhematologic toxicity. Compared with data from the European Organization for Research and Treatment of Cancer/National Cancer Institute of Canada trial 26981-22981/CE.3, patients with an unmethylated MGMT gene promoter appeared not to benefit from intensifying the TMZ schedule regarding the median progression-free survival and overall survival. In contrast, data are promising for patients with a methylated MGMT promoter.

  14. Phase 2 study of the efficacy and safety of the combination of arsenic trioxide, interferon alpha, and zidovudine in newly diagnosed chronic adult T-cell leukemia/lymphoma (ATL).

    PubMed

    Kchour, Ghada; Tarhini, Mahdi; Kooshyar, Mohamad-Mehdi; El Hajj, Hiba; Wattel, Eric; Mahmoudi, Mahmoud; Hatoum, Hassan; Rahimi, Hossein; Maleki, Masoud; Rafatpanah, Houshang; Rezaee, S A Rahim; Yazdi, Mojtaba Tabatabaei; Shirdel, Abbas; de Thé, Hugues; Hermine, Olivier; Farid, Reza; Bazarbachi, Ali

    2009-06-25

    Adult T-cell leukemia/lymphoma (ATL) is resistant to chemotherapy and carries a dismal prognosis particularly for the acute and lymphoma subtypes. Promising results were obtained with the combination of zidovudine and interferon-alpha. Chronic ATL has a relatively better outcome, but poor long-term survival is noted when patients are managed with a watchful-waiting policy or with chemotherapy. In ATL cell lines, arsenic trioxide shuts off constitutive NF-kappaB activation and potentiates interferon-alpha apoptotic effects through proteasomal degradation of Tax. Clinically, arsenic/interferon therapy exhibits some efficacy in refractory aggressive ATL patients. These results prompted us to investigate the efficacy and safety of the combination of arsenic, interferon-alpha, and zidovudine in 10 newly diagnosed chronic ATL patients. An impressive 100% response rate was observed including 7 complete remissions, 2 complete remissions but with more than 5% circulating atypical lymphocytes, and 1 partial response. Responses were rapid and no relapse was noted. Side effects were moderate and mostly hematologic. In conclusion, treatment of chronic ATL with arsenic, interferon-alpha, and zidovudine is feasible and exhibits an impressive response rate with moderate toxicity. Long-term follow up will clarify whether this will translate to disease cure. Overall, these clinical results strengthen the concept of oncogene-targeted cancer therapy.

  15. Anxiety and the Newly Returned Adult Student

    ERIC Educational Resources Information Center

    Cleary, Michelle Navarre

    2012-01-01

    Based on interviews with students who had recently returned to school, this essay demonstrates the need for, challenges of, and ways to respond to the writing anxiety many adults bring with them back to school. Jessica and Sam were two of twenty-five newly returned adult students whom the author spent over sixty hours interviewing in the fall of…

  16. Inverse Association of Serum Docosahexaenoic Acid With Newly Diagnosed Hypertension

    PubMed Central

    Yang, Bo; Ding, Fang; Wang, Feng-Lei; Yu, Wei; Li, Duo

    2016-01-01

    Abstract Observational studies on circulating fatty acid (FA) and primary prevention of hypertension have yielded inconsistent results, and the association among the Chinese population is not fully clear. The aim of the study was to discern important FAs that can discriminate hypertensive patients from normotensive persons, and investigate associations between the important FAs and risk of hypertension. We conducted a case-control study nested within a community-based cohort of 2447 Chinese participants aged 35 to 79 years who completed a baseline assessment between October 2012 and April 2013. In all, 480 patients with newly diagnosed hypertension were identified at baseline and 480 normotensive individuals were randomly selected as matched normotensive controls. Controls were individually matched to cases by age (±2 y), sex, and recruitment center, with a 1:1 case-to-control ratio. Serum FA profile was compared between cases and controls by orthogonal partial least squares-discriminant analyses. Odds ratio (OR) with 95% confidence interval (CI) for newly diagnosed hypertension was estimated by a conditional logistical analysis. After adjustment for body mass index, education, profession, family history of hypertension, salt intake, heart rate, blood lipids, and fasting glucose levels, serum FA profile in hypertensive patients was typically characterized by higher 16:0 and 16:1n-7, and lower 18:2n-6 and 22:6n-3, compared with normotensive controls. Docosahexaenoic acid (22:6n-3) and palmitoleic acid (16:1n-7) were identified as the important FA contributing most to the intergroup separations. When comparing the highest and lowest quartile of FA composition, newly diagnosed hypertension was negatively associated with 22:6n-3 (OR 0.65; 95% CI, 0.45–0.93; P for trend = 0.02), but positively associated with 16:1n-7 (OR 2.14; 95% CI, 1.46–3.12; P for trend < 0.001). The associations remained pronounced after multiple adjustments and in further stratified

  17. Chemotherapy in newly diagnosed primary central nervous system lymphoma

    PubMed Central

    Hashemi-Sadraei, Nooshin; Peereboom, David M.

    2010-01-01

    Primary central nervous system lymphoma (PCNSL) accounts for only 3% of brain tumors. It can involve the brain parenchyma, leptomeninges, eyes and the spinal cord. Unlike systemic lymphoma, durable remissions remain uncommon. Although phase III trials in this rare disease are difficult to perform, many phase II trials have attempted to define standards of care. Treatment modalities for patients with newly diagnosed PCNSL include radiation and/or chemotherapy. While the role of radiation therapy for initial management of PCNSL is controversial, clinical trials will attempt to improve the therapeutic index of this modality. Routes of chemotherapy administration include intravenous, intraocular, intraventricular or intra-arterial. Multiple trials have outlined different methotrexate-based chemotherapy regimens and have used local techniques to improve drug delivery. A major challenge in the management of patients with PCNSL remains the delivery of aggressive treatment with preservation of neurocognitive function. Because PCNSL is rare, it is important to perform multicenter clinical trials and to incorporate detailed measurements of long-term toxicities. In this review we focus on different chemotherapeutic approaches for immunocompetent patients with newly diagnosed PCNSL and discuss the role of local drug delivery in addition to systemic therapy. We also address the neurocognitive toxicity of treatment. PMID:21789140

  18. Early cardiovascular abnormalities in newly diagnosed obstructive sleep apnea

    PubMed Central

    Baguet, Jean-Philippe; Nadra, Marie; Barone-Rochette, Gilles; Ormezzano, Olivier; Pierre, Hélène; Pépin, Jean-Louis

    2009-01-01

    Obstructive sleep apnea (OSA) is associated with high cardiovascular morbidity and mortality. Recent studies have shown that it is associated with atherosclerosis and left ventricular dysfunction markers. The aim of this study was to assess the cardiovascular effects of OSA depending on its severity, in patients without clinically diagnosed cardiovascular disease. One hundred thirty newly diagnosed, nondiabetic OSA patients (mean age 49 ± 10 years), without vasoactive treatment were included. They underwent clinical and ambulatory blood pressure measurements, echocardiography, carotid ultrasound examination, and a carotid–femoral pulse wave velocity (PWV) measurement. Seventy-five percent of the subjects were hypertensive according to the clinical or ambulatory measurement. More patients with the most severe forms (respiratory disturbance index >37/hour) had a nondipper profile (52% vs 34%; P = 0.025) and their left ventricular mass was higher (40 ± 7 vs 36 ± 8 g/m, p = 0.014). This last parameter was independently and inversely associated with mean nocturnal oxygen saturation (P = 0.004). PWV and carotid intima-media thickness did not differ between one OSA severity group to another, but the prevalence of carotid hypertrophy was higher when mean SaO2 was below 93.5% (29.5 vs 16%; P = 0.05). Our study shows that in OSA patients without clinically diagnosed cardiovascular disease, there is a significant left ventricular and arterial effect, which is even more marked when OSA is severe. PMID:20057899

  19. Ocular manifestation of lymphoma in newly diagnosed cats.

    PubMed

    Nerschbach, V; Eule, J C; Eberle, N; Höinghaus, R; Betz, D

    2016-03-01

    Ocular manifestations of lymphoma are described in humans and dogs but rarely in cats. In this prospective study, cats with newly diagnosed and treatment-naïve lymphoma were evaluated concerning clinical stage and ophthalmologic findings. Twenty-six cats were included. In 12 cats (48%), ocular changes were documented. Uveitis anterior and posterior were predominant findings, being present in 58% of affected individuals. Other findings included exophthalmos, corneal surface lesions and chemosis. Eight cats received chemotherapy, two of which had ocular involvement. In these two cats, a complete remission of an anterior and a partial remission of a posterior uveitis were documented. Due to the detection of ocular involvement, a stage migration from stage IV to V occurred in four patients. In the light of these findings, an opthalmological examination may be considered as an important part of staging in feline lymphoma as well as of follow-up examination in affected cats.

  20. Importance of circulating tumor cells in newly diagnosed colorectal cancer.

    PubMed

    van Dalum, Guus; Stam, Gerrit-Jan; Scholten, Loes F A; Mastboom, Walter J B; Vermes, Istvan; Tibbe, Arjan G J; De Groot, Marco R; Terstappen, Leon W M M

    2015-03-01

    Presence of circulating tumor cells (CTC) is associated with poor prognosis in patients with metastatic colorectal cancer (CRC). The present study was conducted to determine if the presence of CTC prior to surgery and during follow‑up in patients with newly diagnosed non-metastatic CRC can identify patients at risk for disease recurrence. In a prospective single center study 183 patients with newly diagnosed non-disseminated CRC, scheduled for surgery, were enrolled and followed-up for a median of 5.1 years. CTC were enumerated with the CellSearch system in 4 aliquots of 7.5 ml of blood before surgery and at several time-points during follow-up after surgery. The results showed that ≥1 CTC/30 ml of blood were detected in 44 (24%) patients before surgery. Patients with CTC before surgery had a significant decrease in recurrence-free survival (RFS, log-rank test p=0.014) and colon cancer related survival (CCRS, p=0.002). The 5-year RFS dropped from 75 to 61% and the 5-year CCRS from 83 to 69% for patients with CTC before surgery. The presence of CTC and positive lymph nodes remained significant factors in multivariate analysis for recurrence-free survival (RFS). Surprisingly, the presence of CTC weeks after surgery was not significantly associated with RFS and CCRD whereas CTC 2-3 years after surgery was again significantly associated with RFS and CCRD. The presence of CTC in patients with stage I-III CRC before surgery is associated with a significant reduction in RFS and CCRS. These findings suggest a role of CTC detection to assess which patients need adjuvant treatment.

  1. Increased gluconeogenesis in youth with newly diagnosed type 2 diabetes

    PubMed Central

    Chung, Stephanie T.; Hsia, Daniel S.; Chacko, Shaji K.; Rodriguez, Luisa M.; Haymond, Morey W.

    2014-01-01

    Aims/hypothesis The role of increased gluconeogenesis as an important contributor to fasting hyperglycaemia at diabetes onset is not known. We evaluated the contribution of gluconeogenesis and glycogenolysis to fasting hyperglycaemia in newly diagnosed youths with type 2 diabetes following an overnight fast. Methods Basal rates (μmol kgFFM−1 min−1) of gluconeogenesis (2H20), glycogenolysis and glycerol production ([2H5] glycerol) were measured in 18 adolescents (nine treatment naive diabetic and nine normal-glucose-tolerant obese adolescents). Results Type 2 diabetes was associated with higher gluconeogenesis (9.2±0.6 vs 7.0±0.3 μmol kgFFM−1 min−1, p < 0.01), plasma fasting glucose (7.0±0.6 vs 5.0±0.2 mmol/l, p = 0.004) and insulin (300±30 vs 126±31 pmol/l, p = 0.001). Glucose production and glycogenolysis were similar between the groups (15.4±0.3 vs 12.4±1.4 μmol kgFFM−1 min−1, p = 0.06; and 6.2±0.8 vs 5.3±0.7 μmol kgFFM−1 min−1, p = 0.5, respectively). After controlling for differences in adiposity, gluconeogenesis, glycogenolysis and glucose production were higher in diabetic youth (p ≤ 0.02). Glycerol concentration (84±6 vs 57±6 μmol/l, p = 0.01) and glycerol production (5.0±0.3 vs 3.6±0.5 μmol kgFFM−1 min−1, p =0.03) were 40% higher in youth with diabetes. The increased glycerol production could account for only ~1/3 of substrate needed for the increased gluconeogenesis in diabetic youth. Conclusion/interpretations Increased gluconeogenesis was a major contributor to fasting hyperglycaemia and hepatic insulin resistance in newly diagnosed untreated adolescents and was an early pathological feature of type 2 diabetes. Increased glycerol availability may represent a significant source of new carbon substrates for increased gluconeogenesis but would not account for all the carbons required to sustain the increased rates. PMID:25447079

  2. Frequency of Ketoacidosis in Newly Diagnosed Type 1 Diabetic Children

    PubMed Central

    Razavi, Zahra

    2010-01-01

    Objectives Diabetic ketoacidosis (DKA) is the leading cause of morbidity and mortality in children with type 1 diabetes mellitus (TIDM). Many patients with newly diagnosed type 1 diabetes present with DKA. The aim of this study is to determine the frequency and the clinical presentation of diabetic ketoacidosis at the diagnosis of type 1 diabetes mellitus in youths in hamadan, Western Province of Iran. Methods The Clinical and laboratory data of a total of 200 patients under 19 years of age with newly diagnosed type 1 diabetes mellitus between 1995-2005 were retrospectively reviewed. Statistical analysis was performed using SPSS 11. Results 48 (24%)of the children were presented in a state of ketoacidosis. Sever form of DKA (pH≤7.2) was observed in 54.5% of patients. The mean age at diagnosis was 7.3±5.15 years in DKA group and 8.59±3.07 in non-DKA group (p=0.22). 60.4% of patient with DKA were female whereas in the non-DKA group, 53.3% of patients were female, the difference was not significant (p=0.38). The duration of symptoms before diagnosis was 14.84±8.19 days in patients with DKA and 22.39±2.27 in the non-DKA group, (p=0.11). No significant difference was found between the age, sex and duration of the symptoms and occurance of DKA. Polydipsia (85.4) polyuria (83.3%), weakness (68.8%) and abdominal pain (52.1%) were the most frequently notified symptoms among the patients. In two cases, diagnosis of DKA was preceded by as appendicitis and the patient underwent appendectomy. Conclusion Frequency of DKA at onset of type 1 diabetes mellitus was significant in the studied region. However, it was lower than other regions in Asia. Polydipsia, polyuria, fatigue and abdominal pain were the most common symptoms on presentation. PMID:22125712

  3. Human Immunodeficiency Virus Infection Newly Diagnosed at Autopsy in New York City, 2008-2012.

    PubMed

    Ramaswamy, Chitra; Ellman, Tanya M; Myers, Julie; Madsen, Ann; Sepkowitz, Kent; Shepard, Colin

    2015-12-01

    Background.  Studying the most extreme example of late diagnosis, new HIV diagnoses after death, may be instructive to HIV testing efforts. Using the results of routine HIV testing of autopsies performed by the Office of Chief Medical Examiner (OCME), we identified new HIV diagnoses after death in New York City (NYC) from 2008 to 2012. Methods.  Population-based registries for HIV and deaths were linked to identify decedents not known to be HIV-infected before death. Multivariable logistic regression models were constructed to determine correlates of a new HIV diagnosis after death among all persons newly diagnosed with HIV and among all HIV-infected decedents receiving an OCME autopsy. Results.  Of 264 893 deaths, 24 426 (9.2%) were autopsied by the NYC OCME. Of these, 1623 (6.6%) were infected with HIV, including 142 (8.8%) with a new HIV diagnosis at autopsy. This represents 0.8% (142 of 18 542) of all new HIV diagnoses during the 5-year period. Decedents newly diagnosed with HIV at OCME autopsy were predominantly male (73.9%), aged 13-64 years (85.9%), non-white (85.2%), unmarried (81.7%), less than college educated (83.8%), and residents of an impoverished neighborhood (62.0%). Of all HIV-infected OCME decedents aged ≥65 years (n = 71), 22.0% were diagnosed at autopsy. The strongest independent correlate of new HIV diagnosis at autopsy in both multivariable models was age ≥65 years. Conclusions.  Human immunodeficiency virus diagnoses first made after death are rare, but, when observed, these diagnoses are more commonly found among persons ≥65 years, suggesting that despite highly visible efforts to promote HIV testing community-wide, timely diagnosis among older adults living in impoverished, high-prevalence neighborhoods may require additional strategies. PMID:26566538

  4. Psychosocial problems among newly diagnosed rheumatoid arthritis patients.

    PubMed

    Gåfvels, C; Hägerström, M; Nordmark, B; Wändell, P E

    2012-03-01

    We identified patients with newly diagnosed rheumatoid arthritis (RA) in the ages 18-65 years who needed psychosocial interventions. A total of 123 patients (90 women) were asked to participate, but 19 declined and 4 dropped out early in the study, leaving a total of 100 patients (75 women) in the sample. Questionnaires used were the Epidemiological Investigation on Rheumatoid Arthritis study questionnaire, the Hospital Anxiety and Depression Scale, the Sense of Coherence (SOC) scale, and the General Coping Questionnaire. Interviews showed that 46% of the included 100 patients had psychosocial problems (PSP). One third of them had problems directly related to RA. The rest had problems with their life situation in general, without or reinforced by RA. Compared to patients without psychosocial problems, PSP patients lived in more strained social situations, especially regarding personal finances and social support. More of the PSP patients were anxious, showed lower SOC scores, and also used more emotion-based coping strategies (resignation, protest, isolation and intrusion) and less problem-oriented (minimization). They also had higher scores on depression and more frequently expected that RA would negatively affect their future. PSP patients also experienced a more negative impact of the disease, a finding not confirmed by the sickness activity score judged by the rheumatologist. Thus, early in the course of RA, screening instruments should be used to identify PSP patients. Psychosocial treatment and support by medical social workers skilled in RA care should be offered. PMID:22089162

  5. Anterior pituitary function in patients with newly diagnosed rheumatoid arthritis.

    PubMed

    Templ, E; Koeller, M; Riedl, M; Wagner, O; Graninger, W; Luger, A

    1996-04-01

    Hormonal dysfunction involving the hypothalamic-pituitary-adrenal (HPA) axis, prolactin (PRL) secretion and sex hormone status has been supposed to contribute to the development or persistence of rheumatoid arthritis (RA). In addition, a reduced number of glucocorticoid receptors on circulating lymphocytes has been found in patients with RA. However, so far most studies have been performed in pre-treated patients. A combined test for total anterior pituitary reserve was performed in 10 patients with newly diagnosed untreated RA. Before and after stimulation with the respective hypothalamic releasing hormones, RA patients showed no difference in plasma concentrations of adrenocorticotrophic hormone (ACTH), cortisol, prolactin (PRL) and thyroid-stimulating hormone (TSH) when compared to healthy controls. In contrast, the growth hormone (GH) response to growth hormone-releasing hormone (GHRH) was blunted in RA patients. The hypothalamic-pituitary-thyroid/gonadal and adrenal axes seem to be unaltered in RA. However, if one considers the presence of chronic inflammation, normal plasma ACTH and cortisol concentrations must be considered as inappropriately low. The observed blunted GH release could be mediated by cytokines (e.g. IL-1), which are known to be elevated in RA.

  6. Current management of newly diagnosed acute promyelocytic leukemia.

    PubMed

    Cicconi, L; Lo-Coco, F

    2016-08-01

    The management of acute promyelocytic leukemia (APL) has considerably evolved during the past two decades. The advent of all-trans retinoic acid (ATRA) and its inclusion in combinatorial regimens with anthracycline chemotherapy has provided cure rates exceeding 80%; however, this widely adopted approach also conveys significant toxicity including severe myelosuppression and rare occurrence of secondary leukemias. More recently, the advent of arsenic trioxide (ATO) and its use in association with ATRA with or without chemotherapy has further improved patient outcome by allowing to minimize the intensity of chemotherapy, thus reducing serious toxicity while maintaining high anti-leukemic efficacy. The advantage of ATRA-ATO over ATRA chemotherapy has been recently demonstrated in two large randomized trials and this option has now become the new standard of care in low-risk (i.e. non-hyperleukocytic) patients. In light of its rarity, abrupt onset and high risk of early death and due to specific treatment requirements, APL remains a challenging condition that needs to be managed in highly experienced centers. We review here the results of large clinical studies conducted in newly diagnosed APL as well as the recommendations for appropriate diagnosis, prevention and management of the main complications associated with modern treatment of the disease. PMID:27084953

  7. Time perspective and weight management behaviors in newly diagnosed Type 2 diabetes: a mediational analysis.

    PubMed

    Hall, Peter A; Fong, Geoffrey T; Cheng, Alice Y

    2012-12-01

    The primary objective of the current study was to examine the extent to which domain-specific time perspective predicts weight management behaviors (dietary behavior and physical activity) among those newly diagnosed with Type 2 diabetes. A secondary objective was to test potential mediators of the hypothesized effect (behavioral intention, self-efficacy and control beliefs). A total of 204 adults newly diagnosed (≤6 months) with Type 2 diabetes participated in the study, which included a baseline assessment of domain-general and domain-specific time perspective, as well as strength of intention to perform two weight-management behaviors (dietary choice and physical activity); both weight-management behaviors were assessed again at 6 month follow-up. Hierarchical multiple regression analyses revealed a prospective association between domain-specific time perspective and uptake of weight management behaviors. Individuals with newly diagnosed T2DM possessing a future-oriented time perspective reported making less frequent fatty food choices and greater increases in physical activity over the 6-month follow-up interval. These effects were selectively mediated by intention strength, and not competing social cognitive variables. For both behaviors, the total effects and meditational models were robust to adjustments for demographics, body composition and disease variables. A future-oriented time perspective is prospectively associated with superior uptake of weight management behaviors among those with newly diagnosed Type 2 diabetes. The facilitating effect of future-oriented thinking appears to occur via enhanced strength of intentions to perform weight management behaviors.

  8. Time perspective and weight management behaviors in newly diagnosed Type 2 diabetes: a mediational analysis.

    PubMed

    Hall, Peter A; Fong, Geoffrey T; Cheng, Alice Y

    2012-12-01

    The primary objective of the current study was to examine the extent to which domain-specific time perspective predicts weight management behaviors (dietary behavior and physical activity) among those newly diagnosed with Type 2 diabetes. A secondary objective was to test potential mediators of the hypothesized effect (behavioral intention, self-efficacy and control beliefs). A total of 204 adults newly diagnosed (≤6 months) with Type 2 diabetes participated in the study, which included a baseline assessment of domain-general and domain-specific time perspective, as well as strength of intention to perform two weight-management behaviors (dietary choice and physical activity); both weight-management behaviors were assessed again at 6 month follow-up. Hierarchical multiple regression analyses revealed a prospective association between domain-specific time perspective and uptake of weight management behaviors. Individuals with newly diagnosed T2DM possessing a future-oriented time perspective reported making less frequent fatty food choices and greater increases in physical activity over the 6-month follow-up interval. These effects were selectively mediated by intention strength, and not competing social cognitive variables. For both behaviors, the total effects and meditational models were robust to adjustments for demographics, body composition and disease variables. A future-oriented time perspective is prospectively associated with superior uptake of weight management behaviors among those with newly diagnosed Type 2 diabetes. The facilitating effect of future-oriented thinking appears to occur via enhanced strength of intentions to perform weight management behaviors. PMID:22105339

  9. Lamotrigine monotherapy for newly diagnosed typical absence seizures in children☆

    PubMed Central

    Holmes, Gregory L.; Frank, L. Matthew; Sheth, Raj D.; Philbrook, Bryan; Wooten, John D.; Vuong, Alain; Kerls, Susan; Hammer, Anne E.; Messenheimer, John

    2008-01-01

    Summary Purpose To evaluate the efficacy, tolerability, and effects on behavior and psychosocial functioning of lamotrigine monotherapy in children with newly diagnosed typical absence seizures. Patients and methods Children meeting enrollment criteria (n = 54) received a confirmatory 24-h ambulatory electroencephalogram (EEG) and then entered a Escalation Phase of up to 20-weeks during which lamotrigine was titrated until seizures were controlled or maximum dose (10.2 mg/kg) was reached. Seizure freedom was assessed by diary review and clinic hyperventilation (clinic HV) and then confirmed by EEG with hyperventilation (HV/EEG). Patients who maintained seizure freedom for two consecutive weekly visits were entered into the Maintenance Phase (n = 30). Diary, clinic HV, and HV/EEG data were supplemented with 24-h ambulatory EEG at baseline and the ends of the Escalation and Maintenance Phases. Health outcome assessments were completed at screening and at the end of the Maintenance Phase. Results By the end of the Escalation Phase, seizure-free rates (responders) were 59% by seizure diary (n = 51), 56% by HV/EEG (n = 54) (primary endpoint), and 49% by 24-h ambulatory EEG (n = 49). During the Maintenance Phase, 89% (week 24) and 86% (week 32) remained seizure free by diary (n = 28), 78% by clinic HV (n = 27), and 81% by 24-h ambulatory EEG (n = 26). Seizure freedom was first observed beginning at the fifth week of the Escalation Phase. The most frequent adverse events were headache and cough. Health outcome scores were either improved or unchanged at the end of the Maintenance Phase. Conclusions Lamotrigine monotherapy results in complete seizure freedom in a substantial number of children with typical absence seizures. Lamotrigine was well tolerated in this study. PMID:18778916

  10. Health care charges for youth with newly diagnosed epilepsy

    PubMed Central

    McGrady, Meghan E.; Guilfoyle, Shanna M.; Junger, Katherine; Arnett, Alex D.; Modi, Avani C.

    2015-01-01

    Objectives: To estimate first-year health care charges for youth with newly diagnosed epilepsy seen within an interdisciplinary pediatric epilepsy team and examine demographic, clinical, and psychosocial predictors of annual charges. Methods: Retrospective chart review was conducted to extract medical, hospital, and physician billing data from the year following an epilepsy diagnosis for 258 patients (aged 2–18 years) seen in a New Onset Seizure Clinic between July 2011 and December 2012. Descriptive statistics were used to estimate per-patient total first-year charges and health care utilization patterns (e.g., hospitalizations, emergency department visits, outpatient visits). Univariate analyses examined differences in health care charges between demographic, clinical, and psychosocial factors. Predictors of health care charges were examined using hierarchical multiple regression analysis. Results: The estimated per-patient total first-year health care charge was $20,084 (95% confidence interval [CI] $16,491–$23,677). Charges were higher for patients who reported having seizures since diagnosis ($25,509; 95% CI $20,162–$30,856) and were associated with more antiepileptic drug side effects (r = 0.18; 95% CI 0.03–0.32). Controlling for demographic and clinical factors, poorer baseline health-related quality of life was associated with higher per-patient health care charges (B = −445.40; 95% CI −865 to −25). Conclusions: The economic impact of pediatric epilepsy in the year following diagnosis is substantial. Cost reduction efforts would be optimized by improving seizure control and targeting health-related quality of life, an outcome amenable to behavioral intervention. PMID:26163432

  11. Cilengitide in newly diagnosed glioblastoma: biomarker expression and outcome

    PubMed Central

    Weller, Michael; Nabors, Louis Burt; Gorlia, Thierry; Leske, Henning; Rushing, Elisabeth; Bady, Pierre; Hicking, Christine; Perry, James; Hong, Yong-Kil; Roth, Patrick; Wick, Wolfgang; Goodman, Simon L.; Hegi, Monika E.; Picard, Martin; Moch, Holger; Straub, Josef; Stupp, Roger

    2016-01-01

    Integrins αvβ3 and αvβ5 regulate angiogenesis and invasiveness in cancer, potentially by modulating activation of the transforming growth factor (TGF)-β pathway. The randomized phase III CENTRIC and phase II CORE trials explored the integrin inhibitor cilengitide in patients with newly diagnosed glioblastoma with versus without O6-methylguanine DNA methyltransferase (MGMT) promoter methylation. These trials failed to meet their primary endpoints. Immunohistochemistry was used to assess the levels of the target integrins of cilengitide, αvβ3 and αvβ5 integrins, of αvβ8 and of their putative target, phosphorylation of SMAD2, in tumor tissues from CENTRIC (n=274) and CORE (n=224). αvβ3 and αvβ5 expression correlated well in tumor and endothelial cells, but showed little association with αvβ8 or pSMAD2 levels. In CENTRIC, there was no interaction between the biomarkers and treatment for prediction of outcome. In CORE, higher αvβ3 levels in tumor cells were associated with improved progression-free survival by central review and with improved overall survival in patients treated with cilengitide. Integrins αvβ3, αvβ5 and αvβ8 are differentially expressed in glioblastoma. Integrin levels do not correlate with the activation level of the canonical TGF-β pathway. αvβ3 integrin expression may predict benefit from integrin inhibition in patients with glioblastoma lacking MGMT promoter methylation. PMID:26918452

  12. Left ventricular diastolic dysfunction in newly diagnosed untreated hypertensive patients.

    PubMed

    Fici, Francesco; Ural, Dilek; Tayfun, Sahin; Kozdag, Guliz; Facchetti, Rita; Brambilla, Gianmaria; Dell'oro, Raffaella; Grassi, Guido; Mancia, Giuseppe

    2012-12-01

    Essential hypertension is characterized by a left ventricular dysfunction. However, the majority of the studies performed so far investigated patients under drug treatment and/or with concomitant diseases, such as obesity, diabetes, metabolic syndrome or coronary heart disease, which per se may affect diastolic function independently on the blood pressure elevation. The present study aimed at investigating left ventricular diastolic function in untreated, uncomplicated and newly diagnosed hypertensive patients by employing both routine echo-Doppler and pulse tissue-Doppler technique. Data were collected in 86 middle-aged essential hypertensive patients and in 18 sex-matched normotensive controls. At the echo-Doppler approach, about half of the hypertensive patients displayed a diastolic dysfunction (n = 44, E/A: 0.79 ± 0.02). They showed body mass index values slightly greater than hypertensive patients without diastolic dysfunction but superimposable blood pressure values and metabolic variables. When assessed via the pulse tissue-Doppler approach, patients with a reduced E/A displayed an Em/Am ratio significantly lower than patients without diastolic dysfunction and control subjects. This was the case when the data were related to the lateral and septal mitral annulus or averaged together. Furthermore, whereas myocardial systolic peak velocity (Sm) was lower in hypertensive patients than in control subjects, no significant between-groups difference in E/Em ratio was observed. Differently from the data obtained via the echo-Doppler approach, the tissue-Doppler method in patients without diastolic dysfunction showed a significant higher deceleration and isovolumetric relaxation times, with a lower Em velocity compared with the normotensive subjects. At the stepwise multiple regression analysis E/A ratio and E'/A' values were related with left ventricular mass index and body mass index after correction for age. These data provide evidence that diastolic

  13. Total therapy with tandem transplants for newly diagnosed multiple myeloma.

    PubMed

    Barlogie, B; Jagannath, S; Desikan, K R; Mattox, S; Vesole, D; Siegel, D; Tricot, G; Munshi, N; Fassas, A; Singhal, S; Mehta, J; Anaissie, E; Dhodapkar, D; Naucke, S; Cromer, J; Sawyer, J; Epstein, J; Spoon, D; Ayers, D; Cheson, B; Crowley, J

    1999-01-01

    . CR duration was significantly longer with early onset of CR and favorable karyotypes. Time-dependent covariate analysis suggested that timely application of a second transplant extended both EFS and OS significantly, independent of cytogenetics and beta-2-microglobulin. Total Therapy represents a comprehensive treatment approach for newly diagnosed myeloma patients, using multi-regimen induction and tandem transplantation followed by interferon maintenance. As a result, the proportion of patients attaining CR increased progressively with continuing therapy. This observation is particularly important because CR is a sine qua non for long-term disease control and, eventually, cure.

  14. Objectively assessed physical activity and lower limb function and prospective associations with mortality and newly diagnosed disease in UK older adults: an OPAL four-year follow-up study

    PubMed Central

    Fox, Kenneth R.; Ku, Po-Wen; Hillsdon, Melvyn; Davis, Mark G.; Simmonds, Bethany A. J.; Thompson, Janice L.; Stathi, Afroditi; Gray, Selena F.; Sharp, Deborah J.; Coulson, Joanne C.

    2015-01-01

    Background: objective measures of physical activity and function with a diverse cohort of UK adults in their 70s and 80s were used to investigate relative risk of all-cause mortality and diagnoses of new diseases over a 4-year period. Participants: two hundred and forty older adults were randomly recruited from 12 general practices in urban and suburban areas of a city in the United Kingdom. Follow-up included 213 of the baseline sample. Methods: socio-demographic variables, height and weight, and self-reported diagnosed diseases were recorded at baseline. Seven-day accelerometry was used to assess total physical activity, moderate-to-vigorous activity and sedentary time. A log recorded trips from home. Lower limb function was assessed using the Short Physical Performance Battery. Medical records were accessed on average 50 months post baseline, when new diseases and deaths were recorded. Analyses: ANOVAs were used to assess socio-demographic, physical activity and lower limb function group differences in diseases at baseline and new diseases during follow-up. Regression models were constructed to assess the prospective associations between physical activity and function with mortality and new disease. Results: for every 1,000 steps walked per day, the risk of mortality was 36% lower (hazard ratios 0.64, 95% confidence interval (CI) 0.44–0.91, P = 0.013). Low levels of moderate-to-vigorous physical activity (incident rate ratio (IRR) 1.67, 95% CI 1.04–2.68, P = 0.030) and low frequency of trips from home (IRR 1.41, 95% CI 0.98–2.05, P = 0.045) were associated with diagnoses of more new diseases. Conclusion: physical activity should be supported for adults in their 70s and 80s, as it is associated with reduced risk of mortality and new disease development. PMID:25377744

  15. Prospective Study of Posttraumatic Stress Disorder in Parents of Children with Newly Diagnosed Type 1 Diabetes.

    ERIC Educational Resources Information Center

    Landolt, Markus A.; Vollrath, Margarete; Laimbacher, Joseph; Gnehm, Hanspeter E.; Sennhauser, Felix H.

    2005-01-01

    Objective: To determine the prevalence, course, and predictors of posttraumatic stress disorder (PTSD) in mothers and fathers of children with newly diagnosed type 1 diabetes. Method: Forty-nine mothers and 48 fathers of 52 children (response rate 65%) with newly diagnosed diabetes (age 6.5-15 years) were assessed at 6 weeks, 6 months, and 12…

  16. Serum vitamin D levels in children with newly diagnosed and chronic immune thrombocytopenia.

    PubMed

    Čulić, Srđana; Markić, Joško; Petrović, Davor; Konjevoda, Paško; Pavelić, Jasminka

    2016-04-01

    The primary objective of the study was to assess the vitamin D (VD) status of patients suffering from ITP. Children from the case cohort (total 21) were recruited from chronic ITP patients (followed as outpatients) and newly diagnosed ITP (prospective study) patients. VD deficiency (values <75 nmol/L) was detected in 11 patients with newly diagnosed ITP, and seven patients with chronic ITP. Only three patients with newly diagnosed, and none with chronic ITP had normal VD values. Newly diagnosed ITP patients had statistically significantly higher values (P <.044) of VD than the patients with chronic type of ITP. Platelets values did not follow VD level. VD deficiency is very common in children with either newly diagnosed or chronic ITP form. Therefore there is a utility supplementing VD in these patients. To investigate the role of VD as an immune modulating drug for patients with ITP, a prospective randomized placebo-controlled trial needs to be performed. PMID:27312171

  17. Treatment of Newly Diagnosed and Recurrent Childhood Brain Tumors

    MedlinePlus

    ... before the cancer is diagnosed and continue for months or years. Childhood brain and spinal cord tumors ... after treatment. Some cancer treatments cause side effects months or years after treatment has ended. These are ...

  18. Prevalence and characteristics of the metabolic syndrome among newly diagnosed hypertensive patients

    PubMed Central

    Osuji, Charles U.; Omejua, Emeka G.

    2012-01-01

    Background: Cardiovascular disease risk factors have a tendency to cluster. The presence of such a cluster in an individual has been designated the metabolic syndrome (MetS). There is a paucity of reports of the prevalence of MetS in hypertensive patients in south east Nigeria. This study was undertaken to determine the prevalence of the metabolic syndrome (MetS) among newly diagnosed hypertensive patients using the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria in a tertiary healthcare centre in South East Nigeria. Materials and Methods: A population of 250 consecutive newly diagnosed adult hypertensive patients (126 males and 124 females) was evaluated. Blood pressure and anthropometric measurements were done using standardized techniques. After an overnight fast, blood samples were taken for glucose and lipid profile assays. The NCEP ATP III criteria were then applied for the diagnosis of MetS. Results: The prevalence of the MetS among the study population was 31.2%. The sex-specific prevalences were 15.1% and 47.6% among male and female patients respectively. A large number of the patients (40.4%) were at a high potential risk of developing the MetS as they already met 2 of the criteria. The MetS prevalence increased progressively from 14.3% through 23.8%, in the patients aged 24-33years and 34-43 years, respectively to a peak (40.4%) among those aged 44-53 years before declining in those aged 54-63 years (31.8%), 64-73 years (33.3%) and 74 years and above (20.6%). Central obesity was the most common component of the MetS being present in 50.4% of patients (28.6% of males and 72.6% of females). Of the other components, low HDL-C was present in 38.8% (26.2% of males and 51.6% of females), elevated FBS in 12.8% (6.3% of males and 19.4% of females) and elevated triglycerides in 8.8% (11.9% of males and 5.6% of females). Conclusion: The prevalence of the MetS is high among newly diagnosed hypertensive patients in Nnewi

  19. Evaluating the Acceptability and Feasibility of Project ACCEPT: An Intervention for Youth Newly Diagnosed with HIV

    ERIC Educational Resources Information Center

    Hosek, Sybil G.; Lemos, Diana; Harper, Gary W.; Telander, Kyle

    2011-01-01

    Given the potential for negative psychosocial and medical outcomes following an HIV diagnosis, Project ACCEPT, a 12-session behavioral intervention, was developed and pilot-tested for youth (aged 16-24) newly diagnosed with HIV. Fifty participants recently diagnosed with HIV were enrolled from 4 sites selected through the Adolescent Medicine…

  20. Insulin oedema in a child with newly diagnosed diabetes mellitus.

    PubMed

    Aravamudhan, Avinash; Gardner, Chris; Smith, Claire; Senniappan, Senthil

    2014-05-01

    Insulin oedema is a rare complication of insulin therapy for diabetes mellitus. It has been reported in type 1 diabetes mellitus, in poorly controlled type 2 diabetes mellitus following either the initiation or intensification of insulin therapy and in underweight patients on large doses of insulin. There are only a few case reports since it was first described in 1928, showing that it is an uncommon and probably an under-reported complication. The majority of those reports have been in the adult population. The generalised oedema tends to develop shortly after initiation or intensification of insulin therapy and resolves spontaneously within few weeks. We present one of the youngest patients reported in the literature, a 9-year-old boy who developed insulin oedema within few days of presenting with diabetic ketoacidosis. The case highlights the importance of recognising this generally transient and self-resolving complication and differentiating it from other serious causes of oedema.

  1. Syphilitic periostitis in a newly diagnosed HIV-positive man.

    PubMed

    Coyne, K; Browne, R; Anagnostopoulos, C; Nwokolo, N

    2006-06-01

    A 36-year-old man presented for an HIV test, which answered positive. He gave a six-week history of headache and fever. His syphilis serology was also positive with a Venereal Disease Research Laboratory (VDRL) titre of 1:32, and positive Treponema pallidum particle agglutination (TPPA) assay and fluorescent treponemal antibody (FTA). When he attended for treatment of the syphilis, he had developed severe pain in both lower limbs. Plain radiographs were normal. An isotope bone scan showed multiple areas of increased uptake, consistent with syphilitic periostitis. Some of these lesions were asymptomatic. He was treated with benzathine penicillin and his pain resolved. The bone scan had normalized after six months. We review the previous literature regarding syphilitic bone pain and periostitis. We discuss the importance of considering syphilis in the differential diagnosis of any sexually active adult presenting with bone pain, and highlight the usefulness of isotope bone scans in clarifying the clinical picture.

  2. Phase I Study of Vandetanib With Radiotherapy and Temozolomide for Newly Diagnosed Glioblastoma

    SciTech Connect

    Drappatz, Jan; Norden, Andrew D.; Wong, Eric T.

    2010-09-01

    Purpose: Increasing evidence has suggested that angiogenesis inhibition might potentiate the effects of radiotherapy and chemotherapy in patients with glioblastoma (GBM). In addition, epidermal growth factor receptor inhibition might be of therapeutic benefit, because the epidermal growth factor receptor is upregulated in GBM and contributes to radiation resistance. We conducted a Phase I study of vandetanib, an inhibitor of vascular endothelial growth factor receptor 2 and epidermal growth factor receptor, in patients with newly diagnosed GBM combined with RT and temozolomide (TMZ). Methods and Materials: A total of 13 GBM patients were treated with vandetanib, radiotherapy, and concurrent and adjuvant TMZ, using a standard '3 + 3' dose escalation. The maximal tolerated dose was defined as the dose with <1 of 6 dose-limiting toxicities during the first 12 weeks of therapy. The eligible patients were adults with newly diagnosed GBM, Karnofsky performance status of {>=}60, normal organ function, who were not taking enzyme-inducing antiepileptic drugs. Results: Of the 13 patients, 6 were treated with vandetanib at a dose of 200mg daily. Of the 6 patients, 3 developed dose-limiting toxicities within the first 12 weeks, including gastrointestinal hemorrhage and thrombocytopenia in 1 patient, neutropenia in 1 patient, and diverticulitis with gastrointestinal perforation in 1 patient. The other 7 patients were treated with 100 mg daily, with no dose-limiting toxicities observed, establishing this dose as the maximal tolerated dose combined with TMZ and RT. Conclusion: Vandetanib can be safely combined with RT and TMZ in GBM patients. A Phase II study in which patients are randomized to vandetanib 100 mg daily with RT and TMZ or RT and TMZ alone is underway.

  3. Vitamin and Mineral Deficiencies Are Highly Prevalent in Newly Diagnosed Celiac Disease Patients

    PubMed Central

    Wierdsma, Nicolette J.; van Bokhorst-de van der Schueren, Marian A. E.; Berkenpas, Marijke; Mulder, Chris J. J.; van Bodegraven, Ad A.

    2013-01-01

    Malabsorption, weight loss and vitamin/mineral-deficiencies characterize classical celiac disease (CD). This study aimed to assess the nutritional and vitamin/mineral status of current “early diagnosed” untreated adult CD-patients in the Netherlands. Newly diagnosed adult CD-patients were included (n = 80, 42.8 ± 15.1 years) and a comparable sample of 24 healthy Dutch subjects was added to compare vitamin concentrations. Nutritional status and serum concentrations of folic acid, vitamin A, B6, B12, and (25-hydroxy) D, zinc, haemoglobin (Hb) and ferritin were determined (before prescribing gluten free diet). Almost all CD-patients (87%) had at least one value below the lower limit of reference. Specifically, for vitamin A, 7.5% of patients showed deficient levels, for vitamin B6 14.5%, folic acid 20%, and vitamin B12 19%. Likewise, zinc deficiency was observed in 67% of the CD-patients, 46% had decreased iron storage, and 32% had anaemia. Overall, 17% were malnourished (>10% undesired weight loss), 22% of the women were underweight (Body Mass Index (BMI) < 18.5), and 29% of the patients were overweight (BMI > 25). Vitamin deficiencies were barely seen in healthy controls, with the exception of vitamin B12. Vitamin/mineral deficiencies were counter-intuitively not associated with a (higher) grade of histological intestinal damage or (impaired) nutritional status. In conclusion, vitamin/mineral deficiencies are still common in newly “early diagnosed” CD-patients, even though the prevalence of obesity at initial diagnosis is rising. Extensive nutritional assessments seem warranted to guide nutritional advices and follow-up in CD treatment. PMID:24084055

  4. Newly Diagnosed

    MedlinePlus

    ... Video Games Video Sharing Sites Webcasts/ Webinars Widgets Wikis Follow Us on New Media Virtual Office Hours ... is good news: by getting linked to HIV medical care early, starting antiretroviral therapy (ART), adhering to ...

  5. Anti-neutrophil cell antibodies in newly diagnosed patients with type-1-diabetes.

    PubMed

    Parlapiano, C; Marangi, M; Campana, E; Giovanniello, T; Pantone, P; Suraci, C; Sanguigni, S

    1999-01-01

    Both anti neutrophil cell antibodies and anti endothelial cell antibodies were found in 7 out of 30 newly-diagnosed type-1 diabetic patients. This confirms the abnormal activation of the immunological system in the early stage of type-1 diabetes mellitus. PMID:10482047

  6. Inverse association of plasma vanadium levels with newly diagnosed type 2 diabetes in a Chinese population.

    PubMed

    Wang, Xia; Sun, Taoping; Liu, Jun; Shan, Zhilei; Jin, Yilin; Chen, Sijing; Bao, Wei; Hu, Frank B; Liu, Liegang

    2014-08-15

    Vanadium compounds have been proposed to have beneficial effects on the pathogenesis and complications of type 2 diabetes. Our objective was to evaluate the association between plasma vanadium levels and type 2 diabetes. We performed a case-control study involving 1,598 Chinese subjects with or without newly diagnosed type 2 diabetes (December 2004-December 2007). Cases and controls were frequency-matched by age and sex. Plasma vanadium concentrations were measured and compared between groups. Analyses showed that plasma vanadium concentrations were significantly lower in cases with newly diagnosed type 2 diabetes than in controls (P = 0.001). Mean plasma vanadium levels in participants with and without diabetes were 1.0 μg/L and 1.2 μg/L, respectively. Participants in the highest quartile of plasma vanadium concentration had a notably lower risk of newly diagnosed type 2 diabetes (odds ratio = 0.26, 95% confidence interval: 0.19, 0.35; P < 0.001), compared with persons in the lowest quartile. The trend remained significant after adjustment for known risk factors and in further stratification analyses. Our results suggested that plasma vanadium concentrations were inversely associated with newly diagnosed type 2 diabetes in this Chinese population.

  7. Brief report: the length of newly diagnosed Barrett's esophagus may be decreasing.

    PubMed

    Nguyen, T; Alsarraj, A; El-Serag, H B

    2015-07-01

    Few studies have examined the temporal trends of length in newly diagnosed Barrett's esophagus (BE) and arrived at conflicting results. The aim of this study was to identify whether there has been a change over time in the length of BE at the time of diagnosis. This is a retrospective, single-center, observational study from Houston, Texas on newly diagnosed BE between 2008 and 2013. All cases were defined by the presence of endoscopically visible BE and histologic confirmation of intestinalized columnar epithelium with goblet cells. The length of BE was measured using the Prague classification. We examined temporal changes in 1-year intervals in the length of BE at the time of diagnosis. Both the frequency and mean length of BE at diagnosis seemed to decrease over time from February 2008 to July 2013. The proportion of patients diagnosed with BE ≥3 cm per year declined during the study period, while the proportion of patients with BE ≥1 and <3 cm increased, and those with <1 cm remained stable. The mean age and the gender of patients diagnosed with BE ≥3 cm did not differ significantly by BE length or year of diagnosis. The mean length of newly diagnosed BE may be decreasing as a result of a decline in BE ≥3 cm. These observations cannot be explained by changes in age and gender.

  8. CPAP Adherence in Patients with Newly Diagnosed Obstructive Sleep Apnea prior to Elective Surgery

    PubMed Central

    Guralnick, Amy S.; Pant, Melissa; Minhaj, Mohammed; Sweitzer, Bobbie Jean; Mokhlesi, Babak

    2012-01-01

    Background: Obstructive sleep apnea (OSA) is prevalent in the surgical population, and it has been suggested that preoperative patients should be screened and treated for OSA. However, it remains unclear whether patients diagnosed with OSA in the preoperative period adhere to prescribed CPAP therapy. Objective: Our aim was to objectively quantify CPAP adherence, investigate predictors of poor CPAP adherence, and to establish an optimal CPAP setting in a cohort of presurgical patients diagnosed with OSA as part of the preoperative work-up. Methods: In a retrospective observational study, we collected data on all adult presurgical patients seen by the Anesthesia Perioperative Medicine Clinic (APMC) who screened positive for OSA on the STOP-Bang questionnaire and underwent an in-laboratory diagnostic polysomnogram (PSG) before surgery. CPAP was offered to patients with moderate or severe OSA. Objective CPAP adherence was recorded during the perioperative period. Factors associated with reduced CPAP adherence were delineated. Patient characteristics were compared between those with STOP-Bang scores of 3-4 and those with higher scores (STOP-Bang score ≥ 5). Results: During a 2-year period, 431 patients were referred and 211 patients completed a PSG. CPAP therapy was required in 65% of patients, and the optimal level was 9 ± 2 cm H2O. Objective CPAP adherence was available in 75% of patients who received CPAP therapy; median adherence was 2.5 h per night, without any significant difference between the STOP-Bang subgroups. African American race, male gender, and depressive symptomatology were independent predictors of reduced CPAP adherence. Severe OSA was significantly more prevalent in patients with a STOP-Bang score ≥ 5 than those whose score was 3-4 (55.1% versus 34.4%, p = 0.005). However, optimum CPAP pressure levels and adherence to therapy did not differ between the 2 STOP-Bang groups. Conclusions: Adherence to prescribed CPAP therapy during the perioperative

  9. Delivering the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cost effectiveness analysis

    PubMed Central

    Dallosso, H M; Dixon, S; Brennan, A; Carey, M E; Campbell, M J; Heller, S; Khunti, K; Skinner, T C; Davies, M J

    2010-01-01

    Objectives To assess the long term clinical and cost effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) intervention compared with usual care in people with newly diagnosed type 2 diabetes. Design We undertook a cost-utility analysis that used data from a 12 month, multicentre, cluster randomised controlled trial and, using the Sheffield type 2 diabetes model, modelled long term outcomes in terms of use of therapies, incidence of complications, mortality, and associated effect on costs and health related quality of life. A further cost-utility analysis was also conducted using current “real world” costs of delivering the intervention estimated for a hypothetical primary care trust. Setting Primary care trusts in the United Kingdom. Participants Patients with newly diagnosed type 2 diabetes. Intervention A six hour structured group education programme delivered in the community by two professional healthcare educators. Main outcome measures Incremental costs and quality adjusted life years (QALYs) gained. Results On the basis of the data in the trial, the estimated mean incremental lifetime cost per person receiving the DESMOND intervention is £209 (95% confidence interval −£704 to £1137; €251, −€844 to €1363; $326, −$1098 to $1773), the incremental gain in QALYs per person is 0.0392 (−0.0813 to 0.1786), and the mean incremental cost per QALY is £5387. Using “real world” intervention costs, the lifetime incremental cost of the DESMOND intervention is £82 (−£831 to £1010) and the mean incremental cost per QALY gained is £2092. A probabilistic sensitivity analysis indicated that the likelihood that the DESMOND programme is cost effective at a threshold of £20 000 per QALY is 66% using trial based intervention costs and 70% using “real world” costs. Results from a one way sensitivity analysis suggest that the DESMOND intervention is cost effective even under more modest

  10. Initial choice of therapy among plenty for newly diagnosed chronic myeloid leukemia.

    PubMed

    Marin, David

    2012-01-01

    Imatinib has been the preferred initial therapy for newly diagnosed chronic myeloid leukemia patients for the past 10 years. Recently, other, possibly better, tyrosine kinase inhibitors have been licensed for first-line use based on the early results of 2 large, randomized clinical trials. The pros and cons of the various alternatives to imatinib are analyzed herein, and I try to answer the question of are we ready to abandon imatinib and, if yes, then what treatment should a patient diagnosed today receive.

  11. Disseminated Trichosporon inkin and Histoplasma capsulatum in a patient with newly diagnosed AIDS.

    PubMed

    David, Consuelo; Martin, Donna Bilu; Deng, April; Cooper, Jennifer Z

    2008-08-01

    Histoplasma capsulatum and Trichosporon inkin may cause disseminated disease in immunocompromised patients. Disseminated T inkin, the causative agent of white piedra, is rare and difficult to diagnose. We report the case of a 28 year-old man with newly diagnosed HIV infection who developed asymptomatic lesions on his trunk and extremities. Histology demonstrated perivascular and intravascular budding yeasts. Blood cultures revealed fungal organisms that were difficult to culture. Specimens were positive for H capsulatum (confirmed by DNA probe) and T inkin. Compared with disseminated histoplasmosis, disseminated Trichosporon is relatively uncommon. Physicians should be aware of this agent in immunocompromised hosts.

  12. Randomised, controlled study of intratumoral recombinant gamma-interferon treatment in newly diagnosed glioblastoma.

    PubMed Central

    Färkkilä, M.; Jääskeläinen, J.; Kallio, M.; Blomstedt, G.; Raininko, R.; Virkkunen, P.; Paetau, A.; Sarelin, H.; Mäntylä, M.

    1994-01-01

    The effect of intratumoral recombinant interferon gamma (rIFN-gamma) as adjuvant to open cytoreduction and external irradiation of 60 Gy on survival in adults with a newly diagnosed high-grade cerebral glioma was studied. The patients were randomised during surgery into the rIFN-gamma group (n = 14) or the control group (n = 17), and the latter received a subcutaneous reservoir of rIFN-gamma injections. Intratumoral rIFN-gamma was given three times a week for 4 weeks until radiotherapy, escalating the dose from 5 micrograms to 50 micrograms. Both groups received external whole-brain irradiation of 40 Gy and a local boost of 20 Gy. After radiotherapy, rIFN-gamma was continued with 50 micrograms twice a week up to 9 weeks. The patients received no chemotherapy. Intratumoral rIFN-gamma was tolerated well with transient fever only. There were 12 glioblastomas (GBs) in the control group and nine in the rIFN-gamma group with completed irradiation. The patients were followed clinically and by computerised tomography (CT) every third month until death. Tumour responses were seen in three interferon-treated (one still alive 45 months after operation) and in two conventionally treated patients. The progression of the tumour volumes on CT did not differ between the IFN-treated and control groups. There were no differences in the survival times. Median survival of the rIFN-gamma-treated patients was 54 weeks (95% CI 35-68) and of the control patients 55 weeks (95% CI 41-77). Intratumoral rIFN-gamma given in the study doses does not seem to inhibit tumour growth or improve the prognosis of patients with high-grade glioma. PMID:8018525

  13. Two-year outcomes of patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF

    PubMed Central

    Bassand, Jean-Pierre; Accetta, Gabriele; Camm, Alan John; Cools, Frank; Fitzmaurice, David A.; Fox, Keith A.A.; Goldhaber, Samuel Z.; Goto, Shinya; Haas, Sylvia; Hacke, Werner; Kayani, Gloria; Mantovani, Lorenzo G.; Misselwitz, Frank; ten Cate, Hugo; Turpie, Alexander G.G.; Verheugt, Freek W.A.; Kakkar, Ajay K.

    2016-01-01

    Aims The relationship between outcomes and time after diagnosis for patients with non-valvular atrial fibrillation (NVAF) is poorly defined, especially beyond the first year. Methods and results GARFIELD-AF is an ongoing, global observational study of adults with newly diagnosed NVAF. Two-year outcomes of 17 162 patients prospectively enrolled in GARFIELD-AF were analysed in light of baseline characteristics, risk profiles for stroke/systemic embolism (SE), and antithrombotic therapy. The mean (standard deviation) age was 69.8 (11.4) years, 43.8% were women, and the mean CHA2DS2-VASc score was 3.3 (1.6); 60.8% of patients were prescribed anticoagulant therapy with/without antiplatelet (AP) therapy, 27.4% AP monotherapy, and 11.8% no antithrombotic therapy. At 2-year follow-up, all-cause mortality, stroke/SE, and major bleeding had occurred at a rate (95% confidence interval) of 3.83 (3.62; 4.05), 1.25 (1.13; 1.38), and 0.70 (0.62; 0.81) per 100 person-years, respectively. Rates for all three major events were highest during the first 4 months. Congestive heart failure, acute coronary syndromes, sudden/unwitnessed death, malignancy, respiratory failure, and infection/sepsis accounted for 65% of all known causes of death and strokes for <10%. Anticoagulant treatment was associated with a 35% lower risk of death. Conclusion The most frequent of the three major outcome measures was death, whose most common causes are not known to be significantly influenced by anticoagulation. This suggests that a more comprehensive approach to the management of NVAF may be needed to improve outcome. This could include, in addition to anticoagulation, interventions targeting modifiable, cause-specific risk factors for death. Clinical Trial Registration http://www.clinicaltrials.gov. Unique identifier: NCT01090362. PMID:27357359

  14. Treatment of newly diagnosed malignant glioma in the elderly people: new trials that impact therapy.

    PubMed

    Chamberlain, M C

    2013-12-01

    Glioblastoma (GB), World Health Organization Grade 4 glioma, is the most common malignant primary brain tumour with an annual incidence of 12,943 cases in the United States . It is a tumour of the elderly people with a median age of onset of 64 years, although children and young adults are also affected. GB is associated with a poor prognosis; despite best treatment, most community-based patients will not survive 1 year . Cures are rare and overall survival rates at 2 and 5 years are 26-48% and 12%, respectively, in highly selected, contemporary, clinical trial eligible patients . For protocol eligible US patients, the median survival is 16-17 months, which is partly a reflection of improved supportive care, recognition of pseudoprogression, exclusion of patients undergoing biopsy only and availability of bevacizumab at recurrence . Initial treatment for patients with high performance [Karnofsky Performance Status (KPS) > 60 and age < 71 years) consists of maximal safe surgical resection followed by adjuvant focal, external beam radiotherapy (RT) with concurrent temozolomide (TMZ) chemotherapy and post-RT TMZ for 6 months . TMZ and carmustine (BCNU) biodegradable wafer (Gliadel) are the only adjuvant chemotherapies that have improved survival in randomised GB clinical trials . The current standard treatment is based upon a European Organization for Research and Treatment of Cancer (EORTC) and National Cancer Institute of Canada (NCIC) randomised, phase 3 trial of 573 patients with newly diagnosed GB (age 19-71 years and World Health Organization Performance Status ≤ 2) that compared RT alone [total dose 60 Gray (Gy)] to TMZ chemotherapy in combination with RT (total 60 Gy), followed by 6 months of post-RT TMZ (4,6,8).

  15. Nilotinib combined with multiagent chemotherapy for newly diagnosed Philadelphia-positive acute lymphoblastic leukemia.

    PubMed

    Kim, Dae-Young; Joo, Young-Don; Lim, Sung-Nam; Kim, Sung-Doo; Lee, Jung-Hee; Lee, Je-Hwan; Kim, Dong Hwan Dennis; Kim, Kihyun; Jung, Chul Won; Kim, Inho; Yoon, Sung-Soo; Park, Seonyang; Ahn, Jae-Sook; Yang, Deok-Hwan; Lee, Je-Jung; Lee, Ho-Sup; Kim, Yang Soo; Mun, Yeung-Chul; Kim, Hawk; Park, Jae Hoo; Moon, Joon Ho; Sohn, Sang Kyun; Lee, Sang Min; Lee, Won Sik; Kim, Kyoung Ha; Won, Jong-Ho; Hyun, Myung Soo; Park, Jinny; Lee, Jae Hoon; Shin, Ho-Jin; Chung, Joo-Seop; Lee, Hyewon; Eom, Hyeon-Seok; Lee, Gyeong Won; Cho, Young-Uk; Jang, Seongsoo; Park, Chan-Jeoung; Chi, Hyun-Sook; Lee, Kyoo-Hyung

    2015-08-01

    We investigated the effects of nilotinib plus multiagent chemotherapy, followed by consolidation/maintenance or allogeneic hematopoietic cell transplantation (allo-HCT) for adult patients with newly diagnosed Philadelphia-positive (Ph-pos) acute lymphoblastic leukemia (ALL). Study subjects received induction treatment that comprised concurrent vincristine, daunorubicin, prednisolone, and nilotinib. After achieving complete hematologic remission (HCR), subjects received either 5 courses of consolidation, followed by 2-year maintenance with nilotinib, or allo-HCT. Minimal residual disease (MRD) was assessed at HCR, and every 3 months thereafter. The molecular responses (MRs) were defined as MR3 for BCR-ABL1/G6PDH ratios ≤10(-3) and MR5 for ratios <10(-5). Ninety evaluable subjects, ages 17 to 71 years, were enrolled in 17 centers. The HCR rate was 91%; 57 subjects received allo-HCT. The cumulative MR5 rate was 94%; the 2-year hematologic relapse-free survival (HRFS) rate was 72% for 82 subjects that achieved HCR, and the 2-year overall survival rate was 72%. Subjects that failed to achieve MR3 or MR5 were 9.1 times (P = .004) or 6.3 times (P = .001) more prone to hematologic relapse, respectively, than those that achieved MR3 or MR5. MRD statuses just before allo-HCT and at 3 months after allo-HCT were predictive of 2-year HRFS. Adverse events occurred mainly during induction, and most were reversible with dose reduction or transient interruption of nilotinib. The combination of nilotinib with high-dose cytotoxic drugs was feasible, and it effectively achieved high cumulative complete molecular remission and HRFS rates. The MRD status at early postremission time was predictive of the HRFS. This trial was registered at www.clinicaltrials.gov as #NCT00844298.

  16. A trend towards increasing viral load in newly diagnosed HIV-infected inpatients in southeast China.

    PubMed

    Chen, Y; Wang, Z; Huang, A; Yuan, J; Wei, D; Ye, H

    2016-06-01

    Peripheral blood viral load is an important indicator of viral production and clearance. Previous studies have suggested that viral load might predict the rate of decrease in CD4+ cell count and progression to AIDS and death. Here, we conducted a retrospective analysis of the trends in HIV-1 viral load in southeast China. Among inpatients newly diagnosed with HIV infection, we found that viral load has increased over the past decade from 4·20 log10 copies/ml in 2002 to 6·61 log10 copies/ml in 2014, with a mean increase of 0·19 log10 copies/ml each year. However, the CD4+ cell count was stable and insensitive to changes in viral load. Thus, increasing viral load appears to be an emerging trend in newly diagnosed HIV-infected inpatients.

  17. The role of Gliadel wafers in the treatment of newly diagnosed GBM: a meta-analysis

    PubMed Central

    Xing, Wei-kang; Shao, Chuan; Qi, Zhen-yu; Yang, Chao; Wang, Zhong

    2015-01-01

    Background Standard treatment for high-grade glioma (HGG) includes surgery followed by radiotherapy and/or chemotherapy. Insertion of carmustine wafers into the resection cavity as a treatment for malignant glioma is currently a controversial topic among neurosurgeons. Our meta-analysis focused on whether carmustine wafer treatment could significantly benefit the survival of patients with newly diagnosed glioblastoma multiforme (GBM). Method We searched the PubMed and Web of Science databases without any restrictions on language using the keywords “Gliadel wafers”, “carmustine wafers”, “BCNU wafers”, or “interstitial chemotherapy” in newly diagnosed GBM for the period from January 1990 to March 2015. Randomized controlled trials (RCTs) and cohort studies/clinical trials that compared treatments designed with and without carmustine wafers and which reported overall survival or hazard ratio (HR) or survival curves were included in this study. Moreover, the statistical analysis was conducted by the STATA 12.0 software. Results Six studies including two RCTs and four cohort studies, enrolling a total of 513 patients (223 with and 290 without carmustine wafers), matched the selection criteria. Carmustine wafers showed a strong advantage when pooling all the included studies (HR =0.63, 95% confidence interval (CI) =0.49–0.81; P=0.019). However, the two RCTs did not show a statistical increase in survival in the group with carmustine wafer compared to the group without it (HR =0.51, 95% CI =0.18–1.41; P=0.426), while the cohort studies demonstrated a significant survival increase (HR =0.59, 95% CI =0.44–0.79; P<0.0001). Conclusion Carmustine-impregnated wafers play a significant role in improving survival when used for patients with newly diagnosed GBM. More studies should be designed for newly diagnosed GBM in the future. PMID:26170620

  18. Frequency of hypovitaminosis D and its associated risk factors in newly diagnosed pulmonary tuberculosis patients

    PubMed Central

    Azam, Fahad; Shaheen, Abida; Arshad, Rabia

    2016-01-01

    Objective: To find out the frequency of hypovitaminosis D and its associated risk factors in newly diagnosed pulmonary tuberculosis patients prior to administration of standard anti tuberculosis therapy. Methods: This cross-sectional study was carried out in Ojha Institute of Chest Diseases-DUHS. After approval from BASR and following written informed consent eighty newly diagnosed, as per WHO criteria, tuberculosis patients were enrolled. Prior to the initiation of anti tuberculosis therapy, the serum vitamin D level was determined by 25-OH Vitamin D kit using the chemiluminescent immunoassay (CLIA) method. A cut off value of >30 ng/mL of serum vitamin D was taken as normal whereas a range between 10-30 ng/mL and <10 ng/mL were considered insufficient and deficient respectively. Frequency of socio-demographic associated risk factors of hypovitaminosis D was also determined. Results: Out of eighty newly diagnosed tuberculosis patients 33 (41.25%) were males and 47(58.75%) were females with their ages ranging from 18-50 years. 54 patients (26 male and 28 female patients) were smokers. BMI of all the patients was found to be less than the normal ranges. Hypovitaminosis was present in all the cases. Vitamin D insufficiency was found in 49 participants (20 male and 29 female) whereas 31 patients (13 male and 18 female) were found to be vitamin D deficient. Conclusion: Prevalence of serum vitamin D level derangement is very high in newly diagnosed patients with pulmonary tuberculosis in our local setting which necessitates administration of adjuvant vitamin D along with standard anti tuberculosis therapy. PMID:27182266

  19. Prevalence of Microvascular Complications in Newly Diagnosed Patients with Type 2 Diabetes

    PubMed Central

    Ali, Alia; Iqbal, Farrukh; Taj, Azeem; Iqbal, Zafar; Amin, Muhammad Joher; Iqbal, Qasim Zafar

    2013-01-01

    Background & Objective: Microvascular complications are the major outcome of type 2 Diabetes Mellitus progression, which reduce the quality of life, incur heavy economic burdens to the health care system and increase diabetic mortality. The aims of this study were to assess the prevalence of microvascular complications among newly diagnosed type 2 diabetic patients and to analyze the association between these complications and poor glycemic control. Methods: This cross sectional hospital based study was carried out in Diabetic Clinic of Shaikh Zayed Postgraduate Medical Institute, Lahore Pakistan. The study was conducted from November 2011 to November 2012 among newly diagnosed type 2 diabetic patients. Relevant information of all patients was recorded with the help of a proforma. They were investigated for retinopathy, nephropathy and neuropathy. Results: We have divided the patients into two groups: Group I with good glycemic control (HbA1c <6.5) and group II with poor glycemic control (HbA1c >6.5). In group II microvascular complications were 89.8%. Neuropathy, nephropathy and retinopathy were present in 68.5%, 56.2% and 31.4% respectively. These similar percentages in Group I were 50%, 0% and 31% respectively and are significantly lower. Conclusion: The study showed that even in newly diagnosed type 2 diabetic patients who had poor glycemic control, frequency of microvascular complications is much higher as compared to those who had average glycemic control. Thus tight glycemic control does count even in newly diagnosed type 2 diabetics to prevent and minimize the occurrence of complications. PMID:24353655

  20. Short-term heart rate variability in older patients with newly diagnosed depression.

    PubMed

    Ha, Jee Hyun; Park, Soyeon; Yoon, Daehyun; Kim, Byungsu

    2015-04-30

    Dysfunction of the autonomic nervous system has been considered to be a risk factor for major depressive disorder (MDD) and cardiovascular disease (CVD). The aim of this study was to evaluate short-term heart rate variability (HRV) in elderly patients with newly diagnosed MDD. Thirty MDD patients over 60 years old newly diagnosed by a structured interview were enrolled, free from antidepressants. Socio-demographic data, blood tests, and heart rate variability (HRV) obtained from 5-min ECG were gathered. The MDD group showed significantly lower very low frequency power, low frequency power, high frequency power, and total power in frequency domain. In time domain analysis, the MDD group showed a significantly smaller standard deviation of the NN, root mean square of the differences of the successive NN, and NN50/total number of all NNs. These findings demonstrated a lower HRV in older patients who were newly diagnosed with depression without a history of CVD and antidepressants effect, compared with the control subjects. Low HRV may be an important predictor of both MDD and CVD in elderly. The use of HRV in elderly depressive patients could be a meaningful screening method for risk of CVD. PMID:25747680

  1. Prevalence of and risk factors for pulmonary tuberculosis among newly diagnosed HIV-1 infected Nigerian children

    PubMed Central

    Ebonyi, Augustine O.; Oguche, Stephen; Ejeliogu, Emeka U.; Agbaji, Oche O.; Shehu, Nathan Y.; Abah, Isaac O.; Sagay, Atiene S.; Ugoagwu, Placid O.; Okonkwo, Prosper I.; Idoko, John A.; Kanki, Phyllis J.

    2016-01-01

    Introduction Studies on the prevalence of and risk factors for tuberculosis (TB) among newly diagnosed human immunodeficiency virus (HIV)-infected children in sub-Saharan Africa are scarce and in Nigeria there is paucity of reported data. We determined the prevalence of and risk factors for pulmonary TB (PTB) in newly diagnosed (treatment-naïve) HIV-1 infected children at the pediatric HIV clinic of the Jos University Teaching Hospital (JUTH) in Nigeria. Methods We performed a retrospective analysis of 876 children, aged 2 months – 13 years, diagnosed with HIV-1 infection between July 2005 and December 2012, of which 286 were diagnosed with PTB at presentation after TB screening. The study site was the AIDS Prevention Initiative in Nigeria (APIN)-supported Pediatric HIV clinic at JUTH, Jos. A multivariate forward logistic regression modelling was used to identify risk factors for PTB-HIV co-infection. Results The prevalence of PTB-HIV co-infection was 32% (286/876). Severe immunosuppression (SI) and World Health Organization (WHO) HIV clinical stage 3/4 were identified as independent risk factors for PTB-HIV co-infection in HIV infected children. The odds of PTB-HIV co-infection was increased two-fold in HIV-infected children with WHO clinical stage 3/4 compared to those with stage 1/2 (adjusted odds ratio (AOR) 1.76 [1.31-2.37], p<0.001) and 1.5-fold in children with SI compared to those without SI (AOR 1.52 [1.12-2.06], p=0.007). Conclusion In our setting, the burden of PTB was high among newly diagnosed HIV-infected children, and late WHO HIV clinical stage and severe immunosuppression were associated with PTB-HIV co-infection. Therefore there is a clear need to improve strategies for early diagnosis of both HIV and PTB to optimize clinical outcomes. PMID:27019829

  2. Diabetes self-management education and training among privately insured persons with newly diagnosed diabetes--United States, 2011-2012.

    PubMed

    Li, Rui; Shrestha, Sundar S; Lipman, Ruth; Burrows, Nilka R; Kolb, Leslie E; Rutledge, Stephanie

    2014-11-21

    Diabetes is a complex chronic disease that requires active involvement of patients in its management. Diabetes self-management education and training (DSMT), "the ongoing process of facilitating the knowledge, skill, and ability necessary for prediabetes and diabetes self-care," is an important component of integrated diabetes care. It is an intervention in which patients learn about diabetes and how to implement the self-management that is imperative to control the disease. The curriculum of DSMT often includes the diabetes disease process and treatment options; healthy lifestyle; blood glucose monitoring; preventing, detecting and treating diabetes complications; and developing personalized strategies for decision making. The American Diabetes Association recommends providing DSMT to those with newly diagnosed diabetes, because data suggest that when diabetes is first diagnosed is the time when patients are most receptive to such engagement. However, little is known about the proportion of persons with newly diagnosed diabetes participating in DSMT. CDC analyzed data from the Marketscan Commercial Claims and Encounters database (Truven Health Analytics) for the period 2009-2012 to estimate the claim-based proportion of privately insured adults (aged 18-64 years) with newly diagnosed diabetes who participated in DSMT during the first year after diagnosis. During 2011-2012, an estimated 6.8% of privately insured, newly diagnosed adults participated in DSMT during the first year after diagnosis of diabetes. These data suggest that there is a large gap between the recommended guideline and current practice, and that there is both an opportunity and a need to enhance rates of DSMT participation among persons newly diagnosed with diabetes.

  3. Newly diagnosed lung cancer patients' preferences for and beliefs about physical activity prior to chemotherapy.

    PubMed

    Karvinen, Kristina H; Vallance, Jeff; Walker, Paul R

    2016-07-01

    Physical activity has been found to have a number of benefits for lung cancer patients yet very little information is available concerning physical activity beliefs and preferences for this population. The purpose of the study was to explore physical activity programming and counseling preferences and beliefs about physical activity in newly diagnosed lung cancer patients scheduled to receive chemotherapy. A total of 43 new diagnosed lung cancer patients completed a researcher-administered survey prior to commencing chemotherapy. Results indicated that only 7 participants (17%) reported meeting public health recommendations for physical activity yet the majority of participants (n = 28) indicated interest or possible interest in physical activity counseling. Many participants also indicated interest or possible interest in an exercise program (n = 29) for lung cancer survivors, preferring it to start during chemotherapy (n = 20), for it to be home based (n = 21), and moderate in intensity (n = 22). The most common behavioral belief (advantage) of physical activity was to build/maintain strength (n = 26) and the most common control belief (barrier) was fatigue (n = 11). These data suggest that physical activity counseling and programming may be well received by newly diagnosed lung cancer patients. Information about physical activity and programming preferences and beliefs from this study may be useful for the design of optimal physical activity interventions for lung cancer patients.

  4. Newly Diagnosed Anemia Increases Risk of Parkinson’s disease: A Population-Based Cohort Study

    PubMed Central

    Hong, Chien Tai; Huang, Yao Hsien; Liu, Hung Yi; Chiou, Hung-Yi; Chan, Lung; Chien, Li-Nien

    2016-01-01

    Anemia and low hemoglobin have been identified to increase Parkinson’s disease (PD) risk. This population-based cohort study investigated PD risk in newly diagnosed anemic patients by using data from the Taiwan National Health Insurance Research Database. All newly diagnosed anemic patients (n = 86,334) without a history of stroke, neurodegenerative diseases, traumatic brain injury, major operations, or blood loss diseases were enrolled. A cohort of nonanemic controls, 1:1 matched with anemic patients on the basis of the demographics and pre-existing medical conditions, was also included. Competing risk analysis was used to evaluate PD risk in anemic patients compared with that in their matched controls. The adjusted hazard ratio (aHR) of PD risk in the anemic patients was 1.36 (95% confidence interval [CI]: 1.22–1.52, p < 0.001). Iron deficiency anemia (IDA) patients tended to exhibit a higher PD risk (aHR: 1.49; 95% CI: 1.24–1.79, p < 0.001). Furthermore, Iron supplement did not significantly affect the PD risk: the aHRs for PD risk were 1.32 (95% CI: 1.07–1.63, p < 0.01) and 1.86 (95% CI: 1.46–2.35, p < 0.001) in IDA patients with and without iron supplementation, respectively. The population-based cohort study indicated newly diagnosed anemia increases PD risk. PMID:27412825

  5. Evaluation Series on Safety and Efficacy of Nutritional Supplements in Newly Diagnosed Hyperglycemia: A Placebo-Controlled, Randomized Study

    PubMed Central

    Thacker, Hemant; Bantwal, Ganapati; Jain, Sunil; Kalra, Sanjay; Kale, Shailaja; Saboo, Banshi; Gupta, Jugal B.; Sivam, Sakthivel

    2016-01-01

    Background: Diabetes is endemic with developing economies contributing to the bulk of this pandemic. Despite the evidence of incremental benefit of glycemic control starting early in life, acceptance of and adherence to modern medications remain suboptimal. Aims: To determine the hemoglobin A1c (HbA1c)-lowering efficacy and safety of nutritional supplement, PreCrea®, in adult Indians with newly diagnosed hyperglycemia. Materials and Methods: Double-blind, randomized study conducted in six diabetes centers in India. A total of 193 treatment-naïve subjects with newly diagnosed hyperglycemia and fasting plasma glucose (FPG) >100 mg/dL were randomized into either PreCrea® 600 mg (n = 90) or matched placebo (n = 89) capsules twice daily, along with lifestyle modification, for 12 weeks. The main outcomes were changes in HbA1c and FPG levels, attainment of the American Diabetes Association (ADA)-defined goals for HbA1c, and clinical and biochemical measures of safety. Results: At 12 weeks, mean HbA1c in PreCrea® group reduced by 0.91% compared with 0.08% increase in the placebo group (P < .001). The reductions in the mean FPG at week 4 (P < .001) and week 12 (P = 0.04) were significant compared to the baseline. ADA goal of HbA1c <7% increased from 15.5% at the baseline to 35.6% at week 12 in PreCrea® subjects. Clinical safety and biochemical safety did not change. Hypoglycemia and weight gain were not observed with PreCrea®. Conclusions: Nearly 1% point reduction in HbA1c at week 12 with PreCrea® is comparable with most first-line glucose-lowering drugs. The safety and tolerability of PreCrea® highlights its potential as a first-line therapy in newly detected hyperglycemia. PMID:27042609

  6. Liver cirrhosis in patients newly diagnosed with neurological phenotype of Wilson's disease.

    PubMed

    Przybyłkowski, Adam; Gromadzka, Grażyna; Chabik, Grzegorz; Wierzchowska, Agata; Litwin, Tomasz; Członkowska, Anna

    2014-01-01

    Wilson's disease (WD) can manifest itself in different clinical forms, the neurological and hepatic ones being the most common. It is suggested that neurological signs and psychiatric symptoms develop secondary to liver involvement. The aim of this study was to characterize the liver disease in patients newly diagnosed with the neurological form of WD. Treatment-naive patients diagnosed with WD were classified into three phenotypic groups: hepatic, neurological and pre-symptomatic. Liver involvement was ascertained through surrogate markers: abdominal ultrasound and laboratory parameters. In addition, study participants were screened for esophageal varices. Of 53 consecutively diagnosed WD patients, 23 individuals (43.4%) had a predominantly neurological presentation. In this group, cirrhosis was diagnosed in 11 (47.8%) subjects. Esophageal varices were present in all of them. In every patient with neurological WD, there was at least one sign of hepatic disease on ultrasound examination, indicating universal presence of liver involvement. The prevalence of surrogate signs of cirrhosis was similar in patients with the neurological and in those with the hepatic phenotype.

  7. Dendritic development of newly generated neurons in the adult brain.

    PubMed

    Ribak, Charles E; Shapiro, Lee A

    2007-10-01

    Ramon y Cajal described the fundamental morphology of the dendritic and axonal growth cones of neurons during development. However, technical limitations at the time prevented him from describing such growth cones from newborn neurons in the adult brain. The phenomenon of adult neurogenesis is briefly reviewed, and the structural description of dendritic and axonal outgrowth for these newly generated neurons in the adult brain is discussed. Axonal outgrowth into the hilus and CA3 region of the hippocampus occurs later than the outgrowth of dendrites into the molecular layer, and the ultrastructural analysis of axonal outgrowth has yet to be completed. In contrast, growth cones on dendrites from newborn neurons in the adult dentate gyrus have been described and this observation suggests that dendrites in adult brains grow in a similar way to those found in immature brains. However, dendrites in adult brains have to navigate through a denser neuropil and a more complex cell layer. Therefore, some aspects of dendritic outgrowth of neurons born in the adult dentate gyrus are different as compared to that found in development. These differences include the radial process of radial glial cells acting as a lattice to guide apical dendritic growth through the granule cell layer and a much thinner dendrite to grow through the neuropil of the molecular layer. Therefore, similarities and differences exist for dendritic outgrowth from newborn neurons in the developing and adult brain.

  8. Selecting the best strategy of treatment in newly diagnosed advanced-stage ovarian cancer patients.

    PubMed

    Minig, Lucas; Zorrero, Cristina; Iserte, Pablo Padilla; Poveda, Andres

    2015-12-26

    Although it is assumed that the combination of chemotherapy and radical surgery should be indicated in all newly diagnosed advanced-stage ovarian cancer patients, one of the main raised questions is how to select the best strategy of initial treatment in this group of patients, neoadjuvant chemotherapy followed by interval debulking surgery or primary debulking surgery followed by adjuvant chemotherapy. The selection criteria to offer one strategy over the other as well as a stepwise patient selection for initial treatment are described. Selecting the best strategy of treatment in newly diagnosed advanced stage ovarian cancer patients is a multifactorial and multidisciplinary decision. Several factors should be taken into consideration: (1) the disease factor, related to the extension and localization of the disease as well as tumor biology; (2) the patient factor, associated with patient age, poor performance status, and co-morbidities; and (3) institutional infrastructure factor, related to the lack of prolonged operative time, an appropriate surgical armamentarium, as well as well-equipped intensive care units with well-trained personnel.

  9. Changes in profile of lipids and adipokines in patients with newly diagnosed hypothyroidism and hyperthyroidism

    PubMed Central

    Chen, Yanyan; Wu, Xiafang; Wu, Ruirui; Sun, Xiance; Yang, Boyi; Wang, Yi; Xu, Yuanyuan

    2016-01-01

    Changes in profile of lipids and adipokines have been reported in patients with thyroid dysfunction. But the evidence is controversial. The present study aimed to explore the relationships between thyroid function and the profile of lipids and adipokines. A cross-sectional study was conducted in 197 newly diagnosed hypothyroid patients, 230 newly diagnosed hyperthyroid patients and 355 control subjects. Hypothyroid patients presented with significantly higher serum levels of total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDLC), fasting insulin, resistin and leptin than control (p < 0.05). Hyperthyroid patients presented with significantly lower serum levels of high-density lipoprotein cholesterol, LDLC and leptin, as well as higher levels of fasting insulin, resistin, adiponectin and homeostasis model insulin resistance index (HOMA-IR) than control (p < 0.05). Nonlinear regression and multivariable linear regression models all showed significant associations of resistin or adiponectin with free thyroxine and association of leptin with thyroid-stimulating hormone (p < 0.001). Furthermore, significant correlation between resistin and HOMA-IR was observed in the patients (p < 0.001). Thus, thyroid dysfunction affects the profile of lipids and adipokines. Resistin may serve as a link between thyroid dysfunction and insulin resistance. PMID:27193069

  10. Chromosome 1 abnormalities in elderly patients with newly diagnosed multiple myeloma treated with novel therapies

    PubMed Central

    Caltagirone, Simona; Ruggeri, Marina; Aschero, Simona; Gilestro, Milena; Oddolo, Daniela; Gay, Francesca; Bringhen, Sara; Musolino, Caterina; Baldini, Luca; Musto, Pellegrino; Petrucci, Maria T.; Gaidano, Gianluca; Passera, Roberto; Bruno, Benedetto; Palumbo, Antonio; Boccadoro, Mario; Omedè, Paola

    2014-01-01

    Multiple myeloma is a plasma cell disorder characterized by malignant plasma cell infiltration in the bone marrow, serum and/or urine monoclonal protein and organ damage. The aim of this study was to investigate the impact of chromosome 1 abnormalities in a group of elderly patients (>65 years) with newly diagnosed multiple myeloma enrolled in the GIMEMA-MM-03-05 trial and treated with bortezomib, melphalan and prednisone or bortezomib, melphalan, prednisone and thalidomide followed by bortezomib and thalidomide maintenance. We also evaluated the link between chromosome 1 abnormalities and other clinical, genetic and immunophenotypic features by a multivariate logistic regression model. Interphase fluorescence in situ hybridization on immunomagnetically purified plasma cells and bone marrow multiparameter flow cytometry were employed. A multivariate Cox model showed that chromosome 1 abnormalities, age >75 years and a CD19+/CD117− immunophenotype of bone marrow plasma cells were independent risk factors for overall survival in elderly patients with newly diagnosed multiple myeloma. Moreover, a detrimental effect of thalidomide, even when administered in association with bortezomib, was observed in patients with abnormal chromosome 1 as well as in those with 17p deletion, while the benefit of adding thalidomide to the bortezomib-melphalan-prednisone regimen was noted in patients carrying an aggressive CD19+/CD117− bone marrow plasma cell immunophenotype. This trial was registered at www.clinicaltri-als.gov as #NCT01063179. PMID:25015938

  11. Magnetic resonance imaging in patients with newly diagnosed breast cancer: a review of the literature.

    PubMed

    Pilewskie, Melissa; King, Tari A

    2014-07-15

    The use of magnetic resonance imaging (MRI) in patients with newly diagnosed breast cancer remains controversial. Here we review the current use of breast MRI and the impact of MRI on short-term surgical outcomes and rates of local recurrence. In addition, we address the use of MRI in specific patient populations, such as those with ductal carcinoma in situ, invasive lobular carcinoma, and occult primary breast cancer, and discuss the potential role of MRI for assessing response to neoadjuvant chemotherapy. Although MRI has improved sensitivity compared with conventional imaging, this has not translated into improved short-term surgical outcomes or long-term patient benefit, such as improved local control or survival, in any patient population. MRI is an important diagnostic test in the evaluation of patients presenting with occult primary breast cancer and has shown promise in monitoring response to neoadjuvant chemotherapy; however, the data do not support the routine use of perioperative MRI in patients with newly diagnosed breast cancer. Cancer 2014;120:120:2080-2089. © 2014 American Cancer Society.

  12. Behavioral Predictors of Medication Adherence Trajectories among Youth with Newly Diagnosed Epilepsy

    PubMed Central

    Loiselle, Kristin; Rausch, Joseph R.; Modi, Avani C.

    2015-01-01

    Objective This study aimed to identify psychosocial predictors of two-year antiepileptic drug (AED) adherence trajectories among youth with newly diagnosed epilepsy, controlling for known demographic and medical factors. Method This study is part of a large, prospective, longitudinal observational study of AED adherence and medical outcomes in youth with newly diagnosed epilepsy. Parents completed questionnaires of psychosocial and family functioning at one-month and one-year following diagnosis. Chart review and questionnaires were used to collect medical variables and seizure outcomes. Previously established two-year AED adherence trajectories (Severe Early Non-Adherence, Variable Non-Adherence, Moderate Non-Adherence, High Adherence) were used as the outcome variable. Results Participants were 91 parents of youth with epilepsy (7.3 ± 2.8 years of age; 60% male) and their families. Early (one-month following diagnosis) predictors of two-year adherence trajectories included socioeconomic status, epilepsy knowledge, family problem-solving, and family communication. Significant predictors one-year following diagnosis included socioeconomic status, parent fears and concerns, and parent life stress. Conclusion There are modifiable parent and family variables that predict two-year adherence trajectories above and beyond known medical (e.g., seizures, side effects) factors. Psychosocial interventions delivered at key points during the course of epilepsy treatment could have a positive impact on adherence outcomes. PMID:26209946

  13. Health-related quality of life of children with newly diagnosed specific learning disability.

    PubMed

    Karande, Sunil; Bhosrekar, Kirankumar; Kulkarni, Madhuri; Thakker, Arpita

    2009-06-01

    The objective of this study was to measure health-related quality of life (HRQL) of children with newly diagnosed specific learning disability (SpLD) using the Child Health Questionnaire-Parent Form 50. We detected clinically significant deficits (effect size > or = -0.5) in 9 out of 12 domains: limitations in family activities, emotional impact on parents, social limitations as a result of emotional-behavioral problems, time impact on parents, general behavior, physical functioning, social limitations as a result of physical health, general health perceptions and mental health; and in both summary scores (psychosocial > physical). Multivariate analysis revealed having > or = 1 non-academic problem(s) (p < 0.0001), attention-deficit hyperactivity disorder (p = 0.005) or first-born status (p = 0.009) predicted a poor psychosocial summary score; and having > or =1 non-academic problem(s) (p = 0.006) or first-born status (p = 0.035) predicted a poor physical summary score. HRQL is significantly compromised in children having newly diagnosed SpLD.

  14. A Pilot Safety Study of Lenalidomide and Radiotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme

    SciTech Connect

    Drappatz, Jan Wong, Eric T.; Schiff, David; Kesari, Santosh; Batchelor, Tracy T.; Doherty, Lisa; LaFrankie, Debra Conrad

    2009-01-01

    Purpose: To define the maximum tolerated dose (MTD) of lenalidomide, an analogue of thalidomide with enhanced immunomodulatory and antiangiogenic properties and a more favorable toxicity profile, in patients with newly diagnosed glioblastoma multiforme (GBM) when given concurrently with radiotherapy. Patients and Methods: Patients with newly diagnosed GBM received radiotherapy concurrently with lenalidomide given for 3 weeks followed by a 1-week rest period and continued lenalidomide until tumor progression or unacceptable toxicity. Dose escalation occurred in groups of 6. Determination of the MTD was based on toxicities during the first 12 weeks of therapy. The primary endpoint was toxicity. Results: Twenty-three patients were enrolled, of whom 20 were treated and evaluable for both toxicity and tumor response and 2 were evaluable for toxicity only. Common toxicities included venous thromboembolic disease, fatigue, and nausea. Dose-limiting toxicities were eosinophilic pneumonitis and transaminase elevations. The MTD for lenalidomide was determined to be 15 mg/m{sup 2}/d. Conclusion: The recommended dose for lenalidomide with radiotherapy is 15 mg/m{sup 2}/d for 3 weeks followed by a 1-week rest period. Venous thromboembolic complications occurred in 4 patients, and prophylactic anticoagulation should be considered.

  15. Preserved muscle oxidative metabolic phenotype in newly diagnosed non-small cell lung cancer cachexia

    PubMed Central

    Op den Kamp, Celine M; Gosker, Harry R; Lagarde, Suzanne; Tan, Daniel Y; Snepvangers, Frank J; Dingemans, Anne-Marie C; Langen, Ramon CJ; Schols, Annemie MWJ

    2015-01-01

    Background Cachexia augments cancer-related mortality and has devastating effects on quality of life. Pre-clinical studies indicate that systemic inflammation-induced loss of muscle oxidative phenotype (OXPHEN) stimulates cancer-induced muscle wasting. The aim of the current proof of concept study is to validate the presence of muscle OXPHEN loss in newly diagnosed patients with lung cancer, especially in those with cachexia. Methods Quadriceps muscle biopsies of comprehensively phenotyped pre-cachectic (n = 10) and cachectic (n = 16) patients with non-small cell lung cancer prior to treatment were compared with healthy age-matched controls (n = 22). OXPHEN was determined by assessing muscle fibre type distribution (immunohistochemistry), enzyme activity (spectrophotometry), and protein expression levels of mitochondrial complexes (western blot) as well as transcript levels of (regulatory) oxidative genes (quantitative real-time PCR). Additionally, muscle fibre cross-sectional area (immunohistochemistry) and systemic inflammation (multiplex analysis) were assessed. Results Muscle fibre cross-sectional area was smaller, and plasma levels of interleukin 6 were significantly higher in cachectic patients compared with non-cachectic patients and healthy controls. No differences in muscle fibre type distribution or oxidative and glycolytic enzyme activities were observed between the groups. Mitochondrial protein expression and gene expression levels of their regulators were also not different. Conclusion Muscle OXPHEN is preserved in newly diagnosed non-small cell lung cancer and therefore not a primary trigger of cachexia in these patients. PMID:26136192

  16. Influence of Dapagliflozin on Glycemic Variations in Patients with Newly Diagnosed Type 2 Diabetes Mellitus

    PubMed Central

    Li, Feng-fei; Gao, Gu; Li, Qian; Zhu, Hong-hong; Su, Xiao-fei; Wu, Jin-dan

    2016-01-01

    Objectives. To observe changes in blood glycemic variations and oxidative stress level before and after dapagliflozin treatment in patients with newly diagnosed T2DM. Methods. This was a randomized, double-blind, placebo-controlled, phase 3 trial. A total of 28 patients with newly diagnosed T2DM with HbA1c levels of 7.5–10.5% were randomly selected to receive dapagliflozin or placebo treatment for 24 weeks. After baseline data were collected, we analyzed glycemic variations and plasma 8-iso PGF2α level at baseline and at the endpoint. Primary outcome was the changes of mean amplitude glycemic excursion (MAGE) within groups. Results. After 24-week dapagliflozin therapy, our data showed the significant improvement of MAGE with dapagliflozin therapy (P = 0.010). Compared with control group, patients in dapagliflozin group exhibited reduction in 24-hour MBG (P = 0.026) and lower mean plasma glucose concentrations, especially during periods from 2400 to 0200 and 1300 to 1800 (P < 0.05, resp.). In addition, plasma 8-iso PGF2α level was notably decreased in the treatment group compared to the control group (P = 0.034). Conclusions. In conclusion, this study shows the ability of dapagliflozin to improve glycemic variations and associate with reduction of oxidative stress in patients with T2DM, which may benefit the cardiovascular system. PMID:27738639

  17. RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma

    ClinicalTrials.gov

    2015-09-28

    Acoustic Schwannoma; Adult Anaplastic (Malignant) Meningioma; Adult Anaplastic Astrocytoma; Adult Anaplastic Ependymoma; Adult Brain Stem Glioma; Adult Choroid Plexus Neoplasm; Adult Craniopharyngioma; Adult Diffuse Astrocytoma; Adult Ependymoblastoma; Adult Ependymoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Grade I Meningioma; Adult Grade II Meningioma; Adult Medulloblastoma; Adult Mixed Glioma; Adult Myxopapillary Ependymoma; Adult Oligodendroglioma; Adult Papillary Meningioma; Adult Pilocytic Astrocytoma; Adult Pineal Gland Astrocytoma; Adult Pineoblastoma; Adult Pineocytoma; Adult Primary Melanocytic Lesion of Meninges; Adult Subependymal Giant Cell Astrocytoma; Adult Subependymoma; Adult Supratentorial Primitive Neuroectodermal Tumor; Malignant Adult Intracranial Hemangiopericytoma

  18. Young Offenders' Diagnoses as Predictors of Subsequent Adult Criminal Behaviour.

    ERIC Educational Resources Information Center

    Bevc, Irene; Duchesne, Thierry; Rosenthal, Jeffrey; Rossman, Lianne; Theodor, Frances; Sowa, Edward

    This longitudinal study of 248 male offenders examined the relationship between psychiatric disorders, diagnosed in adolescence, and subsequent adult criminal activity. Criminal offences were tracked for an average of 8.7 years from age 18-33. Cox Proportional Intensity regression analyses were conducted to predict the rates of adult offending of…

  19. Contact lenses as the best conservative treatment of newly diagnosed keratoconus--epidemiological retrospective study.

    PubMed

    Mrazovac, Danijela; Barisić Kutija, Marija; Vidas, Sania; Kuzman, Tomislav; Petricek, Igor; Jandroković, Sonja; Kalauz, Miro; Cerovski, Branimir

    2014-12-01

    Keratoconus is a progressive, non-inflammatory corneal ectasia characterized by thinning and weakening of the corneal stroma which results in its' protrusion. The onset is during puberty and progresses until the fourth decade of life. In earlier stages, good visual acuity can be provided with spectacles. With progression, contact lenses are considered to be a better therapy. Aim of this study was to determine if there is statistically significant difference between best corrected visual acuity (BCVA) obtained by spectacles and contact lenses in newly diagnosed keratoconus patients, as well as to determine which type of contact lenses provide better BCVA in keratoconus patients. We conducted a 5-year retrospective study of all 2891 patients attending our Contact Lens Department for the first time, searching for patients newly diagnosed with keratoconus. Data were obtained on gender, age, education level, treated eyes, corneal changes, keratoconus severity, BCVA with spectacles, contact lenses and best fitted contact lens type. All patients underwent standard ophthalmic exam, refractometry and keratometry have been done, followed by a spectacles correction and lens fitting. Wilcoxon signed rank test was used for statistical analysis. Results showed that of all 2891 patients examined for the first time, 137 patients (4.74%) have been newly diagnosed with heratoconus, there was male bias (72.26%), mean age 27.7 +/- 9.9 years. Most patients had high school education (51.11%), 3.70% had present corneal changes, 50.37% had mild heratoconus. Majority had keratoconus on both eyes (36.3%) or keratoconus of right eye (26.67%). There was a statistically significant difference (p<0.001) between the BCVA obtained with contact lenses (0.82 +/- 0.21 Snellen chart) rather than spectacles (0.37 +/- 0.27 Snellen chart). The best corrected visual acuity was achieved with rigid gas permeable (RGP) lenses in majority of kera- toconus eyes (51.85%), with semi-gas permeable (SGP) lenses

  20. Contact lenses as the best conservative treatment of newly diagnosed keratoconus--epidemiological retrospective study.

    PubMed

    Mrazovac, Danijela; Barisić Kutija, Marija; Vidas, Sania; Kuzman, Tomislav; Petricek, Igor; Jandroković, Sonja; Kalauz, Miro; Cerovski, Branimir

    2014-12-01

    Keratoconus is a progressive, non-inflammatory corneal ectasia characterized by thinning and weakening of the corneal stroma which results in its' protrusion. The onset is during puberty and progresses until the fourth decade of life. In earlier stages, good visual acuity can be provided with spectacles. With progression, contact lenses are considered to be a better therapy. Aim of this study was to determine if there is statistically significant difference between best corrected visual acuity (BCVA) obtained by spectacles and contact lenses in newly diagnosed keratoconus patients, as well as to determine which type of contact lenses provide better BCVA in keratoconus patients. We conducted a 5-year retrospective study of all 2891 patients attending our Contact Lens Department for the first time, searching for patients newly diagnosed with keratoconus. Data were obtained on gender, age, education level, treated eyes, corneal changes, keratoconus severity, BCVA with spectacles, contact lenses and best fitted contact lens type. All patients underwent standard ophthalmic exam, refractometry and keratometry have been done, followed by a spectacles correction and lens fitting. Wilcoxon signed rank test was used for statistical analysis. Results showed that of all 2891 patients examined for the first time, 137 patients (4.74%) have been newly diagnosed with heratoconus, there was male bias (72.26%), mean age 27.7 +/- 9.9 years. Most patients had high school education (51.11%), 3.70% had present corneal changes, 50.37% had mild heratoconus. Majority had keratoconus on both eyes (36.3%) or keratoconus of right eye (26.67%). There was a statistically significant difference (p<0.001) between the BCVA obtained with contact lenses (0.82 +/- 0.21 Snellen chart) rather than spectacles (0.37 +/- 0.27 Snellen chart). The best corrected visual acuity was achieved with rigid gas permeable (RGP) lenses in majority of kera- toconus eyes (51.85%), with semi-gas permeable (SGP) lenses

  1. Impaired Glucose Tolerance or Newly Diagnosed Diabetes Mellitus Diagnosed during Admission Adversely Affects Prognosis after Myocardial Infarction: An Observational Study

    PubMed Central

    George, Anish; Bhatia, Raghav T.; Buchanan, Gill L.; Whiteside, Anne; Moisey, Robert S.; Beer, Stephen F.; Chattopadhyay, Sudipta; Sathyapalan, Thozhukat; John, Joseph

    2015-01-01

    Objective To investigate the prognostic effect of newly diagnosed diabetes mellitus (NDM) and impaired glucose tolerance (IGT) post myocardial infarction (MI). Research Design and Methods Retrospective cohort study of 768 patients without preexisting diabetes mellitus post-MI at one centre in Yorkshire between November 2005 and October 2008. Patients were categorised as normal glucose tolerance (NGT n = 337), IGT (n = 279) and NDM (n = 152) on pre- discharge oral glucose tolerance test (OGTT). Primary end-point was the first occurrence of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal MI, severe heart failure (HF) or non-haemorrhagic stroke. Secondary end-points were all cause mortality and individual components of MACE. Results Prevalence of NGT, impaired fasting glucose (IFG), IGT and NDM changed from 90%, 6%, 0% and 4% on fasting plasma glucose (FPG) to 43%, 1%, 36% and 20% respectively after OGTT. 102 deaths from all causes (79 as first events of which 46 were cardiovascular), 95 non fatal MI, 18 HF and 9 non haemorrhagic strokes occurred during 47.2 ± 9.4 months follow up. Event free survival was lower in IGT and NDM groups. IGT (HR 1.54, 95% CI: 1.06–2.24, p = 0.024) and NDM (HR 2.15, 95% CI: 1.42–3.24, p = 0.003) independently predicted MACE free survival. IGT and NDM also independently predicted incidence of MACE. NDM but not IGT increased the risk of secondary end-points. Conclusion Presence of IGT and NDM in patients presenting post-MI, identified using OGTT, is associated with increased incidence of MACE and is associated with adverse outcomes despite adequate secondary prevention. PMID:26571120

  2. A factorial randomised controlled trial of decision analysis and an information video plus leaflet for newly diagnosed hypertensive patients.

    PubMed Central

    Montgomery, Alan A; Fahey, Tom; Peters, Tim J

    2003-01-01

    BACKGROUND: There is a lack of evidence regarding the value of tools designed to aid decision making in patients with newly diagnosed hypertension. AIM: To evaluate two interventions for assisting newly diagnosed hypertensive patients in the decision whether to start drug therapy for reducing blood pressure. DESIGN OF STUDY: Factorial randomised controlled trial. SETTING: Twenty-one general practices in south-west England, UK. METHOD: Adults aged 32 to 80 years with newly diagnosed hypertension were randomised to receive either: (a) computerised utility assessment interview with individualized risk assessment and decision analysis; or (b) information video and leaflet about high blood pressure; or (c) both interventions; or (d) neither intervention. Outcome measures were decisional conflict, knowledge, state anxiety, intentions regarding starting treatment, and actual treatment decision. RESULTS: Of 217 patients randomised, 212 (98%) were analysed at the primary follow-up (mean age = 59 years, 49% female). Decision analysis patients had lower decisional conflict than those who did not receive this intervention (27.6 versus 38.9, 95% confidence interval [CI] for adjusted difference = -13.0 to -5.8, P < 0.001), greater knowledge about hypertension (73% versus 67%, adjusted 95% CI = 2% to 9%, P = 0.003) and no evidence of increased state anxiety (34.8 versus 36.8, adjusted 95% CI = -5.6 to 0.1, P = 0.055). Video/leaflet patients had lower decisional conflict than corresponding controls (30.3 versus 36.8, adjusted 95% CI = -7.4 to -0.6, P = 0.021), greater knowledge (75% versus 65%, adjusted 95% CI = 6% to 13%, P < 0.001) and no evidence of increased state anxiety (35.7 versus 36.1, adjusted 95% CI = -3.9 to 1.7, P = 0.46). There were no differences between either of the interventions and their respective controls in the proportion of patients prescribed antihypertensive medication (67%). CONCLUSIONS: This trial demonstrates that, among patients facing a real treatment

  3. Effects of Fluroquinolones in Newly Diagnosed, Sputum-Positive Tuberculosis Therapy: A Systematic Review and Network Meta-Analysis

    PubMed Central

    Li, Dandan; Wang, Tiansheng; Shen, Su; Cheng, Sheng; Yu, Junxian; Zhang, Yang; Zhang, Chao; Tang, Huilin

    2015-01-01

    Background Tuberculosis is a major public health problem especially in developing countries, the comparative efficacy and safety of fluroquinolones (FQs) for adult patients with newly diagnosed, sputum-positive tuberculosis remains controversial. We aimed to investigate the benefits and risks of FQs-containing (addition/substitution) regimens in this population. Methods A network meta-analysis was performed to compare FQs (C: ciprofloxacin; O: ofloxacin; Lo: levofloxacin; M: moxifloxacin; G: gatifloxacin) addition/substitution regimen with standard HRZE regimen (ie isoniazid, rifampicin, pyrazinamide and ethambutol) in newly diagnosed, sputum-positive tuberculosis. Medline, Embase and Cochrane Central Register of Controlled Trials were systematically searched, randomized trials with duration longer than 8 weeks were included. The primary outcome was week-8 sputum negativity, and secondary outcomes included treatment failure, serious adverse events and death from all cause. Results Twelve studies comprising 6465 participants were included in the network meta-analysis. Löwenstein-Jensen culture method showed that HRZEM (OR 4.96, 95% CI 2.83–8.67), MRZE (OR 1.48, 95% CI 1.19–1.84) and HRZM (OR 1.32, 95% CI 1.08–1.62) had more sputum conversion than HRZE by the eighth week, whereas HRC (OR 0.39, 95% CI 0.19–0.77) and HRZO (OR 0.47, 95% CI 0.24–0.92) were worse than HRZE. Moxifloxacin-containing regimens showed more conversion than HRZE by liquid method at the end of two months. But by the end of treatment, FQs-containing regimens didn’t show superiority than HRZE on treatment failure. There were no significant differences between any regimens on other outcomes like serious adverse events and all-cause death. Conclusion This comprehensive network meta-analysis showed that compared with HRZE, moxifloxacin-containing regimens could significantly increase sputum conversion by the eighth week for patients with newly diagnosed pulmonary tuberculosis while HRC

  4. Review of thalidomide in the treatment of newly diagnosed multiple myeloma

    PubMed Central

    Cavallo, Federica; Boccadoro, Mario; Palumbo, Antonio

    2007-01-01

    The role of thalidomide has been well established in the setting of relapsed or refractory multiple myeloma (MM). More recently, studies have been focused on upfront induction therapy. In newly diagnosed MM patients, thalidomide improved the response rates and the event-free survival induced by both high-dose and conventional chemotherapy regimens. The effect on survival needs to be further investigated. The efficacy of this drug is counterbalanced by a significant rate of both acute and long-term toxicities. Thus best timing of initiation, dosing schemes and duration of therapy is still unclear. Evidence is now emerging that clinical response can be achieved also at lower doses with minimal long term toxicity. PMID:18472975

  5. Analysis of Inflammatory Mediators in Prediabetes and Newly Diagnosed Type 2 Diabetes Patients

    PubMed Central

    Feng, Wen-Ming; Qiu, Wei

    2016-01-01

    This study evaluated the inflammatory markers in prediabetes and newly diagnosed type 2 diabetes mellitus (T2DM). Inflammatory markers levels were analyzed using one-way analysis of covariance and the association with prediabetes or T2DM risks was examined by logistic regression models. Our data showed increased levels of hypersensitivity C-reactive protein (hs-CRP), interleukin (IL-4), IL-10, and tryptase in prediabetes subjects and hs-CRP, immunoglobulin E (IgE), IL-4, and IL-10 in T2DM subjects. We concluded that Hs-CRP, IgE, IL-4, IL-10, and tryptase were positively associated with prediabetes or T2DM. Further large prospective studies are warranted to assess a temporal relation between inflammatory biomarkers and incidence of prediabetes or T2DM and its associated chronic diseases. PMID:27478850

  6. A short-term psychoeducational intervention for patients newly diagnosed with cancer.

    PubMed

    Fawzy, F I

    1995-07-01

    The psychological and medical problems encountered by cancer patients are numerous and unique. The diagnosis of cancer frequently produces psychological distress. A review of the literature and the authors' clinical and research experience suggest that cancer patients may benefit from a variety of psychological intervention programs. A structured, psychiatric intervention consisting of health education, stress management/behavioral training, coping (including problem-solving techniques), and psychosocial group support offers the greatest potential benefit for patients newly diagnosed or in the early stages of their treatment. Early-stage interventions that encourage active behavioral coping and active cognitive coping rather than avoidance or passive acceptance of the illness can be helpful psychologically. These active behavioral and cognitive coping behaviors, which can be learned, can attenuate the psychological distress caused by stressful illness, decrease the amount of psychosocial adjustment to the illness needed, improve overall quality of life, and may also be associated with longer survival times.

  7. A Multidimensional Analysis of Body Image Concerns Among Newly Diagnosed Patients with Oral Cavity Cancer

    PubMed Central

    Fingeret, Michelle Cororve; Vidrine, Damon J.; Reece, Gregory P.; Gillenwater, Ann M.; Gritz, Ellen R.

    2009-01-01

    Background Body image is a critical psychosocial issue for patients facing treatment for oral cancer yet there is limited research conducted in this area. This study utilizes a multidimensional approach to body image assessment and evaluates relationships between body image, demographic, health, and psychosocial variables. Methods Newly diagnosed patients with oral cancer completed self-report questionnaires and a structured clinical interview. Results Most participants identified current and/or future body image concerns primarily related to impending surgery. Adequate psychometric properties were demonstrated on a range of body image measures. Depression was the strongest and most consistent predictor of body image outcomes. Conclusions Preliminary evidence supports the importance of evaluating body image concerns in oral cancer patients prior to surgical intervention. Our findings have implications for developing validated body image tools and can be used to guide psychosocial interventions targeting body image disturbance. PMID:19626634

  8. Influence of Obesity on Efficacy and Toxicity of Induction Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia

    PubMed Central

    Lin, Andrew; Othus, Megan; McQuary, Amy; Chi, Mary; Estey, Elihu

    2015-01-01

    Background Increased body mass index (BMI) is associated with increased risk of treatment-related complications and inferior overall survival in children and adolescents with AML. The growing proportion of the general population who are obese raises the dilemma of whether the pharmacokinetic differences in obese patients necessitate chemotherapy dosage adjustments. This also poses the question of whether obese patients experience differing outcomes or toxicities with chemotherapy. Objective We are retrospectively evaluating the association between percentage of ideal body weight (IBW) and complete remission (CR) among newly diagnosed, previously untreated AML patients. We also describe secondary objectives including associations between IBW and overall survival (OS), platelet and neutrophil recovery, and incidence of grade 3-4 hematologic and nonhematologic toxic effects. Additionally, we characterize the dosing strategies used for induction chemotherapy in obese patients with AML at a single institution. Methods This is a retrospective study of obesity and its impact on outcome in 63 newly diagnosed, previously untreated adults with AML receiving standard induction chemotherapy with 7 + 3 from 2006 to 2010. Results The median percentage of ideal body weight was 121% (range 86-246%). Thirty-five percent of patients were obese (≥ 130% IBW). Controlling for history of prior malignancies, FLT3-ITD status, and NPM1, obesity was not associated with CR (odds ratio [OR] = 0.97, p=0.88), OS (hazard ratio=0.48, p=0.52), platelet recovery by 30 days (OR=1.14, p=0.52), or neutrophil recovery by 30 days (OR=1.12, p=0.60). Among obese patients, CR rates were not significantly different comparing patients not dose adjusted to patients with obesity-related adjustments (CR=86% vs. 67%, p=0.55) Conclusion In this study population, obesity was not an independent prognostic factor of outcome or toxicity. Empiric dose reductions based on obesity did not result is significantly

  9. Clofarabine, idarubicin, and cytarabine (CIA) as frontline therapy for patients ≤60 years with newly diagnosed acute myeloid leukemia.

    PubMed

    Nazha, Aziz; Kantarjian, Hagop; Ravandi, Farhad; Huang, Xuelin; Choi, Sangbum; Garcia-Manero, Guillermo; Jabbour, Elias; Borthakur, Gautam; Kadia, Tapan; Konopleva, Marina; Cortes, Jorge; Ferrajoli, Alessandra; Kornblau, Steve; Daver, Naval; Pemmaraju, Naveen; Andreeff, Michael; Estrov, Zeev; Du, Min; Brandt, Mark; Faderl, Stefan

    2013-11-01

    Clofarabine is a second generation nucleoside analogue with activity in adults with acute myeloid leukemia (AML). A phase I trial of clofarabine, idarubicin, and cytarabine (CIA) in relapsed and refractory AML had shown an overall response rate (ORR) of 48%. To explore this combination further, we conducted a phase II study of (CIA) in patients with newly diagnosed AML ≤60 years. Patients ≥18-60 years with AML and adequate organ function were enrolled. Induction therapy consisted of clofarabine (C) 20 mg m⁻² IV daily (days 1-5), idarubicin (I) 10 mg m⁻² IV daily (days 1-3), and cytarabine (A) 1 g m⁻² IV daily (days 1-5). Patients in remission received up to six consolidation cycles (C 15 mg m⁻² × 3, I 8 mg m⁻² × 2, and A 0.75 g m⁻² × 3). Fifty-seven patients were evaluable. ORR was 79%. With a median follow up of 10.9 months, the median overall survival (OS) was not reached, the median event-free survival (EFS) was 13.5 months. Most toxicities were ≤grade 2. Four week mortality was 2%. In subgroup analysis, patients ≤40 years had better OS (P = 0.04) and EFS (P = 0.04) compared to patients >40 years. Compared to historical patients treated with idarubicin and cyarabine (IA), the OS and EFS were significantly longer for CIA treated patients. In multivariate analysis, CIA retained its favorable impact on OS compared to IA. Thus, CIA is an effective and safe therapy for patients ≤60 years with newly diagnosed AML.

  10. A randomised controlled trial of a self-management plan for patients with newly diagnosed angina.

    PubMed Central

    Lewin, R J P; Furze, G; Robinson, J; Griffith, K; Wiseman, S; Pye, M; Boyle, R

    2002-01-01

    BACKGROUND: There are approximately 1.8 million patients with angina in the United Kingdom, many of whom report a poor quality of life, including raised levels of anxiety and depression. AIM: To evaluate the effect of a cognitive behavioural disease management programme, the Angina Plan, on psychological adjustment in patients newly diagnosed with angina pectoris. DESIGN OF STUDY: Randomised controlled trial. SETTING: Patients from GP practices in a Northern UK city (York) between April 1999 and May 2000. METHOD: Recruited patients were randomised to receive the Angina Plan or to a routine, practice nurse-led secondary prevention educational session. RESULTS: Twenty of the 25 practices invited to join the study supplied patients' names; 142 patients attended an assessment clinic and were randomised There were no significant differences in any baseline measures. At the six month post-treatment follow-up, 130 (91%) patients were reassessed. When compared with the educational session patients (using analysis of covariance adjusted for baseline scores in an intention-to-treat analysis) Angina Plan patients showed a greater reduction in anxiety (P = 0.05) and depression (P = 0.01), the frequency of angina (reduced by three episodes per week, versus a reduction of 0.4 per week, P = 0.016) the use of glyceryl trinitrate (reduced by 4.19 fewer doses per week versus a reduction of 0.59 per week, P = 0.018), and physical limitations (P<0.001: Seattle Angina Questionnaire). They were also more likely to report having changed their diet (41 versus 21, P<0.001) and increased their daily walking (30 versus 2, P<0.001). There was no significant difference between the groups on the other sub-scales of the Seattle Angina Questionnaire or in any of the medical variables measured. CONCLUSION: The Angina Plan appears to improve the psychological, symptomatic, and functional status of patients newly diagnosed with angina. PMID:12030661

  11. Continuous remission of newly diagnosed and relapsed central nervous system atypical teratoid/rhabdoid tumor.

    PubMed

    Zimmerman, Mary Ann; Goumnerova, Liliana C; Proctor, Mark; Scott, R Michael; Marcus, Karen; Pomeroy, Scott L; Turner, Christopher D; Chi, Susan N; Chordas, Christine; Kieran, Mark W

    2005-03-01

    Atypical teratoid/rhabdoid tumors (AT/RT) are highly malignant lesions of childhood that carry a very poor prognosis. AT/RT can occur in the central nervous system (CNS AT/RT) and disease in this location carries an even worse prognosis with a median survival of 7 months. In spite of multiple treatment regimens consisting of maximal surgical resection (including second look surgery), radiation therapy (focal and craniospinal), and multi-agent intravenous, oral and intrathecal chemotherapy, with or without high-dose therapy and stem cell rescue, only seven long-term survivors of CNS AT/RT have been reported, all in patients with newly diagnosed disease. For this reason, many centers now direct such patients, particularly those under 5 years of age, or those with recurrent disease, towards comfort care rather than attempt curative therapy. We now report on four children, two with newly diagnosed CNS AT/RT and two with progressive disease after multi-agent chemotherapy who are long term survivors (median follow-up of 37 months) using a combination of surgery, radiation therapy, and intensive chemotherapy. The chemotherapy component was modified from the Intergroup Rhabdomyosarcoma Study Group (IRS III) parameningeal protocol as three of the seven reported survivors in the literature were treated using this type of therapy. Our four patients, when added to the three reported survivors in the literature using this approach, suggest that patients provided this aggressive therapy can significantly alter the course of their disease. More importantly, we report on the first two survivors after relapse with multi-agent intravenous and intrathecal chemotherapy treated with this modified regimen. PMID:15803379

  12. Newly diagnosed rheumatic heart disease among indigenous populations in the Pacific

    PubMed Central

    Mirabel, Mariana; Tafflet, Muriel; Noël, Baptiste; Parks, Tom; Axler, Olivier; Robert, Jacques; Nadra, Marie; Phelippeau, Gwendolyne; Descloux, Elodie; Cazorla, Cécile; Missotte, Isabelle; Gervolino, Shirley; Barguil, Yann; Rouchon, Bernard; Laumond, Sylvie; Jubeau, Thierry; Braunstein, Corinne; Empana, Jean-Philippe; Marijon, Eloi; Jouven, Xavier

    2015-01-01

    Objectives Rheumatic heart disease (RHD) remains the leading acquired heart disease in the young worldwide. We aimed at assessing outcomes and influencing factors in the contemporary era. Methods Hospital-based cohort in a high-income island nation where RHD remains endemic and the population is captive. All patients admitted with newly diagnosed RHD according to World Heart Federation echocardiographic criteria were enrolled (2005–2013). The incidence of major cardiovascular events (MACEs) including heart failure, peripheral embolism, stroke, heart valve intervention and cardiovascular death was calculated, and their determinants identified. Results Of the 396 patients, 43.9% were male with median age 18 years (IQR 10–40)). 127 (32.1%) patients presented with mild, 131 (33.1%) with moderate and 138 (34.8%) with severe heart valve disease. 205 (51.8%) had features of acute rheumatic fever. 106 (26.8%) presented with at least one MACE. Among the remaining 290 patients, after a median follow-up period of 4.08 (95% CI 1.84 to 6.84) years, 7 patients (2.4%) died and 62 (21.4%) had a first MACE. The annual incidence of first MACE and of heart failure were 59.05‰ (95% CI 44.35 to 73.75) and 29.06‰ (95% CI 19.29 to 38.82), respectively. The severity of RHD at diagnosis (moderate vs mild HR 3.39 (0.95 to 12.12); severe vs mild RHD HR 10.81 (3.11 to 37.62), p<0.001) and ongoing secondary prophylaxis at follow-up (HR 0.27 (0.12 to 0.63), p=0.01) were the two most influential factors associated with MACE. Conclusions Newly diagnosed RHD is associated with poor outcomes, mainly in patients with moderate or severe valve disease and no secondary prophylaxis. PMID:26537732

  13. Nondisclosure of HIV Status in a Clinical Trial Setting: Antiretroviral Drug Screening Can Help Distinguish Between Newly Diagnosed and Previously Diagnosed HIV Infection

    PubMed Central

    Marzinke, Mark A.; Clarke, William; Wang, Lei; Cummings, Vanessa; Liu, Ting-Yuan; Piwowar-Manning, Estelle; Breaud, Autumn; Griffith, Sam; Buchbinder, Susan; Shoptaw, Steven; del Rio, Carlos; Magnus, Manya; Mannheimer, Sharon; Fields, Sheldon D.; Mayer, Kenneth H.; Wheeler, Darrell P.; Koblin, Beryl A.; Eshleman, Susan H.; Fogel, Jessica M.

    2014-01-01

    In The HIV Prevention Trials Network 061 study, 155 human immunodeficiency virus (HIV)–infected men reported no prior HIV diagnosis; 83 of those men had HIV RNA levels of <1000 copies/mL at enrollment. Antiretroviral drug testing revealed that 65 of the 83 (78.3%) men were on antiretroviral treatment. Antiretroviral drug testing can help distinguish between newly diagnosed and previously diagnosed HIV infection. PMID:24092804

  14. Emotion Episodes during Psychotherapy Sessions among Women Newly Diagnosed with Gynecological Cancers

    PubMed Central

    Virtue, Shannon Myers; Manne, Sharon L.; O’Neill, Kathleen; Heckman, Carolyn J.; Ozga, Melissa; Kissane, David; Rubin, Stephen; Rosenblum, Norman

    2015-01-01

    Objective To describe emotion episodes during early and late psychotherapy sessions among women newly diagnosed with gynecological cancer and to examine whether the total number of emotional episodes during early and later sessions were associated with baseline psychological distress, dispositional emotion expressivity, and patient-rated therapeutic progress. Methods The study utilized data from an ongoing study examining the efficacy of two psychotherapy interventions, a coping and communication intervention (CCI) and a supportive counseling intervention (SC), for women diagnosed with gynecological cancer. Emotion episode coding was completed for the first and sixth psychotherapy session for each patient randomized to receive psychotherapy (N = 173). Patients completed baseline survey measures of psychological distress and dispositional emotional expressivity and post-session ratings of therapeutic progress. Results The average number of emotion episodes was 7.4 in the first session and 5.2 episodes in the sixth session. In both sessions, the majority of emotion episodes contained only negative emotions and focused on a cancer-related topic. A higher1number of emotion episodes in the first session was associated with higher psychological distress reported in the baseline survey (p = .02). A higher number of emotions episodes in the sixth session was associated with a higher number of emotion episodes in the first session (p < .001) and higher patient-rated progress as rated in the sixth session (p = .016). Conclusion The findings highlight the importance of expressed emotions, particularly negative emotions about cancer-related topics, in therapeutic progress during psychotherapy among women diagnosed with gynecological cancer. PMID:25521772

  15. Apparent diffusion coefficient and fractional anisotropy of newly diagnosed grade II gliomas†

    PubMed Central

    Khayal, Inas S.; McKnight, Tracy R.; McGue, Colleen; Vandenberg, Scott; Lamborn, Kathleen R.; Chang, Susan M.; Cha, Soonmee; Nelson, Sarah J.

    2013-01-01

    Distinguishing between low-grade oligodendrogliomas (ODs) and astrocytomas (AC) is of interest for defining prognosis and stratifying patients to specific treatment regimens. The purpose of this study was to determine if the apparent diffusion coefficient (ADC) and fractional anisotropy (FA) from diffusion imaging can help to differentiate between newly diagnosed grade II OD and AC subtypes and to evaluate the ADC and FA values for the mixed population of oligoastrocytomas (OA). Fifty-three patients with newly diagnosed grade II gliomas were studied using a 1.5T whole body scanner (23 ODs, 16 ACs, and 14 OAs). The imaging protocol included post-gadolinium T1-weighted images, T2-weighted images, and either three and/or six directional diffusion imaging sequence with b = 1000 s/mm2. Diffusion-weighted images were analyzed using in-house software to calculate maps of ADC and for six directional acquisitions, FA. The intensity values were normalized by values from normal appearing white matter (NAWM) to generate maps of normalized apparent diffusion coefficient (nADC) and normalized fractional anisotropy (nFA). The hyperintense region in the T2 weighted image was defined as the T2All region. A Mann–Whitney rank-sum test was performed on the 25th, median, and 75th nADC and nFA among the three subtypes. Logistic regression was performed to determine how well the nADC and nFA predict subtype. Lesions diagnosed as being OD had significantly lower nADC and significantly higher nFA, compared to AC. The nADC and nFA values individually classified the data with an accuracy of 87%. Combining the two did not enhance the classification. The patients with OA had nADC and nFA values between those of OD and AC. This suggests that ADC and FA may be helpful in directing tissue sampling to the most appropriate regions for taking biopsies in order to make a definitive diagnosis. PMID:19125391

  16. Assessing the Concordance of Measures Used to Diagnose Adult ADHD

    ERIC Educational Resources Information Center

    Belendiuk, Katherine A.; Clarke, Tana L.; Chronis, Andrea M.; Raggi, Veronica L.

    2007-01-01

    Objective: Recent evidence suggests that ADHD persists into adulthood, but the best means of diagnosis and the concordance of measures used to diagnose adult ADHD are unknown. Method: The current study explores the relationships of these measures in a sample of 69 mothers of children with ADHD. Results: This study determines the concordance of (a)…

  17. Childhood Risk Factors in Dually Diagnosed Homeless Adults.

    ERIC Educational Resources Information Center

    Blankertz, Laura E.; And Others

    1993-01-01

    Examined prevalence of five childhood risk factors (sexual abuse, physical abuse, parental mental illness, substance abuse, out-of-home placement) among dually diagnosed (mentally ill and substance abusing) homeless adults (n=156) in rehabilitation programs. Findings suggest that childhood risk factors, whether single or multiple, are very…

  18. Failure-Free Survival and Radiotherapy in Patients With Newly Diagnosed Nonmetastatic Prostate Cancer

    PubMed Central

    James, Nicholas D.; Spears, Melissa R.; Clarke, Noel W.; Dearnaley, David P.; Mason, Malcolm D.; Parker, Christopher C.; Ritchie, Alastair W. S.; Russell, J. Martin; Schiavone, Francesca; Attard, Gerhardt; de Bono, Johann S.; Birtle, Alison; Engeler, Daniel S.; Elliott, Tony; Matheson, David; O’Sullivan, Joe; Pudney, Delia; Srihari, Narayanan; Wallace, Jan; Barber, Jim; Syndikus, Isabel; Parmar, Mahesh K. B.; Sydes, Matthew R.

    2016-01-01

    IMPORTANCE The natural history of patients with newly diagnosed high-risk nonmetastatic (M0) prostate cancer receiving hormone therapy (HT) either alone or with standard-of-care radiotherapy (RT) is not well documented. Furthermore, no clinical trial has assessed the role of RT in patients with node-positive (N+) M0 disease. The STAMPEDE Trial includes such individuals, allowing an exploratory multivariate analysis of the impact of radical RT. OBJECTIVE To describe survival and the impact on failure-free survival of RT by nodal involvement in these patients. DESIGN, SETTING, AND PARTICIPANTS Cohort study using data collected for patients allocated to the control arm (standard-of-care only) of the STAMPEDE Trial between October 5, 2005, and May 1, 2014. Outcomes are presented as hazard ratios (HRs) with 95% CIs derived from adjusted Cox models; survival estimates are reported at 2 and 5 years. Participants were high-risk, hormone-naive patients with newly diagnosed M0 prostate cancer starting long-term HT for the first time. Radiotherapy is encouraged in this group, but mandated for patients with node-negative (N0) M0 disease only since November 2011. EXPOSURES Long-term HT either alone or with RT, as per local standard. Planned RT use was recorded at entry. MAIN OUTCOMES AND MEASURES Failure-free survival (FFS) and overall survival. RESULTS A total of 721 men with newly diagnosed M0 disease were included: median age at entry, 66 (interquartile range [IQR], 61-72) years, median (IQR) prostate-specific antigen level of 43 (18-88) ng/mL. There were 40 deaths (31 owing to prostate cancer) with 17 months’ median follow-up. Two-year survival was 96% (95% CI, 93%-97%) and 2-year FFS, 77% (95% CI, 73%-81%). Median (IQR) FFS was 63 (26 to not reached) months. Time to FFS was worse in patients with N+ disease (HR, 2.02 [95% CI, 1.46-2.81]) than in those with N0 disease. Failure-free survival outcomes favored planned use of RT for patients with both N0M0 (HR, 0.33 [95% CI

  19. Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma

    ClinicalTrials.gov

    2016-08-09

    Contiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Stage I Adult Lymphoblastic Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Untreated Adult Acute Lymphoblastic Leukemia

  20. Effectiveness of Initial Extracorporeal Shock Wave Therapy on the Newly Diagnosed Lateral or Medial Epicondylitis

    PubMed Central

    Lee, Sang Seok; Park, Noh Kyoung; Lee, Chan Woo; Song, Ho Sup; Sohn, Min Kyun; Cho, Kang Hee; Kim, Jung Hwan

    2012-01-01

    Objective To evaluate the effectiveness of initial extracorporeal shock wave therapy (ESWT) for patients newly diagnosed with lateral or medial epicondylitis, compared to local steroid injection. Method An analysis was conducted of twenty-two patients who were newly confirmed as lateral or medial epicondylitis through medical history and physical examination. The ESWT group (n=12) was treated once a week for 3 weeks using low energy (0.06-0.12 mJ/mm2, 2,000 shocks), while the local steroid injection group (n=10) was treated once with triamcinolone 10 mg mixed with 1% lidocaine solution. Nirschl score and 100 point score were assessed before and after the treatments of 1st, 2nd, 4th and 8th week. And Roles and Maudsley score was assessed one and eight weeks after the treatments. Results Both groups showed significant improvement in Nirschl score and 100 point score during the entire period. The local steroid injection group improved more in Nirschl score at the first week and in 100 point score at the first 2 weeks, compared to those of the ESWT group. But the proportion of excellent and good grades of Roles and Maudsley score in the ESWT group increased more than that of local steroid injection group by the final 8th week. Conclusion The ESWT group improved as much as the local steroid injection group as treatment for medial and lateral epicondylitis. Therefore, ESWT can be a useful treatment option in patients for whom local steroid injection is difficult. PMID:23185733

  1. Phase II Trial of Hypofractionated IMRT With Temozolomide for Patients With Newly Diagnosed Glioblastoma Multiforme

    SciTech Connect

    Reddy, Krishna; Damek, Denise; Gaspar, Laurie E.; Ney, Douglas; Waziri, Allen; Lillehei, Kevin; Stuhr, Kelly; Kavanagh, Brian D.; Chen Changhu

    2012-11-01

    Purpose: To report toxicity and overall survival (OS) in patients with newly diagnosed glioblastoma multiforme (GBM) treated with hypofractionated intensity-modulated radiotherapy (hypo-IMRT) with concurrent and adjuvant temozolomide (TMZ). Methods and Materials: Patients with newly diagnosed GBM after biopsy or resection and with adequate performance status and organ or bone marrow function were eligible for this study. Patients received postoperative hypo-IMRT to the surgical cavity and residual tumor seen on T1-weighted brain MRI with a 5-mm margin to a total dose of 60 Gy in 10 fractions (6 Gy/fraction) and to the T2 abnormality on T2-weighted MRI with 5-mm margin to 30 Gy in 10 fractions (3 Gy/fraction). Concurrent TMZ was given at 75 mg/m{sup 2}/day for 28 consecutive days. Adjuvant TMZ was given at 150 to 200 mg/m{sup 2}/day for 5 days every 28 days. Toxicities were defined using Common Terminology Criteria for Adverse Events version 3.0. Results: Twenty-four patients were treated, consisting of 14 men, 10 women; a median age of 60.5 years old (range, 27-77 years); and a median Karnofsky performance score of 80 (range, 60-90). All patients received hypo-IMRT and concurrent TMZ according to protocol, except for 2 patients who received only 14 days of concurrent TMZ. The median number of adjuvant TMZ cycles was 6.5 (range, 0-14).With a median follow-up of 14.8 months (range, 2.7-34.2 months) for all patients and a minimum follow-up of 20.6 months for living patients, no instances of grade 3 or higher nonhematologic toxicity were observed. The median OS was 16.6 months (range, 4.1-35.9 months). Six patients underwent repeated surgery for suspected tumor recurrence; necrosis was found in 50% to 100% of the resected specimens. Conclusion: In selected GBM patients, 60 Gy hypo-IMRT delivered in 6-Gy fractions over 2 weeks with concurrent and adjuvant TMZ is safe. OS in this small cohort of patients was comparable to that treated with current standard of care

  2. Vitamin D and Sunlight Exposure in Newly-Diagnosed Parkinson's Disease.

    PubMed

    Wang, Juan; Yang, Deyu; Yu, Yu; Shao, Gaohai; Wang, Qunbo

    2016-03-04

    Circulating vitamin D has previously been found to be lower in patients with Parkinson's disease (PD), while the effects of sunlight exposure have not yet been fully investigated. Therefore, we evaluated the associations between serum vitamin D, vitamin D intake, sunlight exposure, and newly-diagnosed PD patients in a Chinese population. This case-control study measured serum 25-hydroxyvitamin D (25(OH)D) levels and sunlight exposure in 201 patients with newly-diagnosed PD and 199 controls without neurodegenerative diseases. Data on vitamin D intake and sunlight exposure were obtained using a self-report questionnaire. Multivariable logistic regressions were employed to evaluate the associations between serum 25(OH)D levels, sunlight exposure, and PD. Adjustments were made for sex, age, smoking, alcohol use, education, BMI, and vitamin D intake. There were significantly lower levels of serum 25(OH)D (20.6 ± 6.5 ng/mL), daily vitamin D intake (8.3 ± 3.7 g/day), and sunlight exposure (9.7 ± 4.1 h/week) in patients with PD compared to healthy controls (p < 0.05). Crude odds ratios (ORs) for PD in the quartiles of serum 25(OH)D were 1 (reference), 0.710 (0.401, 1.257), 0.631 (0.348, 1.209), and 0.483 (0.267, 0.874), respectively. Crude ORs for PD in quartiles of sunlight exposure were 1 (reference), 0.809 (0.454, 1.443), 0.623 (0.345, 1.124) and 0.533 (0.294, 0.966), respectively. A significant positive correlation between serum 25(OH)D and sunlight exposure was found, but serum 25(OH)D was not correlated with daily vitamin D intake. This study indicates that lower levels of serum 25(OH)D and sunlight exposure are significantly associated with an increased risk for PD.

  3. Brain putamen volume changes in newly-diagnosed patients with obstructive sleep apnea.

    PubMed

    Kumar, Rajesh; Farahvar, Salar; Ogren, Jennifer A; Macey, Paul M; Thompson, Paul M; Woo, Mary A; Yan-Go, Frisca L; Harper, Ronald M

    2014-01-01

    Obstructive sleep apnea (OSA) is accompanied by cognitive, motor, autonomic, learning, and affective abnormalities. The putamen serves several of these functions, especially motor and autonomic behaviors, but whether global and specific sub-regions of that structure are damaged is unclear. We assessed global and regional putamen volumes in 43 recently-diagnosed, treatment-naïve OSA (age, 46.4 ± 8.8 years; 31 male) and 61 control subjects (47.6 ± 8.8 years; 39 male) using high-resolution T1-weighted images collected with a 3.0-Tesla MRI scanner. Global putamen volumes were calculated, and group differences evaluated with independent samples t-tests, as well as with analysis of covariance (covariates; age, gender, and total intracranial volume). Regional differences between groups were visualized with 3D surface morphometry-based group ratio maps. OSA subjects showed significantly higher global putamen volumes, relative to controls. Regional analyses showed putamen areas with increased and decreased tissue volumes in OSA relative to control subjects, including increases in caudal, mid-dorsal, mid-ventral portions, and ventral regions, while areas with decreased volumes appeared in rostral, mid-dorsal, medial-caudal, and mid-ventral sites. Global putamen volumes were significantly higher in the OSA subjects, but local sites showed both higher and lower volumes. The appearance of localized volume alterations points to differential hypoxic or perfusion action on glia and other tissues within the structure, and may reflect a stage in progression of injury in these newly-diagnosed patients toward the overall volume loss found in patients with chronic OSA. The regional changes may underlie some of the specific deficits in motor, autonomic, and neuropsychologic functions in OSA.

  4. Left atrial dimension is related to blood pressure variability in newly diagnosed untreated hypertensive patients.

    PubMed

    Cipollini, Franco; Arcangeli, Enrica; Seghieri, Giuseppe

    2016-08-01

    Variability in daily blood pressure (BPV) recorded 24-h ambulatory blood pressure monitoring (ABPM) is known to be related to left ventricular hypertrophy and an increased incidence of cardiovascular events in hypertensive patients. The aim of this study was to evaluate whether left atrium dimension, which increases early in hypertensive subjects, was related to BPV in a group of 167 drug-naive patients (100M/67F, age: 46±11yr). The patients were chosen among those consecutively sent by their general practitioners to confirm the existence of arterial hypertension and afterwards diagnosed as hypertensive (mean 24-h ABPM ⩾130/80 mm Hg). In each patient, the left atrial posteroanterior diameter index for height (LADi) and the left ventricular mass standardized for body surface area (LVMi) were measured using standardized echocardiographic methods. BPV was calculated as the weighted mean of daytime and nighttime systolic and diastolic blood pressure s.d.'s (ws.d.), according to the formula ws.d.=[(daytime s.d. × 10)+nighttime s.d. × 6)]/16. An increase in left atrial dimension (LADi>24 mm m(-1)) was present in 36 patients (21.6% of the total population). In a univariate regression, LVMi was significantly related to systolic BPV (r=0.24; P=0.02) only in men, whereas LADi was significantly related to both systolic and diastolic BPV in both genders. After adjusting for sex, age, BMI, heart rate, diastolic function and estimated glomerular filtration rate, both systolic and diastolic BPV remained significantly related to LADi (P=0.02 for both) but not to LVMi. In conclusion, this study suggests that BVP, as measured as BPws.d., is significantly and independently associated with increased LADi in newly diagnosed, treatment-naive hypertensive patients. PMID:27009578

  5. Psychiatric illness and psychosocial concerns of patients with newly diagnosed lung cancer.

    PubMed Central

    Ginsburg, M L; Quirt, C; Ginsburg, A D; MacKillop, W J

    1995-01-01

    OBJECTIVE: To determine the nature and incidence of psychiatric illness, symptoms of potential psychiatric significance, substance abuse and psychosocial concerns among patients with newly diagnosed lung cancer. DESIGN: Case series. SETTING: Kingston Regional Cancer Centre, a tertiary care facility for ambulatory cancer patients. PATIENTS: Seventy-one consecutive English-speaking patients with recently diagnosed lung cancer undergoing radiotherapy or chemotherapy were asked to participate; 52 of the 57 patients who agreed were available for evaluation. OUTCOME MEASURES: Current and previous psychiatric diagnoses of affective, anxiety and adjustment disorders, and alcohol and tobacco abuse; symptoms of sadness, fear, shock, anger, denial, acceptance, guilt, suicidal ideation, thoughts of death, insomnia, loss of libido, impaired concentration and reduced level of work or interest; psychosocial concerns about family, work and finances; and an impression of coping. RESULTS: At the time of the interview two (4%) of the patients were found to have an affective disorder, none had an anxiety disorder, and six (12%) had an adjustment disorder. Previously, 16 patients (31%) had had an affective or anxiety disorder or both. Two (4%) had had an adjustment disorder following the diagnosis of their lung cancer that had resolved before the interview. At some point in their lives 24 patients (46%) had abused alcohol, and 7 (13%) were currently abusing alcohol. All had smoked, 33 (63%) having been tobacco dependent. Feelings of sadness were expressed by 23 (44%), fear by 15 (29%), anger by 2 (4%), shock by 9 (17%) and guilt by 4 (8%). Seven (13%) had considered suicide, and thoughts of death were reported by 16 (31%). Twenty (38%) were accepting of their diagnosis, and 5 (10%) expressed optimism. Twenty-seven (52%) had insomnia, which was reported to be severe by 15 (29%). Loss of libido was reported by 25 (48%) and was severe in 14 (27%). Difficulty concentrating was reported by

  6. Alteration of cardiac autonomic function in patients with newly diagnosed epilepsy.

    PubMed

    Goit, Rajesh K; Jha, Santosh K; Pant, Bhawana N

    2016-06-01

    The aim of the study was to determine if heart rate variability (HRV) showed any changes in patients with newly diagnosed epilepsy in comparison with controls. Sixty-five patients with epilepsy (38 males and 27 females), aged 30-50 years, who had never previously received treatment with antiepileptic drugs were eligible for inclusion in this study. Resting electrocardiogram (ECG) at spontaneous respiration was recorded for 5 min in supine position. Time-domain analysis, frequency-domain analysis, and Poincare plot of HRV were recorded from ECG In time-domain measures, the square root of the mean of the sum of the squares of differences between adjacent RR intervals (RMSSD) and percentage of consecutive RR intervals that differ by more than 50 msec (pNN50) were significantly less in patients with epilepsy. In frequency-domain measures, high frequency [(HF) msec(2)], HF (nu), and low frequency [LF (msec(2))] were significantly less in patients with epilepsy while LF (nu) and LF/HF were significantly high in patients with epilepsy. In Poincare plot, standard deviation perpendicular to line of Poincare plot (SD1) and standard deviation along the line of entity in Poincare plot (SD2) were significantly less in patients with epilepsy. Our results suggest that epileptic patients have an impact on the cardiac autonomic function as measured by HRV.

  7. Telomere Length and Pulse Pressure in Newly Diagnosed, Antipsychotic-Naive Patients With Nonaffective Psychosis

    PubMed Central

    Fernandez-Egea, Emilio; Bernardo, Miguel; Heaphy, Christopher M.; Griffith, Jeffrey K.; Parellada, Eduard; Esmatjes, Enric; Conget, Ignacio; Nguyen, Linh; George, Varghese; Stöppler, Hubert; Kirkpatrick, Brian

    2009-01-01

    Introduction: Recent studies suggest that in addition to factors such as treatment side effects, suicide, and poor health habits, people with schizophrenia may have an increased risk of diabetes prior to antipsychotic treatment. Diabetes is associated with an increased pulse pressure (PP) and a shortened telomere. We tested the hypothesis that prior to antipsychotic treatment, schizophrenia and related disorders are associated with a shortened telomere, as well as an increased PP. Methods: Telomere content (which is highly correlated with telomere length) and PP were measured in newly diagnosed, antipsychotic-naive patients with schizophrenia and related disorders on first clinical contact and in matched control subjects. Both groups were also administered an oral glucose tolerance test. Results: Compared with control subjects, the patients with psychosis had decreased telomere content and an increased PP. As previously reported, they also had increased glucose concentrations at 2 hours. These differences could not be attributed to differences in age, ethnicity, smoking, gender, body mass index, neighborhood of residence, socioeconomic status, aerobic conditioning, or an increased cortisol concentration in the psychotic subjects. Discussion: These results suggest that prior to antipsychotic use, nonaffective psychosis is associated with reduced telomere content and increased PP, indices that have been linked to an increased risk of diabetes and hypertension. PMID:19279086

  8. Outcomes for newly diagnosed patients with acute myeloid leukemia dosed on actual or adjusted body weight

    PubMed Central

    Bivona, Cory; Rockey, Michelle; Henry, Dave; Grauer, Dennis; Abhyankar, Sunil; Aljitawi, Omar; Ganguly, Siddhartha; McGuirk, Joseph; Singh, Anurag; Lin, Tara L.

    2015-01-01

    Purpose Data from solid tumor malignancies suggest that actual body weight (ABW) dosing improves overall outcomes. There is the potential to compromise efficacy when chemotherapy dosages are reduced, but the impact of dose adjustment on clinical response and toxicity in hematologic malignancies is unknown. The purpose of this study was to evaluate the outcomes of utilizing a percent of ABW for acute myeloid leukemia (AML) induction chemotherapy dosing. Methods This retrospective, single-center study included 146 patients who received 7 + 3 induction (cytarabine and anthracycline) for treatment of AML. Study design evaluated the relationship between percentage of ABW dosing and complete response (CR) rates in patients newly diagnosed with AML. Results Percentage of ABW dosing did not influence CR rates in patients undergoing induction chemotherapy for AML (p = 0.83); nor did it influence rate of death at 30 days or relapse at 6 months (p = 0.94). When comparing patients dosed at 90–100 % of ABW compared to <90 % ABW, CR rates were not significantly different in patients classified as poor risk (p = 0.907). All favorable risk category patients obtained CR. Conclusions Preemptive dose reductions for obesity did not influence CR rates for patients with AML undergoing induction chemotherapy and did not influence the composite endpoint of death at 30 days or disease relapse at 6 months. PMID:26231954

  9. Primary failure of bortezomib in newly diagnosed multiple myeloma--understanding the magnitude, predictors, and significance.

    PubMed

    Cohen, Yael C; Joffe, Erel; Benyamini, Noam; Dimopoulos, Meletios A; Terpos, Evangelos; Trestman, Svetlana; Held-Kuznetsov, Viki; Avivi, Irit; Kastritis, Efstathios

    2016-01-01

    Botezomib-based induction is highly effective for the treatment of newly diagnosed multiple myeloma (NDMM). We investigated the outcomes of NDMM patients who failed to respond to bortezomib-based induction in a 'real-life' clinical setting. In a cohort of 295 consecutive NDMM patients in 3 medical centers, 74 (25%) failed to achieve at least partial response after 4 induction cycles, and were classified as non-responsive. Compared to induction responders, they were older, more frequently anemic, had a higher incidence of del17p and ISS-3, and a worse performance status. In multivariable analysis, bortezomib-based induction failure occurred in 25% of patients and was the strongest independent factor predicting mortality with a 5-fold hazard ratio (95% CI 1.44-8.68). Three-year overall survival in responsive vs. non-responsive patients were 76% vs. 53%, respectively (p < 0.0001). Survival from time of salvage second-line treatment was significantly shorter among induction non-responders vs. responders (25 months vs. not-reached, p = 0.024). PMID:26727104

  10. In silico analysis suggests differential response to bevacizumab and radiation combination therapy in newly diagnosed glioblastoma

    PubMed Central

    Hawkins-Daarud, Andrea; Rockne, Russell; Corwin, David; Anderson, Alexander R. A.; Kinahan, Paul; Swanson, Kristin R.

    2015-01-01

    Recently, two phase III studies of bevacizumab, an anti-angiogenic, for newly diagnosed glioblastoma (GBM) patients were released. While they were unable to statistically significantly demonstrate that bevacizumab in combination with other therapies increases the overall survival of GBM patients, there remains a question of potential benefits for subpopulations of patients. We use a mathematical model of GBM growth to investigate differential benefits of combining surgical resection, radiation and bevacizumab across observed tumour growth kinetics. The differential hypoxic burden after gross total resection (GTR) was assessed along with the change in radiation cell kill from bevacizumab-induced tissue re-normalization when starting therapy for tumours at different diagnostic sizes. Depending on the tumour size at the time of treatment, our model predicted that GTR would remove a variable portion of the hypoxic burden ranging from 11% to 99.99%. Further, our model predicted that the combination of bevacizumab with radiation resulted in an additional cell kill ranging from 2.6×107 to 1.1×1010 cells. By considering the outcomes given individual tumour kinetics, our results indicate that the subpopulation of patients who would receive the greatest benefit from bevacizumab and radiation combination therapy are those with large, aggressive tumours and who are not eligible for GTR. PMID:26202682

  11. Nonmyeloablative allografting for newly diagnosed multiple myeloma: the experience of the Gruppo Italiano Trapianti di Midollo

    PubMed Central

    Rotta, Marcello; Patriarca, Francesca; Mattei, Daniele; Allione, Bernardino; Carnevale-Schianca, Fabrizio; Sorasio, Roberto; Rambaldi, Alessandro; Casini, Marco; Parma, Matteo; Bavaro, Pasqua; Onida, Francesco; Busca, Alessandro; Castagna, Luca; Benedetti, Edoardo; Iori, Anna Paola; Giaccone, Luisa; Palumbo, Antonio; Corradini, Paolo; Fanin, Renato; Maloney, David; Storb, Rainer; Baldi, Ileana; Ricardi, Umberto; Boccadoro, Mario

    2009-01-01

    Despite recent advances, allografting remains the only potential cure for myeloma. From July 1999 to June 2005, 100 newly diagnosed patients younger than 65 years were enrolled in a prospective multicenter study. First-line treatment included vincristin, adriamycin, and dexamethasone (VAD)–based induction chemotherapy, a cytoreductive autograft (melphalan 200 mg/m2) followed by a single dose of nonmyeloablative total body irradiation and allografting from an human leukocyte antigen (HLA)–identical sibling. Primary end points were the overall survival (OS) and event-free survival (EFS) from diagnosis. After a median follow-up of 5 years, OS was not reached, and EFS was 37 months. Incidences of acute and chronic graft-versus-host disease (GVHD) were 38% and 50%, respectively. Complete remission (CR) was achieved in 53% of patients. Profound cytoreduction (CR or very good partial remission) before allografting was associated with achievement of posttransplantation CR (hazard ratio [HR] 2.20, P = .03) and longer EFS (HR 0.33, P < .01). Conversely, development of chronic GVHD was not correlated with CR or response duration. This tandem transplantation approach allows prolonged survival and long-term disease control in patients with reduced tumor burden at the time of allografting. We are currently investigating the role of “new drugs” in intensifying pretransplantation cytoreduction and posttransplantation graft-versus-myeloma effects to further improve clinical outcomes. (http://ClinicalTrials.gov; NCT-00702247.) PMID:19064724

  12. Experience in fractionated stereotactic body radiation therapy boost for newly diagnosed nasopharyngeal carcinoma

    SciTech Connect

    Chen, Helen H.W.; Tsai, S.-T.; Wang, M.-S.; Wu, Y.-H.; Hsueh, W.-T.; Yang, M.-W.; Yeh, I-C.; Lin, J.-C. . E-mail: jclin@vghtc.gov.tw

    2006-12-01

    Purpose: Radiotherapy is the most effective treatment for nasopharyngeal carcinoma (NPC). The aim of this study is to evaluate the efficacy and toxicity of fractionated stereotactic body radiation therapy (SBRT) boost for NPC. Methods and Materials: Sixty-four patients with newly diagnosed, nonmetastatic NPC were treated with conventional radiotherapy 64.8-68.4 Gy followed by fractionated SBRT boost 12-15 Gy between January 2002 and July 2004. Most patients (72%) presented with Stage III-IV disease. Fifty-two patients also received cisplatin-based concurrent (38) or neoadjuvant (14) chemotherapy. The major endpoints were local control, overall survival, and complications. Results: All patients finished the planned dose of radiotherapy. After a median follow-up of 31 months (range, 22-54), 15 patients developed tumor recurrences-3 in the nasopharynx, 4 in the neck, 5 in distant sites, 1 in both nasopharynx and neck, 2 in the neck and a distant site. The 3-year actuarial rate of local control was 93.1%, regional control 91.4%, freedom from distant metastasis 90.3%, and overall survival 84.9%, respectively. There were no Grade 4 acute or chronic radiation-related complications. Conclusions: Fractionated SBRT boost for NPC is technically feasible and provides good local control without any severe complications.

  13. A psychoeducational nursing intervention to enhance coping and affective state in newly diagnosed malignant melanoma patients.

    PubMed

    Fawzy, N W

    1995-12-01

    The primary purpose of this study was to determine if a psychoeducational nursing intervention including (a) health education, (b) stress management, and (c) the teaching of coping skills could enhance the coping behavior and affective state of newly diagnosed Stage I/II malignant melanoma patients. The secondary purpose was to determine if this intervention could be implemented by a nurse and integrated into the overall patient care program. Sixty-one patients were randomized to a control condition or an experimental condition that received and educational manual plus 3 h of individual nurse teaching. Despite randomization, experimental patients had significantly higher baseline distress. By 3 months there was a complete reversal of the baseline trend in Profile of Mood States (POMS) total mood disturbance (TMD), suggesting that the experimental subjects were experiencing less distress over time. Between-group analysis of change scores found significant decreases in experimental subjects for POMS TMD, fatigue, and Brief Symptom Index (BSI) somatization. Within-group analysis found significant experimental decreases for BSI somatization, anxiety, grand total, General Severity Index, and Positive Symptom Distress Index as well as for POMS anxiety, fatigue, confusion, vigor, and TMD. No significant changes were found for controls. Experimental patients were using significantly fewer ineffective passive resignation coping strategies than controls at 3 months.

  14. A Guide for Clinicians in the Evaluation of Emerging Molecular Diagnostics for Newly Diagnosed Prostate Cancer

    PubMed Central

    Canfield, Steven E; Kibel, Adam S; Kemeter, Michael J; Febbo, Phillip G; Lawrence, H. Jeffrey; Moul, Judd W

    2014-01-01

    Prostate-specific antigen (PSA) screening is associated with a decline in prostate cancer-related mortality. However, screening has also led to overdiagnosis and overtreatment of clinically insignificant tumors. Recently, certain national guidelines (eg, US Preventive Services Task Force) have recommended against PSA screening, which may lead to a reverse-stage migration. Although many prostate tumors are indolent at presentation, others are aggressive and are appropriate targets for treatment interventions. Utilization of molecular markers may improve our ability to measure tumor biology and allow better discrimination of indolent and aggressive tumors at diagnosis. Many emerging commercial molecular diagnostic assays have been designed to provide more accurate risk stratification for newly diagnosed prostate cancer. Unfamiliarity with molecular diagnostics may make it challenging for some clinicians to navigate and interpret the medical literature to ascertain whether particular assays are appropriately developed and validated for clinical use. Herein, the authors provide a framework for practitioners to use when assessing new tissue-based molecular assays. This review outlines aspects of assay development, clinical and analytic validation and clinical utility studies, and regulatory issues, which collectively determine whether tests (1) are actionable for specific clinical indications, (2) measurably influence treatment decisions, and (3) are sufficiently validated to warrant incorporation into clinical practice. PMID:25548544

  15. New Breast Cancer Recursive Partitioning Analysis Prognostic Index in Patients With Newly Diagnosed Brain Metastases

    SciTech Connect

    Niwinska, Anna; Murawska, Magdalena

    2012-04-01

    Purpose: The aim of the study was to present a new breast cancer recursive partitioning analysis (RPA) prognostic index for patients with newly diagnosed brain metastases as a guide in clinical decision making. Methods and Materials: A prospectively collected group of 441 consecutive patients with breast cancer and brain metastases treated between the years 2003 and 2009 was assessed. Prognostic factors significant for univariate analysis were included into RPA. Results: Three prognostic classes of a new breast cancer RPA prognostic index were selected. The median survival of patients within prognostic Classes I, II, and III was 29, 9, and 2.4 months, respectively (p < 0.0001). Class I included patients with one or two brain metastases, without extracranial disease or with controlled extracranial disease, and with Karnofsky performance status (KPS) of 100. Class III included patients with multiple brain metastases with KPS of {<=}60. Class II included all other cases. Conclusions: The breast cancer RPA prognostic index is an easy and valuable tool for use in clinical practice. It can select patients who require aggressive treatment and those in whom whole-brain radiotherapy or symptomatic therapy is the most reasonable option. An individual approach is required for patients from prognostic Class II.

  16. Evaluation of expert criteria for preoperative magnetic resonance imaging of newly diagnosed breast cancer.

    PubMed

    Behrendt, Carolyn E; Tumyan, Lusine; Gonser, Laura; Shaw, Sara L; Vora, Lalit; Paz, I Benjamin; Ellenhorn, Joshua D I; Yim, John H

    2014-08-01

    Despite 2 randomized trials reporting no reduction in operations or local recurrence at 1 year, preoperative magnetic resonance imaging (MRI) is increasingly used in diagnostic workup of breast cancer. We evaluated 5 utilization criteria recently proposed by experts. Of women (n = 340) newly diagnosed with unilateral breast cancer who underwent bilateral MRI, most (69.4%) met at least 1 criterion before MRI: mammographic density (44.4%), under consideration for partial breast irradiation (PBI) (19.7%), genetic-familial risk (12.9%), invasive lobular carcinoma (11.8%), and multifocal/multicentric disease (10.6%). MRI detected occult malignant lesion or extension of index lesion in 21.2% of index, 3.3% of contralateral, breasts. No expert criterion was associated with MRI-detected malignant lesion, which associated instead with pre-MRI plan of lumpectomy without PBI (48.2% of subjects): Odds Ratio 3.05, 95% CI 1.57-5.91 (p adjusted for multiple hypothesis testing = 0.007, adjusted for index-vs-contralateral breast and covariates). The expert guidelines were not confirmed by clinical evidence.

  17. Lamivudine versus Entecavir for Newly Diagnosed Hepatitis B Virus-Related Hepatocellular Carcinoma

    PubMed Central

    Kim, Jung Hee; Sinn, Dong Hyun; Kim, Kyunga; Kim, Hyeseung; Gwak, Geum-Youn; Paik, Yong-Han; Choi, Moon Seok; Lee, Joon Hyeok; Koh, Kwang Cheol; Paik, Seung Woon

    2016-01-01

    Background/Aims Antiviral therapy is a key component in the management of hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) patients. However, whether the potent drug entecavir is more effective than a less potent drug, such as lamivudine, in HBV-related HCC is not clear. Methods A retrospective cohort of 451 newly diagnosed, HBV-related HCC patients without antiviral therapy at diagnosis, who started antiviral therapy with either entecavir (n=249) or lamivudine (n=202), were enrolled. Results The median survival was longer for the entecavir group than for the lamivudine group, and lamivudine use (vs entecavir) was an independent factor for mortality (hazard ratio [HR], 1.49; p=0.002). Lamivudine use (vs entecavir) was an independent risk factor for new-onset hepatic decompensation (HR, 1.67; p=0.010) in 318 patients without previous hepatic decompensation, and it was also an independent risk factor for recurrence after curative therapy (HR, 1.84; p=0.002) in 117 patients who received curative therapy. The findings were similar in a propensity score-matched cohort. Conclusions Overall survival, decompensation-free survival, and recurrence-free survival were better in the entecavir-treated patients than in the lamivudine treated-patients, indicating that the potent antiviral drug should be the preferred choice in HBV-related HCC patients. PMID:27282264

  18. Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

    ClinicalTrials.gov

    2016-04-25

    Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in Adults; AML (Adult) With 11q23 (MLL) Abnormalities; AML (Adult) With Del(5q); AML (Adult) With Inv(16)(p13;q22); AML (Adult) With t(16;16)(p13;q22); AML (Adult) With t(8;21)(q22;q22); Secondary AML (Adult); Untreated AML (Adult)

  19. Motor regulation problems and pain in adults diagnosed with ADHD

    PubMed Central

    2013-01-01

    Background Most children who are diagnosed with attention deficit-hyperactivity disorder (ADHD) have moderate-to-severe motor problems using the Motor Function Neurological Assessment battery (MFNU). The MFNU focuses on specific muscle adjustment problems associated with ADHD, especially motor inhibition problems and high muscle tone. Here we investigated whether adults with ADHD/hyperkinetic disorder (HKD) have similar motor problems. In our clinical experience, adults with ADHD often complain about back, shoulder, hip, and leg pain. We also investigate reported pain in adults with ADHD. Methods Twenty-five adult outpatients diagnosed with ADHD/HKD who were responders to methylphenidate (MPH) were compared to 23 non-ADHD controls on 16 MFNU subtests and using a ‘total score’ (‘TS’) parameter. The MFNU test leader was blinded to group identity. The two groups were also compared using the Pain Drawing and Numerical Pain Rating Scale. Results The adult ADHD group had significantly (p < .001) more motor problems (higher TS) than controls. On the muscle regulation subtests, 36–96% of the ADHD group showed ‘moderate’ to ‘severe’ problems compared to 13–52% of the control group, and 80% of the ADHD group reported widespread pain. Highly significant differences were found between the ADHD and control groups for the variables ‘pain level’ (p < .001) and ‘pain location’ (p < .001). Significant correlations were found between TS and ‘pain location’ and between TS and ‘pain level’. Conclusions These findings suggest that similar to children with ADHD, adults diagnosed with ADHD also have motor inhibition problems and heightened muscle tone. The presence of significantly higher pain levels and more widespread pain in the ADHD group compared to non-ADHD controls might indicate that pain is a long-term secondary effect of heightened muscle tone and restricted movement that can be demonstrated in children and adults by the MFNU

  20. Motor Skills of Children Newly Diagnosed with Attention Deficit Hyperactivity Disorder Prior to and Following Treatment with Stimulant Medication

    ERIC Educational Resources Information Center

    Brossard-Racine, Marie; Shevell, Michael; Snider, Laurie; Belanger, Stacey Ageranioti; Majnemer, Annette

    2012-01-01

    Motor difficulties are common in children with Attention Deficit Hyperactivity Disorder (ADHD). Although preliminary evidence has suggested that methylphenidate can improve the motor skills in children with ADHD and Developmental Coordination Disorder (DCD), the effect of stimulant medication on motor performance in children newly diagnosed with…

  1. Expansion of the E138A mutation in newly diagnosed HIV-infected patients in Gran Canaria.

    PubMed

    Chamizo, Francisco; Gilarranz, Raúl; Tosco, Tomás; Carrillo, Deyanira; Holguín, África; Santana, Évora; Pérez-Arellano, Jose Luís; Hernández, Michele; Francés, Adela; Cárdenes, Miguel Ángel; Zarzalejos, Jose María; Pena-López, María José

    2016-09-01

    Molecular epidemiology allows us to know local HIV transmission and to design strategies of prevention. We studied 25 HIV newly diagnosed patients with the E138A mutation since the year 2010. Most transmission networks involved young and promiscuous men who have sex with men. Recent infection was only documented in patients grouped into the smaller clusters. PMID:27352730

  2. Phase I study of iniparib concurrent with monthly or continuous temozolomide dosing schedules in patients with newly diagnosed malignant gliomas.

    PubMed

    Blakeley, Jaishri O; Grossman, Stuart A; Mikkelsen, Tom; Rosenfeld, Myrna R; Peereboom, David; Nabors, L Burt; Chi, Andrew S; Emmons, Gary; Garcia Ribas, Ignacio; Supko, Jeffrey G; Desideri, Serena; Ye, Xiaobu

    2015-10-01

    Iniparib is a prodrug that converts to highly reactive cytotoxic metabolites intracellularly with activity in preclinical glioma models. We investigated the maximum tolerated dose (MTD) of iniparib with monthly (m) and continuous (c) temozolomide (TMZ) dosing schedules in patients with malignant gliomas (MG). Adults with newly diagnosed MG who had successfully completed ≥80% of radiation (RT) and TMZ without toxicity received mTMZ dosing (150-200 mg/m(2) days 1-5/28 days) or cTMZ dosing (75 mg/m(2)/days × 6 weeks) in conjunction with iniparib (i.v. 2 days/week) in the adjuvant setting. Iniparib was dose escalated using a modified continual reassessment method (mCRM). 43 patients (32 male; 34 GBM, 8 AA, 1 gliosarcoma; median age 54 years; median KPS 90) were enrolled across 4 dose levels. In the mTMZ group, 2/4 patients had dose limiting toxicities (DLT) at 19 mg/kg/week (rash/hypersensitivity). At 17.2 mg/kg/week, 1/9 patients had a DLT (grade 3 fatigue). Additional grade 3 toxicities were neutropenia, lymphopenia, and nausea. In the cTMZ group, one DLT (thromboembolic event) occurred at 10.2 mg/kg/week. Dose escalation stopped at 16 mg/kg/week based on mCRM. The mean maximum plasma concentration of iniparib increased with dose. Concentration of the two major circulating metabolites, 4-iodo-3-aminobenzamide and 4-iodo-3-aminobenzoic acid, was ≤5% of the corresponding iniparib concentration. Iniparib is well tolerated, at doses higher than previously investigated, in combination with TMZ after completion of RT + TMZ in patients with MG. Recommended phase 2 dosing of iniparib based on mCRM is 17.2 mg/kg/week with mTMZ and 16 mg/kg/week with cTMZ. An efficacy study of TMZ/RT + iniparib followed by TMZ + iniparib in newly diagnosed GBM using these doses has completed enrollment. Survival assessment is ongoing. PMID:26285766

  3. Phase I study of iniparib concurrent with monthly or continuous temozolomide dosing schedules in patients with newly diagnosed malignant gliomas

    PubMed Central

    Blakeley, Jaishri O.; Grossman, Stuart A.; Mikkelsen, Tom; Rosenfeld, Myrna R.; Peereboom, David; Nabors, L. Burt; Chi, Andrew S.; Emmons, Gary; Ribas, Ignacio Garcia; Supko, Jeffrey G.; Desideri, Serena; Ye, Xiaobu

    2016-01-01

    Background Iniparib is a prodrug that converts to highly reactive cytotoxic metabolites intracellularly with activity in preclinical glioma models. We investigated the maximum tolerated dose (MTD) of iniparib with monthly (m) and continuous (c) temozolomide (TMZ) dosing schedules in patients with malignant gliomas (MG). Methods Adults with newly diagnosed MG who had successfully completed ≥ 80% of radiation (RT) and TMZ without toxicity received mTMZ dosing (150-200 mg/m2 days 1-5/28 days) or cTMZ dosing (75 mg/m2/d × 6weeks) in conjunction with iniparib (i.v. 2 days/wk) in the adjuvant setting. Iniparib was dose escalated using a modified continual reassessment method (mCRM). Results 43 patients (32 male; 34 GBM, 8 AA, 1 gliosarcoma; median age 54 yrs; median KPS 90) were enrolled across 4 dose levels. In the mTMZ group, 2/4 patients had dose limiting toxicities (DLT) at 19mg/kg/week (rash/hypersensitivity). At 17.2mg/kg/week, 1/9 patients had a DLT (grade 3 fatigue). Additional grade 3 toxicities were neutropenia, lymphopenia, and nausea. In the cTMZ group, one DLT (thromboembolic event) occurred at 10.2mg/kg/wk. Dose escalation stopped at 16mg/kg/week based on mCRM. The mean maximum plasma concentration of iniparib increased with dose. Concentration of the two major circulating metabolites, 4-iodo-3-aminobenzamide and 4-iodo-3-aminobenzoic acid, was ≤ 5% of the corresponding iniparib concentration. Conclusions Iniparib is well tolerated, at doses higher than previously investigated, in combination with TMZ after completion of RT + TMZ in patients with MG. Recommended phase 2 dosing of iniparib based on mCRM is 17.2mg/kg/wk with mTMZ and 16mg/kg/wk with cTMZ. An efficacy study of TMZ/RT + iniparib followed by TMZ + iniparib in newly diagnosed GBM using these doses has completed enrollment. Survival assessment is ongoing. PMID:26285766

  4. Risk of Adverse Vascular Events in Newly Diagnosed Glioblastoma Multiforme Patients Treated with Bevacizumab: a Systematic Review and Meta-Analysis.

    PubMed

    Li, Xiaoqing; Huang, Rongzhong; Xu, Zhongye

    2015-01-01

    Previous evidence suggests that the humanized anti-VEGF antibody bevacizumab increases thrombosis risk in glioma patients. Here, we comprehensively assessed the risk of adverse vascular events in adult glioma patients receiving bevacizumab therapy. Systematic searches of MEDLINE, EMBASE, and the Cochrane Library were conducted to find prospective phase II/III clinical trials on adult bevacizumab-treated glioma patients and non-bevacizumab-treated controls that reported data on adverse vascular events. Four high-quality trials were finally included in the systematic review, scoring greater than or equal to 7/8 on the Newcastle-Ottawa Scale. Three trials provided sufficient data for four meta-analytical comparisons between bevacizumab-treated and control groups of newly diagnosed glioblastoma multiforme (GBM) patients: all-cause discontinuation, thrombocytopenia, deep vein thrombosis (DVT), and pulmonary embolism. None of these adverse outcomes were found to be significantly different between bevacizumab-treated and control groups (P > 0.05); however, there was a trend toward significance with regard to bevacizumab therapy and the risk of pulmonary embolism (P = 0.07). As there was a trend toward significance with regard to bevacizumab therapy and the risk of pulmonary embolism, anticoagulation may be advisable in certain newly diagnosed adult GBM patients who display a history of thromboembolism and/or more serious risk factors for thromboembolic events.

  5. Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

    ClinicalTrials.gov

    2015-07-14

    Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

  6. Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia

    ClinicalTrials.gov

    2014-05-09

    Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Childhood Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Refractory Anemia With Excess Blasts; Refractory Anemia With Excess Blasts in Transformation; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Untreated Adult Acute Myeloid Leukemia

  7. Imbalance of Fecal Microbiota at Newly Diagnosed Type 1 Diabetes in Chinese Children

    PubMed Central

    Qi, Cui-Juan; Zhang, Qian; Yu, Miao; Xu, Jian-Ping; Zheng, Jia; Wang, Tong; Xiao, Xin-Hua

    2016-01-01

    Background: Recent studies have indicated that an imbalance of gut microbiota is associated with the development of type 1 diabetes mellitus (T1DM) and there is no literature regarding it in Chinese children yet. The aim of this study was to evaluate the alteration of gut microbiota between children with newly diagnosed T1DM and healthy controls and to determine if gut microbiota could partly explain the etiology of this disease. Methods: A case-control study was carried out with 15 children with T1DM and 15 healthy children. The fecal bacteria composition was investigated by high-throughput sequencing of the V3–V4 region of the 16S rDNA gene and analyzed by the estimators of community richness (Chao) indexes. Results: There was a notable lower richness of fecal bacteria in T1DM group than controls (156.53 ± 36.96 vs. 130.0 ± 32.85, P = 0.047). At the genus level, the composition of Blautia was increased in T1DM group than control group whereas the composition of Haemophilus, Lachnospira, Dialister, and Acidaminococcus was decreased. In addition, we found that the percentage of Blautia was correlated positively with HbA1c (ρ = 0.40, P = 0.031), the numbers of T1DM autoantibodies (ρ = 0.42, P = 0.023), and the titers of tyrosine phosphatase autoantibodies (IA-2) (ρ = 0.82, P = 0.000) in the study. Conclusions: This study showed that gut microbiota was associated with the development of T1DM by affecting the autoimmunity, and the results suggested a potential therapy for T1DM via modulating the gut microbiota. PMID:27231166

  8. Transmission of resistant HIV type 1 variants and epidemiological chains in Italian newly diagnosed individuals.

    PubMed

    Lai, Alessia; Violin, Michela; Ebranati, Erika; Franzetti, Marco; Micheli, Valeria; Gismondo, Maria Rita; Capetti, Amedeo; Meraviglia, Paola; Simonetti, Francesco Roberto; Bozzi, Giorgio; Ciccozzi, Masimo; Galli, Massimo; Zehender, Gianguglielmo; Balotta, Claudia

    2012-08-01

    Transmission of HIV-1 and drug resistance continue to occur at a considerable level in Italy, influenced mainly by changes in modality of infection. However, the long period of infectivity makes difficult the interpretation of epidemiological networks, based on epidemiological data only. We studied 510 naive HIV-1-infected individuals, of whom 400 (78.4%) were newly diagnosed patients with an unknown duration of infection (NDs), with the aim of identifying sexual epidemiological networks and transmitted drug resistance (TDR) over a 7-year period. Clusters were identified by Bayesian methods for 412 patients with B subtype; 145 individuals (35.2%) clustered in 34 distinct clades. Within epidemiological networks males were 93.1% (n=135); the same proportion of patients has been infected by the sexual route; 62.1% (n=90) were men having sex with men (MSM) of whom 67.8% (n=61) were NDs. Among heterosexuals (n=44), males were predominant (79.5%, n=35) and 77.3% (n=34) were NDs. TDR in clusters was 11.7 % (n=17), of whom 76.5% (n=13) was found in MSM. TDR was predominantly associated with NRTI resistance in individuals with chronic infection (n=11). A high prevalence of epidemiological networks has been found in the metropolitan area of Milan, indicating a high frequency of transmission events. The cluster analysis of networks suggested that the source of new infections was mainly represented by males and MSM who have long lasting HIV-1 infection. Notably, the prevalence of resistance-conferring mutations was higher in chronically infected patients, carrying mainly resistance to thymidine analogs, the backbone of first antiretroviral (ARV) generation. Intervention strategies of public health are needed to limit HIV-1 transmission and the associated TDR.

  9. European Myeloma Network recommendations on the evaluation and treatment of newly diagnosed patients with multiple myeloma

    PubMed Central

    Engelhardt, Monika; Terpos, Evangelos; Kleber, Martina; Gay, Francesca; Wäsch, Ralph; Morgan, Gareth; Cavo, Michele; van de Donk, Niels; Beilhack, Andreas; Bruno, Benedetto; Johnsen, Hans Erik; Hajek, Roman; Driessen, Christoph; Ludwig, Heinz; Beksac, Meral; Boccadoro, Mario; Straka, Christian; Brighen, Sara; Gramatzki, Martin; Larocca, Alessandra; Lokhorst, Henk; Magarotto, Valeria; Morabito, Fortunato; Dimopoulos, Meletios A.; Einsele, Hermann; Sonneveld, Pieter; Palumbo, Antonio

    2014-01-01

    Multiple myeloma management has undergone profound changes in the past thanks to advances in our understanding of the disease biology and improvements in treatment and supportive care approaches. This article presents recommendations of the European Myeloma Network for newly diagnosed patients based on the GRADE system for level of evidence. All patients with symptomatic disease should undergo risk stratification to classify patients for International Staging System stage (level of evidence: 1A) and for cytogenetically defined high- versus standard-risk groups (2B). Novel-agent-based induction and up-front autologous stem cell transplantation in medically fit patients remains the standard of care (1A). Induction therapy should include a triple combination of bortezomib, with either adriamycin or thalidomide and dexamethasone (1A), or with cyclophosphamide and dexamethasone (2B). Currently, allogeneic stem cell transplantation may be considered for young patients with high-risk disease and preferably in the context of a clinical trial (2B). Thalidomide (1B) or lenalidomide (1A) maintenance increases progression-free survival and possibly overall survival (2B). Bortezomib-based regimens are a valuable consolidation option, especially for patients who failed excellent response after autologous stem cell transplantation (2A). Bortezomib-melphalan-prednisone or melphalan-prednisone-thalidomide are the standards of care for transplant-ineligible patients (1A). Melphalan-prednisone-lenalidomide with lenalidomide maintenance increases progression-free survival, but overall survival data are needed. New data from the phase III study (MM-020/IFM 07-01) of lenalidomide-low-dose dexamethasone reached its primary end point of a statistically significant improvement in progression-free survival as compared to melphalan-prednisone-thalidomide and provides further evidence for the efficacy of lenalidomide-low-dose dexamethasone in transplant-ineligible patients (2B). PMID:24497560

  10. Tumor regrowth between surgery and initiation of adjuvant therapy in patients with newly diagnosed glioblastoma

    PubMed Central

    Pirzkall, Andrea; McGue, Colleen; Saraswathy, Suja; Cha, Soonmee; Liu, Raymond; Vandenberg, Scott; Lamborn, Kathleen R.; Berger, Mitchel S.; Chang, Susan M.; Nelson, Sarah J.

    2009-01-01

    To assess incidence and degree of regrowth in glioblastoma between surgery and radiation therapy (RT) and to correlate regrowth with presurgical imaging and survival, we examined images of 32 patients with newly diagnosed glioblastoma who underwent MR spectroscopic imaging (MRSI), perfusion-weighted imaging (PWI), and diffusion-weighted imaging (DWI) prior to surgery, after surgery, and prior to RT/temozolomide. Contrast enhancement (CE) in the pre-RT MR image was compared with postsurgical DWI to differentiate tumor growth from postsurgical infarct. MRSI and PWI parameters were analyzed prior to surgery and pre-RT. Postsurgical MRI indicated that 18 patients had gross total and 14 subtotal resections. Twenty-one patients showed reduced diffusion, and 25 patients showed new or increased CE. In eight patients (25%), the new CE was confined to areas of postsurgical reduced diffusion. In the other 17 patients (53%), new CE was found to be indicative of tumor growth or a combination of tumor growth and surgical injury. Higher perfusion and creatine within nonenhancing tumor in the presurgery MR were associated with subsequent tumor growth. High levels of choline and reduced diffusion in pre-RT CE suggested active metabolism and tumor cell proliferation. Median survival was 14.6 months in patients with interim tumor growth and 24 months in patients with no growth. Increased volume or new onset of CE between surgery and RT was attributed to tumor growth in 53% of patients and was associated with shorter survival. This suggests that reducing the time between surgery and adjuvant therapy may be important. The acquisition of metabolic and physiologic imaging data prior to adjuvant therapy may also be valuable in assessing regions of new CE and nonenhancing tumor. PMID:19229057

  11. Survival analysis in patients with newly diagnosed glioblastoma using pre- and postradiotherapy MR spectroscopic imaging†

    PubMed Central

    Li, Yan; Lupo, Janine M.; Parvataneni, Rupa; Lamborn, Kathleen R.; Cha, Soonmee; Chang, Susan M.; Nelson, Sarah J.

    2013-01-01

    Background The objective of this study was to examine the predictive value of parameters of 3D 1H magnetic resonance spectroscopic imaging (MRSI) prior to treatment with radiation/chemotherapy (baseline) and at a postradiation 2-month follow-up (F2mo) in relationship to 6-month progression-free survival (PFS6) and overall survival (OS). Methods Sixty-four patients with newly diagnosed glioblastoma multiforme (GBM) being treated with radiation and concurrent chemotherapy were involved in this study. Evaluated were metabolite indices and metabolite ratios. Logistic linear regression and Cox proportional hazards models were utilized to evaluate PFS6 and OS, respectively. These analyses were adjusted by age and MR scanner field strength (1.5 T or 3 T). Stepwise regression was performed to determine a subset of the most relevant variables. Results Associated with shorter PFS6 were a decrease in the ratio of N-acetyl aspartate to choline-containing compounds (NAA/Cho) in the region with a Cho-to-NAA index (CNI) >3 at baseline and an increase of the CNI within elevated CNI regions (>2) at F2mo. Patients with higher normalized lipid and lactate at either time point had significantly worse OS. Patients who had larger volumes with abnormal CNI at F2mo had worse PFS6 and OS. Conclusions Our study found more 3D MRSI parameters that predicted PFS6 and OS for patients with GBM than did anatomic, diffusion, or perfusion imaging, which were previously evaluated in the same population of patients. PMID:23393206

  12. Proteomic characteristics of circulating microparticles in patients with newly-diagnosed type 2 diabetes

    PubMed Central

    Xu, Min-Dan; Wu, Xian-Zheng; Zhou, Yun; Xue, Ying; Zhang, Ke-Qin

    2016-01-01

    Objective: This study aimed to evaluate the proteomic characteristics of plasma microparticles (MPs) from patients with newly diagnosed type 2 diabetes (T2DM). Methods: The subjects comprised eight male T2DM patients recruited between December 2013 and March 2014, as well as eight age and sex-matched healthy controls enrolled during the same period. Plasma microparticles (MPs) were extracted from the blood of each subject, and subjected to proteomics analysis using label-free methods. Bioinformatic analyses were performed using specialized software. Results: 3,148 unique peptides and 496 proteins were identified, among these, 46 proteins were differentially expressed between the two groups. Among these 46 candidates, 20 proteins had higher expression in T2DM group compared with the control group, whereas 3 proteins displayed lower expression. There were 17 proteins only detected in T2DM group, and 6 proteins only detected in the control group. Gene ontology (GO) analysis revealed significant differences between the two groups in some functional nodes, including neutrophil accumulation, chemokine production, platelet activation, and blood coagulation. Pathway analysis showed that proteins involved in platelet activation, cell adhesion, focal adhesion, and extracellular matrix-receptor interaction were differentially expressed between the 2 groups. Network analysis indicated that ubiquitin was the protein with the highest degree of connectivity. Conclusions: Blood MPs from T2DM patients are enriched in proteins involved in platelet activation, cell adhesion, and inflammation. Therefore, MPs in T2DM patients might be associated with hypercoagulable state in diabetic patients and the development of diabetic complications. PMID:27069554

  13. Prevalence, severity and correlates of fatigue in newly diagnosed patients with myelodysplastic syndromes.

    PubMed

    Efficace, Fabio; Gaidano, Gianluca; Breccia, Massimo; Criscuolo, Marianna; Cottone, Francesco; Caocci, Giovanni; Bowen, David; Lübbert, Michael; Angelucci, Emanuele; Stauder, Reinhard; Selleslag, Dominik; Platzbecker, Uwe; Sanpaolo, Grazia; Jonasova, Anna; Buccisano, Francesco; Specchia, Giorgina; Palumbo, Giuseppe A; Niscola, Pasquale; Wan, Chonghua; Zhang, Huiyong; Fenu, Susanna; Klimek, Virginia; Beyne-Rauzy, Odile; Nguyen, Khanh; Mandelli, Franco

    2015-02-01

    The primary objective of this study was to investigate factors associated with fatigue severity in newly diagnosed patients with higher-risk myelodysplastic syndromes (MDS). The secondary objectives were to assess symptom prevalence and to examine the relationships between fatigue, quality of life (QoL) and overall symptom burden in these patients. The analyses were conducted in 280 higher-risk MDS patients. Pre-treatment patient-reported fatigue was evaluated with the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale and QoL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Female gender (P = 0·018), poor performance status (i.e., ECOG of 2-4) (P < 0·001) and lower levels of haemoglobin (Hb) (P = 0·026) were independently associated with higher fatigue severity. The three most prevalent symptoms were as follows: fatigue (92%), dyspnoea (63%) and pain (55%). Patients with higher levels of fatigue also had greater overall symptom burdens. The mean global QoL scores of patients with the highest versus those with the lowest levels of fatigue were 29·2 [standard deviation (SD), 18·3] and 69·0 (SD, 18·8), respectively and this difference was four times the magnitude of a clinically meaningful difference. Patient-reported fatigue severity revealed the effects of disease burden on overall QoL more accurately than did degree of anaemia. Special attention should be given to the female patients in the management of fatigue. PMID:25272332

  14. Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia

    ClinicalTrials.gov

    2014-10-01

    Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

  15. Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

    ClinicalTrials.gov

    2015-06-03

    Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

  16. Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

    ClinicalTrials.gov

    2016-04-05

    Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

  17. Sirolimus, Idarubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

    ClinicalTrials.gov

    2016-06-03

    Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Untreated Adult Acute Myeloid Leukemia

  18. Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

    ClinicalTrials.gov

    2013-01-08

    Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

  19. Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

    ClinicalTrials.gov

    2016-02-01

    Adult Malignant Mesenchymoma; Adult Rhabdomyosarcoma; Childhood Alveolar Rhabdomyosarcoma; Childhood Botryoid-Type Embryonal Rhabdomyosarcoma; Childhood Embryonal Rhabdomyosarcoma; Childhood Malignant Mesenchymoma; Non-Metastatic Childhood Soft Tissue Sarcoma; Stage I Adult Soft Tissue Sarcoma; Stage II Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Untreated Childhood Rhabdomyosarcoma

  20. Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

    ClinicalTrials.gov

    2016-10-24

    Adult B Acute Lymphoblastic Leukemia; Adult T Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia; Childhood T Acute Lymphoblastic Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia

  1. HIV-1 Transmitted Drug Resistance Mutations in Newly Diagnosed Antiretroviral-Naive Patients in Turkey.

    PubMed

    Sayan, Murat; Sargin, Fatma; Inan, Dilara; Sevgi, Dilek Y; Celikbas, Aysel K; Yasar, Kadriye; Kaptan, Figen; Kutlu, Selda; Fisgin, Nuriye T; Inci, Ayse; Ceran, Nurgul; Karaoglan, Ilkay; Cagatay, Atahan; Celen, Mustafa K; Koruk, Suda T; Ceylan, Bahadir; Yildirmak, Taner; Akalın, Halis; Korten, Volkan; Willke, Ayse

    2016-01-01

    HIV-1 replication is rapid and highly error-prone. Transmission of a drug-resistant HIV-1 strain is possible and occurs within the HIV-1-infected population. In this study, we aimed to determine the prevalence of transmitted drug resistance mutations (TDRMs) in 1,306 newly diagnosed untreated HIV-1-infected patients from 21 cities across six regions of Turkey between 2010 and 2015. TDRMs were identified according to the criteria provided by the World Health Organization's 2009 list of surveillance drug resistance mutations. The HIV-1 TDRM prevalence was 10.1% (133/1,306) in Turkey. Primary drug resistance mutations (K65R, M184V) and thymidine analogue-associated mutations (TAMs) were evaluated together as nucleos(t)ide reverse transcriptase inhibitor (NRTI) mutations. NRTI TDRMs were found in 8.1% (107/1,306) of patients. However, TAMs were divided into three categories and M41L, L210W, and T215Y mutations were found for TAM1 in 97 (7.4%) patients, D67N, K70R, K219E/Q/N/R, T215F, and T215C/D/S mutations were detected for TAM2 in 52 (3.9%) patients, and M41L + K219N and M41L + T215C/D/S mutations were detected for the TAM1 + TAM2 profile in 22 (1.7%) patients, respectively. Nonnucleoside reverse transcriptase inhibitor-associated TDRMs were detected in 3.3% (44/1,306) of patients (L100I, K101E/P, K103N/S, V179F, Y188H/L/M, Y181I/C, and G190A/E/S) and TDRMs to protease inhibitors were detected in 2.3% (30/1,306) of patients (M46L, I50V, I54V, Q58E, L76V, V82A/C/L/T, N83D, I84V, and L90M). In conclusion, long-term and large-scale monitoring of regional levels of HIV-1 TDRMs informs treatment guidelines and provides feedback on the success of HIV-1 prevention and treatment efforts. PMID:26414663

  2. Baseline and longitudinal grey matter changes in newly diagnosed Parkinson's disease: ICICLE-PD study.

    PubMed

    Mak, Elijah; Su, Li; Williams, Guy B; Firbank, Michael J; Lawson, Rachael A; Yarnall, Alison J; Duncan, Gordon W; Owen, Adrian M; Khoo, Tien K; Brooks, David J; Rowe, James B; Barker, Roger A; Burn, David J; O'Brien, John T

    2015-10-01

    Mild cognitive impairment in Parkinson's disease is associated with progression to dementia (Parkinson's disease dementia) in a majority of patients. Determining structural imaging biomarkers associated with prodromal Parkinson's disease dementia may allow for the earlier identification of those at risk, and allow for targeted disease modifying therapies. One hundred and five non-demented subjects with newly diagnosed idiopathic Parkinson's disease and 37 healthy matched controls had serial 3 T structural magnetic resonance imaging scans with clinical and neuropsychological assessments at baseline, which were repeated after 18 months. The Movement Disorder Society Task Force criteria were used to classify the Parkinson's disease subjects into Parkinson's disease with mild cognitive impairment (n = 39) and Parkinson's disease with no cognitive impairment (n = 66). Freesurfer image processing software was used to measure cortical thickness and subcortical volumes at baseline and follow-up. We compared regional percentage change of cortical thinning and subcortical atrophy over 18 months. At baseline, cases with Parkinson's disease with mild cognitive impairment demonstrated widespread cortical thinning relative to controls and atrophy of the nucleus accumbens compared to both controls and subjects with Parkinson's disease with no cognitive impairment. Regional cortical thickness at baseline was correlated with global cognition in the combined Parkinson's disease cohort. Over 18 months, patients with Parkinson's disease with mild cognitive impairment demonstrated more severe cortical thinning in frontal and temporo-parietal cortices, including hippocampal atrophy, relative to those with Parkinson's disease and no cognitive impairment and healthy controls, whereas subjects with Parkinson's disease and no cognitive impairment showed more severe frontal cortical thinning compared to healthy controls. At baseline, Parkinson's disease with no cognitive impairment

  3. Risk of Early Mortality in Patients With Newly Diagnosed Multiple Myeloma

    PubMed Central

    Hsu, Pei; Lin, Ting-Wei; Gau, Jyh-Pyng; Yu, Yuan-Bin; Hsiao, Liang-Tsai; Tzeng, Cheng-Hwai; Chen, Po-Min; Chiou, Tzeon-Jye; Liu, Jin-Hwang; Liu, Yao-Chung; Liu, Chia-Jen

    2015-01-01

    Abstract The overall survival of patients with multiple myeloma (MM) has been improved greatly over the last 2 decades with the broader use of novel drugs and autologous tandem transplantation. However, more than one tenth of myeloma patients still die shortly after diagnosis. We therefore aim to investigate the risk factors of early mortality (death within 60 days after diagnosis) in patients with MM. We included in this study 451 consecutive patients with MM, newly diagnosed at an Asian tertiary medical center between January 1, 2002 and April 30, 2015. A total of 57 subjects who experienced early mortality were identified. Risk factors for early mortality in myeloma patients were collected and analyzed. Early mortality occurred in 57 (12.6%) of the myeloma patients. In the multivariate analysis, being male (adjusted OR 2.93, 95% CI 1.17–7.31), serum albumin < 3.5 g/dL (adjusted OR 2.71, 95% CI 1.09–6.74), primary plasma cell leukemia (adjusted OR 17.61, 95% CI 1.01–306.05), serum albumin (adjusted OR 2.70, 95% CI 1.15–6.38), corrected serum calcium ≥ 12 mg/dL (adjusted OR 2.94, 95% CI 1.21–7.14), and LDH ≥ 250 U/L (adjusted OR 3.07, 95% CI 1.50–6.27) were identified as independent risk factors of early mortality. Pneumonia with other infections contributed most to early mortality (n = 36, 65%), followed by renal failure and cardiac failure. The early mortality rate is high (12.6%) in patients with MM. Patients who are male and those with primary plasma cell leukemia, low serum albumin, high-corrected serum calcium, or LDH are at risk of early mortality. Nearly two thirds of the myeloma patients who experienced early mortality in our study (37 of 57, 65%) died of infection. Once a high-risk group is identified, much effort is required to target new approaches for prevention, early detection, and treatment of infections. PMID:26683968

  4. Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia

    ClinicalTrials.gov

    2016-07-26

    Acute Undifferentiated Leukemia; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Mast Cell Leukemia; Myeloid/NK-cell Acute Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia

  5. Comparative analysis of survival, treatment, cost and resource use among patients newly diagnosed with brain metastasis by initial primary cancer.

    PubMed

    Ray, Saurabh; Dacosta-Byfield, Stacey; Ganguli, Arijit; Bonthapally, Vijayveer; Teitelbaum, April

    2013-08-01

    Brain metastases are a frequent complication of many systemic cancers and portend a poor prognosis. This retrospective analysis of health claims data compared survival, treatment and health care utilization and costs in patients with brain metastasis by primary tumor site. Adult commercial and Medicare Advantage enrollees newly diagnosed with brain metastasis in 01 Jan 2004 through 30 Apr 2010 were identified. Inclusion required at least 2 claims that identified the same primary cancer site prior to diagnosis of brain metastasis and no evidence of primary brain tumors. Health care utilization rates and costs were calculated at the patient level for each month of follow-up. Differences among primary cancer site cohorts were assessed by ANOVA (continuous variables), Chi square test (proportions) and the Poisson distribution (utilization rates). The primary cancer cohorts comprised 1,031 lung cancer, 93 melanoma and 395 female breast cancer patients. During the 6 months prior to brain metastasis diagnosis, 59 % of lung cancer patients had no evidence of lymph node involvement or other metastatic disease compared to 55 and 42 % of melanoma and breast cancer patients (P < 0.001). Survival after brain metastasis diagnosis was less than 3 months for 52, 43 and 39 % for lung cancer, breast cancer and melanoma, respectively (P < 0.001). Melanoma patients had the highest rate of inpatient stays and outpatient visits (P ≤ 0.003). Total monthly all-cause costs were: melanoma, $23,426; breast cancer $19,708; lung cancer, $17,007 (P = 0.003). Health care utilization and costs after brain metastasis diagnosis were substantial and differed by primary tumor site.

  6. Phase II Trial of Erlotinib during and after Radiotherapy in Children with Newly Diagnosed High-Grade Gliomas

    PubMed Central

    Qaddoumi, Ibrahim; Kocak, Mehmet; Pai Panandiker, Atmaram S.; Armstrong, Gregory T.; Wetmore, Cynthia; Crawford, John R.; Lin, Tong; Boyett, James M.; Kun, Larry E.; Boop, Fredrick A.; Merchant, Thomas E.; Ellison, David W.; Gajjar, Amar; Broniscer, Alberto

    2014-01-01

    Background: Epidermal growth factor receptor is overexpressed in most pediatric high-grade gliomas (HGG). Since erlotinib had shown activity in adults with HGG, we conducted a phase II trial of erlotinib and local radiotherapy (RT) in children with newly diagnosed HGG. Methods: Following maximum surgical resection, patients between 3 and 21 years with non-metastatic HGG received local RT at 59.4 Gy (54 Gy for spinal tumors and those with ≥70% brain involvement). Erlotinib started on day 1 of RT (120 mg/m2 per day) and continued for 2 years unless there was tumor progression or intolerable toxicities. The 2-year progression-free survival (PFS) was estimated for patients with intracranial anaplastic astrocytoma (AA) and glioblastoma (GBM). Results: Median age at diagnosis for 41 patients with intracranial tumors (21 with GBM and 20 with AA) was 10.9 years (range, 3.3–19 years). The 2-year PFS for patients with AA and GBM was 15 ± 7 and 19 ± 8%, respectively. Only five patients remained alive without tumor progression. Twenty-six patients had at least one grade 3 or 4 toxicity irrespective of association with erlotinib; only four required dose modifications. The main toxicities were gastrointestinal (n = 11), dermatologic (n = 5), and metabolic (n = 4). One patient with gliomatosis cerebri who required prolonged corticosteroids died of septic shock associated with pancreatitis. Conclusion: Although therapy with erlotinib was mostly well-tolerated, it did not change the poor outcome of our patients. Our results showed that erlotinib is not a promising medication in the treatment of children with intracranial AA and GBM. PMID:24744992

  7. Mitomycin C in combination with orchiectomy for newly diagnosed metastatic prostate cancer: preliminary results on a randomized trial.

    PubMed

    Van Poppel, H; van den Broucke, F; Derluyn, J; Popelier, G; Casselman, J; Billiet, I; van Uytsel, L; Paridaens, R; Baert, L

    1993-06-01

    The preliminary results of a randomized trial comparing orchiectomy versus orchiectomy and mitomycin C in 119 newly diagnosed metastatic prostate cancer patients are presented. Of 109 evaluable patients 57 were treated with orchiectomy alone and 52 received adjuvant intravenous mitomycin C. Mean interval to progression was 13 months in the orchiectomy group versus 11 months in the mitomycin C group. Preliminary analysis did not demonstrate a favorable effect of the combination with this chemotherapeutic agent compared to orchiectomy alone (p = 0.3).

  8. Childhood risk factors in dually diagnosed homeless adults.

    PubMed

    Blankertz, L E; Cnaan, R A; Freedman, E

    1993-09-01

    Although the negative long-term effects of specific childhood risk factors--sexual and physical abuse, parental mental illness and substance abuse, and out-of-home placement--have been recognized, most studies have focused on just one of these risks. This article examines the prevalence of these five childhood risk factors among dually diagnosed (mentally ill and substance abusing) homeless adults in rehabilitation programs. It further assesses the impact of each risk factor individually and in combinations of two on the social functioning skills and rehabilitation progress of these multiply disadvantaged clients.

  9. Childhood risk factors in dually diagnosed homeless adults.

    PubMed

    Blankertz, L E; Cnaan, R A; Freedman, E

    1993-09-01

    Although the negative long-term effects of specific childhood risk factors--sexual and physical abuse, parental mental illness and substance abuse, and out-of-home placement--have been recognized, most studies have focused on just one of these risks. This article examines the prevalence of these five childhood risk factors among dually diagnosed (mentally ill and substance abusing) homeless adults in rehabilitation programs. It further assesses the impact of each risk factor individually and in combinations of two on the social functioning skills and rehabilitation progress of these multiply disadvantaged clients. PMID:8211318

  10. Association between Growth Differentiation Factor 15 (GDF15) and Cardiovascular Risk in Patients with Newly Diagnosed Type 2 Diabetes Mellitus

    PubMed Central

    2016-01-01

    We investigated an association between serum Growth Differentiation Factor 15 (GDF15) level and cardiovascular risk in patients with newly diagnosed type 2 diabetes mellitus (T2D). A total of 107 participants were screened for T2D and divided into a T2D group and a control group (without diabetes). We used the Framingham risk score (FRS) and the New Pooled Cohort Equation score to estimate the 10-year risk of atherosclerotic cardiovascular disease. Serum GDF15 levels were measured using an enzyme-linked immunosorbent assay. Correlation analyses were performed to evaluate the associations between GDF15 level and cardiovascular risk scores. The mean serum GDF15 level was elevated in the T2D group compared to the control group (P < 0.001). A positive correlation was evident between serum GDF15 level and age (r = 0.418, P = 0.001), the FRS (r = 0.457, P < 0.001), and the Pooled Cohort Equation score (r = 0.539, P < 0.001). After adjusting for age, LDL-C level, and body mass index (BMI), the serum GDF15 level was positively correlated with the FRS and the New Pooled Cohort Equation score. The serum GDF15 level is independently associated with cardiovascular risk scores of newly diagnosed T2D patients. This suggests that the level of GDF15 may be a useful predictive biomarker of cardiovascular risk in newly diagnosed T2D patients. PMID:27510384

  11. Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

    ClinicalTrials.gov

    2016-07-19

    Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

  12. Alienation appraisals distinguish adults diagnosed with DID from PTSD.

    PubMed

    DePrince, Anne P; Huntjens, Rafaële J C; Dorahy, Martin J

    2015-11-01

    Studies are beginning to show the importance of appraisals to different types and severities of psychiatric disorders. Yet, little work in this area has assessed whether trauma-related appraisals can differentiate complex trauma-related disorders, such as posttraumatic stress disorder (PTSD) and dissociative identity disorder (DID). The current study evaluated whether any of 6 trauma-related appraisals distinguished adults diagnosed with DID from those diagnosed with PTSD. To accomplish this, we first examined the basic psychometric properties of a Dutch-translated short-form of the Trauma Appraisals Questionnaire (TAQ) in healthy control (n = 57), PTSD (n = 27) and DID (n = 12) samples. The short-form Dutch translation of the TAQ showed good internal reliability and criterion-related validity for all 6 subscales (betrayal, self-blame, fear, alienation, shame, anger). Of the 6 subscales, the alienation appraisal subscale specifically differentiated DID from PTSD, with the former group reporting more alienation. Abuse-related appraisals that emphasize disconnection from self and others may contribute to reported problems of memory and identity common in DID. The current findings suggest that addressing experiences of alienation may be particularly important in treatment for clients diagnosed with DID. PMID:26168348

  13. Alienation appraisals distinguish adults diagnosed with DID from PTSD.

    PubMed

    DePrince, Anne P; Huntjens, Rafaële J C; Dorahy, Martin J

    2015-11-01

    Studies are beginning to show the importance of appraisals to different types and severities of psychiatric disorders. Yet, little work in this area has assessed whether trauma-related appraisals can differentiate complex trauma-related disorders, such as posttraumatic stress disorder (PTSD) and dissociative identity disorder (DID). The current study evaluated whether any of 6 trauma-related appraisals distinguished adults diagnosed with DID from those diagnosed with PTSD. To accomplish this, we first examined the basic psychometric properties of a Dutch-translated short-form of the Trauma Appraisals Questionnaire (TAQ) in healthy control (n = 57), PTSD (n = 27) and DID (n = 12) samples. The short-form Dutch translation of the TAQ showed good internal reliability and criterion-related validity for all 6 subscales (betrayal, self-blame, fear, alienation, shame, anger). Of the 6 subscales, the alienation appraisal subscale specifically differentiated DID from PTSD, with the former group reporting more alienation. Abuse-related appraisals that emphasize disconnection from self and others may contribute to reported problems of memory and identity common in DID. The current findings suggest that addressing experiences of alienation may be particularly important in treatment for clients diagnosed with DID.

  14. Does Valproic Acid or Levetiracetam Improve Survival in Glioblastoma? A Pooled Analysis of Prospective Clinical Trials in Newly Diagnosed Glioblastoma

    PubMed Central

    Happold, Caroline; Gorlia, Thierry; Chinot, Olivier; Gilbert, Mark R.; Nabors, L. Burt; Wick, Wolfgang; Pugh, Stephanie L.; Hegi, Monika; Cloughesy, Timothy; Roth, Patrick; Reardon, David A.; Perry, James R.; Mehta, Minesh P.; Stupp, Roger

    2016-01-01

    Purpose Symptomatic epilepsy is a common complication of glioblastoma and requires pharmacotherapy. Several uncontrolled retrospective case series and a post hoc analysis of the registration trial for temozolomide indicated an association between valproic acid (VPA) use and improved survival outcomes in patients with newly diagnosed glioblastoma. Patients and Methods To confirm the hypothesis suggested above, a combined analysis of survival association of antiepileptic drug use at the start of chemoradiotherapy with temozolomide was performed in the pooled patient cohort (n = 1,869) of four contemporary randomized clinical trials in newly diagnosed glioblastoma: AVAGlio (Avastin in Glioblastoma; NCT00943826), CENTRIC (Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status; NCT00689221), CORE (Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status; NCT00813943), and Radiation Therapy Oncology Group 0825 (NCT00884741). Progression-free survival (PFS) and overall survival (OS) were compared between: (1) any VPA use and no VPA use at baseline or (2) VPA use both at start of and still after chemoradiotherapy. Results of Cox regression models stratified by trial and adjusted for baseline prognostic factors were analyzed. The same analyses were performed with levetiracetam (LEV). Results VPA use at start of chemoradiotherapy was not associated with improved PFS or OS compared with all other patients pooled (PFS: hazard ratio [HR], 0.91; 95% CI, 0.77 to 1.07; P = .241; OS: HR, 0.96; 95% CI, 0.80 to 1.15; P = .633). Furthermore, PFS and OS of patients taking VPA both at start of and still after chemoradiotherapy were not different from those without antiepileptic drug use at both time points (PFS: HR, 0.92; 95% CI, 0.74 to 1.15; P = .467; OS: HR, 1.10; 95% CI, 0.86 to 1.40; P = .440). Similarly, no

  15. Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer

    ClinicalTrials.gov

    2016-05-12

    Breast Cancer; Chemotherapeutic Agent Toxicity; Cognitive/Functional Effects; Fatigue; Long-term Effects Secondary to Cancer Therapy in Adults; Neurotoxicity; Psychosocial Effects of Cancer and Its Treatment

  16. Study of Physical and Mental Health of Older Patients With Newly Diagnosed Cancer

    ClinicalTrials.gov

    2015-10-01

    Cognitive/Functional Effects; Depression; Hematopoietic/Lymphoid Cancer; Malnutrition; Pain; Psychosocial Effects of Cancer and Its Treatment; Unspecified Adult Solid Tumor, Protocol Specific; Weight Changes

  17. Depressive Symptoms and Their Impact on Health-seeking Behaviors in Newly-diagnosed HIV-infected Patients in Durban, South Africa

    PubMed Central

    Regan, Susan; Giddy, Janet; Chetty, Senica; Ross, Douglas; Katz, Jeffrey N.; Freedberg, Kenneth A.; Walensky, Rochelle P.; Losina, Elena; Bassett, Ingrid V.

    2012-01-01

    We evaluated the prevalence and correlates of depressive symptoms prior to HIV diagnosis and determined the effect of these symptoms on seeking HIV care at an urban and rural clinic in Durban, South Africa. Adults were administered a questionnaire which included the 5-item Mental Health Index (MHI-5) before HIV testing. We determined the depressive symptoms among HIV-infected subjects. Of 1,545 newly-diagnosed HIV-infected subjects, 55% had depressive symptoms by MHI-5 score. Enrolling at the urban clinic and decreasing functional activity score were associated with depressive symptoms. Subjects with depressive symptoms who were referred for HIV testing by a healthcare provider were less likely to obtain a CD4 count than those without depressive symptoms who self-referred for testing. Depressive symptoms were common among newly-diagnosed HIV-infected participants and impacted CD4 uptake. Depression screening at the time of HIV diagnosis is critical for improving linkage to mental health and HIV services in South Africa. PMID:22451351

  18. Phase II Evaluation of Gefitinib in Patients With Newly Diagnosed Grade 4 Astrocytoma: Mayo/North Central Cancer Treatment Group Study N0074

    SciTech Connect

    Uhm, Joon H.; Ballman, Karla V.; Wu Wenting; Giannini, Caterina; Krauss, J.C.; Buckner, Jan C.; James, C.D.; Scheithauer, Bernd W.; Behrens, Robert J.; Flynn, Patrick J.; Schaefer, Paul L.; Dakhill, Shaker R.; Jaeckle, Kurt A.

    2011-06-01

    Purpose: Amplification of the epidermal growth factor receptor (EGFR) gene represents one of the most frequent gene alterations in glioblastoma (GBM). In the current study, we evaluated gefitinib, a potent EGFR inhibitor, in the treatment of adults with newly diagnosed GBM. Methods and Materials: Ninety-eight patients (96 evaluable) were accrued between May 18, 2001, and August 2, 2002. All were newly diagnosed GBM patients who were clinically and radiographically stable/improved after radiation treatment (enrollment within 5 weeks of radiation completion). No prior chemotherapy was permitted. EGFR amplification/mutation, as assessed by fluorescence in situ hybridization and immunohistochemistry, was not required for treatment with gefitinib but was studied when tissues were available. Gefitinib was administered at 500 mg each day; for patients receiving dexamethasone or enzyme-inducing (CYP3A4) agents, dose was escalated to a maximum of 1,000 mg QD. Treatment cycles were repeated at 4-week intervals with brain magnetic resonance imaging at 8-week intervals. Results: Overall survival (OS; calculated from time of initial surgery) at 1 year (primary end point) with gefitinib was 54.2%, which was not statistically different compared with that of historical control population (48.9%, data from three previous Phase III North Central Cancer Treatment Group studies of newly diagnosed GBM patients). Progression-free survival (PFS) at 1 year post-RT (16.7%) was also not significantly different to that of historical controls (30.3%). Clinical outcome was not affected by EGFR status (amplification or vIII mutation). Fatigue (41%), rash (62%), and loose stools (58%) constituted the most frequent adverse events, the majority of these being limited to Grade 1/2. Of note, the occurrence of drug-related adverse effects, such as loose stools was associated with improved OS. Conclusions: In our evaluation of nearly 100 patients with newly diagnosed GBM, treatment with adjuvant

  19. Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

    ClinicalTrials.gov

    2016-09-08

    Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1; Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia

  20. The Feasibility of a Pilot Intervention for Parents of Young Children Newly Diagnosed with Type 1 Diabetes

    PubMed Central

    Mackey, Eleanor Race; Herbert, Linda; Monaghan, Maureen; Cogen, Fran; Wang, Jichuan; Streisand, Randi

    2016-01-01

    Objective Evaluate the feasibility, acceptability, and indicators of preliminary efficacy of the pilot of a parent-focused, phone-based intervention to improve glycemic control and parental and child well-being in young children newly diagnosed with type 1 diabetes (T1D). Methods Thirty mothers of young children ages 1–6 diagnosed with T1D for less than 6 months were randomized to either a phone-based intervention or physical activity education comparison program. Child HbA1c and parent report of depressive symptoms, stress, social support, and child quality of life were assessed at baseline, 1, 6, and 12 months post intervention. Results The program was feasible, as the majority of participants completed more than 80% of the intervention or comparison education sessions and reported high levels of satisfaction. Overall, there was a significant time by treatment intervention where the intervention group demonstrated improved social support and quality of life over time as compared to the comparison education group. The intervention demonstrated a trend towards moderating the association between baseline maternal depressive symptoms and prospective worsening of HbA1c. Conclusions Parents of young children newly diagnosed with T1D can be engaged in a phone-based program to provide support during this vulnerable period. PMID:27088065

  1. Randomized Trial of a Pre-Surgical Scheduled Reduced Smoking Intervention for Patients Newly Diagnosed with Cancer

    PubMed Central

    Ostroff, Jamie S.; Burkhalter, Jack E.; Cinciripini, Paul M.; Li, Yuelin; Shiyko, Mariya P.; Lam, Cho Y.; Hay, Jennifer L.; Dhingra, Lara K.; Lord-Bessen, Jennifer; Holland, Susan M.; Manna, Ruth

    2014-01-01

    Objective Cancer patients are advised to quit smoking to reduce treatment complications and future cancer risk. This study's main objective was to evaluate the efficacy of a novel, pre-surgical cessation intervention in newly diagnosed cancer patients scheduled for surgical hospitalization. Methods We conducted a parallel-arm, randomized controlled trial comparing the efficacy of our hospital-based, tobacco cessation “best practices” treatment model (BP; cessation counseling and nicotine replacement therapy) with BP enhanced by a behavioral tapering regimen (scheduled reduced smoking; BP+SRS) administered by a handheld computer before hospitalization for surgery. Cessation outcomes were short (hospital admission and three months) and longer-term (6 months) biochemically-verified smoking abstinence. We hypothesized that BP+SRS would be superior to BP alone. One hundred eighty-five smokers were enrolled. Results Overall, 7-day-point prevalence, confirmed abstinence rates at six months for BP alone (32%) and BP+SRS (32%) were high; however, no main effect of treatment was observed. Patients who were older and diagnosed with lung cancer were more likely to quit smoking. Conclusions Compared to best practices for treating tobacco dependence, a pre-surgical, scheduled reduced smoking intervention did not improve abstinence rates among newly diagnosed cancer patients. PMID:23895203

  2. Effects of intensive insulin therapy upon pancreatic β cell function in patients newly diagnosed with type II diabetes

    PubMed Central

    Wang, Defeng; Sun, Li; Song, Guangyao; Chen, Shuchun

    2015-01-01

    Objective: This study was designed to evaluate the clinical efficacy of intensive insulin therapy for patients newly diagnosed with type 2 diabetes. Methods: A total of 219 patients newly diagnosed with type 2 diabetes were randomly assigned into insulin group (n = 55), gliclazide group (n = 52), metformin group (n = 55) and pioglitazone group (n = 57). On the basis of diet and physical interventions, patients in the insulin group received intensive insulin therapy. Those in other three groups were given oral intake of medication. All treatment schemes endured for 12 weeks. A variety of indexes including fasting blood-glucose (FPG), FPG at 2 h after diet (FPG 2 h), hemoglobin A1 c (HbAlc), area under the curve (AUC) for insulin (insulin AUC) after glucose load, C-peptide AUC after glucose load (C-peptide AUC), changes in insulin secretion index (Homa-β) and insulin resistance index( Homa-IR) were accurately measured and statistically among different groups. Results: The insulin AUC at 0-30 min, C-peptide AUC at 0-30 min and Homa-β in the insulin group were equally significantly higher compared with those levels in the other three groups. In addition, the level of Homa-IR in the insulin, metformin and pioglitazone groups were all significantly reduced compared with the values prior to respective treatment (all P < 0.05). Conclusion: Compared with oral administration of hypoglycemic drugs, intensive insulin therapy is able to better improve pancreatic β cell function and insulin resistance for newly-diagnosed type 2 diabetes patients. PMID:25785143

  3. Addition of Bevacizumab to Standard Radiation Therapy and Daily Temozolomide Is Associated With Minimal Toxicity in Newly Diagnosed Glioblastoma Multiforme

    SciTech Connect

    Vredenburgh, James J.; Desjardins, Annick; Kirkpatrick, John P.; Reardon, David A.; Peters, Katherine B.; Herndon, James E.; Marcello, Jennifer; Bailey, Leighann; Threatt, Stevie; Sampson, John; Friedman, Allan; Friedman, Henry S.

    2012-01-01

    Purpose: To determine the safety of the addition of bevacizumab to standard radiation therapy and daily temozolomide for newly diagnosed glioblastoma multiforme (GBM). Methods and Materials: A total of 125 patients with newly diagnosed GBM were enrolled in the study, and received standard radiation therapy and daily temozolomide. All patients underwent a craniotomy and were at least 2 weeks postoperative. Radiation therapy was administered in 1.8-Gy fractions, with the clinical target volume for the primary course treated to a dose of 45 to 50.4 Gy, followed by a boost of 9 to 14.4 Gy, to a total dose of 59.4 Gy. Patients received temozolomide at 75 mg/m{sup 2} daily throughout the course of radiation therapy. Bevacizumab was given at 10 mg/kg intravenously every 14 days, beginning a minimum of 4 weeks postoperatively. Results: Of the 125 patients, 120 (96%) completed the protocol-specified radiation therapy. Five patients had to stop the protocol therapy, 2 patients with pulmonary emboli, and 1 patient each with a Grade 2 central nervous system hemorrhage, Grade 4 pancytopenia, and wound dehiscence requiring surgical intervention. All 5 patients ultimately finished the radiation therapy. After radiation therapy, 3 patients had progressive disease, 2 had severe fatigue and decreased performance status, 1 patient had a colonic perforation, and 1 had a rectal fissure; these 7 patients therefore did not proceed with the protocol-specified adjuvant temozolomide, bevacizumab, and irinotecan. However, 113 patients (90%) were able to continue on study. Conclusions: The addition of bevacizumab to standard radiation therapy and daily temozolomide was found to be associated with minimal toxicity in patients newly diagnosed with GBM.

  4. Why Newly Diagnosed Cancer Patients Require Supportive Care? An Audit from a Regional Cancer Center in India

    PubMed Central

    Ghoshal, Sushmita; Miriyala, Raviteja; Elangovan, Arun; Rai, Bhavana

    2016-01-01

    Purpose: The present study was planned to record the distressing symptoms of newly diagnosed cancer patients and evaluate how the symptoms were addressed by the treating oncologists. Materials and Methods: All newly diagnosed cancer patients referred to the Department of Radiotherapy during May 2014 were asked to complete a questionnaire after taking their consent. The Edmonton symptom assessment scale-regular questionnaire was used to assess the frequency and intensity of distressing symptoms. The case records of these patients were then reviewed to compare the frequency and intensity documented by the treating physician. The difference in the two sets of symptoms documented was statistically analyzed by nonparametric tests using SPSS software version 16. Results: Eighty-nine patients participated in this study, of which only 19 could fill the questionnaire on their own. Anxiety was the most common symptom (97.8%) followed by depression (89.9%), tiredness (89.9%), and pain (86.5%). The treating physicians recorded pain in 83.1% whereas the other symptoms were either not documented or grossly underreported. Anxiety was documented in 3/87 patients, but depression was not documented in any. Tiredness was documented in 12/80 patients, and loss of appetite in 54/77 patients mentioning them in the questionnaire. Significant statistical correlation could be seen between the presence of pain, anxiety, depression, tiredness, and loss of appetite in the patients. Conclusion: The study reveals that the distressing symptoms experienced by newly diagnosed cancer patients are grossly underreported and inadequately addressed by treating oncologists. Sensitizing the oncologists and incorporating palliative care principles early in the management of cancer patients could improve their holistic care. PMID:27559263

  5. Impact of initial topical medical therapy on short-term quality of life in newly diagnosed patients with primary glaucoma

    PubMed Central

    Arora, Vishal; Bali, Shveta Jindal; Gupta, Sanjeev Kumar; Vashisht, Praveen; Agarwal, Tushar; Sreenivas, Vishnubhatla; Dada, Tanuj

    2015-01-01

    Purpose: To evaluate the impact of initial topical medical therapy on newly diagnosed glaucoma patients using the Indian Vision Function Questionnaire (IND-VFQ33). Patients and Methods: The IND-VFQ33 was used to evaluate the quality of life (QoL) in 62 newly diagnosed patients with moderate to severe primary glaucoma and 60 healthy controls. IND-VFQ33 is a 33 item QoL assessment tool with three domains: General functioning, psychosocial impact and visual symptoms. The glaucoma patients were started on medical therapy and the QoL assessment was repeated after 3 months. Results: Glaucoma patients (mean age: 55.6 ± 9.6 years, range 40–77 years) and controls (mean age: 54.9 ± 6.7 years, 42–73 years) were matched with respect to age (P = 0.72), gender (P = 0.91) and literacy (P = 0.18). Glaucoma patients had significantly worse QoL as compared to controls at baseline across all the three domains (P < 0.001). 3 months after initiation of treatment, the overall QoL life significantly worsened from baseline with a decrease in general functioning (P < 0.001) and psychosocial impact (P = 0.041). Visual acuity in better eye significantly co-related to poor QoL at baseline (P < 0.001) and at 3 months (P = 0.04). In addition, the use of >2 topical medications significantly co-related to poor QoL at 3 months (P = 0.01). Conclusions: Evaluation using the IND-VFQ33 revealed that newly diagnosed glaucoma patients have a significant worsening of QoL after initiation of topical ocular hypotensive therapy. This should be an important consideration when educating patients about the disease and its therapy. PMID:26265642

  6. Global and Regional Brain Non-Gaussian Diffusion Changes in Newly Diagnosed Patients with Obstructive Sleep Apnea

    PubMed Central

    Tummala, Sudhakar; Palomares, Jose; Kang, Daniel W.; Park, Bumhee; Woo, Mary A.; Harper, Ronald M.; Kumar, Rajesh

    2016-01-01

    Study Objectives: Obstructive sleep apnea (OSA) patients show brain structural injury and functional deficits in autonomic, affective, and cognitive regulatory sites, as revealed by mean diffusivity (MD) and other imaging procedures. The time course and nature of gray and white matter injury can be revealed in more detail with mean kurtosis (MK) procedures, which can differentiate acute from chronic injury, and better show extent of damage over MD procedures. Our objective was to examine global and regional MK changes in newly diagnosed OSA, relative to control subjects. Methods: Two diffusion kurtosis image series were collected from 22 recently-diagnosed, treatment-naïve OSA and 26 control subjects using a 3.0-Tesla MRI scanner. MK maps were generated, normalized to a common space, smoothed, and compared voxel-by-voxel between groups using analysis of covariance (covariates; age, sex). Results: No age or sex differences appeared, but body mass index, sleep, neuropsychologic, and cognitive scores significantly differed between groups. MK values were significantly increased globally in OSA over controls, and in multiple localized sites, including the basal forebrain, extending to the hypothalamus, hippocampus, thalamus, insular cortices, basal ganglia, limbic regions, cerebellar areas, parietal cortices, ventral temporal lobe, ventrolateral medulla, and midline pons. Multiple sites, including the insular cortices, ventrolateral medulla, and midline pons showed more injury over previously identified damage with MD procedures, with damage often lateralized. Conclusions: Global mean kurtosis values are significantly increased in obstructive sleep apnea (OSA), suggesting acute tissue injury, and these changes are principally localized in critical sites mediating deficient functions in the condition. The mechanisms for injury likely include altered perfusion and hypoxemia-induced processes, leading to acute tissue changes in recently diagnosed OSA. Citation: Tummala S

  7. Endocarditis due to Gemella haemolysans in a newly diagnosed multiple myeloma patient

    PubMed Central

    Liu, Dongyan; Bateman, Thomas; Carr, Elisabeth; Foster, Paul

    2016-01-01

    An 87-year-old Caucasian woman with hypertension, diabetes mellitus type 2, and COPD was admitted with 1-week duration of back pain and weight gain. The physical examination revealed jugular venous distention, rales in the left lower lung field, and severe pitting edema over lower extremities. As workup for leukocytosis, blood cultures grew Gemella haemolysans. Subsequently, a transthoracic echocardiogram revealed vegetation on the non-coronary aortic leaflet and mild aortic stenosis. She was treated with ampicillin and gentamicin. After further investigation, the patient was diagnosed with plasma cell myeloma, the monoclonal lambda type. This is the first reported case of G. haemolysans endocarditis in a multiple myeloma patient. PMID:27609731

  8. Endocarditis due to Gemella haemolysans in a newly diagnosed multiple myeloma patient.

    PubMed

    Liu, Dongyan; Bateman, Thomas; Carr, Elisabeth; Foster, Paul

    2016-01-01

    An 87-year-old Caucasian woman with hypertension, diabetes mellitus type 2, and COPD was admitted with 1-week duration of back pain and weight gain. The physical examination revealed jugular venous distention, rales in the left lower lung field, and severe pitting edema over lower extremities. As workup for leukocytosis, blood cultures grew Gemella haemolysans. Subsequently, a transthoracic echocardiogram revealed vegetation on the non-coronary aortic leaflet and mild aortic stenosis. She was treated with ampicillin and gentamicin. After further investigation, the patient was diagnosed with plasma cell myeloma, the monoclonal lambda type. This is the first reported case of G. haemolysans endocarditis in a multiple myeloma patient. PMID:27609731

  9. Exploring Unprotected Anal Intercourse among Newly Diagnosed HIV Positive Men Who Have Sex with Men in China: An Ethnographic Study

    PubMed Central

    Li, Haochu; Holroyd, Eleanor; Lau, Joseph

    2015-01-01

    Background Unprotected anal intercourse (UAI) is a major pathway towards secondary HIV transmission among men who have sex with men (MSM). We explored the socio-cultural environment and individual beliefs and experiences conducive to UAI in the context of Southern China. Methods We employed an ethnographic approach utilizing a socio-ecological framework to conduct repeated in-depth interviews with thirty one newly diagnosed HIV positive MSM as well as participant observations in Shenzhen based healthcare settings, MSM venues and NGO offices. Results Some men (6/31) reported continuing to practice UAI after an initial diagnosis of being HIV positive. For MSM who had existing lovers or stable partners, the fear of losing partners in a context of non-serostatus disclosure was testified to be a major concern. MSM with casual partners reported that anonymous sexual encounters and moral judgments played a significant role in their sexual risk behaviors. Simultaneously, self-reported negative emotional and psychological status, perception and idiosyncratic risk interpretation, as well as substance abuse informed the intrapersonal context for UAI. Conclusion UAI among these HIV positive MSM was embedded in an intrapersonal context, related to partner type, shaped by anonymous sexual encounters, psychological status, and moral judgments. It is important that prevention and intervention for secondary HIV transmission among newly diagnosed HIV positive MSM in China take into account these contextual factors. PMID:26461258

  10. Symptoms, psychological distress, social support, and quality of life of Chinese patients newly diagnosed with gastrointestinal cancer.

    PubMed

    Yan, Hu; Sellick, Ken

    2004-01-01

    This study aims to describe symptoms, psychological distress, social support, and quality of life of Chinese patients newly diagnosed with gastrointestinal tract (GIT) cancer, and to identify the extent to which demographic, physical, and psychosocial factors predict their quality of life. A convenience sample of 146 newly diagnosed GIT cancer patients recruited from 3 major hospitals in Shanghai completed a self-report questionnaire. The questionnaire was designed to obtain demographic and medical data and measures of symptoms, psychological distress, social support, health-related quality of life (HRQoL), and global quality of life (GQoL). Measures developed in English were translated into Chinese using the procedure advocated by WHO. The results showed that the most common signs and symptoms reported were fatigue, pain, and weight loss; 28% of the patients were depressed; and overall, patients had a moderate quality of life. Comparative analyses found some difference on measures for demographic and diagnostic subgroups. Depression, symptom distress, and social support accounted for 44% of the total variance for HRQoL, while perceived financial difficulty and symptom distress accounted for 20% of the total variance for GQoL. Findings from this research give insights into the importance of quality of life assessment, symptom management, and intervention to improve the quality of life of Chinese cancer patients. It also raises questions about measures of quality of life that are culturally relevant. PMID:15525867

  11. Factors associated with newly diagnosed tic disorders among children in Taiwan: a 10-year nationwide longitudinal study.

    PubMed

    Chen, Chuan-Yu; Liang, Hsin-Yi; Chang, Chia-Ming; Lin, Ju-Hwa; Chang, Tsung-Kai; Tsai, Hui-Ju

    2013-08-01

    Increased attention has been paid to tic disorders clinically, yet relatively few studies have probed potential factors that account for the occurrence of tic disorders in the general population. In this study, we used data derived from the Taiwan's National Health Insurance Research Database to examine an array of factors related to the diagnosis of tic disorders and to further probe gender heterogeneity in clinical manifestation. Poisson regression analyses were applied to model the effects of birth cohort, period, and age, separately, on tic disorders. A total of 880 newly diagnosed tic disorders were identified from 2002 to 2009 among 100,516 youngsters in the study dataset who were born between 1997 and 2005. The results showed that a significant increase in the adjusted incidence rate ratio (IRR) was observed when age increased, with the highest adjusted IRR found at age 8-9 years. Compared to the time period from 2002 to 2005, an elevated IRR was found in the time period from 2006 to 2009 (adjusted IRR: 1.37; 95% CI: 1.05-1.80). Boys tended to be more likely to receive their initial diagnosis from psychiatrists and have higher comorbid attention-deficit/hyperactivity disorder (ADHD), as compared with their girl counterparts. In conclusion, the findings indicate that the effects of age and period, respectively, influence the occurrence of newly diagnosed tic disorders. Gender difference and higher frequent comorbid ADHD in boys than in girls were observed in this study.

  12. Untreated newly diagnosed essential hypertension is associated with nonalcoholic fatty liver disease in a population of a hypertensive center

    PubMed Central

    Michopoulos, Spyros; Chouzouri, Vasiliki I; Manios, Efstathios D; Grapsa, Eirini; Antoniou, Zoi; Papadimitriou, Christos A; Zakopoulos, Nikolaos; Dimopoulos, Athanasios-Meletios

    2016-01-01

    Purpose Recent studies have demonstrated that hypertension (HTN) is associated with nonalcoholic fatty liver disease (NAFLD) in treated hypertensive patients. The aim of this study was to investigate the association between newly diagnosed essential HTN and NAFLD in untreated hypertensive patients. Patients and methods A consecutive series of 240 subjects (143 hypertensives and 97 normotensives), aged 30–80 years, without diabetes mellitus were enrolled in the study. Subjects with 24-hour systolic blood pressure (SBP) values ≥130 mmHg and/or diastolic BP values ≥80 mmHg were defined as hypertensives. NAFLD was defined as the presence of liver hyperechogenicity on ultrasound. Results Body mass index (P=0.002) and essential HTN (P=0.016) were independently associated with NAFLD in the multivariate logistic regression model. Furthermore, the multivariate analysis revealed that morning SBP (P=0.044) was independently associated with NAFLD. Conclusion Untreated, newly diagnosed essential HTN is independently associated with NAFLD. Ambulatory BP monitoring could be used for the diagnosis of essential HTN in patients with NAFLD. PMID:26834493

  13. 3.0 Tesla vs 1.5 Tesla breast magnetic resonance imaging in newly diagnosed breast cancer patients

    PubMed Central

    Butler, Reni S; Chen, Christine; Vashi, Reena; Hooley, Regina J; Philpotts, Liane E

    2013-01-01

    AIM: To compare 3.0 Tesla (T) vs 1.5T magnetic resonance (MR) imaging systems in newly diagnosed breast cancer patients. METHODS: Upon Institutional Review Board approval, a Health Insurance Portability and Accountability Act-compliant retrospective review of 147 consecutive 3.0T MR examinations and 98 consecutive 1.5T MR examinations in patients with newly diagnosed breast cancer between 7/2009 and 5/2010 was performed. Eleven patients who underwent neoadjuvant chemotherapy in the 3.0T group were excluded. Mammographically occult suspicious lesions (BIRADS Code 4 and 5) additional to the index cancer in the ipsilateral and contralateral breast were identified. Lesion characteristics and pathologic diagnoses were recorded, and results achieved with both systems compared. Statistical significance was analyzed using Fisher’s exact test. RESULTS: In the 3.0T group, 206 suspicious lesions were identified in 55% (75/136) of patients and 96% (198/206) of these lesions were biopsied. In the 1.5T group, 98 suspicious lesions were identified in 53% (52/98) of patients and 90% (88/98) of these lesions were biopsied. Biopsy results yielded additional malignancies in 24% of patients in the 3.0T group vs 14% of patients in the 1.5T group (33/136 vs 14/98, P = 0.07). Average size and histology of the additional cancers was comparable. Of patients who had a suspicious MR imaging study, additional cancers were found in 44% of patients in the 3.0T group vs 27% in the 1.5T group (33/75 vs 14/52, P = 0.06), yielding a higher positive predictive value (PPV) for biopsies performed with the 3.0T system. CONCLUSION: 3.0T MR imaging detected more additional malignancies in patients with newly diagnosed breast cancer and yielded a higher PPV for biopsies performed with the 3.0T system. PMID:24003354

  14. Normal IQ in a 55-year-old with newly diagnosed rhombencephalosynapsis.

    PubMed

    Bell, Brian D; Stanko, Heather A; Levine, Ross L

    2005-07-01

    Rhombencephalosynapsis (RS) is a rare congenital disorder characterized principally by agenesis/hypogenesis of the cerebellar vermis and fusion of the dentate nuclei and cerebellar hemispheres. Fusion of the peduncles and colliculi is common, and associated anomalies of the cerebral hemispheres also can be present. Only about 50 cases with RS have been described and the majority of these have been children. While the literature suggests that RS often is associated with behavioral and/or intellectual impairment, no previous report has described overall neuropsychological functioning. This report describes an employed male who was diagnosed with RS by MRI at age 55. The neurological examination revealed only subtle sensory-motor abnormalities and the results of the neuropsychological evaluation were generally within normal limits, with the exception of poor immediate visual memory and motor dexterity. These findings suggest RS is not inevitably associated with substantial cognitive impairment. PMID:15905069

  15. Increasing trends in primary NNRTI resistance among newly HIV-1-diagnosed individuals in Buenos Aires, Argentina

    PubMed Central

    Rodriguez-Rodrigues, Nahuel; Duran, Adriana; Bouzas, María Belen; Zapiola, Ines; Vila, Marcelo; Indyk, Debbie; Bissio, Emiliano; Salomon, Horacio; Dilernia, Dario A

    2013-01-01

    Objective Our objective was to estimate primary resistance in an urban setting in a developing country characterized by high antiretroviral (ARV) coverage over the diagnosed population and also by an important proportion of undiagnosed individuals, in order to determine whether any change in primary resistance occurred in the past five years. Design We carried out a multi-site resistance surveillance study according to WHO HIV resistance guidelines, using a weighted sampling technique based on annual HIV case reports per site. Methods Blood samples were collected from 197 drug-naive HIV-1-infected individuals diagnosed between March 2010 and August 2011 at 20 HIV voluntary counselling and testing centres in Buenos Aires. Clinical records of enrolled patients at the time of diagnosis were compiled. Viral load and CD4 counts were performed on all samples. The pol gene was sequenced and the resistance profile determined. Phylogenetic analysis was performed by neighbour-joining (NJ) trees and bootscanning analysis. Results We found that 12 (7.9%) of the 152 successfully sequenced samples harboured primary resistance mutations, of which K103N and G190A were the most prevalent. Non-nucleoside reverse transcriptase inhibitors (NNRTI) resistance mutations were largely the most prevalent (5.9%), accounting for 75% of all primary resistance and exhibiting a significant increase (p=0.0072) in prevalence during the past 10 years as compared to our previous study performed in 1997–2000 and in 2003–2005. Nucleoside reverse transcriptase inhibitor (NRTI) and protease inhibitor primary resistance were low and similar to the one previously reported. Conclusions Levels of primary NNRTI resistance in Buenos Aires appear to be increasing in the context of a sustained ARV coverage and a high proportion of undiagnosed HIV-positive individuals. PMID:24093951

  16. Best practices in the management of newly diagnosed multiple myeloma patients who will not undergo transplant.

    PubMed

    Niesvizky, Ruben; Coleman, Morton; Mark, Tomer

    2010-03-01

    No survival advantage of autologous stem cell transplantation (ASCT) has been documented for patients older than 65 years, and in the era of thalidomide (Thalomid), bortezomib (Velcade), and lenalidomide (Revlimid), ASCT has a diminished role in the front-line treatment of older patients with myeloma. For these individuals and for those who cannot or choose not to undergo ASCT, the initial treatment regimens now recommended by both the National Comprehensive Cancer Network and the International Myeloma Working Group are melphalan (Alkeran)/prednisone/thalidomide (MPT), bortezomib/melphalan/prednisone (VMP), and lenalidomide/low-dose dexamethasone. Melphalan/prednisone should no longer be considered the reference treatment, although it may be appropriate for a small number of patients with serious comorbidity and/or poor performance status. Advantages of VMP over MPT include rapid response, high rates of complete response, patient compliance, and more extensive evidence of efficacy in patients with certain cytogenetic abnormalities. Lenalidomide/low-dose dexamethasone is particularly appropriate for patients with preexisting neurotoxicity and those who wish to postpone ASCT. Toxicity profiles differ among the newly established and emerging regimens, and oncology teams must take care to apply the appropriate risk management measures, including dose reduction where necessary.

  17. QuickStats: Percentage of Adult Day Services Center Participants, by Selected Diagnoses

    MedlinePlus

    ... MMWR ) MMWR Share Compartir QuickStats: Percentage of Adult Day Services Center Participants,* by Selected Diagnoses † — National Study ... which is the estimated number of enrolled adult day services center participants in the United States on ...

  18. Are patients with newly diagnosed breast cancer getting appropriate DEXA scans? A District General Hospital experience.

    PubMed

    Dong, Huan; Dayananda, Pete; Preece, Shay-Anne; Carmichael, Amtul

    2015-01-01

    Breast cancer patients are often at high risk of fragility fractures partly due to adjuvant endocrine therapy such as aromatase inhibitors and chemotherapy. Baseline dual energy X-ray absorptiometry (DEXA) scanning is recommended as a standard of care in identifying patients who are at risk so they can be commenced on bone protective therapy. NICE guideline 80 - "Early and locally advanced breast cancer"[1] states that patients with early invasive breast cancer should have a baseline DEXA scan to assess BMD before the commencement of aromatase inhibitor treatment; if patients have treatment-induced menopause or are starting ovarian ablation/suppression therapy. We have audited the performance of a DGH against these guidelines with a target of 100% concordance. During a one year period (April 2012-April 2013), 100 patients with a new diagnosis of breast cancer were selected at random from the hospital coding database. 100 patients were chosen as this was a convenient sample size. We gathered information for these patients using electronic records, letters, and imaging. This showed a poor compliance of 38% against NICE guidelines. This in turn means that patients with low BMD at diagnosis of breast cancer are being under diagnosed and under treated, resulting in increased potential morbidity associated with fragility fractures. The interventions that resulted from this audit were: dissemination of these results to surgical and oncology departments, posters summarising the guidelines put up in breast clinics, and breast MDTs to discuss the need for DEXA scans for patients with breast cancer. A re-audit was performed for patients diagnosed with early, invasive breast cancer in January 2014 where a compliance of 90% was achieved. This represents a huge improvement in compliance from the baseline measure of 38%. In order to show that this improvement could be sustained, two further cycles were performed in February and March 2014, where the compliance was 92% and 100

  19. Prevalence of Lynch Syndrome among Patients with Newly Diagnosed Endometrial Cancers

    PubMed Central

    Egoavil, Cecilia; Alenda, Cristina; Castillejo, Adela; Paya, Artemio; Peiro, Gloria; Sánchez-Heras, Ana-Beatriz; Castillejo, Maria-Isabel; Rojas, Estefanía; Barberá, Víctor-Manuel; Cigüenza, Sonia; Lopez, Jose-Antonio; Piñero, Oscar; Román, Maria-Jose; Martínez-Escoriza, Juan-Carlos; Guarinos, Carla; Perez-Carbonell, Lucia; Aranda, Francisco-Ignacio; Soto, Jose-Luis

    2013-01-01

    Background Lynch syndrome (LS) is a hereditary condition that increases the risk for endometrial and other cancers. The identification of endometrial cancer (EC) patients with LS has the potential to influence life-saving interventions. We aimed to study the prevalence of LS among EC patients in our population. Methods Universal screening for LS was applied for a consecutive series EC. Tumor testing using microsatellite instability (MSI), immunohistochemistry (IHC) for mismatch-repair (MMR) protein expression and MLH1-methylation analysis, when required, was used to select LS-suspicious cases. Sequencing of corresponding MMR genes was performed. Results One hundred and seventy-three EC (average age, 63 years) were screened. Sixty-one patients (35%) had abnormal IHC or MSI results. After MLH1 methylation analysis, 27 cases were considered suspicious of LS. From these, 22 were contacted and referred for genetic counseling. Nineteen pursued genetic testing and eight were diagnosed of LS. Mutations were more frequent in younger patients (<50 yrs). Three cases had either intact IHC or MSS and reinforce the need of implement the EC screening with both techniques. Conclusion The prevalence of LS among EC patients was 4.6% (8/173); with a predictive frequency of 6.6% in the Spanish population. Universal screening of EC for LS is recommended. PMID:24244552

  20. Magnetic Resonance Imaging-Based Radiomic Profiles Predict Patient Prognosis in Newly Diagnosed Glioblastoma Before Therapy

    PubMed Central

    McGarry, Sean D.; Hurrell, Sarah L.; Kaczmarowski, Amy L.; Cochran, Elizabeth J.; Connelly, Jennifer; Rand, Scott D.; Schmainda, Kathleen M.; LaViolette, Peter S.

    2016-01-01

    Magnetic resonance imaging (MRI) is used to diagnose and monitor brain tumors. Extracting additional information from medical imaging and relating it to a clinical variable of interest is broadly defined as radiomics. Here, multiparametric MRI radiomic profiles (RPs) of de novo glioblastoma (GBM) brain tumors is related with patient prognosis. Clinical imaging from 81 patients with GBM before surgery was analyzed. Four MRI contrasts were aligned, masked by margins defined by gadolinium contrast enhancement and T2/fluid attenuated inversion recovery hyperintensity, and contoured based on image intensity. These segmentations were combined for visualization and quantification by assigning a 4-digit numerical code to each voxel to indicate the segmented RP. Each RP volume was then compared with overall survival. A combined classifier was then generated on the basis of significant RPs and optimized volume thresholds. Five RPs were predictive of overall survival before therapy. Combining the RP classifiers into a single prognostic score predicted patient survival better than each alone (P < .005). Voxels coded with 1 RP associated with poor prognosis were pathologically confirmed to contain hypercellular tumor. This study applies radiomic profiling to de novo patients with GBM to determine imaging signatures associated with poor prognosis at tumor diagnosis. This tool may be useful for planning surgical resection or radiation treatment margins. PMID:27774518

  1. Comparison of Acarbose and Metformin on Albumin Excretion in Patients With Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial.

    PubMed

    Pan, Qingrong; Xu, Yuan; Yang, Ning; Gao, Xia; Liu, Jia; Yang, Wenying; Wang, Guang

    2016-04-01

    Increased urinary albumin excretion in diabetes not only signals nephropathy but also serves as a risk marker for cardiovascular disease. The data of MARCH (Metformin and AcaRbose in Chinese as the initial Hypoglycaemic treatment) trial demonstrated that acarbose and metformin were similarly efficacious at lowering blood glucose and blood pressure, as well as improving insulin sensitivity in Chinese patients newly diagnosed with type 2 diabetes mellitus. The purpose of this study was to identify the effects of acarbose and metformin therapy on albumin excretion in MARCH study.Baseline urine albumin/creatinine ratio (ACR) of 762 newly diagnosed, drug-naïve patients with type 2 diabetes mellitus was measured. Included patients were randomized to receive either acarbose or metformin and followed for 48 weeks. In addition to change in ACR, the estimated glomerular filtration rates (eGFR) and frequency of metabolic syndrome (MetS) were also assessed.Elevated ACR levels (≥30 mg/g) were present at baseline in 21.9% of all participants. A significant decline in urine ACR was observed in both the acarbose and metformin groups at week 24 and 48 (all P < 0.001). The proportion of patients with elevated ACRs was also reduced in both treatment groups at week 24 and 48 compared with baseline values (all P < 0.05). The change in urine ACR at week 48 was significantly greater in patients prescribed acarbose than in those prescribed metformin (P = 0.01). Both acarbose and metformin significantly decreased the frequency of MetS at week 24 and 48 (both P < 0.05). Neither treatment affected eGFR.In sum, both acarbose and metformin decreased urine ACR levels and reduced the frequency of elevated ACR and MetS in Chinese patients with newly diagnosed type 2 diabetes mellitus without affecting eGFR. After 48 weeks' intervention, acarbose therapy resulted in a greater reduction in urine ACR compared with metformin.

  2. Pituitary tumor disappearance in a patient with newly diagnosed acromegaly primarily treated with octreotide LAR.

    PubMed

    Resmini, E; Murialdo, G; Giusti, M; Boschetti, M; Minuto, F; Ferone, D

    2005-02-01

    We describe the case of an acromegalic patient primarily treated with octreotide LAR in whom the pituitary tumor disappeared after 18 months of treatment. A 68-yr-old woman, with clinical suspicion of acromegaly, was admitted to our Unit with the ultrasonographical evidence of cardiac hypertrophy, arrhythmias, right branch block and interatrial septum aneurism. She referred hands and feet enlargement since the age of 30 and facial disfigurements since the age of 50. At the age of 45 she underwent surgery for carpal tunnel syndrome and at the age of 61 an euthyroid nodular goiter was diagnosed. Hormonal evaluation showed elevated circulating GH levels (25+/-3.2 ng/ml), not suppressible after oral glucose load, and elevated IGF-I levels (646 ng/ml), whereas the remaining pituitary function was normal. Visual perimetry was normal, whereas magnetic resonance imaging (MRI) showed an intrasellar pituitary adenoma with maximal diameter of 9 mm. In order to improve cardiovascular function before surgery, the patient started octreotide LAR 20 mg every 4 weeks for 3 months. Then based on IGF-I values, the dose was adjusted to 30 mg. After 6 months a second MRI showed significant tumor reduction (>50% of baseline maximal diameter), GH and IGF-I were within the normal range and the patient continued the treatment. After one-year therapy, an improvement of cardiac alterations was recorded and the patient was referred to the neurosurgeon. However, she refused the operation. At 18-month follow-up, MRI showed the complete disappearance of direct and indirect signs of pituitary adenoma. To our knowledge, this is the first case of complete radiological remission of pituitary tumor during octreotide LAR treatment in acromegaly.

  3. Deficit of short-term memory in newly diagnosed untreated parkinsonian patients: reversal after L-dopa therapy.

    PubMed

    Marini, P; Ramat, S; Ginestroni, A; Paganini, M

    2003-10-01

    We assessed the effect of pathology and L-dopa therapy on attention, working memory, and executive functions, in newly diagnosed Parkinson's disease patients. Twenty-one consecutive outpatients who met the criteria for de novo Parkinson's disease, and were naive for L-dopa therapy, were observed for the first time. All patients underwent clinical and neuropsychological evaluations (cognitive decline, memory, executive control). Each patient was reevaluated on standard L-dopa therapy. Serial Position Curves showed an increased primacy effect (5.18+/-2.07) and a decreased recency effect (13.35+/-5.51). These findings normalized after L-dopa therapy (3.50+/-1.72 and 16.20+/-3.09 respectively). The effect of L-dopa on working memory is discussed.

  4. Recent Infection, Sexually Transmitted Infections and Transmission Clusters Frequently Observed Among Persons Newly-Diagnosed with HIV in San Francisco

    PubMed Central

    Truong, Hong-Ha M.; Pipkin, Sharon; O’Keefe, Kara J.; Louie, Brian; Liegler, Teri; McFarland, Willi; Grant, Robert M.; Bernstein, Kyle; Scheer, Susan

    2015-01-01

    There were 1,311 newly-diagnosed HIV cases in San Francisco between 2005 and 2011 that were linked to care at publicly-funded facilities and had viral sequences available for analysis. Of the 214 cases characterized as recently-infected with HIV at time of diagnosis, 25% had a recent sexually transmitted infection (STI) diagnosis (vs. 10% among longer-standing HIV infections, p<0.001) and 57% were part of a phylogenetic transmission cluster (vs. 42% among longer-standing HIV infection, p<0.001). The association observed between recent HIV infection and having a STI diagnosis during the interval overlapping likely HIV acquisition points to potential opportunities to interrupt HIV transmission. PMID:25967271

  5. All-Trans Retinoic Acid plus Arsenic Trioxide versus All-Trans Retinoic Acid plus Chemotherapy for Newly Diagnosed Acute Promyelocytic Leukemia: A Meta-Analysis

    PubMed Central

    Ma, Yafang; Liu, Lu; Jin, Jie; Lou, Yinjun

    2016-01-01

    Background Recently, the all-trans retinoic acid (ATRA) plus arsenic trioxide (ATO) protocol has become a promising first-line therapeutic approach in patients with newly diagnosed acute promyelocytic leukemia (APL), but its benefits compared with standard ATRA plus chemotherapy regimen needs to be proven. Herein, we conducted a meta-analysis comparing the efficacy of ATRA plus ATO with ATRA plus chemotherapy for adult patients with newly diagnosed APL. Methods We systematically searched biomedical electronic databases and conference proceedings through February 2016. Two reviewers independently assessed all studies for relevance and validity. Results Overall, three studies were eligible for inclusion in this meta-analysis, which included a total of 585 patients, with 317 in ATRA plus ATO group and 268 in ATRA plus chemotherapy group. Compared with patients who received ATRA and chemotherapy, patients who received ATRA plus ATO had a significantly better event-free survival (hazard ratio [HR] = 0.38, 95% confidence interval [CI]: 0.22–0.67, p = 0.009), overall survival (HR = 0.44, 95% CI: 0.24–0.82, p = 0.009), complete remission rate (relative risk [RR] = 1.05; 95% CI: 1.01–1.10; p = 0.03). There were no significant differences in early mortality (RR = 0.48; 95% CI: 0.22–1.05; p = 0.07). Conclusion Thus, this analysis indicated that ATRA plus ATO protocol may be preferred to standard ATRA plus chemotherapy protocol, particularly in low-to-intermediate risk APL patients. Further larger trials were needed to provide more evidence in high-risk APL patients. PMID:27391027

  6. Treatment of newly diagnosed symptomatic pure low-grade oligodendrogliomas with PCV chemotherapy.

    PubMed

    Lebrun, C; Fontaine, D; Bourg, V; Ramaioli, A; Chanalet, S; Vandenbos, F; Lonjon, M; Fauchon, F; Paquis, P; Frenay, M

    2007-04-01

    Based on studies relating to anaplastic oligodendroglioma (OG) chemosensitivity and benefit of time to progression or overall survival, chemotherapy for pure OG has been proposed. Several studies have reported the efficacy of various chemotherapeutic agents in a small number of patients with low-grade gliomas, e.g. pure astrocytomas, OG or mixed histologies. The 5-year survival rate varies from 61% to 89% with a mean time to progression of 5 years. We report the outcome of 33 consecutive patients with pure low-grade OG diagnosed between 1990 and 2006 systematically treated for residual or non-removable tumor with PCV chemotherapy regimen as the front-line treatment after surgery. All the tumors were low grade (grade II) pure OG according to the WHO classification. All patients were symptomatic at presentation and underwent neurosurgical procedure for histological diagnosis. Response was evaluated by clinical assessment and brain magnetic resonance imaging. Twenty-one men and 12 women with a mean age at pathological diagnosis of 46.5 years were studied. The most common first symptom was partial epileptic seizure (73.7%). Six patients (18%) had initial gadolinium enhancement, associated with methoxyisobutyl (MIBI) hypermetabolism (P < 0.001). The resection was partial in seven cases (21%), and 26 patients (79%) had biopsy only. Eleven patients (36%) had a malignant transformation during the follow-up with a median time to progression of 19 months. Favorable prognostic factors were lack of contrast enhancement (P < 0.0001), and age <40 years (P < 0.0003); 90% of patients were progression-free at 1 year. Survival rates at 2, 5 and 10 years were 85%, 75% and 50%, respectively. Up-front chemotherapy with PCV regimen is a good treatment for symptomatic pure low-grade OG, as it increases the number of progression-free patients and time to progression. These results suggest that radiotherapy could be postponed until the malignant transformation occurs to delay cognitive

  7. Genetic impact on cognition and brain function in newly diagnosed Parkinson's disease: ICICLE-PD study.

    PubMed

    Nombela, Cristina; Rowe, James B; Winder-Rhodes, Sophie E; Hampshire, Adam; Owen, Adrian M; Breen, David P; Duncan, Gordon W; Khoo, Tien K; Yarnall, Alison J; Firbank, Michael J; Chinnery, Patrick F; Robbins, Trevor W; O'Brien, John T; Brooks, David J; Burn, David J; Barker, Roger A

    2014-10-01

    associated with memory encoding. This study demonstrates that neurocognitive deficits are common even in recently diagnosed patients with Parkinson's disease, and that the associated regional brain activations are influenced by genotype. These data further support the dual syndrome hypothesis of cognitive change in Parkinson's disease. Longitudinal data will confirm the extent to which these early neurocognitive changes, and their genetic factors, influence the long-term risk of dementia in Parkinson's disease. The combination of genetics and functional neuroimaging provides a potentially useful method for stratification and identification of candidate markers, in future clinical trials against cognitive decline in Parkinson's disease.

  8. Changing prevalence of retinopathy in newly diagnosed non-insulin dependent diabetes mellitus patients in Hong Kong.

    PubMed

    Wang, W Q; Ip, T P; Lam, K S

    1998-03-01

    In this retrospective study, the prevalence of chronic microangiopathic complications was determined in 474 Chinese patients with non-insulin dependent diabetes mellitus (NIDDM) who presented within 1 year of diagnosis to the diabetes clinic from January 1990 to December 1996. Mean age (+/- S.E.) was 53.6 (+/- 0.6) years. The overall prevalence of retinopathy was 21.9%. A significant increase was observed from 1990 to 1994 (P < 0.005), with the prevalence being 14.8, 13.0, 24.5, 32.3 and 35.4%, respectively, in consecutive years. A decreasing prevalence was seen from 1994 to 1996 (P < 0.001), being 8.2 and 7.4% in 1995 and 1996, respectively. A total of 95% of patients had nonproliferative retinopathy--proliferative retinopathy was found in 5% only. The overall prevalence of clinical nephropathy (proteinuria > 0.5 g/day) was 3.7%. Clinical neuropathy (increased vibration perception threshold) was found in 12.8% of patients. Patients with retinopathy and neuropathy were older (P < 0.0001 and P < 0.005, respectively) than those without the complications and systolic hypertension was more prevalent in patients with retinopathy (P < 0.05). In conclusion, a high prevalence of diabetic microangiopathic complications, especially of retinopathy, is present in newly diagnosed NIDDM patients in our population. It remains to be determined whether the changing prevalence of retinopathy at diagnosis bears any relationship to the increasing public awareness of diabetes and its complications in Hong Kong in recent years. Examination for chronic microangiopathic complications should be carried out in all newly diagnosed NIDDM patients.

  9. Basal and glucose-suppressed GH levels less than 1 microg/L in newly diagnosed acromegaly.

    PubMed

    Freda, Pamela U; Reyes, Carlos M; Nuruzzaman, Abu T; Sundeen, Robert E; Bruce, Jeffrey N

    2003-01-01

    The development of highly sensitive and specific GH assays has necessitated a critical re-evaluation of the biochemical criteria needed for the diagnosis of acromegaly. Use of these assays has revealed that GH levels after oral glucose in healthy subjects and postoperative patients with active acromegaly can be significantly less than previously recognized with older GH assays. In order to assess GH criteria for newly diagnosed acromegaly with a modern assay we have evaluated GH levels in 25 patients referred to our Neuroendocrine Unit for evaluation of untreated acromegaly. All patients underwent measurement of basal GH and IGF-I levels and 15 of these patients also underwent oral glucose tolerance testing for GH suppression (OGTT). Basal GH levels were < 1.0 microg/L at diagnosis in 5 of these 25 patients. Nadir GH levels were less than 1 microg/L also in 5 of 15 patients, and as low as 0.42 microg/L. All patients had elevated IGF-I levels preoperatively and pathological confirmation of a GH secreting pituitary tumor at the time of transsphenoidal surgery. The clinical presentations of these patients was variable. Most patients presented with classical manifestations of acromegaly, but 3 of the 5 patients with low nadir GH values had only very subtle signs of acromegaly. Although most newly diagnosed patients have classically elevated GH levels and obvious clinical features of acromegaly, early recognition of disease may uncover patients with milder biochemical and clinical abnormalities. The diagnosis should not be discounted in patients who have elevated IGF-I levels, but have basal or nadir GH levels less than 1 microg/L. Conventional GH criteria for the diagnosis of acromegaly cannot be applied to the use of modern sensitive and specific GH assays. PMID:15237928

  10. A Phase I Trial of Tipifarnib With Radiation Therapy, With and Without Temozolomide, for Patients With Newly Diagnosed Glioblastoma

    SciTech Connect

    Nghiemphu, Phioanh Leia; Wen, Patrick Y.; Drappatz, Jan; Fink, Karen; Malkin, Mark G.; Lieberman, Frank S.; DeAngelis, Lisa M.; Torres-Trejo, Alejandro; Chang, Susan M.; Abrey, Lauren; Fine, Howard A.; Demopoulos, Alexis; Lassman, Andrew B.; Kesari, Santosh; Prados, Michael D.; Cloughesy, Timothy F.

    2011-12-01

    Purpose: To determine the maximum tolerated dose (MTD) of tipifarnib in combination with conventional radiotherapy for patients with newly diagnosed glioblastoma. The MTD was evaluated in three patient cohorts, stratified based on concurrent use of enzyme-inducing antiepileptic drugs (EIAED) or concurrent treatment with temozolomide (TMZ): Group A: patients not receiving EIAED and not receiving TMZ; Group A-TMZ: patients not receiving EIAED and receiving treatment with TMZ; Group B: any patients receiving EIAED but not TMZ. Patients and Methods: After diagnostic surgery or biopsy, treatment with tipifarnib started 5 to 9 days before initiating radiotherapy, twice daily, in 4-week cycles using discontinuous dosing (21 out of 28 days), until toxicity or progression. For Group A-TMZ, patients also received TMZ daily during radiotherapy and then standard 5/28 days dosing after radiotherapy. Dose-limiting toxicity (DLT) was determined over the first 10 weeks of therapy for all cohorts. Results: Fifty-one patients were enrolled for MTD determination: 10 patients in Group A, 21 patients in Group A-TMZ, and 20 patients in Group B. In the Group A and Group A-TMZ cohorts, patients achieved the intended MTD of 300 mg twice daily (bid) with DLTs including rash and fatigue. For Group B, the MTD was determined as 300 mg bid, half the expected dose. The DLTs included rash and one intracranial hemorrhage. Thirteen of the 20 patients evaluated in Group A-TMZ were alive at 1 year. Conclusion: Tipifarnib is well tolerated at 300 mg bid given discontinuously (21/28 days) in 4-week cycles, concurrently with standard chemo/radiotherapy. A Phase II study should evaluate the efficacy of tipifarnib with radiation and TMZ in patients with newly diagnosed glioblastoma and not receiving EIAED.

  11. Cost-Effectiveness of Bevacizumab and Ranibizumab for Newly Diagnosed Neovascular Macular Degeneration (An American Ophthalmological Society Thesis)

    PubMed Central

    Stein, Joshua D.; Newman-Casey, Paula Anne; Mrinalini, Tavag; Lee, Paul P.; Hutton, David W.

    2013-01-01

    Purpose: To determine the most cost-effective treatment for patients with newly diagnosed neovascular macular degeneration: monthly or as-needed bevacizumab injections, or monthly or as-needed ranibizumab injections. Methods: Using a Markov model with a 20-year time horizon, we compared the incremental cost-effectiveness of treating a hypothetical cohort of 80-year-old patients with newly diagnosed neovascular macular degeneration using monthly bevacizumab, as-needed bevacizumab, monthly ranibizumab, or as-needed ranibizumab. Data came from the Comparison of Age-Related Macular Degeneration Treatment Trial (CATT), the Medicare Fee Schedules, and the medical literature. Results: Compared with as-needed bevacizumab, the incremental cost-effectiveness ratio of monthly bevacizumab is $242,357 per quality-adjusted life year (QALY). Monthly ranibizumab gains an additional 0.02 QALYs vs monthly bevacizumab at an incremental cost-effectiveness ratio of more than $10 million per QALY. As-needed ranibizumab was dominated by monthly bevacizumab. In sensitivity analyses assuming a willingness to pay of $100,000 per QALY, the annual risk of serious vascular events would have to be at least 2.5 times higher with bevacizumab than that observed in the CATT trial for as-needed ranibizumab to have an incremental cost-effectiveness ratio of <$100,000 per QALY. In another sensitivity analysis, even if every patient receiving bevacizumab experienced declining vision by one category (eg, from 20/25–20/40 to 20/50–20/80) after 2 years but all patients receiving ranibizumab retained their vision level, as-needed ranibizumab would have an incremental cost-effectiveness ratio of $97,340 per QALY. Conclusion: Even after considering the potential for differences in risks of serious adverse events and therapeutic effectiveness, bevacizumab confers considerably greater value than ranibizumab for the treatment of neovascular macular degeneration. PMID:24167325

  12. A phase I trial of tipifarnib with radiation therapy, with and without temozolomide, for patients with newly diagnosed glioblastoma

    PubMed Central

    Nghiemphu, Phioanh Leia; Wen, Patrick Y.; Lamborn, Kathleen R.; Drappatz, Jan; Robins, H. Ian; Fink, Karen; Malkin, Mark G.; Lieberman, Frank S.; DeAngelis, Lisa M.; Torres-Trejo, Alejandro; Chang, Susan M.; Abrey, Lauren; Fine, Howard A.; Demopoulos, Alexis; Lassman, Andrew B.; Kesari, Santosh; Mehta, Minesh P.; Prados, Michael D.; Cloughesy, Timothy F.

    2010-01-01

    Purpose To determine the maximum tolerated dose (MTD) of tipifarnib in combination with conventional radiotherapy (RT) for patients with newly diagnosed glioblastoma (GBM). MTD was evaluated in three patient cohorts, stratified based on concurrent use of enzyme inducing antiepileptic drugs (EIAED) or concurrent treatment with temozolomide (TMZ): Group A - patients not receiving EIAED and not receiving TMZ; Group A-TMZ - patients not on EIAED, and on treatment with TMZ; Group B – any patients receiving EIAED, but no TMZ. Methods and Materials After diagnostic surgery or biopsy, treatment with tipifarnib started 5–9 days before initiating RT, twice daily, in four-week cycles using discontinuous dosing (21 out of 28 days), until toxicity or progression. For Group A-TMZ, patients also received TMZ daily during radiotherapy and then standard 5/28 days dosing after radiotherapy. Dose limiting toxicity (DLT) was determined over the first 10 weeks of therapy for all cohorts. Results Fifty-one patients were enrolled for MTD determination: 10 patients in Group A, 21 patients in Group A-TMZ, 20 patients in Group B. In Group A and Group A-TMZ cohorts, patients achieved the intended MTD of 300 mg bid with DLTs including rash and fatigue. For Group B, the MTD was determined as 300 mg bid, half the expected dose. DLTs included rash and 1 intracranial hemorrhage. Thirteen of the 20 patients evaluated in Group A-TMZ were alive at one year. Conclusion Tipifarnib is well tolerated at 300 mg bid given discontinuously (21/28 days) in 4-week cycles, concurrently with standard chemo/radiotherapy. A phase II study should evaluate the efficacy of tipifarnib with radiation and TMZ in patients with newly diagnosed GBM and not on EIAED. PMID:20934264

  13. Diagnosing FASD in adults: the development and operation of an adult FASD clinic in Ontario, Canada.

    PubMed

    Temple, Valerie K; Ives, Jillian; Lindsay, Ann

    2015-01-01

    This paper describes the development and operation of an interdisciplinary Fetal Alcohol Spectrum Disorders (FASD) diagnostic clinic focussing specifically on adults. The clinic is embedded within a community-based interdisciplinary health agency specializing in intellectual and developmental disabilities. A review of the clinic’s assessment process is presented describing the steps from intake to feedback and intervention. To date, the clinic has received 93 referrals and given 41 alcohol-related diagnoses including 10 completed using videoconferencing technology. Issues unique to adult diagnosis are discussed as well as some of the challenges, including high rates of cancellations/no-shows for appointments, obtaining background and historical information, establishing maternal alcohol history, working collaboratively with other support sectors such as children’s protective services and the justice system, and finding appropriate follow-up and intervention services in the community. Recommendations for future work to support adults with FASD and their families are presented.

  14. Retrospective Study of Palliative Radiotherapy in Newly Diagnosed Head and Neck Carcinoma

    SciTech Connect

    Stevens, Christiaan M.; Huang Shaohui; Fung, Sharon; Bayley, Andrew J.; Cho, John B.; Cummings, Bernard J.; Dawson, Laura A.; Hope, Andrew J.; Kim, John J.; O'Sullivan, Brian; Waldron, John N.; Ringash, Jolie

    2011-11-15

    Purpose: To examine the patterns of care, outcomes, and prognostic factors for patients with head-and-neck cancer (HNC) treated with palliative radiotherapy (RT). Methods and Materials: An institutional HNC anthology and electronic patient records were used to identify patients with previously untreated HNC of mucosal or salivary gland origin who underwent palliative RT at our institution between July 2003 and June 2008. Overall survival was determined from the start date of RT to either the date of death or the date of last follow-up for living patients. The data were censored if the subject was either lost to follow-up or had not been seen for follow-up at our institution for {>=}4 months. Results: We identified 148 eligible patients. The median age was 72 years (range, 19-94). Of the 148 patients, 12 had Stage II-III, 39 Stage IVA, 36 Stage IVB, and 54 Stage IVC; for 7 patients, the stage was unknown. Oropharyngeal primary cancer (40) was the most common primary site. The Eastern Cooperative Oncology Group performance status was 0 in 15, 1 in 69, 2 in 40, 3 in 19, and 4 in 5 patients. The Adult Co-morbidity Evaluation-27 scale was 0 in 33, 1 in 47, 2 in 44, and 3 in 21. The median radiation dose was 50 Gy (range, 2-70), the median fraction number was 20 (range, 1-40), and the median total treatment time (including breaks) was 29 days (range, 1-80). At analysis, 108 patients (73%) had died, 20 (13.5%) were alive, and 20 (13.5%) had been censored. The median follow-up was 4.8 months, and the median survival time was 5.2 months. Information on the treatment response was available for 103 patients (70%). On multivariate analysis, the radiation dose was an independent predictor of both overall survival (hazard ratio 0.97, 95% confidence interval 0.96-0.99, p <.01) and treatment response (odds ratio 1.05, 95% confidence interval 1.01-1.08, p <.01). Conclusion: For patients considered unsuitable for curative RT, the radiation dose might be an independent predictive

  15. Late presentation and loss to follow-up of immigrants newly diagnosed with HIV in the HAART era.

    PubMed

    Saracino, A; Tartaglia, A; Trillo, G; Muschitiello, C; Bellacosa, C; Brindicci, G; Monno, L; Angarano, G

    2014-08-01

    To compare clinical characteristics and therapeutic management of newly HIV-diagnosed immigrants to natives. Patients with a first HIV diagnosis from 1996 to 2010 were included. Of 716 new diagnoses, 85 (12 %) were immigrants. Migrants were younger, more frequently females and sexually infected, less likely to voluntarily request testing, and less HCV-coinfected. Late presenters (CD4 <350 or AIDS) were 76 % among migrants versus 56 % in natives (p = 0.006) with an increasing trend over time. HAART was initiated in 76.5 % of natives and 72.4 % of immigrants; the number/type of adverse events and treatment discontinuation were similar. Immigrants received more NNRTIs-based regimens. A similar proportion of patients reached virological suppression at month 1-3-6 after HAART initiation, but 43 % of immigrants versus 27 % of natives resulted lost to follow-up (p < 0.001). Diagnosis of HIV was often delayed among migrants, who also presented a higher rate of lost to follow-up.

  16. When is Genomic Testing Cost-Effective? Testing for Lynch Syndrome in Patients with Newly-Diagnosed Colorectal Cancer and Their Relatives

    PubMed Central

    Grosse, Scott D.

    2015-01-01

    Varying estimates of the cost-effectiveness of genomic testing applications can reflect differences in study questions, settings, methods and assumptions. This review compares recently published cost-effectiveness analyses of testing strategies for Lynch Syndrome (LS) in tumors from patients newly diagnosed with colorectal cancer (CRC) for either all adult patients or patients up to age 70 along with cascade testing of relatives of probands. Seven studies published from 2010 through 2015 were identified and summarized. Five studies analyzed the universal offer of testing to adult patients with CRC and two others analyzed testing patients up to age 70; all except one reported incremental cost-effectiveness ratios (ICERs) < $ 100,000 per life-year or quality-adjusted life-year gained. Three studies found lower ICERs for selective testing strategies using family history-based predictive models compared with universal testing. However, those calculations were based on estimates of sensitivity of predictive models derived from research studies, and it is unclear how sensitive such models are in routine clinical practice. Key model parameters that are influential in ICER estimates included 1) the number of first-degree relatives tested per proband identified with LS and 2) the cost of gene sequencing. Others include the frequency of intensive colonoscopic surveillance, the cost of colonoscopy, and the inclusion of extracolonic surveillance and prevention options. PMID:26473097

  17. Associations of A-FABP with Anthropometric and Metabolic Indices and Inflammatory Cytokines in Obese Patients with Newly Diagnosed Type 2 Diabetes

    PubMed Central

    Niu, Guifen; Li, Jian; Wang, Huaiguo; Ren, Yuan

    2016-01-01

    The study aimed to evaluate the relationship between anthropometric and metabolic indices, inflammatory cytokines, and adipocyte fatty acid-binding protein (A-FABP) in obese patients with newly diagnosed type 2 diabetes. The study included 48 nonobese subjects with newly diagnosed type 2 diabetes, 42 obese subjects with newly diagnosed type 2 diabetes, 30 simple obese subjects, and 30 matched normal subjects. Serum A-FABP was assessed by enzyme-linked immunosorbent assay. Pearson's correlations and multiple linear regression stepwise analysis were used to analyze correlations of A-FABP with anthropometric and metabolic indices and inflammatory cytokines. Obese subjects with newly diagnosed type 2 diabetes had elevated A-FABP compared to normal control, nondiabetic obese patients, and nonobese diabetic patients. A-FABP was significantly correlated with glycated hemoglobin A1C (HbA1C), BMI, triglyceride, Homeostasis Model Assessment Index (HOMA-IR), waist hip rate, C-reactive protein, IL-6, and HDL-C in obese subjects with type 2 diabetes. In multiple linear regression stepwise analysis, BMI, HbA1C, and HOMA-IR were significantly independent determinants for A-FABP. BMI, HbA1C, and HOMA-IR are independently associated with A-FABP in obese subjects with newly diagnosed type 2 diabetes. A-FABP may be related to insulin resistance and inflammation in type 2 diabetes and concomitant obesity.

  18. Challenges with Diagnosing and Managing Sepsis in Older Adults.

    PubMed

    Clifford, Kalin M; Dy-Boarman, Eliza A; Haase, Krystal K; Maxvill, Kristen; Pass, Steven E; Alvarez, Carlos A

    2016-01-01

    Sepsis in older adults has many challenges that affect rate of septic diagnosis, treatment, and monitoring parameters. Numerous age-related changes and comorbidities contribute to increased risk of infections in older adults, but also atypical symptomatology that delays diagnosis. Due to various pharmacokinetic/pharmacodynamic changes in the older adult, medications are absorbed, metabolized, and eliminated at different rates as compared to younger adults, which increases risk of adverse drug reactions due to use of drug therapy needed for sepsis management. This review provides information to aid in diagnosis and offers recommendations for monitoring and treating sepsis in the older adult population.

  19. Decreasing Proportion of Recent Infections among Newly Diagnosed HIV-1 Cases in Switzerland, 2008 to 2013 Based on Line-Immunoassay-Based Algorithms

    PubMed Central

    Schüpbach, Jörg; Niederhauser, Christoph; Yerly, Sabine; Regenass, Stephan; Gorgievski, Meri; Aubert, Vincent; Ciardo, Diana; Klimkait, Thomas; Dollenmaier, Günter; Andreutti, Corinne; Martinetti, Gladys; Brandenberger, Marcel; Gebhardt, Martin D.

    2015-01-01

    Background HIV surveillance requires monitoring of new HIV diagnoses and differentiation of incident and older infections. In 2008, Switzerland implemented a system for monitoring incident HIV infections based on the results of a line immunoassay (Inno-Lia) mandatorily conducted for HIV confirmation and type differentiation (HIV-1, HIV-2) of all newly diagnosed patients. Based on this system, we assessed the proportion of incident HIV infection among newly diagnosed cases in Switzerland during 2008-2013. Methods and Results Inno-Lia antibody reaction patterns recorded in anonymous HIV notifications to the federal health authority were classified by 10 published algorithms into incident (up to 12 months) or older infections. Utilizing these data, annual incident infection estimates were obtained in two ways, (i) based on the diagnostic performance of the algorithms and utilizing the relationship ‘incident = true incident + false incident’, (ii) based on the window-periods of the algorithms and utilizing the relationship ‘Prevalence = Incidence x Duration’. From 2008—2013, 3’851 HIV notifications were received. Adult HIV-1 infections amounted to 3’809 cases, and 3’636 of them (95.5%) contained Inno-Lia data. Incident infection totals calculated were similar for the performance- and window-based methods, amounting on average to 1’755 (95% confidence interval, 1588—1923) and 1’790 cases (95% CI, 1679—1900), respectively. More than half of these were among men who had sex with men. Both methods showed a continuous decline of annual incident infections 2008—2013, totaling -59.5% and -50.2%, respectively. The decline of incident infections continued even in 2012, when a 15% increase in HIV notifications had been observed. This increase was entirely due to older infections. Overall declines 2008—2013 were of similar extent among the major transmission groups. Conclusions Inno-Lia based incident HIV-1 infection surveillance proved useful and

  20. GABA regulates synaptic integration of newly generated neurons in the adult brain

    NASA Astrophysics Data System (ADS)

    Ge, Shaoyu; Goh, Eyleen L. K.; Sailor, Kurt A.; Kitabatake, Yasuji; Ming, Guo-Li; Song, Hongjun

    2006-02-01

    Adult neurogenesis, the birth and integration of new neurons from adult neural stem cells, is a striking form of structural plasticity and highlights the regenerative capacity of the adult mammalian brain. Accumulating evidence suggests that neuronal activity regulates adult neurogenesis and that new neurons contribute to specific brain functions. The mechanism that regulates the integration of newly generated neurons into the pre-existing functional circuitry in the adult brain is unknown. Here we show that newborn granule cells in the dentate gyrus of the adult hippocampus are tonically activated by ambient GABA (γ-aminobutyric acid) before being sequentially innervated by GABA- and glutamate-mediated synaptic inputs. GABA, the major inhibitory neurotransmitter in the adult brain, initially exerts an excitatory action on newborn neurons owing to their high cytoplasmic chloride ion content. Conversion of GABA-induced depolarization (excitation) into hyperpolarization (inhibition) in newborn neurons leads to marked defects in their synapse formation and dendritic development in vivo. Our study identifies an essential role for GABA in the synaptic integration of newly generated neurons in the adult brain, and suggests an unexpected mechanism for activity-dependent regulation of adult neurogenesis, in which newborn neurons may sense neuronal network activity through tonic and phasic GABA activation.

  1. Nonverbal Social Skills of Adults with Mild Intellectual Disability Diagnosed with Depression

    ERIC Educational Resources Information Center

    Hartley, Sigan L.; Birgenheir, Denis G.

    2009-01-01

    Depression is one of the most common psychiatric disorders in adults with intellectual disability (ID), yet little is known about depressive behaviors in an ID population. This study examined the nonverbal social skills of 18 adults with mild ID diagnosed with depression and a matched sample of adults with mild ID without depression. Nonverbal…

  2. The AGE-RAGE Axis and Its Relationship to Markers of Cardiovascular Disease in Newly Diagnosed Diabetic Patients

    PubMed Central

    Villegas-Rodríguez, Ma. Etzabel; Uribarri, Jaime; Solorio-Meza, Sergio E.; Fajardo-Araujo, Martha E.; Cai, Weijing; Torres-Graciano, Sofía; Rangel-Salazar, Rubén; Wrobel, Kazimierz; Garay-Sevilla, Ma. Eugenia

    2016-01-01

    Aim The purpose of the study was the simultaneous measurement of all the different components of the AGE-RAGE axis as well as several non-invasive markers of cardiovascular disease (CVD) in a cohort of newly diagnosed diabetic patients. Materials and Methods In 80 newly diagnosed diabetic patients we measured serum carboxymethyllysine (CML), soluble RAGE (sRAGE) and peripheral mononuclear (PMNC) RAGE and AGER1 mRNA together with ICAM-1, VCAM-1, and malondialdehyde (MDA). We also assessed cardiovascular function by measurement of flow-mediated vasodilation (FMD), intima-media thickness (IMT) and arterial stiffness. Univariant correlation analysis was used to determine correlation between the variables in the study and multiple regression analysis was used to examine the association between the AGE-RAGE axis components and FMD, IMT and arterial stiffness. Results Serum CML correlated positively with sRAGE, PMNC RAGE, HOMA-IR, ICAM-1, VCAM-1 and MDA, but inversely with PMNC AGER1. sRAGE and RAGE was positively correlated with AGER; IMT was positively correlated with HOMA-IR, ICAM-1, VCAM-1, MDA, and sRAGE and arterial stiffness had correlation with HOMA-IR, ICAM-1, VCAM-1, MDA, CML, sRAGE, AGER1 and RAGE. In multivariate analysis we found a significant relationship between CML with PMNC RAGE, HOMA-IR; sRAGE with VCAM-1 and MDA; PMNC RAGE with PMNC AGER1and CML; PMNC AGER1 with PMNC RAGE; FMD with sRAGE, CML and HbA1c; IMT with sRAGE, and arterial stiffness with sRAGE, sCML and AGER1 Conclusions We found significant and strong associations between the different components of the AGE-RAGE axis and also found significant association between AGE-RAGE axis markers, especially sRAGE with several noninvasive markers of cardiovascular disease risk. sRAGE, an easily measured parameter in blood, may potentially be used as a surrogate marker of AGEs-RAGE in patients with diabetes. PMID:27434539

  3. Utilization of 18F-FDG PET/CT as a staging tool in patients with newly diagnosed lymphoma.

    PubMed

    Cho, Shih-Feng; Chang, Chin-Chuan; Liu, Yi-Chang; Chang, Chao-Sung; Hsiao, Hui-Hua; Liu, Ta-Chih; Huang, Chiung-Tang; Lin, Sheng-Fung

    2015-03-01

    The aim of this study was to investigate the role of 2-fluorine-18-fluoro-2-deoxy-D-glucose ((18)F-FDG) positron emission tomography/computed tomography (PET/CT) in the initial staging and prediction of bone marrow involvement in patients with newly diagnosed lymphoma. A total of 185 patients with newly diagnosed lymphoma were enrolled. All patients received PET/CT and bone marrow biopsy as part of a staging work-up. At the initial staging, 17 patients (9.2%) with occult nodal or extranodal lesions were upstaged after a review of the PET/CT studies. PET/CT was found to be useful in the differentiation of aggressive lymphoma subtypes from the indolent subtype based on higher standardized uptake value (SUV) (16.67 vs. 7.98, p < 0.001). The results of bone marrow biopsy and PET/CT in the detection of bone marrow involvement were concordant in 152 patients (82.1%); positive concordance was observed in 21 patients, and negative concordance was observed in 131 patients. A high concordance rate was found between aggressive B cell lymphoma and Hodgkin's lymphoma (88.1% and 93.8%, respectively). High negative predictive values (NPVs) for excluding bone marrow involvement were observed in aggressive B-cell lymphoma (93.2%) and Hodgkin's lymphoma (100%). Diffuse bone marrow FDG uptake accurately predicted bone marrow in aggressive B-cell lymphoma with a positive predictive value (PPV) of 100%. The concordance rate was lower in indolent B-cell lymphoma (66.0%). In conclusion, PET/CT resulted in the upstaging of patients with occult extranodal or nodal lesions. A high SUV level can predict aggressive subtype of lymphoma and detect aggressive components in indolent lymphoma. PET/CT had a high PPV for aggressive B-cell lymphoma with diffuse bone marrow FDG uptake and high NPVs for excluding bone marrow involvement in aggressive B-cell lymphoma and Hodgkin's lymphoma. Bone marrow biopsy may be omitted for the above subgroups of patients with medical conditions not suitable for

  4. Psychological Disorders and Psychosocial Resources of Patients with Newly Diagnosed Bladder and Kidney Cancer: A Cross-Sectional Study

    PubMed Central

    Yang, Yi-Long; Liu, Li; Li, Meng-Yao; Shi, Meng; Wang, Lie

    2016-01-01

    Purpose Psychological disorders have been proven to be associated with poor physiological, psychological and immune outcomes in cancer patients. However, despite of many challenges of the changed self-image/body image and the altered sexual/urinary function, relatively little is known about psychological disorders of patients with newly diagnosed bladder and kidney cancer. We aimed to investigate the prevalence of depression, anxiety, post-traumatic stress disorder (PTSD) and the associated psychosocial factors among bladder/kidney cancer patients. Methods A cross-sectional study was conducted of consecutive inpatients with bladder/kidney cancer in the First Affiliated Hospital of China Medical University in Liaoning Province, northeast China. A total of 489 early-stage cancer patients eligible for this study completed questionnaires on demographic and clinical variables, depression, anxiety, PTSD, perceived social support and positive psychological variables (hope, optimism and resilience) anonymously during October 2013 and August 2014. Hierarchical regression analysis was used to examine the relationships between psychosocial resources and psychological disorders, while controlling for possible covariates. Results The prevalence of depression, anxiety and PTSD was 77.5%, 69.3% and 25.2%, respectively, while 24.9% of patients had psychological co-morbidity. Psychosocial resources together explained more than one-third of the variance on psychological disorders. Under standardized estimate (β) sequence, patient’s perception of social support from family was significantly associated with depression, anxiety and PTSD (p < 0.01). Optimism and resilience showed integrated and independent effects on psychological disorders, and hope represented the significant association with PTSD only (p < 0.01). Conclusions The high prevalence of psychological disorders in newly diagnosed patients with early-stage bladder/kidney cancer should receive more attention in Chinese

  5. Phase I Trial of Hypofractionated Intensity-Modulated Radiotherapy With Temozolomide Chemotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme

    SciTech Connect

    Chen Changhu; Damek, Denise; Gaspar, Laurie E.; Waziri, Allen; Lillehei, Kevin; Kleinschmidt-DeMasters, B.K.; Robischon, Monica; Stuhr, Kelly; Rusthoven, Kyle E.; Kavanagh, Brian D.

    2011-11-15

    Purpose: To determine the maximal tolerated biologic dose intensification of radiotherapy using fractional dose escalation with temozolomide (TMZ) chemotherapy in patients with newly diagnosed glioblastoma multiforme. Methods and Materials: Patients with newly diagnosed glioblastoma multiforme after biopsy or resection and with adequate performance status, bone marrow, and organ function were eligible. The patients underwent postoperative intensity-modulated radiotherapy (IMRT) with concurrent and adjuvant TMZ. All patients received a total dose of 60 Gy to the surgical cavity and residual tumor, with a 5-mm margin. IMRT biologic dose intensification was achieved by escalating from 3 Gy/fraction (Level 1) to 6 Gy/fraction (Level 4) in 1-Gy increments. Concurrent TMZ was given at 75 mg/m{sup 2}/d for 28 consecutive days. Adjuvant TMZ was given at 150-200 mg/m{sup 2}/d for 5 days every 28 days. Dose-limiting toxicity was defined as any Common Terminology Criteria for Adverse Events, version 3, Grade 3-4 nonhematologic toxicity, excluding Grade 3 fatigue, nausea, and vomiting. A standard 3+3 Phase I design was used. Results: A total of 16 patients were accrued (12 men and 4 women, median age, 69 years; range, 34-84. The median Karnofsky performance status was 80 (range, 60-90). Of the 16 patients, 3 each were treated at Levels 1 and 2, 4 at Level 3, and 6 at Level 4. All patients received IMRT and concurrent TMZ according to the protocol, except for 1 patient, who received 14 days of concurrent TMZ. The median number of adjuvant TMZ cycles was 7.5 (range, 0-12). The median survival was 16.2 months (range, 3-33). One patient experienced vision loss in the left eye 7 months after IMRT. Four patients underwent repeat surgery for suspected tumor recurrence 6-12 months after IMRT; 3 had radionecrosis. Conclusions: The maximal tolerated IMRT fraction size was not reached in our study. Our results have shown that 60 Gy IMRT delivered in 6-Gy fractions within 2 weeks with

  6. [The efficacy of non-pharmacological intervention in obese patients with newly diagnosed diabetes mellitus type II].

    PubMed

    Gilis-Januszewska, A; Szurkowska, M; Szybiński, K; Głab, G; Szybiński, Z; Spodaryk, K; Urbanik, A

    2001-09-01

    In Poland like in other countries we observe an increasing number of diabetes mellitus cases with about half of the patients in whom the disease remains undiagnosed. Therefore it seems necessary to improve early diagnoses and prevention of the disease. The aim of the study was to assess the efficiency of a 3-month non-pharmacological intervention based on diet and increased physical activity in patients with newly diagnosed diabetes type 2 (diagnosis based on oral glucose tolerance test (OGTT), WHO 1999). We investigated 37 newly diagnosed diabetic type 2 patients, 16 men (aged 52.4 +/- 5.4) and 21 women (aged 51.0 +/- 5.7). Anthropometric and biochemical measurements were performed before and after intervention. Two-kilometres Walking Test with an intermediate estimation of VO2max and fitness index (FI) was performed before and after intervention. Total abdominal fat volume (measured from diaphragm to pubis): visceral fat volume (VFV) and subcutaneous fat volume (SFV) (mm3) were assessed according to the standard protocol of NMR abdominal examination. Patients completed 12 weeks of supervised intervention focused on weight reduction, increase of physical activity, changes of nutritional habits. Students t-test, Mann-Whitney test and Spearman's correlation were used for statistical analysis. In women the average weight reduction was 4.7 kg (5.8% of initial body weight), whereas in men 5.9 kg (5.9% of initial body weight). In women VO2 max increased from 23.7 +/- 6.4 to 24.9 +/- 4.8 (ns), and fitness index increased from 78.7 +/- 11.7 to 83 +/- 14.7 (ns). In men VO2 max increased from 22.5 +/- 6.7 to 26.6 +/- 8.6 (ns) and fitness index increased from 55.1 +/- 12.5 to 64.8 +/- 13.7 (p < 0.05). In women the level of fasting glycaemia decreased from 6.47 +/- 1.2 to 4.84 mmol/l +/- 0.6 (p < 0.01) and the level of glycaemia at 120 minutes of OGTT decreased from 13.2 +/- 2.5 to 6.76 +/- 2.7 mmol/l (p < 0.01). The decrease of plasma glucose was accompanied by the decrease

  7. Coping with a newly diagnosed high-grade glioma: patient-caregiver dyad effects on quality of life.

    PubMed

    Baumstarck, K; Leroy, T; Hamidou, Z; Tabouret, E; Farina, P; Barrié, M; Campello, C; Petrirena, G; Chinot, O; Auquier, P

    2016-08-01

    Patients with high-grade gliomas (HGG) and their caregivers have to confront a very aggressive disease that produces major lifestyle disruptions. There is an interest in studying the ability of patients and their caregivers to cope with the difficulties that affect quality of life (QoL). We examine, in a sample of patient-caregiver dyads in the specific context of newly diagnosed cases of HGG, whether the QoL of patients and caregivers is influenced by the coping processes they and their relatives use from a specific actor-partner interdependence model (APIM). This cross-sectional study involved 42 dyads with patients having recent diagnoses of HGG and assessed in the time-frame between diagnosis and treatment initiation. The self-reported data included QoL (Patient-Generated Index, EORTC QLQ-C30, and CareGiver Oncology QoL), emotional status, and coping strategies (BriefCope). The APIM was used to test the dyadic effects of coping strategies on QoL. Coping strategies, such as social support, avoidance, and problem solving, exhibited evidence of either an actor effect (degree to which the individual's coping strategies are associated with their own QoL) or partner effect (degree to which the individual's coping strategies are associated with the QoL of the other member of the dyad) for patients or caregivers. For positive-thinking coping strategies, actor and partner effect were not observed. This study emphasizes that the QoL for patients and their caregivers was directly related to the coping strategies they used. This finding suggests that targeted interventions should be offered to help patients and their relatives to implement more effective coping strategies. PMID:27300523

  8. Histological classification and stage of newly diagnosed bladder cancer in a population-based study from the Northeastern United States*

    PubMed Central

    SCHNED, ALAN R.; ANDREW, ANGELINE S.; MARSIT, CARMEN J.; KELSEY, KARL T.; ZENS, MICHAEL S.; KARAGAS, MARGARET R.

    2009-01-01

    Objective There are limited data on the distribution of bladder cancers in the general population, classified by World Health Organization (WHO)/International Society of Urological Pathology (ISUP) criteria. This study evaluated the classification and stage of bladder cancers as part of a population-based epidemiological study of bladder cancer in the Northeastern United States. Material and methods All New Hampshire residents with bladder cancer newly diagnosed from 1998 to 2000 were identified through the state cancer registry. All slides were reviewed by a single pathologist. Tumors were classified by two sets of standard criteria. Results The retrieval rate for cases was over 90%. Of 342 cases reviewed, 15 were excluded for technical reasons or because malignancy was not definitively diagnosed. According to WHO/ISUP criteria, 25.7% of tumors were papillary urothelial neoplasms of low malignant potential (PUNLMP), 34.3% low-grade papillary carcinomas, 22.6% high-grade papillary carcinomas, 10.1% non-papillary urothelial carcinomas and 5.5% carcinoma in situ. By WHO (1973) criteria, 52.5% of tumors were grade 1, 21.4% grade 2 and 26.1% grade 3. Two-thirds of all tumors were stage Ta, 20.8% stage T1 and 7.6% stage ≥T2. 100% of PUNLMPs were non-invasive, 6.3% of low-grade carcinomas were invasive and 64.9% of high-grade carcinomas were invasive. Conclusions Compared to clinic or hospital referral-based series, this study documents a higher percentage of non-invasive tumors and a lower percentage of muscle-invasive tumors. There was also a higher percentage of PUNLMP tumors and fewer high-grade papillary carcinomas than in other series. These results may more accurately reflect prevalence data for bladder cancer grade and stage, although geographic variability may exist. PMID:18432530

  9. Comparison of anti-D immunoglobulin, methylprednisolone, or intravenous immunoglobulin therapy in newly diagnosed pediatric immune thrombocytopenic purpura.

    PubMed

    Celik, Muhittin; Bulbul, Ali; Aydogan, Gönül; Tugcu, Deniz; Can, Emrah; Uslu, Sinan; Dursun, Mesut

    2013-02-01

    This study aimed to evaluate the efficacy, cost, and effects of anti-D immunoglobulin (anti-D Ig), methylprednisolone, or intravenous immunoglobulin (IVIG) therapy on the development of chronic disease in children who are Rh-positive with diagnosed immune thrombocytopenic purpura (ITP). Children with newly diagnosed ITP and platelet count <20,000/mm(3) were prospectively randomized to treatment with anti-D Ig (50 μg/kg), methylprednisolone (2 mg/kg/day), or IVIG (0.4 g/kg/day, 5 days). Sixty children with a mean age of 6.7 years were divided into three equal groups. No difference was observed between platelet counts before treatment and on day 3 of treatment. However, platelet counts at day 7 were lower in the methylprednisolone group than in the IVIG group (P = 0.03). In the anti-D Ig group, hemoglobin and hematocrit levels were significantly lower at the end of treatment (P < 0.05). Chronic ITP developed in 30% of the anti-D Ig group, 35% of the methylprednisolone group, and 25% of the IVIG group, but no significant difference was noted among the groups. The cost analysis revealed that the mean cost of IVIG was 7.4 times higher than anti-D Ig and 10.9 times higher than methylprednisolone. In the treatment of ITP in childhood, one 50 μg/kg dose of anti-D Ig has similar effects to IVIG and methylprednisolone. Among patients who were treated with anti-D Ig, serious anemia was not observed, and the cost of treatment was less than that of IVIG treatment.

  10. Newly diagnosed congenital factor VII deficiency and utilization of recombinant activated factor VII (NovoSeven®)

    PubMed Central

    Bartosh, Nicole S; Tomlin, Tara; Cable, Christian; Halka, Kathleen

    2013-01-01

    This case report presents a newly diagnosed congenital factor VII deficiency treated with recombinant activated factor VII (rFVIIa). Congenital factor VII deficiency is a rare autosomal-recessive bleeding disorder that occurs in fewer than 1/500,000 persons. Its presentation can vary from epistaxis to hemarthroses and severe central nervous system bleeding, and correlates poorly with factor VII levels. Our patient had not had a significant hemostatic challenge prior to his presentation and therefore never had any symptomatology suggestive of this disease. He was treated with rFVIIa, and was able to undergo repair of his fractures without bleeding. Case report A 19-year-old African-American male presented to the emergency room after an altercation that resulted in significant trauma. He sustained bilateral mandibular angle fractures and orbital floor fractures, requiring urgent surgical correction. On initial evaluation, he was noted to have a prolonged prothrombin time of 40.1 seconds, with an International Normalized Ratio of 4.0, a normal activated partial thromboplastin time of 29.9 seconds, and a platelet count of 241. After receiving vitamin K and fresh frozen plasma, he was taken to the operating room for a temporary rigid maxillomandibular fixation. A 1:1 mixing study with normal plasma corrected the prothrombin time (decreasing from 40.7 to 14.7 seconds) and a factor VII assay revealed 5% of the normal factor VII level. The patient was diagnosed with congenital factor VII deficiency. Due to his coagulopathy and the extensive surgical correction needed, rFVIIa was administered and surgery was accomplished without hemorrhagic sequelae. Conclusion This case report and review describes a rare congenital disease, the history of rFVIIa use, and its mechanism. rFVIIA use in our patient provided a treatment option that allowed the necessary surgical correction, but further prospective studies on dose optimization would ensure adequate dosing with minimal risk of

  11. Timing of entry to care by newly diagnosed HIV cases before and after the 2010 New York State HIV testing law.

    PubMed

    Gordon, Daniel E; Bian, Fuqin; Anderson, Bridget J; Smith, Lou C

    2015-01-01

    Prompt entry to care after HIV diagnosis benefits the infected individual and reduces the likelihood of further transmission of the virus. The New York State HIV Testing Law of 2010 requires diagnosing providers to refer persons newly diagnosed with HIV to follow-up medical care. This study used routinely collected HIV-related laboratory data from the New York State HIV surveillance system to assess whether the fraction of newly diagnosed cases entering care within 90 days of diagnosis increased after the implementation of the law. Laboratory data on 23,302 newly diagnosed cases showed that entry to care within 90 days rose steadily from 72.0% in 2007 to 85.4% in 2012. The rise was observed across all race/ethnic groups, ages, transmission risk groups, sexes, and regions of residence. Logistic regression analyses of entry to care pre-law and post-law, controlling for demographic characteristics, transmission risk, and geographic area, indicate that percentage of newly diagnosed cases entering care within 90 days grew more rapidly in the post-law period. This is consistent with a positive effect of the law on entry to care.

  12. Phase 3 study of nilotinib vs imatinib in Chinese patients with newly diagnosed chronic myeloid leukemia in chronic phase: ENESTchina

    PubMed Central

    Wang, Jianxiang; Shen, Zhi-Xiang; Saglio, Giuseppe; Jin, Jie; Huang, He; Hu, Yu; Du, Xin; Li, Jianyong; Meng, Fanyi; Zhu, Huanling; Hu, Jianda; Wang, Jianmin; Hou, Ming; Hertle, Sabine; Menssen, Hans D.; Ortmann, Christine-Elke; Tribouley, Catherine; Yuan, Ye; Baccarani, Michele

    2015-01-01

    Treatment with a tyrosine kinase inhibitor (TKI) targeting BCR-ABL1 is currently the standard of care for patients with chronic myeloid leukemia (CML) in chronic phase (CML-CP). In this study, we present results of the ENESTchina (Evaluating Nilotinib Efficacy and Safety in Clinical Trials–China) that was conducted to investigate nilotinib 300 mg twice daily vs imatinib 400 mg once daily in a Chinese population. ENESTchina met its primary end point with a statistically significant higher rate of major molecular response (MMR; BCR-ABL1 ≤0.1% on the International Scale) at 12 months in the nilotinib arm vs the imatinib arm (52.2% vs 27.8%; P < .0001), and MMR rates remained higher with nilotinib vs imatinib throughout the follow-up period. Rates of complete cytogenetic response (0% Philadelphia chromosome–positive [Ph+] metaphases by standard cytogenetics) were comparable and ≥80% by 24 months in both arms. The estimated rate of freedom from progression to accelerated phase/blast crisis at 24 months was 95.4% in each arm. The safety profiles of both drugs were similar to those from previous studies. In conclusion, rates of MMR at 12 months were superior with nilotinib vs imatinib in Chinese patients with newly diagnosed Ph+ CML-CP. This trial was registered at www.clinicaltrials.gov as #NCT01275196. PMID:25766724

  13. Autologous tumor lysate-pulsed dendritic cell immunotherapy for pediatric patients with newly diagnosed or recurrent high-grade gliomas.

    PubMed

    Lasky, Joseph L; Panosyan, Eduard H; Plant, Ashley; Davidson, Tom; Yong, William H; Prins, Robert M; Liau, Linda M; Moore, Theodore B

    2013-05-01

    Immunotherapy has the potential to improve clinical outcomes with little toxicity for pediatric patients with brain tumors. We conducted a pilot feasibility study of tumor lysate-pulsed dendritic cell (DC) vaccination in pediatric patients (1 to 18 years old) with newly diagnosed or recurrent high-grade glioma (HGG). A total of nine DC vaccine doses, each containing 1 × 10(6) cells per dose were administered to three out of the seven originally enrolled patients. Toxicities were limited to mild side-effects, except in one case of elevated alkaline phosphatase, which resolved without clinical consequences. Two patients with primary lesions amongst the three vaccinated were alive at the time of writing, both without evidence of disease. Pre- and post-vaccination tumor samples from a patient with an anaplastic oligoastrocytoma that recurred failed to demonstrate immune cell infiltration by immunohistochemistry. Peripheral cytokine levels were evaluated in one patient following DC vaccination and demonstrated some changes in relation to vaccination. DC vaccine is tolerable and feasible with some limitations for pediatric patients with HGG. Dendritic cell based immunotherapy may provide some clinical benefit in pediatric patients with glioma, especially for patients with minimal residual disease, but further investigation of this modality is required. PMID:23645755

  14. Autologous Tumor Lysate-pulsed Dendritic Cell Immunotherapy for Pediatric Patients with Newly Diagnosed or Recurrent High-grade Gliomas

    PubMed Central

    Lasky, Joseph L.; Panosyan, Eduard H.; Plant, Ashley; Davidson, Tom; Yong, William H.; Prins, Robert M.; Liau, Linda M.; Moore, Theodore B.

    2014-01-01

    Immunotherapy has the potential to improve clinical outcomes with little toxicity for pediatric patients with brain tumors. We conducted a pilot feasibility study of tumor lysate-pulsed dendritic cell (DC) vaccination in pediatric patients (1 to 18 years old) with newly diagnosed or recurrent high-grade glioma (HGG). A total of nine DC vaccine doses, each containing 1×106 cells per dose were administered to three out of the seven originally enrolled patients. Toxicities were limited to mild side-effects, except in one case of elevated alkaline phosphatase, which resolved without clinical consequences. Two patients with primary lesions amongst the three vaccinated were alive at the time of writing, both without evidence of disease. Pre- and post-vaccination tumor samples from a patient with an anaplastic oligoastrocytoma that recurred failed to demonstrate immune cell infiltration by immunohistochemistry. Peripheral cytokine levels were evaluated in one patient following DC vaccination and demonstrated some changes in relation to vaccination. DC vaccine is tolerable and feasible with some limitations for pediatric patients with HGG. Dendritic cell based immunotherapy may provide some clinical benefit in pediatric patients with glioma, especially for patients with minimal residual disease, but further investigation of this modality is required. PMID:23645755

  15. Health Behaviors Predict Higher Interleukin-6 levels Among Patients Newly Diagnosed with Head and Neck Squamous Cell Carcinoma

    PubMed Central

    Duffy, Sonia A.; Teknos, Theodoros; Taylor, Jeremy M.G.; Fowler, Karen E.; Islam, Mozaffarul; Wolf, Gregory T.; McLean, Scott; Ghanem, Tamer A.; Terrell, Jeffrey E.

    2013-01-01

    Background Health behaviors have been shown to be associated with recurrence risk and survival rates in cancer patients and are also associated with Interleukin-6 levels, but few epidemiologic studies have investigated the relationship of health behaviors and Interleukin-6 among cancer populations. The purpose of the study is to look at the relationship between five health behaviors: smoking, alcohol problems, body mass index (a marker of nutritional status), physical activity, and sleep and pretreatment Interleukin-6 levels in persons with head and neck cancer. Methods Patients (N=409) were recruited in otolaryngology clinic waiting rooms and invited to complete written surveys. A medical record audit was also conducted. Descriptive statistics and multivariate analyses were conducted to determine which health behaviors were associated with higher Interleukin-6 levels controlling for demographic and clinical variables among newly diagnosed head and neck cancer patients. Results While smoking, alcohol problems, body mass index, physical activity, and sleep were associated with Interleukin-6 levels in bivariate analysis, only smoking (current and former) and decreased sleep were independent predictors of higher Interleukin-6 levels in multivariate regression analysis. Covariates associated with higher Interleukin-6 levels were age and higher tumor stage, while comorbidities were marginally significant. Conclusion Health behaviors, particularly smoking and sleep disturbances, are associated with higher Interleukin-6 levels among head and neck cancer patients. Impact Treating health behavior problems, especially smoking and sleep disturbances, may be beneficial to decreasing Interleukin-6 levels which could have a beneficial effect on overall cancer treatment outcomes. PMID:23300019

  16. Low nourishment of B-vitamins is associated with hyperhomocysteinemia and oxidative stress in newly diagnosed cardiac patients

    PubMed Central

    Ali, Amanat; Al-Nassri, Amira; Al-Mukhaini, Mohamed; Valliatte, John; Al-Farsi, Yahya

    2015-01-01

    We are currently witnessing a dramatic change in lifestyle and food choices that is accompanied with an increase in the rate of morbidity and mortality from cardiovascular diseases (CVD). Although studies have reported an association of CVD with hyperhomocysteinemia-mediated oxidative stress, the biochemical basis is not known. This case–control study was aimed to evaluate the nutritional and biochemical status of B-vitamins in relation to hyperhomocysteinemia and oxidative stress in newly diagnosed cardiac patients. The retrospective dietary intake of the study subjects (cases and controls) was estimated using a semi-quantitative food frequency questionnaire, and fasting blood samples were drawn to assess their serum levels of B-vitamins (folate, vitamins B6 and B12), homocysteine (HCY), and oxidative stress indices such as glutathione (GSH), total antioxidant capacity (TAC), malondialdehyde (MDA), and nitrites and nitrates (NN). It was observed that the cases had a lower dietary intake of B-vitamins as compared to their matched control subjects as well as to the corresponding recommended dietary allowances. Biochemical analysis of cases, as compared to controls, indicated depletion of GSH, impairment of TAC, and an elevation in the serum levels of HCY, MDA, and NN. These results suggest that lower status (dietary intake and serum levels) of B-vitamins is involved in the etiology of hyperhomocysteinemia and oxidative stress, the typical risk factors for CVD. PMID:26246496

  17. Superiority of radiobinding assay over ELISA for detection of IAAs in newly diagnosed type I diabetic children

    SciTech Connect

    Levy-Marchal, C.; Bridel, M.P.; Sodoyez-Goffaux, F.; Koch, M.; Tichet, J.; Czernichow, P.; Sodoyez, J.C. )

    1991-01-01

    Liquid- or solid-phase assays have been used for insulin autoantibody (IAA) determination, and the method of IAA measurement has not been standardized. IAAs were determined by radiobinding assay (RBA) and enzyme-linked immunosorbent assay (ELISA) in two large age-matched groups of nondiabetic and newly diagnosed insulin-dependent (type I) diabetic children. Positivity for IAA by RBA (greater than or equal to nondiabetic mean + 3SD) was 2 of 178 (1.1%) and 55 of 173 (32%) in nondiabetic and diabetic children, respectively. Prevalence of IAA by RBA was significantly higher in the youngest age-group (63% between 0-4 yr). Positivity for IAA by ELISA was 1 of 178 (0.6%) and 8 of 169 (4.7%) in nondiabetic and diabetic children, respectively. Concordance rates between both assays were 0 of 3 (0%) in control subjects and 5 of 58 (8.6%) in diabetic children. We conclude that RBA is more appropriate than ELISA for IAA detection at the onset of the disease. In addition, because available data suggest that IAAs detected by RBA only are high-affinity antibodies, it is tempting to speculate that IAAs reflect a mature immune reaction against endogenous insulin.

  18. The Effect of Garcin® in Preventing AntiTB-Induced Hepatitis in Newly Diagnosed Tuberculosis Patients

    PubMed Central

    Tabarsi, Payam; Fahimi, Fanak; Heidarzadeh, Nader; Haghgoo, Roodabeh; Kazempour, Mehdi; Masjedi, Mohammadreza; Velayati, Ali Akbar

    2014-01-01

    Adverse effects of antituberculosis agents such as hepatotoxicity may reduce treatment effectiveness, because they significantly contribute to nonadherence and eventually result in treatment failure, relapse or the emergence of drug resistance. Garlic is an ancient herbal substance, which its effectiveness on isoniazid and rifampicin-induced hepatic injury in animal models has been demonstrated (1). In the present study a randomized, double blind, placebo-controlled, parallel group clinical trial was designed to assess the effect(s) of garlic tablets (1000 mg daily) administered for two weeks orally. Fifty eight newly diagnosed, smear positive pulmonary tuberculosis patients, with age ranges between 18-65 years old, were randomly allocated into two groups. Each patient received either garlic or placebo tablets for the first two weeks of tuberculosis treatment. Of total 58 patients, 31 received garlic tablets while 27 received placebo. No significant difference was found between the two groups regarding age, sex, nationality, smoking, underlying diseases and opium usage. During 8 weeks of anti-TB (antituberculosis) treatment, 8 (13.0%) patients developed drug-induced hepatotoxicity (DIH). Of them, 6 (75%) occurred in the first two weeks of treatment. Fifty percent of the patients who developed DIH were in garlic group. Results indicated no significant difference between groups in developing DIH (p=1.000). We could not show a significant role in preventing DIH by 1000 mg daily garlic administration. PMID:24711843

  19. The Effect of Garcin® in Preventing AntiTB-Induced Hepatitis in Newly Diagnosed Tuberculosis Patients.

    PubMed

    Tabarsi, Payam; Fahimi, Fanak; Heidarzadeh, Nader; Haghgoo, Roodabeh; Kazempour, Mehdi; Masjedi, Mohammadreza; Velayati, Ali Akbar

    2014-01-01

    Adverse effects of antituberculosis agents such as hepatotoxicity may reduce treatment effectiveness, because they significantly contribute to nonadherence and eventually result in treatment failure, relapse or the emergence of drug resistance. Garlic is an ancient herbal substance, which its effectiveness on isoniazid and rifampicin-induced hepatic injury in animal models has been demonstrated (1). In the present study a randomized, double blind, placebo-controlled, parallel group clinical trial was designed to assess the effect(s) of garlic tablets (1000 mg daily) administered for two weeks orally. Fifty eight newly diagnosed, smear positive pulmonary tuberculosis patients, with age ranges between 18-65 years old, were randomly allocated into two groups. Each patient received either garlic or placebo tablets for the first two weeks of tuberculosis treatment. Of total 58 patients, 31 received garlic tablets while 27 received placebo. No significant difference was found between the two groups regarding age, sex, nationality, smoking, underlying diseases and opium usage. During 8 weeks of anti-TB (antituberculosis) treatment, 8 (13.0%) patients developed drug-induced hepatotoxicity (DIH). Of them, 6 (75%) occurred in the first two weeks of treatment. Fifty percent of the patients who developed DIH were in garlic group. Results indicated no significant difference between groups in developing DIH (p=1.000). We could not show a significant role in preventing DIH by 1000 mg daily garlic administration. PMID:24711843

  20. The prognostic significance of CD45 expression by clonal bone marrow plasma cells in patients with newly diagnosed multiple myeloma.

    PubMed

    Gonsalves, Wilson I; Timm, Michael M; Rajkumar, S Vincent; Morice, William G; Dispenzieri, Angela; Buadi, Francis K; Lacy, Martha Q; Dingli, David; Leung, Nelson; Kapoor, Prashant; Kyle, Robert A; Gertz, Morie A; Kumar, Shaji K

    2016-05-01

    Evaluation of clonal plasma cells (PCs) in the bone marrow (BM) of multiple myeloma (MM) patients reveals two distinct clonal PC populations based on the presence or absence of CD45 expression. We explored the prognostic significance of CD45 expression by clonal PCs in the BM of MM patients in the era of novel agent therapy. All 156 MM patients seen at the Mayo Clinic, Rochester from 2009 to 2011 who had their BM evaluated by multiparametric flow cytometry were included. Patients whose BM had ≥20% of the clonal PCs expressing CD45 were classified as CD45 positive (+) and the rest as CD45 negative (-). Of these patients, the median overall survival (OS) for patients in the CD45 (+) group (n=43, 28%) was 38 months versus not reached for the CD45 (-) group (n=113, 72%) (P=0.009). In a multivariable analysis, CD45 (+) status was an independent predictor of inferior OS among newly diagnosed patients with MM. CD45 expression may be a surrogate for a more aggressive phenotype of MM and warrants further investigation.

  1. [Clinical curative efficacy of inducing remission for the newly diagnosed aged AML patients by chemotherapy with IA and DA regimens].

    PubMed

    Tian, Dong-Hua; Gan, Si-Lin; Xing, Hai-Zhou; Liu, Yan-Fang; Xie, Xin-Sheng; Sun, Hui

    2014-10-01

    This study was aimed to explore the clinical efficacy and toxicity of idarubicin (IA regimen) and daunoru-bicin combined with cytarabine (DA regimen) for treating aged patients with AML as induction chemotherapy. The clinical data of 60 newly diagnosed AML aged patients treated with IA or DA regimen were analyzed retrospectively. IA regimen group included 22 patients (8 male and 14 females with median age of 66 yrs), while the DA regimen group included 38 patients (20 males and 18 females with median age of 64 yrs). The complete remission rate, total effective rate and adverse effects after one chemotherapy course were compared. The results showed that the CR rate in IA regimen group was 63.63%, which was significantly higer than that in DA regimen group (31.58%) (P < 0.05). The total effective rate was 63.63% and 36.84% respectively in IA and DA regimen groups, there was significant difference between the two groups (P < 0.05). Both the hematological and non-hematological adverse effects were observed and no difference was found in the two regimen groups, neither in myelosupression (P > 0.05), the major hematological adverse effects, nor in non-hematological adverse effects (P > 0.05). It is concluded that for aged AML patients, IA regimen can achieve a higher CR rate and higher total effective rate than that in DA regimen without increase of adverse effects after one induction chemotherapy course.

  2. Monokine induced by interferon gamma (MIG/CXCL9) is an independent prognostic factor in newly diagnosed myeloma.

    PubMed

    Bolomsky, Arnold; Schreder, Martin; Hübl, Wolfgang; Zojer, Niklas; Hilbe, Wolfgang; Ludwig, Heinz

    2016-11-01

    Immune suppression is a hallmark of multiple myeloma (MM), but data on soluble factors involved in the fate of immune effector cells are limited. The CXCR3-binding chemokine monokine induced by interferon-gamma (MIG/CXCL9) has been associated with tumor progression, immune escape, and angiogenesis in several malignancies. We here aimed to evaluate the prognostic relevance of MIG in MM. MIG serum levels were significantly elevated in newly diagnosed MM patients (n = 105) compared to patients with monoclonal gammopathy of undetermined significance (MGUS; n = 17) and healthy controls (n = 37). MIG expression in stromal compartments but not purified MM cells correlated with serum levels. High MIG serum levels were significantly associated with established prognostic markers (international staging system: R = 0.25, p = 0.001; age: R = 0.47, p < 0.0001; lactate-dehydrogenase: R = 0.34, p = 0.0005) and poor overall survival (OS) (median OS 17.0 months vs. not reached, p < 0.001). A similar association was found for CXCL10 and CXCL11. Multivariate regression analysis indicated MIG as an independent prognostic factor of OS. PMID:26999330

  3. A retrospective analysis of cytogenetic alterations in patients with newly diagnosed multiple myeloma: a single center study in Korea

    PubMed Central

    Li, Shuhua; Lim, Hyeon-Ho; Woo, Kwang-Sook; Kim, Sung-Hyun

    2016-01-01

    Background The accurate identification of cytogenetic abnormalities in multiple myeloma (MM) has become more important over recent years for the development of new diagnostic and prognostic markers. In this study, we retrospectively analyzed the cytogenetic aberrations in MM cases as an initial assessment in a single institute. Methods We reviewed the cytogenetic results from 222 patients who were newly diagnosed with MM between January 2000 and December 2015. Chromosomal analysis was performed on cultured bone marrow samples by standard G-banding technique. At least 20 metaphase cells were analyzed for karyotyping. Results Clonal chromosome abnormalities were detected in 45.0% (100/222) of the patients. Among these results, 80 cases (80.0%) had both numerical and structural chromosome abnormalities. Overall hyperdiploidy with structural cytogenetic aberrations was the most common finding (44.0%), followed by hypodiploidy with structural aberrations (28.0%). Amplification of the long arm of chromosome 1 and -13/del(13q) were the most frequent recurrent abnormalities, and were detected in 50 patients (50.0%) and 40 patients (40.0%) with clonal abnormalities, respectively. The most common abnormality involving 14q32 was t(11;14)(q13;q32), which was observed in 19 cases. Conclusion These findings demonstrate that myeloma cells exhibit complex aberrations regardless of ploidy, even from a single center in Korea. Conventional cytogenetic analysis should be included in the initial diagnostic work-up for patients suspected of having MM. PMID:27382557

  4. Characteristics of elderly patients with COPD and newly diagnosed lung cancer, and factors associated with treatment decision

    PubMed Central

    Qin, Jianwen; Li, Guangsheng; Zhou, Jingmin

    2016-01-01

    Objective To investigate the clinical features, diagnosis, and treatment status of elderly patients with chronic obstructive pulmonary disease (COPD) complicated with lung cancer. Patients and methods This was a retrospective study of 206 patients aged >60 years with COPD and newly diagnosed lung cancer at the Tianjin Chest Hospital Respiratory Centre between September 2008 and September 2013. Lung function, radiology, and clinical data were retrieved. Results Among all patients, 57% (117/206) were hospitalized due to acute COPD aggravation, 47% (96/206) had COPD grade III or IV, 95% (195/206), showed diffusion dysfunction in pulmonary function examination, 90% (185/206) had a history of smoking, and 26% (54/206) were treated with inhaled corticosteroids for COPD treatment. Ninety-eight patients suffered from squamous carcinoma, 73 from adenocarcinoma, and 35 from small-cell carcinoma. Clinical staging was I in 36 patients, II in 47 patients, III in 78 patients, and IV in 45 patients. Initial treatments were surgery in 59 patients, chemotherapy in 30 patients, and no treatment in 117 patients. Multivariate analysis showed that age (P<0.001), COPD grades (P=0.01), clinical staging (P<0.001), and pulmonary diffusion function (P=0.007) were independent factors associated with patients with COPD being given treatments for lung cancer. Conclusion Younger patients with lower COPD grades, earlier lung cancer stage, and better pulmonary diffusion function are more likely to receive treatments. PMID:27445471

  5. White matter microstructural characteristics in newly diagnosed Parkinson’s disease: An unbiased whole-brain study

    PubMed Central

    Wen, Ming-Ching; Heng, Hannah S. E.; Ng, Samuel Y. E.; Tan, Louis C. S.; Chan, Ling Ling; Tan, Eng King

    2016-01-01

    Parkinson’s disease (PD) is a debilitating neurodegenerative disorder. Findings on specific white matter (WM) alterations in PD have been inconsistent. We hypothesized that WM changes occur in early PD patients and unbiased whole-brain analysis may provide additional evidence of pathological WM changes in PD. In this study, we examined various indexes of WM microstructure in newly diagnosed PD patients at the whole-brain level. 64 PDs with Hoehn & Yahr stage 1 (HY1PDs), 87 PDs with Hoehn & Yahr stage 2 (HYPD2s), and 60 controls (HCs) were recruited. Tract-based spatial statistics (TBSS) and diffusion connectometry were used to identify changes of WM pathways associated with PD. There were no significant differences in axial diffusivity, but HY1PDs exhibited greater fractional anisotropy (FA) and decreased mean and radial diffusivities (MD and RD) in callosal, projection, and association fibres than HCs and HY2PDs. Motor severity was inversely correlated with FA, but positively correlated with MD and RD in PD patients. Connectometry analysis also revealed increased WM density in the aforementioned tracts in PD patients, compared with HCs. Our study reveals WM enhancement, suggesting neural compensations in early PD. Longitudinal follow-up studies are warranted to identify the trajectory of WM changes alongside the progression of PD. PMID:27762307

  6. Newly diagnosed panic disorder and the risk of erectile dysfunction: A population-based cohort study in Taiwan.

    PubMed

    Wang, Yao-Ting; Chen, Hsi-Han; Lin, Ching-Heng; Lee, Shih-Hsiung; Chan, Chin-Hong; Huang, Shiau-Shian

    2016-10-30

    Previous studies indicated that panic disorder is correlated with erectile dysfunction (ED). The primary aim of this study was to explore the incidence rate of ED among panic disorder patients in an Asian country. The secondary aim was to compare the risk of ED in panic disorder patients that were treated with different kinds of antidepressants, and to explore the possible mechanism between these two disorders. We identified 1393 male patients with newly diagnosed panic disorder from the Taiwan's National Health Insurance Database. Four matched controls per case were selected for the study group by propensity score. After adjusting for age, obesity and comorbidities, the panic disorder patients had a higher hazard ratio of ED diagnosis than the controls, especially among the untreated panic disorder patients. This retrospective dynamic cohort study supports the link between ED and prior panic disorder in a large sample of panic disorder patients. This study points out the need of early antidepressant treatment for panic disorder to prevent further ED. PMID:27497294

  7. Depression and HIV Serostatus Disclosure to Sexual Partners Among Newly HIV-Diagnosed Men Who Have Sex with Men.

    PubMed

    Abler, Laurie; Sikkema, Kathleen J; Watt, Melissa H; Hansen, Nathan B; Wilson, Patrick A; Kochman, Arlene

    2015-10-01

    HIV disclosure to sexual partners facilitates joint decision-making and risk reduction strategies for safer sex behaviors, but disclosure may be impacted by depression symptoms. Disclosure is also associated with disclosure self-efficacy, which in turn may also be influenced by depressive symptoms. This study examined the relationship between depression and HIV disclosure to partners following diagnosis among men who have sex with men (MSM), mediated by disclosure self-efficacy. Newly HIV-diagnosed MSM (n=92) who reported sexual activity after diagnosis completed an assessment soon after diagnosis which measured depressive symptoms, and another assessment within 3 months of diagnosis that measured disclosure self-efficacy and disclosure. Over one-third of the sample reported elevated depressive symptoms soon after diagnosis and equal proportions (one-third each) disclosed to none, some, or all partners in the 3 months after diagnosis. Depressive symptoms were negatively associated with disclosure self-efficacy and disclosure to partners, while disclosure self-efficacy was positively associated with disclosure. Disclosure self-efficacy partially mediated the relationship between depression and disclosure, accounting for 33% of the total effect. These findings highlight the importance of addressing depression that follows diagnosis to enhance subsequent disclosure to sexual partners. PMID:26430721

  8. Predicting Clinical Binary Outcome Using Multivariate Longitudinal Data: Application to Patients with Newly Diagnosed Primary Open-Angle Glaucoma

    PubMed Central

    Gao, Feng; Miller, J Philip; Beiser, Julia A; Xiong, Chengjie; Gordon, Mae O

    2015-01-01

    Primary open angle glaucoma (POAG) is a chronic, progressive, irreversible, and potentially blinding optic neuropathy. The risk of blindness due to progressive visual field (VF) loss varies substantially from patient to patient. Early identification of those patients destined to rapid progressive visual loss is crucial to prevent further damage. In this article, a latent class growth model (LCGM) was developed to predict the binary outcome of VF progression using longitudinal mean deviation (MD) and pattern standard deviation (PSD). Specifically, the trajectories of MD and PSD were summarized by a functional principal component (FPC) analysis, and the estimated FPC scores were used to identify subgroups (latent classes) of individuals with distinct patterns of MD and PSD trajectories. Probability of VF progression for an individual was then estimated as weighted average across latent classes, weighted by posterior probability of class membership given baseline covariates and longitudinal MD/PSD series. The model was applied to the participants with newly diagnosed POAG from the Ocular Hypertension Treatment Study (OHTS), and the OHTS data was best fit by a model with 4 latent classes. Using the resultant optimal LCGM, the OHTS participants with and without VF progression could be accurately differentiated by incorporating longitudinal MD and PSD. PMID:26904374

  9. Comparison of Newly Diagnosed Ocular Hypertension and Open-Angle Glaucoma: Ocular Variables, Risk Factors, and Disease Severity

    PubMed Central

    Buys, Yvonne M.; Harasymowycz, Paul; Gaspo, Rania; Kwok, Kenneth; Hutnik, Cindy M. L.; Blondeau, Pierre; Birt, Catherine M.; Piemontesi, Robert L. G.; Gould, Lisa F.; Lesk, Mark R.; Ahmed, Iqbal K.

    2012-01-01

    Purpose. To describe the distribution of ocular variables, risk factors, and disease severity in newly diagnosed ocular hypertension (OH) or open-angle glaucoma (OAG). Methods. Eligible subjects underwent a complete history and examination. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) obtained from multiple logistic regression models were used to compare OAG to OH and advanced to early/moderate OAG. Results. 405 subjects were enrolled: 292 (72.1%) with OAG and 113 (27.9%) with OH. 51.7% had early, 27.1% moderate, and 20.9% advanced OAG. The OR for OAG versus OH was 8.19 (P < 0.0001) for disc notch, 5.36 (P < 0.0001) for abnormal visual field, 1.45 (P = 0.001) for worsening mean deviation, 1.91 (P < 0.0001) for increased cupping, 1.03 for increased age (P = 0.030), and 0.36 (P = 0.010) for smoking. Conclusions. Increased age was a risk for OAG, and smoking decreased the risk of OAG compared to OH. Almost half of the OAG subjects had moderate/advanced disease at diagnosis. PMID:21869921

  10. Autologous tumor lysate-pulsed dendritic cell immunotherapy for pediatric patients with newly diagnosed or recurrent high-grade gliomas.

    PubMed

    Lasky, Joseph L; Panosyan, Eduard H; Plant, Ashley; Davidson, Tom; Yong, William H; Prins, Robert M; Liau, Linda M; Moore, Theodore B

    2013-05-01

    Immunotherapy has the potential to improve clinical outcomes with little toxicity for pediatric patients with brain tumors. We conducted a pilot feasibility study of tumor lysate-pulsed dendritic cell (DC) vaccination in pediatric patients (1 to 18 years old) with newly diagnosed or recurrent high-grade glioma (HGG). A total of nine DC vaccine doses, each containing 1 × 10(6) cells per dose were administered to three out of the seven originally enrolled patients. Toxicities were limited to mild side-effects, except in one case of elevated alkaline phosphatase, which resolved without clinical consequences. Two patients with primary lesions amongst the three vaccinated were alive at the time of writing, both without evidence of disease. Pre- and post-vaccination tumor samples from a patient with an anaplastic oligoastrocytoma that recurred failed to demonstrate immune cell infiltration by immunohistochemistry. Peripheral cytokine levels were evaluated in one patient following DC vaccination and demonstrated some changes in relation to vaccination. DC vaccine is tolerable and feasible with some limitations for pediatric patients with HGG. Dendritic cell based immunotherapy may provide some clinical benefit in pediatric patients with glioma, especially for patients with minimal residual disease, but further investigation of this modality is required.

  11. Autologous bone marrow transplantation as consolidation therapy in newly diagnosed non-Hodgkin's lymphoma: long-term outcome.

    PubMed

    Montuoro, A; Lalle, M; Ingletto, D

    2000-10-01

    Autologous bone marrow transplantation (ABMT) often produces durable remission in patients with intermediate-high grade non-Hodgkin's lymphoma (NHL). We present a retrospective review of 32 eligible newly diagnosed patients with NHL treated with conventional induction chemotherapy followed by ABMT consolidation therapy. These patients were treated in our department between 1984-1994 and followed up for 5-172 months with a median time of 82 months. In our patients the status of disease at transplant was 30 complete remissions and 2 partial remissions. All patients received a CBV-like high-dose preparative regimen. At 136 months the probability of disease-free survival (DFS) and overall (OS) is 66% and 70% respectively. Seven patients died from the disease. There was one case of toxicity related death. Our aim was to achieve a status of minimal disease and then consolidate it with high-dose polychemotherapy regimen. This study confirms that a significant number of patients with aggressive responding NHL can achieve prolonged RFS and OS after ABMT. Our data document the importance of long-term follow-up in interpreting the results of ABMT in NHL. PMID:10995890

  12. Insulin autoantibodies: evidence of autoimmune disease among a group of Puerto Rican children with newly diagnosed type 1 diabetes mellitus.

    PubMed

    González de Pijem, L; Nieves-Rivera, F

    2001-06-01

    Type 1 diabetes is a chronic disease caused by a cell-specific destruction of the insulin producing cells of the pancreas. Although Puerto Rico has the highest incidence of type 1 diabetes among Latin American countries, there is scanty data on the presence of antibodies against insulin producing cells. To this end, 20 children (8 males, 12 females), ages 1-15 years, admitted to the University Pediatric Hospital with type 1 diabetes de novo between November 2000 and April 2001 were prospectively studied to determine the presence of serum antibodies against Islet cells (ICA), glutamic acid decarboxylase (GAD-65) and insulin autoantibodies (IAA). IAA was found to be present in 45% of the subjects with 85% of positive rate in subjects under age 5. GAD-65 was present in 66% and ICA was present in 23% of the subjects. We found evidence of autoimmunity against islet cell surface and intracellular components among a cohort of Puerto Rican children with newly diagnosed type 1 diabetes. These findings compared favorably with reports from other ethnicities.

  13. Therapeutic approach beyond conventional temozolomide for newly diagnosed glioblastoma: Review of the present evidence and future direction

    PubMed Central

    Mallick, Supriya; Gandhi, Ajeet Kumar; Rath, Goura Kishor

    2015-01-01

    Glioblastoma multiforme (GBM) is the most aggressive form of primary brain tumor. Maximal safe surgical resection followed by adjuvant partial brain radiation with concurrent and adjuvant temozolomide (TMZ) (oral alkylating agent) is the standard of care. Five years survival in TMZ treated patient reaches 9.8%. We aimed to summarize the changes in the management of GBM beyond conventional temozolomide based adjuvant treatment. We searched the PUBMED with the following key words: Glioblastoma, phase III trial, Phase II trial, adjuvant treatment in GBM. Clinical research has found a wide range of molecular aberrations in GBM and attempts are being made to further improve survival with the addition of different classes of drugs. Angiogenesis inhibitors, oncolytic vaccines, dose dense TMZ, and anti-epidermal growth factor receptor monoclonal antibody in phase III trials have failed to improve survival. Recent studies have also shown that the management strategies might be different and needs to be customized as per the age of patients such as pediatric and elderly patients. In addition, treatments should be personalized depending on the molecular aberrations. We reviewed all published phase III trials for newly diagnosed GBM as well as also looked into possible future directions in this review. Limited progress has happed beyond conventional TMZ in the adjuvant treatment of GBM. Newer insights are emerging about treatment intensification and introduction of newer molecular targeted drugs with more information about molecular aberrations. PMID:26811592

  14. Triplet vs doublet lenalidomide-containing regimens for the treatment of elderly patients with newly diagnosed multiple myeloma.

    PubMed

    Magarotto, Valeria; Bringhen, Sara; Offidani, Massimo; Benevolo, Giulia; Patriarca, Francesca; Mina, Roberto; Falcone, Antonietta Pia; De Paoli, Lorenzo; Pietrantuono, Giuseppe; Gentili, Silvia; Musolino, Caterina; Giuliani, Nicola; Bernardini, Annalisa; Conticello, Concetta; Pulini, Stefano; Ciccone, Giovannino; Maisnar, Vladimír; Ruggeri, Marina; Zambello, Renato; Guglielmelli, Tommasina; Ledda, Antonio; Liberati, Anna Marina; Montefusco, Vittorio; Hajek, Roman; Boccadoro, Mario; Palumbo, Antonio

    2016-03-01

    Lenalidomide-dexamethasone improved outcome in newly diagnosed elderly multiple myeloma patients. We randomly assigned 662 patients who were age ≥65 years or transplantation-ineligible to receive induction with melphalan-prednisone-lenalidomide (MPR) or cyclophosphamide-prednisone-lenalidomide (CPR) or lenalidomide plus low-dose dexamethasone (Rd). The primary end point was progression-free survival (PFS) in triplet (MPR and CPR) vs doublet (Rd) lenalidomide-containing regimens. After a median follow-up of 39 months, the median PFS was 22 months for the triplet combinations and 21 months for the doublet (P = .284). The median overall survival (OS) was not reached in either arms, and the 4-year OS was 67% for the triplet and 58% for the doublet arms (P = .709). By considering the 3 treatment arms separately, no difference in outcome was detected among MPR, CPR, and Rd. The most common grade ≥3 toxicity was neutropenia: 64% in MPR, 29% in CPR, and 25% in Rd patients (P < .0001). Grade ≥3 nonhematologic toxicities were similar among arms and were mainly infections (6.5% to 11%), constitutional (3.5% to 9.5%), and cardiac (4.5% to 6%), with no difference among the arms. In conclusion, in the overall population, the alkylator-containing triplets MPR and CPR were not superior to the alkylator-free doublet Rd, which was associated with lower toxicity. This study was registered at www.clinicaltrials.gov as #NCT01093196. PMID:26729895

  15. Long Term Outcome of Routine Image-enhanced Endoscopy in Newly Diagnosed Head and Neck Cancer: a Prospective Study of 145 Patients

    PubMed Central

    Chung, Chen-Shuan; Lo, Wu-Chia; Wen, Ming-Hsun; Hsieh, Chen-Hsi; Lin, Yu-Chin; Liao, Li-Jen

    2016-01-01

    Synchronous second primary tumors (SPTs), especially esophageal squamous cell neoplasia (ESCN), in patients with head and neck squamous cell carcinoma (HNSCC) are not uncommon. Image-enhanced endoscopy (IEE) screening may identify SPTs while there is no evidence to support its benefit. We prospectively recruited an adult cohort with newly-diagnosed HNSCC for IEE screening of upper gastrointestinal (UGI) tract neoplasia. 145 HNSCC patients were recruited. 22 (15.2%) patients had synchronous UGI tract neoplasia, including 20 ESCNs and 2 gastric adenocarcinoma. At a median follow-up of 2.72 (±1.73) years, the 3-year overall survival (OS) rate was 0.71. HNSCC patients with synchronous ESCN/UGI tract neoplasia had poorer prognosis than those without (multivariate analysis, hazard ratio [HR] 2.75/2.79, 95% confidence interval [CI] 1.11~6.82/1.15~6.80, p = 0.03/0.02). HNSCC patients with advanced (stage III&IV) ESCN had worst survivals (p < 0.001). Among those with synchronous ESCNs, hypopharyngeal cancers were associated with poorer prognosis when compared with oral cancers (HR 2.36, 95% CI 1.08~5.15, p = 0.03). IEE screening for UGI SPTs in HNSCC patients could be used for risk stratification and prognosis prediction. HNSCC patients with advanced ESCN had the worst prognosis. Further studies are needed to demonstrate the survival benefits from IEE screening. PMID:27387103

  16. The Development and Feasibility of a Brief Risk Reduction Intervention for Newly HIV-Diagnosed Men Who Have Sex with Men

    ERIC Educational Resources Information Center

    Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene; Santos, Jonathan; Watt, Melissa H.; Wilson, Patrick A.; DeLorenzo, Allyson; Laudato, Jay; Mayer, Gal

    2011-01-01

    Men who have sex with men (MSM) represent more than half of all new HIV infections in the United States. Utilizing a collaborative, community-based approach, a brief risk reduction intervention was developed and pilot tested among newly HIV-diagnosed MSM receiving HIV care in a primary care setting. Sixty-five men, within 3 months of diagnosis,…

  17. High IFIT1 expression predicts improved clinical outcome, and IFIT1 along with MGMT more accurately predicts prognosis in newly diagnosed glioblastoma.

    PubMed

    Zhang, Jin-Feng; Chen, Yao; Lin, Guo-Shi; Zhang, Jian-Dong; Tang, Wen-Long; Huang, Jian-Huang; Chen, Jin-Shou; Wang, Xing-Fu; Lin, Zhi-Xiong

    2016-06-01

    Interferon-induced protein with tetratricopeptide repeat 1 (IFIT1) plays a key role in growth suppression and apoptosis promotion in cancer cells. Interferon was reported to induce the expression of IFIT1 and inhibit the expression of O-6-methylguanine-DNA methyltransferase (MGMT).This study aimed to investigate the expression of IFIT1, the correlation between IFIT1 and MGMT, and their impact on the clinical outcome in newly diagnosed glioblastoma. The expression of IFIT1 and MGMT and their correlation were investigated in the tumor tissues from 70 patients with newly diagnosed glioblastoma. The effects on progression-free survival and overall survival were evaluated. Of 70 cases, 57 (81.4%) tissue samples showed high expression of IFIT1 by immunostaining. The χ(2) test indicated that the expression of IFIT1 and MGMT was negatively correlated (r = -0.288, P = .016). Univariate and multivariate analyses confirmed high IFIT1 expression as a favorable prognostic indicator for progression-free survival (P = .005 and .017) and overall survival (P = .001 and .001), respectively. Patients with 2 favorable factors (high IFIT1 and low MGMT) had an improved prognosis as compared with others. The results demonstrated significantly increased expression of IFIT1 in newly diagnosed glioblastoma tissue. The negative correlation between IFIT1 and MGMT expression may be triggered by interferon. High IFIT1 can be a predictive biomarker of favorable clinical outcome, and IFIT1 along with MGMT more accurately predicts prognosis in newly diagnosed glioblastoma. PMID:26980050

  18. Smoking Cessation Carries a Short-Term Rising Risk for Newly Diagnosed Diabetes Mellitus Independently of Weight Gain: A 6-Year Retrospective Cohort Study

    PubMed Central

    Sung, Yi-Ting; Hsiao, Cheng-Ting; Chang, I-Jen; Lin, Yu-Chih

    2016-01-01

    Background. The effects of smoking on human metabolism are complex. Although smoking increases risk for diabetes mellitus, smoking cessation was also reported to be associated with weight gain and incident diabetes mellitus. We therefore conducted this study to clarify the association between smoking status and newly diagnosed diabetes mellitus. Methods. An analysis was done using the data of a mass health examination performed annually in an industrial park from 2007 to 2013. The association between smoking status and newly diagnosed diabetes mellitus was analyzed with adjustment for weight gain and other potential confounders. Results. Compared with never-smokers, not only current smokers but also ex-smokers in their first two years of abstinence had higher odds ratios (ORs) for newly diagnosed diabetes mellitus (never-smokers 3.6%, OR as 1; current smokers 5.5%, OR = 1.499, 95% CI = 1.147–1.960, and p = 0.003; ex-smokers in their first year of abstinence 7.5%, OR = 1.829, 95% CI = 0.906–3.694, and p = 0.092; and ex-smokers in their second year of abstinence 9.0%, OR = 2.020, 95% CI = 1.031–3.955, and p = 0.040). Conclusion. Smoking cessation generally decreased risk for newly diagnosed diabetes mellitus. However, increased odds were seen within the first 2 years of abstinence independently of weight gain. PMID:27478846

  19. Correlation of Notch1/Hes1 Genes Expression Levels in Egyptian Paediatric Patients with Newly Diagnosed and Persistent Primary Immune(Idiopathic) Thrombocytopenic Purpura.

    PubMed

    Gawdat, Rania Mohsen; Hammam, Amira Ahmed; Ezzat, Dina Ahmed

    2016-09-01

    Notch signalling is involved in the development of several autoimmune diseases, one of such diseases is ITP. The aim of this study was to investigate and compare the expression levels of Notch1 receptor and its target Hes1 gene in Egyptian paediatric ITP patients. Real-time quantitative reverse transcriptase polymerase chain reaction was used to analyse the expression levels of Notch1 and Hes1 in 42 children with primary ITP (22 newly diagnosed and 20 persistent) cases. Twenty age and sex matched non-ITP controls were included. The expression levels of Notch1 were higher in newly diagnosed and persistent cases than controls with high statistical significant difference (P value < 0.001, P < 0.001) respectively, similarly as regards the expression levels of HES1 (P value < 0.001, P < 0.007) respectively. A significant positive correlation was found between Notch1 and Hes1 expression levels in newly diagnosed cases (r = 0.587, P value = 0.004). There was an association between levels of both genes in most of ITP patients but Hes1 was markedly elevated than Notch1 in few cases. High expression levels of Notch1/Hes1 indicated the important role of Notch signalling in both newly diagnosed and persistent ITP. High expression levels of Hes1 than Notch1 may shed light on its value as a therapeutic target for future research in ITP. PMID:27429531

  20. A Pilot Cost-Effectiveness Analysis of Treatments in Newly Diagnosed High-Grade Gliomas: The Example of 5-Aminolevulinic Acid Compared With White-Light Surgery

    PubMed Central

    Alves, Marta; Castel-Branco, Marta; Stummer, Walter

    2015-01-01

    BACKGROUND: High-grade gliomas are aggressive, incurable tumors characterized by extensive diffuse invasion of the normal brain parenchyma. Novel therapies at best prolong survival; their costs are formidable and benefit is marginal. Economic restrictions thus require knowledge of the cost-effectiveness of treatments. Here, we show the cost-effectiveness of enhanced resections in malignant glioma surgery using a well-characterized tool for intraoperative tumor visualization, 5-aminolevulinic acid (5-ALA). OBJECTIVE: To evaluate the cost-effectiveness of 5-ALA fluorescence-guided neurosurgery compared with white-light surgery in adult patients with newly diagnosed high-grade glioma, adopting the perspective of the Portuguese National Health Service. METHODS: We used a Markov model (cohort simulation). Transition probabilities were estimated with the use of data from 1 randomized clinical trial and 1 noninterventional prospective study. Utility values and resource use were obtained from published literature and expert opinion. Unit costs were taken from official Portuguese reimbursement lists (2012 values). The health outcomes considered were quality-adjusted life-years, life-years, and progression-free life-years. Extensive 1-way and probabilistic sensitivity analyses were performed. RESULTS: The incremental cost-effectiveness ratios are below €10 000 in all evaluated outcomes, being around €9100 per quality-adjusted life-year gained, €6700 per life-year gained, and €8800 per progression-free life-year gained. The probability of 5-ALA fluorescence-guided surgery cost-effectiveness at a threshold of €20000 is 96.0% for quality-adjusted life-year, 99.6% for life-year, and 98.8% for progression-free life-year. CONCLUSION: 5-ALA fluorescence-guided surgery appears to be cost-effective in newly diagnosed high-grade gliomas compared with white-light surgery. This example demonstrates cost-effectiveness analyses for malignant glioma surgery to be feasible on

  1. Antiplatelet antibodies detected by the MAIPA assay in newly diagnosed immune thrombocytopenia are associated with chronic outcome and higher risk of bleeding.

    PubMed

    Grimaldi, David; Canouï-Poitrine, Florence; Croisille, Laure; Lee, Ketty; Roudot-Thoraval, Françoise; Languille, Laetitia; Khellaf, Medhi; Michel, Marc; Godeau, Bertrand; Bierling, Philippe

    2014-02-01

    Immune thrombocytopenia (ITP) results in part from the presence of platelet antibodies, which can be demonstrated by the Monoclonal Antibody-Specific Immobilization of Platelet Antigens (MAIPA) assay. The aim of our study was to correlate the presence of antiplatelet autoantibodies and the natural history of ITP. We performed a retrospective, single-center study of 108 adults with newly diagnosed ITP who had indirect MAIPA assay performed at disease onset. Chronic ITP was defined by the presence of thrombocytopenia after 1 year. Bleeding diathesis was evaluated with a bleeding score. At baseline, patients with a positive indirect MAIPA have a greater bleeding score than patients with negative MAIPA assay [median (interquartile) = 8 (6-12) vs 2 (0-6), p = 0.002]. Patients with a positive indirect MAIPA also had a higher rate of chronic ITP (92.9 vs 68.7 %, p = 0.06). In multivariate analysis, a positive indirect MAIPA result and a platelet count at onset ≥10 × 10(9)/L remained independently associated with chronic ITP [adjusted OR (aOR) = 8.01; 95 % confidence interval (CI), 0.98-66.6; p = 0.05 and aOR = 3.09; 95 % CI, 1.18-8.10; p = 0.02, respectively]. Furthermore, when we analyzed together the results of direct (n = 41) and indirect MAIPA, the same results were observed. Thus, indirect MAIPA positivity at disease onset is associated with more severe hemorrhage and predicts a chronic course in adult ITP patients. MAIPA assay could be useful in the management of ITP patients when it is performed at diagnosis. PMID:23912633

  2. Perturbations in the Lipid Profile of Individuals with Newly Diagnosed Type 1 Diabetes Mellitus: Lipidomics Analysis of a Diabetes Antibody Standardization Program Sample Subset

    SciTech Connect

    Sorensen, Christina M.; Ding, Jie; Zhang, Qibin; Alquier, Thierry; Zhao, Rui; Mueller, Patricia W.; Smith, Richard D.; Metz, Thomas O.

    2010-08-01

    Objectives: To characterize the lipid profile of individuals with newly diagnosed type 1 diabetes mellitus using LC-MS-based lipidomics and the accurate mass and time (AMT) tag approach. Design and methods: Lipids were extracted from plasma and sera of 10 subjects from the Diabetes Antibody Standardization Program (years 2000-2005) and 10 non-diabetic subjects and analyzed by capillary liquid chromatography coupled with a hybrid ion-trap-Fourier transform ion cyclotron resonance mass spectrometer. Lipids were identified and quantified using the AMT tag approach. Results: Five hundred sixty lipid features differentiated (q < 0.05) diabetic from healthy individuals in a partial least-squares analysis, characterizing of individuals with recently diagnosed type 1 diabetes mellitus. Conclusions: A lipid profile associated with newly diagnosed type 1 diabetes may aid in further characterization of biochemical pathways involved in lipid regulation or mobilization and lipotoxicity of pancreatic beta-cells.

  3. Drug resistance among newly-diagnosed HIV-infected children in the era of more efficacious antiretroviral prophylaxis

    PubMed Central

    Kuhn, Louise; Hunt, Gillian; Technau, Karl-Günter; Coovadia, Ashraf; Ledwaba, Johanna; Pickerill, Sam; Penazzato, Martina; Bertagnolio, Silvia; Mellins, Claude A.; Black, Vivian; Morris, Lynn; Abrams, Elaine J.

    2015-01-01

    Background In the era of more efficacious prevention of mother-to-child transmission (PMTCT) regimens, documenting the profile of drug resistance in HIV-infected infants and young children is critical to our efforts to improve care and treatment for children. Methods HIV drug resistance mutations in plasma virus were ascertained using population sequencing among 230 newly-diagnosed HIV-infected children under 2 years of age recruited in Johannesburg, South Africa, during 2011. By this time, more effective PMTCT regimens, including combination antiretroviral therapy (cART) for pregnant women, were being implemented. Results Two-thirds (67.4%) of HIV-infected children had been exposed to some form of maternal (89%) and/or infant (97%) PMTCT. Among PMTCT-exposed, 56.8% had non-nucleoside reverse transcriptase inhibitor (NNRTI), 14.8% nucleoside reverse transcriptase inhibitor (NRTI), and 1.3% protease inhibitor (PI) mutations. NNRTI mutations were strongly related to younger age. The remaining third (32.6%) had no reported or recorded PMTCT exposures but resistance to NNRTI was detected in 24.0%, NRTI in 10.7% and PI in 1.3%. Conclusion The new PMTCT strategies dramatically reduce the number of children who acquire infection but among those who do become infected, NNRTI resistance prevalence is high. In this South African setting with high PMTCT coverage, almost a quarter of children with no reported or recorded PMTCT also have drug resistance mutations. PMTCT history is an inadequate means of ruling out pre-treatment drug resistance. Our results support the use of PI-based first-line regimens in HIV-infected infants and young children regardless of PMTCT history. PMID:24785949

  4. CSF β-Amyloid 1-42 Predicts Progression to Cognitive Impairment in Newly Diagnosed Parkinson Disease.

    PubMed

    Terrelonge, Mark; Marder, Karen S; Weintraub, Daniel; Alcalay, Roy N

    2016-01-01

    Low CSF β-amyloid 1-42 has been associated with cognitive decline in advanced Parkinson's disease; data from a single cohort suggest β-amyloid 1-42 may be an early marker of cognitive impairment. Newly diagnosed Parkinson's participants (mean duration, 6.9 months) in the Parkinson's Progression Markers Initiative (n = 341) were assessed at baseline (untreated state) and followed for 2 years. CSF β-amyloid 1-42, α-synuclein, total tau, and tau phosphorylated at threonine 181 were collected at baseline. Participants were classified as having cognitive impairment (CI) if scores on two of six cognitive tests were 1.5 standard deviations below the standardized mean based on published norms in healthy controls. Multivariable regression analyses were used to determine the association between baseline CSF markers with cognitive impairment, defined by neuropsychological testing performance at 2-year follow-up. Fifty-five participants (16.1 %) had CI at baseline and were not included in further analyses. Thirty-seven of the 286 participants without CI at baseline (12.9 %) developed CI at 2 years. Participants with CI at 2 years had significantly lower mean baseline CSF β-amyloid 1-42 levels than non-CI participants (343.8 vs. 380.4 pg/mL, p < 0.01); no significant difference was seen for α-synuclein, T-tau, or P-tau 181. In a regression model of 286 participants without baseline CI adjusted for age, gender, disease duration, education, motor severity, and depression status, lower baseline β-amyloid 1-42 levels were associated with higher odds of CI at 2 years. (OR(10pg/mL) = 1.04, 95 % CI 1.01-1.08, p < 0.05). CSF β-amyloid 1-42 level at disease onset is an independent predictor of cognitive impairment in early Parkinson's disease.

  5. CHOD/BVAM CHEMOTHERAPY AND WHOLE-BRAIN RADIOTHERAPY FOR NEWLY DIAGNOSED PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA

    PubMed Central

    Laack, Nadia N.; O’Neill, Brian Patrick; Ballman, Karla V.; O’Fallon, Judith Rich; Carrero, Xiomara W.; Kurtin, Paul J.; Scheithauer, Bernd W.; Brown, Paul D.; Habermann, Thomas M.; Colgan, Joseph P.; Gilbert, Mark R.; Hawkins, Roland B.; Morton, Roscoe F.; Windschitl, Harry E.; Fitch, Tom R.; Pajon, Eduardo R.

    2014-01-01

    Purpose To assess the efficacy and toxicity of chemotherapy consisting of cyclophosphamide, doxorubicin (Adriamycin), vincristine, and dexamethasone (CHOD) plus bis-chloronitrosourea (BCNU), cytosine arabinoside, and methotrexate (BVAM) followed by whole-brain irradiation (WBRT) for patients with primary central nervous system lymphoma (PCNSL). Methods and Materials Patients 70 years old and younger with newly diagnosed, biopsy-proven PCNSL received one cycle of CHOD followed by two cycles of BVAM. Patients then received WBRT, 30.6 Gy, if a complete response was evoked, or 50.4 Gy if the response was less than complete; both doses were given in 1.8-Gy daily fractions. The primary efficacy endpoint was 1-year survival. Results Thirty-six patients (19 men, 17 women) enrolled between 1995 and 2000. Median age was 60.5 years (range, 34 to 69 years). Thirty (83%) patients had baseline Eastern Cooperative Oncology Group performance scores of 0 to 1. All 36 patients were eligible for survival and response evaluations. Median time to progression was 12.3 months, and median survival was 18.5 months. The percentages of patients alive at 1, 2, and 3 years were 64%, 36%, and 33%, respectively. The best response was complete response in 10 patients and immediate progression in 7 patients. Ten (28%) patients had at least one grade 3 or higher neurologic toxicity. Conclusions This regimen did improve the survival of PCNSL patients but also caused substantial toxicity. The improvement in survival is less than that reported with high-dose methotrexate-based therapies. PMID:20800387

  6. Comparison of Newly Diagnosed and Relapsed Patients with Acute Promyelocytic Leukemia Treated with Arsenic Trioxide: Insight into Mechanisms of Resistance

    PubMed Central

    Chendamarai, Ezhilarasi; Ganesan, Saravanan; Alex, Ansu Abu; Kamath, Vandana; Nair, Sukesh C.; Nellickal, Arun Jose; Janet, Nancy Beryl; Srivastava, Vivi; Lakshmi, Kavitha M.; Viswabandya, Auro; Abraham, Aby; Aiyaz, Mohammed; Mullapudi, Nandita; Mugasimangalam, Raja; Padua, Rose Ann; Chomienne, Christine; Chandy, Mammen; Srivastava, Alok; George, Biju; Balasubramanian, Poonkuzhali; Mathews, Vikram

    2015-01-01

    There is limited data on the clinical, cellular and molecular changes in relapsed acute promyeloytic leukemia (RAPL) in comparison with newly diagnosed cases (NAPL). We undertook a prospective study to compare NAPL and RAPL patients treated with arsenic trioxide (ATO) based regimens. 98 NAPL and 28 RAPL were enrolled in this study. RAPL patients had a significantly lower WBC count and higher platelet count at diagnosis. IC bleeds was significantly lower in RAPL cases (P=0.022). The ability of malignant promyelocytes to concentrate ATO intracellularly and their in-vitro IC50 to ATO was not significantly different between the two groups. Targeted NGS revealed PML B2 domain mutations in 4 (15.38%) of the RAPL subset and none were associated with secondary resistance to ATO. A microarray GEP revealed 1744 genes were 2 fold and above differentially expressed between the two groups. The most prominent differentially regulated pathways were cell adhesion (n=92), cell survival (n=50), immune regulation (n=74) and stem cell regulation (n=51). Consistent with the GEP data, immunophenotyping revealed significantly increased CD34 expression (P=0.001) in RAPL cases and there was in-vitro evidence of significant microenvironment mediated innate resistance (EM-DR) to ATO. Resistance and relapse following treatment with ATO is probably multi-factorial, mutations in PML B2 domain while seen only in RAPL may not be the major clinically relevant cause of subsequent relapses. In RAPL additional factors such as expansion of the leukemia initiating compartment along with EM-DR may contribute significantly to relapse following treatment with ATO based regimens. PMID:25822503

  7. RTOG 0211: A Phase 1/2 Study of Radiation Therapy With Concurrent Gefitinib for Newly Diagnosed Glioblastoma Patients

    SciTech Connect

    Chakravarti, Arnab; Wang, Meihua; Robins, H. Ian; Lautenschlaeger, Tim; Curran, Walter J.; Brachman, David G.; Schultz, Christopher J.; Choucair, Ali; Dolled-Filhart, Marisa; Christiansen, Jason; Gustavson, Mark; Molinaro, Annette; Mischel, Paul; Dicker, Adam P.; and others

    2013-04-01

    Purpose: To determine the safety and efficacy of gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in combination with radiation for newly diagnosed glioblastoma (GBM) patients. Methods and Materials: Between March 21, 2002, and May 3, 2004, Radiation Therapy Oncology Group (RTOG) 0211 enrolled 31 and 147 GBM patients in the phase 1 and 2 arms, respectively. Treatment consisted of daily oral gefinitnib started at the time of conventional cranial radiation therapy (RT) and continued post RT for 18 months or until progression. Tissue microarrays from 68 cases were analyzed for EGFR expression. Results: The maximum tolerated dose (MTD) of gefitinib was determined to be 500 mg in patients on non-enzyme-inducing anticonvulsant drugs (non-EIAEDs). All patients in the phase 2 component were treated at a gefitinib dose of 500 mg; patients receiving EIADSs could be escalated to 750 mg. The most common side effects of gefitinib in combination with radiation were dermatologic and gastrointestinal. Median survival was 11.5 months for patients treated per protocol. There was no overall survival benefit for patients treated with gefitinib + RT when compared with a historical cohort of patients treated with RT alone, matched by RTOG recursive partitioning analysis (RPA) class distribution. Younger age was significantly associated with better outcome. Per protocol stratification, EGFR expression was not found to be of prognostic value for gefitinib + RT-treated patients. Conclusions: The addition of gefitinib to RT is well tolerated. Median survival of RTOG 0211 patients treated with RT with concurrent and adjuvant gefitinib was similar to that in a historical control cohort treated with radiation alone.

  8. Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma.

    PubMed

    Mai, E K; Bertsch, U; Dürig, J; Kunz, C; Haenel, M; Blau, I W; Munder, M; Jauch, A; Schurich, B; Hielscher, T; Merz, M; Huegle-Doerr, B; Seckinger, A; Hose, D; Hillengass, J; Raab, M S; Neben, K; Lindemann, H-W; Zeis, M; Gerecke, C; Schmidt-Wolf, I G H; Weisel, K; Scheid, C; Salwender, H; Goldschmidt, H

    2015-08-01

    We aimed at demonstrating non-inferiority of bortezomib/cyclophosphamide/dexamethasone (VCD) compared to bortezomib/doxorubicin/dexamethasone (PAd) induction therapy with respect to very good partial response rates or better (⩾VGPR) in 504 newly diagnosed, transplant-eligible multiple myeloma patients. VCD was found to be non-inferior to PAd with respect to ⩾VGPR rates (37.0 versus 34.3%, P=0.001). The rates of progressive disease (PD) were 0.4% (VCD) versus 4.8% (PAd; P=0.003). In the PAd arm, 11 of 12 patients with PD had either renal impairment (creatinine ⩾2 mg/dl) at diagnosis or the cytogenetic abnormality gain 1q21, whereas no PD was observed in these subgroups in the VCD arm. Leukocytopenia/neutropenia (⩾3°) occurred more frequently in the VCD arm (35.2% versus 11.3%, P<0.001). Neuropathy rates (⩾2°) were higher in the PAd group (14.9 versus 8.4%, P=0.03). Serious adverse events, both overall and those related to thromboembolic events, were higher in the PAd group (32.7 versus 24.0%, P=0.04 and 2.8 versus 0.4%, P=0.04). Stem cell collection was not impeded by VCD. VCD is as effective as PAd in terms of achieving ⩾VGPR rates with fewer PD and has a favorable toxicity profile. Therefore, VCD is preferable to PAd as induction therapy. PMID:25787915

  9. Hypofractionation vs Conventional Radiation Therapy for Newly Diagnosed Diffuse Intrinsic Pontine Glioma: A Matched-Cohort Analysis

    SciTech Connect

    Janssens, Geert O.; Jansen, Marc H.; Nowak, Peter J.; Oldenburger, Foppe R.; Bouffet, Eric; Kamphuis-van Ulzen, Karin; Lindert, Erik J. van; Schieving, Jolanda H.; Boterberg, Tom; Kaspers, Gertjan J.; Gidding, Corrie E.; Hargrave, Darren

    2013-02-01

    Purpose: Despite conventional radiation therapy, 54 Gy in single doses of 1.8 Gy (54/1.8 Gy) over 6 weeks, most children with diffuse intrinsic pontine glioma (DIPG) will die within 1 year after diagnosis. To reduce patient burden, we investigated the role of hypofractionation radiation therapy given over 3 to 4 weeks. A 1:1 matched-cohort analysis with conventional radiation therapy was performed to assess response and survival. Methods and Materials: Twenty-seven children, aged 3 to 14, were treated according to 1 of 2 hypofractionation regimens over 3 to 4 weeks (39/3 Gy, n=16 or 44.8/2.8 Gy, n=11). All patients had symptoms for {<=}3 months, {>=}2 signs of the neurologic triad (cranial nerve deficit, ataxia, long tract signs), and characteristic features of DIPG on magnetic resonance imaging. Twenty-seven patients fulfilling the same diagnostic criteria and receiving at least 50/1.8 to 2.0 Gy were eligible for the matched-cohort analysis. Results: With hypofractionation radiation therapy, the overall survival at 6, 9, and 12 months was 74%, 44%, and 22%, respectively. Progression-free survival at 3, 6, and 9 months was 77%, 43%, and 12%, respectively. Temporary discontinuation of steroids was observed in 21 of 27 (78%) patients. No significant difference in median overall survival (9.0 vs 9.4 months; P=.84) and time to progression (5.0 vs 7.6 months; P=.24) was observed between hypofractionation vs conventional radiation therapy, respectively. Conclusions: For patients with newly diagnosed DIPG, a hypofractionation regimen, given over 3 to 4 weeks, offers equal overall survival with less treatment burden compared with a conventional regimen of 6 weeks.

  10. Phase 3 trial of three thalidomide-containing regimens in patients with newly diagnosed multiple myeloma not transplant-eligible.

    PubMed

    Hungria, V T M; Crusoé, E Q; Maiolino, A; Bittencourt, R; Fantl, D; Maciel, J F R; Pessoa de Magalhaes, R J; Almeida, M S S; Cury, P; Hisgashi, F; Peres, A L; Chiattone, C S

    2016-01-01

    The introduction of agents such as thalidomide, lenalidomide, and bortezomib has changed the management of patients with multiple myeloma who are not eligible for autologous transplantation, many of whom are elderly. We sought to compare three thalidomide-based oral regimens among such patients in Latin America. We randomized patients with newly diagnosed multiple myeloma with measurable disease to one of the following regimens: melphalan, prednisone, and thalidomide (MPT); cyclophosphamide, thalidomide, and dexamethasone (CTD); and thalidomide and dexamethasone (TD). The TD arm was closed prematurely and was analyzed only descriptively. The primary endpoint was the overall response rate (ORR), whereas progression-free survival (PFS) and overall survival (OS) were secondary endpoints. The accrual rate was slower than expected, and the study was terminated after 82 patients had been randomized. The ORRs were 67.9 % with MPT, 89.7 % with CTD, and 68.7 % with TD (p = 0.056 for the comparison between MPT and CTD). The median PFS was 24.1 months for MPT, 25.9 months for CTD, and 21.5 months for TD. There were no statistically significant differences in PFS or OS between MPT and CTD. In an unplanned logistic regression analysis, ORR was significantly associated with treatment with CTD (p = 0.046) and with performance status of 0 or 1 (p = 0.035). Based on the current results, no definitive recommendations can be made regarding the comparative merit of the regimens tested. Nevertheless and until the results of further studies become available, we recommend either CTD or MPT as suitable frontline regimens for patients with multiple myeloma who are not candidates to transplantation in settings where lenalidomide and bortezomib are not available.

  11. Incidence and outcome of newly-diagnosed tuberculosis in schizophrenics: a 12-year, nationwide, retrospective longitudinal study

    PubMed Central

    2013-01-01

    Background To control tuberculosis (TB), it is critical to identify at risk populations. Schizophrenia is recognized as an important risk factor for TB. However, previous studies have been confounded by comorbidities, and reports of TB infection outcomes are rare. Therefore, the current nation-wide study aimed to compare the adjusted incidence and outcome of TB diseases in schizophrenics and the general population. Method Using the National Health Insurance Research Database from 1998 to 2009, this retrospective longitudinal study included 60,409 schizophrenics and general population matched for age, Charlson’s score, and comorbidities. Diagnosis of TB was based on the international classification of disease, ninth revision and use of anti-TB drugs. Unfavorable outcome for TB was defined as death, loss to follow-up, or use of anti-TB treatment for more than 9 months. Results The adjusted incidence of TB in schizophrenics was significantly higher than in the general population [hazard ratio, 1.52; 95% confidence interval (CI), 1.29-1.79; p < 0.001; Kaplan-Meier log-rank test, p < 0.001]. Cox regression revealed age and male gender as risk factors for newly-diagnosed TB. The outcome of TB was comparable in schizophrenics and the general population [odds ratio (OR), 0.78; 95% CI, 0.55-1.09; p =0.144]. Logistic regression revealed a statistical trend for diabetes mellitus to predict poor outcome in schizophrenics with TB (OR, 2.30; 95% CI, 0.96-5.74; p = 0.062). Conclusions Schizophrenics are at increased risk for TB, and screening may be warranted for those living in areas with high prevalence of TB. PMID:23895638

  12. Prospective Evaluation of Radiotherapy With Concurrent and Adjuvant Temozolomide in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma

    SciTech Connect

    Jalali, Rakesh; Raut, Nirmal; Arora, Brijesh; Gupta, Tejpal; Dutta, Debnarayan; Munshi, Anusheel; Sarin, Rajiv; Kurkure, Purna

    2010-05-01

    Purpose: To present outcome data in a prospective study of radiotherapy (RT) with concurrent and adjuvant temozolomide (TMZ) in children with diffuse intrinsic pontine gliomas (DIPGs). Methods and Materials: Pediatric patients with newly diagnosed DIPGs were prospectively treated with focal RT to a dose of 54 Gy in 30 fractions along with concurrent daily TMZ (75 mg/m{sup 2}, Days 1-42). Four weeks after completing the initial RT-TMZ schedule, adjuvant TMZ (200 mg/m{sup 2}, Days 1-5) was given every 28 days to a maximum of 12 cycles. Response was evaluated clinically and radiologically with magnetic resonance imaging and positron emission tomography scans. Results: Between March 2005 and November 2006, 20 children (mean age, 8.3 years) were accrued. Eighteen patients have died from disease progression, one patient is alive with progressive disease, and one patient is alive with stable disease. Median overall survival and progression-free survival were 9.15 months and 6.9 months, respectively. Grade III/IV toxicity during the concurrent RT-TMZ phase included thrombocytopenia in 3 patients, leucopenia in 2, and vomiting in 7. Transient Grade II skin toxicity developed in the irradiated fields in 18 patients. During the adjuvant TMZ phase, Grade III/IV leucopenia developed in 2 patients and Grade IV thrombocytopenia in 1 patient. Patients with magnetic resonance imaging diagnosis of a high-grade tumor had worse survival than those with a low-grade tumor (p = 0.001). Patients with neurologic improvement after RT-TMZ had significantly better survival than those who did not (p = 0.048). Conclusions: TMZ with RT has not yielded any improvement in the outcome of DIPG compared with RT alone. Further clinical trials should explore novel treatment modalities.

  13. CHOD/BVAM Chemotherapy and Whole-Brain Radiotherapy for Newly Diagnosed Primary Central Nervous System Lymphoma

    SciTech Connect

    Laack, Nadia N.; O'Neill, Brian Patrick; Ballman, Karla V.; O'Fallon, Judith Rich; Carrero, Xiomara W.; Kurtin, Paul J.; Scheithauer, Bernd W.; Brown, Paul D.; Habermann, Thomas M.; Colgan, Joseph P.; Gilbert, Mark R.; Hawkins, Roland B.; Morton, Roscoe F.; Windschitl, Harry E.; Fitch, Tom R.; Pajon, Eduardo R.

    2011-10-01

    Purpose: To assess the efficacy and toxicity of chemotherapy consisting of cyclophosphamide, doxorubicin (Adriamycin), vincristine, and dexamethasone (CHOD) plus bis-chloronitrosourea (BCNU), cytosine arabinoside, and methotrexate (BVAM) followed by whole-brain irradiation (WBRT) for patients with primary central nervous system lymphoma (PCNSL). Methods and Materials: Patients 70 years old and younger with newly diagnosed, biopsy-proven PCNSL received one cycle of CHOD followed by two cycles of BVAM. Patients then received WBRT, 30.6 Gy, if a complete response was evoked, or 50.4 Gy if the response was less than complete; both doses were given in 1.8-Gy daily fractions. The primary efficacy endpoint was 1-year survival. Results: Thirty-six patients (19 men, 17 women) enrolled between 1995 and 2000. Median age was 60.5 years (range, 34 to 69 years). Thirty (83%) patients had baseline Eastern Cooperative Oncology Group performance scores of 0 to 1. All 36 patients were eligible for survival and response evaluations. Median time to progression was 12.3 months, and median survival was 18.5 months. The percentages of patients alive at 1, 2, and 3 years were 64%, 36%, and 33%, respectively. The best response was complete response in 10 patients and immediate progression in 7 patients. Ten (28%) patients had at least one grade 3 or higher neurologic toxicity. Conclusions: This regimen did improve the survival of PCNSL patients but also caused substantial toxicity. The improvement in survival is less than that reported with high-dose methotrexate-based therapies.

  14. Spatial Characteristics of Newly Diagnosed Grade 3 Glioma Assessed by Magnetic Resonance Metabolic and Diffusion Tensor Imaging1

    PubMed Central

    Ozturk-Isik, Esin; Pirzkall, Andrea; Lamborn, Kathleen R; Cha, Soonmee; Chang, Susan M; Nelson, Sarah J

    2012-01-01

    The spatial heterogeneity in magnetic resonance (MR) metabolic and diffusion parameters and their relationship were studied for patients with treatment-naive grade 3 gliomas. MR data were evaluated from 51 patients with newly diagnosed grade 3 gliomas. Anatomic, diffusion, and metabolic imaging data were considered. Variations in metabolite levels, apparent diffusion coefficient (ADC), and fractional anisotropy (FA) were evaluated in regions of gadolinium enhancement and T2 hyperintensity as well as regions with abnormal metabolic signatures. Contrast enhancement was present in only 21 of the 51 patients. When present, the enhancing component of the lesion had higher choline-to-N-acetylaspartate index (CNI), higher choline, lower N-acetylaspartate, similar creatine, similar ADC and FA, and higher lactate/lipid than the nonenhancing lesion. Regions with CNI ≥ 4 had higher choline, lower N-acetylaspartate, higher lactate/lipid, higher ADC, and lower FA than normal-appearing white matter and regions with intermediate CNI values. For lesions that exhibited gadolinium enhancement, the metabolite levels and diffusion parameters in the region of enhancement were consistent with it corresponding to the most abnormal portion of the tumor. For nonenhancing lesions, areas with CNI ≥ 4 were the most abnormal in metabolic and diffusion parameters. This suggests that the region with the highest CNI might provide a good target for biopsies for nonenhancing lesions to obtain a representative histologic diagnosis of its degree of malignancy. Metabolic and diffusion parameter levels may be of interest not only for directing tissue sampling but also for defining the targets for focal therapy and assessing response to therapy. PMID:22348171

  15. Spatial characteristics of newly diagnosed grade 3 glioma assessed by magnetic resonance metabolic and diffusion tensor imaging.

    PubMed

    Ozturk-Isik, Esin; Pirzkall, Andrea; Lamborn, Kathleen R; Cha, Soonmee; Chang, Susan M; Nelson, Sarah J

    2012-02-01

    The spatial heterogeneity in magnetic resonance (MR) metabolic and diffusion parameters and their relationship were studied for patients with treatment-naive grade 3 gliomas. MR data were evaluated from 51 patients with newly diagnosed grade 3 gliomas. Anatomic, diffusion, and metabolic imaging data were considered. Variations in metabolite levels, apparent diffusion coefficient (ADC), and fractional anisotropy (FA) were evaluated in regions of gadolinium enhancement and T2 hyperintensity as well as regions with abnormal metabolic signatures. Contrast enhancement was present in only 21 of the 51 patients. When present, the enhancing component of the lesion had higher choline-to-N-acetylaspartate index (CNI), higher choline, lower N-acetylaspartate, similar creatine, similar ADC and FA, and higher lactate/lipid than the nonenhancing lesion. Regions with CNI ≥ 4 had higher choline, lower N-acetylaspartate, higher lactate/lipid, higher ADC, and lower FA than normal-appearing white matter and regions with intermediate CNI values. For lesions that exhibited gadolinium enhancement, the metabolite levels and diffusion parameters in the region of enhancement were consistent with it corresponding to the most abnormal portion of the tumor. For nonenhancing lesions, areas with CNI ≥ 4 were the most abnormal in metabolic and diffusion parameters. This suggests that the region with the highest CNI might provide a good target for biopsies for nonenhancing lesions to obtain a representative histologic diagnosis of its degree of malignancy. Metabolic and diffusion parameter levels may be of interest not only for directing tissue sampling but also for defining the targets for focal therapy and assessing response to therapy.

  16. Tumor Vascular Permeability Pattern Is Associated With Complete Response in Immunocompetent Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

    PubMed Central

    Chung, Sae Rom; Choi, Young Jun; Kim, Ho Sung; Park, Ji Eun; Shim, Woo Hyun; Kim, Sang Joon

    2016-01-01

    Abstract A dynamic contrast-enhanced MR imaging (DCE-MRI) could provide the information about tumor drug delivery efficacy. We investigated the potential utility of the permeability pattern of DCE-MRI for predicting tumor response to high dose-methotrexate treatment and progression-free survival (PFS) in patients with primary CNS lymphoma (PCNSL). Clinical and conventional imaging parameters were assessed as potential predictors of tumor response in 48 immunocompetent PCNSL patients in a preliminary study. Fifty additional immunocompetent patients (27 men and 23 women; mean age, 60.6 years) with PCNSL underwent DCE-MRI before starting first-line treatment with high dose-methotrexate. The DCE-MRI pattern was categorized as diffuse or nondiffuse. After 4 courses of high dose methotrexate, patients underwent follow-up brain MR imaging to identify their complete response (CR). Predictors of CR and PFS were analyzed using clinical parameters, conventional MRI, and DCE-MRI. CR was noted in 20 (74.1%) of 27 patients with diffuse DCE-MRI pattern and in 4 (17.4%) of 23 patients with nondiffuse DCE-MRI pattern. The diffuse DCE-MRI pattern showed a significantly higher association with CR than the nondiffuse pattern (P < 0.001). Multivariate Cox proportional hazards model revealed that the DCE-MRI pattern (hazard ratio = 0.70; P = 0.045), age (hazard ratio = 1.47; P = 0.041), and adjuvant autologous stem-cell transplantation (hazard ratio = 6.97; P = 0.003) tended to be associated with a PFS. The pretreatment diffuse DCE-MRI pattern can be used as a potential imaging biomarker for predicting CR and a longer PFS in patients with newly diagnosed PCNSLs. PMID:26871782

  17. Phase I Trial of Gross Total Resection, Permanent Iodine-125 Brachytherapy, and Hyperfractionated Radiotherapy for Newly Diagnosed Glioblastoma Multiforme

    SciTech Connect

    Chen, Allen M.; Chang, Susan; Pouliot, Jean; Sneed, Penny K.; Prados, Michael D.; Lamborn, Kathleen R.; Malec, Mary K.; McDermott, Michael W.; Berger, Mitchell S.; Larson, David A.

    2007-11-01

    Purpose: To evaluate the feasibility of gross total resection and permanent I-125 brachytherapy followed by hyperfractionated radiotherapy for patients with newly diagnosed glioblastoma. Methods and Materials: From April 1999 to May 2002, 21 patients with glioblastoma multiforme were enrolled on a Phase I protocol investigating planned gross total resection and immediate placement of permanent I-125 seeds, followed by postoperative hyperfractionated radiotherapy to a dose of 60 Gy at 100 cGy b.i.d., 5 days per week. Median age and Karnofsky performance status were 50 years (range, 32-65 years) and 90 (range, 70-100), respectively. Toxicity was assessed according to Radiation Therapy Oncology Group criteria. Results: Eighteen patients completed treatment according to protocol. The median preoperative tumor volume on magnetic resonance imaging was 18.6 cm{sup 3} (range, 4.4-41.2 cm{sup 3}). The median brachytherapy dose measured 5 mm radially outward from the resection cavity was 400 Gy (range, 200-600 Gy). Ten patients underwent 12 reoperations, with 11 of 12 reoperations demonstrating necrosis without evidence of tumor. Because of high toxicity, the study was terminated early. Median progression-free survival and overall survival were 57 and 114 weeks, respectively, but not significantly improved compared with historical patients treated at University of California, San Francisco, with gross total resection and radiotherapy without brachytherapy. Conclusions: Treatment with gross total resection and permanent I-125 brachytherapy followed by hyperfractionated radiotherapy as performed in this study results in high toxicity and reoperation rates, without demonstrated improvement in survival.

  18. Gender difference in the relation blood pressure-left ventricular mass and geometry in newly diagnosed arterial hypertension.

    PubMed

    Cipollini, Franco; Arcangeli, Enrica; Greco, Emanuela; Franconi, Flavia; Pettinà, Giuseppe; Seghieri, Giuseppe

    2012-08-01

    Much evidence suggests sexual dimorphism in the relationship linking blood pressure (BP) to both left ventricular mass (LVM) and geometry in hypertension. To better evaluate gender-associated characteristics in the relation BP-LVM among newly diagnosed hypertension (24-h average ambulatory BP monitoring, ABPM, > 125/80 mmHg), we measured indexed LVM and relative wall thickness (RWT) by standardized echographic methods in 209 Caucasian drug-naïve subjects, of whom 162 (100M/62F) were recognized to be hypertensive. Mean office systolic (SBP)/diastolic (DBP), 24-h average and night-time BP values were similar between sexes and significantly related to indexed LVM in both genders. Daytime SBP was significantly related to indexed LVM only in females (r =0.41; p =0.0008 in women; r =0.11; p = NS in males), while LVM was more sensitive to day-to-night SBP change in females. RWT was, on the contrary, significantly related to ABPM values only in males. All these findings were confirmed after adjusting for possible confounders. Percentage of LVM variance explained by 24-h average, daytime or night-time SBP values were higher in females than in males (17% vs 3%; 11% vs 1%; and 17% vs 8%). In conclusion, in early hypertension, LVM was significantly associated with daytime BP and more sensitive to reduced percentage of night BP fall in females. LVM variance explained by ABPM SBP was much higher in females than in males. RWT, expressing concentric LVM remodelling was, conversely, more related to BP increase in males. PMID:22545829

  19. Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia With an IDH1 and/or IDH2 Mutation

    ClinicalTrials.gov

    2016-08-15

    Newly Diagnosed Acute Myeloid Leukemia (AML); Untreated AML; AML Arising From Myelodysplastic Syndrome (MDS); AML Arising From Antecedent Hematologic Disorder (AHD); AML Arising After Exposure to Genotoxic Injury

  20. Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

    ClinicalTrials.gov

    2014-10-10

    Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

  1. Changes in Characteristics and Treatment Patterns of Patients with Newly Diagnosed Type 2 Diabetes in a Large United States Integrated Health System between 2008 and 2013

    PubMed Central

    Pantalone, Kevin M.; Hobbs, Todd M.; Wells, Brian J.; Kong, Sheldon X.; Kattan, Michael W.; Bouchard, Jonathan; Chagin, Kevin M.; Yu, Changhong; Sakurada, Brian; Milinovich, Alex; Weng, Wayne; Bauman, Janine M.; Zimmerman, Robert S.

    2016-01-01

    To assess changes in the clinical characteristics and treatment patterns of patients with newly diagnosed type 2 diabetes (T2D), the electronic health record system at Cleveland Clinic was used to create cross-sectional summaries of all patients with new-onset T2D in 2008 and 2013. Differences between the 2008 and 2013 data sets were assessed after adjusting for age, gender, race, and income. Approximately one-third of patients with newly diagnosed T2D in 2008 and 2013 had an A1C ≥8%, suggesting the continued presence of a delayed recognition of the disease. Patients with newly diagnosed T2D in 2008 were older than those in 2013. Hypertension, cardiovascular disease, and neuropathy were highly prevalent among patients diagnosed with T2D. The prevalence of neuropathy, cerebrovascular disease, and peripheral vascular disease increased from 2008 to 2013. Metformin was the most commonly prescribed antidiabetic medication. Sulfonylurea usage remained unchanged, while use of thiazolidinediones decreased considerably. PMID:27398040

  2. Risk-Factor Profile and Comorbidities in 2398 Patients With Newly Diagnosed Hypertension From the Abuja Heart Study

    PubMed Central

    Ojji, Dike B.; Libhaber, Elena; Atherton, John J.; Abdullahi, Bolaji; Nwankwo, Ada; Sliwa, Karen

    2015-01-01

    Abstract Risk factors, comorbidities, and end-organ damage in newly diagnosed hypertension (HT) are poorly described in larger cohorts of urban African patients undergoing epidemiological transition. We therefore decided to characterize a large cohort of hypertensive subjects presenting to a tertiary health center in sub-Saharan Africa. It is an observational cross-sectional study. We prospectively collected detailed clinical, biochemical, electrocardiography, and echocardiography data of all subjects with HT as the primary diagnosis in patients presenting at the Cardiology Unit of the University of Abuja Teaching Hospital over an 8-year period. Of 2398 subjects, 1187 patients (49.4%) were female with a mean age of 51 ± 12.8 years. Presenting symptoms and signs were most commonly palpitation in 691 (28.8%) followed by dyspnoea on exertion in 541 (22.6%), orthopnea in 532 (22.2%), pedal oedema in 468 (19.5%), paroxysmal nocturnal dyspnoea in 332 (13.8%), whereas only 31 (1.3%) presented with chest pain. Risk factors were obesity in 671 (28%); 523 (21.8%) had total cholesterol >5.2 mmol/L, diabetes mellitus was present in 201 (8.4%) and 187 (7.8%) were smokers. End-organ damage was present in form of echocardiographic left ventricular hypertrophy in 1336 (55.7%) followed by heart failure in 542 (22.6%). Arrhythmias occurred in 110 (4.6%) of cases, cerebrovascular accident in 103 (4.3%), chronic kidney disease in 26 (1.1%), hypertensive encephalopathy in 10 (0.4%), and coronary artery disease in 6 (0.26%). There were marked differences in sex as women were more obese and men presented with more advanced disease. The burden of HT and its complications in this carefully characterized African cohort is quite enormous with more than three-fourth having one form of complication. The need of effective primary and secondary preventive measures to be mapped out to tackle this problem cannot be overemphasized. PMID:26426662

  3. Risk-Factor Profile and Comorbidities in 2398 Patients With Newly Diagnosed Hypertension From the Abuja Heart Study.

    PubMed

    Ojji, Dike B; Libhaber, Elena; Atherton, John J; Abdullahi, Bolaji; Nwankwo, Ada; Sliwa, Karen

    2015-09-01

    Risk factors, comorbidities, and end-organ damage in newly diagnosed hypertension (HT) are poorly described in larger cohorts of urban African patients undergoing epidemiological transition. We therefore decided to characterize a large cohort of hypertensive subjects presenting to a tertiary health center in sub-Saharan Africa. It is an observational cross-sectional study. We prospectively collected detailed clinical, biochemical, electrocardiography, and echocardiography data of all subjects with HT as the primary diagnosis in patients presenting at the Cardiology Unit of the University of Abuja Teaching Hospital over an 8-year period. Of 2398 subjects, 1187 patients (49.4%) were female with a mean age of 51 ± 12.8 years. Presenting symptoms and signs were most commonly palpitation in 691 (28.8%) followed by dyspnoea on exertion in 541 (22.6%), orthopnea in 532 (22.2%), pedal oedema in 468 (19.5%), paroxysmal nocturnal dyspnoea in 332 (13.8%), whereas only 31 (1.3%) presented with chest pain. Risk factors were obesity in 671 (28%); 523 (21.8%) had total cholesterol >5.2 mmol/L, diabetes mellitus was present in 201 (8.4%) and 187 (7.8%) were smokers. End-organ damage was present in form of echocardiographic left ventricular hypertrophy in 1336 (55.7%) followed by heart failure in 542 (22.6%). Arrhythmias occurred in 110 (4.6%) of cases, cerebrovascular accident in 103 (4.3%), chronic kidney disease in 26 (1.1%), hypertensive encephalopathy in 10 (0.4%), and coronary artery disease in 6 (0.26%). There were marked differences in sex as women were more obese and men presented with more advanced disease. The burden of HT and its complications in this carefully characterized African cohort is quite enormous with more than three-fourth having one form of complication. The need of effective primary and secondary preventive measures to be mapped out to tackle this problem cannot be overemphasized.

  4. Toll-like Receptor-4 Polymorphisms and Serum Matrix Metalloproteinase-9 in Newly Diagnosed Patients With Calcified Neurocysticercosis and Seizures.

    PubMed

    Lachuriya, Gaurav; Garg, Ravindra Kumar; Jain, Amita; Malhotra, Hardeep Singh; Singh, Arvind Kumar; Jain, Bhawna; Kumar, Neeraj; Verma, Rajesh; Sharma, Praveen Kumar

    2016-04-01

    We evaluated seizure profile, Toll-like receptor (TLR)-4 polymorphisms, and serum matrix metalloproteinases (MMPs) in patients with calcified neurocysticercosis.One-hundred nine patients with calcified neurocysticercosis with newly diagnosed seizures and 109 control subjects were enrolled. TLR-4 Asp299Gly and Thr399Ile polymorphisms and serum MMP-9 levels were evaluated. The patients were followed for 1 year.Asp/Gly (P = 0.012) and Thr/Ile (P = 0.002), Gly (Asp/Gly plus Gly/Gly) (P = 0.008) and Ile (Thr/Ile plus Ile/Ile) (P = 0.003) genotypes were significantly associated with calcified neurocysticercosis compared with controls. Gly/Gly and Ile/Ile genotypes were not significantly associated (P = 0.529 for Gly/Gly, P = 0.798 for Ile/Ile) with either group. The levels of MMP-9 were higher in calcified neurocysticercosis (P =  < 0.001). The levels of MMP-9 were higher in patients with multiple calcified neurocysticercosis compared with single calcified neurocysticercosis (P =  < 0.001).Headache (P = 0.031), status epilepticus (P = 0.029), Todd paralysis (P = 0.039), lesion size >10 mm (P = 0.001), and perilesional edema (P =  < 0.001) were significantly associated with seizure recurrence. Heterozygous form Asp/Gly (P =  < 0.001) and heterozygous form Thr/Ile (P =  < 0.001) were significantly associated with seizure recurrence. The Gly (Asp/Gly plus Gly/Gly) (P =  < 0.001) and Ile (Thr/Ile plus Ile/Ile) (P =  < 0.001) genotypes were also significantly associated with seizure recurrence. Higher serum MMP-9 levels were significantly associated with seizure recurrence (P =  < 0.001).The TLR-4 gene abnormalities may trigger inflammation around calcified neurocysticercosis leading to an increase in perilesional edema and provocation of seizures.

  5. Risk-Factor Profile and Comorbidities in 2398 Patients With Newly Diagnosed Hypertension From the Abuja Heart Study.

    PubMed

    Ojji, Dike B; Libhaber, Elena; Atherton, John J; Abdullahi, Bolaji; Nwankwo, Ada; Sliwa, Karen

    2015-09-01

    Risk factors, comorbidities, and end-organ damage in newly diagnosed hypertension (HT) are poorly described in larger cohorts of urban African patients undergoing epidemiological transition. We therefore decided to characterize a large cohort of hypertensive subjects presenting to a tertiary health center in sub-Saharan Africa. It is an observational cross-sectional study. We prospectively collected detailed clinical, biochemical, electrocardiography, and echocardiography data of all subjects with HT as the primary diagnosis in patients presenting at the Cardiology Unit of the University of Abuja Teaching Hospital over an 8-year period. Of 2398 subjects, 1187 patients (49.4%) were female with a mean age of 51 ± 12.8 years. Presenting symptoms and signs were most commonly palpitation in 691 (28.8%) followed by dyspnoea on exertion in 541 (22.6%), orthopnea in 532 (22.2%), pedal oedema in 468 (19.5%), paroxysmal nocturnal dyspnoea in 332 (13.8%), whereas only 31 (1.3%) presented with chest pain. Risk factors were obesity in 671 (28%); 523 (21.8%) had total cholesterol >5.2 mmol/L, diabetes mellitus was present in 201 (8.4%) and 187 (7.8%) were smokers. End-organ damage was present in form of echocardiographic left ventricular hypertrophy in 1336 (55.7%) followed by heart failure in 542 (22.6%). Arrhythmias occurred in 110 (4.6%) of cases, cerebrovascular accident in 103 (4.3%), chronic kidney disease in 26 (1.1%), hypertensive encephalopathy in 10 (0.4%), and coronary artery disease in 6 (0.26%). There were marked differences in sex as women were more obese and men presented with more advanced disease. The burden of HT and its complications in this carefully characterized African cohort is quite enormous with more than three-fourth having one form of complication. The need of effective primary and secondary preventive measures to be mapped out to tackle this problem cannot be overemphasized. PMID:26426662

  6. Toll-like Receptor-4 Polymorphisms and Serum Matrix Metalloproteinase-9 in Newly Diagnosed Patients With Calcified Neurocysticercosis and Seizures

    PubMed Central

    Lachuriya, Gaurav; Garg, Ravindra Kumar; Jain, Amita; Malhotra, Hardeep Singh; Singh, Arvind Kumar; Jain, Bhawna; Kumar, Neeraj; Verma, Rajesh; Sharma, Praveen Kumar

    2016-01-01

    Abstract We evaluated seizure profile, Toll-like receptor (TLR)-4 polymorphisms, and serum matrix metalloproteinases (MMPs) in patients with calcified neurocysticercosis. One-hundred nine patients with calcified neurocysticercosis with newly diagnosed seizures and 109 control subjects were enrolled. TLR-4 Asp299Gly and Thr399Ile polymorphisms and serum MMP-9 levels were evaluated. The patients were followed for 1 year. Asp/Gly (P = 0.012) and Thr/Ile (P = 0.002), Gly (Asp/Gly plus Gly/Gly) (P = 0.008) and Ile (Thr/Ile plus Ile/Ile) (P = 0.003) genotypes were significantly associated with calcified neurocysticercosis compared with controls. Gly/Gly and Ile/Ile genotypes were not significantly associated (P = 0.529 for Gly/Gly, P = 0.798 for Ile/Ile) with either group. The levels of MMP-9 were higher in calcified neurocysticercosis (P =  < 0.001). The levels of MMP-9 were higher in patients with multiple calcified neurocysticercosis compared with single calcified neurocysticercosis (P =  < 0.001). Headache (P = 0.031), status epilepticus (P = 0.029), Todd paralysis (P = 0.039), lesion size >10 mm (P = 0.001), and perilesional edema (P =  < 0.001) were significantly associated with seizure recurrence. Heterozygous form Asp/Gly (P =  < 0.001) and heterozygous form Thr/Ile (P =  < 0.001) were significantly associated with seizure recurrence. The Gly (Asp/Gly plus Gly/Gly) (P =  < 0.001) and Ile (Thr/Ile plus Ile/Ile) (P =  < 0.001) genotypes were also significantly associated with seizure recurrence. Higher serum MMP-9 levels were significantly associated with seizure recurrence (P =  < 0.001). The TLR-4 gene abnormalities may trigger inflammation around calcified neurocysticercosis leading to an increase in perilesional edema and provocation of seizures. PMID:27124018

  7. Toll-like Receptor-4 Polymorphisms and Serum Matrix Metalloproteinase-9 in Newly Diagnosed Patients With Calcified Neurocysticercosis and Seizures.

    PubMed

    Lachuriya, Gaurav; Garg, Ravindra Kumar; Jain, Amita; Malhotra, Hardeep Singh; Singh, Arvind Kumar; Jain, Bhawna; Kumar, Neeraj; Verma, Rajesh; Sharma, Praveen Kumar

    2016-04-01

    We evaluated seizure profile, Toll-like receptor (TLR)-4 polymorphisms, and serum matrix metalloproteinases (MMPs) in patients with calcified neurocysticercosis.One-hundred nine patients with calcified neurocysticercosis with newly diagnosed seizures and 109 control subjects were enrolled. TLR-4 Asp299Gly and Thr399Ile polymorphisms and serum MMP-9 levels were evaluated. The patients were followed for 1 year.Asp/Gly (P = 0.012) and Thr/Ile (P = 0.002), Gly (Asp/Gly plus Gly/Gly) (P = 0.008) and Ile (Thr/Ile plus Ile/Ile) (P = 0.003) genotypes were significantly associated with calcified neurocysticercosis compared with controls. Gly/Gly and Ile/Ile genotypes were not significantly associated (P = 0.529 for Gly/Gly, P = 0.798 for Ile/Ile) with either group. The levels of MMP-9 were higher in calcified neurocysticercosis (P =  < 0.001). The levels of MMP-9 were higher in patients with multiple calcified neurocysticercosis compared with single calcified neurocysticercosis (P =  < 0.001).Headache (P = 0.031), status epilepticus (P = 0.029), Todd paralysis (P = 0.039), lesion size >10 mm (P = 0.001), and perilesional edema (P =  < 0.001) were significantly associated with seizure recurrence. Heterozygous form Asp/Gly (P =  < 0.001) and heterozygous form Thr/Ile (P =  < 0.001) were significantly associated with seizure recurrence. The Gly (Asp/Gly plus Gly/Gly) (P =  < 0.001) and Ile (Thr/Ile plus Ile/Ile) (P =  < 0.001) genotypes were also significantly associated with seizure recurrence. Higher serum MMP-9 levels were significantly associated with seizure recurrence (P =  < 0.001).The TLR-4 gene abnormalities may trigger inflammation around calcified neurocysticercosis leading to an increase in perilesional edema and provocation of seizures. PMID:27124018

  8. Phase II and pharmacogenomics study of enzastaurin plus temozolomide during and following radiation therapy in patients with newly diagnosed glioblastoma multiforme and gliosarcoma

    PubMed Central

    Butowski, Nicholas; Chang, Susan M.; Lamborn, Kathleen R.; Polley, Mei–Yin; Pieper, Russell; Costello, Joseph F.; Vandenberg, Scott; Parvataneni, Rupa; Nicole, Angelina; Sneed, Patricia K.; Clarke, Jennifer; Hsieh, Emily; Costa, Bruno M.; Reis, Rui M.; Hristova-Kazmierski, Maria; Nicol, Steven J.; Thornton, Donald E.; Prados, Michael D.

    2011-01-01

    This open-label, single-arm, phase II study combined enzastaurin with temozolomide plus radiation therapy (RT) to treat glioblastoma multiforme (GBM) and gliosarcoma. Adults with newly diagnosed disease and Karnofsky performance status (KPS) ≥ 60 were enrolled. Treatment was started within 5 weeks after surgical diagnosis. RT consisted of 60 Gy over 6 weeks. Temozolomide was given at 75 mg/m2 daily during RT and then adjuvantly at 200 mg/m2 daily for 5 days, followed by a 23-day break. Enzastaurin was given once daily during RT and in the adjuvant period at 250 mg/day. Cycles were 28 days. The primary end point was overall survival (OS). Progression-free survival (PFS), toxicity, and correlations between efficacy and molecular markers analyzed from tumor tissue samples were also evaluated. A prospectively planned analysis compared OS and PFS of the current trial with outcomes from 3 historical phase II trials that combined novel agents with temozolomide plus RT in patients with GBM or gliosarcoma. Sixty-six patients were enrolled. The treatment regimen was well tolerated. OS (median, 74 weeks) and PFS (median, 36 weeks) results from the current trial were comparable to those from a prior phase II study using erlotininb and were significantly better than those from 2 other previous studies that used thalidomide or cis-retinoic acid, all in combination with temozolomide plus RT. A positive correlation between O-6-methylguanine-DNA methyltransferase promoter methylation and OS was observed. Adjusting for age and KPS, no other biomarker was associated with survival outcome. Correlation of relevant biomarkers with OS may be useful in future trials. PMID:21896554

  9. Phase II Study of Erlotinib Plus Temozolomide During and After Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

    PubMed Central

    Prados, Michael D.; Chang, Susan M.; Butowski, Nicholas; DeBoer, Rebecca; Parvataneni, Rupa; Carliner, Hannah; Kabuubi, Paul; Ayers-Ringler, Jennifer; Rabbitt, Jane; Page, Margaretta; Fedoroff, Anne; Sneed, Penny K.; Berger, Mitchel S.; McDermott, Michael W.; Parsa, Andrew T.; Vandenberg, Scott; James, C. David; Lamborn, Kathleen R.; Stokoe, David; Haas-Kogan, Daphne A.

    2009-01-01

    Purpose This open-label, prospective, single-arm, phase II study combined erlotinib with radiation therapy (XRT) and temozolomide to treat glioblastoma multiforme (GBM) and gliosarcoma. The objectives were to determine efficacy of this treatment as measured by survival and to explore the relationship between molecular markers and treatment response. Patients and Methods Sixty-five eligible adults with newly diagnosed GBM or gliosarcoma were enrolled. We intended to treat patients not currently treated with enzyme-inducing antiepileptic drugs (EIAEDs) with 100 mg/d of erlotinib during XRT and 150 mg/d after XRT. Patients receiving EIAEDs were to receive 200 mg/d of erlotinib during XRT and 300 mg/d after XRT. After XRT, the erlotinib dose was escalated until patients developed tolerable grade 2 rash or until the maximum allowed dose was reached. All patients received temozolomide during and after XRT. Molecular markers of epidermal growth factor receptor (EGFR), EGFRvIII, phosphatase and tensin homolog (PTEN), and methylation status of the promotor region of the MGMT gene were analyzed from tumor tissue. Survival was compared with outcomes from two historical phase II trials. Results Median survival was 19.3 months in the current study and 14.1 months in the combined historical control studies, with a hazard ratio for survival (treated/control) of 0.64 (95% CI, 0.45 to 0.91). Treatment was well tolerated. There was a strong positive correlation between MGMT promotor methylation and survival, as well as an association between MGMT promotor-methylated tumors and PTEN positivity shown by immunohistochemistry with improved survival. Conclusion Patients treated with the combination of erlotinib and temozolomide during and following radiotherapy had better survival than historical controls. Additional studies are warranted. PMID:19075262

  10. Phase II and pharmacogenomics study of enzastaurin plus temozolomide during and following radiation therapy in patients with newly diagnosed glioblastoma multiforme and gliosarcoma.

    PubMed

    Butowski, Nicholas; Chang, Susan M; Lamborn, Kathleen R; Polley, Mei-Yin; Pieper, Russell; Costello, Joseph F; Vandenberg, Scott; Parvataneni, Rupa; Nicole, Angelina; Sneed, Patricia K; Clarke, Jennifer; Hsieh, Emily; Costa, Bruno M; Reis, Rui M; Hristova-Kazmierski, Maria; Nicol, Steven J; Thornton, Donald E; Prados, Michael D

    2011-12-01

    This open-label, single-arm, phase II study combined enzastaurin with temozolomide plus radiation therapy (RT) to treat glioblastoma multiforme (GBM) and gliosarcoma. Adults with newly diagnosed disease and Karnofsky performance status (KPS) ≥ 60 were enrolled. Treatment was started within 5 weeks after surgical diagnosis. RT consisted of 60 Gy over 6 weeks. Temozolomide was given at 75 mg/m(2) daily during RT and then adjuvantly at 200 mg/m(2) daily for 5 days, followed by a 23-day break. Enzastaurin was given once daily during RT and in the adjuvant period at 250 mg/day. Cycles were 28 days. The primary end point was overall survival (OS). Progression-free survival (PFS), toxicity, and correlations between efficacy and molecular markers analyzed from tumor tissue samples were also evaluated. A prospectively planned analysis compared OS and PFS of the current trial with outcomes from 3 historical phase II trials that combined novel agents with temozolomide plus RT in patients with GBM or gliosarcoma. Sixty-six patients were enrolled. The treatment regimen was well tolerated. OS (median, 74 weeks) and PFS (median, 36 weeks) results from the current trial were comparable to those from a prior phase II study using erlotinib and were significantly better than those from 2 other previous studies that used thalidomide or cis-retinoic acid, all in combination with temozolomide plus RT. A positive correlation between O-6-methylguanine-DNA methyltransferase promoter methylation and OS was observed. Adjusting for age and KPS, no other biomarker was associated with survival outcome. Correlation of relevant biomarkers with OS may be useful in future trials.

  11. Pre-chemotherapy risk factors for invasive fungal diseases: prospective analysis of 1,192 patients with newly diagnosed acute myeloid leukemia (SEIFEM 2010-a multicenter study)

    PubMed Central

    Caira, Morena; Candoni, Anna; Verga, Luisa; Busca, Alessandro; Delia, Mario; Nosari, Annamaria; Caramatti, Cecilia; Castagnola, Carlo; Cattaneo, Chiara; Fanci, Rosa; Chierichini, Anna; Melillo, Lorella; Mitra, Maria Enza; Picardi, Marco; Potenza, Leonardo; Salutari, Prassede; Vianelli, Nicola; Facchini, Luca; Cesarini, Monica; De Paolis, Maria Rosaria; Di Blasi, Roberta; Farina, Francesca; Venditti, Adriano; Ferrari, Antonella; Garzia, Mariagrazia; Gasbarrino, Cristina; Invernizzi, Rosangela; Lessi, Federica; Manna, Annunziata; Martino, Bruno; Nadali, Gianpaolo; Offidani, Massimo; Paris, Laura; Pavone, Vincenzo; Rossi, Giuseppe; Spadea, Antonio; Specchia, Giorgina; Trecarichi, Enrico Maria; Vacca, Adriana; Cesaro, Simone; Perriello, Vincenzo; Aversa, Franco; Tumbarello, Mario; Pagano, Livio

    2015-01-01

    Correct definition of the level of risk of invasive fungal infections is the first step in improving the targeting of preventive strategies. We investigated the potential relationship between pre-hospitalization exposure to sources of fungi and the development of invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia after their first course of chemotherapy. From January 2010 to April 2012, all consecutive acute myeloid leukemia patients in 33 Italian centers were prospectively registered. Upon first admission, information about possible pre-chemotherapy risk factors and environmental exposure was collected. We recorded data regarding comorbid conditions, employment, hygienic habits, working and living environment, personal habits, hobbies, and pets. All invasive fungal infections occurring within 30 days after the first course of chemotherapy were recorded. Of the 1,192 patients enrolled in this study, 881 received intensive chemotherapy and were included in the present analysis. Of these, 214 developed an invasive fungal infection, including 77 proven/probable cases (8.7%). Of these 77 cases, 54 were proven/probable invasive mold infections (6.1%) and 23 were proven yeast infections (2.6%). Upon univariate analysis, a significant association was found between invasive mold infections and age, performance status, diabetes, chronic obstructive pulmonary disease, smoking, cocaine use, job, hobbies, and a recent house renovation. Higher body weight resulted in a reduced risk of invasive mold infections. Multivariate analysis confirmed the role of performance status, job, body weight, chronic obstructive pulmonary disease, and house renovation. In conclusion, several hospital-independent variables could potentially influence the onset of invasive mold infections in patients with acute myeloid leukemia. Investigation of these factors upon first admission may help to define a patient’s risk category and improve targeted prophylactic

  12. Pre-chemotherapy risk factors for invasive fungal diseases: prospective analysis of 1,192 patients with newly diagnosed acute myeloid leukemia (SEIFEM 2010-a multicenter study).

    PubMed

    Caira, Morena; Candoni, Anna; Verga, Luisa; Busca, Alessandro; Delia, Mario; Nosari, Annamaria; Caramatti, Cecilia; Castagnola, Carlo; Cattaneo, Chiara; Fanci, Rosa; Chierichini, Anna; Melillo, Lorella; Mitra, Maria Enza; Picardi, Marco; Potenza, Leonardo; Salutari, Prassede; Vianelli, Nicola; Facchini, Luca; Cesarini, Monica; De Paolis, Maria Rosaria; Di Blasi, Roberta; Farina, Francesca; Venditti, Adriano; Ferrari, Antonella; Garzia, Mariagrazia; Gasbarrino, Cristina; Invernizzi, Rosangela; Lessi, Federica; Manna, Annunziata; Martino, Bruno; Nadali, Gianpaolo; Offidani, Massimo; Paris, Laura; Pavone, Vincenzo; Rossi, Giuseppe; Spadea, Antonio; Specchia, Giorgina; Trecarichi, Enrico Maria; Vacca, Adriana; Cesaro, Simone; Perriello, Vincenzo; Aversa, Franco; Tumbarello, Mario; Pagano, Livio

    2015-02-01

    Correct definition of the level of risk of invasive fungal infections is the first step in improving the targeting of preventive strategies. We investigated the potential relationship between pre-hospitalization exposure to sources of fungi and the development of invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia after their first course of chemotherapy. From January 2010 to April 2012, all consecutive acute myeloid leukemia patients in 33 Italian centers were prospectively registered. Upon first admission, information about possible pre-chemotherapy risk factors and environmental exposure was collected. We recorded data regarding comorbid conditions, employment, hygienic habits, working and living environment, personal habits, hobbies, and pets. All invasive fungal infections occurring within 30 days after the first course of chemotherapy were recorded. Of the 1,192 patients enrolled in this study, 881 received intensive chemotherapy and were included in the present analysis. Of these, 214 developed an invasive fungal infection, including 77 proven/probable cases (8.7%). Of these 77 cases, 54 were proven/probable invasive mold infections (6.1%) and 23 were proven yeast infections (2.6%). Upon univariate analysis, a significant association was found between invasive mold infections and age, performance status, diabetes, chronic obstructive pulmonary disease, smoking, cocaine use, job, hobbies, and a recent house renovation. Higher body weight resulted in a reduced risk of invasive mold infections. Multivariate analysis confirmed the role of performance status, job, body weight, chronic obstructive pulmonary disease, and house renovation. In conclusion, several hospital-independent variables could potentially influence the onset of invasive mold infections in patients with acute myeloid leukemia. Investigation of these factors upon first admission may help to define a patient's risk category and improve targeted prophylactic

  13. Stigma, Subsistence, Intimacy, Face, Filial Piety, and Mental Health Problems Among Newly HIV-Diagnosed Men Who Have Sex With Men in China

    PubMed Central

    Li, Haochu (Howard); Holroyd, Eleanor; Lau, Joseph; Li, Xiaoming

    2015-01-01

    High rates of mental health problems among people living with HIV (PLWH) have been widely reported in the literature; however, an understanding of the socioecological contexts of these presentations remains limited, particularly in China. In order to explore potential socioecological factors associated with mental health problems among newly diagnosed HIV-infected migrant men who have sex with men (MSM), we employed a life profile approach conducting semi-structured in-depth interviews with 31 newly diagnosed HIV-infected MSM residing in a city in Southern China. Participants’ life profile accounts outlined their concerns, including internalized stigma, subsistence living, difficulties finding a lover or a stable partner, loss of face, and deviation from filial piety. We contend that targeted interventions should address socioecological issues such as migrant adversities, social suffering, and cultural trauma when providing culturally based mental health services for this marginalized population within the context of Chinese society. PMID:26066696

  14. Stigma, Subsistence, Intimacy, Face, Filial Piety, and Mental Health Problems Among Newly HIV-Diagnosed Men Who Have Sex With Men in China.

    PubMed

    Li, Haochu Howard; Holroyd, Eleanor; Lau, Joseph; Li, Xiaoming

    2015-01-01

    High rates of mental health problems among people living with HIV (PLWH) have been widely reported in the literature; however, an understanding of the socioecological contexts of these presentations remains limited, particularly in China. In order to explore potential socioecological factors associated with mental health problems among newly diagnosed HIV-infected migrant men who have sex with men (MSM), we employed a life profile approach conducting semi-structured in-depth interviews with 31 newly diagnosed HIV-infected MSM residing in a city in Southern China. Participants' life profile accounts outlined their concerns, including internalized stigma, subsistence living, difficulties finding a lover or a stable partner, loss of face, and deviation from filial piety. We contend that targeted interventions should address socio-ecological issues such as migrant adversities, social suffering, and cultural trauma when providing culturally based mental health services for this marginalized population within the context of Chinese society.

  15. Trends on epidemiological, virological, and clinical features among newly diagnosed HIV-1 persons in Northwest Spain over the last 10 years.

    PubMed

    Pernas, B; Mena, A; Cañizares, A; Grandal, M; Castro-Iglesias, A; Pértega, S; Pedreira, J D; Poveda, E

    2015-08-01

    To describe temporal trend and characteristics of newly HIV-diagnosed patients in a medical care area in Northwest Spain over the last 10 years. All newly diagnosed patients for HIV-infection from 2004 to 2013 at a reference medical care area in Northwest of Spain were identified. Epidemiological, virological, immunological, and clinical data, as well as HIV genotype and drug resistance information were recorded. A total of 565 newly HIV-diagnosed patients were identified. The number of new cases increased in the last 5 years (66 cases/year). Overall, 53.1% had a median CD4 counts < 350 cells/µl and 33.6% had an AIDS defining criteria. Non-B variants were found in 34.4% of patients being subtype F (25.8%) the most common non-B subtype. The rate of transmitted drug resistance (TDR) over the study period was 3.7%, but a decreased to 2.6% was observed in the last 5 years. The most prevalent TDR mutations were: T215 revertants (1.5%), K219QENR (1.2%), for NRTIs; K103N (1.9%), for NNRTIs; L90M (0.3%), for PIs. Overall, 73.2% of patients started antiretroviral treatment and 9.9% of patients died during follow-up. The number of newly HIV diagnosed patients increased since year 2009. There is a high prevalence of late diagnosis (53%) and 33% had an AIDS defining criteria. Interestingly, the most prevalent non-B subtype in our population was F (25.8%). These findings support the need to facilitate the access for HIV testing to reduce the rate of late HIV diagnosis, improve the clinical outcome and prevent HIV transmission.

  16. Cost-effectiveness analysis of fesoterodine flexible dose in newly diagnosed patients with overactive bladder in routine clinical practice in Spain

    PubMed Central

    Peral, Carmen; Sánchez-Ballester, Francisco; García-Mediero, José M; Ramos, Jaime; Rejas, Javier

    2016-01-01

    Objective To carry out cost-effectiveness analysis from the Spanish National Health System perspective, of treating overactive bladder (OAB), in newly diagnosed patients with two flexible doses of fesoterodine in routine clinical practice. Patients and methods Economic evaluation of flexible-dose fesoterodine in newly diagnosed patients, including two treatment groups: standard escalating from 4 to 8 mg or fast escalating to 8 mg. Costs were estimated from health care resources utilization related to OAB, and were expressed in 2015 Euros. Quality-adjusted life-years (QALYs) were obtained from overactive bladder questionnaire-short form. Univariate and probabilistic sensitivity analyses were carried out. Results Three hundred and ninety symptomatic OAB patients treated with fesoterodine and newly diagnosed (141 in fast escalating group and 249 in standard escalating) were analyzed. Adjusted health care total costs were not statistically different; difference −€4.1 (confidence interval: −153.3; 25.1) P=0.842. QALYs were higher in fast escalating to high dose vs standard escalating group, resulting in a cost of −€16,020/QALY gained for fast escalating vs standard escalating group. Conclusion When the cost-effectiveness threshold is set at a maximum value of €30,000/QALY gained, fesoterodine fast escalating group was cost-effective vs standard escalating group 67.6% of the time. The treatment with fesoterodine, in female patients newly diagnosed, fast escalating to 8 mg was a cost-effective option relative to escalating traditionally from 4 to 8 mg, in the management of OAB in routine clinical practice, from the Spanish National Health System perspective. PMID:27713646

  17. Risk Profiles and Antithrombotic Treatment of Patients Newly Diagnosed with Atrial Fibrillation at Risk of Stroke: Perspectives from the International, Observational, Prospective GARFIELD Registry

    PubMed Central

    Kakkar, Ajay K.; Mueller, Iris; Bassand, Jean-Pierre; Fitzmaurice, David A.; Goldhaber, Samuel Z.; Goto, Shinya; Haas, Sylvia; Hacke, Werner; Lip, Gregory Y. H.; Mantovani, Lorenzo G.; Turpie, Alexander G. G.; van Eickels, Martin; Misselwitz, Frank; Rushton-Smith, Sophie; Kayani, Gloria; Wilkinson, Peter; Verheugt, Freek W. A.

    2013-01-01

    Background Limited data are available on the characteristics, clinical management, and outcomes of patients with atrial fibrillation at risk of stroke, from a worldwide perspective. The aim of this study was to describe the baseline characteristics and initial therapeutic management of patients with non-valvular atrial fibrillation across the spectrum of sites at which these patients are treated. Methods and Findings The Global Anticoagulant Registry in the FIELD (GARFIELD) is an observational study of patients newly diagnosed with non-valvular atrial fibrillation. Enrollment into Cohort 1 (of 5) took place between December 2009 and October 2011 at 540 sites in 19 countries in Europe, Asia-Pacific, Central/South America, and Canada. Investigator sites are representative of the distribution of atrial fibrillation care settings in each country. Cohort 1 comprised 10,614 adults (≥18 years) diagnosed with non-valvular atrial fibrillation within the previous 6 weeks, with ≥1 investigator-defined stroke risk factor (not limited to those in existing risk-stratification schemes), and regardless of therapy. Data collected at baseline included demographics, medical history, care setting, nature of atrial fibrillation, and treatments initiated at diagnosis. The mean (SD) age of the population was 70.2 (11.2) years; 43.2% were women. Mean±SD CHADS2 score was 1.9±1.2, and 57.2% had a score ≥2. Mean CHA2DS2-VASc score was 3.2±1.6, and 8,957 (84.4%) had a score ≥2. Overall, 38.0% of patients with a CHADS2 score ≥2 did not receive anticoagulant therapy, whereas 42.5% of those at low risk (score 0) received anticoagulant therapy. Conclusions These contemporary observational worldwide data on non-valvular atrial fibrillation, collected at the end of the vitamin K antagonist-only era, indicate that these drugs are frequently not being used according to stroke risk scores and guidelines, with overuse in patients at low risk and underuse in those at high risk of stroke

  18. The Relation between Serum Uric Acid and HbA1c Is Dependent upon Hyperinsulinemia in Patients with Newly Diagnosed Type 2 Diabetes Mellitus

    PubMed Central

    Cui, Yuliang; Bu, Hemei; Zhao, Sha; Li, Xiaona; Lu, Shan

    2016-01-01

    Objective. The aim of our study was to explore the dependent condition of the relationship between uric acid and blood glucose in type 2 diabetes. Research Design and Methods. We measured the HbA1c, serum uric acid, creatinine, lipids profiles, and so forth of 605 newly diagnosed type 2 diabetes patients, and oral glucose tolerance tests (OGTTs) were performed on each patient. The population was divided into high and low insulin groups. Multiple linear regression analyses were conducted to assess the relationship between uric acid and HbA1c. Results. Serum uric acid and HbA1c levels were low in newly diagnosed type 2 diabetes patients. However, we found no significant relationship between uric acid and HbA1c by regression analysis after adjusting total insulin. The concentration of uric acid was inversely correlated with HbA1c in the high insulin group, regardless of patient sex. However, no associations were found in low insulin group. Conclusions. The negative correlation between uric acid and HbA1c is conditional in newly diagnosed type 2 diabetes patients and is related to hyperinsulinemia. Therefore, uric acid is likely only useful as a biomarker of blood glucose in patients exhibiting hyperinsulinemia. PMID:27403443

  19. Use of reverse-transcriptase-based HIV-1 viral load assessment to confirm low viral loads in newly diagnosed patients in Switzerland

    PubMed Central

    2014-01-01

    Background Treatment-naïve patients newly diagnosed with HIV occasionally present with low viral RNA of ≤1’000 copies/ml, raising concerns about viral load underestimation. Because falsely low or undetectable viral loads might lead to inadvertent virus transmission or treatment delays, confirmation of such cases by a sequence-independent viral load test is recommended in Switzerland. Methods HIV-1 RNA ≤1’000 cp/ml by Roche’s or Abbott’s tests in patients newly diagnosed from 2010 to 2012 in Switzerland were subjected to viral load testing by the product-enhanced-reverse transcriptase (PERT) assay. These investigations were complemented with repeat and/or alternative viral RNA measurements. Results HIV-1 RNA ≤1’000 cp/ml was observed in 71 of 1814 newly diagnosed patients. The PERT assay suggested clinically relevant viral load underestimation in 7 of 32 cases that could be investigated. In four patients, the PERT viral load was 10-1’000-fold higher; this was confirmed by alternative HIV-1 RNA tests. Six of the 7 underestimates had been obtained with meanwhile outdated versions of Roche’s HIV-1 RNA test. In the seventh patient, follow-up revealed similar results for RNA and PERT based viral loads. Conclusion PERT assay revealed occasional severe viral load underestimation by versions of HIV-1 RNA tests meanwhile outdated. Underestimation by contemporary tests appears rare, however. PMID:24524626

  20. Associations between Retinal Markers of Microvascular Disease and Cognitive Impairment in Newly Diagnosed Type 2 Diabetes Mellitus: A Case Control Study

    PubMed Central

    Amiel, Stephanie; Kohli, Reena; Crosby-Nwaobi, Roxanne

    2016-01-01

    Objective To investigate associations between retinal microvascular changes and cognitive impairment in newly diagnosed type 2 diabetes mellitus. Design Case control study. Setting A primary care cohort with newly diagnosed type 2 diabetes mellitus. Methods For this analysis, we compared 69 cases with lowest decile scores (for the cohort) on the Modified Telephone Interview for Cognitive Status and 68 controls randomly selected from the remainder of the cohort. Retinal images were rated and the following measures compared between cases and controls: retinal vessel calibre, arterio-venous ratio, retinal fractal dimension, and simple and curvature retinal vessel tortuosity. Results Total and venular (but not arteriolar) simple retinal vessel tortuosity levels were significantly higher in cases than controls (t = 2.45, p = 0.015; t = 2.53, p = 0.013 respectively). The associations persisted after adjustment for demographic factors, retinopathy, neuropathy, obesity and blood pressure. There were no other significant differences between cases and controls in retinal measures. Conclusions A novel association was found between higher venular tortuosity and cognitive impairment in newly diagnosed type 2 diabetes mellitus. This might be accounted for by factors such as hypoxia, thrombus formation, increased vasoendothelial growth factor release and inflammation affecting both the visible retinal and the unobserved cerebral microvasculature. PMID:26771382

  1. Comparison of the Effects of Continuous Subcutaneous Insulin Infusion and Add-On Therapy with Sitagliptin in Patients with Newly Diagnosed Type 2 Diabetes Mellitus.

    PubMed

    Wan, Heng; Zhao, Defu; Shen, Jie; Lu, Lu; Zhang, Tong; Chen, Zhi

    2016-01-01

    To identify a new regimen to optimize treatment for patients with newly diagnosed type 2 diabetes (T2DM) by short-term continuous subcutaneous insulin infusion (CSII) alone. Methods. 60 patients with newly diagnosed T2DM were randomized into two groups (n = 30 each) and treated for 2 weeks with CSII alone (CSII group) or with CSII plus sitagliptin (CSII + Sig group). The glycemic variability of the patients was measured using a continuous glucose monitoring system (CGMS) for the last 72 hours. A standard meal test was performed before and after the interventions, and the levels of glycated albumin, fasting glucose, fasting C-peptide, postprandial 2 h blood glucose, and postprandial 2 h C-peptide were examined. Results. Compared with the CSII group, the indicators of glycemic variability, such as the mean amplitude of glycemic excursion (MAGE) and the standard deviation of blood glucose (SDBG), were decreased significantly in the CSII + Sig group. The changes before and after treatment in the C-peptide reactivity index (ΔCPI) and the secretory unit of islet in transplantation index (ΔSUIT) indicated a significant improvement in the CSII + Sig group. Conclusions. Add-on therapy with sitagliptin may be an optimized treatment for patients with newly diagnosed T2DM compared with short-term CSII alone. PMID:26798658

  2. Comparison of the Effects of Continuous Subcutaneous Insulin Infusion and Add-On Therapy with Sitagliptin in Patients with Newly Diagnosed Type 2 Diabetes Mellitus

    PubMed Central

    Wan, Heng; Zhao, Defu; Shen, Jie; Lu, Lu; Zhang, Tong; Chen, Zhi

    2016-01-01

    To identify a new regimen to optimize treatment for patients with newly diagnosed type 2 diabetes (T2DM) by short-term continuous subcutaneous insulin infusion (CSII) alone. Methods. 60 patients with newly diagnosed T2DM were randomized into two groups (n = 30 each) and treated for 2 weeks with CSII alone (CSII group) or with CSII plus sitagliptin (CSII + Sig group). The glycemic variability of the patients was measured using a continuous glucose monitoring system (CGMS) for the last 72 hours. A standard meal test was performed before and after the interventions, and the levels of glycated albumin, fasting glucose, fasting C-peptide, postprandial 2 h blood glucose, and postprandial 2 h C-peptide were examined. Results. Compared with the CSII group, the indicators of glycemic variability, such as the mean amplitude of glycemic excursion (MAGE) and the standard deviation of blood glucose (SDBG), were decreased significantly in the CSII + Sig group. The changes before and after treatment in the C-peptide reactivity index (ΔCPI) and the secretory unit of islet in transplantation index (ΔSUIT) indicated a significant improvement in the CSII + Sig group. Conclusions. Add-on therapy with sitagliptin may be an optimized treatment for patients with newly diagnosed T2DM compared with short-term CSII alone. PMID:26798658

  3. Frequency and Determinants of Preventive Care Counseling by HIV Medical Care Providers during Encounters with Newly Diagnosed and Established HIV-Infected Patients.

    PubMed

    Mgbere, Osaro; Rodriguez-Barradas, Maria C; Bell, Tanvir K; Khuwaja, Salma; Arafat, Raouf; Essien, Ekere J; Singh, Mamta; Simmons, Paul; Aguilar, Jonathan

    2016-05-01

    This study evaluates the frequency and determinants of preventive care counseling by HIV medical care providers (HMCPs) during encounters with newly diagnosed and established HIV-infected patients. Data used were from a probability sample of HMCPs in Houston/Harris County, Texas, surveyed in 2009. Overall, HMCPs offered more preventive care counseling to newly diagnosed than the established patients (adjusted odds ratio [AOR] = 7.28; 95% confidence interval [CI] = 2.86-16.80). They were more likely to counsel newly diagnosed patients than the established ones on medication and adherence (AOR = 14.70; 95% CI = 1.24-24.94), HIV risk reduction (AOR = 5.91; 95% CI = 0.48-7.13), and disease screening (AOR = 7.20; 95% CI = 0.72-11.81). HIV medical care providers who were less than 45 years of age, infectious disease specialists, and had less than 30 minutes of encounter time were less likely to counsel patients regardless of the status. Our findings suggest the need for HMCPs to improve their preventive care counseling efforts, in order to help patients build skills for adopting and maintaining safe behavior that could assist in reducing the risk of HIV transmission.

  4. Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up.

    PubMed

    Larson, R A; Hochhaus, A; Hughes, T P; Clark, R E; Etienne, G; Kim, D-W; Flinn, I W; Kurokawa, M; Moiraghi, B; Yu, R; Blakesley, R E; Gallagher, N J; Saglio, G; Kantarjian, H M

    2012-10-01

    Evaluating Nilotinib Efficacy and Safety in Clinical Trials Newly Diagnosed Patients compares nilotinib and imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). With a minimum follow-up of 3 years, major molecular response, molecular response of BCR-ABL≤ 0.01% expressed on the international scale (BCR-ABL(IS); MR(4)) and BCR-ABL(IS)≤ 0.0032% (MR(4.5)) rates were significantly higher with nilotinib compared with imatinib, and differences in the depth of molecular response between nilotinib and imatinib have increased over time. No new progressions occurred on treatment since the 2-year analysis. Nilotinib was associated with a significantly lower probability of progression to accelerated phase/blast crisis vs imatinib (two (0.7%) progressions on nilotinib 300 mg twice daily, three (1.1%) on nilotinib 400 mg twice daily and 12 (4.2%) on imatinib). When considering progressions occurring after study treatment discontinuation, the advantage of nilotinib over imatinib in preventing progression remained significant (nine (3.2%) progressions on nilotinib 300 mg twice daily, six (2.1%) on nilotinib 400 mg twice daily and 19 (6.7%) on imatinib). Both nilotinib and imatinib were well tolerated, with minimal changes in safety over time. Nilotinib continues to demonstrate superior efficacy in all key response and outcome parameters compared with imatinib for the treatment of patients with newly diagnosed CML-CP.

  5. Social Perception and WAIS-IV Performance in Adolescents and Adults Diagnosed with Asperger's Syndrome and Autism

    ERIC Educational Resources Information Center

    Holdnack, James; Goldstein, Gerald; Drozdick, Lisa

    2011-01-01

    Previous research using the Wechsler scales has identified areas of cognitive weaknesses in children, adolescents, and adults diagnosed with Autism or Asperger's syndrome. The current study evaluates cognitive functioning in adolescents and adults diagnosed with Autism or Asperger's syndrome using the Wechsler Adult Intelligence Scale-Fourth…

  6. Catapulting through life stages. When younger adults are diagnosed with life-threatening illnesses.

    PubMed

    Rancour, Patrice

    2002-02-01

    Knowledge of developmental stages through the life cycle has always been a hallmark of quality nursing care. The knowledge base gleaned from the older adult literature, such as Schachter-Shalomi and Miller's construct of sage-ing (1995), can help nurses understand that many of the completion tasks usually associated with aging suddenly are thrust to the forefront for younger adult patients diagnosed with a life-threatening illness. Using this knowledge base, nurses can facilitate developmental stage work facing younger adult patients whose illness catapults them into more mature stages for which they may have been unprepared. When younger adult patients are so diagnosed, nurses need to recognize the signs of catapulting life stage work and support it. It is no small task to complete the gestalt of one's life tapestry, but it is especially difficult when one is young. PMID:11852713

  7. Catapulting through life stages. When younger adults are diagnosed with life-threatening illnesses.

    PubMed

    Rancour, Patrice

    2002-02-01

    Knowledge of developmental stages through the life cycle has always been a hallmark of quality nursing care. The knowledge base gleaned from the older adult literature, such as Schachter-Shalomi and Miller's construct of sage-ing (1995), can help nurses understand that many of the completion tasks usually associated with aging suddenly are thrust to the forefront for younger adult patients diagnosed with a life-threatening illness. Using this knowledge base, nurses can facilitate developmental stage work facing younger adult patients whose illness catapults them into more mature stages for which they may have been unprepared. When younger adult patients are so diagnosed, nurses need to recognize the signs of catapulting life stage work and support it. It is no small task to complete the gestalt of one's life tapestry, but it is especially difficult when one is young.

  8. Religious commitment, adult attachment, and marital adjustment in newly married couples.

    PubMed

    Lopez, Jamie L; Riggs, Shelley A; Pollard, Sara E; Hook, Joshua N

    2011-04-01

    Existing literature on the role of religiosity in marital functioning is often difficult to interpret due to the frequent use of convenience samples, statistical approaches inadequate for interdependent dyadic data, and the lack of a theoretical framework. The current study examined the effects of religious commitment and insecure attachment on marital adjustment. Newly married couples who did not have children (N = 92 couples, 184 individuals) completed measures of religious commitment, adult attachment, and marital functioning. There was a small positive association between religious commitment and marital adjustment. Religious commitment buffered the negative association between attachment avoidance and marital adjustment, but exacerbated the negative association between attachment anxiety and marital adjustment.

  9. Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma

    ClinicalTrials.gov

    2013-01-15

    Adult Anaplastic Astrocytoma; Adult Anaplastic Ependymoma; Adult Anaplastic Oligodendroglioma; Adult Diffuse Astrocytoma; Adult Ependymoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Mixed Glioma; Adult Myxopapillary Ependymoma; Adult Oligodendroglioma; Adult Pilocytic Astrocytoma; Adult Pineal Gland Astrocytoma; Adult Subependymoma

  10. Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas

    ClinicalTrials.gov

    2016-06-06

    Adult Grade III Lymphomatoid Granulomatosis; Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Childhood Burkitt Lymphoma; Childhood Diffuse Large Cell Lymphoma; Childhood Grade III Lymphomatoid Granulomatosis; Childhood Immunoblastic Large Cell Lymphoma; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Contiguous Stage II Adult Burkitt Lymphoma; Contiguous Stage II Adult Diffuse Large Cell Lymphoma; Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Contiguous Stage II Adult Lymphoblastic Lymphoma; Contiguous Stage II Grade 1 Follicular Lymphoma; Contiguous Stage II Grade 2 Follicular Lymphoma; Contiguous Stage II Grade 3 Follicular Lymphoma; Contiguous Stage II Mantle Cell Lymphoma; Contiguous Stage II Marginal Zone Lymphoma; Contiguous Stage II Small Lymphocytic Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Grade 3 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Noncutaneous Extranodal Lymphoma; Peripheral T-cell Lymphoma; Progressive Hairy Cell Leukemia, Initial Treatment; Small Intestine Lymphoma; Splenic Marginal Zone

  11. Online Narratives by Adults with ADHD Who Were Diagnosed in Adulthood

    ERIC Educational Resources Information Center

    Fleischmann, Amos; Miller, Erez C.

    2013-01-01

    This study systematically analyzed life stories of adults with attention-deficit hyperactivity disorder (ADHD) who were diagnosed in adulthood, using an adapted version of Labov's textual-analysis method. These life stories provided an opportunity to examine the processes experienced by these individuals before and after the diagnosis of ADHD,…

  12. Reliability of Diagnosing Clinical Hypothyroidism in Adults with Down Syndrome. Brief Report.

    ERIC Educational Resources Information Center

    Prasher, V. P.

    1995-01-01

    The accuracy of diagnosing hypothyroidism in 160 adults with Down syndrome was examined. A significant association between a clinical diagnosis of hypothyroidism and increasing age was found but no significant association was found between a clinical and a biochemical diagnosis. Regular biochemical screening is recommended. (Author/SW)

  13. Lived Experiences of Adult Children Who Have a Parent Diagnosed with Parkinson's Disease

    ERIC Educational Resources Information Center

    Blanchard, Amy; Hodgson, Jennifer; Lamson, Angela; Dosser, David

    2009-01-01

    Little is known about the experience among adult children who have a parent with Parkinson's Disease (PD). The purpose of this study was to explore, appreciate, and describe their experiences using a phenomenological methodology. Narratives were collected from seven participants who have a parent diagnosed with PD and analyzed according to…

  14. Storytelling by Adults Diagnosed with Terminal Illness: Narrative Identifying through Dialogical Research

    ERIC Educational Resources Information Center

    Sauer, Michael Paul

    2012-01-01

    The purpose of this dialogical qualitative research study was to gain insight into the process of storytelling with adults diagnosed with terminal illness as a way of making meaning of their experiences and lives. The study was informed by the conceptual frameworks of story, storytelling, and story listening which are grounded in the theory of…

  15. Late Adolescent and Young Adult Outcomes of Girls Diagnosed with ADHD in Childhood: An Exploratory Investigation

    ERIC Educational Resources Information Center

    Babinski, Dara E.; Pelham, William E., Jr.; Molina, Brooke S. G.; Gnagy, Elizabeth M.; Waschbusch, Daniel A.; Yu, Jihnhee; MacLean, Michael G.; Wymbs, Brian T.; Sibley, Margaret H.; Biswas, Aparajita; Robb, Jessica A.; Karch, Kathryn M.

    2011-01-01

    Objective: To characterize the late adolescent and young adult outcomes of girls diagnosed with ADHD in childhood. Method: The study included 58 women from a larger longitudinal study of ADHD. A total of 34 (M = 19.97 years old) met "DSM" criteria for ADHD in childhood, whereas the remaining 24 (M = 19.83 years old) did not. Self- and…

  16. Aspects of Sexuality in Adolescents and Adults Diagnosed with Autism Spectrum Disorders in Childhood

    ERIC Educational Resources Information Center

    Fernandes, Lucrecia Cabral; Gillberg, Carina I.; Cederlund, Mats; Hagberg, Bibbi; Gillberg, Christopher; Billstedt, Eva

    2016-01-01

    The literature concerning sexuality in autism spectrum disorders (ASDs) is limited regarding inappropriate sexual behaviours and paraphilias and its relation to age, verbal ability, symptom severity, intellectual ability, or adaptive functioning. A cohort of 184 adolescents and young adults (ages 15-39 years) with ASD diagnosed in childhood,…

  17. When Diagnosing ADHD in Young Adults Emphasize Informant Reports, "DSM" Items, and Impairment

    ERIC Educational Resources Information Center

    Sibley, Margaret H.; Pelham, William E., Jr.; Molina, Brooke S. G.; Gnagy, Elizabeth M.; Waxmonsky, James G.; Waschbusch, Daniel A.; Derefinko, Karen J.; Wymbs, Brian T.; Garefino, Allison C.; Babinski, Dara E.; Kuriyan, Aparajita B.

    2012-01-01

    Objective: This study examined several questions about the diagnosis of attention-deficit/hyperactivity disorder (ADHD) in young adults using data from a childhood-diagnosed sample of 200 individuals with ADHD (age M = 20.20 years) and 121 demographically similar non-ADHD controls (total N = 321). Method: We examined the use of self- versus…

  18. Overactive Pattern Separation Memory Associated with Negative Emotionality in Adults Diagnosed with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    South, M.; Stephenson, K. G.; Nielson, C. A.; Maisel, M.; Top, D. N.; Kirwan, C. B.

    2015-01-01

    Bowler et al. ("Journal of Autism and Developmental Disorders" 44(9):2355-2362. doi:10.1007/s10803-014-2105-y, 2014) have suggested that a specific memory impairment in autism spectrum disorders (ASD) arises from hippocampal failure to consolidate multiple related pieces of information. Twenty-four adults diagnosed with ASD and matched…

  19. Diagnosing Dyslexia. A Guide to the Assessment of Adults with Specific Learning Difficulties.

    ERIC Educational Resources Information Center

    Klein, Cynthia

    This book offers tutors in adult, further, and higher education materials for diagnosing students with specific learning disabilities (dyslexia). It provides information for setting up an appropriate individualized teaching program and making recommendations for supporting such students. Materials and methods can be used with students from basic…

  20. Coming Together to Calm the Hunger: Group Therapy Program for Adults Diagnosed with Anorexia Nervosa

    ERIC Educational Resources Information Center

    Ponech, Heather; McBride, Dawn Lorraine

    2012-01-01

    This project provides a comprehensive overview of the research literature on anorexia nervosa in female adults and concludes by offering 14 group therapy lesson plans for anorexia nervosa that therapists may use in their practice. There is a remarkable lack of research on the efficacy of treatment designed for individuals diagnosed with anorexia…

  1. Interpersonal relationship narratives of older adults with schizophrenia-spectrum diagnoses.

    PubMed

    Ogden, Lydia P

    2014-11-01

    Shared themes connected to interpersonal relationships across the life courses of older adults with schizophrenia-spectrum diagnoses were identified in first-person life history narratives and explored in depth. Findings were developed through thematic narrative analysis of 35 interviews with 7 older adults currently in treatment for schizophrenia-spectrum diagnoses. A combination of open-ended questions, life history calendars, and time diaries were used to structure interviews, and narrative and analytical development. Themes of relational losses, relational voids, relational adjustments, relational adaptations, and the need for solitude were identified and located as they occurred in patterns across the life course. Specific implications for theoretical development, practice, policy, and future research on interventions that address social recovery for older adults with schizophrenia are discussed.

  2. Positron Emission Tomography Using Fluorine F 18 EF5 to Find Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Newly Diagnosed Brain Tumors

    ClinicalTrials.gov

    2013-01-15

    Adult Anaplastic Astrocytoma; Adult Anaplastic Ependymoma; Adult Anaplastic Oligodendroglioma; Adult Brain Stem Glioma; Adult Central Nervous System Germ Cell Tumor; Adult Choroid Plexus Tumor; Adult Craniopharyngioma; Adult Diffuse Astrocytoma; Adult Ependymoblastoma; Adult Ependymoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Grade I Meningioma; Adult Grade II Meningioma; Adult Grade III Meningioma; Adult Medulloblastoma; Adult Meningeal Hemangiopericytoma; Adult Mixed Glioma; Adult Myxopapillary Ependymoma; Adult Oligodendroglioma; Adult Pilocytic Astrocytoma; Adult Pineoblastoma; Adult Pineocytoma; Adult Subependymoma; Adult Supratentorial Primitive Neuroectodermal Tumor (PNET); Meningeal Melanocytoma

  3. Busulfan, Melphalan, Topotecan Hydrochloride, and a Stem Cell Transplant in Treating Patients With Newly Diagnosed or Relapsed Solid Tumor

    ClinicalTrials.gov

    2016-05-04

    Solid Tumor; Adult Central Nervous System Germ Cell Tumor; Adult Rhabdomyosarcoma; Childhood Central Nervous System Germ Cell Tumor; Childhood Soft Tissue Sarcoma; Ewing Sarcoma; Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Ovarian Mixed Germ Cell Tumor; Previously Untreated Childhood Rhabdomyosarcoma; Recurrent Adult Brain Tumor; Recurrent Adult Soft Tissue Sarcoma; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Ependymoma; Recurrent Childhood Malignant Germ Cell Tumor; Recurrent Childhood Medulloblastoma; Recurrent Childhood Pineoblastoma; Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor; Recurrent Childhood Visual Pathway and Hypothalamic Glioma; Recurrent Childhood Visual Pathway Glioma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Extragonadal Germ Cell Tumor; Recurrent Extragonadal Non-seminomatous Germ Cell Tumor; Recurrent Malignant Testicular Germ Cell Tumor; Recurrent Neuroblastoma; Recurrent Ovarian Germ Cell Tumor; Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

  4. Characterizing Newly Repopulated Microglia in the Adult Mouse: Impacts on Animal Behavior, Cell Morphology, and Neuroinflammation

    PubMed Central

    Elmore, Monica R. P.; Lee, Rafael J.; West, Brian L.; Green, Kim N.

    2015-01-01

    Microglia are the primary immune cell in the brain and are postulated to play important roles outside of immunity. Administration of the dual colony-stimulating factor 1 receptor (CSF1R)/c-Kit kinase inhibitor, PLX3397, to adult mice results in the elimination of ~99% of microglia, which remain eliminated for as long as treatment continues. Upon removal of the inhibitor, microglia rapidly repopulate the entire adult brain, stemming from a central nervous system (CNS) resident progenitor cell. Using this method of microglial elimination and repopulation, the role of microglia in both healthy and diseased states can be explored. Here, we examine the responsiveness of newly repopulated microglia to an inflammatory stimulus, as well as determine the impact of these cells on behavior, cognition, and neuroinflammation. Two month-old wild-type mice were placed on either control or PLX3397 diet for 21 d to eliminate microglia. PLX3397 diet was then removed in a subset of animals to allow microglia to repopulate and behavioral testing conducted beginning at 14 d repopulation. Finally, inflammatory profiling of the microglia-repopulated brain in response to lipopolysaccharide (LPS; 0.25 mg/kg) or phosphate buffered saline (PBS) was determined 21 d after inhibitor removal using quantitative real time polymerase chain reaction (RT-PCR), as well as detailed analyses of microglial morphologies. We find mice with repopulated microglia to perform similarly to controls by measures of behavior, cognition, and motor function. Compared to control/resident microglia, repopulated microglia had larger cell bodies and less complex branching in their processes, which resolved over time after inhibitor removal. Inflammatory profiling revealed that the mRNA gene expression of repopulated microglia was similar to normal resident microglia and that these new cells appear functional and responsive to LPS. Overall, these data demonstrate that newly repopulated microglia function similarly to the

  5. Characterizing newly repopulated microglia in the adult mouse: impacts on animal behavior, cell morphology, and neuroinflammation.

    PubMed

    Elmore, Monica R P; Lee, Rafael J; West, Brian L; Green, Kim N

    2015-01-01

    Microglia are the primary immune cell in the brain and are postulated to play important roles outside of immunity. Administration of the dual colony-stimulating factor 1 receptor (CSF1R)/c-Kit kinase inhibitor, PLX3397, to adult mice results in the elimination of ~99% of microglia, which remain eliminated for as long as treatment continues. Upon removal of the inhibitor, microglia rapidly repopulate the entire adult brain, stemming from a central nervous system (CNS) resident progenitor cell. Using this method of microglial elimination and repopulation, the role of microglia in both healthy and diseased states can be explored. Here, we examine the responsiveness of newly repopulated microglia to an inflammatory stimulus, as well as determine the impact of these cells on behavior, cognition, and neuroinflammation. Two month-old wild-type mice were placed on either control or PLX3397 diet for 21 d to eliminate microglia. PLX3397 diet was then removed in a subset of animals to allow microglia to repopulate and behavioral testing conducted beginning at 14 d repopulation. Finally, inflammatory profiling of the microglia-repopulated brain in response to lipopolysaccharide (LPS; 0.25 mg/kg) or phosphate buffered saline (PBS) was determined 21 d after inhibitor removal using quantitative real time polymerase chain reaction (RT-PCR), as well as detailed analyses of microglial morphologies. We find mice with repopulated microglia to perform similarly to controls by measures of behavior, cognition, and motor function. Compared to control/resident microglia, repopulated microglia had larger cell bodies and less complex branching in their processes, which resolved over time after inhibitor removal. Inflammatory profiling revealed that the mRNA gene expression of repopulated microglia was similar to normal resident microglia and that these new cells appear functional and responsive to LPS. Overall, these data demonstrate that newly repopulated microglia function similarly to the

  6. [Factors associated with development of tuberculosis among children and young adults: a study of newly registered cases].

    PubMed

    Komatsu, R; Kitai, A; Mori, T; Yamada, Y

    1990-03-01

    In order to elucidate the factors relevant to the management and prevention of tuberculosis among children and young adults, a total of 191 tuberculosis cases who were newly registered at Health Centers in Saitama Prefecture and were aged less than 30 years were interviewed, and case-finding processes, treatment course and risk factors for clinical development were studied. Analyses of the time course from the patients' becoming aware of the clinical symptoms through the establishment of the diagnosis showed that the bacteriologically positive patients and the patients with cavitary lesion took a longer time before initiating medical action and before being finally diagnosed as tuberculous. Follow-up observation of patients' course of treatment revealed that 13% of the patients took prescribed medication irregularly or were lost to treatment. A case-control study was performed to determine the relationship between life style and disease risk. The control group was selected to match the patients for age and sex and also roughly with occupation. The risk factors found to be associated with the development of tuberculosis in this study included; family members' present or past history of tuberculosis, working night shift every week, eating at home less than once a day, diet not well balanced, indifference to personal health, lack of knowledge about tuberculosis and not attending 'cram' school. Also, patients were more likely to be taller and slimmer than controls.

  7. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia: results from the 24-month follow-up of the BELA trial

    PubMed Central

    Brümmendorf, Tim H; Cortes, Jorge E; de Souza, Cármino Antonio; Guilhot, Francois; Duvillié, Ladan; Pavlov, Dmitri; Gogat, Karïn; Countouriotis, Athena M; Gambacorti-Passerini, Carlo

    2015-01-01

    Bosutinib is an oral, dual SRC/ABL1 tyrosine kinase inhibitor for resistant/intolerant chronic myeloid leukaemia (CML). We assessed the efficacy and safety of bosutinib 500 mg/d (n = 250) versus imatinib 400 mg/d (n = 252) after >24 months from accrual completion in newly diagnosed chronic phase (CP)-CML (Bosutinib Efficacy and Safety in Newly Diagnosed CML trial [BELA]). Cumulative complete cytogenetic response (CCyR) rates by 24 months were similar (bosutinib, 79%; imatinib, 80%); cumulative major molecular response (MMR) rates were 59% for bosutinib and 49% for imatinib. Responses were durable; 151/197 vs. 172/204 and 125/153 vs. 117/131 responders remained on treatment and maintained CCyR and MMR, respectively. Since the 12-month primary analysis, no new accelerated-/blast-phase transformations occurred with bosutinib; four occurred with imatinib. Early response (BCR-ABL1/ABL1 ≤ 10%, 3 months) was associated with better CCyR and MMR rates by 12 and 24 months (both arms). Gastrointestinal events and liver function test elevations were more common, and neutropenia, musculoskeletal events and oedema were less common with bosutinib. Discontinuations due to adverse events were more common with bosutinib versus imatinib (most commonly alanine aminotransferase elevation: 4% vs. <1%); most occurred within the first 12 months. Cardiovascular adverse events were similar in both arms. Bosutinib continues to demonstrate good efficacy and manageable tolerability in newly diagnosed CP-CML patients. PMID:25196702

  8. Low-Grade Inflammation and Increased Arterial Stiffness in Chinese Youth and Adolescents with Newly-Diagnosed Type 2 Diabetes Mellitus

    PubMed Central

    Li, Xin; Deng, You Ping; Yang, Miao; Wu, Yu-Wen; Sun, Su-Xin; Sun, Jia-Zhong

    2015-01-01

    Objective: To investigate the relationship between low-grade inflammation (LI) and increased arterial stiffness in Chinese youth and adolescents with newly-diagnosed type 2 diabetes mellitus (T2DM). Methods: Ninety-eight subjects aged 10 to 24 years with newly-diagnosed T2DM were investigated for findings of general inflammation. Anthropometric measurements were taken. Data related to arterial stiffness [brachial artery distensibility (Branch D), augmentation index (AIx), carotid-femoral pulse wave velocity (CF-PWV)] were collected. The subjects were divided into a non-LI group (NLI, n=42) and a LI group (n=56) according to their high-sensitivity C-reactive protein (Hs-CRP) levels. Results: There were no significant differences in age and gender between the LI group and the NLI group. CF-PWV and AIx values of the LI group were higher than those of the NLI group (p<0.01), while Branch D values were lower in the LI group (p<0.01). Branch D, CF-PWV, and AIx values correlated significantly with Hs-CRP overall (r=-0.32, 0.34, 0.33, all p<0.01). Multivariate models revealed that in either group (LI or NLI), Hs-CRP, as a continuous variable, was an independent determinant of arterial stiffness parameters even after adjusting for other risk factors. Conclusion: Newly-diagnosed T2DM youth and adolescents with LI present a more adverse cardiovascular disease risk profile and stiffer arteries. Hs-CRP levels correlated with arterial stiffness parameters and constituted an independent determinant of arterial stiffness. PMID:26777037

  9. Phase II trial of hypofractionated intensity-modulated radiation therapy combined with temozolomide and bevacizumab for patients with newly diagnosed glioblastoma.

    PubMed

    Ney, Douglas E; Carlson, Julie A; Damek, Denise M; Gaspar, Laurie E; Kavanagh, Brian D; Kleinschmidt-DeMasters, B K; Waziri, Allen E; Lillehei, Kevin O; Reddy, Krishna; Chen, Changhu

    2015-03-01

    Bevacizumab blocks the effects of VEGF and may allow for more aggressive radiotherapy schedules. We evaluated the efficacy and toxicity of hypofractionated intensity-modulated radiation therapy with concurrent and adjuvant temozolomide and bevacizumab in patients with newly diagnosed glioblastoma. Patients with newly diagnosed glioblastoma were treated with hypofractionated intensity modulated radiation therapy to the surgical cavity and residual tumor with a 1 cm margin (PTV1) to 60 Gy and to the T2 abnormality with a 1 cm margin (PTV2) to 30 Gy in 10 daily fractions over 2 weeks. Concurrent temozolomide (75 mg/m(2) daily) and bevacizumab (10 mg/kg) was administered followed by adjuvant temozolomide (200 mg/m(2)) on a standard 5/28 day cycle and bevacizumab (10 mg/kg) every 2 weeks for 6 months. Thirty newly diagnosed patients were treated on study. Median PTV1 volume was 131.1 cm(3) and the median PTV2 volume was 342.6 cm(3). Six-month progression-free survival (PFS) was 90 %, with median follow-up of 15.9 months. The median PFS was 14.3 months, with a median overall survival (OS) of 16.3 months. Grade 4 hematologic toxicity included neutropenia (10 %) and thrombocytopenia (17 %). Grades 3/4 non-hematologic toxicity included fatigue (13 %), wound dehiscence (7 %) and stroke, pulmonary embolism and nausea each in 1 patient. Presumed radiation necrosis with clinical decline was seen in 50 % of patients, two with autopsy documentation. The study was closed early to accrual due to this finding. This study demonstrated 90 % 6-month PFS and OS comparable to historic data in patients receiving standard treatment. Bevacizumab did not prevent radiation necrosis associated with this hypofractionated radiation regimen and large PTV volumes may have contributed to high rates of presumed radiation necrosis. PMID:25524817

  10. Randomized multicenter phase II study of flavopiridol (alvocidib), cytarabine, and mitoxantrone (FLAM) versus cytarabine/daunorubicin (7+3) in newly diagnosed acute myeloid leukemia

    PubMed Central

    Zeidner, Joshua F.; Foster, Matthew C.; Blackford, Amanda L.; Litzow, Mark R.; Morris, Lawrence E.; Strickland, Stephen A.; Lancet, Jeffrey E.; Bose, Prithviraj; Levy, M. Yair; Tibes, Raoul; Gojo, Ivana; Gocke, Christopher D.; Rosner, Gary L.; Little, Richard F.; Wright, John J.; Doyle, L. Austin; Smith, B. Douglas; Karp, Judith E.

    2015-01-01

    Serial studies have demonstrated that induction therapy with FLAM [flavopiridol (alvocidib) 50 mg/m2 days 1–3, cytarabine 667 mg/m2/day continuous infusion days 6–8, and mitoxantrone (FLAM) 40 mg/m2 day 9] yields complete remission rates of nearly 70% in newly diagnosed poor-risk acute myeloid leukemia. Between May 2011–July 2013, 165 newly diagnosed acute myeloid leukemia patients (age 18–70 years) with intermediate/adverse-risk cytogenetics were randomized 2:1 to receive FLAM or 7+3 (cytarabine 100 mg/m2/day continuous infusion days 1–7 and daunorubicin 90 mg/m2 days 1–3), across 10 institutions. Some patients on 7+3 with residual leukemia on day 14 received 5+2 (cytarabine 100 mg/m2/day continuous infusion days 1–5 and daunorubicin 45 mg/m2 days 1–2), whereas patients on FLAM were not re-treated based on day 14 bone marrow findings. The primary objective was to compare complete remission rates between one cycle of FLAM and one cycle of 7+3. Secondary end points included safety, overall survival and event-free survival. FLAM led to higher complete remission rates than 7+3 alone (70% vs. 46%; P=0.003) without an increase in toxicity, and this improvement persisted after 7+3+/−5+2 (70% vs. 57%; P=0.08). There were no significant differences in overall survival and event-free survival in both arms but post-induction strategies were not standardized. These results substantiate the efficacy of FLAM induction in newly diagnosed AML. A phase III study is currently in development. This study is registered with clinicaltrials.gov identifier: 01349972. PMID:26022709

  11. Randomized multicenter phase II study of flavopiridol (alvocidib), cytarabine, and mitoxantrone (FLAM) versus cytarabine/daunorubicin (7+3) in newly diagnosed acute myeloid leukemia.

    PubMed

    Zeidner, Joshua F; Foster, Matthew C; Blackford, Amanda L; Litzow, Mark R; Morris, Lawrence E; Strickland, Stephen A; Lancet, Jeffrey E; Bose, Prithviraj; Levy, M Yair; Tibes, Raoul; Gojo, Ivana; Gocke, Christopher D; Rosner, Gary L; Little, Richard F; Wright, John J; Doyle, L Austin; Smith, B Douglas; Karp, Judith E

    2015-09-01

    Serial studies have demonstrated that induction therapy with FLAM [flavopiridol (alvocidib) 50 mg/m(2) days 1-3, cytarabine 667 mg/m(2)/day continuous infusion days 6-8, and mitoxantrone (FLAM) 40 mg/m(2) day 9] yields complete remission rates of nearly 70% in newly diagnosed poor-risk acute myeloid leukemia. Between May 2011-July 2013, 165 newly diagnosed acute myeloid leukemia patients (age 18-70 years) with intermediate/adverse-risk cytogenetics were randomized 2:1 to receive FLAM or 7+3 (cytarabine 100 mg/m(2)/day continuous infusion days 1-7 and daunorubicin 90 mg/m(2) days 1-3), across 10 institutions. Some patients on 7+3 with residual leukemia on day 14 received 5+2 (cytarabine 100 mg/m(2)/day continuous infusion days 1-5 and daunorubicin 45 mg/m(2) days 1-2), whereas patients on FLAM were not re-treated based on day 14 bone marrow findings. The primary objective was to compare complete remission rates between one cycle of FLAM and one cycle of 7+3. Secondary end points included safety, overall survival and event-free survival. FLAM led to higher complete remission rates than 7+3 alone (70% vs. 46%; P=0.003) without an increase in toxicity, and this improvement persisted after 7+3+/-5+2 (70% vs. 57%; P=0.08). There were no significant differences in overall survival and event-free survival in both arms but post-induction strategies were not standardized. These results substantiate the efficacy of FLAM induction in newly diagnosed AML. A phase III study is currently in development. This study is registered with clinicaltrials.gov identifier: 01349972.

  12. Influence of BAK-Preserved Prostaglandin Analog Treatment on the Ocular Surface Health in Patients with Newly Diagnosed Primary Open-Angle Glaucoma

    PubMed Central

    Tomić, Martina; Kaštelan, Snježana; Metež Soldo, Kata; Salopek-Rabatić, Jasminka

    2013-01-01

    Purpose. Primary open-angle glaucoma (POAG), a chronic, degenerative optic neuropathy, requires persistent decrease of intraocular pressure so as to prevent visual impairment and blindness. However, long-term use of topical ocular medications may affect ocular surface health. Purpose of this study was to evaluate the influence of BAK-preserved prostaglandin analog treatment on the ocular surface health in patients with newly diagnosed POAG. Methods. 40 newly diagnosed POAG patients were included in this prospective study. Intraocular pressure (IOP), tear break-up time (TBUT), and ocular surface disease index (OSDI) were assessed at baseline and 3-month after starting treatment with BAK-preserved travoprost 0.004%. Results. IOP decreased in all patients from baseline to 3-month final visit (23.80 ± 1.73 mmHg versus 16.78 ± 1.27 mmHg; P < 0.001). Mean TBUT decreased from 11.70 ± 1.86 seconds at baseline to 8.30 ± 1.29 seconds at 3-month final visit (<0.001). Mean OSDI score increased from 31.63 ± 18.48 to 44.41 ± 16.48 (P < 0.001). Conclusions. This study showed that BAK-preserved travoprost 0.004% is an effective medication in newly diagnosed POAG patients, but its long-term use may negatively influence ocular surface health by disrupting the tear film stability. Further studies are needed to better understand the clinical effects of different preservative types and concentrations on the ocular surface. PMID:23971041

  13. A Multicenter, Phase II, Randomized, Noncomparative Clinical Trial of Radiation and Temozolomide with or without Vandetanib in Newly Diagnosed Glioblastoma Patients

    PubMed Central

    Lee, Eudocia Q.; Kaley, Thomas J.; Duda, Dan G.; Schiff, David; Lassman, Andrew B.; Wong, Eric T.; Mikkelsen, Tom; Purow, Benjamin W.; Muzikansky, Alona; Ancukiewicz, Marek; Huse, Jason T.; Ramkissoon, Shakti; Drappatz, Jan; Norden, Andrew D.; Beroukhim, Rameen; Weiss, Stephanie E.; Alexander, Brian M.; McCluskey, Christine S.; Gerard, Mary; Smith, Katrina H.; Jain, Rakesh K.; Batchelor, Tracy T.; Ligon, Keith L.; Wen, Patrick Y.

    2016-01-01

    Purpose Vandetanib, a tyrosine kinase inhibitor of KDR (VEGFR2), EGFR, and RET, may enhance sensitivity to chemotherapy and radiation. We conducted a randomized, noncomparative, phase II study of radiation (RT) and temozolomide with or without vandetanib in patients with newly diagnosed glioblastoma (GBM). Experimental Design We planned to randomize a total of 114 newly diagnosed GBM patients in a ratio of 2:1 to standard RT and temozolomide with (76 patients) or without (38 patients) vandetanib 100 mg daily. Patients with age ≥ 18 years, Karnofsky performance status (KPS) ≥ 60, and not on enzyme-inducing antiepileptics were eligible. Primary end-point was median overall survival (OS) from the date of randomization. Secondary endpoints included median progression-free survival (PFS), 12-month PFS, and safety. Correlative studies included pharmacokinetics as well as tissue and serum biomarker analysis. Results The study was terminated early for futility based on the results of an interim analysis. We enrolled 106 patients (36 in the RT/temozolomide arm and 70 in the vandetanib/RT/temozolomide arm). Median OS was 15.9 months [95% confidence interval (CI), 11.0–22.5 months] in the RT/temozolomide arm and 16.6 months (95% CI, 14.9–20.1 months) in the vandetanib/RT/temozolomide (log-rank P = 0.75). Conclusions The addition of vandetanib at a dose of 100 mg daily to standard chemoradiation in patients with newly diagnosed GBM or gliosarcoma was associated with potential pharmacodynamic biomarker changes and was reasonably well tolerated. However, the regimen did not significantly prolong OS compared with the parallel control arm, leading to early termination of the study. PMID:25910950

  14. Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation

    ClinicalTrials.gov

    2016-10-10

    Acute Myeloid Leukemia With FLT3/ITD Mutation; Acute Myeloid Leukemia With Gene Mutations; FLT3 Tyrosine Kinase Domain Point Mutation; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

  15. An Adult Case of Unicommissural Unicuspid Aortic Valve Diagnosed Based on the Intraoperative Findings.

    PubMed

    Yamanaka, Tetsuo; Fukatsu, Toru; Ichinohe, Yoshimaro; Komatsu, Hirotaka; Seki, Masahiro; Sasaki, Kenichi; Takai, Hideaki; Kunihara, Takashi; Hirata, Yasunobu

    2016-01-01

    We herein report an adult case of unicommissural unicuspid aortic valve (UAV). A 59-year-old man, who was noted to have a cardiac murmur at 31 years of age, was admitted to our hospital due to acute heart failure. Severe calcification in the aortic valve with severe low-flow/low-gradient aortic stenosis and moderate aortic regurgitation was observed and thought to be the cause of heart failure, however, the etiology of aortic valve dysfunction was not clear. Aortic valve replacement was subsequently performed, and unicommissural UAV was diagnosed according to the intraoperative findings. UAV is very rare congenital aortic valve disease which is rarely diagnosed preoperatively.

  16. An Adult Case of Unicommissural Unicuspid Aortic Valve Diagnosed Based on the Intraoperative Findings.

    PubMed

    Yamanaka, Tetsuo; Fukatsu, Toru; Ichinohe, Yoshimaro; Komatsu, Hirotaka; Seki, Masahiro; Sasaki, Kenichi; Takai, Hideaki; Kunihara, Takashi; Hirata, Yasunobu

    2016-01-01

    We herein report an adult case of unicommissural unicuspid aortic valve (UAV). A 59-year-old man, who was noted to have a cardiac murmur at 31 years of age, was admitted to our hospital due to acute heart failure. Severe calcification in the aortic valve with severe low-flow/low-gradient aortic stenosis and moderate aortic regurgitation was observed and thought to be the cause of heart failure, however, the etiology of aortic valve dysfunction was not clear. Aortic valve replacement was subsequently performed, and unicommissural UAV was diagnosed according to the intraoperative findings. UAV is very rare congenital aortic valve disease which is rarely diagnosed preoperatively. PMID:27629961

  17. Assessment of the Relationship between Diagnoses of ASD and Caregiver Symptom Endorsement in Adults Diagnosed with Intellectual Disability

    ERIC Educational Resources Information Center

    Matson, Johnny L.; Hess, Julie A.; Mahan, Sara; Fodstad, Jill C.; Neal, Daniene

    2013-01-01

    Individuals diagnosed with an intellectual disability (ID) share overlapping traits with those diagnosed with both ID and an Autism Spectrum Disorder (ASD). Therefore, the purpose of this study was to determine if caregivers' reports of symptoms of ASD are of value (i.e., when comparing them to clinical diagnoses of ASD) and to determine which…

  18. The Utility of Ambulatory Blood Pressure Monitoring for Diagnosing White Coat Hypertension in Older Adults.

    PubMed

    Reynolds, Kristi; Bowling, C Barrett; Sim, John J; Sridharan, Lakshmi; Harrison, Teresa N; Shimbo, Daichi

    2015-11-01

    The beneficial effect of antihypertensive medication on reducing the risk of cardiovascular disease (CVD) events is supported by data from randomized controlled trials of older adults with hypertension. However, in clinical practice, overtreatment of hypertension in older adults may lead to side effects and an increased risk of falls. The diagnosis and treatment of hypertension is primarily based on blood pressure measurements obtained in the clinic setting. Ambulatory blood pressure monitoring (ABPM) complements clinic blood pressure by measuring blood pressure in the out-of-clinic setting. ABPM can be used to identify white coat hypertension, defined as elevated clinic blood pressure and non-elevated ambulatory blood pressure. White coat hypertension is common in older adults but does not appear to be associated with an increased risk of CVD events among this population. Herein, we review the current literature on ABPM in the diagnoses of white coat hypertension in older adults, including its potential role in preventing overtreatment.

  19. The Utility of Ambulatory Blood Pressure Monitoring for Diagnosing White Coat Hypertension in Older Adults.

    PubMed

    Reynolds, Kristi; Bowling, C Barrett; Sim, John J; Sridharan, Lakshmi; Harrison, Teresa N; Shimbo, Daichi

    2015-11-01

    The beneficial effect of antihypertensive medication on reducing the risk of cardiovascular disease (CVD) events is supported by data from randomized controlled trials of older adults with hypertension. However, in clinical practice, overtreatment of hypertension in older adults may lead to side effects and an increased risk of falls. The diagnosis and treatment of hypertension is primarily based on blood pressure measurements obtained in the clinic setting. Ambulatory blood pressure monitoring (ABPM) complements clinic blood pressure by measuring blood pressure in the out-of-clinic setting. ABPM can be used to identify white coat hypertension, defined as elevated clinic blood pressure and non-elevated ambulatory blood pressure. White coat hypertension is common in older adults but does not appear to be associated with an increased risk of CVD events among this population. Herein, we review the current literature on ABPM in the diagnoses of white coat hypertension in older adults, including its potential role in preventing overtreatment. PMID:26400076

  20. Estimating The Health And Economic Burden Of Cancer Among Those Diagnosed As Adolescents And Young Adults

    PubMed Central

    Guy, Gery P.; Yabroff, K. Robin; Ekwueme, Donatus U.; Smith, Ashley Wilder; Dowling, Emily C.; Rechis, Ruth; Nutt, Stephanie; Richardson, Lisa C.

    2015-01-01

    Adolescent and young adult cancer survivors—those who were ages 15–39 at their first cancer diagnosis—have important health limitations. These survivors are at risk for higher health care expenditures and lost productivity, compared to adults without a history of cancer. Using Medical Expenditure Panel Survey data, we present nationally representative estimates of the economic burden among people who were diagnosed with cancer in adolescence or young adulthood. Our findings demonstrate that surviving cancer at this age is associated with a substantial economic burden. Compared to adults without a history of cancer, adolescent and young adult cancer survivors had excess annual medical expenditures of $3,170 per person and excess annual productivity losses of $2,250 per person. Multifaceted prevention strategies, including education and sustained intervention programs to ensure access to lifelong risk-based follow-up care, may be effective ways to improve the economic outcomes associated with cancer survivorship in this population. PMID:24889952

  1. Normal for an Asperger: notions of the meanings of diagnoses among adults with Asperger syndrome.

    PubMed

    Bertilsdotter Rosqvist, Hanna

    2012-04-01

    This study explores the production of a counterhegemonic discourse of "autistic normalcy" among adults with high-functioning autism by analyzing notions of diagnosis. The discourse analyses are based on material from ethnographic fieldwork in a Swedish educational setting. Study participants were 3 male and 9 female adults who had been diagnosed with Asperger syndrome. The notion of diagnosis comprises issues concerning coming out and knowledge production. The findings capture an ongoing reformulation process among people involved in the autistic self-advocacy movement when it comes to the meanings of Asperger syndrome and what it means to be a person with Asperger syndrome.

  2. Newly diagnosed hyperthyroidism in the 25th gestational week of pregnancy presenting with systolic arterial hypertension only.

    PubMed

    Zaveljcina, Janez; Legan, Mateja; Gaberšček, Simona

    2016-05-01

    We present a case of a 30-year-old woman diagnosed with arterial hypertension in the 25th week of pregnancy. Our search for secondary causes of arterial hypertension revealed hyperthyroid Hashimoto's thyroiditis (HT), which was treated with propilthiouracil. Three weeks after delivery, she was normotensive without medication. In the next four months, she developed hypothyroidism and treatment with L-thyroxine was started. In conclusion, in the second half of pregnancy, a hyperthyroid HT can occur - in spite of the well-known amelioration of autoimmune thyroid disorders in that period, and can be the only cause of arterial hypertension. PMID:26979941

  3. Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial

    PubMed Central

    Merz, Maximilian; Salwender, Hans; Haenel, Mathias; Mai, Elias K.; Bertsch, Uta; Kunz, Christina; Hielscher, Thomas; Blau, Igor W.; Scheid, Christof; Hose, Dirk; Seckinger, Anja; Jauch, Anna; Hillengass, Jens; Raab, Marc S.; Schurich, Baerbel; Munder, Markus; Schmidt-Wolf, Ingo G.H.; Gerecke, Christian; Lindemann, Hans-Walter; Zeis, Matthias; Weisel, Katja; Duerig, Jan; Goldschmidt, Hartmut

    2015-01-01

    We investigated the impact of subcutaneous versus intravenous bortezomib in the MM5 trial of the German-Speaking Myeloma Multicenter Group which compared bortezomib, doxorubicin, and dexamethasone with bortezomib, cyclophosphamide, and dexamethasone induction therapy in newly diagnosed multiple myeloma. Based on data from relapsed myeloma, the route of administration for bortezomib was changed from intravenous to subcutaneous after 314 of 604 patients had been enrolled. We analyzed 598 patients who received at least one dose of trial medication. Adverse events were reported more frequently in patients treated with intravenous bortezomib (intravenous=65%; subcutaneous=56%, P=0.02). Rates of grade 2 or more peripheral neuropathy were higher in patients treated with intravenous bortezomib during the third cycle (intravenous=8%; subcutaneous=2%, P=0.001). Overall response rates were similar in patients treated intravenously or subcutaneously. The presence of International Staging System stage III disease, renal impairment or adverse cytogenetic abnormalities did not have a negative impact on overall response rates in either group. To our knowledge this is the largest study to present data comparing subcutaneous with intravenous bortezomib in newly diagnosed myeloma. We show better tolerance and similar overall response rates for subcutaneous compared to intravenous bortezomib. The clinical trial is registered at eudract.ema.europa.eu as n. 2010-019173-16. PMID:25840597

  4. A Phase II trial of weekly bortezomib and dexamethasone in veterans with newly diagnosed multiple myeloma not eligible for or who deferred autologous stem cell transplantation.

    PubMed

    Girnius, Saulius K; Lee, Saem; Kambhampati, Suman; Rose, Michal G; Mohiuddin, Abid; Houranieh, Antoun; Zimelman, Abraham; Grady, Terrence; Mehta, Paulette; Behler, Caroline; Hayes, Teresa G; Efebera, Yvonne A; Prabhala, Rao H; Han, Andrew; Yellapragada, Sarvari V; Klein, Catherine E; Roodman, Garson D; Lichtenstein, Alan; Munshi, Nikhil C

    2015-04-01

    Once-weekly administration of bortezomib has reduced bortezomib-induced peripheral neuropathy without affecting response rates, but this has only been demonstrated prospectively in three- and four- drug combinations. We report a phase II trial of alternate dosing and schedule of bortezomib and dexamethasone in newly diagnosed multiple myeloma patients who are not eligible for or refused autologous stem cell transplantation. Bortezomib 1·6 mg/m(2) intravenously was given once-weekly for six cycles, together with dexamethasone 40 mg on the day of and day after bortezomib. Fifty patients were enrolled; 58% did not require any dose modification. The majority of patients had multiple co-morbidities, including cardiovascular (76%) and renal insufficiency (54%), and the median number of medications prior to enrollment was 13. Of all evaluable patients, the overall response rate was 79% and at least 45% had at least a very good partial response. The median time to first response was 1·3 months (range, 0·25-2·4 months). The progression-free and overall survivals were 8 months and 46·5 months, respectively. Twenty-four percent developed worsening neuropathy. We conclude that alternate dosing and scheduling of bortezomib and dexamethasone is both safe and effective for management of newly diagnosed multiple myeloma in frail patients. (ClinicalTrials.gov number, NCT01090921).

  5. Long-term efficacy and safety of all-trans retinoic acid/arsenic trioxide-based therapy in newly diagnosed acute promyelocytic leukemia.

    PubMed

    Hu, Jiong; Liu, Yuan-Fang; Wu, Chuan-Feng; Xu, Fang; Shen, Zhi-Xiang; Zhu, Yong-Mei; Li, Jun-Min; Tang, Wei; Zhao, Wei-Li; Wu, Wen; Sun, Hui-Ping; Chen, Qiu-Sheng; Chen, Bing; Zhou, Guang-Biao; Zelent, Arthur; Waxman, Samuel; Wang, Zhen-Yi; Chen, Sai-Juan; Chen, Zhu

    2009-03-01

    All-trans retinoic acid (ATRA)/arsenic trioxide (ATO) combination-based therapy has benefitted newly diagnosed acute promyelocytic leukemia (APL) in short-term studies, but the long-term efficacy and safety remained unclear. From April 2001, we have followed 85 patients administrated ATRA/ATO with a median follow-up of 70 months. Eighty patients (94.1%) entered complete remission (CR). Kaplan-Meier estimates of the 5-year event-free survival (EFS) and overall survival (OS) for all patients were 89.2% +/- 3.4% and 91.7% +/- 3.0%, respectively, and the 5-year relapse-free survival (RFS) and OS for patients who achieved CR (n = 80) were 94.8% +/- 2.5% and 97.4% +/- 1.8%, respectively. Upon ATRA/ATO, prognosis was not influenced by initial white blood cell count, distinct PML-RARalpha types, or FLT3 mutations. The toxicity profile was mild and reversible. No secondary carcinoma was observed, and 24 months after the last dose of ATRA/ATO, patients had urine arsenic concentrations well below the safety limit. These results demonstrate the high efficacy and minimal toxicity of ATRA/ATO treatment for newly diagnosed APL in long-term follow-up, suggesting a potential frontline therapy for de novo APL.

  6. L-asparaginase-based regimen as a first-line treatment for newly diagnosed nasal type extranodal natural killer cell/T-cell lymphoma

    PubMed Central

    BU, SHANSHAN; YUAN, FANGFANG; WEI, XUDONG; YIN, QINGSONG; LI, YUFU; MI, RUIHUA; YANG, HAIPING; LI, HONGYI; GE, SHOUBEI; LIU, YANYAN; SONG, YONGPING

    2016-01-01

    The aim of the present study was to compare the efficacy of an L-asparaginase-based regimen and a CHOP regimen followed by radiotherapy as first-line treatments for newly diagnosed nasal type extranodal natural killer cell/T-cell lymphoma (ENKTL). A total of 69 patients received the CHOP regimen as the first-line treatment and 112 patients received the L-asparaginase-based regimen. All patients received radical radiotherapy following two cycles of chemotherapy. The overall response rates of the L-asparaginase-based and CHOP treatment groups were 90.18 and 72.46%, respectively (P=0.002). The one, two, and five-year overall survival (OS) rates and progression-free survival (PFS) rates of the L-asparaginase group were 96.0, 88.3, 65.1, 94.2, 79.8 and 50.0%, respectively. The one, two, and five-year OS and PFS rates of the CHOP group were 82.6, 61.9, 25.8, 63.8, 44.0 and 21.0%, respectively (P<0.001). Compared with CHOP treatment, L-asparaginase-based chemotherapy combined with radiotherapy was a safe and highly effective treatment for newly diagnosed ENKTL. PMID:27313673

  7. Validation of the Effectiveness and Safety of Temozolomide during and after Radiotherapy for Newly Diagnosed Glioblastomas: 10-year Experience of a Single Institution

    PubMed Central

    Joo, Jin-Deok; Kim, Hansol; Kim, Young-Hoon; Han, Jung Ho

    2015-01-01

    This study was performed to validate the effectiveness and safety of concurrent chemoradiotherapy and adjuvant therapy with temozolomide for newly diagnosed glioblastoma multiforme as a standard treatment protocol. Between 2004 and 2011, patients newly diagnosed with glioblastoma who were treated with temozolomide during concurrent chemoradiotherapy and adjuvant chemotherapy were included from a single institution and analyzed retrospectively. The primary endpoint was overall survival, and the secondary endpoints were progression-free survival, response, and safety. A total of 71 patients were enrolled in this study. The response rate was 41% (29/71), and the tumor control rate was 80% (57/71). In the 67 patients who completed the concurrent chemoradiotherapy with temozolomide, the median overall survival was 19 months and the 1- and 2-yr overall survival rates were 78.3% and 41.7%, respectively. The median progression free survival was 9 months, and the 1- and 2-yr progression free survival rates were 33.8% and 14.3%, respectively. The mean duration of survival after progression of disease in salvage treatment group was 11.9 (1.3-53.2) months. Concurrent chemoradiotherapy with temozolomide resulted in grade 3 or 4 hematologic toxic effects in 2.8% of the patients. The current protocol of temozolomide during and after radiation therapy is both effective and safe and is still appropriate as the standard protocol for treatment of glioblastoma. An active salvage treatment might be required for a better prognosis. PMID:26539003

  8. Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial.

    PubMed

    Merz, Maximilian; Salwender, Hans; Haenel, Mathias; Mai, Elias K; Bertsch, Uta; Kunz, Christina; Hielscher, Thomas; Blau, Igor W; Scheid, Christof; Hose, Dirk; Seckinger, Anja; Jauch, Anna; Hillengass, Jens; Raab, Marc S; Schurich, Baerbel; Munder, Markus; Schmidt-Wolf, Ingo G H; Gerecke, Christian; Lindemann, Hans-Walter; Zeis, Matthias; Weisel, Katja; Duerig, Jan; Goldschmidt, Hartmut

    2015-07-01

    We investigated the impact of subcutaneous versus intravenous bortezomib in the MM5 trial of the German-Speaking Myeloma Multicenter Group which compared bortezomib, doxorubicin, and dexamethasone with bortezomib, cyclophosphamide, and dexamethasone induction therapy in newly diagnosed multiple myeloma. Based on data from relapsed myeloma, the route of administration for bortezomib was changed from intravenous to subcutaneous after 314 of 604 patients had been enrolled. We analyzed 598 patients who received at least one dose of trial medication. Adverse events were reported more frequently in patients treated with intravenous bortezomib (intravenous=65%; subcutaneous=56%, P=0.02). Rates of grade 2 or more peripheral neuropathy were higher in patients treated with intravenous bortezomib during the third cycle (intravenous=8%; subcutaneous=2%, P=0.001). Overall response rates were similar in patients treated intravenously or subcutaneously. The presence of International Staging System stage III disease, renal impairment or adverse cytogenetic abnormalities did not have a negative impact on overall response rates in either group. To our knowledge this is the largest study to present data comparing subcutaneous with intravenous bortezomib in newly diagnosed myeloma. We show better tolerance and similar overall response rates for subcutaneous compared to intravenous bortezomib. The clinical trial is registered at eudract.ema.europa.eu as n. 2010-019173-16.

  9. An open-label phase I/II study of cyclophosphamide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone in newly diagnosed myeloma.

    PubMed

    Nishihori, Taiga; Baz, Rachid; Shain, Kenneth; Kim, Jongphil; Ochoa-Bayona, Jose L; Yue, Binglin; Sullivan, Daniel; Dalton, William; Alsina, Melissa

    2015-11-01

    We conducted a phase 1/2 trial evaluating the combination of cyclophosphamide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone (CVDD) for newly diagnosed multiple myeloma (MM). The primary objective of the phase 1 was to evaluate the safety and tolerability of maximum planned dose (MPD) and the phase 2 was to assess the overall response rate. Patients received 6-8 cycles of CVDD at four dose levels. There were no dose-limiting toxicities. The MPD was cyclophosphamide 750 mg/m(2) IV on day 1, bortezomib 1.3 mg/m(2) IV on days 1, 4, 8, 11, pegylated liposomal doxorubicin 30 mg/m(2) IV on day 4, and dexamethasone 20 mg orally on the day of and after bortezomib (21-d cycle). Forty-nine patients were treated at the MPD of which 22% had high-risk myeloma. The most common grade ≥3 toxicities included myelosuppression, infection, and fatigue. Overall response and complete response rates were 91% and 26% in standard-risk, and 100% and 58% in high-risk cohort, respectively. After a median follow-up of 34 months, the median progression-free survival was 31.3 months. The 2-yr overall survival was 91.1% in the standard-risk and 88.9% in the high-risk cohort, respectively. CVDD regimen was well tolerated and was highly active in newly diagnosed MM.

  10. The Influence of Health Literacy on Information Needs Among Women Newly Diagnosed With Breast Cancer, With Special Reference to Employment Status.

    PubMed

    Schmidt, Anna; Kowalski, Christoph; Pfaff, Holger; Wesselmann, Simone; Wirtz, Markus; Ernstmann, Nicole

    2015-01-01

    Breast cancer is the most frequent type of malignancy among women throughout Germany. The present analysis aimed to identify information needs and aspects of health literacy in women of working age newly diagnosed with breast cancer. PIAT is a prospective multicenter cohort study in which patients were asked about their information needs at 3 assessment points: postoperatively, after 10 weeks, and after 40 weeks. The present analysis includes data from 1,344 female patients after the first assessment point. In addition to descriptive analyses, logistic regression analyses were calculated. Results of the study show that, in addition to sociodemographic characteristics, the level of health literacy and the employment status of the women who responded to the inquiry influence specific unmet information needs. Most frequently mentioned unmet information needs relate to supplementary naturopathy, nutrition, health-promoting measures, and working during breast cancer. Patients with breast cancer are often provided with large amounts of information during their hospital stay indicating this information is not targeted to patient needs and may be overwhelming. The results show that information on everyday life needs such as supplementary naturopathy were important for the sample newly diagnosed with breast cancer. Employed women in particular have questions regarding working during cancer or tax relief.

  11. Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma

    ClinicalTrials.gov

    2016-10-10

    Adult Anaplastic Astrocytoma; Adult Anaplastic Ependymoma; Adult Anaplastic Oligodendroglioma; Adult Brain Stem Glioma; Adult Diffuse Astrocytoma; Adult Ependymoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Mixed Glioma; Adult Myxopapillary Ependymoma; Adult Oligodendroglioma; Adult Pilocytic Astrocytoma; Adult Pineal Gland Astrocytoma; Adult Subependymal Giant Cell Astrocytoma; Adult Subependymoma

  12. Hospital Resource Utilization for Common Noncardiac Diagnoses in Adult Survivors of Single Cardiac Ventricle.

    PubMed

    Seckeler, Michael D; Moe, Tabitha G; Thomas, Ian D; Meziab, Omar; Andrews, Jennifer; Heller, Elissa; Klewer, Scott E

    2015-12-01

    Single ventricle congenital heart disease (SV CHD) has transformed from a nearly universally fatal condition to a chronic illness. As the number of adults living with SV CHD continues to increase, there needs to be an understanding of health care resource utilization (HCRU), particularly for noncardiac conditions, for this patient population. We performed a retrospective database review of the University HealthSystem Consortium Clinical Database/Resource Manager for adult patients with SV CHD hospitalized for noncardiac conditions from January 2011 to November 2014. Patients with SV CHD were identified using International Classification of Disease (ICD)-9 codes associated with SV CHD (hypoplastic left heart, tricuspid atresia, and SV) and stratified into 2 groups by age (18 to 29 years and 30 to 40 years). Direct cost, length of stay (LOS), intensive care unit (ICU) admission rate and mortality data were compared with age-matched patients without CHD. There were 2,083,651 non-CHD and 590 SV CHD admissions in Group 1 and 2,131,046 non-CHD and 297 SV CHD admissions in Group 2. There was no difference in LOS in Group 1, but there were higher costs for several diagnoses. LOS and costs were higher for several diagnoses in Group 2. ICU admission rate and in-hospital mortality were higher for several diagnoses for patients with SV CHD in both groups. In conclusion, adults with SV CHD admitted for noncardiac diagnoses have higher HCRU (longer LOS and higher ICU admission rates) compared with similarly aged patients without CHD. These findings stress the importance of good primary care in this population with complex, chronic cardiac disease to prevent hospitalizations and higher HCRU. PMID:26455384

  13. Sitagliptin/Metformin Versus Insulin Glargine Combined With Metformin in Obese Subjects With Newly Diagnosed Type 2 Diabetes

    PubMed Central

    Ji, Ming; Xia, Libin; Cao, Jingzhu; Zou, Dajin

    2016-01-01

    Abstract To compare the therapeutic effects of different regimens in Chinese obese type 2 diabetic mellitus (T2DM) patients. From October 2013 to July 2014, a total of 166 T2DM outpatients who attended the Shanghai Changhai Hospital and the Yijishan Hospital of Wannan Medical College were randomly assigned into an experimental sitagliptin/metformin combined with low caloric diet group (n = 115) and an insulin glargine combined with metformin control group (n = 51). Inclusion criteria were body mass index (BMI) ≥ 25 kg/m2 and diagnosed with T2DM with glycosylated hemoglobin (glycated hemoglobin A1C [HbA1c]) >9%. Main outcome parameters were fasting plasma glucose, postprandial plasma glucose, BMI, HbA1c, fasting C-peptide, 2-h postprandial C-peptide, triglyceride (TG), total cholesterol (TC), high-density cholesterol (HDL-C), and low-density cholesterol (LDL-C), which were determined by the 75 g steamed-bun meal tolerance test before and 4, 8, 12, and 24 weeks after the treatment started. Treatment costs and life quality were also assessed. BMI, HbA1C, TG, TC, and LDL were significantly more reduced (P < 0.000) and HbA1c significantly better improved in the experimental group than in the control group (<6.5% in 24 [20.87%] vs 2 [3.92%], P < 0.001; <7% in 65 [56.52%] vs 12 [23.53%], P < 0.001). Quality of life scores in the experimental group increased more than in the control group (P < 0.001). The costs for the experimental group medication were less than for other regimens. For obese T2DM patients diagnosed with a glycosylated hemoglobin level >9%, oral sitagliptin/metformin combined with a low caloric diet effectively and economically maintained glycemic control and significantly improved life quality. PMID:26986104

  14. Sitagliptin/Metformin Versus Insulin Glargine Combined With Metformin in Obese Subjects With Newly Diagnosed Type 2 Diabetes.

    PubMed

    Ji, Ming; Xia, Libin; Cao, Jingzhu; Zou, Dajin

    2016-03-01

    To compare the therapeutic effects of different regimens in Chinese obese type 2 diabetic mellitus (T2DM) patients. From October 2013 to July 2014, a total of 166 T2DM outpatients who attended the Shanghai Changhai Hospital and the Yijishan Hospital of Wannan Medical College were randomly assigned into an experimental sitagliptin/metformin combined with low caloric diet group (n = 115) and an insulin glargine combined with metformin control group (n = 51). Inclusion criteria were body mass index (BMI) ≥ 25 kg/m and diagnosed with T2DM with glycosylated hemoglobin (glycated hemoglobin A1C [HbA1c]) >9%. Main outcome parameters were fasting plasma glucose, postprandial plasma glucose, BMI, HbA1c, fasting C-peptide, 2-h postprandial C-peptide, triglyceride (TG), total cholesterol (TC), high-density cholesterol (HDL-C), and low-density cholesterol (LDL-C), which were determined by the 75 g steamed-bun meal tolerance test before and 4, 8, 12, and 24 weeks after the treatment started. Treatment costs and life quality were also assessed. BMI, HbA1C, TG, TC, and LDL were significantly more reduced (P < 0.000) and HbA1c significantly better improved in the experimental group than in the control group (<6.5% in 24 [20.87%] vs 2 [3.92%], P < 0.001; <7% in 65 [56.52%] vs 12 [23.53%], P < 0.001). Quality of life scores in the experimental group increased more than in the control group (P < 0.001). The costs for the experimental group medication were less than for other regimens. For obese T2DM patients diagnosed with a glycosylated hemoglobin level >9%, oral sitagliptin/metformin combined with a low caloric diet effectively and economically maintained glycemic control and significantly improved life quality.

  15. Sitagliptin/Metformin Versus Insulin Glargine Combined With Metformin in Obese Subjects With Newly Diagnosed Type 2 Diabetes.

    PubMed

    Ji, Ming; Xia, Libin; Cao, Jingzhu; Zou, Dajin

    2016-03-01

    To compare the therapeutic effects of different regimens in Chinese obese type 2 diabetic mellitus (T2DM) patients. From October 2013 to July 2014, a total of 166 T2DM outpatients who attended the Shanghai Changhai Hospital and the Yijishan Hospital of Wannan Medical College were randomly assigned into an experimental sitagliptin/metformin combined with low caloric diet group (n = 115) and an insulin glargine combined with metformin control group (n = 51). Inclusion criteria were body mass index (BMI) ≥ 25 kg/m and diagnosed with T2DM with glycosylated hemoglobin (glycated hemoglobin A1C [HbA1c]) >9%. Main outcome parameters were fasting plasma glucose, postprandial plasma glucose, BMI, HbA1c, fasting C-peptide, 2-h postprandial C-peptide, triglyceride (TG), total cholesterol (TC), high-density cholesterol (HDL-C), and low-density cholesterol (LDL-C), which were determined by the 75 g steamed-bun meal tolerance test before and 4, 8, 12, and 24 weeks after the treatment started. Treatment costs and life quality were also assessed. BMI, HbA1C, TG, TC, and LDL were significantly more reduced (P < 0.000) and HbA1c significantly better improved in the experimental group than in the control group (<6.5% in 24 [20.87%] vs 2 [3.92%], P < 0.001; <7% in 65 [56.52%] vs 12 [23.53%], P < 0.001). Quality of life scores in the experimental group increased more than in the control group (P < 0.001). The costs for the experimental group medication were less than for other regimens. For obese T2DM patients diagnosed with a glycosylated hemoglobin level >9%, oral sitagliptin/metformin combined with a low caloric diet effectively and economically maintained glycemic control and significantly improved life quality. PMID:26986104

  16. Prevalence of metabolic syndrome among patients with major depressive disorder--differences between newly diagnosed first episode and recurrent disease.

    PubMed

    Ljubicic, Rudolf; Jakovac, Hrvoje; Bistrović, Ivana Ljubicić; Franceski, Tanja; Mufić, Ana Kovak; Karlović, Dalibor

    2013-12-01

    The objective of the present study was to assess differences in prevalence of the metabolic syndrome among depressed patients in regard to the duration of the illness (first episode versus recurrent episodes). A total of 190 patients suffering from major depressive disorder were included in the study, diagnosed according to International classification of disorders, 10th revision. The same criteria were used to divide participants into two groups: first episode major depressive disorder and major depressive disorder with recurrent episodes. The metabolic syndrome was defined according to the criteria of the American National Cholesterol Education Program-Treatment Panel III. Results showed that metabolic syndrome is significantly more prevalent in patients with recurrent major depressive disorder (45.2%) compared to patients with first episode of major depressive disorder (27.3%), mainly due to differences in plasma glucose, triglycerides and HDL-cholesterol levels. These findings indicate the importance of the duration of depression and the number of recurring episodes as factors involved in etiopathogenesis of the associated metabolic syndrome.

  17. Pediatric Phase II Trials of Poly-ICLC in the Management of Newly Diagnosed and Recurrent Brain Tumors

    PubMed Central

    Hartman, Lisa L.R.; Crawford, John R.; Makale, Milan T.; Milburn, Mehrzad; Joshi, Shweta; Salazar, Andres M.; Hasenauer, Beth; VandenBerg, Scott R.; MacDonald, Tobey J.; Durden, Donald L.

    2015-01-01

    Summary Brain tumors are the most common solid tumor diagnosed in childhood that account for significant morbidity and mortality. New therapies are urgently needed; hence, we conducted the first ever prospective open-label phase II trials of the biological response modifier, poly-ICLC, in children with brain tumors. Poly-ICLC is a synthetic double-stranded RNA that has direct antiviral, antineoplastic, and immune adjuvant effects. A total of 47 children representing a variety of brain tumor histopathologic subtypes were treated with poly-ICLC. On the basis of the results of the initial phase II trial, an expanded prospective phase II trial in low-grade glioma (LGG) has been initiated. MRI was used to acquire volume-based measures of tumor response. No dose-limiting toxicities have been observed. In the initial study 3 of 12 subjects with progressive high-grade gliomas (HGGs) responded, and 2 of 4 children with progressive LGG experienced stable disease for 18 to 24 months. In the follow-up LGG phase II study, 2 of 5 LGG patients were stable over 18 months, with 1 stable for 6 months. Overall 5 of 10 LGG patients have responded. On the basis of low toxicity and the promising LGG response, poly-ICLC may be effective for childhood LGG, and the results justify biomarker studies for personalization of poly-ICLC as a single agent or adjuvant. PMID:24309609

  18. Utility of a partner communication scale and a personal meaning scale in newly diagnosed HIV-infected persons.

    PubMed

    Buscher, April; Latini, David M; Hartman, Christine; Kallen, Michael; Sansgiry, Shubhada; Giordano, Thomas P

    2013-01-01

    No studies to our knowledge have examined the Lepore Social Constraint Scale or Fife Constructed Meaning Scale in recently diagnosed HIV-infected persons. Twenty-four participants in a prospective observational cohort completed the social-constraint measure, and 47 completed the constructed-meaning scale at either 3 or 9 months after diagnosis. Participants completed a 4-week visual analogue scale to assess adherence to antiretroviral therapy, and validated depression and self-efficacy scales. Spearman correlation coefficients compared measures. In cross-sectional analyses, participants with higher social-constraint scores had lower constructed meaning and adherence. Higher social constraint correlated negatively with self-efficacy and positively with depression. Higher constructed-meaning scores did not correlate with adherence but correlated positively with self-efficacy and negatively with depression. The quality of HIV-infected individuals' discussions of HIV with their partners and positive constructed meaning were associated with better mental health and could be targets for improving medication adherence.

  19. A comparison of the information needs of women newly diagnosed with breast cancer in Malaysia and the United kingdom.

    PubMed

    Gopal, Raja Lexshimi Raja; Beaver, Kinta; Barnett, Tony; Ismail, Nik Safiah Nik

    2005-01-01

    Little is known about the information needs of women with breast cancer in non-Western societies. This study examined the priority information needs of 100 women with breast cancer in Malaysia and compared the findings to previous work involving 150 women diagnosed with breast cancer in the United Kingdom. The study used a valid and reliable measure, the Information Needs Questionnaire (INQ). The INQ contained 9 items of information related to physical, psychological, and social care, used successfully in Canada and the United Kingdom. The INQ was shown to have cross-cultural relevance and sensitivity. For Malaysian women, information about likelihood of cure, sexual attractiveness, and spread of disease were the most important information needs. For UK women, similar priorities were evident, apart from the item on sexual attractiveness, which was ranked much lower by women in the United Kingdom. The cultural similarities and differences that emerged from this study have implications for nurses in the cancer field caring for people from a diversity of cultural backgrounds. Breast care nurses are not a feature of the Malaysian healthcare system, although the findings from this study support the view that specialist nurses have a vital role to play in meeting the psychosocial needs of women with breast cancer in non-Western societies.

  20. A prospective phase II study of L-asparaginase- CHOP plus radiation in newly diagnosed extranodal NK/T-cell lymphoma, nasal type

    PubMed Central

    2013-01-01

    Purpose To explore the efficacy and safety of L-asparaginase in newly-diagnosed extranodal nature killer (NK)/T –cell lymphoma (ENKTL), we conducted a prospective phase II study of L-asparaginase, cyclophosphamide, vincristine, doxorubicin and dexamethasone (CHOP-L) regimen in combination with radiotherapy. Patients and methods Patients with newly diagnosed ENKTL and an ECOG performance status of 0 to 2 were eligible for enrollment. Treatment included 6–8 cycles of CHOP-L (cyclophosphamide, 750 mg/m2 day 1; vincristine, 1.4 mg/m2 day 1 (maximal dose 2 mg), doxorubicin 50 mg/m2 day 1; dexamethasone 10 mg days 1–8; L-asparaginase 6000 u/m2 days 2–8). Radiotherapy was scheduled after 4–6 cycles of CHOP-L regimen, depending on stage and primary anatomic site. The primary endpoint was complete response (CR) rate. Results A total of 38 eligible patients were enrolled. The median age was 40.5 years (range, 15 to 71 years). Their clinical characteristics were male to female ratio, 24:14; Ann Arbor stage I, 20; II, 11; III, 3; IV, 4. CR and overall response rates were 81.6% (95% CI, 69.3% to 93.9%) and 84.2%, respectively. With a median follow-up of 25 months, the 2-year overall survival, progression-free survival and disease-free survival rates were 80.1% (95%CI, 73.3% to 86.9%), 81% (95%CI, 74.5% to 87.5%) and 93.6% (95%CI, 89.3% to 97.9%), respectively. The major adverse events were myelosuppression, liver dysfunction, and digestive tract toxicities. Grade 3 to 4 leukopenia and neutropenia were 76.3% and 84.2%, respectively. No treatment-related death was observed. Conclusion CHOP-L chemotherapy in combination with radiotherapy is a safe and highly effective treatment for newly diagnosed ENKTL. PMID:23816178

  1. Cellular HIV type 1 DNA levels are equivalent among drug-sensitive and drug-resistant strains in newly diagnosed and antiretroviral naive patients.

    PubMed

    Antoniadou, Zoi-Anna; Hezka, Johana; Kousiappa, Ioanna; Mamais, Ioannis; Skoura, Lemonia; Pilalas, Dimitris; Metallidis, Simeon; Nicolaidis, Pavlos; Malisiovas, Nicolaos; Kostrikis, Leondios G

    2014-03-01

    The emergence of resistance against current antiretroviral drugs to human immunodeficiency virus type 1 (HIV-1) is an increasingly important concern to the continuous success of antiretroviral therapy to HIV-1-infected patients. In the past decade, a number of studies reported that the prevalence of transmitted drug resistance among newly diagnosed patients has reached an overall 9% prevalence worldwide. Also, a number of studies using longitudinal HIV-1 patient study cohorts demonstrated that the cellular HIV-1 DNA level in peripheral blood mononuclear cells (PBMCs) has a prognostic value for the progression of HIV-1 disease independently of plasma HIV-1 RNA load and CD4 count. Using a previously established molecular-beacon-based real-time PCR methodology, cellular HIV-1 DNA levels were quantified in newly diagnosed and antiretroviral-naive patients in Northern Greece recruited between 2009 and 2010 using a predefined enrolling strategy, in an effort to investigate whether there is any relationship between cellular HIV-1 DNA levels and HIV-1 transmitted drug resistance. As part of the same study, DNA sequences encoding the env (C2-C5 region of gp120) were also amplified from PBMC-extracted DNA in order to determine the genotypic coreceptor tropism and genetic subtype. Cellular HIV-1 DNA levels had a median of 3.309 log10 HIV-1 copies per 10(6) PBMCs and demonstrated no correlation between cellular HIV-1 DNA levels and HIV-1 transmitted drug resistance. An absence of association between cellular HIV-1 DNA levels with plasma viral HIV-1 RNA load and CD4 levels was also found reconfirming the previously published study. Genotypic analysis of coreceptor tropism indicated that 96% of samples, independently of the presence or not of genotypic drug resistance, were CCR5-tropic. Overall, the findings reconfirmed the previously proposed proposition that transmitted drug resistance does not have an impact on disease progression in HIV-1-infected individuals. Also, CCR5

  2. A combination of TERT promoter mutation and MGMT methylation status predicts clinically relevant subgroups of newly diagnosed glioblastomas.

    PubMed

    Arita, Hideyuki; Yamasaki, Kai; Matsushita, Yuko; Nakamura, Taishi; Shimokawa, Asanao; Takami, Hirokazu; Tanaka, Shota; Mukasa, Akitake; Shirahata, Mitsuaki; Shimizu, Saki; Suzuki, Kaori; Saito, Kuniaki; Kobayashi, Keiichi; Higuchi, Fumi; Uzuka, Takeo; Otani, Ryohei; Tamura, Kaoru; Sumita, Kazutaka; Ohno, Makoto; Miyakita, Yasuji; Kagawa, Naoki; Hashimoto, Naoya; Hatae, Ryusuke; Yoshimoto, Koji; Shinojima, Naoki; Nakamura, Hideo; Kanemura, Yonehiro; Okita, Yoshiko; Kinoshita, Manabu; Ishibashi, Kenichi; Shofuda, Tomoko; Kodama, Yoshinori; Mori, Kanji; Tomogane, Yusuke; Fukai, Junya; Fujita, Koji; Terakawa, Yuzo; Tsuyuguchi, Naohiro; Moriuchi, Shusuke; Nonaka, Masahiro; Suzuki, Hiroyoshi; Shibuya, Makoto; Maehara, Taketoshi; Saito, Nobuhito; Nagane, Motoo; Kawahara, Nobutaka; Ueki, Keisuke; Yoshimine, Toshiki; Miyaoka, Etsuo; Nishikawa, Ryo; Komori, Takashi; Narita, Yoshitaka; Ichimura, Koichi

    2016-01-01

    The prognostic impact of TERT mutations has been controversial in IDH-wild tumors, particularly in glioblastomas (GBM). The controversy may be attributable to presence of potential confounding factors such as MGMT methylation status or patients' treatment. This study aimed to evaluate the impact of TERT status on patient outcome in association with various factors in a large series of adult diffuse gliomas. We analyzed a total of 951 adult diffuse gliomas from two cohorts (Cohort 1, n = 758; Cohort 2, n = 193) for IDH1/2, 1p/19q, and TERT promoter status. The combined IDH/TERT classification divided Cohort 1 into four molecular groups with distinct outcomes. The overall survival (OS) was the shortest in IDH wild-type/TERT mutated groups, which mostly consisted of GBMs (P < 0.0001). To investigate the association between TERT mutations and MGMT methylation on survival of patients with GBM, samples from a combined cohort of 453 IDH-wild-type GBM cases treated with radiation and temozolomide were analyzed. A multivariate Cox regression model revealed that the interaction between TERT and MGMT was significant for OS (P = 0.0064). Compared with TERT mutant-MGMT unmethylated GBMs, the hazard ratio (HR) for OS incorporating the interaction was the lowest in the TERT mutant-MGMT methylated GBM (HR, 0.266), followed by the TERT wild-type-MGMT methylated (HR, 0.317) and the TERT wild-type-MGMT unmethylated GBMs (HR, 0.542). Thus, patients with TERT mutant-MGMT unmethylated GBM have the poorest prognosis. Our findings suggest that a combination of IDH, TERT, and MGMT refines the classification of grade II-IV diffuse gliomas. PMID:27503138

  3. The HYPERFlax trial for determining the anti-HYPERtensive effects of dietary flaxseed in newly diagnosed stage 1 hypertensive patients: study protocol for a randomized, double-blinded, controlled clinical trial

    PubMed Central

    2014-01-01

    Background In 2013 the World Health Organization deemed hypertension as a global crisis as it is the leading risk factor attributed to global mortality. Therefore, there is a great need for effective alternative treatment strategies to combat a condition that affects 40% of adults worldwide. Recently, the FlaxPAD Trial observed a significant reduction in systolic and diastolic blood pressure in hypertensive patients with peripheral arterial disease that consumed 30 g of milled flaxseed per day for one year. However, these patients were already on anti-hypertensive medication. Therefore, there is a need to assess if dietary flaxseed can effectively reduce blood pressure in the absence of peripheral arterial disease and anti-hypertensive medication in newly diagnosed hypertensive patients. Methods/Design The HYPERFlax Trial is a parallel, superiority, phase II/III, randomized, double-blinded, controlled clinical trial. St. Boniface Hospital and the Health Sciences Centre of Winnipeg, Canada, will recruit 100 participants newly diagnosed with stage 1 hypertension who have yet to be administered anti-hypertensive medication. Participants will be randomly allocated with a 1:1 ratio into a flaxseed or control group and provided food products to consume daily for six months. At baseline, two, four, and six months, participant assessments will include the primary outcome measure, averaged automated blood pressure, and secondary measures: 24-hour food recall, international physical activity questionnaire, anthropometrics, and blood and urine sampling for biochemical analysis. Plasma will be assessed for lipids, metabolomics profiling, and molecules that regulate vascular tone. Urine will be collected for metabolomics profiling. With an estimated dropout rate of 20%, the trial will have a power of 0.80 to detect differences between groups and across time, out of an effect size of 0.7 (SD) at an α level of 0.05. Discussion This trial will determine if dietary flaxseed is

  4. Verbal fluency in adults diagnosed with attention-deficit hyperactivity disorder (ADHD) in childhood.

    PubMed

    Andreou, Georgia; Trott, Kate

    2013-12-01

    It has been increasingly believed that attention-deficit hyperactivity disorder (ADHD) is a disorder with lifelong course associated with cognitive difficulties including among others, language production, verbal learning, and verbal fluency. However, research is limited to children and adolescents, and very few researchers have examined the impact of ADHD in adulthood on the cognitive domain. The aim of the present study is to examine the performance of adults, diagnosed with ADHD in childhood, on semantic and phonemic verbal fluency tasks. It is hypothesized that adults with ADHD will perform worse on both tasks than matched controls. Sixty university students (30 diagnosed with ADHD in childhood and 30 matched controls) of mean age 20.5 participated in the study. They all completed two verbal fluency tasks. The ADHD group had statistically significant lower scores than the non-ADHD group on the phonemic, but not the semantic task. The study provides some evidence that ADHD in childhood has a negative impact on adults' phonemic verbal fluency. This finding could be probably explained by the fact that phonemic fluency is considered more cognitively demanding and impacting more on the frontal lobe functions, known to be impaired in ADHD, than semantic fluency.

  5. The association between self-consciousness about appearance and psychological adjustment among newly diagnosed breast cancer patients and survivors: the moderating role of appearance investment.

    PubMed

    Moreira, Helena; Canavarro, Maria Cristina

    2012-03-01

    This study examined the moderating role of two facets of appearance investment (self-evaluative salience (SES) and motivational salience (MS)) in the relationship between self-consciousness about appearance and psychological adjustment (depression, anxiety and psychological quality of life (QoL)) in a sample of 134 breast cancer patients (68 newly diagnosed patients and 66 survivors). No significant differences were found between groups on body image variables. Among survivors, the associations between self-consciousness about appearance and the outcome variables were only significant at high (depression, psychological QoL) levels and at moderate (psychological QoL) levels of SES. Self-consciousness about appearance contributed to poor adjustment in both groups. This study demonstrates that appearance investment plays a key role in patients' adjustment and highlights the SES-MS distinction. SES seems to be a vulnerability factor for poor adjustment, and MS seems to be a protective factor that helps women cope with changes in appearance.

  6. The prevalence and correlates of receiving confirmatory HIV test results among newly diagnosed HIV-positive individuals at a community-based testing center.

    PubMed

    Feldman, Matthew; Wu, Elwin; Mendoza, Moira; Lowry, Blakely; Ford, Lynnette; Holloway, Ian

    2012-10-01

    This study examined the prevalence and correlates of completing the HIV testing process-specifically receiving a confirmatory HIV test and returning for the results-in a sample of newly diagnosed HIV-positive individuals at an HIV testing center in New York City. Of the 213 individuals who received a reactive rapid HIV test result, 82% received a confirmatory HIV test. Of the 236 individuals who received a positive result on a rapid or traditional HIV test that was validated by a positive confirmatory HIV test, 65% returned for the confirmatory test results. Multivariate analyses revealed that being a non-U.S. citizen, homeless/living in transitional housing, being uninsured, and testing off-site were significantly associated with completing the HIV testing process. The findings indicate the need to explore strategies that address obstacles to receiving confirmatory HIV testing and returning for the results, in addition to the feasibility of a rapid confirmatory HIV test. PMID:23016505

  7. IMATINIB 800MG DAILY INDUCES DEEPER MOLECULAR RESPONSES THAN IMATINIB 400MG DAILY: RESULTS OF SWOG S0325, AN INTERGROUP RANDOMIZED PHASE II TRIAL IN NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOID LEUKAEMIA

    PubMed Central

    Deininger, Michael W.; Kopecky, Kenneth J.; Radich, Jerald P.; Kamel-Reid, Suzanne; Stock, Wendy; Paietta, Elisabeth; Emanuel, Peter D.; Tallman, Martin; Wadleigh, Martha; Larson, Richard A.; Lipton, Jeffrey H.; Slovak, Marilyn L.; Appelbaum, Frederick R.; Druker, Brian J.

    2014-01-01

    The standard dose of imatinib for newly diagnosed patients with chronic phase chronic myeloid leukemia (CP-CML) is 400mg daily (IM400), but the optimal dose is unknown. This randomized phase II study compared the rates of molecular, haematologic and cytogenetic response to IM400 vs. imatinib 400mg twice daily (IM800) in 153 adult patients with CP-CML. Dose adjustments for toxicity were flexible to maximize retention on study. Molecular response (MR) at 12 months was deeper in the IM800 arm (4-log reduction of BCR-ABL1 mRNA: 25% vs. 10% of patients, P=0.038; 3-log reduction: 53% vs. 35%, P=0.049). During the first 12 months BCR-ABL1 levels in the IM800 arm were an average 2.9-fold lower than in the IM400 arm (P=0.010). Complete haematologic response was similar, but complete cytogenetic response was higher with IM800 (85% vs. 67%, P=0.040). Grade 3–4 toxicities were more common for IM800 (58% vs. 31%, P=0.0007), and were most commonly haematologic. Few patients have relapsed, progressed or died, but progression-free (P=0.048) and relapse-free (P=0.031) survival were superior for IM800. In newly diagnosed CP-CML patients, IM800 induced deeper molecular responses than IM400, with a trend for improved progression-free and overall survival, but was associated with more severe toxicity. PMID:24383843

  8. Mass screening for celiac disease from the perspective of newly diagnosed adolescents and their parents: A mixed-method study

    PubMed Central

    2011-01-01

    in the CD screening were partly non-personal, and diagnosis was met with surprise, adolescents and parents felt grateful that they were made aware. They welcomed future CD screening, but suggested that it should be conducted earlier in life. Thus, CD mass screening seemed acceptable to most of those who were diagnosed and their parents. PMID:22017750

  9. Prognostic significance of bone marrow infiltration detected by PET-CT in newly diagnosed diffuse large B cell lymphoma

    PubMed Central

    Liang, Jin-Hua; Sun, Jin; Wang, Li; Fan, Lei; Chen, Yao-Yu; Qu, Xiao-Yan; Li, Tian-Nv; Li, Jian-Yong; Xu, Wei

    2016-01-01

    The aim of this study was to examine the prognostic value of bone marrow involvement (BMI) assessed by baseline PET-CT (PET(0)-BMI) in treatment-naïve patients with diffuse large B-cell lymphoma (DLBCL). All patients from a single centre diagnosed as DLBCL between 2005 and 2014 had data extracted from staging PET-CT (PET(0)-CT), bone marrow biopsy (BMB), and treatment records. The PET(3)-CT (PET-CT scan after cycle 3 of immunochemotherapy) was performed on all the patients with PET(0)-BMI positivity (PET(0)-BMI(+)). Of 169 patients, 20 (11.8%) had BMI on BMB, whereas 35 (20.7%) were PET(0)-BMI positive. Among PET(0)-BMI(+) patients, patients with maximum of standard uptake value (SUVmax) of bone marrow (SUVmax(BM)) more than 8.6 were significantly associated with high IPI score (3–5) (P=0.002), worse progression-free survival (PFS) and overall survival (OS) (P=0.025 and P=0.002, respectively). In the 68 stage IV cases, 3-year OS was higher in the patients with negative PET(0)-BMI (PET(0)-BMI(−)) than that with PET(0)-BMI(+) (84.2%±6.5% vs. 44.1%±8.6%; P=0.003), while 3-year PFS only shown a trend of statistic significance (P=0.077) between the two groups. Among the 69 patients of inter-risk of IPI (2–3), patients with PET(0)-BMI(+) had significantly inferior PFS and OS than that with PET(0)-BMI(−) (P=0.009 and P<0.001, respectively). The cut-off value of the decreased percentage of SUVmax(BM) between PET(0)-CT and PET(3)-CT (ΔSUVmax(BM)) was 70.0%, which can predict PFS (P=0.003) and OS (P=0.023). These data confirmed that along with the increased sensitivity and accuracy of identifying bone marrow by PET-CT, novel prognostic values of marrow involvement were found in patients with DLBCL. PMID:26919239

  10. Multiple strokes and bilateral carotid dissections: a fulminant case of newly diagnosed Ehlers-Danlos syndrome type IV.

    PubMed

    Dohle, C; Baehring, J M

    2012-07-15

    Ehlers-Danlos Syndrome is a rare group of inheritable disorders resulting in abnormal collagen production, leading to skin fragility, joint hypermobility and easy bruising. Six major subtypes have been identified, of which Type IV most often leads to neurovascular complications, may lead to inner organ rupture and overall has the worst prognosis. Early recognition followed by genetic testing is key, since this diagnosis will guide decision making in the management of complications, influence the choice of antiplatelet medications versus anticoagulants and allow for potentially affected family members to be identified, undergo genetic testing and reproductive counseling. We here report the case of a 50 year old woman with a fulminant presentation of Ehlers Danlos Syndrome Type IV, including bilateral carotid and vertebral artery dissection, multiple strokes and liver rupture. Of note, this patient did not have a known history or obvious clinical features of connective tissue disease. Genetic testing confirmed the diagnosis. Review of her family history revealed multiple family members with a history of aortic dissection or aneurysm rupture. This case illustrates that Ehlers Danlos Syndrome Type IV is an important differential diagnosis even in adult patients without a known history of connective tissue disease and no prior complications.

  11. Survival of European children and young adults with cancer diagnosed 1995-2002.

    PubMed

    Gatta, Gemma; Zigon, Giulia; Capocaccia, Riccardo; Coebergh, Jan Willem; Desandes, Emmanuel; Kaatsch, Peter; Pastore, Guido; Peris-Bonet, Rafael; Stiller, Charles A

    2009-04-01

    This study analyses survival in 40,392 children (age 0-14 years) and 30,187 adolescents/young adults (age 15-24 years) diagnosed with cancer between 1995 and 2002. The cases were from 83 European population-based cancer registries in 23 countries participating in EUROCARE-4. Five-year survival in countries and in regional groupings of countries was compared for all cancers combined and for major cancers. Survival for 15 rare cancers in children was also analysed. Five-year survival for all cancers combined was 81% in children and 87% in adolescents/young adults. Between-country survival differences narrowed for both children and adolescents/young adults. Relative risk of death reduced significantly, by 8% in children and by 13% in adolescents/young adults, from 1995-1999 to 2000-2002. Survival improved significantly over time for acute lymphoid leukaemia and primitive neuroectodermal tumours in children and for non-Hodgkin lymphoma in adolescents/young adults. Cancer survival in patients <25 years is poorly documented in Eastern European countries. Complete cancer registration should be a priority for these countries as an essential part of a policy for effective cancer control in Europe.

  12. A Critical Review of Trials of First-Line BCR-ABL Inhibitor Treatment in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

    PubMed Central

    Jabbour, Elias; Lipton, Jeffrey H.

    2015-01-01

    The characteristic expression of the constitutively active oncoprotein, BCR-ABL tyrosine kinase, in chronic myeloid leukemia (CML) was the basis for the development of BCR-ABL tyrosine kinase inhibitors for treatment. Three BCR-ABL inhibitors, imatinib, nilotinib, and dasatinib, have been approved by the US Food and Drug Administration for first-line treatment of patients with newly diagnosed CML in chronic phase (CML-CP). This article reviews the key phase III clinical trials supporting the use of first-line imatinib, nilotinib, and dasatinib in patients with CML-CP as well as findings of supportive phase II studies. At the time of its approval in 2001, imatinib induced unprecedented response rates in patients with CML-CP; however, resistance and intolerance to imatinib prevent 20% to 30% of patients from deriving full therapeutic benefit. Nilotinib and dasatinib, both approved in 2010 for first-line CML-CP treatment, are more potent than imatinib and less susceptible to imatinib resistance mechanisms. Comparative clinical trials of each agent with imatinib have shown that they are associated with significantly deeper and more rapid responses than standard-dose imatinib, without compromising safety. Given that evidence suggests achievement of an early response is predictive of improved long-term outcomes, earlier use of these compounds may lead to more rapid, deeper responses corresponding with improvements in patient outcome. Although future studies will benefit from more uniform definitions of endpoints and methods of analysis, data from published studies of first-line BCR-ABL inhibitor treatment for patients with newly diagnosed CML-CP support the use of either dasatinib or nilotinib in place of imatinib. PMID:24095296

  13. A prospective multicenter study of venous thromboembolism in patients with newly-diagnosed high-grade glioma: hazard rate and risk factors

    PubMed Central

    Ye, Xiaobu; Kickler, Thomas S.; Desideri, Serena; Jani, Jayesh; Fisher, Joy; Grossman, Stuart A.

    2015-01-01

    Venous thromboembolism (VTE) is a common complication in patients with high-grade gliomas. The purpose of this prospective multicenter study was to determine the hazard rate of first symptomatic VTE in newly-diagnosed glioma patients and identify clinical and laboratory risk factors. On enrollment, demographic and clinical information were recorded and a comprehensive coagulation evaluation was performed. Patients were followed until death. The study end point was objectively-documented symptomatic VTE. One hundred seven patients were enrolled with a median age of 57 years (range 29–85) between June 2005 and April 2008. Ninety-one (85 %) had glioblastoma multiforme (GBM). During an average survival of 17.7 months, 26 patients (24 %) (95 % CI 17–34 %) developed VTE (hazard rate 0.15 per person-year) and 94 patients (88 %) died. Median time to VTE was 14.2 weeks post-operation (range 3–126). Patients with an initial tumor biopsy were 3.0 fold more likely to suffer VTE (p = 0.02). Patients with an elevated factor VIII activity (>147 %) were 2.1-fold more likely to develop VTE. ABO blood group, D dimer and thrombin generation were not associated with VTE. No fatal VTE occurred. VTE is a common complication in patients with newly-diagnosed high grade gliomas, particularly in the first six months after diagnosis. Patients with an initial tumor biopsy and elevated factor VIII levels are at increased risk. However, VTE was not judged to be pri-marily responsible for any patient deaths. Therefore, out-patient primary VTE prophylaxis remains investigational until more effective primary prophylaxis strategies and therapies for glioma are identified. PMID:26100546

  14. Frequency of joint involvement in juvenile idiopathic arthritis during a 5-year follow-up of newly diagnosed patients: implications for MR imaging as outcome measure.

    PubMed

    Hemke, Robert; Nusman, Charlotte M; van der Heijde, Désirée M F M; Doria, Andrea S; Kuijpers, Taco W; Maas, Mario; van Rossum, Marion A J

    2015-02-01

    To assess the sequence and type of active joints in a cohort of newly diagnosed juvenile idiopathic arthritis (JIA) patients with full access to current treatment at first visit and during a follow-up period of 5-years, in order to identify an index joint/group of joints for magnetic resonance imaging in JIA. Patient charts of all consecutive newly diagnosed JIA patients with a follow-up duration of at least 5 years were analyzed. Patients were derived from two tertiary pediatric rheumatology centers. Patient characteristics and data concerning the presence of joints with arthritis and the use of medication were recorded. Findings from 95 JIA patients [39 (41 %) oligoarticular and 56 (59 %) polyarticular] were analyzed. At first visit, distribution of active joints among patients was as follows: knee (n = 70, 74 %), ankle (n = 55, 58 %), elbow (n = 23, 24 %), wrist (n = 23, 24 %), metacarpophalangeal (MCP) (n = 20, 21 %), proximal interphalangeal (PIP) (n = 13, 14 %), hip (n = 6, 6 %), shoulder (n = 5, 5 %), and distal interphalangeal (DIP) (n = 4, 4 %) joints. After a follow-up period of 5 years, the cumulative percentage of patients with specific joint involvement changed into: knee (n = 88, 93 %), ankle (n = 79, 83 %), elbow (n = 43, 45 %), wrist (n = 38, 40 %), MCP (n = 36, 38 %), PIP (n = 29, 31 %), shoulder (n = 20, 21 %), hip (n = 17, 19 %), and DIP (n = 9, 10 %) joints. Despite changes in treatment strategies over the years, the knee remains the most commonly involved joint at onset and during follow-up in JIA, followed by the ankle, elbow, and wrist. For the evaluation of outcome with MRI, the knee appears the most appropriate joint in JIA.

  15. Six-month progression-free survival as an alternative primary efficacy endpoint to overall survival in newly diagnosed glioblastoma patients receiving temozolomide

    PubMed Central

    Polley, Mei-Yin C.; Lamborn, Kathleen R.; Chang, Susan M.; Butowski, Nicholas; Clarke, Jennifer L.; Prados, Michael

    2010-01-01

    We assessed six-month progression-free survival (PFS) as an alternative primary efficacy endpoint to overall survival in newly diagnosed glioblastoma multiforme (GBM) patients receiving temozolomide (TMZ). A total of 183 patients with newly diagnosed GBM enrolled in 3 phase II protocols at the University of California–San Francisco were included. Patients were treated with interventions based on the Stupp regimen, each with the added component of a second oral agent given concurrently with radiotherapy and TMZ, followed by its coadministration with adjuvant TMZ. We examined whether progression status at 2, 4, and 6 months predicted subsequent survival using the landmark analysis. The hazard ratios of death as a function of progression status were estimated based on the Cox proportional hazards model after adjustment for putative prognostic factors. Progression status at 2, 4, and 6 months were all consistently found to be strong predictors of subsequent survival in all studies. The study-specific hazard ratios associated with progression status at 6 months ranged from 2.03 to 3.39. The hazard ratios associated with the earlier time points (2- and 4-month progression) all exceeded 2 in magnitude, ranging from 2.29 to 4.73. P-values were statistically significant for all time points. In this report, we demonstrated a strong association between the endpoints of PFS at 2, 4, and 6 months and survival. Patients who showed the signs of early progression were at significantly higher risk of earlier death. Our analysis suggests that 6-month PFS may be an appropriate primary endpoint in the context of phase II upfront GBM trials in the TMZ era. PMID:20167815

  16. The evolution of accelerated, partial breast irradiation as a potential treatment option for women with newly diagnosed breast cancer considering breast conservation.

    PubMed

    Dirbas, Frederick M; Jeffrey, Stefanie S; Goffinet, Don R

    2004-12-01

    Breast conservation therapy (BCT) is a safe, effective alternative to mastectomy for many women with newly diagnosed breast cancer. This approach involves local excision of the malignancy with tumor-free margins, followed by 5-7 weeks of external beam whole breast (WB) radiotherapy (XRT) to minimize the risk of an in-breast tumor recurrence (IBTR). Though clearly beneficial, the extended course of almost daily postoperative radiotherapy interrupts normal activities and lengthens care. Additional options are now available that shorten the radiotherapy treatment time to 1-5 days (accelerated) and focus an increased dose of radiation on just the breast tissue around the excision cavity (partial breast). Recent trials with accelerated, partial breast irradiation (APBI) have shown promise as a potential replacement to the longer, whole breast treatments for select women with early-stage breast cancer. Current APBI approaches include interstitial brachytherapy, intracavitary (balloon) brachytherapy, and accelerated external beam (3-D conformal) radiotherapy, all of which normally complete treatment over 5 days, while intraoperative radiotherapy (IORT) condenses the entire treatment into a single dose delivered immediately after tumor excision. Each approach has benefits and limitations. This study covers over 2 decades of clinical trials exploring APBI, discusses treatment variables that appear necessary for successful implementation of this new form of radiotherapy, compares and contrasts the various APBI approaches, and summarizes current and planned randomized trials that will shape if and how APBI is introduced into routine clinical care. Some of the more important outcome variables from these trials will be local toxicity, local and regional recurrence, and overall survival. If APBI options are ultimately demonstrated to be as safe and effective as current whole breast radiotherapy approaches, breast conservation may become an even more appealing choice, and the

  17. Do improvements in dietary behaviour contribute to cardiovascular risk factor reduction over and above cardio-protective medication in newly diagnosed diabetes patients?

    PubMed Central

    Cooper, Andrew J. M.; Schliemann, Desiree; Long, Gráinne H.; Griffin, Simon J.; Simmons, Rebecca K.

    2015-01-01

    Background/objectives A healthy diet is an integral component of successful diabetes management. However, the comparative importance of adopting a healthy diet for cardiovascular risk factor reduction over and above medication use among newly diagnosed diabetes patients remains unclear. Subjects/Methods We computed a dietary score consistent with American Diabetes Association and Diabetes UK recommendations in 574 newly diagnosed diabetes patients by summing standardised values for the intake of total energy, saturated fat, sodium, fibre and plasma vitamin C. In linear regression analyses, stratified by cardio-protective medication use (yes/no), we quantified the comparative longitudinal associations of baseline diet and change in diet over 1-year with change in blood pressure, HbA1c and lipids. Results Baseline diet was generally not predictive of change in cardiovascular risk factor levels at 1-year. In contrast, dietary change over 1-year among patients prescribed and not prescribed cardio-protective medication after baseline was associated with comparative (p-interaction all ≥0.95) reductions in diastolic blood pressure (−2.38 vs. −2.93 mmHg, respectively) and triglycerides (−0.31 vs. −0.21 mmol/l, respectively), independent of potential confounding factors and change from baseline to follow-up in physical activity and smoking status. Conclusions Modest dietary change over the first year following diagnosis of diabetes was associated with reductions in blood pressure and triglycerides, over and above the effects of cardio-protective medication. Our findings support the notion that dietary change should be viewed as an integral component of successful diabetes self-management, irrespective of medication use. PMID:24801371

  18. Prognostic significance of peripheral monocytic myeloid-derived suppressor cells and monocytes in patients newly diagnosed with diffuse large b-cell lymphoma

    PubMed Central

    Wu, Chongyang; Wu, Xiangyang; Zhang, Xiaoni; Chai, Ye; Guo, Qi; Li, Lijuan; Yue, Lingling; Bai, Jun; Wang, Zhiping; Zhang, Liansheng

    2015-01-01

    Objective: The revised International Prognostic Index (R-IPI) aids in predicting the prognosis of patients with diffuse large B cell lymphoma (DLBCL), but R-IPI yields no significant differences in assessing different subtypes of DLBCL. It is necessary to identify patients with a high-risk of DLBCL and alternative therapy should be delivered as early as possible. Methods: In total, 144 patients newly diagnosed with DLBCL including 63 GCB-DLBCL and 81 non-GCB-DLBCL and 30 healthy controls were enrolled. Peripheral monocytic myeloid-derived suppressor cells (M-MDSC) (CD14+HLA-DRlow/-) were detected by flow cytometry and the percentage of monocytes (MΦ) was evaluated by completed blood count (CBC). The correlation between M-MDSC% and MΦ% was statistically analyzed. Results: Compared with healthy controls, significant increase was observed in M-MDSC% and MΦ% in DLBCL patients (both P<0.001). Significant difference of M-MDSC% was found between GCB-DLBCL and non-GCB-DLBCL patients in both poor (P<0.001) and very good groups (P=0.03), whereas no statistical significance in the good group (P>0.05). The MΦ% in non-GCB-DLBCL patients was significantly higher than that in GCB-DLBCL counterparts merely in the poor group (P<0.001). Positive correlation was noted between MΦ% and M-MDSC in all DLBCL patients rather than in healthy controls (r=0.227 P=0.229). Conclusion: The percentage of peripheral MΦ was positively correlated with M-MDSC% in patients with different subtypes and risks of DLBCL. Peripheral MΦ% and M-MDSC% combined with R-IPI score may be useful for predicting the prognosis of patients newly-diagnosed with DLBCL. PMID:26629001

  19. Relationship of Hemoglobin A1c with β Cell Function and Insulin Resistance in Newly Diagnosed and Drug Naive Type 2 Diabetes Patients

    PubMed Central

    Hou, Xinguo; Liu, Jinbo; Song, Jun; Wang, Chuan; Liang, Kai; Sun, Yu; Ma, Zeqiang; Yang, Weifang; Li, Chengqiao; Zhang, Xiuping; Lin, Peng; Gong, Lei; Wang, Meijian; Liu, Fuqiang; Li, Wenjuan; Yan, Fei; Qin, Jun; Wang, Lingshu; Liu, Jidong; Zhao, Ruxing; Chen, Shihong; Chen, Li

    2016-01-01

    Objective. To investigate changes in the glycated hemoglobin A1c (A1c) level and those in β cell function and insulin resistance in newly diagnosed and drug naive type 2 diabetes patients and to evaluate the relationship between them. Design and Methods. A total of 818 newly diagnosed diabetic individuals who were ≥40 years of age were recruited. The subjects were grouped by A1c values (<6.5%, 6.5–7%, 7-8%, 8-9%, and ≥9%). The homeostasis model assessment (HOMA) was used to evaluate pancreatic β cell function (HOMA-β) and insulin resistance (HOMA-IR). ANOVA, t-tests, and binary logistic regression analysis were used for data analysis. Results. Compared with subjects with A1c values <6.5%, individuals with an A1c of 6.5–7% exhibited an increased HOMA-β index. However, the HOMA-β index was significantly decreased at A1c values ≥7% and further decreased by 9.3% and by 23.7%, respectively, at A1c values of 7-8% and 8-9%. As A1c increased to ≥9%, a 62% reduction in β cell function was observed, independently of age, gender, body mass index (BMI), blood pressure (BP), blood lipids, and hepatic enzyme levels. Meanwhile, insulin resistance was significantly increased with an increase in A1c values. Conclusions. Elevated A1c values (≥7%) were associated with substantial reductions in β cell function. PMID:26640807

  20. In cats with newly diagnosed diabetes mellitus, use of a near-euglycemic management paradigm improves remission rate over a traditional paradigm.

    PubMed

    Nack, Robert; DeClue, Amy E

    2014-01-01

    The object of this retrospective study was to compare the effect on remission rates of a near euglycemic paradigm (NEP) to a traditional paradigm (TP) of glycemic control in cats with newly diagnosed diabetes mellitus. Medical records of 54 cats with naïve diabetes mellitus managed with low carbohydrate, high protein prescription diets, and twice daily subcutaneous glargine insulin injections were reviewed. Cats were assigned to an NEP or TP group based on frequency of evaluation of blood glucose concentration and the criteria used to assess glycemic control. The two groups were compared with regard to the incidence of clinical and biochemical hypoglycemia and remission rates. Multiple logistic regression was used to evaluate the association between remission and independent variables. Fourteen of 18 cats (78%) in the NEP group achieved remission, whereas five of the 36 (14%) of the TP group achieved remission (p < 0.001). For the NEP group, biochemical hypoglycemia was noted in 8/18 (44%) and clinical hypoglycemia was documented in 2/18 (11%) of the cats. In the TP group, biochemical hypoglycemia was noted in 12/36 (33%) cats and 5/36 (14%) had clinical hypoglycemia. In conclusion, management of newly diagnosed diabetic cats using an NEP of glycemic control results in higher remission rates without an increased incidence of observed clinical or biochemical hypoglycemia. Although an NEP appears to have benefit it should be evaluated further with regard to its overall and long term effects on health and quality of life as well as its overall cost effectiveness.

  1. Electronic health record use to classify patients with newly diagnosed versus preexisting type 2 diabetes: infrastructure for comparative effectiveness research and population health management.

    PubMed

    Kudyakov, Rustam; Bowen, James; Ewen, Edward; West, Suzanne L; Daoud, Yahya; Fleming, Neil; Masica, Andrew

    2012-02-01

    Use of electronic health record (EHR) content for comparative effectiveness research (CER) and population health management requires significant data configuration. A retrospective cohort study was conducted using patients with diabetes followed longitudinally (N=36,353) in the EHR deployed at outpatient practice networks of 2 health care systems. A data extraction and classification algorithm targeting identification of patients with a new diagnosis of type 2 diabetes mellitus (T2DM) was applied, with the main criterion being a minimum 30-day window between the first visit documented in the EHR and the entry of T2DM on the EHR problem list. Chart reviews (N=144) validated the performance of refining this EHR classification algorithm with external administrative data. Extraction using EHR data alone designated 3205 patients as newly diagnosed with T2DM with classification accuracy of 70.1%. Use of external administrative data on that preselected population improved classification accuracy of cases identified as new T2DM diagnosis (positive predictive value was 91.9% with that step). Laboratory and medication data did not help case classification. The final cohort using this 2-stage classification process comprised 1972 patients with a new diagnosis of T2DM. Data use from current EHR systems for CER and disease management mandates substantial tailoring. Quality between EHR clinical data generated in daily care and that required for population health research varies. As evidenced by this process for classification of newly diagnosed T2DM cases, validation of EHR data with external sources can be a valuable step.

  2. Diabetes Reduces the Rate of Sputum Culture Conversion in Patients With Newly Diagnosed Multidrug-Resistant Tuberculosis.

    PubMed

    Salindri, Argita D; Kipiani, Maia; Kempker, Russell R; Gandhi, Neel R; Darchia, Lasha; Tukvadze, Nestani; Blumberg, Henry M; Magee, Matthew J

    2016-09-01

    Background.  Diabetes is a risk factor for active tuberculosis (TB), but little is known about the relationship between diabetes and multidrug-resistant (MDR) TB. We aimed to assess risk factors for primary MDR TB, including diabetes, and determine whether diabetes reduced the rate of sputum culture conversion among patients with MDR TB. Methods.  From 2011 to 2014, we conducted a cohort study at the National Center for Tuberculosis and Lung Diseases in Tbilisi, Georgia. Adult (≥35 years) patients with primary TB were eligible. Multidrug-resistant TB was defined as resistance to at least rifampicin and isoniazid. Patients with capillary glycosylated hemoglobin (HbA1c) ≥ 6.5% or previous diagnosis were defined to have diabetes. Polytomous regression was used to estimate the association of patient characteristics with drug resistance. Cox regression was used to compare rates of sputum culture conversion in patients with and without diabetes. Results.  Among 318 patients with TB, 268 had drug-susceptibility test (DST) results. Among patients with DST results, 19.4% (52 of 268) had primary MDR TB and 13.4% (36 of 268) had diabetes. In multivariable analyses, diabetes (adjusted odds ratio [aOR], 2.51; 95% confidence interval [CI], 1.00-6.31) and lower socioeconomic status (aOR, 3.51; 95% CI, 1.56-8.20) were associated with primary MDR TB. Among patients with primary MDR TB, 44 (84.6%) converted sputum cultures to negative. The rate of sputum culture conversion was lower among patients with diabetes (adjusted hazard ratio [aHR], 0.34; 95% CI, .13-.87) and among smokers (aHR, 0.16; 95% CI, .04-.61). Conclusions.  We found diabetes was associated with an increased risk of primary MDR TB; both diabetes and smoking were associated with a longer time to sputum culture conversion.

  3. Diabetes Reduces the Rate of Sputum Culture Conversion in Patients With Newly Diagnosed Multidrug-Resistant Tuberculosis.

    PubMed

    Salindri, Argita D; Kipiani, Maia; Kempker, Russell R; Gandhi, Neel R; Darchia, Lasha; Tukvadze, Nestani; Blumberg, Henry M; Magee, Matthew J

    2016-09-01

    Background.  Diabetes is a risk factor for active tuberculosis (TB), but little is known about the relationship between diabetes and multidrug-resistant (MDR) TB. We aimed to assess risk factors for primary MDR TB, including diabetes, and determine whether diabetes reduced the rate of sputum culture conversion among patients with MDR TB. Methods.  From 2011 to 2014, we conducted a cohort study at the National Center for Tuberculosis and Lung Diseases in Tbilisi, Georgia. Adult (≥35 years) patients with primary TB were eligible. Multidrug-resistant TB was defined as resistance to at least rifampicin and isoniazid. Patients with capillary glycosylated hemoglobin (HbA1c) ≥ 6.5% or previous diagnosis were defined to have diabetes. Polytomous regression was used to estimate the association of patient characteristics with drug resistance. Cox regression was used to compare rates of sputum culture conversion in patients with and without diabetes. Results.  Among 318 patients with TB, 268 had drug-susceptibility test (DST) results. Among patients with DST results, 19.4% (52 of 268) had primary MDR TB and 13.4% (36 of 268) had diabetes. In multivariable analyses, diabetes (adjusted odds ratio [aOR], 2.51; 95% confidence interval [CI], 1.00-6.31) and lower socioeconomic status (aOR, 3.51; 95% CI, 1.56-8.20) were associated with primary MDR TB. Among patients with primary MDR TB, 44 (84.6%) converted sputum cultures to negative. The rate of sputum culture conversion was lower among patients with diabetes (adjusted hazard ratio [aHR], 0.34; 95% CI, .13-.87) and among smokers (aHR, 0.16; 95% CI, .04-.61). Conclusions.  We found diabetes was associated with an increased risk of primary MDR TB; both diabetes and smoking were associated with a longer time to sputum culture conversion. PMID:27419188

  4. Diabetes Reduces the Rate of Sputum Culture Conversion in Patients With Newly Diagnosed Multidrug-Resistant Tuberculosis

    PubMed Central

    Salindri, Argita D.; Kipiani, Maia; Kempker, Russell R.; Gandhi, Neel R.; Darchia, Lasha; Tukvadze, Nestani; Blumberg, Henry M.; Magee, Matthew J.

    2016-01-01

    Background. Diabetes is a risk factor for active tuberculosis (TB), but little is known about the relationship between diabetes and multidrug-resistant (MDR) TB. We aimed to assess risk factors for primary MDR TB, including diabetes, and determine whether diabetes reduced the rate of sputum culture conversion among patients with MDR TB. Methods. From 2011 to 2014, we conducted a cohort study at the National Center for Tuberculosis and Lung Diseases in Tbilisi, Georgia. Adult (≥35 years) patients with primary TB were eligible. Multidrug-resistant TB was defined as resistance to at least rifampicin and isoniazid. Patients with capillary glycosylated hemoglobin (HbA1c) ≥ 6.5% or previous diagnosis were defined to have diabetes. Polytomous regression was used to estimate the association of patient characteristics with drug resistance. Cox regression was used to compare rates of sputum culture conversion in patients with and without diabetes. Results. Among 318 patients with TB, 268 had drug-susceptibility test (DST) results. Among patients with DST results, 19.4% (52 of 268) had primary MDR TB and 13.4% (36 of 268) had diabetes. In multivariable analyses, diabetes (adjusted odds ratio [aOR], 2.51; 95% confidence interval [CI], 1.00–6.31) and lower socioeconomic status (aOR, 3.51; 95% CI, 1.56–8.20) were associated with primary MDR TB. Among patients with primary MDR TB, 44 (84.6%) converted sputum cultures to negative. The rate of sputum culture conversion was lower among patients with diabetes (adjusted hazard ratio [aHR], 0.34; 95% CI, .13–.87) and among smokers (aHR, 0.16; 95% CI, .04–.61). Conclusions. We found diabetes was associated with an increased risk of primary MDR TB; both diabetes and smoking were associated with a longer time to sputum culture conversion. PMID:27419188

  5. Posttraumatic stress in older adults: when medical diagnoses or treatments cause traumatic stress.

    PubMed

    Moye, Jennifer; Rouse, Susan J

    2015-03-01

    Most older patients adapt after catastrophic medical diagnoses and treatments, but a significant number may develop posttraumatic stress disorder (PTSD) symptoms. PTSD symptoms create added burden for the individual, family, and health care system for the patient's recovery. Medical-related PTSD may be underdiagnosed by providers who may be unaware that these health problems can lead to PTSD symptoms. Treatment research is lacking, but pharmacologic and nonpharmacologic approaches to treatment may be extrapolated and adjusted from the literature focusing on younger adults. Additional study is needed.

  6. Posttraumatic stress in older adults: when medical diagnoses or treatments cause traumatic stress.

    PubMed

    Moye, Jennifer; Rouse, Susan J

    2014-08-01

    Most older patients adapt after catastrophic medical diagnoses and treatments, but a significant number may develop posttraumatic stress disorder (PTSD) symptoms. PTSD symptoms create added burden for the individual, family, and health care system for the patient's recovery. Medical-related PTSD may be underdiagnosed by providers who may be unaware that these health problems can lead to PTSD symptoms. Treatment research is lacking, but pharmacologic and nonpharmacologic approaches to treatment may be extrapolated and adjusted from the literature focusing on younger adults. Additional study is needed.

  7. Teaching self-control to small groups of dually diagnosed adults.

    PubMed

    Dixon, M R; Holcomb, S

    2000-01-01

    The present study examined the use of a progressive delay procedure to teach self-control to two groups of dually diagnosed adults. When given a choice between an immediate smaller reinforcer and a larger delayed reinforcer, both groups chose the smaller reinforcer during baseline. During treatment, progressive increases in work requirements for gaining access to a larger reinforcer resulted in both groups selecting larger delayed reinforcers. The results are discussed with respect to increasing cooperative work behavior and self-control. PMID:11214034

  8. Ability of newly emerged adult Culex quinquefasciatus (Diptera: Culicidae) mosquitoes to exit belowground stormwater treatment systems via lateral conveyance pipes.

    PubMed

    Metzger, Marco E; Harbison, Justin E; Burns, Joseph E; Hu, Renjie

    2012-03-01

    Culex quinquefasciatus Say mosquitoes flourish in belowground stormwater systems in the southern United States. Recent evidence suggests that oviposition-site-seeking females may have difficulties locating, entering, and ovipositing inside permanent water chambers when surface entry through pickholes in manhole covers are sealed. It remains unknown, however, if newly emerged adults are able to detect cues necessary to exit these partly sealed systems via lateral conveyance pipes or if they perish belowground. Fourth instar Cx. quinquefasciatus were placed within proprietary belowground stormwater treatment systems to determine the percentage of newly emerged adults able to escape treatment chambers via a single lateral conveyance pipe. Overall, 56% of deployed mosquitoes were captured in adult exit traps with an 1:1 male:female ratio. The percentage of adults captured varied significantly among chambers, but was not associated with structural site characteristics such as the chamber depth or the length and course of conveyance pipe to the exit trap. Empirical observations suggested that longbodied cellar spiders, Pholcus phalangioides (Fuesslin), ubiquitous in these structures, may have reduced adult trap capture. Findings demonstrate that newly emerged Cx. quinquefasciatus can exit subterranean chambers under potentially difficult structural conditions but suggest that a portion may perish in the absence of surface exit points in manhole shafts.

  9. The adult literacy evaluator: An intelligent computer-aided training system for diagnosing adult illiterates

    NASA Technical Reports Server (NTRS)

    Yaden, David B., Jr.

    1992-01-01

    An important part of NASA's mission involves the secondary application of its technologies in the public and private sectors. One current application being developed is The Adult Literacy Evaluator, a simulation-based diagnostic tool designed to assess the operant literacy abilities of adults having difficulties in learning to read and write. Using ICAT system technology in addition to speech recognition, closed-captioned television (CCTV), live video and other state-of-the art graphics and storage capabilities, this project attempts to overcome the negative effects of adult literacy assessment by allowing the client to interact with an intelligent computer system which simulates real-life literacy activities and materials and which measures literacy performance in the actual context of its use. The specific objectives of the project are as follows: (1) To develop a simulation-based diagnostic tool to assess adults' prior knowledge about reading and writing processes in actual contexts of application; (2) to provide a profile of readers' strengths and weaknesses; and (3) to suggest instructional strategies and materials which can be used as a beginning point for remediation. In the first and developmental phase of the project, descriptions of literacy events and environments are being written and functional literacy documents analyzed for their components. Examples of literacy events and situations being considered included interactions with environmental print (e.g., billboards, street signs, commercial marquees, storefront logos, etc.), functional literacy materials (e.g., newspapers, magazines, telephone books, bills, receipts, etc.) and employment related communication (i.e., job descriptions, application forms, technical manuals, memorandums, newsletters, etc.). Each of these situations and materials is being analyzed for its literacy requirements in terms of written display (i.e., knowledge of printed forms and conventions), meaning demands (i

  10. Substance use among ADHD adults: implications of late onset and subthreshold diagnoses.

    PubMed

    Faraone, Stephen V; Wilens, Timothy E; Petty, Carter; Antshel, Kevin; Spencer, Thomas; Biederman, Joseph

    2007-01-01

    Diagnosing ADHD in adults is difficult when the diagnostician cannot establish an onset prior to the DSM-IV criterion of age seven or if the number of symptoms does not achieve the DSM threshold for diagnosis. These diagnostic issues are an even larger concern for clinicians faced with adults with substance use disorders (SUD). The present study compared four groups of adults: full ADHD subjects who met all DSM-IV criteria for childhood onset ADHD, late onset ADHD subjects who met all criteria except the age at onset criterion, subthreshold ADHD subjects who did not meet full symptom criteria, and non-ADHD subjects who did not meet any of the above criteria. Diagnoses were by the Structured Clinical Interview for DSM-IV, and the Drug Use Severity Index (DUSI) was used for self-report of substance use. Cigarette and marijuana use was significantly greater in all ADHD groups relative to non-ADHD controls. Although usage rates of other drugs failed to reach significance, the ADHD groups were more likely to have used each drug (except alcohol) compared with the non-ADHD group. The late onset and full ADHD groups were more likely to have endorsed ever having a problem due to use of cigarettes, alcohol, or marijuana and reported more trouble resisting use of drugs or alcohol. The full ADHD group was more likely than the other groups to have reported "getting high" as their reason for using their preferred drug. Adults with ADHD have elevated rates of substance use and related impairment. Data about late onset ADHD provides further support for the idea that the DSM-IV age at onset criterion is too stringent. In contrast, subthreshold ADHD seems to be a milder form of the disorder, or perhaps a heterogeneous group of true ADHD cases and false positives.

  11. Estimating the health and economic burden of cancer among those diagnosed as adolescents and young adults.

    PubMed

    Guy, Gery P; Yabroff, K Robin; Ekwueme, Donatus U; Smith, Ashley Wilder; Dowling, Emily C; Rechis, Ruth; Nutt, Stephanie; Richardson, Lisa C

    2014-06-01

    Adolescent and young adult cancer survivors-those who were ages 15-39 at their first cancer diagnosis-have important health limitations. These survivors are at risk for higher health care expenditures and lost productivity, compared to adults without a history of cancer. Using Medical Expenditure Panel Survey data, we present nationally representative estimates of the economic burden among people who were diagnosed with cancer in adolescence or young adulthood. Our findings demonstrate that surviving cancer at this age is associated with a substantial economic burden. Compared to adults without a history of cancer, adolescent and young adult cancer survivors had excess annual medical expenditures of $3,170 per person and excess annual productivity losses of $2,250 per person. Multifaceted prevention strategies, including education and sustained intervention programs to ensure access to lifelong risk-based follow-up care, may be effective ways to improve the economic outcomes associated with cancer survivorship in this population. PMID:24889952

  12. Correlation of 18F-fluoroethyl tyrosine positron-emission tomography uptake values and histomorphological findings by stereotactic serial biopsy in newly diagnosed brain tumors using a refined software tool

    PubMed Central

    Lopez, William Omar Contreras; Cordeiro, Joacir Graciolli; Albicker, Ulrich; Doostkam, Soroush; Nikkhah, Guido; Kirch, Robert D; Trippel, Michael; Reithmeier, Thomas

    2015-01-01

    Background Magnetic resonance imaging (MRI) is the standard neuroimaging method to diagnose neoplastic brain lesions, as well as to perform stereotactic biopsy surgical planning. MRI has the advantage of providing structural anatomical details with high sensitivity, though histological specificity is limited. Although combining MRI with other imaging modalities, such as positron-emission tomography (PET), has proven to increment specificity, exact correlation between PET threshold uptake ratios (URs) and histological diagnosis and grading has not yet been described. Objectives The aim of this study was to correlate exactly the histopathological criteria of the biopsy site to its PET uptake value with high spatial resolution (mm3), and to analyze the diagnostic value of PET using the amino acid O-(2-[18F]fluoroethyl)-l-tyrosine (18F-FET) PET in patients with newly diagnosed brain lesions in comparison to histological findings obtained from stereotactic serial biopsy. Patients and methods A total of 23 adult patients with newly diagnosed brain tumors on MRI were enrolled in this study. Subsequently to diagnoses, all patients underwent a 18F-FET PET-guided stereotactic biopsy, using an original newly developed software module, which is presented here. Conventional MRI, stereotactic computed tomography series, and 18F-FET PET images were semiautomatically fused, and hot-spot detection was performed for target planning. UR was determined using the uptake value from the biopsy sites in relation to the contralateral frontal white matter. UR values ≥1.6 were considered positive for glioma. High-grade glioma (HGG) was suspected with URs ≥3.0, while low-grade glioma (LGG) was suspected with URs between 1.6 and 3.0. Stereotactic serial biopsies along the trajectory at multiple sites were performed in millimeter steps, and the FET URs for each site were correlated exactly with a panel of 27 different histopathological markers. Comparisons between FET URs along the biopsy

  13. Efficacy of a Satyananda Yoga Intervention for Reintegrating Adults Diagnosed with Posttraumatic Stress Disorder.

    PubMed

    Quiñones, Natalia; Maquet, Yvonne Gómez; Vélez, Diana María Agudelo; López, Maria Adelaida

    2015-01-01

    The prevalence of posttraumatic stress disorder (PTSD) in ex-combatants from illegal armed groups in Colombia has been estimated at 37.4%. This high prevalence indicates a need to explore alternative and adjunctive therapies in the treatment of PTSD. A randomized controlled trial was undertaken to evaluate the efficacy and safety of a protocol based on Satyananda Yoga® in PTSD-diagnosed reintegrating adults in Colombia. One hundred reintegrating adults (n = 50 for each of the yoga and control arms) from Bogota and Medellin participated in this study. Yoga participants engaged in a Satyananda Yoga intervention for 16 weeks while the control group continued the regular demobilization program. The Posttraumatic Stress Disorder Checklist - Civilian Version (PCL-C) was used to evaluate the effects of the applied therapy. Outcomes were assessed before entry and after the treatment. T-tests revealed a treatment effect of d = 1.15 for the yoga group and a between-groups effect size of d = .73. The difference in improvement in PCL-C scores between both groups was 18.91% (p < 0.05). The highest percentage of improvement was observed in the re-experiencing symptom cluster (23.71%; p < 0.05), with a treatment effect of d = 1.40 for the yoga group and a between-groups effect size of d = 1.15. The data suggest that Satyananda Yoga methodology is an effective therapy for reintegrating adults diagnosed with PTSD. Further research is needed in order to evaluate prolonged effects of this alternative therapy.

  14. Advice for the Newly Diagnosed

    MedlinePlus

    ... would be ridiculous to suggest that a positive mental attitude is achievable all the time. But there are various methods that can help ... in challenging activities that you enjoy: classes, artwork, travel, community work, ... medical treatment for mental ills. Don't let yourself become isolated. Pick ...

  15. Efficacy and patient-reported outcomes with dose-intense temozolomide in patients with newly diagnosed pure and mixed anaplastic oligodendroglioma: a phase II multicenter study.

    PubMed

    Ahluwalia, Manmeet S; Xie, Hao; Dahiya, Saurabh; Hashemi-Sadraei, Nooshin; Schiff, David; Fisher, Paul G; Chamberlain, Marc C; Pannullo, Susan; Newton, Herbert B; Brewer, Cathy; Wood, Laura; Prayson, Richard; Elson, Paul; Peereboom, David M

    2015-03-01

    Standard initial therapy for patients with pure and mixed anaplastic oligodendrogliomas (AO/MAO) includes chemotherapy and radiation therapy. Anaplastic oligodendrogliomas with 1p/19q co-deletion are more responsive to chemotherapy. There is concern for potential long-term CNS toxicity of radiation. Hence an approach using chemotherapy initially and reserving radiation for progressive disease is attractive. This multicenter phase II trial included patients with newly diagnosed AO/MAO with central pathology review and 1p/19q assay. Temozolomide was given 150 mg/m(2) days 1-7 and 15-21, every 28 days for 8 cycles. The primary endpoint was progression free survival (PFS). Secondary endpoints included response rate, overall survival (OS), treatment toxicity and health-related quality of life (HRQL). Data from 62 patients enrolled between December 2001 and April 2007 at seven centers were analyzed. Among patients with measurable disease, 8 % achieved complete remission, 56 % had stable disease and 36 % had progression. The median PFS and OS were 27.2 months (95 % CI 11.9-36.3) and 105.8 months (95 % CI 51.5-N/A), respectively. Both 1p loss and 1p/19q co-deletion were positive prognostic factors for PFS (p < 0.001) and OS (p < 0.001); and there was some suggestion that 1p/19q co-deletion also predicted better response to chemotherapy (p = 0.007). Grade 3/4 toxicities were mainly hematological. Significantly improved HRQL in the future uncertainty domain of the brain cancer module was seen after cycle 4 (p < 0.001). This trial achieved outcomes similar to those reported previously. Toxicities from dose-intense temozolomide were manageable. Improvement in at least one HRQL domain increased over time. This trial supports the further study of first-line temozolomide monotherapy as an alternative to radiation therapy for patients with newly diagnosed AO/MAO with 1p 19q co-deleted tumors.

  16. Is anxiety more common in school students with newly diagnosed specific learning disabilities? A cross-sectional questionnaire-based study in Mumbai, Maharashtra, India

    PubMed Central

    Thakkar, AN; Karande, S; Bala, N; Sant, H; Gogtay, NJ; Sholapurwala, R

    2016-01-01

    Background and Objectives: School students with specific learning disabilities (SpLDs) experience chronic academic underachievement and resultant stress. The present study aimed to determine if school students with newly diagnosed SpLD were more likely to have anxiety than their regular peers. Materials and Methods: The study cases (aged 8-15 years) were recruited from our institute's learning disability clinic. The matched controls were recruited from four schools in Mumbai, Maharashtra, India. Anxiety was measured using the Spence Children's Anxiety Scale (SCAS)-child self-report version questionnaire. Median SCAS scores and the proportion of students with an SCAS score in the “clinical anxiety” range were compared between the groups. Results: SCAS scores were significantly higher in 8-11-year-old learning-disabled male and female students (P < 0.0001 for both groups) and 12-15-year-old female students (P = 0.004), as compared with matched controls. A significantly higher number of learning-disabled students were found to have “clinical anxiety” [24.64% vs 4.35%, crude odds ratio (OR) = 7.19, 95% confidence interval (CI) 2.91-17.78, P = 0.0001], as compared with the controls regardless of gender, age group, presence of comorbid attention-deficit/hyperactivity disorder (ADHD), or associated medical conditions. A significantly higher proportion of 8-11-year-old learning-disabled students, especially males, were found to have “clinical anxiety” as compared with 12-15-year-old learning-disabled students (crude OR = 4.38, 95% CI 1.94-9.92, P = 0.0004). Gender, presence of comorbid ADHD or associated medical conditions, and type of school attended or curriculum did not impact the prevalence of “clinical anxiety” in learning-disabled students. Interpretation and Conclusions: Students with newly diagnosed SpLD have greater odds of being “clinically anxious” relative to their regular peers. We recommend screening for anxiety in children with Sp

  17. Gliadel wafer implantation combined with standard radiotherapy and concurrent followed by adjuvant temozolomide for treatment of newly diagnosed high-grade glioma: a systematic literature review.

    PubMed

    Ashby, Lynn S; Smith, Kris A; Stea, Baldassarre

    2016-08-24

    Since 2003, only two chemotherapeutic agents, evaluated in phase III trials, have been approved by the US Food and Drug Administration for treatment of newly diagnosed high-grade glioma (HGG): Gliadel wafers (intracranially implanted local chemotherapy) and temozolomide (TMZ) (systemic chemotherapy). Neither agent is curative, but each has been shown to improve median overall survival (OS) compared to radiotherapy (RT) alone. To date, no phase III trial has tested these agents when used in sequential combination; however, a number of smaller trials have reported favorable results. We performed a systematic literature review to evaluate the combination of Gliadel wafers with standard RT (60 Gy) plus concurrent and adjuvant TMZ (RT/TMZ) for newly diagnosed HGG. A literature search was conducted for the period of January 1995 to September 2015. Data were extracted and categorized, and means and ranges were determined. A total of 11 publications met criteria, three prospective trials and eight retrospective studies, representing 411 patients who received Gliadel plus standard RT/TMZ. Patients were similar in age, gender, and performance status. The weighted mean of median OS was 18.2 months (ten trials, n = 379, range 12.7 to 21.3 months), and the weighted mean of median progression-free survival was 9.7 months (seven trials, n = 287, range 7 to 12.9 months). The most commonly reported grade 3 and 4 adverse events were myelosuppression (10.22 %), neurologic deficit (7.8 %), and healing abnormalities (4.3 %). Adverse events reflected the distinct independent safety profiles of Gliadel wafers and RT/TMZ, with little evidence of enhanced toxicity from their use in sequential combination. In the 11 identified trials, an increased benefit from sequentially combining Gliadel wafers with RT/TMZ was strongly suggested. Median OS tended to be improved by 3 to 4 months beyond that observed for Gliadel wafers or TMZ when used alone in the respective phase III

  18. Independent Association of Circulating Level of Chemerin With Functional and Early Morphological Vascular Changes in Newly Diagnosed Type 2 Diabetic Patients

    PubMed Central

    Lu, Bin; Zhao, Ming; Jiang, Weimin; Ma, Jian; Yang, Cuihua; Shao, Jiaqing; Gu, Ping

    2015-01-01

    Abstract There is growing evidence that chemerin, a novel adipokine elevated in obesity and metabolic syndromes, plays a crucial role in advanced atherosclerosis. This study aimed to determine the chemerin levels in diabetes and evaluate the effects of increased chemerin on early atherosclerosis. A total of 245 newly diagnosed diabetic patients and 148 age-matched, healthy, normal glucose tolerant (NGT) controls were enrolled. Anthropometric measurements and plasma parameters were examined, including body mass index (BMI), waist circumference, blood pressure, glucose, lipid profiles, inflammation markers, adipokines, and cell adhesion molecules. Vascular healthy was measured with brachial flow-mediated dilatation (FMD) and carotid intima-media thickness (IMT). Compared with NGT controls, plasma chemerin levels were higher in diabetic patients (P < 0.01) and higher chemerin level was an independent risk factor of occurrence of diabetes even after metabolic profiles were adjusted (odds ratio [OR] = 1.352, 95% CI: 1.181–1.543, P < 0.01). In patients with type 2 diabetes, chemerin was positively associated with intercellular adhesion molecule-1 (ICAM-1), E-selectin, but not vascular adhesion molecule-1 (VCAM-1) and P-selectin. We also explored that plasma chemerin level was negatively associated with brachial FMD and positively with carotid IMT. Chemerin also retained a strong association with ICAM-1, FMD, and IMT even after adjusted for age, sex, and other risk factors (ICAM-1: r = 0.150, P = 0.024; FMD: r = −0.126, P = 0.001; IMT: r = 0.325, P < 0.001). By multiple linear regression analysis, plasma chemerin levels were related to ICAM-1 even after adjustments for conventional cardiovascular risk factors (β = 0.192, P = 0.017). Moreover, logistic regression analysis showed that high chemerin level was an independent predictive variable for impaired endothelial function (OR = 1.066, 95% CI: 1.012–1.142, P = 0

  19. Effect of Bevacizumab Plus Temozolomide-Radiotherapy for Newly Diagnosed Glioblastoma with Different MGMT Methylation Status: A Meta-Analysis of Clinical Trials

    PubMed Central

    Du, Chigang; Ren, Junquan; Zhang, Rui; Xin, Tao; Li, Zhongmin; Zhang, Zhiti; Xu, Xinghua; Pang, Qi

    2016-01-01

    Background MGMT methylation status can influence the therapeutic effect and prognosis of glioblastoma (GBM). There are conflicting results from studies evaluating the efficacy of bevacizumab (BV) when it is combined with temozolomide (TMZ) and radiotherapy (RT) in patients diagnosed with GBM with different MGMT methylation status. Material/Methods Data were extracted from publications in PubMed, Embase, and The Cochrane Library, with the last search performed March 23, 2016. Data on overall survival (OS), progression-free survival (PFS), and MGMT methylation status were obtained. Results Data from 3 clinical trials for a total of 1443 subjects were used for this meta-analysis. MGMT methylated and unmethylated patients showed improved PFS in the BV group (pooled HRs, 0.769, 95% CIs 0.604–0.978, P=0.032; 0.675, 95%CIs 0.466–0.979, P=0.038). For patients with either type of GBM, BV did not improve the OS based on the pooled HRs 1.132 (95% CIs 0.876–1.462; P=0.345) for methylated and 1.018 (95% CIs 0.879–1.179; P=0.345) for unmethylated. Conclusions Bevacizumab combined with temozolomide-radiotherapy correlated with improved PFS for treatment of patients with different MGMT methylation status of newly diagnosed GBM. There was insufficient evidence to determine the synergistic effects of combining BV with TMZ and RT on improving survival in patients with different MGMT methylation status. PMID:27684457

  20. BRCA1/2 testing in newly diagnosed breast and ovarian cancer patients without prior genetic counselling: the DNA-BONus study.

    PubMed

    Høberg-Vetti, Hildegunn; Bjorvatn, Cathrine; Fiane, Bent E; Aas, Turid; Woie, Kathrine; Espelid, Helge; Rusken, Tone; Eikesdal, Hans Petter; Listøl, Wenche; Haavind, Marianne T; Knappskog, Per M; Haukanes, Bjørn Ivar; Steen, Vidar M; Hoogerbrugge, Nicoline

    2016-06-01

    Germline BRCA1/2 testing of breast and ovarian cancer patients is growing rapidly as the result affects both treatment and cancer prevention in patients and relatives. Through the DNA-BONus study we offered BRCA1/2 testing and familial risk assessment to all new patients with breast (N=893) or ovarian (N=122) cancer diagnosed between September 2012 and April 2015, irrespective of family history or age, and without prior face-to-face genetic counselling. BRCA1/2 testing was accepted by 405 (45.4%) and 83 (68.0%) of the patients with breast or ovarian cancer, respectively. A pathogenic BRCA1/2 variant was found in 7 (1.7%) of the breast cancer patients and 19 (22.3%) of the ovarian cancer patients. In retrospect, all BRCA1/2 mutation carriers appeared to fulfill current criteria for BRCA1/2 testing. Hospital Anxiety and Depression Scale (HADS) scores showed that the mean levels of anxiety and depression were comparable to those reported for breast and gynecological cancer patients in general, with a significant drop in anxiety symptoms during a 6-month follow-up period, during which the test result was forwarded to the patients. These results show that BRCA1/2 testing is well accepted in newly diagnosed breast and ovarian cancer patients. Current test criteria based on age and family history are sufficient to identify most BRCA1/2 mutation carriers among breast cancer patients. We recommend germline BRCA1/2 testing in all patients with epithelial ovarian cancer because of the high prevalence of pathogenic BRCA1/2 variants.

  1. Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial

    PubMed Central

    Oza, Amit M; Cook, Adrian D; Pfisterer, Jacobus; Embleton, Andrew; Ledermann, Jonathan A; Pujade-Lauraine, Eric; Kristensen, Gunnar; Carey, Mark S; Beale, Philip; Cervantes, Andrés; Park-Simon, Tjoung-Won; Rustin, Gordon; Joly, Florence; Mirza, Mansoor R; Plante, Marie; Quinn, Michael; Poveda, Andrés; Jayson, Gordon C; Stark, Dan; Swart, Ann Marie; Farrelly, Laura; Kaplan, Richard; Parmar, Mahesh K B; Perren, Timothy J

    2015-01-01

    Summary Background The ICON7 trial previously reported improved progression-free survival in women with ovarian cancer with the addition of bevacizumab to standard chemotherapy, with the greatest effect in patients at high risk of disease progression. We report the final overall survival results of the trial. Methods ICON7 was an international, phase 3, open-label, randomised trial undertaken at 263 centres in 11 countries across Europe, Canada, Australia and New Zealand. Eligible adult women with newly diagnosed ovarian cancer that was either high-risk early-stage disease (International Federation of Gynecology and Obstetrics [FIGO] stage I–IIa, grade 3 or clear cell histology) or more advanced disease (FIGO stage IIb–IV), with an Eastern Cooperative Oncology Group performance status of 0–2, were enrolled and randomly assigned in a 1:1 ratio to standard chemotherapy (six 3-weekly cycles of intravenous carboplatin [AUC 5 or 6] and paclitaxel 175 mg/m2 of body surface area) or the same chemotherapy regimen plus bevacizumab 7·5 mg per kg bodyweight intravenously every 3 weeks, given concurrently and continued with up to 12 further 3-weekly cycles of maintenance therapy. Randomisation was done by a minimisation algorithm stratified by FIGO stage, residual disease, interval between surgery and chemotherapy, and Gynecologic Cancer InterGroup group. The primary endpoint was progression-free survival; the study was also powered to detect a difference in overall survival. Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN91273375. Findings Between Dec 18, 2006, and Feb 16, 2009, 1528 women were enrolled and randomly assigned to receive chemotherapy (n=764) or chemotherapy plus bevacizumab (n=764). Median follow-up at the end of the trial on March 31, 2013, was 48·9 months (IQR 26·6–56·2), at which point 714 patients had died (352 in the chemotherapy group and 362 in the

  2. AIDA (all-trans retinoic acid + idarubicin) in newly diagnosed acute promyelocytic leukemia: a Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) pilot study.

    PubMed

    Avvisati, G; Lo Coco, F; Diverio, D; Falda, M; Ferrara, F; Lazzarino, M; Russo, D; Petti, M C; Mandelli, F

    1996-08-15

    From March 1993 to October 1993, 20 consecutive, newly diagnosed acute promyelocytic leukemia (APL) patients from 13 Italian institutions entered in a pilot study named AIDA, combining all-trans retinoic acid (ATRA) with idarubicin (IDA). ATRA was administered orally beginning on the first day of induction at the dosage of 45 mg/m2/d until complete remission (CR), whereas IDA was administered intravenously at the dosage of 12 mg/m2/d on days 2, 4, 6, and 8 of the induction. Patients who achieved CR were consolidated with 3 courses of chemotherapy without ATRA; thereafter, they were followed up for molecular and hematologic CR. The median age was 35.3 years (range, 6.5 to 67.6 years); 8 patients were males and 12 females; 4 had the hypogranular variant of APL (M3v), and 4 (2 with M3v) presented with leukocyte counts > or = 10,000/microL. Molecular analysis for the promyelocytic leukemia-retinoic acid receptor alpha (PML-RAR alpha) hybrid gene at diagnosis was performed in 16 patients by means of reverse transcription-polymerase chain reaction (RT-PCR) analysis, and all were RT-PCR+ for the hybrid gene. In the remaining 4 patients, the cytogenetic study showed the presence of the t(15;17). After a median time of 36 days (range, 28 to 52 days) 18 (90%) patients achieved CR; the remaining 2 patients died 12 and 34 days after diagnosis from myocardial infarction caused by fungal myocarditis and from massive hemoptysis, respectively. ATRA syndrome was observed in only 2 patients, and, after the prompt discontinuation of ATRA and initiation of dexamethasone, both recovered from the syndrome. However, after recovering, 1 patient achieved CR, whereas the other died at day 34 because of massive hemoptysis; other side effects were very limited. At recovery from the third consolidation course, only 3 of 14 (21.4%) tested patients were RT-PCR+ for the PML-RAR alpha hybrid gene. Of these, 2 relapsed shortly afterwards; however, in the last patient, the PML-RAR alpha disappeared

  3. Provider views of harm reduction versus abstinence policies within homeless services for dually diagnosed adults.

    PubMed

    Henwood, Benjamin F; Padgett, Deborah K; Tiderington, Emmy

    2014-01-01

    Harm reduction is considered by many to be a legitimate alternative to abstinence-based services for dually diagnosed individuals, yet there is limited understanding of how varying approaches affect front-line practice within services for homeless adults. This paper examines how front-line providers working with individuals who have experienced homelessness, serious mental illness, and addiction view policies of harm reduction versus abstinence within two different approaches to homeless services: the traditional or "treatment first" approach that requires abstinence, and the more recent housing first approach that incorporates harm reduction. As part of a federally funded qualitative study, 129 in-depth interviews conducted with 41 providers were thematically analyzed to understand how providers view harm reduction versus abstinence approaches. Themes included the following: (a) harm reduction as a welcomed alternative, (b) working with ambiguity, and (c) accommodating abstinence. Drawing on recovery principles, the authors consider the broader implications of the findings for behavioral health care with this population.

  4. Successful desensitization to imiglucerase of an adult patient diagnosed with type I Gaucher disease.

    PubMed

    Erdoğdu, Derya; Gelincik, Aslı; Canbaz, Bülent; Colakoğlu, Bahattin; Büyüköztürk, Suna; Tanakol, Refik

    2013-01-01

    Gaucher disease is the most common lysosomal storage disorder, and enzyme replacement therapy, such as administration of imiglucerase, is the standard therapy. Anaphylaxis to imiglucerase is rarely reported. Here, we report a 26-year-old female who was diagnosed with type 1 Gaucher disease and referred to our Allergy Outpatient Clinic because of an anaphylactic reaction due to imiglucerase enzyme therapy. A desensitization protocol was administered with two different dilutions with an increasing rate of administration delivered in 10 consecutive steps by intravenous infusion in an intensive care setting. No reactions occurred during the procedure, and the total final dose of 2,000 U was successfully administered. To our knowledge, this is the first adult case with successful desensitization to imiglucerase. Desensitization protocols to drugs in chronic disease patients for whom no alternative therapies are available can be lifesaving. PMID:23018845

  5. Aspects of Sexuality in Adolescents and Adults Diagnosed with Autism Spectrum Disorders in Childhood.

    PubMed

    Fernandes, Lucrecia Cabral; Gillberg, Carina I; Cederlund, Mats; Hagberg, Bibbi; Gillberg, Christopher; Billstedt, Eva

    2016-09-01

    The literature concerning sexuality in autism spectrum disorders (ASDs) is limited regarding inappropriate sexual behaviours and paraphilias and its relation to age, verbal ability, symptom severity, intellectual ability, or adaptive functioning. A cohort of 184 adolescents and young adults (ages 15-39 years) with ASD diagnosed in childhood, including both low and high functioning individuals, was examined. The large majority were found to have a sexual interest and showed interest towards the opposite sex. Inappropriate sexual behaviours and paraphilias were reported for about a fourth of the individuals. No relationships were found between inappropriate sexual behaviours and any of the background variables listed above. However, associations were found between paraphilias and ASD symptom severity, intellectual ability, and adaptive functioning. PMID:27401993

  6. Non-daily Smoking and Alcohol Use, Hazardous Drinking, and Alcohol Diagnoses among Young Adults

    PubMed Central

    Harrison, Emily L.R.; Desai, Rani A.; McKee, Sherry A.

    2008-01-01

    Background Non-daily smoking and heavy alcohol use are prevalent behaviors among young adults, with non-daily smoking occurring primarily in the context of alcohol use. Although the relationship between drinking and daily smoking has been well characterized in young adults, few epidemiological investigations have investigated the association between non-daily smoking and drinking behavior. Methods We examined Wave 1 of the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC; Grant et al., 2003; n=43,093). Young adults (age 18-25; n=5,838) were stratified on current smoking behavior (daily, non-daily, and non-smokers in the past 12 months) and differences in weekly quantity of alcohol use, frequency of alcohol use, frequency of binge drinking behavior, rates of NIAAA-defined hazardous drinking, and rates of DSM-IV alcohol diagnoses were investigated. College student status was examined. Results 25% were current smokers and 7% were smoking on a non-daily basis. 71% were current drinkers, 39% reported binge drinking at least once a month, 41% met criteria for hazardous drinking, and 18% had alcohol use disorders. Across all measures of alcohol use there was a significant effect of smoking status, with daily smokers having greater alcohol use patterns, compared to non-daily smokers, with non-smokers consuming the least. Non-daily smokers were more likely to report any binge drinking in the past 12 months. However, daily smokers were more likely to report daily binge drinking. With regard to hazardous drinking and alcohol use disorders, non-daily smoking conferred the greatest risk, followed by daily smoking with non-smoking as the reference group. Multinomial logistic regression demonstrated the odds of being a hazardous drinker were 16 times greater (95% CI 9.46 — 26.48) in a non-daily smoker compared to a non-smoker, whereas the odds for a daily smoker were increased by 7-fold (95% CI 5.54 — 9.36). A similar pattern of results was demonstrated

  7. Cigarette Smoking Is Associated with a Lower Prevalence of Newly Diagnosed Diabetes Screened by OGTT than Non-Smoking in Chinese Men with Normal Weight

    PubMed Central

    Chen, Peizhu; Lu, Jun; Ma, Xiaojing; Lu, Juming; Weng, Jianping; Ji, Linong; Shan, Zhongyan; Liu, Jie; Tian, Haoming; Ji, Qiuhe; Zhu, Dalong; Ge, Jiapu; Lin, Lixiang; Chen, Li; Guo, Xiaohui; Zhao, Zhigang; Li, Qiang; Zhou, Zhiguang; Yang, Wenying; Jia, Weiping

    2016-01-01

    Different studies have produced conflicting results regarding the association between smoking and diabetes mellitus, and detailed analysis of this issue in Chinese males based on nationwide samples is lacking. We explored the association between cigarette smoking and newly-diagnosed diabetes mellitus (NDM) in Chinese males using a population-based case-control analysis; 16,286 male participants without previously diagnosed diabetes were included. Prediabetes and NDM were diagnosed using the oral glucose tolerance test. The cohort included 6,913 non-smokers (42.4%), 1,479 ex-smokers (9.1%) and 7,894 current smokers (48.5%). Age-adjusted glucose concentrations (mmol/L) were significantly lower at fasting and 120 min in current smokers than non-smokers (5.25 vs. 5.30, 6.46 vs. 6.55, respectively, both P < 0.01). After adjustment for demographic and behavioral variables (age, region, alcohol consumption status, physical activity, education, and family history of diabetes), logistic regression revealed significant negative associations between smoking and NDM in males of a normal weight (BMI < 25 kg/m2: adjusted odds ratio [AOR] = 0.75, P = 0.007; waist circumference < 90 cm: AOR = 0.71, P = 0.001) and males living in southern China (AOR = 0.75, P = 0.009), but not in males who were overweight/obese, males with central obesity, or males living in northern China. Compared to non-smokers, current smokers were less likely to be centrally obese or have elevated BP (AOR: 0.82 and 0.74, both P < 0.05), and heavy smokers (≥ 20 pack-years) were less likely to have elevated TG (AOR = 0.84, P = 0.012) among males of a normal weight. There were no significant associations between quitting smoking and metabolic disorders either among males of a normal weight or males who were overweight/obese. In conclusion, smokers have a lower likelihood of NDM than non-smokers among Chinese males with a lower BMI/smaller waist. PMID:26954355

  8. Cigarette Smoking Is Associated with a Lower Prevalence of Newly Diagnosed Diabetes Screened by OGTT than Non-Smoking in Chinese Men with Normal Weight.

    PubMed

    Hou, Xuhong; Qiu, Jieyuzhen; Chen, Peizhu; Lu, Jun; Ma, Xiaojing; Lu, Juming; Weng, Jianping; Ji, Linong; Shan, Zhongyan; Liu, Jie; Tian, Haoming; Ji, Qiuhe; Zhu, Dalong; Ge, Jiapu; Lin, Lixiang; Chen, Li; Guo, Xiaohui; Zhao, Zhigang; Li, Qiang; Zhou, Zhiguang; Yang, Wenying; Jia, Weiping

    2016-01-01

    Different studies have produced conflicting results regarding the association between smoking and diabetes mellitus, and detailed analysis of this issue in Chinese males based on nationwide samples is lacking. We explored the association between cigarette smoking and newly-diagnosed diabetes mellitus (NDM) in Chinese males using a population-based case-control analysis; 16,286 male participants without previously diagnosed diabetes were included. Prediabetes and NDM were diagnosed using the oral glucose tolerance test. The cohort included 6,913 non-smokers (42.4%), 1,479 ex-smokers (9.1%) and 7,894 current smokers (48.5%). Age-adjusted glucose concentrations (mmol/L) were significantly lower at fasting and 120 min in current smokers than non-smokers (5.25 vs. 5.30, 6.46 vs. 6.55, respectively, both P < 0.01). After adjustment for demographic and behavioral variables (age, region, alcohol consumption status, physical activity, education, and family history of diabetes), logistic regression revealed significant negative associations between smoking and NDM in males of a normal weight (BMI < 25 kg/m2: adjusted odds ratio [AOR] = 0.75, P = 0.007; waist circumference < 90 cm: AOR = 0.71, P = 0.001) and males living in southern China (AOR = 0.75, P = 0.009), but not in males who were overweight/obese, males with central obesity, or males living in northern China. Compared to non-smokers, current smokers were less likely to be centrally obese or have elevated BP (AOR: 0.82 and 0.74, both P < 0.05), and heavy smokers (≥ 20 pack-years) were less likely to have elevated TG (AOR = 0.84, P = 0.012) among males of a normal weight. There were no significant associations between quitting smoking and metabolic disorders either among males of a normal weight or males who were overweight/obese. In conclusion, smokers have a lower likelihood of NDM than non-smokers among Chinese males with a lower BMI/smaller waist.

  9. Cigarette Smoking Is Associated with a Lower Prevalence of Newly Diagnosed Diabetes Screened by OGTT than Non-Smoking in Chinese Men with Normal Weight.

    PubMed

    Hou, Xuhong; Qiu, Jieyuzhen; Chen, Peizhu; Lu, Jun; Ma, Xiaojing; Lu, Juming; Weng, Jianping; Ji, Linong; Shan, Zhongyan; Liu, Jie; Tian, Haoming; Ji, Qiuhe; Zhu, Dalong; Ge, Jiapu; Lin, Lixiang; Chen, Li; Guo, Xiaohui; Zhao, Zhigang; Li, Qiang; Zhou, Zhiguang; Yang, Wenying; Jia, Weiping

    2016-01-01

    Different studies have produced conflicting results regarding the association between smoking and diabetes mellitus, and detailed analysis of this issue in Chinese males based on nationwide samples is lacking. We explored the association between cigarette smoking and newly-diagnosed diabetes mellitus (NDM) in Chinese males using a population-based case-control analysis; 16,286 male participants without previously diagnosed diabetes were included. Prediabetes and NDM were diagnosed using the oral glucose tolerance test. The cohort included 6,913 non-smokers (42.4%), 1,479 ex-smokers (9.1%) and 7,894 current smokers (48.5%). Age-adjusted glucose concentrations (mmol/L) were significantly lower at fasting and 120 min in current smokers than non-smokers (5.25 vs. 5.30, 6.46 vs. 6.55, respectively, both P < 0.01). After adjustment for demographic and behavioral variables (age, region, alcohol consumption status, physical activity, education, and family history of diabetes), logistic regression revealed significant negative associations between smoking and NDM in males of a normal weight (BMI < 25 kg/m2: adjusted odds ratio [AOR] = 0.75, P = 0.007; waist circumference < 90 cm: AOR = 0.71, P = 0.001) and males living in southern China (AOR = 0.75, P = 0.009), but not in males who were overweight/obese, males with central obesity, or males living in northern China. Compared to non-smokers, current smokers were less likely to be centrally obese or have elevated BP (AOR: 0.82 and 0.74, both P < 0.05), and heavy smokers (≥ 20 pack-years) were less likely to have elevated TG (AOR = 0.84, P = 0.012) among males of a normal weight. There were no significant associations between quitting smoking and metabolic disorders either among males of a normal weight or males who were overweight/obese. In conclusion, smokers have a lower likelihood of NDM than non-smokers among Chinese males with a lower BMI/smaller waist. PMID:26954355

  10. Early cerebral volume reductions and their associations with reduced lupus disease activity in patients with newly-diagnosed systemic lupus erythematosus.

    PubMed

    Mak, Anselm; Ho, Roger Chun-Man; Tng, Han-Ying; Koh, Hui Li; Chong, Joanna Su Xian; Zhou, Juan

    2016-03-01

    We examined if cerebral volume reduction occurs very early during the course of systemic lupus erythematosus (SLE), and observed prospectively whether gray (GMV) and white matter volumes (WMV) of the brain would improve with lowered SLE disease activity. T1-weighted MRI brain images were obtained from 14 healthy controls (HC) and 14 newly-diagnosed SLE patients within 5 months of diagnosis (S1) and after achieving low disease activity (S2). Whole brain voxel-based morphometry was used to detect differences in the GMV and WMV between SLE patients and HC and those between SLE patients at S1 and S2. SLE patients were found to have lower GMV than HC in the middle cingulate cortex, middle frontal gyrus and right supplementary motor area, and lower WMV in the superior longitudinal fasciculus, cingulum cingulate gyrus and inferior fronto-occipital fasciculus at both S1 and S2. Whole-brain voxel-wise analysis revealed increased GMV chiefly in the prefrontal regions at S2 compared to S1 in SLE patients. The GMV increase in the left superior frontal gyrus was significantly associated with lowered SLE disease activity. In conclusion, GMV and WMV reduced very early in SLE patients. Reduction of SLE disease activity was accompanied by region-specific GMV improvement in the prefrontal regions.

  11. Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomised phase-2 study (NordCML006)

    PubMed Central

    Hjorth-Hansen, Henrik; Stenke, Leif; Söderlund, Stina; Dreimane, Arta; Ehrencrona, Hans; Gedde-Dahl, Tobias; Gjertsen, Bjørn Tore; Höglund, Martin; Koskenvesa, Perttu; Lotfi, Kourosh; Majeed, Waleed; Markevärn, Berit; Ohm, Lotta; Olsson-Strömberg, Ulla; Remes, Kari; Suominen, Merja; Simonsson, Bengt; Porkka, Kimmo; Mustjoki, Satu; Richter, Johan

    2015-01-01

    We randomised 46 newly diagnosed patients with chronic myeloid leukaemia (median age 56) to receive dasatinib 100 mg QD or imatinib 400 mg QD and report outcome as an intention-to-treat analysis with 36 months follow-up. Early cytogenetic and molecular responses were superior in the dasatinib group, with a tendency that imatinib patients caught up with time. For instance, MR3.0 was reached at 3 months in 36% vs. 8% (P = 0.02), at 12 months in 81% vs. 46% (P = 0.02) and at 18 months in 73% vs. 65% (n.s.) of the patients in the two groups. In contrast, MR4.5 was consistently superior in the dasatinib group at all time points from 6 months onwards, reaching 61% vs. 21% (P < 0.05) at 36 months. Sixty-four vs. 71% of the patients in the dasatinib and imatinib arms, respectively, remained on assigned drug. Dasatinib dose was frequently reduced, but with maintained excellent effect. One imatinib patient progressed to blastic phase, but no CML-related deaths occurred. In conclusion, our data compare favourably with those of the dasatinib registration study, DASISION. The fast and deep molecular responses induced by dasatinib compared with imatinib may be exploited to increase the proportion of patients who can achieve a treatment-free remission after treatment discontinuation. PMID:25082346

  12. Long-term outcome of patients with newly diagnosed chronic myeloid leukemia: a randomized comparison of stem cell transplantation with drug treatment.

    PubMed

    Gratwohl, A; Pfirrmann, M; Zander, A; Kröger, N; Beelen, D; Novotny, J; Nerl, C; Scheid, C; Spiekermann, K; Mayer, J; Sayer, H G; Falge, C; Bunjes, D; Döhner, H; Ganser, A; Schmidt-Wolf, I; Schwerdtfeger, R; Baurmann, H; Kuse, R; Schmitz, N; Wehmeier, A; Fischer, J Th; Ho, A D; Wilhelm, M; Goebeler, M-E; Lindemann, H W; Bormann, M; Hertenstein, B; Schlimok, G; Baerlocher, G M; Aul, C; Pfreundschuh, M; Fabian, M; Staib, P; Edinger, M; Schatz, M; Fauser, A; Arnold, R; Kindler, T; Wulf, G; Rosselet, A; Hellmann, A; Schäfer, E; Prümmer, O; Schenk, M; Hasford, J; Heimpel, H; Hossfeld, D K; Kolb, H-J; Büsche, G; Haferlach, C; Schnittger, S; Müller, M C; Reiter, A; Berger, U; Saußele, S; Hochhaus, A; Hehlmann, R

    2016-03-01

    Tyrosine kinase inhibitors represent today's treatment of choice in chronic myeloid leukemia (CML). Allogeneic hematopoietic stem cell transplantation (HSCT) is regarded as salvage therapy. This prospective randomized CML-study IIIA recruited 669 patients with newly diagnosed CML between July 1997 and January 2004 from 143 centers. Of these, 427 patients were considered eligible for HSCT and were randomized by availability of a matched family donor between primary HSCT (group A; N=166 patients) and best available drug treatment (group B; N=261). Primary end point was long-term survival. Survival probabilities were not different between groups A and B (10-year survival: 0.76 (95% confidence interval (CI): 0.69-0.82) vs 0.69 (95% CI: 0.61-0.76)), but influenced by disease and transplant risk. Patients with a low transplant risk showed superior survival compared with patients with high- (P<0.001) and non-high-risk disease (P=0.047) in group B; after entering blast crisis, survival was not different with or without HSCT. Significantly more patients in group A were in molecular remission (56% vs 39%; P=0.005) and free of drug treatment (56% vs 6%; P<0.001). Differences in symptoms and Karnofsky score were not significant. In the era of tyrosine kinase inhibitors, HSCT remains a valid option when both disease and transplant risk are considered. PMID:26464170

  13. [Randomized comparison of intravenous immunoglobulin and methylprednisolone pulse therapy in children with newly diagnosed idiopathic thrombocytic purpura. The Danish ITP Study Group].

    PubMed

    Rosthøj, S; Nielsen, S M; Pedersen, F K

    1998-03-01

    Forty three children with newly diagnosed idiopathic thrombocytopenic purpura (ITP), platelet count (pl.c.) below 20 x 10(9)/l, and either clinically significant bleeding or failure to show a spontaneous platelet rise within three days of admission were randomly allocated to treatment with intravenous infusions of either immunoglobulin (IVIG) 1 g/kg or methylprednisolone (MPPT) 30 mg/kg on two consecutive days. Prompt induction of partial remission with pl.c. > 50 x 10(9)/l after 72 hours was seen in 21/23 given IVIG versus 10/20 given MPPT (exact p = 0.003); mean pl.c.s after 72 hours were 188 versus 77 x 10(9)/l (2p < 0.001). Poor responders were then given the alternative infusions in addition. After six days, complete remission with pl.c. > 150 x 10(9)/l was achieved in 16/23 versus 10/20 (p = 0.16). During six months follow-up, there were no significant differences regarding relapse rates or chronic course. Eleven children with relapse were crossed over to the alternative treatment arm: the estimated treatment effect in pl.c. after 72 hours was 134 x 10(9)/l in favour of IVIG. These results indicate that IVIG infusions may be preferable to high-dose corticosteroids as initial treatment for children with ITP. PMID:9522658

  14. Variations in the Role of Social Support on Disclosure Among Newly Diagnosed HIV-Infected People Who Inject Drugs in Vietnam.

    PubMed

    Go, Vivian F; Latkin, Carl; Le Minh, Nguyen; Frangakis, Constantine; Ha, Tran Viet; Sripaipan, Teerada; Mo, Tran Thi; Davis, Wendy W; Vu, Pham The; Quan, Vu Minh

    2016-01-01

    Stigma and perceived social support can influence the decision to disclose HIV positive status, especially for people who inject drugs (PWID). In this analysis, the association between social support and HIV disclosure among 336 newly diagnosed HIV-infected PWID in Northern Vietnam was assessed. One month after diagnosis, 34.8 % of participants had not disclosed to anyone. Disclosure to anyone and to a family member specifically, was associated with baseline social support in the form of positive interactions and a history of incarceration. Disclosing to a family member was less likely among those who had unprotected sex in the previous 3 months. Disclosure to an injecting partner was more likely among those with a history of being in a drug treatment program, knowing someone on ART and believing that ART is safe. These data suggest that social support may facilitate disclosure among family members, including spouses, while disclosure to injecting partners is greater when PWID know that ART is a safe and viable option.

  15. Selective activation of T cells in newly diagnosed insulin-dependent diabetic patients: evidence for heterogeneity of T cell receptor usage.

    PubMed Central

    Kontiainen, S; Toomath, R; Lowder, J; Feldmann, M

    1991-01-01

    Cell surface phenotyping of 58 newly diagnosed diabetic children and 25 controls confirmed the presence of activated T cells, expressing HLA class II antigens or receptors for interleukin-2 (IL-2R, CD25) in the majority of the patients. Some of these cells putatively include those involved in islet cell destruction, as reported previously. Monoclonal antibodies recognizing three families of the variable regions of the beta chain (V beta) of the T cell receptor were used to determine the percentage of peripheral blood cells expressing those specific gene segment products. The number of the activated T cells from each V beta family was compared with that of the resting T cells of the same family in the patients and the controls. In 18 out of 58 (31%) of these patients there was evidence of oligoclonal proliferation of activated T cells as judged by marked increases in cells expressing a V beta family in the IL-2R+ T cell pool, compared with the total T cell pool. However, different V beta families were augmented in individual patients, indicating considerable heterogeneity of T cell activation in different patients. These results are in contrast to murine models of autoimmunity, where virtually monoclonal T cell activation, restricted to a single V beta family has been reported. PMID:1825939

  16. Long-term outcome of patients with newly diagnosed chronic myeloid leukemia: a randomized comparison of stem cell transplantation with drug treatment.

    PubMed

    Gratwohl, A; Pfirrmann, M; Zander, A; Kröger, N; Beelen, D; Novotny, J; Nerl, C; Scheid, C; Spiekermann, K; Mayer, J; Sayer, H G; Falge, C; Bunjes, D; Döhner, H; Ganser, A; Schmidt-Wolf, I; Schwerdtfeger, R; Baurmann, H; Kuse, R; Schmitz, N; Wehmeier, A; Fischer, J Th; Ho, A D; Wilhelm, M; Goebeler, M-E; Lindemann, H W; Bormann, M; Hertenstein, B; Schlimok, G; Baerlocher, G M; Aul, C; Pfreundschuh, M; Fabian, M; Staib, P; Edinger, M; Schatz, M; Fauser, A; Arnold, R; Kindler, T; Wulf, G; Rosselet, A; Hellmann, A; Schäfer, E; Prümmer, O; Schenk, M; Hasford, J; Heimpel, H; Hossfeld, D K; Kolb, H-J; Büsche, G; Haferlach, C; Schnittger, S; Müller, M C; Reiter, A; Berger, U; Saußele, S; Hochhaus, A; Hehlmann, R

    2016-03-01

    Tyrosine kinase inhibitors represent today's treatment of choice in chronic myeloid leukemia (CML). Allogeneic hematopoietic stem cell transplantation (HSCT) is regarded as salvage therapy. This prospective randomized CML-study IIIA recruited 669 patients with newly diagnosed CML between July 1997 and January 2004 from 143 centers. Of these, 427 patients were considered eligible for HSCT and were randomized by availability of a matched family donor between primary HSCT (group A; N=166 patients) and best available drug treatment (group B; N=261). Primary end point was long-term survival. Survival probabilities were not different between groups A and B (10-year survival: 0.76 (95% confidence interval (CI): 0.69-0.82) vs 0.69 (95% CI: 0.61-0.76)), but influenced by disease and transplant risk. Patients with a low transplant risk showed superior survival compared with patients with high- (P<0.001) and non-high-risk disease (P=0.047) in group B; after entering blast crisis, survival was not different with or without HSCT. Significantly more patients in group A were in molecular remission (56% vs 39%; P=0.005) and free of drug treatment (56% vs 6%; P<0.001). Differences in symptoms and Karnofsky score were not significant. In the era of tyrosine kinase inhibitors, HSCT remains a valid option when both disease and transplant risk are considered.

  17. Elimination of islet cell antibodies and glutamic acid decarboxylase antibodies II in a patient with newly diagnosed insulin-dependent diabetes mellitus.

    PubMed

    Richter, W O; Donner, M G; Schwandt, P

    1997-01-01

    Islet cell antibodies and glutamic acid decarboxylase II (GAD II) antibodies have been discussed in the autoimmune pathogenesis of insulin-dependent diabetes mellitus (IDDM). Hence, immunosuppressants, intravenous immunoglobulins, and plasmapheresis have been used in an effort to modulate autoimmune activity and thereby prevent the destruction of pancreatic beta-cells. We describe the autoantibody (islet cell antibody and GAD II) kinetics and clinical course in a patient with newly diagnosed IDDM treated with a specific immunoglobulin apheresis technique. Five days after the initial diagnosis a 37-year-old patient with IDDM underwent a series of seven immunoglobulin aphereses. Immunoglobulin (IgG, IgA, IgM), islet cell antibody, GAD II, and C-peptide concentrations were monitored for a time course of 74 days. Daily insulin requirements were recorded. One single immunoglobulin apheresis decreased IgG by 66.2 +/- 9.1%, IgA by 66.8 +/- 8.7%, and IgM by 57.7 +/- 12.9%. GAD II antibodies were reduced by 61.9 +/- 12.4%. The islet cell antibody titer declined from 1:32 to 1:4 after the treatment series. There were no relevant changes in the safety parameters determined nor were there any clinical side effects. The efficient decrease in islet cell antibodies and glutamic acid decarboxylase II antibodies in a patient with IDDM encourages further investigations into the impact of this treatment on the clinical course of this autoimmune disorder.

  18. Early cerebral volume reductions and their associations with reduced lupus disease activity in patients with newly-diagnosed systemic lupus erythematosus

    PubMed Central

    Mak, Anselm; Ho, Roger Chun-Man; Tng, Han-Ying; Koh, Hui Li; Chong, Joanna Su Xian; Zhou, Juan

    2016-01-01

    We examined if cerebral volume reduction occurs very early during the course of systemic lupus erythematosus (SLE), and observed prospectively whether gray (GMV) and white matter volumes (WMV) of the brain would improve with lowered SLE disease activity. T1-weighted MRI brain images were obtained from 14 healthy controls (HC) and 14 newly-diagnosed SLE patients within 5 months of diagnosis (S1) and after achieving low disease activity (S2). Whole brain voxel-based morphometry was used to detect differences in the GMV and WMV between SLE patients and HC and those between SLE patients at S1 and S2. SLE patients were found to have lower GMV than HC in the middle cingulate cortex, middle frontal gyrus and right supplementary motor area, and lower WMV in the superior longitudinal fasciculus, cingulum cingulate gyrus and inferior fronto-occipital fasciculus at both S1 and S2. Whole-brain voxel-wise analysis revealed increased GMV chiefly in the prefrontal regions at S2 compared to S1 in SLE patients. The GMV increase in the left superior frontal gyrus was significantly associated with lowered SLE disease activity. In conclusion, GMV and WMV reduced very early in SLE patients. Reduction of SLE disease activity was accompanied by region-specific GMV improvement in the prefrontal regions. PMID:26928214

  19. Siltuximab (CNTO 328) with lenalidomide, bortezomib and dexamethasone in newly-diagnosed, previously untreated multiple myeloma: an open-label phase I trial

    PubMed Central

    Shah, J J; Feng, L; Thomas, S K; Berkova, Z; Weber, D M; Wang, M; Qazilbash, M H; Champlin, R E; Mendoza, T R; Cleeland, C; Orlowski, R Z

    2016-01-01

    The safety and efficacy of siltuximab (CNTO 328) was tested in combination with lenalidomide, bortezomib and dexamethasone (RVD) in patients with newly-diagnosed, previously untreated symptomatic multiple myeloma. Fourteen patients were enrolled in the study, eleven of whom qualified to receive therapy. A majority of patients (81.8%) completed the minimal number or more of the four required cycles, while two patients completed only three cycles. The maximum tolerated dose (MTD) of siltuximab with RVD was dose level −1 (siltuximab: 8.3 mg/kg; bortezomib: 1.3 mg/m2; lenalidomide: 25 mg; dexamethasone: 20 mg). Serious adverse events were grade 3 pneumonia and grade 4 thrombocytopenia, and no deaths occurred during the study or with follow-up (median follow-up 28.1 months). An overall response rate, after 3–4 cycles of therapy, of 90.9% (95% confidence interval (CI): 58.7%, 99.8%) (9.1% complete response (95% CI: 0.2%, 41.3%), 45.5% very good partial response (95% CI: 16.7%, 76.6%) and 36.4% partial response (95% CI: 10.9%, 69.2%)) was seen. Two patients withdrew consent, and nine patients (81.8%) opted for autologous stem cell transplantation. PMID:26871714

  20. Variations in the Role of Social Support on Disclosure Among Newly Diagnosed HIV-Infected People Who Inject Drugs in Vietnam.

    PubMed

    Go, Vivian F; Latkin, Carl; Le Minh, Nguyen; Frangakis, Constantine; Ha, Tran Viet; Sripaipan, Teerada; Mo, Tran Thi; Davis, Wendy W; Vu, Pham The; Quan, Vu Minh

    2016-01-01

    Stigma and perceived social support can influence the decision to disclose HIV positive status, especially for people who inject drugs (PWID). In this analysis, the association between social support and HIV disclosure among 336 newly diagnosed HIV-infected PWID in Northern Vietnam was assessed. One month after diagnosis, 34.8 % of participants had not disclosed to anyone. Disclosure to anyone and to a family member specifically, was associated with baseline social support in the form of positive interactions and a history of incarceration. Disclosing to a family member was less likely among those who had unprotected sex in the previous 3 months. Disclosure to an injecting partner was more likely among those with a history of being in a drug treatment program, knowing someone on ART and believing that ART is safe. These data suggest that social support may facilitate disclosure among family members, including spouses, while disclosure to injecting partners is greater when PWID know that ART is a safe and viable option. PMID:25972071

  1. Long-term outcome of patients with newly diagnosed chronic myeloid leukemia: a randomized comparison of stem cell transplantation with drug treatment

    PubMed Central

    Gratwohl, A; Pfirrmann, M; Zander, A; Kröger, N; Beelen, D; Novotny, J; Nerl, C; Scheid, C; Spiekermann, K; Mayer, J; Sayer, H G; Falge, C; Bunjes, D; Döhner, H; Ganser, A; Schmidt-Wolf, I; Schwerdtfeger, R; Baurmann, H; Kuse, R; Schmitz, N; Wehmeier, A; Th Fischer, J; Ho, A D; Wilhelm, M; Goebeler, M-E; Lindemann, H W; Bormann, M; Hertenstein, B; Schlimok, G; Baerlocher, G M; Aul, C; Pfreundschuh, M; Fabian, M; Staib, P; Edinger, M; Schatz, M; Fauser, A; Arnold, R; Kindler, T; Wulf, G; Rosselet, A; Hellmann, A; Schäfer, E; Prümmer, O; Schenk, M; Hasford, J; Heimpel, H; Hossfeld, D K; Kolb, H-J; Büsche, G; Haferlach, C; Schnittger, S; Müller, M C; Reiter, A; Berger, U; Saußele, S; Hochhaus, A; Hehlmann, R

    2016-01-01

    Tyrosine kinase inhibitors represent today's treatment of choice in chronic myeloid leukemia (CML). Allogeneic hematopoietic stem cell transplantation (HSCT) is regarded as salvage therapy. This prospective randomized CML-study IIIA recruited 669 patients with newly diagnosed CML between July 1997 and January 2004 from 143 centers. Of these, 427 patients were considered eligible for HSCT and were randomized by availability of a matched family donor between primary HSCT (group A; N=166 patients) and best available drug treatment (group B; N=261). Primary end point was long-term survival. Survival probabilities were not different between groups A and B (10-year survival: 0.76 (95% confidence interval (CI): 0.69–0.82) vs 0.69 (95% CI: 0.61–0.76)), but influenced by disease and transplant risk. Patients with a low transplant risk showed superior survival compared with patients with high- (P<0.001) and non-high-risk disease (P=0.047) in group B; after entering blast crisis, survival was not different with or without HSCT. Significantly more patients in group A were in molecular remission (56% vs 39% P=0.005) and free of drug treatment (56% vs 6% P<0.001). Differences in symptoms and Karnofsky score were not significant. In the era of tyrosine kinase inhibitors, HSCT remains a valid option when both disease and transplant risk are considered. PMID:26464170

  2. Pilot Study to Explore the Accuracy of Current Prediction Equations in Assessing Energy Needs of Patients with Newly Diagnosed Glioblastoma Multiforme.

    PubMed

    Little, Rebecca B; Oster, Robert A; Darnell, Betty E; Demark-Wahnefried, Wendy; Nabors, L Burt

    2016-01-01

    Glioblastoma multiforme (GBM) is rare, yet it is the most common brain malignancy and has a poor prognosis. In regard to GBM, there is a dearth of research on resting energy expenditure (REE) and the accuracy of extant prediction equations. The aim of this cross-sectional study was to compare measured REE (mREE) to commonly used prediction equations in newly diagnosed GBM patients. REE was collected by indirect calorimetry in 20 GBM patients. Calculated REE was derived from Harris-Benedict (again with weight adjusted for obesity), Mifflin-St Jeor, and the 20 kcal/kg body weight ratio method. Paired t-tests and Bland-Altman analyses were used to compare group means, evaluate the bias, and find the limits of agreement. Clinical accuracy was assessed by determining the percentage of patients with predicted REE within ±10% of mREE. Subjects were evenly distributed with regard to gender, primarily Caucasian, and largely overweight or obese and had a mean age of 57 years. All equations overestimated mREE. Mifflin-St Jeor and adjusted Harris-Benedict had the narrowest limits of agreement and accurately predicted 60% and 65% of subjects, respectively. Clinicians should be aware of the discrepancy between commonly used prediction equations and REE. More research is needed to verify these findings and decipher the cause and significance in the GBM population. PMID:27341142

  3. Counterpoint: implementing population genetic screening for Lynch Syndrome among newly diagnosed colorectal cancer patients--will the ends justify the means?

    PubMed

    Hall, Michael J

    2010-05-01

    Inherited mutations in 1 of 4 known mismatch repair genes (MLH1, MSH2, MSH6, PMS2) are associated with various cancer risks collectively referred to as Lynch syndrome. Roughly 3 of every 100 new colorectal cancers (CRCs) have an underlying Lynch mutation. Tumor-based screening for Lynch among all patients with newly diagnosed CRC could theoretically improve the ability to identify Lynch and prevent cancer among at-risk family members, but the patient-level and social implications of this approach must be carefully considered before adopting this strategy. Poorly addressed issues include the role/timing of informed consent for testing, access and cost barriers associated with genetic counseling and DNA testing, psychosocial burdens to the thousands of middle-aged and elderly patients with CRC coping with surgical and chemotherapy treatments and poor prognosis, the need for providers to warn third-party relatives of risk for Lynch syndrome, limited effectiveness of screening, and the cost burden to society when poor DNA testing uptake, test limitations, and modest screening compliance are considered. Diverse barriers to the success of a population-based Lynch screening program in the United States remain (e.g., clinical resource needs, financial limitations, clinical expertise gaps, educational deficits). Data supporting clinical efficacy (feasibility) and effectiveness (real-life performance) are critical before important policy changes are adopted, especially where issues of hereditary cancer risk and genetic privacy are involved.

  4. Residual normal stem cells can be detected in newly diagnosed chronic myeloid leukemia patients by a new flow cytometric approach and predict for optimal response to imatinib.

    PubMed

    Janssen, J J W M; Deenik, W; Smolders, K G M; van Kuijk, B J; Pouwels, W; Kelder, A; Cornelissen, J J; Schuurhuis, G J; Ossenkoppele, G J

    2012-05-01

    Insensitivity of chronic myeloid leukemia (CML) hematopoietic stem cells to tyrosine kinase inhibitors (TKIs) prevents eradication of the disease and may be involved in clinical resistance. For improved treatment results more knowledge about CML stem cells is needed. We here present a new flow cytometric approach enabling prospective discrimination of CML stem cells from their normal counterparts within single-patient samples. In 24 of 40 newly diagnosed CML patients residual normal CD34(+)CD38(-) stem cells could be identified by lower CD34 and CD45 expression, lower forward/sideward light scatter and by differences of lineage marker expression (CD7, CD11b and CD56) and of CD90. fluorescent in situ hybridization (FISH) analysis on Fluorescence-activated cell sorting sorted cells proved that populations were BCR-ABL positive or negative and long-term liquid culture assays with subsequent colony forming unit assays and FISH analysis proved their stem cell character. Patients with residual non-leukemic stem cells had lower clinical risk scores (Sokal, Euro), lower hematological toxicity of imatinib (IM) and better molecular responses to IM than patients without. This new approach will expand our possibilities to separate CML and normal stem cells, present in a single bone marrow or peripheral blood sample, thereby offering opportunities to better identify new CML stem-cell-specific targets. Moreover, it may guide optimal clinical CML management. PMID:22157734

  5. Prospective serial evaluation of 2-hydroxyglutarate, during treatment of newly diagnosed acute myeloid leukemia, to assess disease activity and therapeutic response.

    PubMed

    Fathi, Amir T; Sadrzadeh, Hossein; Borger, Darrell R; Ballen, Karen K; Amrein, Philip C; Attar, Eyal C; Foster, Julia; Burke, Meghan; Lopez, Hector U; Matulis, Christina R; Edmonds, Katherine M; Iafrate, A John; Straley, Kimberly S; Yen, Katharine E; Agresta, Samuel; Schenkein, David P; Hill, Cedric; Emadi, Ashkan; Neuberg, Donna S; Stone, Richard M; Chen, Yi-Bin

    2012-11-29

    Mutations of genes encoding isocitrate dehydrogenase (IDH1 and IDH2) have been recently described in acute myeloid leukemia (AML). Serum and myeloblast samples from patients with IDH-mutant AML contain high levels of the metabolite 2-hydroxyglutarate (2-HG), a product of the altered IDH protein. In this prospective study, we sought to determine whether 2-HG can potentially serve as a noninvasive biomarker of disease burden through serial measurements in patients receiving conventional therapy for newly diagnosed AML. Our data demonstrate that serum, urine, marrow aspirate, and myeloblast 2-HG levels are significantly higher in IDH-mutant patients, with a correlation between baseline serum and urine 2-HG levels. Serum and urine 2-HG, along with IDH1/2-mutant allele burden in marrow, decreased with response to treatment. 2-HG decrease was more rapid with induction chemotherapy compared with DNA-methyltransferase inhibitor therapy. Our data suggest that serum or urine 2-HG may serve as noninvasive biomarkers of disease activity for IDH-mutant AML.

  6. Updated survival analysis of two sequential prospective trials of R-MACLO-IVAM followed by maintenance for newly diagnosed mantle cell lymphoma

    PubMed Central

    Hosein, Peter J.; Sandoval-Sus, Jose D.; Goodman, Deborah; Arteaga, Alexandra Gomez; Reis, Isildinha; Hoffman, James; Stefanovic, Alexandra; Rosenblatt, Joseph D.; Lossos, Izidore S.

    2015-01-01

    A phase II trial of R-MACLO-IVAM followed by thalidomide maintenance for mantle cell lymphoma (MCL) demonstrated promising progression-free survival (PFS) and overall survival (OS) rates. Thalidomide maintenance was associated with significant toxicity and was subsequently modified to rituximab maintenance. Herein we present updated results and follow-up. Two sequential phase II trials included chemotherapy-naïve patients with MCL up to 75 years old. Four cycles of R-MACLO-IVAM chemotherapy were delivered as previously described. Patients who achieved complete responses (CR) were eligible for thalidomide or rituximab maintenance therapy. Among 36 patients enrolled, the mantle cell lymphoma International Prognostic Index (MIPI) was low in 53%, intermediate in 36% and high in 11%. Thirty-five patients completed at least 2 cycles of chemotherapy; 34 (94%) achieved a CR. After a median follow-up of 74.4 months, the 5-year PFS was 51% (95% CI 33% – 68%) and the 5-year OS was 85% (95% CI 73% – 97%). Two deaths occurred during the chemotherapy phase due to disease progression and neutropenic sepsis respectively. One patient developed secondary acute myeloid leukemia after 7 years. R-MACLO-IVAM chemotherapy is effective for patients with newly diagnosed MCL. PMID:25737247

  7. Influence of Using Different Databases and ‘Look Back’ Intervals to Define Comorbidity Profiles for Patients with Newly Diagnosed Hypertension: Implications for Health Services Researchers

    PubMed Central

    Chen, Guanmin; Lix, Lisa; Tu, Karen; Hemmelgarn, Brenda R.; Campbell, Norm R. C.; McAlister, Finlay A.; Quan, Hude

    2016-01-01

    Objective To determine the data sources and ‘look back’ intervals to define comorbidities. Data Sources Hospital discharge abstracts database (DAD), physician claims, population registry and death registry from April 1, 1994 to March 31, 2010 in Alberta, Canada. Study Design Newly-diagnosed hypertension cases from 1997 to 2008 fiscal years were identified and followed up to 12 years. We defined comorbidities using data sources and duration of retrospective observation (6 months, 1 year, 2 years, and 3 years). The C-statistics for logistic regression and concordance index (CI) for Cox model of mortality and cardiovascular disease hospitalization were used to evaluate discrimination performance for each approach of defining comorbidities. Principal Findings The comorbidities prevalence became higher with a longer duration. Using DAD alone underestimated the prevalence by about 75%, compared to using both DAD and physician claims. The C-statistic and CI were highest when both DAD and physician claims were used, and model performance improved when observation duration increased from 6 months to one year or longer. Conclusion The comorbidities prevalence is greatly impacted by the data source and duration of retrospective observation. A combination of DAD and physicians claims with at least one year observation duration improves predictions for cardiovascular disease and one-year mortality outcome model performance. PMID:27583532

  8. Oblimersen Sodium and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I, Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

    ClinicalTrials.gov

    2012-10-11

    Contiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Stage I Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma

  9. Rituximab plus hyper-CVAD alternating with MTX/Ara-C in patients with newly diagnosed mantle cell lymphoma: 15-year follow-up of a phase II study from the MD Anderson Cancer Center.

    PubMed

    Chihara, Dai; Cheah, Chan Y; Westin, Jason R; Fayad, Luis E; Rodriguez, Maria A; Hagemeister, Fredrick B; Pro, Barbara; McLaughlin, Peter; Younes, Anas; Samaniego, Felipe; Goy, Andre; Cabanillas, Fernando; Kantarjian, Hagop; Kwak, Larry W; Wang, Michael L; Romaguera, Jorge E

    2016-01-01

    Intensive chemotherapy regimens containing cytarabine have substantially improved remission durability and overall survival in younger adults with mantle cell lymphoma (MCL). However, there have been no long-term follow-up results for patients treated with these regimens. We present long-term survival outcomes from a pivotal phase II trial of rituximab, hyper-fractionated cyclophosphamide, vincristine, doxorubicin and dexamethasone alternating with methotrexate and cytarabine (R-HCVAD/MA). At 15 years of follow-up (median: 13·4 years), the median failure-free survival (FFS) and overall survival (OS) for all patients was 4·8 years and 10·7 years, respectively. The FFS seems to have plateaued after 10 years, with an estimated 15-year FFS of 30% in younger patients (≤65 years). Patients who achieved complete response (CR) after 2 cycles had a favourable median FFS of 8·8 years. Six patients developed myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML) whilst in first CR. The 10-year cumulative incidence of MDS/AML of patients in first remission was 6·2% (95% confidence interval: 2·5-12·2%). In patients with newly diagnosed MCL, R-HCVAD/MA showed sustained efficacy, with a median OS exceeding 10 years in all patients and freedom from disease recurrence of nearly 15 years in almost one-third of the younger patients (≤65 years).

  10. Late Adolescent and Young Adult Outcomes of Girls Diagnosed with ADHD in Childhood: An Exploratory Investigation

    PubMed Central

    Babinski, Dara E.; Pelham, William E.; Molina, Brooke S.G.; Gnagy, Elizabeth M.; Waschbusch, Daniel A.; Yu, Jihnhee; MacLean, Michael G.; Wymbs, Brian T.; Sibley, Margaret H.; Biswas, Aparajita; Robb, Jessica A.; Karch, Kathryn M.

    2010-01-01

    Objective The study aims to characterize the late adolescent and young adult outcomes of girls diagnosed with ADHD in childhood. Method The study included 58 females from a larger longitudinal study of ADHD. Thirty-four (M=19.97 years old) met DSM criteria for ADHD in childhood, while the remaining 24 (M=19.83 years old) did not. Self- and parent-reports of psychopathology, delinquency, interpersonal relationships, academic achievement, job performance, and substance use were collected. Results The findings suggest that girls with ADHD experience difficulties in late adolescence and young adulthood, such as more conflict with their mothers, being involved in fewer romantic relationships, and experiencing more depressive symptoms than comparison women. However, differences did not emerge in all domains, such as job performance, substance use, and self-reported ADHD symptomatology. Conclusion The findings of this study add to the literature on the negative late adolescent and young adult outcomes associated with childhood ADHD in females. PMID:20562386

  11. Social Relationships of Dually Diagnosed Homeless Adults Following Enrollment in Housing First or Traditional Treatment Services

    PubMed Central

    Henwood, Benjamin F.; Stefancic, Ana; Petering, Robin; Schreiber, Sarah; Abrams, Courtney; Padgett, Deborah K.

    2015-01-01

    Objective Strong and effective social support is a critical element of mental health recovery, yet social support is often lacking for adults experiencing homelessness. This study examines differences in the social networks of participants newly enrolled in programs that use either a Housing First (HF) approach (i.e., provides immediate access to permanent housing with ongoing consumer-driven support services) or a treatment first (TF) approach (i.e., traditional clinician-driven staircse model that requires temporary or transitional housing and treatment placements before accessing permanent housing). Method We use a mixed-methods social network analysis approach to assess group differences of 75 individuals based on program type (HF or TF) and program retention. Results Quantitative results show that compared with TF, HF participants have a greater proportion of staff members in their network. TF participants are more likely than HF participants to maintain mixed-quality relationships (i.e., relationships with elements of support and conflict). As compared with participants who remain in a program, those who disengage from programs have a greater proportion of mixed relationships and relationships that grow distant. Qualitative analyses suggest that HF participants regard housing as providing a stable foundation from which to reconnect or restore broken relationships. However, HF participants are guarded about close relationships for fear of being exploited due to their newly acquired apartments. TF participants report that they are less inclined to develop new relationships with peers or staff members due to the time-limited nature of the TF programs. Conclusions These findings suggest that HF participants are not more socially isolated than those in traditional care. Implications for practice, policy and future research are discussed. PMID:26635919

  12. Child abuse predicts adult PTSD symptoms among individuals diagnosed with intellectual disabilities

    PubMed Central

    Catani, Claudia; Sossalla, Iris M.

    2015-01-01

    Prior research has shown that people with intellectual disabilities (ID) are more likely to experience child abuse as well as other forms of traumatic or negative events later in life compared to the general population. Little is known however, about the association of these experiences with adult mental health in intellectually disabled individuals. The present study aimed to assess whether child abuse in families and institutions as well as other types of adverse life events, were associated with current posttraumatic stress disorder (PTSD) and depression symptoms in individuals with ID. We conducted clinical interviews which included standardized self-report measures for childhood abuse, PTSD, and depression in an unselected sample of 56 persons with a medical diagnosis of ID who were attending a specialized welfare center. The frequency of traumatic experiences was very high, with physical and emotional child abuse being the most common trauma types. 87% of the persons reported at least one aversive experience on the family violence spectrum, and 50% of the sample reported a violent physical attack later in adulthood. 25% were diagnosed with PTSD and almost 27% had a critical score on the depression scale. Physical and emotional child abuse was positively correlated with the amount of institutional violence and the number of general traumatic events, whereas childhood sexual abuse was related to the experience of intimate partner violence in adult life. A linear regression model revealed child abuse in the family to be the only significant independent predictor of PTSD symptom severity. The current findings underscore the central role of child maltreatment in the increased risk of further victimization and in the development of mental health problems in adulthood in intellectually disabled individuals. Our data have important clinical implications and demonstrate the need for targeted prevention and intervention programs that are tailored to the specific needs

  13. Child abuse predicts adult PTSD symptoms among individuals diagnosed with intellectual disabilities.

    PubMed

    Catani, Claudia; Sossalla, Iris M

    2015-01-01

    Prior research has shown that people with intellectual disabilities (ID) are more likely to experience child abuse as well as other forms of traumatic or negative events later in life compared to the general population. Little is known however, about the association of these experiences with adult mental health in intellectually disabled individuals. The present study aimed to assess whether child abuse in families and institutions as well as other types of adverse life events, were associated with current posttraumatic stress disorder (PTSD) and depression symptoms in individuals with ID. We conducted clinical interviews which included standardized self-report measures for childhood abuse, PTSD, and depression in an unselected sample of 56 persons with a medical diagnosis of ID who were attending a specialized welfare center. The frequency of traumatic experiences was very high, with physical and emotional child abuse being the most common trauma types. 87% of the persons reported at least one aversive experience on the family violence spectrum, and 50% of the sample reported a violent physical attack later in adulthood. 25% were diagnosed with PTSD and almost 27% had a critical score on the depression scale. Physical and emotional child abuse was positively correlated with the amount of institutional violence and the number of general traumatic events, whereas childhood sexual abuse was related to the experience of intimate partner violence in adult life. A linear regression model revealed child abuse in the family to be the only significant independent predictor of PTSD symptom severity. The current findings underscore the central role of child maltreatment in the increased risk of further victimization and in the development of mental health problems in adulthood in intellectually disabled individuals. Our data have important clinical implications and demonstrate the need for targeted prevention and intervention programs that are tailored to the specific needs

  14. Entinostat and Clofarabine in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Poor-Risk Acute Lymphoblastic Leukemia or Bilineage/Biphenotypic Leukemia

    ClinicalTrials.gov

    2014-07-16

    Acute Leukemias of Ambiguous Lineage; Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Lymphoblastic Leukemia

  15. Phase 2 Trial of Hypofractionated High-Dose Intensity Modulated Radiation Therapy With Concurrent and Adjuvant Temozolomide for Newly Diagnosed Glioblastoma

    SciTech Connect

    Iuchi, Toshihiko; Hatano, Kazuo; Kodama, Takashi; Sakaida, Tsukasa; Yokoi, Sana; Kawasaki, Koichiro; Hasegawa, Yuzo; Hara, Ryusuke

    2014-03-15

    Purpose/Objectives: To assess the effect and toxicity of hypofractionated high-dose intensity modulated radiation therapy (IMRT) with concurrent and adjuvant temozolomide (TMZ) in 46 patients with newly diagnosed glioblastoma multiforme (GBM). Methods and Materials: All patients underwent postsurgical hypofractionated high-dose IMRT. Three layered planning target volumes (PTVs) were contoured. PTV1 was the surgical cavity and residual tumor on T1-weighted magnetic resonance images with 5-mm margins, PTV2 was the area with 15-mm margins surrounding the PTV1, and PTV3 was the high-intensity area on fluid-attenuated inversion recovery images. Irradiation was performed in 8 fractions at total doses of 68, 40, and 32 Gy for PTV1, PTV2, and PTV3, respectively. Concurrent TMZ was given at 75 mg/m{sup 2}/day for 42 consecutive days. Adjuvant TMZ was given at 150 to 200 mg/m{sup 2}/day for 5 days every 28 days. Overall and progression-free survivals were evaluated. Results: No acute IMRT-related toxicity was observed. The dominant posttreatment failure pattern was dissemination. During a median follow-up time of 16.3 months (range, 4.3-80.8 months) for all patients and 23.7 months (range, 12.4-80.8 months) for living patients, the median overall survival was 20.0 months after treatment. Radiation necrosis was diagnosed in 20 patients and was observed not only in the high-dose field but also in the subventricular zone (SVZ). Necrosis in the SVZ was significantly correlated with prolonged survival (hazard ratio, 4.08; P=.007) but caused deterioration in the performance status of long-term survivors. Conclusions: Hypofractionated high-dose IMRT with concurrent and adjuvant TMZ altered the dominant failure pattern from localized to disseminated and prolonged the survival of patients with GBM. Necrosis in the SVZ was associated with better patient survival, but the benefit of radiation to this area remains controversial.

  16. Behavioral and psychosocial effects of rapid genetic counseling and testing in newly diagnosed breast cancer patients: Design of a multicenter randomized clinical trial

    PubMed Central

    2011-01-01

    Background It has been estimated that between 5% and 10% of women diagnosed with breast cancer have a hereditary form of the disease, primarily caused by a BRCA1 or BRCA2 gene mutation. Such women have an increased risk of developing a new primary breast and/or ovarian tumor, and may therefore opt for preventive surgery (e.g., bilateral mastectomy, oophorectomy). It is common practice to offer high-risk patients genetic counseling and DNA testing after their primary treatment, with genetic test results being available within 4-6 months. However, some non-commercial laboratories can currently generate test results within 3 to 6 weeks, and thus make it possible to provide rapid genetic counseling and testing (RGCT) prior to primary treatment. The aim of this study is to determine the effect of RGCT on treatment decisions and on psychosocial health. Methods/Design In this randomized controlled trial, 255 newly diagnosed breast cancer patients with at least a 10% risk of carrying a BRCA gene mutation are being recruited from 12 hospitals in the Netherlands. Participants are randomized in a 2:1 ratio to either a RGCT intervention group (the offer of RGCT directly following diagnosis with tests results available before surgical treatment) or to a usual care control group. The primary behavioral outcome is the uptake of direct bilateral mastectomy or delayed prophylactic contralateral mastectomy. Psychosocial outcomes include cancer risk perception, cancer-related worry and distress, health-related quality of life, decisional satisfaction and the perceived need for and use of additional decisional counseling and psychosocial support. Data are collected via medical chart audits and self-report questionnaires administered prior to randomization, and at 6 month and at 12 month follow-up. Discussion This trial will provide essential information on the impact of RGCT on the choice of primary surgical treatment among women with breast cancer with an increased risk of hereditary

  17. Recent Transmission Clustering of HIV-1 C and CRF17_BF Strains Characterized by NNRTI-Related Mutations among Newly Diagnosed Men in Central Italy

    PubMed Central

    Orchi, Nicoletta; Gori, Caterina; Bertoli, Ada; Forbici, Federica; Montella, Francesco; Pennica, Alfredo; De Carli, Gabriella; Giuliani, Massimo; Continenza, Fabio; Pinnetti, Carmela; Nicastri, Emanuele; Ceccherini-Silberstein, Francesca; Mastroianni, Claudio Maria; Girardi, Enrico; Andreoni, Massimo; Antinori, Andrea; Santoro, Maria Mercedes; Perno, Carlo Federico

    2015-01-01

    Background Increased evidence of relevant HIV-1 epidemic transmission in European countries is being reported, with an increased circulation of non-B-subtypes. Here, we present two recent HIV-1 non-B transmission clusters characterized by NNRTI-related amino-acidic mutations among newly diagnosed HIV-1 infected men, living in Rome (Central-Italy). Methods Pol and V3 sequences were available at the time of diagnosis for all individuals. Maximum-Likelihood and Bayesian phylogenetic-trees with bootstrap and Bayesian-probability supports defined transmission-clusters. HIV-1 drug-resistance and V3-tropism were also evaluated. Results Among 534 new HIV-1 non-B cases, diagnosed from 2011 to 2014, in Central-Italy, 35 carried virus gathering in two distinct clusters, including 27 HIV-1 C and 8 CRF17_BF subtypes, respectively. Both clusters were centralized in Rome, and their origin was estimated to have been after 2007. All individuals within both clusters were males and 37.1% of them had been recently-infected. While C-cluster was entirely composed by Italian men-who-have-sex-with-men, with a median-age of 34 years (IQR:30–39), individuals in CRF17_BF-cluster were older, with a median-age of 51 years (IQR:48–59) and almost all reported sexual-contacts with men and women. All carried R5-tropic viruses, with evidence of atypical or resistance amino-acidic mutations related to NNRTI-drugs (K103Q in C-cluster, and K101E+E138K in CRF17_BF-cluster). Conclusions These two epidemiological clusters provided evidence of a strong and recent circulation of C and CRF17_BF strains in central Italy, characterized by NNRTI-related mutations among men engaging in high-risk behaviours. These findings underline the role of molecular epidemiology in identifying groups at increased risk of HIV-1 transmission, and in enhancing additional prevention efforts. PMID:26270824

  18. Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

    ClinicalTrials.gov

    2016-09-08

    Stage II Contiguous Adult Diffuse Large Cell Lymphoma; Stage II Non-Contiguous Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma

  19. Panobinostat as part of induction and maintenance for elderly patients with newly diagnosed acute myeloid leukemia: phase Ib/II panobidara study

    PubMed Central

    Ocio, Enrique M.; Herrera, Pilar; Olave, María-Teresa; Castro, Nerea; Pérez-Simón, José A.; Brunet, Salut; Oriol, Albert; Mateo, Marta; Sanz, Miguel-Ángel; López, Javier; Montesinos, Pau; Chillón, María-Carmen; Prieto-Conde, María-Isabel; Díez-Campelo, María; González, Marcos; Vidriales, María-Belén; Mateos, María-Victoria; San Miguel, Jesús F.

    2015-01-01

    This phase Ib/II trial combined the pan-deacetylase inhibitor panobinostat with chemotherapy followed by panobinostat maintenance in elderly patients with newly diagnosed acute myeloid leukemia. Patients with prior history of myelodysplastic syndrome were excluded and 38 evaluable patients were included in the study (median age: 71 years; range: 65–83). Study patients received an induction with idarubicin (8 mg/m2 iv days 1–3) plus cytarabine (100 mg/m2 iv days 1–7) plus panobinostat po at escalating doses (days 8, 10, 12, 15, 17 and 19) that could be repeated in non-responding patients. Patients achieving complete remission received a consolidation cycle with the same schema, followed by panobinostat maintenance (40 mg po 3 days/week) every other week until progression. Thirty-one patients were treated at the maximum tolerated dose of panobinostat in the combination (10 mg) with good tolerability. Complete remission rate was 64% with a time to relapse of 17.0 months (12.8–21.1). Median overall survival for the whole series was 17 months (5.5–28.4). Moreover, in 4 of 5 patients with persistent minimal residual disease before maintenance, panobinostat monotherapy reduced its levels, with complete negativization in two of them. Maintenance phase was well tolerated. The most frequent adverse events were thrombocytopenia (25% grades 3/4), and gastrointestinal toxicity, asthenia and anorexia (mainly grades 1/2). Five patients required dose reduction during this phase, but only one discontinued therapy due to toxicity. These results suggest that panobinostat is one of the first novel agents with activity in elderly acute myeloid leukemia patients, and suggest further investigation is warranted, particularly in the context of maintenance therapy. This trial is registered at clinicaltrials.gov identifier: 00840346. PMID:26160880

  20. R-MPV followed by high-dose chemotherapy with TBC and autologous stem-cell transplant for newly diagnosed primary CNS lymphoma.

    PubMed

    Omuro, Antonio; Correa, Denise D; DeAngelis, Lisa M; Moskowitz, Craig H; Matasar, Matthew J; Kaley, Thomas J; Gavrilovic, Igor T; Nolan, Craig; Pentsova, Elena; Grommes, Christian C; Panageas, Katherine S; Baser, Raymond E; Faivre, Geraldine; Abrey, Lauren E; Sauter, Craig S

    2015-02-26

    High-dose methotrexate-based chemotherapy is the mainstay of treatment of primary central nervous system lymphoma (PCNSL), but relapses remain frequent. High-dose chemotherapy (HDC) with autologous stem-cell transplant (ASCT) may provide an alternative to address chemoresistance and overcome the blood-brain barrier. In this single-center phase-2 study, newly diagnosed PCNSL patients received 5 to 7 cycles of chemotherapy with rituximab, methotrexate (3.5 g/m(2)), procarbazine, and vincristine (R-MPV). Those with a complete or partial response proceeded with consolidation HDC with thiotepa, cyclophosphamide, and busulfan, followed by ASCT and no radiotherapy. Primary end point was 1-year progression-free survival (PFS), N = 32. Median age was 57, and median Karnofsky performance status 80. Following R-MPV, objective response rate was 97%, and 26 (81%) patients proceeded with HDC-ASCT. Among all patients, median PFS and overall survival (OS) were not reached (median follow-up: 45 months). Two-year PFS was 79% (95% confidence interval [CI], 58-90), with no events observed beyond 2 years. Two-year OS was 81% (95% CI, 63-91). In transplanted patients, 2-year PFS and OS were 81%. There were 3 treatment-related deaths. Prospective neuropsychological evaluations suggested relatively stable cognitive functions posttransplant. In conclusion, this treatment was associated with excellent disease control and survival, an acceptable toxicity profile, and no evidence of neurotoxicity thus far. This trial was registered at www.clinicaltrials.gov as NCT00596154.

  1. Immunologic Escape After Prolonged Progression-Free Survival With Epidermal Growth Factor Receptor Variant III Peptide Vaccination in Patients With Newly Diagnosed Glioblastoma

    PubMed Central

    Sampson, John H.; Heimberger, Amy B.; Archer, Gary E.; Aldape, Kenneth D.; Friedman, Allan H.; Friedman, Henry S.; Gilbert, Mark R.; Herndon, James E.; McLendon, Roger E.; Mitchell, Duane A.; Reardon, David A.; Sawaya, Raymond; Schmittling, Robert J.; Shi, Weiming; Vredenburgh, James J.; Bigner, Darell D.

    2010-01-01

    Purpose Immunologic targeting of tumor-specific gene mutations may allow precise eradication of neoplastic cells without toxicity. Epidermal growth factor receptor variant III (EGFRvIII) is a constitutively activated and immunogenic mutation not expressed in normal tissues but widely expressed in glioblastoma multiforme (GBM) and other neoplasms. Patients and Methods A phase II, multicenter trial was undertaken to assess the immunogenicity of an EGFRvIII-targeted peptide vaccine and to estimate the progression-free survival (PFS) and overall survival (OS) of vaccinated patients with newly diagnosed EGFRvIII-expressing GBM with minimal residual disease. Intradermal vaccinations were given until toxicity or tumor progression was observed. Sample size was calculated to differentiate between PFS rates of 20% and 40% 6 months after vaccination. Results There were no symptomatic autoimmune reactions. The 6-month PFS rate after vaccination was 67% (95% CI, 40% to 83%) and after diagnosis was 94% (95% CI, 67% to 99%; n = 18). The median OS was 26.0 months (95% CI, 21.0 to 47.7 months). After adjustment for age and Karnofsky performance status, the OS of vaccinated patients was greater than that observed in a control group matched for eligibility criteria, prognostic factors, and temozolomide treatment (hazard ratio, 5.3; P = .0013; n = 17). The development of specific antibody (P = .025) or delayed-type hypersensitivity (P = .03) responses to EGFRvIII had a significant effect on OS. At recurrence, 82% (95% CI, 48% to 97%) of patients had lost EGFRvIII expression (P < .001). Conclusion EGFRvIII-targeted vaccination in patients with GBM warrants investigation in a phase III, randomized trial. PMID:20921459

  2. Factors Affecting Recruitment of Participants for Studies of Diabetes Technology in Newly Diagnosed Youth with Type 1 Diabetes: A Qualitative Focus Group Study with Parents and Children

    PubMed Central

    Allen, Janet; Tauschmann, Martin; Randell, Tabitha; Trevelyan, Nicola; Hovorka, Roman

    2016-01-01

    Abstract Background: Relatively little is known about parents' or children's attitudes toward recruitment for, and participation in, studies of new diabetes technologies immediately after diagnosis. This study investigated factors affecting recruitment of participants for studies in newly diagnosed youth with type 1 diabetes. Methods: Qualitative focus group study incorporating four recorded focus groups, conducted in four outpatient pediatric diabetes clinics in large regional hospitals in England. Participants comprised four groups of parents (n = 22) and youth (n = 17) with type 1 diabetes, purposively sampled on the basis of past involvement (either participation or nonparticipation) in an ongoing two-arm randomized trial comparing multiple daily injection with conventional continuous subcutaneous insulin infusion regimens from the onset of type 1 diabetes. Results: Stress associated with diagnosis presents significant challenges in terms of study recruitment, with parents demonstrating varied levels of willingness to be approached soon after diagnosis. Additional challenges arise regarding the following: randomization when study arms are perceived as sharply differentiated in terms of therapy effectiveness; burdens arising from study participation; and the need to surrender new technologies following the end of the study. However, these challenges were mostly insufficient to rule out study participation. Participants emphasized the benefits and reassurance arising from support provided by staff and fellow study participants. Conclusions: Recruitment to studies of new diabetes technologies immediately after diagnosis in youth presents significant challenges, but these are not insurmountable. The stress and uncertainty arising from potential participation may be alleviated by personalized discussion with staff and peer support from fellow study participants. PMID:27355100

  3. Genetic variation of the HIV-1 integrase region in newly diagnosed anti-retroviral drug-naïve patients with HIV/AIDS in Korea.

    PubMed

    Kim, J-Y; Kim, E-J; Choi, J-Y; Kwon, O-K; Kim, G J; Choi, S Y; Kim, S S

    2011-08-01

    The survival time of HIV/AIDS patients in Korea has increased since HAART (highly active anti-retroviral therapy) was introduced. However, the occurrence of drug-resistant strains requires new anti-retroviral drugs, one of which, an integrase inhibitor (INI), was approved by the US Food and Drug Administration (FDA) in 2007. INIs have been used for therapy in many countries and are about to be employed in Korea. Therefore, it is important to identify basic mutant variants prior to the introduction of INIs in order to estimate their efficacy. To monitor potential drug-resistant INI mutations in Korean HIV/AIDS patients, the polymorphism of the int gene was investigated together with the pol gene using a genotypic assay for 75 randomly selected Korean HIV-1 patients newly diagnosed in 2007. The drug-resistant mutation sequences were analysed using the Stanford HIV DB and the International AIDS Society resistance testing-USA panel (IAS-USA). Seventy strains of Korean subtype B were compared with foreign subtype-B strains, and there were no significantly different variants of the int gene region in the study population. Major mutation sites in the integrase (E92Q, F121Y, G140A/S, Y143C/R, Q148H/R/K and N155H) were not detected, and only a few minor mutation sites (L74M, V151I, E157Q, V165I, I203M, S230N and D232N) were identified in 21 strains (28%). Resistance due to mutations in the pol gene was observed in a single strain (1.3%) resistant to protease inhibitors (PIs) and in four strains (5.3%) resistant to reverse transcriptase inhibitors (RTIs). In summary, this demonstrates that INIs will be susceptible to drug naïve HIV/AIDS patients in Korea.

  4. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide.

    PubMed

    Delforge, Michel; Minuk, Leonard; Eisenmann, Jean-Claude; Arnulf, Bertrand; Canepa, Letizia; Fragasso, Alberto; Leyvraz, Serge; Langer, Christian; Ezaydi, Yousef; Vogl, Dan T; Giraldo-Castellano, Pilar; Yoon, Sung-Soo; Zarnitsky, Charles; Escoffre-Barbe, Martine; Lemieux, Bernard; Song, Kevin; Bahlis, Nizar Jacques; Guo, Shien; Monzini, Mara Silva; Ervin-Haynes, Annette; Houck, Vanessa; Facon, Thierry

    2015-06-01

    We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients' health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ-MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeated-measures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide.

  5. Suppression of the noninvolved pair of the myeloma isotype correlates with poor survival in newly diagnosed and relapsed/refractory patients with myeloma.

    PubMed

    Ludwig, Heinz; Milosavljevic, Dejan; Berlanga, Oscar; Zojer, Niklas; Hübl, Wolfgang; Fritz, Veronique; Harding, Stephen

    2016-03-01

    Heavy light chain (HLC) assays allow precise measurement of the monoclonal and of the noninvolved polyclonal immunoglobulins of the same isotype as the M-protein (e.g., monoclonal IgAκ and polyclonal IgAλ in case of an IgAκ myeloma), which was not possible before. The noninvolved polyclonal immunoglobulin is termed 'HLC-matched pair'. We investigated the impact of the suppression of the HLC-matched pair on outcome in 203 patients with multiple myeloma, a phenomenon that likely reflects the host's attempt to control the myeloma clone. Severe (>50%) HLC-matched pair suppression was identified in 54.5% of the 156 newly diagnosed patients and was associated with significantly shorter survival (45.4 vs. 71.9 months, P = 0.019). This correlation was statistically significant in IgG patients (46.4 vs. 105.1 months, P = 0.017), but not in patients with IgA myelomas (32.9 vs. 54.1 months, P = 0.498). At best response, HLC-matched pair suppression improved only in patients with ≥VGPR, indicating partial or complete humoral immune reconstitution during remission in those with excellent response. Severe HLC-matched pair suppression retained its prognostic impact also during follow-up after first response. In the 47 pretreated patients with relapsed/refractory disease, a similar correlation between severe HLC suppression and survival was noted (22.8 vs. not reached, P = 0.028). Suppression of the polyclonal immunoglobulins of the other isotypes than the myeloma protein correlated neither with HLC-matched pair suppression, nor with outcome. Multivariate analysis identified severe HLC-matched pair suppression as independent risk factor for shorter survival, highlighting the impact of isotype specific immune dysregulation on outcome in multiple myeloma.

  6. RTOG 0913: A Phase 1 Study of Daily Everolimus (RAD001) in Combination With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

    SciTech Connect

    Chinnaiyan, Prakash; Won, Minhee; Wen, Patrick Y.; Wendland, Merideth; Dipetrillo, Thomas A.; Corn, Benjamin W.; Mehta, Minesh P.

    2013-08-01

    Purpose: To determine the safety of the mammalian target of rapamycin inhibitor everolimus (RAD001) administered daily with concurrent radiation and temozolomide in newly diagnosed glioblastoma patients. Methods and Materials: Everolimus was administered daily with concurrent radiation (60 Gy in 30 fractions) and temozolomide (75 mg/m{sup 2} per day). Everolimus was escalated from 2.5 mg/d (dose level 1) to 5 mg/d (dose level 2) to 10 mg/d (dose level 3). Adjuvant temozolomide was delivered at 150 to 200 mg/m{sup 2} on days 1 to 5, every 28 days, for up to 12 cycles, with concurrent everolimus at the previously established daily dose of 10 mg/d. Dose escalation continued if a dose level produced dose-limiting toxicities (DLTs) in fewer than 3 of the first 6 evaluable patients. Results: Between October 28, 2010, and July 2, 2012, the Radiation Therapy Oncology Group 0913 protocol initially registered a total of 35 patients, with 25 patients successfully meeting enrollment criteria receiving the drug and evaluable for toxicity. Everolimus was successfully escalated to the predetermined maximum tolerated dose of 10 mg/d. Two of the first 6 eligible patients had a DLT at each dose level. DLTs included gait disturbance, febrile neutropenia, rash, fatigue, thrombocytopenia, hypoxia, ear pain, headache, and mucositis. Other common toxicities were grade 1 or 2 hypercholesterolemia and hypertriglyceridemia. At the time of analysis, there was 1 death reported, which was attributed to tumor progression. Conclusions: Daily oral everolimus (10 mg) combined with both concurrent radiation and temozolomide followed by adjuvant temozolomide is well tolerated, with an acceptable toxicity profile. A randomized phase 2 clinical trial with mandatory correlative biomarker analysis is currently under way, designed to both determine the efficacy of this regimen and identify molecular determinants of response.

  7. Knowledge, care-seeking behavior, and factors associated with patient delay among newly-diagnosed pulmonary tuberculosis patients, Federal Capital Territory, Nigeria, 2010

    PubMed Central

    Biya, Oladayo; Gidado, Saheed; Abraham, Ajibola; Waziri, Ndadilnasiya; Nguku, Patrick; Nsubuga, Peter; Suleman, Idris; Oyemakinde, Akin; Nasidi, Abdulsalami; Sabitu, Kabir

    2014-01-01

    Introduction Early treatment of Tuberculosis (TB) cases is important for reducing transmission, morbidity and mortality associated with TB. In 2007, Federal Capital Territory (FCT), Nigeria recorded low TB case detection rate (CDR) of 9% which implied that many TB cases were undetected. We assessed the knowledge, care-seeking behavior, and factors associated with patient delay among pulmonary TB patients in FCT. Methods We enrolled 160 newly-diagnosed pulmonary TB patients in six directly observed treatment short course (DOTS) hospitals in FCT in a cross-sectional study. We used a structured questionnaire to collect data on socio-demographic variables, knowledge of TB, and care-seeking behavior. Patient delay was defined as > 4 weeks between onset of cough and first hospital contact. Results Mean age was 32.8 years (± 9 years). Sixty two percent were males. Forty seven percent first sought care in a government hospital, 26% with a patent medicine vendor and 22% in a private hospital. Forty one percent had unsatisfactory knowledge of TB. Forty two percent had patient delay. Having unsatisfactory knowledge of TB (p = 0.046) and multiple care-seeking (p = 0.02) were significantly associated with patient delay. After controlling for travel time and age, multiple care-seeking was independently associated with patient delay (Adjusted Odds Ratio = 2.18, 95% CI = 1.09-4.35). Conclusion Failure to immediately seek care in DOTS centers and having unsatisfactory knowledge of TB are factors contributing to patient delay. Strategies that promote early care-seeking in DOTS centers and sustained awareness on TB should be implemented in FCT. PMID:25328625

  8. Concurrent IMRT and weekly cisplatin followed by GDP chemotherapy in newly diagnosed, stage IE to IIE, nasal, extranodal NK/T-Cell lymphoma.

    PubMed

    Ke, Q-H; Zhou, S-Q; Du, W; Liang, G; Lei, Y; Luo, F

    2014-01-01

    On the basis of the benefits of frontline radiation in early-stage, extranodal natural killer (NK)/T-cell lymphoma (ENKTL), we conducted the trial of concurrent chemoradiotherapy (CCRT) followed by three cycles of gemcitabine, dexamethasone and cisplatin (GDP). Thirty-two patients with newly diagnosed, stage IE to IIE, nasal ENKTL received CCRT (that is, all patients received intensity-modulated radiotherapy 56 Gy and cisplatin 30 mg/m(2) weekly, 3-5 weeks). Three cycles of GDP (gemcitabine 1000 mg/m(2) intravenously (i.v.) on days 1 and 8, dexamethasone 40 mg orally on days 1-4 and cisplatin 75 mg/m(2) i.v. on day 1 (GDP), every 21 days as an outpatient were scheduled after CCRT. All patients completed CCRT, which resulted in 100% response that included 24 complete responses (CRs) and eight partial responses. The CR rate after CCRT was 75.0% (that is, 24 of 32 responses). Twenty-eight of the 32 patients completed the planned three cycles of GDP, whereas four patients did not because they withdrew (n = 1) or because they had an infection (n = 3). The overall response rate and the CR rate were 90.6% (that is, 29 of 32 responses) and 84.4% (that is, 27 of 32 responses), respectively. Only two patient experienced grade 3 toxicity during CCRT (nausea), whereas 13 of the 30 patients experienced grade 4 neutropenia. The estimated 3-year overall survival and progression-free rates were 87.50% and 84.38%, respectively. In conclusion, CCRT followed by GDP chemotherapy can be a feasible and effective treatment strategy for stage IE to IIE nasal ENKTL.

  9. Phase II Trial of Pre-Irradiation and Concurrent Temozolomide in Patients with Newly Diagnosed Anaplastic Oligodendrogliomas and Mixed Anaplastic Oligoastrocytomas: Long Term Results of RTOG BR0131

    PubMed Central

    Vogelbaum, Michael A.; Hu, Chen; Peereboom, David M.; Macdonald, David R.; Giannini, Caterina; Suh, John H.; Jenkins, Robert B.; Laack, Nadia N.; Brachman, David G.; Shrieve, Dennis C.; Souhami, Luis; Mehta, Minesh P.

    2015-01-01

    BACKGROUND We report on the long-term results of a phase II study of pre-irradiation temozolomide followed by concurrent temozolomide and radiotherapy (RT) in patients with newly diagnosed anaplastic oligodendroglioma (AO) and mixed anaplastic oligoastrocytoma (MOA). METHODS Pre-RT temozolomide was given for up to 6 cycles. RT with concurrent temozolomide was administered to patients with less than a complete radiographic response. RESULTS Forty eligible patients were entered and 32 completed protocol treatment. With a median follow-up time of 8.7 years (range: 1.1 to 10.1), median progression-free survival (PFS) is 5.8 years (95% C.I. 2.0, NR) and median overall survival (OS) has not been reached (5.9, NR). 1p/19q data are available in 37 cases; 23 tumors had codeletion while 14 tumors had no loss or loss of only 1p or 19q (non-codeleted). In codeleted patients, 9 patients have progressed and 4 have died; neither median PFS nor OS have been reached and two patients who received only pre-RT temozolomide and no RT have remained progression-free for over 7 years. 3-year PFS and 6-year OS are 78% (95% CI: 61-95%) and 83% (95% CI: 67-98%), respectively. Codeleted patients show a trend towards improved 6-year survival when compared to the codeleted procarbazine/CCNU/vincristrine (PCV) and RT cohort in RTOG 9402 (67%, 95% CI:55-79%). For non-codeleted patients, median PFS and OS are 1.3 and 5.8 years, respectively. CONCLUSIONS These updated results suggest that the regimen of dose intense, pre-RT temozolomide followed by concurrent RT/temozolomide has significant activity, particularly in patients with 1p/19q codeleted AOs and MAOs. PMID:26088460

  10. Clinical symptoms and chemotherapy completion in elderly patients with newly diagnosed acute leukemia: a retrospective comparison study with a younger cohort

    PubMed Central

    2011-01-01

    Background Cancer affects older adults disproportionately. The disease is often difficult to diagnose and treat due to co-morbidities and performance status, and patients tend to discontinue chemotherapy prematurely. There are no systemic studies of the reasons and factors that create a higher withdrawal rate in older acute leukemia patients. This study tried to understand the initial characteristics, blood counts and bone marrow measurements in older acute leukemia patients by comparing them with a younger group to provide information and assistance in early clinical diagnosis, treatment and reasons for treatment withdrawal. Methods Using retrospective medical record reviews, we examined clinical characteristics and chemotherapy completion status in the patients of two groups (age ≥ 60, n = 183 and age <60, n = 183) who were diagnosed with acute leukemia for the first time and were hospitalized in Union Hospital Affiliated with Fujian Medical University from 2004 to 2008. Results There were no statistical differences in initial presenting symptoms of fatigue (67.2% vs. 57.9%, P>0.05) and pallor (53% vs. 59.6%, P>0.05) between the two groups, but older patients demonstrated more underlying diseases including lung infections (25.7%, P = <0.001), cardiovascular disease (4.4%, P = 0.007), and hypertension (20.8%, P =< 0.001). The complete remission rate after chemotherapy (1 to 2 courses) was 49.5% in the older group and 66.7% in the younger group (χ2 = 6.202, P = 0.013). The percentage of patients age 60 and older who prematurely discontinued chemotherapy (50.3%), mainly due to the influences of traditional Chinese concept of critical illness, financial difficulties, and intolerance to adverse reactions to chemotherapy, was significantly higher than that of younger patients (37.7%) (χ2 = 5.866, P = 0.015). Conclusions A comprehensive approach to diagnosis, treatment selection, and toxicity management, and implementing strategies to enhance treatment compliance

  11. Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

    ClinicalTrials.gov

    2014-09-16

    Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

  12. A Comparison of Psychotropic Drug Side Effect Profiles in Adults Diagnosed with Intellectual Disabilities and Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Hess, Julie; Matson, Johnny; Neal, Daniene; Mahan, Sara; Fodstad, Jill; Bamburg, Jay; Holloway, Jodie

    2010-01-01

    Forty-eight adults diagnosed with intellectual disabilities and Autistic Disorder or Pervasive Developmental Disorder-Not Otherwise Specified were examined with regard to psychotropic medication side effects. Participants were divided into 4 groups: no psychotropic medication group (n = 9); atypical antipsychotic medication group (n = 13);…

  13. Disrupted-In-Schizophrenia 1 regulates integration of newly generated neurons in the adult brain

    PubMed Central

    Duan, Xin; Chang, Jay H.; Ge, Shaoyu; Faulkner, Regina L.; Kim, Ju Young; Kitabatake, Yasuji; Liu, Xiao-bo; Yang, Chih-Hao; Jordan, J. Dedrick; Ma, Dengke K.; Liu, Cindy Y.; Ganesan, Sundar; Cheng, Hwai-Jong; Ming, Guo-li; Lu, Bai; Song, Hongjun

    2007-01-01

    Summary Adult neurogenesis occurs throughout life in discrete regions of the adult mammalian brain. Little is known about the mechanism governing the sequential developmental process that leads to integration of new neurons from adult neural stem cells into the existing circuitry. Here, we investigated roles of Disrupted-In-Schizophrenia 1 (DISC1), a schizophrenia susceptibility gene, in adult hippocampal neurogenesis. Unexpectedly, down regulation of DISC1 leads to accelerated neuronal integration, resulting in aberrant morphological development and mis-positioning of new dentate granule cells in a cell-autonomous fashion. Functionally, newborn neurons with DISC1 knockdown exhibit enhanced excitability and accelerated dendritic development and synapse formation. Furthermore, DISC1 cooperates with its binding partner Ndel1 in regulating adult neurogenesis. Taken together, our study identifies DISC1 as a key regulator that orchestrates the tempo of functional neuronal integration in the adult brain and demonstrates essential roles of a susceptibility gene for major mental illness in neuronal development, including adult neurogenesis. PMID:17825401

  14. Chronic Social Stress Affects Synaptic Maturation of Newly Generated Neurons in the Adult Mouse Dentate Gyrus

    PubMed Central

    Chen, Chien-Chung; Huang, Chiung-Chun

    2016-01-01

    Background: Chronic stress has been found to suppress adult neurogenesis, but it remains unclear whether it may affect the maturation process of adult-born neurons. Here, we examined the influence of chronic social defeat stress on the morphological and electrophysiological properties of adult-born dentate granule cells at different developmental stages. Methods: Adult C57BL/6 mice were subjected to 10 days of chronic social defeat stress followed by a social interaction test 24 hours after the last defeat. Defeated mice were segregated into susceptible and unsusceptible subpopulations based on a measure of social interaction test. Combining electrophysiology with retrovirus-mediated birth-dating and labeling, we examined the impact of chronic social defeat stress on temporal regulation of synaptic plasticity of adult-born dentate granule cells along their maturation. Results: Chronic social defeat stress decreases the survival and dendritic complexity of adult-born dentate granule cells. While chronic social defeat stress doesn’t alter the intrinsic electrophysiological properties and synaptic transmission of surviving adult-born dentate granule cells, it promotes the developmental switch in synaptic N-methyl-D-aspartate receptors from predominant GluN2B- to GluN2A-containing receptors, which transform the immature synapse of adult-born dentate granule cells from one that exhibits enhanced long-term potentiation to one that has normal levels of long-term potentiation. Furthermore, chronic social defeat stress increases the level of endogenous repressor element-1 silencing transcription factor mRNA in adult-born dentate granule cells, and knockdown of the repressor element-1 silencing transcription factor in adult-born dentate granule cells rescues chronic social defeat stress-induced morphological deficits and accelerated developmental switch in synaptic N-methyl-D-aspartate receptor subunit composition. Conclusions: These results uncover a previously

  15. Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

    ClinicalTrials.gov

    2016-11-02

    Adult T Acute Lymphoblastic Leukemia; Childhood T Acute Lymphoblastic Leukemia; Stage II Adult T-Cell Leukemia/Lymphoma; Stage II Childhood Lymphoblastic Lymphoma; Stage II Contiguous Adult Lymphoblastic Lymphoma; Stage II Non-Contiguous Adult Lymphoblastic Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Adult T-Cell Leukemia/Lymphoma; Stage III Childhood Lymphoblastic Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Adult T-Cell Leukemia/Lymphoma; Stage IV Childhood Lymphoblastic Lymphoma; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia

  16. Social perception and WAIS-IV Performance in adolescents and adults diagnosed with Asperger's Syndrome and Autism.

    PubMed

    Holdnack, James; Goldstein, Gerald; Drozdick, Lisa

    2011-06-01

    Previous research using the Wechsler scales has identified areas of cognitive weaknesses in children, adolescents, and adults diagnosed with Autism or Asperger's syndrome. The current study evaluates cognitive functioning in adolescents and adults diagnosed with Autism or Asperger's syndrome using the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) and the Social Perception subtest from the Advanced Clinical Solutions. Deficits in social perception, verbal comprehension, and processing speed were found in the Autism sample. Additionally, they exhibited inconsistent performance on auditory working memory and perceptual reasoning tasks. The Asperger's syndrome group had better overall cognitive skills than the Autism group, but compared with controls, they had weaknesses in processing speed, social perception, and components of auditory working memory. Both groups had relatively low scores on the WAIS-IV Comprehension subtest compared with the other verbal comprehension subtests. Clinical application and utility of the WAIS-IV and Social Perception in Autism Spectrum Disorders are discussed.

  17. Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia

    ClinicalTrials.gov

    2015-10-29

    B-cell Adult Acute Lymphoblastic Leukemia; Blastic Phase Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia; Untreated Adult Acute Lymphoblastic Leukemia

  18. Gastric Inhibitory Polypeptide Receptor Methylation in Newly Diagnosed, Drug-Naïve Patients with Type 2 Diabetes: A Case-Control Study

    PubMed Central

    Canivell, Silvia; Ruano, Elena G.; Sisó-Almirall, Antoni; Kostov, Belchin; González-de Paz, Luis; Fernandez-Rebollo, Eduardo; Hanzu, Felicia; Párrizas, Marcelina; Novials, Anna; Gomis, Ramon

    2013-01-01

    GIP action in type 2 diabetic (T2D) patients is altered. We hypothesized that methylation changes could be present in GIP receptor of T2D patients. This study aimed to assess the differences in DNA methylation profile of GIPR promoter between T2D patients and age- and Body Mass Index (BMI)-matched controls. We included 93 T2D patients (cases) that were uniquely on diet (without any anti-diabetic pharmacological treatment). We matched one control (with oral glucose tolerance test negative, non diabetic), by age and BMI, for every case. Cytokines and hormones were determined by ELISA. DNA was extracted from whole blood and DNA methylation was assessed using the Sequenom EpiTYPER system. Our results showed that T2D patients were more insulin resistant and had a poorer β cell function than their controls. Fasting adiponectin was lower in T2D patients as compared to controls (7.0±3.8 µgr/mL vs. 10.0±4.2 µgr/mL). Levels of IL 12 in serum were almost double in T2D patients (52.8±58.3 pg/mL vs. 29.7±37.4 pg/mL). We found that GIPR promoter was hypomethylated in T2D patients as compared to controls. In addition, HOMA-IR and fasting glucose correlated negatively with mean methylation of GIPR promoter, especially in T2D patients. This case-control study confirms that