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Sample records for adults newly diagnosed

  1. Newly Diagnosed: Older Adults

    MedlinePlus

    ... Children Newly Diagnosed: Older Adults Related Topics on AIDS.gov Aging with HIV/AIDS National HIV/AIDS ... an Emerging Challenge Last revised: 07/10/2015 AIDS.gov HIV/AIDS Basics • Federal Resources • Using New ...

  2. Newly Diagnosed

    MedlinePlus

    ... of transmitting HIV to others. Do I Have AIDS? Being HIV-positive does NOT necessarily mean you ... Children Newly Diagnosed: Older Adults Related Topics on AIDS.gov Stages of HIV Infection Immune System 101 ...

  3. 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 ...

  4. Ageing with HIV: newly diagnosed older adults in Italy.

    PubMed

    Orchi, N; Balzano, R; Scognamiglio, P; Navarra, A; De Carli, G; Elia, P; Grisetti, S; Sampaolesi, A; Giuliani, M; De Filippis, A; Puro, V; Ippolito, G; Girardi, E

    2008-04-01

    The prevalence of HIV/AIDS among people in midlife and late adulthood has been increasing in Western countries over the last decade. We analyzed data from a prospective, observational multi-centre study on individuals newly diagnosed with HIV between January 2004 and March 2007 in 10 public counselling and testing sites in Latium, Italy. At diagnosis, routine demographic, epidemiological, clinical and laboratory data are recorded, and patients are asked to complete a questionnaire investigating socio-demographic and psycho-behavioural aspects. To analyze the association of individual characteristics with age, we compared older adults (> or = 50 years) with their younger counterpart (18-49 years). To adjust for potential confounding effect of the epidemiological, clinical and behavioural characteristics, to identify factors associated with older age at HIV diagnosis, multivariate logistic regression analysis was performed. Overall, 1073 individuals were identified, 125 of whom (11.6%) were aged 50 years or above. The questionnaire was completed by 41% (440/1073). Compared with their younger counterparts, a higher proportion of older patients were males, born in Italy, reported heterosexual or unknown HIV risk exposure, were never tested for HIV before and were in a more advanced stage of HIV infection at diagnosis. In addition, older adults had a lower educational level and were more frequently living with their partners or children. With respect to psycho-behavioural characteristics, older patients were more likely to have paid money for sex and have never used recreational drugs. Interestingly, no differences were found regarding condom use, which was poor in both age groups. These findings may have important implications for the management of older adults with HIV, who should be targeted by appropriate public health actions, such as opportunistic screening and easier access to healthcare. Moreover, strategies including information on HIV and prevention of risk

  5. Associations of obesity with newly diagnosed and previously known atopic diseases in Chinese adults: a case-control study

    PubMed Central

    Xie, Biao; Wang, Zhiqiang; Wang, Yupeng; Liu, Meina; Wang, Yongchen

    2017-01-01

    To assess the associations of obesity with newly diagnosed and previously known atopic disorders in Chinese adults. 4,629 adults aged 18 years or older were recruited in Harbin, China. Among them, 1,114 were previously diagnosed atopic cases, 1,298 were newly diagnosed cases, and 2,217 non-atopic controls. Obesity and overweight are defined according to the criteria established by the Working Group on Obesity in China. The associations of obesity with known and newly diagnosed atopic disorders were assessed using logistic regressions. Obesity was significantly associated with known atopic disorders (adjusted OR = 2.41 (95% CI: 1.81, 3.22)). The association of obesity with newly diagnosed atopic cases was not as strong as that with known cases, and was not statistically significant (adjusted OR = 1.27 (95% CI: 0.94, 1.72)). The similar pattern was observed in different allergic diseases, gender and age stratifications. The association between overweight and atopic diseases were not significant. Obesity is strongly associated with previously diagnosed atopic cases but not so with newly diagnosed atopic cases in Chinese adults. It is likely that people with atopic disorders have a higher risk of developing obesity. Our findings are important for the management of atopic disorders and chronic disease prevention among atopic disease patients. PMID:28252017

  6. Eltrombopag and high-dose dexamethasone as frontline treatment of newly diagnosed immune thrombocytopenia in adults.

    PubMed

    Gómez-Almaguer, David; Herrera-Rojas, Miguel A; Jaime-Pérez, José C; Gómez-De León, Andrés; Cantú-Rodríguez, Olga G; Gutiérrez-Aguirre, César H; Tarín-Arzaga, Luz; Hernández-Reyes, Jesús; Ruiz-Arguelles, Guillermo J

    2014-06-19

    Immune thrombocytopenia (ITP) results from platelet destruction and production suppression. Eltrombopag belongs to a new class of thrombopoietin-mimetic drugs that raise platelet counts in ITP patients. We performed a single-arm study to assess the response to a single course of dexamethasone (40 mg by mouth, days 1-4) in combination with eltrombopag (50 mg, days 5-32) in 12 adults with newly diagnosed ITP in an outpatient setting. Median follow-up was 12.5 months. After therapy (day 33), 100% of patients achieved at least ≥30 × 10(9)/L platelets. Four patients relapsed. Complete response at 6 months (platelets ≥100 × 10(9)/L) was achieved in 50% of patients and response at 6 months (platelets ≥30 <100 × 10(9)/L) was achieved in another 25%; relapse-free survival was 66.7% at 12 months (median response duration of 8.3 months). In conclusion, eltrombopag/dexamethasone is a feasible frontline therapy for ITP. This trial is registered at www.clinicaltrials.gov as NCT01652599.

  7. PEG-asparaginase in BFM-90 regimen improves outcomes in adults with newly diagnosed lymphoblastic lymphoma

    PubMed Central

    Zheng, Wen; Ren, Hanyun; Ke, Xiaoyan; Xue, Mei; Zhang, Yongqing; Xie, Yan; Lin, Ningjing; Tu, Meifeng; Liu, Weiping; Ping, Lingyan; Ying, Zhitao; Zhang, Chen; Deng, Lijuan; Wang, Xiaopei; Song, Yuqin; Zhu, Jun

    2017-01-01

    Objective Although L-asparaginase (L-ASP) is a standard treatment for lymphoblastic lymphoma (LBL), hypersensitivity reactions by some patients limit its application. Polyethylene glycol-conjugated asparaginase (PEG-ASP) has a lower immunogenicity and is a standard treatment in all pediatric acute lymphoblastic leukemia (ALL). In this study, we investigated the efficacy and toxicity of PEG-ASP instead of L-ASP as used in the BFM-90 regimen (PEG-ASP-BFM-90) for adult LBL. Methods Between June 2012 and July 2015, we treated 30 adult patients with newly diagnosed LBL, using PEG-ASP-BFM-90 in a prospective, multicenter and single-arm clinical study at 5 participating institutions in China. Results All the 30 patients, including 19 males and 11 females with a median age of 30 (range: 18–62) years, completed 128 times of the PEG-ASP, with the median of 4 (range: 2–6) times. Patients did not receive radiotherapy at this time. The overall response rate was 86.7% (26/30), with 50.0% (15/30) complete response and 36.7% (11/30) partial response. The 3-year overall survival was 46.0% [95% confidence interval (95% CI), 28.2%–64.8%], and the 3-year progression-free survival was 43.0% (95% CI, 25.7%–62.0%). Major adverse events were myelosuppression, reduced fibrinogen, liver dysfunction and digestive tract toxicities. No allergic reaction and no treatment-related mortality or severe complications were recorded. Conclusions Our clinical data and observed outcomes indicate that 1 dose of PEG-ASP can replace multiple doses of native L-ASP in BFM-90, with predominantly grade 3–4 neutropenia for adult LBL, and no therapy-related deaths. The effect is similar to previous reports of PEG-ASP-containing regimens for adult ALL. Major advantages include less serious allergic reactions, 2–3 weeks of action duration, and convenience for patients and physicians. PMID:28373755

  8. 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.

  9. Outcomes in newly diagnosed epilepsy in adolescents and adults: Insights across a generation in Scotland.

    PubMed

    Brodie, Martin J

    2017-01-01

    The outpatient services at the Epilepsy Unit in the Western Infirmary, Glasgow, Scotland was set up in September 1982. From the outset patient data were collected prospectively. A focused approach to patients with newly diagnosed epilepsy was developed and a series of 4 analyses have been undertaken over the intervening years, with results from the latest still being written up for publication. A total of 16 published papers have described patient outcomes over the years, focusing on response to different drug schedules. A number of factors contributing to a poorer prognosis has been identified and follow up data over 30 years has confirmed the lack of overall improvement in prognosis despite the introduction of 14 new AEDs for the common epilepsies in the UK with different mechanisms of action over this time. Patterns of response have confirmed that a majority of patients will go into remission with around 25% of the population appearing to have refractory epilepsy de novo. Since all available options are antiseizure and not antiepilepsy drugs, some patients, who are initially well controlled, are seen to relapse over time and to develop refractory epilepsy. A new approach in identifying and treating epileptogenesis is necessary, if this disappointing scenario is to be reversed with the next generation of antiepileptic drugs.

  10. Long-term monotherapy with lamotrigine in newly diagnosed epilepsy in adults.

    PubMed

    Chmielewska, B; Kamiński, M L; Kawka, Z

    2001-01-01

    Lamotrigine (LTG) as both effective against a wide range of seizure types and epileptic syndromes and well tolerated drug is being used in mono--as well as in polytherapy of pharmacoresistant epilepsy. The aim of this study was to evaluate the efficacy, safety and neuropsychological functioning after LTG (mean daily dose: 316 mg) as long-term monotherapy (12 mo) in 24 young adult out-patients (22.5 ys) with newly recognised and not-previously treated epilepsy in an open, non-comparative trial. 67% of patients were responders (above 50% reduction in seizure frequency) and 42% reported seizures remission. The best were results in patients with generalised convulsive fits (87% with remission). Adverse events in the early phase of medication in 21% of patients typically concerned CNS and gastrointestinal system (headache, asthenia, insomnia, nausea, gastric aches) and resolved spontaneously without treatment discontinuation. Biochemical examinations were normal and transient leucopenia and diminishion of MCV were clinically not significant. Neurodynamic abilities, neuropsychological examination results, memory verbal and visual tests and organic evaluation in organic triada tests did not show deterioration after LTG treatment. Slight difficulties in abstractive and operative thinking and some focal symptoms of fronto-temporal origin should be considered a result of drug but also the epilepsy per se. No significant differences in latencies and amplitudes of evoked potentials (VEP, BAEP, SEP and especially ERP-300) were measured after LTG. Preliminary results obtained in this study supported good efficacy and tolerability and especially lack of unfavourable influence of LTG on neuropsychological functioning in young previously untreated patients with epilepsy.

  11. A Nation-Wide Epidemiological Study of Newly Diagnosed Primary Spine Tumor in the Adult Korean Population, 2009–2011

    PubMed Central

    Sohn, Seil; Kim, Jinhee; Chung, Chun Kee; Lee, Na Rae; Sohn, Moon Jun; Kim, Sung Hwan

    2017-01-01

    Objective This 2009–2011 nation-wide study of adult Koreans was aimed to provide characteristics, medical utilization states, and survival rates for newly diagnosed patients with primary nonmalignant and malignant spine tumors. Methods Data for patients with primary spine tumors were selected from the Korean Health Insurance Review and Assessment Service database. The data included their age, sex, health insurance type, co-morbidities, medical cost, and hospital stay duration. Hospital stay duration and medical costs per person occurring in one calendar year were used. In addition, survival rates of patients with primary malignant spine tumors were evaluated. Results The incidence rate of a primary spine tumor increased with age, and the year of diagnosis (p≤0.0001). Average annual medical costs ranged from 1627 USD (pelvis & sacrum & coccyx tumors) to 6601 USD (spinal cord tumor) for primary nonmalignant spine tumor and from 12137 USD (spinal meningomas) to 20825 USD (pelvis & sacrum & coccyx tumors) for a primary malignant spine tumor. Overall survival rates for those with a primary malignant spine tumor were 87.0%, 75.3%, and 70.6% at 3, 12, and 24 months, respectively. The Cox regression model results showed that male sex, medicare insurance were significantly positive factors affecting survival after a diagnosis of primary malignant spine tumor. Conclusion Our study provides a detailed view of the characteristics, medical utilization states, and survival rates of patients newly diagnosed with primary spine tumors in Korea. PMID:28264240

  12. Newly Diagnosed Acute Promyelocytic Leukemia

    PubMed Central

    Avvisati, Giuseppe

    2011-01-01

    Acute promyelocytic leukemia (APL) represents a medical emergency with a high rate of early mortality. As a consequence, as soon as the diagnosis is suspected based upon cytologic criteria, it is necessary to start all- trans retinoic acid (ATRA) treatment without delay. For patients with newly diagnosed APL, induction therapy with ATRA plus anthracycline based chemotherapy is recommended. At present the combination of arsenic trioxide plus ATRA should be considered for patients who are not candidates for anthracycline-based therapy. For pediatric and adult patients with APL aged < 60 years who achieve a CR with induction, I recommend 3 intensive courses of consolidation chemotherapy associated to ATRA, targeted on the basis of the risk group at diagnosis. In patients treated with a very intensive consolidation chemotherapy maintenance treatment can be omitted. However If a maintenance treatment has to be adopted I suggest the use of intermittent ATRA for 15 days every 3 months for a period of 2 years, rather than ATRA associated to chemotherapy. Moreover, taking into account the medical literature, a reduced dosage of ATRA ( 25 mg/m2) in pediatric patients and a consolidation chemotherapy of reduced intensity in elderly patients is recommended. Furthermore, in order to maximize survival, careful attention should be reserved to the coagulopathy and to the appearance of the differentiation syndrome. Finally, PCR for the PML/RARA fusion gene on a bone marrow specimen every three months for two years, and then every six months for additional three years are needed during the follow-up. PMID:22220261

  13. 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.

  14. 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

  15. Predictors of Linkage to Care for Newly Diagnosed HIV-Positive Adults

    PubMed Central

    Aaron, Erika; Alvare, Tyler; Gracely, Ed J.; Riviello, Ralph; Althoff, Amy

    2015-01-01

    Introduction Linkage to care following a human immunodeficiency virus (HIV) diagnosis is critical. In the U.S. only 69% of patients are successfully linked to care, which results in delayed receipt of antiretroviral therapy leading to immune system dysfunction and risk of transmission to others. Methods We evaluated predictors of failure to link to care at a large urban healthcare center in Philadelphia in order to identify potential intervention targets. We conducted a cohort study between May 2007 and November 2011 at hospital-affiliated outpatient clinics, emergency departments (EDs), and inpatient units. Results Of 87 patients with a new HIV diagnosis, 63 (72%) were linked to care: 23 (96%) from the outpatient setting and 40 (63%) from the hospital setting (ED or inpatient) (p<0.01). Those who were tested in the hospital-based settings were more likely to be black (p=0.01), homeless (p=0.03), and use alcohol or drugs (p=0.03) than those tested in the outpatient clinics. Patients tested in the ED or inpatient units had a 10.9 fold (p=0.03) higher odds of failure to link compared to those diagnosed in an outpatient clinic. When testing site was controlled, unemployment (OR 12.2;p<0.01) and substance use (OR 6.4;p<0.01) were associated with failure to link. Conclusion Our findings demonstrate the comparative success of linkage to care in outpatient medical clinics versus hospital-based settings. This study both reinforces the importance of routine opt-out HIV testing in outpatient practices, and demonstrates the need to better understand barriers to linkage. PMID:26265965

  16. 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

  17. What next for newly diagnosed glioblastoma?

    PubMed Central

    Domingo-Musibay, Evidio; Galanis, Evanthia

    2015-01-01

    Glioblastoma is the most common primary brain tumor in adults. Despite current multimodality treatment including surgical resection and temozolomide-based chemoradiotherapy, median survival is only 14–16 months. Characterization of molecular alterations in glioblastoma has identified prognostic subgroups and therapeutic opportunities for clinical trials across glioblastoma subsets. Following a number of negative Phase III trials testing temozolomide dose intensification and angiogenesis inhibition, recent interim analysis data indicate survival prolongation with use of a device (Optune™) delivering alternating electrical field therapy in newly diagnosed glioblastoma patients. In this review, we present an overview of the data supporting the current standard of care and discuss novel experimental therapies in early and late phase clinical testing including devices, small molecule drugs, angiogenesis inhibitors, oncolytic virotherapy and immunotherapy. PMID:26558493

  18. 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

  19. High rates of diabetes reversal in newly diagnosed Asian Indian young adults with type 2 diabetes mellitus with intensive lifestyle therapy

    PubMed Central

    Sarathi, Vijaya; Kolly, Anish; Chaithanya, H. B.; Dwarakanath, C. S.

    2017-01-01

    Aims: There are variable reports on the reversibility of type 2 diabetes mellitus (type 2 DM) with higher rates among younger patients with short duration of diabetes. Hence, we studied the reversibility of diabetes among young adults with newly diagnosed type 2 DM. Methods: This prospective study included 32 patients with newly diagnosed type 2 DM. All type 2 DM patients were initially treated with intensive lifestyle therapy (ILT) (low-calorie diet [1500 kcal/day] and brisk walking for 1 h/day]). Four patients who with HbA1C <9.0% were treated with ILT alone. Except for three patients with concomitant infections who were treated with insulin, remaining 25 patients with HbA1C ≥9.0% were treated with metformin (1000–2000 g) in addition to ILT. When fasting plasma glucose was <126 mg/dl or HbA1C was <6.5% antidiabetic drug dose was reduced or stopped. The patients were followed for a minimum period of 2 years. Results: Reversal/remission rates at 3 months, 1 year, and 2 years were 24 (75%), 24 (75%), and 22 (68.75%), respectively. Seventeen (53.1%) patients achieved complete reversal and seven (21.9%) patients achieved partial reversal at 3 months. Rates of complete and partial remission at 1 year were 50% and 25% and at 2 years were 46.9% and 21.9%, respectively. Conclusion: Young adults with newly diagnosed type 2 DM have high rates of diabetes reversal and should receive ILT to achieve reversal of diabetes. PMID:28250676

  20. 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

  1. Use of PEG-asparaginase in newly diagnosed adults with standard-risk acute lymphoblastic leukemia compared with E. coli-asparaginase: a retrospective single-center study.

    PubMed

    Liu, Wen-Jian; Wang, Hua; Wang, Wei-da; Zhu, Meng-Yuan; Liu, Cheng-Cheng; Wang, Jing-Hua; Lu, Yue

    2016-12-21

    Acute lymphoblastic leukemia (ALL) is a heterogeneous disease, and the long-term survival varies with different ages. We performed a retrospective analysis of 122 newly diagnosed adults with standard-risk ALL treated with Escherichia coli asparaginase (E. coli-asparaginase, n = 50) and polyethylene glycol-conjugated asparaginase (PEG-asparaginase, n = 72). No treatment-related mortality (TRM) occurred in the E. coli-asparaginase group, and 3 TRM events occurred in the PEG-asparaginase group without relation to asparaginase. In addition, 22 (44.0%) and 48 (66.7%) patients achieved a complete response (CR) on day 14 in the E. coli-asparaginase and PEG-asparaginase groups, respectively (P = 0.032). No different 5-year event-free survival (EFS) or overall survival (OS) rate (P = 0.632 and 0.769) was observed. Multivariate analysis revealed later CR (P = 0.008) and older age (P = 0.049) as adverse prognostic factors for both EFS and OS. In addition, we specifically monitored the known adverse effects of asparaginase, and no asparaginase-related death was observed. Allergy occurred in 9 patients using E. coli-asparaginase, and no patient in the PEG-asparaginase group suffered from allergies (P < 0.001). The incidence of other asparaginase-related toxicities was similar. We conclude that PEG-asparaginase can be safely and effectively used as asparaginase in adults with newly diagnosed standard-risk ALL.

  2. Use of PEG-asparaginase in newly diagnosed adults with standard-risk acute lymphoblastic leukemia compared with E. coli-asparaginase: a retrospective single-center study

    PubMed Central

    Liu, Wen-jian; Wang, Hua; Wang, Wei-da; Zhu, Meng-yuan; Liu, Cheng-cheng; Wang, Jing-hua; Lu, Yue

    2016-01-01

    Acute lymphoblastic leukemia (ALL) is a heterogeneous disease, and the long-term survival varies with different ages. We performed a retrospective analysis of 122 newly diagnosed adults with standard-risk ALL treated with Escherichia coli asparaginase (E. coli-asparaginase, n = 50) and polyethylene glycol-conjugated asparaginase (PEG-asparaginase, n = 72). No treatment-related mortality (TRM) occurred in the E. coli-asparaginase group, and 3 TRM events occurred in the PEG-asparaginase group without relation to asparaginase. In addition, 22 (44.0%) and 48 (66.7%) patients achieved a complete response (CR) on day 14 in the E. coli-asparaginase and PEG-asparaginase groups, respectively (P = 0.032). No different 5-year event-free survival (EFS) or overall survival (OS) rate (P = 0.632 and 0.769) was observed. Multivariate analysis revealed later CR (P = 0.008) and older age (P = 0.049) as adverse prognostic factors for both EFS and OS. In addition, we specifically monitored the known adverse effects of asparaginase, and no asparaginase-related death was observed. Allergy occurred in 9 patients using E. coli-asparaginase, and no patient in the PEG-asparaginase group suffered from allergies (P < 0.001). The incidence of other asparaginase-related toxicities was similar. We conclude that PEG-asparaginase can be safely and effectively used as asparaginase in adults with newly diagnosed standard-risk ALL. PMID:28000713

  3. Prevalence and Correlates of Genital Infections Among Newly Diagnosed Human Immunodeficiency Virus–Infected Adults Entering Human Immunodeficiency Virus Care in Windhoek, Namibia

    PubMed Central

    Djomand, Gaston; Schlefer, Madeleine; Gutreuter, Steve; Tobias, Sarah; Patel, Roopal; DeLuca, Nickolas; Hood, Julia; Sawadogo, Souleymane; Chen, Cheng; Muadinohamba, Alexinah; Lowrance, David W.; Bock, Naomi

    2016-01-01

    Background Identifying and treating genital infections, including sexually transmitted infections (STI), among newly diagnosed human immunodeficiency virus (HIV)-infected individuals may benefit both public and individual health. We assessed prevalence of genital infections and their correlates among newly diagnosed HIV-infected individuals enrolling in HIV care services in Namibia. Methods Newly diagnosed HIV-infected adults entering HIV care at 2 health facilities in Windhoek, Namibia, were recruited from December 2012 to March 2014. Participants provided behavioral and clinical data including CD4+ T lymphocyte counts. Genital and blood specimens were tested for gonorrhea, Chlamydia, trichomoniasis, Mycoplasma genitalium, syphilis, bacterial vaginosis, and vulvovaginal candidiasis. Results Among 599 adults, 56% were women and 15% reported consistent use of condoms in the past 6 months. The most common infections were bacterial vaginosis (37.2%), trichomoniasis (34.6%) and Chlamydia (14.6%) in women and M. genitalium (11.4%) in men. Correlates for trichomoniasis included being female (adjusted relative risk, [aRR], 7.18; 95% confidence interval [CI], 4.07–12.65), higher education (aRR, 0.58; 95% CI, 0.38–0.89), and lower CD4 cell count (aRR, 1.61; 95% CI, 1.08–2.40). Being female (aRR, 2.39; 95% CI, 1.27–4.50), nonmarried (aRR, 2.30; (95% CI, 1.28–4.14), and having condomless sex (aRR, 2.72; 95% CI, 1.06–7.00) were independently associated with chlamydial infection. Across all infections, female (aRR, 2.31; 95% CI, 1.79–2.98), nonmarried participants (aRR, 1.29; 95% CI, 1.06–1.59), had higher risk to present with any STI, whereas pregnant women (aRR, 1.16, 95% CI 1.03–1.31) were at increased risk of any STI or reproductive tract infection. PMID:27893600

  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. 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

    2012-01-05

    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.

  6. 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.

  7. 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

  8. Pre-irradiation chemotherapy for newly diagnosed high grade astrocytoma.

    PubMed

    Mathieu, N Tubiana; Genet, D; Labrousse, F; Bouillet, P; Denes, S Lavau; Martin, J; Labourey, J L; Venat, L; Clavere, P; Moreau, J J

    2004-01-01

    The purpose of this work was to determine the response rate and toxicity of a combination of Carmustine and Cisplatin administered before radiation in patients with newly diagnosed high grade astrocytoma. A good response rate has been published with this association in primary cerebral high grade tumor. This protocol was administered in a homogeneous population of 37 adult patients with measurable tumor on magnetic resonance imaging (MRI) or CT scan. After biopsy or subtotal resection, the patients received BCNU 40 mg/m2/d and CODP 40 mg/m2/d, for 3 days every 28 days for 3 cycles. Evaluation was performed before each cycle. Radiation therapy began 4 weeks after completing the chemotherapy or immediately if there was evidence of tumor progression on chemotherapy. Seven out of 37 (19%) demonstrated tumor regression with a median duration to progression of 11 months. Median survival was 6 months. Myelosuppression was the predominant but manageable toxicity. This work indicated that the first chemotherapy protocol gave poor results in a homogeneous group of patients, with bad prognosis.

  9. Focally enhanced gastritis in newly diagnosed pediatric inflammatory bowel disease.

    PubMed

    Ushiku, Tetsuo; Moran, Christopher J; Lauwers, Gregory Y

    2013-12-01

    Although the significance of focally enhanced gastritis (FEG) as a marker of Crohn disease (CD) in adults has been contested, several studies suggest that it may be more specific of CD in pediatric patients. This study describes the detailed histologic features of FEG in pediatric inflammatory bowel disease (IBD) and clarifies its association with CD. A series of 119 consecutive newly diagnosed IBD patients (62 CD cases, 57 ulcerative colitis [UC] cases) with upper and lower gastrointestinal biopsies were evaluated. The histology of the gastric biopsies was reviewed blinded to final diagnoses and compared with age-matched healthy controls (n=66). FEG was present in 43% of IBD patients (CD 55% vs. UC 30%, P=0.0092) and in 5% of controls. Among CD patients, FEG was more common in younger patients (73% in children aged 10 y and below, 43% in children above 10 y of age, P=0.0358), with the peak in the 5- to 10-year age group (80%). The total number of glands involved in each FEG focus was higher in UC (6.4±5.1 glands) than in CD (4.0±3.0 glands, P=0.0409). Amongst the CD cohort, patients with FEG were more likely than those without FEG to have active ileitis (79% vs. 40%, P=0.0128) and granulomas elsewhere in the gastrointestinal tract (82% vs. 43%, P=0.0016). There was no correlation between FEG and other gastrointestinal findings of UC. We demonstrate that differences in FEG seen in pediatric CD and UC relate to not only their frequencies but also the morphology and relationship with other gastrointestinal lesions. Further, FEG is associated with disease activity and the presence of granulomas in pediatric CD.

  10. 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 ...

  11. Disseminated mucormycosis in an adolescent with newly diagnosed diabetes mellitus.

    PubMed

    McCrory, Michael C; Moore, Blake A; Nakagawa, Thomas A; Givner, Laurence B; Jason, Donald R; Palavecino, Elizabeth L; Ajizian, Samuel J

    2014-10-01

    We report a 16-year-old, previously healthy female who presented with disseminated mucormycosis leading to multiorgan failure and death with newly diagnosed type 1 diabetes mellitus and ketoacidosis. We review previous reported cases of mucormycosis in children with diabetes to demonstrate that this uncommon invasive infection may cause significant morbidity and mortality in this population.

  12. 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…

  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. Insulin Oedema in Newly Diagnosed Type 1 Diabetes Mellitus

    PubMed Central

    Çetinkaya, Semra; Yılmaz Ağladıoğlu, Sebahat; Peltek Kendirici, Havva Nur; Bilgili, Hatice; Yıldırım, Nurdan; Aycan, Zehra

    2010-01-01

    Despite the essential role of insulin in the management of patients with insulin deficiency, insulin use can lead to adverse effects such as hypoglycaemia and weight gain. Rarely, crucial fluid retention can occur with insulin therapy, resulting in an oedematous condition. Peripheral or generalised oedema is an extremely rare complication of insulin therapy in the absence of heart, liver or renal involvement. It has been reported in newly diagnosed type 1 diabetes, in poorly controlled type 2 diabetes following the initiation of insulin therapy, and in underweight patients on large doses of insulin. The oedema occurs shortly after the initiation of intensive insulin therapy. We describe two adolescent girls with newly diagnosed type 1 diabetes, who presented with oedema of the lower extremities approximately one week after the initiation of insulin treatment; other causes of oedema were excluded. Spontaneous recovery was observed in both patients. Conflict of interest:None declared. PMID:21274337

  15. Reduced parasympathetic tone in newly diagnosed essential hypertension

    PubMed Central

    Goit, Rajesh Kumar; Ansari, Abdul Haque

    2016-01-01

    Aim The aim of the study was to compare heart rate variability (HRV) of newly diagnosed essential hypertensive subjects with controls. Methods The study was conducted on 120 hypertensive subjects and 120 controls. Results The time-domain measures, standard deviation of all RR intervals (SDNN), 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 ms (pNN50) which reflect parasympathetic activity were significantly less in hypertensive subjects. In frequency-domain measures, high frequency [HF (ms2)] and [HF (nu)], which reflects parasympathetic activity, was significantly less in hypertensive subjects while LF (nu) and LF/HF (%), which reflect sympathetic activity, were comparable between the groups. Conclusion These findings suggest that HRV is reduced in subjects with newly diagnosed essential hypertension and the parasympathetic dysregulation is present in the early stage of essential hypertension. PMID:27133323

  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. Acute Stress in Parents of Children Newly Diagnosed With Cancer

    PubMed Central

    Patiño-Fernández, Anna Maria; Pai, Ahna L.H.; Alderfer, Melissa; Hwang, Wei-Ting; Reilly, Anne; Kazak, Anne E.

    2010-01-01

    Objective Acute Stress Disorder (ASD) and subclinical symptoms of acute stress (SAS) may be a useful framework for understanding the psychological reactions of mothers and fathers of children newly diagnosed with a pediatric malignancy. Patients and Methods Mothers (N = 129) and fathers (N = 72) of 138 children newly diagnosed with cancer completed questionnaires assessing acute distress, anxiety, and family functioning. Demographic data were also gathered. Inclusion criteria were: a confirmed diagnosis of a pediatric malignancy in a child under the age of 18 years without prior chronic or life threatening illness and fluency in English or Spanish. Results Descriptive statistics and multiple linear regressions were used to examine predictors of SAS. Fifty-one percent (N = 66) of mothers and 40% (N = 29) of fathers met DSM-IV diagnostic criteria for ASD. The majority of the sample reported experiencing at least one SAS. General anxiety, but not family functioning, was a strong predictor of SAS in both mothers and fathers even after controlling for demographic characteristics. Conclusions Immediately following their child’s diagnosis of cancer, most mothers and fathers experience SAS, with a subsample meeting criteria for ASD. More anxious parents are at heightened risk of more intense reactions. The findings support the need for evidence-based psychosocial support at diagnosis and throughout treatment for families who are at risk for acute distress reactions. PMID:17514742

  18. 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

  19. Sleep duration is a potential risk factor for newly diagnosed type 2 diabetes mellitus.

    PubMed

    Chao, Chi-Yuan; Wu, Jin-Shang; Yang, Yi-Ching; Shih, Chi-Chen; Wang, Ru-Hsueh; Lu, Feng-Hwa; Chang, Chih-Jen

    2011-06-01

    U-shaped patterns have been observed for the relationship between sleep duration and diabetes. In addition, prediabetes is associated with the risk of cardiovascular diseases and diabetes. However, there are few studies investigating the relationship between sleep duration and prediabetes/newly diagnosed diabetes. The aim of this study is to examine the relationship between sleep duration and prediabetes/newly diagnosed diabetes in a Taiwanese population. After excluding the subjects with a high risk of obstructive sleep apnea, those with a positive history of diabetes, or those taking hypnotic drugs, a total of 3470 adults were recruited from a health checkup center. Each subject completed a self-administrated structured questionnaire on sleep duration and lifestyle factors. Prediabetes/diabetes was defined following the definition of the American Diabetes Association. Subjects with different sleep durations were classified into short (<6.0 hours), normal (6.0∼8.49 hours), and long sleepers (≥8.5 hours). The proportion of subjects with normal glucose tolerance, prediabetes, and newly diagnosed diabetes was 71.9%, 22.9%, and 5.2%, respectively. There were significant differences in age, sex, weight, education level, body mass index, waist-to-hip ratio, systolic and diastolic blood pressure, alcohol and coffee drinking habits, family history of diabetes, and sleep duration among the 3 glycemic groups. In multinomial regression, both short and long sleepers had a higher risk of newly diagnosed diabetes; and the odds ratio were 1.55 (95% confidence interval, 1.07-2.24) and 2.83 (1.19-6.73), respectively. However, sleep duration was not found to relate to prediabetes. In conclusion, both short and long sleep durations were independently associated with newly diagnosed diabetes, but not with prediabetes.

  20. Bone Disease in Newly Diagnosed Lupus Nephritis Patients

    PubMed Central

    Resende, Aline Lázara; dos Reis, Luciene Machado; Dias, Cristiane Bitencourt; Custódio, Melani Ribeiro; Jorgetti, Vanda; Woronik, Viktoria

    2014-01-01

    Introduction Bone loss in Lupus Nephritis (LN) patients is common and multifactorial. The aim of this study was to evaluate the bone status of newly diagnosed LN patients and their correlation with inflammatory factors involved in LN physiopathology. Methods We studied 15 pre-menopausal patients with ≤2 months of diagnosed SLE and LN. Patients with prior kidney or bone disease were excluded. In addition to biochemical evaluation (including 25-hydroxyvitamin D3 [25(OH)D] and Monocyte Chemotactic Protein (MCP1) dosage), we performed bone biopsies followed by osteoblast culture, histomorphometric and immunohistochemistry analysis. Results LN patients presented a mean age of 29.5±10 years, a proteinuria of 4.7±2.9 g/day and an estimated glomerular filtration rate (GFR) of 37(31–87) ml/min/1,73 m2. They were on glucocorticoid therapy for 34±12 days. All patients presented vitamin D insufficiency (9.9±4.4 ng/ml, range 4–20). Urinary MCP1 correlated negatively with 25(OH)D (r = −0.53, p = 0.003) and positively with serum deoxypyridinoline (r = 0.53, p = 0.004). Osteoblasts isolated from LN bone biopsies presented a significantly higher expression of MCP-1 when compared to controls (32.0.±9.1 vs. 22.9±5.3 mean fluorescence intensities, p = 0.01). LN patients presented a significantly reduced osteoid volume, osteoid thickness, osteoid surface, mineralization surface and bone formation rate, associated with an increased eroded surface and osteoclast surface. Patient’s bone specimens demonstrated a reduced immunostaining for osteoprotegerin (0.61±0.82 vs. 1.08±0.50%, p = 0.003), and an increased expression of Receptor Activator of NF-κB ligand (RANKL) (1.76±0.92 vs. 0.41±0.28%, p<0.001) when compared to controls. Discussion Newly diagnosed LN patients presented a significant disturbance in bone metabolism, characterized by an impaired bone formation and mineralization, associated with an increase in resorption parameters

  1. 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.

  2. Uninvolved immunoglobulins predicting hematological response in newly diagnosed AL amyloidosis.

    PubMed

    Muchtar, Eli; Magen, Hila; Itchaki, Gilad; Cohen, Amos; Rosenfeld, Ra'ama; Shochat, Tzippy; Kornowski, Ran; Iakobishvili, Zaza; Raanani, Pia

    2016-02-01

    Immunoparesis serves as a marker for elevated risk for progression in plasma cell proliferative disorders. However, the impact of immunoparesis in AL amyloidosis has not been addressed. Immunoparesis was defined qualitatively as any decrease below the low reference levels of the uninvolved immunoglobulins and quantitatively, as the relative difference between the uninvolved immunoglobulins and the lower reference values. Forty-one newly diagnosed AL amyloidosis patients were included. Sixty-six percent of patients had a suppression of the uninvolved immunoglobulins. The median relative difference of the uninvolved immunoglobulins was 18% above the low reference levels [range (-71%)-210%]. Ninety percent of the patients were treated with novel agents-based regimens, mostly bortezomib-containing regimens. Nineteen percent of the patients did not attain response to first line treatment. Patients with relative difference of uninvolved immunoglobulins below -25% of the low reference levels were less likely to respond to first line treatment compared to patients with a relative difference of -25% and above [odds ratio for no response vs. partial response and better 30 [(95% CI 4.1-222.2), P=0.0004]. Patients who failed first line treatment were successfully salvaged with lenalidomide-based treatment. Immunoparesis, if assessed quantitatively, may serve as a predictor of response in AL amyloidosis patients treated with bortezomib-containing regimens.

  3. 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.

  4. 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.

  5. Treatment for patients with newly diagnosed multiple myeloma in 2015.

    PubMed

    Mateos, María-Victoria; Ocio, Enrique M; Paiva, Bruno; Rosiñol, Laura; Martínez-López, Joaquín; Bladé, Joan; Lahuerta, Juan-José; García-Sanz, Ramón; San Miguel, Jesús F

    2015-11-01

    Multiple myeloma is the second most frequent haematological disease. The introduction of high-dose melphalan followed by autologous haematopoietic cell transplant (HDT/ASCT) for young patients and the availability of novel agents for young and elderly patients with multiple myeloma have dramatically changed the perspective of treatment. However, further research is necessary if we want to definitively cure the disease. Treatment goals for transplant-eligible and non-transplant-eligible patients should be to prolong survival by achieving the best possible response, while ensuring quality of life. The treatment should be individualized on the basis of host and disease features and better monitoring of the response upon use of high-sensitivity techniques for evaluating residual disease. For young patients, HDT/ASCT is a standard of care for treatment and its efficacy has been enhanced and challenged by the new drugs. For elderly patients, treatment options were limited to alkylators, but new upfront treatment combinations based on novel agents (proteasome inhibitors and immunomodulatory drugs) combined or not with alkylators have significantly improved outcomes.Extended treatment for young and elderly patients improves the quality and duration of clinical responses; however,the optimal scheme, appropriate doses and duration of long-term therapy have not yet been fully determined.This review summarises the progress in the treatment of patients with newly diagnosed multiple myeloma, addressing critical questions such as the optimal induction, early versus late ASCT, consolidation and/or maintenance for young patients, and how we can choose the best option for non-transplant-eligible patients.

  6. 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

  7. Diagnosing heel pain in adults.

    PubMed

    Aldridge, Tracy

    2004-07-15

    Heel pain is a common condition in adults that may cause significant discomfort and disability. A variety of soft tissue, osseous, and systemic disorders can cause heel pain. Narrowing the differential diagnosis begins with a history and physical examination of the lower extremity to pinpoint the anatomic origin of the heel pain. The most common cause of heel pain in adults is plantar fasciitis. Patients with plantar fasciitis report increased heel pain with their first steps in the morning or when they stand up after prolonged sitting. Tenderness at the calcaneal tuberosity usually is apparent on examination and is increased with passive dorsiflexion of the toes. Tendonitis also may cause heel pain. Achilles tendonitis is associated with posterior heel pain. Bursae adjacent to the Achilles tendon insertion may become inflamed and cause pain. Calcaneal stress fractures are more likely to occur in athletes who participate in sports that require running and jumping. Patients with plantar heel pain accompanied by tingling, burning, or numbness may have tarsal tunnel syndrome. Heel pad atrophy may present with diffuse plantar heel pain, especially in patients who are older and obese. Less common causes of heel pain, which should be considered when symptoms are prolonged or unexplained, include osteomyelitis, bony abnormalities (such as calcaneal stress fracture), or tumor. Heel pain rarely is a presenting symptom in patients with systemic illnesses, but the latter may be a factor in persons with bilateral heel pain, pain in other joints, or known inflammatory arthritis conditions.

  8. 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

  9. 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…

  10. The effect of first-line imatinib interim therapy on the outcome of allogeneic stem cell transplantation in adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

    PubMed

    Lee, Seok; Kim, Yoo-Jin; Min, Chang-Ki; Kim, Hee-Je; Eom, Ki-Sung; Kim, Dong-Wook; Lee, Jong-Wook; Min, Woo-Sung; Kim, Chun-Choo

    2005-05-01

    Previously, we suggested that imatinib incorporation into conventional chemotherapy as an alternative (imatinib interim therapy) might be a useful strategy for bridging the time to allogeneic stem cell transplantation (SCT) for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph(+) ALL). Here, we provide an updated report on this strategy in 29 patients. At the time of enrollment, 23 patients (79.3%) achieved complete remission (CR). After the first imatinib cycle, the median breakpoint cluster region-Abelson oncogene locus (BCR-ABL)/ABL ratios decreased by 0.77 log in 25 (86.2%) responders, and their BCR-ABL/ABL ratios decreased further by 0.34 log after the second imatinib cycle, which included 7 molecular CR. One patient (4.3%) relapsed during the imatinib therapy. The remaining 3 patients were primarily refractory to both imatinib and chemotherapy. Twenty-five (86.2%) of the 29 patients received transplants in first CR. With a median follow-up duration of 25 months after SCT, the 3-year estimated probabilities of relapse, nonrelapse mortality, disease-free survival, and overall survival were 3.8%, 18.7%, 78.1%, and 78.1%, respectively. In comparison to our historical control data, first-line imatinib interim therapy appears to provide a good quality of CR and a survival advantage for patients with Ph(+) ALL. Further long-term follow-up is needed to validate the results of this study.

  11. Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial

    PubMed Central

    2008-01-01

    Objective To evaluate the effectiveness of a structured group education programme on biomedical, psychosocial, and lifestyle measures in people with newly diagnosed type 2 diabetes. Design Multicentre cluster randomised controlled trial in primary care with randomisation at practice level. Setting 207 general practices in 13 primary care sites in the United Kingdom. Participants 824 adults (55% men, mean age 59.5 years). Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care. Main outcome measures Haemoglobin A1c levels, blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, and emotional impact of diabetes at baseline and up to 12 months. Main results Haemoglobin A1c levels at 12 months had decreased by 1.49% in the intervention group compared with 1.21% in the control group. After adjusting for baseline and cluster, the difference was not significant: 0.05% (95% confidence interval −0.10% to 0.20%). The intervention group showed a greater weight loss: −2.98 kg (95% confidence interval −3.54 to −2.41) compared with 1.86 kg (−2.44 to −1.28), P=0.027 at 12 months. The odds of not smoking were 3.56 (95% confidence interval 1.11 to 11.45), P=0.033 higher in the intervention group at 12 months. The intervention group showed significantly greater changes in illness belief scores (P=0.001); directions of change were positive indicating greater understanding of diabetes. The intervention group had a lower depression score at 12 months: mean difference was −0.50 (95% confidence interval −0.96 to −0.04); P=0.032. A positive association was found between change in perceived personal responsibility and weight loss at 12 months (β=0.12; P=0.008). Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes resulted in greater

  12. 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…

  13. 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.

  14. Baseline CD4 Cell Counts of Newly Diagnosed HIV Cases in China: 2006–2012

    PubMed Central

    Tang, Houlin; Mao, Yurong; Shi, Cynthia X.; Han, Jing; Wang, Liyan; Xu, Juan; Qin, Qianqian; Detels, Roger; Wu, Zunyou

    2014-01-01

    Background Late diagnosis of HIV infection is common. We aim to assess the proportion of newly diagnosed HIV cases receiving timely baseline CD4 count testing and the associated factors in China. Methods Data were extracted from the Chinese HIV/AIDS Comprehensive Response Information Management System. Adult patients over 15 years old who had been newly diagnosed with HIV infection in China between 2006 and 2012 were identified. The study cohort comprised individuals who had a measured baseline CD4 count. Results Among 388,496 newly identified HIV cases, the median baseline CD4 count was 294 cells/µl (IQR: 130–454), and over half (N = 130,442, 58.8%) were less than 350 cells/µl. The median baseline CD4 count increased from 221 (IQR: 63–410) in 2006 to 314 (IQR: 159–460) in 2012. A slight majority of patients (N = 221,980, 57.1%) received baseline CD4 count testing within 6 months of diagnosis. The proportion of individuals who received timely baseline CD4 count testing increased significantly from 20.0% in 2006 to 76.9% in 2012. Factors associated with failing to receiving timely CD4 count testing were: being male (OR: 1.17, 95% CI: 1.15–1.19), age 55 years or older (OR:1.03, 95% CI: 1.00–1.06), educational attainment of primary school education or below (OR: 1.30, 95% CI: 1.28–1.32), infection with HIV through injection drug use (OR: 2.07, 95% CI: 2.02–2.12) or sexual contact and injection drug use (OR: 1.87, 95% CI: 1.76–1.99), diagnosis in a hospital (OR: 1.91, 95% CI: 1.88–1.95) or in a detention center (OR: 1.75, 95% CI: 1.70–1.80), and employment as a migrant worker (OR:1.55, 95% CI:1.53–1.58). Conclusion The proportion of newly identified HIV patients receiving timely baseline CD4 testing has increased significantly in China from 2006–2012. Continued effort is needed for further promotion of early HIV diagnosis and timely baseline CD4 cell count testing. PMID:24901790

  15. 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.

  16. Contemporary practice patterns in the management of newly diagnosed hypertension

    PubMed Central

    McAlister, F A; Teo, K K; Lewanczuk, R Z; Wells, G; Montague, T J

    1997-01-01

    OBJECTIVE: To determine what proportion of patients with hypertension are managed in accordance with guidelines established by the Canadian Hypertension Society. DESIGN: Retrospective medical record review. SETTING: Outpatients seen in primary care offices and internal medicine referral clinics in Edmonton. PATIENTS: All 969 adults who presented with a new diagnosis of essential hypertension from Sept. 1, 1993, to Dec. 31, 1995. OUTCOME MEASURES: Initial laboratory tests performed, advice concerning nonpharmacologic treatment given, antihypertensive drugs prescribed and any contraindications to thiazide diuretics or beta-adrenergic blocking agents documented. RESULTS: The mean age of the 969 patients in the sample was 52.5 years; 129 (13%) of the patients were older than 70 years of age; and 500 (52%) were women. Most of the patients (704, 73%) had mild or moderate diastolic hypertension. In the 617 patients who underwent laboratory tests related to hypertension, the creatinine level was determined in 466 (76%), the cholesterol level in 372 (60%), a urinalysis was conducted in 378 (61%), the serum potassium level was checked in 343 (56%), the sodium level in 323 (52%) and an electrocardiogram was performed in 303 (49%). Liver function tests, which are not recommended in the guidelines, were performed in 338 patients (55%). Although there were differences in prescribing among physicians in the 711 patients given first-line therapy, most (238, 34%) were prescribed angiotensin-converting-enzyme (ACE) inhibitors. Lifestyle modification, without drug therapy, was suggested for 180 (25%) of the patients. Although the guidelines recommend their use for first-line drug therapy, only 82 patients (12%) were given beta-adrenergic blocking agents and only 75 (11%) were given thiazide diuretics. Of the patients who were prescribed an antihypertensive other than a thiazide or beta-adrenergic blocking agent as first-line drug therapy, only 161 (43%) had a documented

  17. 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

  18. Body image and emotional distress in newly diagnosed cancer patients: The mediating role of dysfunctional attitudes and rumination.

    PubMed

    Liu, Jianlin; Peh, Chao Xu; Mahendran, Rathi

    2016-12-06

    Body image concerns (BIC) has been reported to be associated with emotional distress for cancers across various sites. This study sought to examine two cognitive vulnerability mechanisms: dysfunctional attitudes and rumination, and their combined effects on the relationship between BIC and emotional distress in newly diagnosed Asian cancer patients. Participants were 221 newly diagnosed adult cancer patients who were assessed on BIC, rumination, dysfunctional attitudes, and emotional distress. Path analysis was used to examine the hypothesized mediation model. The hypothesized mediation model controlling for age, sex, marital status, education level, cancer type, cancer stage, and treatment modality revealed that both dysfunctional attitudes and rumination mediated the relationship between BIC and emotional distress. The present study provides evidence for a mediating role of dysfunctional attitudes and rumination between BIC and emotional distress. Psychological treatment should target dysfunctional attitudes and rumination in cancer patients experiencing BIC.

  19. Abdominal obesity validates the association between elevated alanine aminotransferase and newly diagnosed diabetes mellitus.

    PubMed

    Yueh, Chen-Yu; Yang, Yao-Hsu; Sung, Yi-Ting; Lee, Li-Wen

    2014-01-01

    To examine how elevated alanine aminotransferase (ALT) could be associated with newly diagnosed diabetes mellitus. We conducted a cross-sectional analysis on a mass health examination. The odds ratios (ORs) for diabetes mellitus and newly diagnosed diabetes mellitus were compared between people with and without abdominal obesity, together with and without elevated ALT levels. 5499 people were included in this study. Two hundred fifty two (4.6%) fulfilled the diagnosis of diabetes mellitus with 178 (3.2%) undiagnosed before. Metabolic syndrome was vigorously associated with diabetes mellitus and newly diagnosed diabetes mellitus (12.4% vs. 1.4% and 9.0% vs. 0.9%), but elevated ALT alone was not. However, coexisting with obesity, elevated ALTs were robustly associated with diabetes mellitus and newly diagnosed diabetes mellitus. For the incidence of newly diagnosed diabetes mellitus, in comparison to non-obese people with normal ALT (1.7%, OR = 1), obese people especially with elevated ALT levels had significantly higher ORs (obese with ALT ≤ 40 U/L: 4.7%, OR 1.73, 95% CI 1.08-2.77, P 0.023; ALT 41-80 U/L: 6.8%, OR 2.06, 95% CI 1.20-3.55, P 0.009; ALT 81-120 U/L: 8.8%, OR 3.07, 95% CI 1.38-6.84, P 0.006; ALT > 120 U/L: 18.2%, OR 7.44, 95% CI 3.04-18.18, P < 0.001). Abdominal obesity validates the association between elevated alanine aminotransferase and diabetes mellitus and newly diagnosed diabetes mellitus. People with abdominal obesity, especially with coexisting elevated ALT levels should be screened for undiagnosed diabetes mellitus.

  20. Newly-diagnosed pediatric epilepsy is associated with elevated autoantibodies to glutamic acid decarboxylase but not cardiolipin.

    PubMed

    Veri, Kadi; Uibo, Oivi; Talvik, Tiina; Talvik, Inga; Metsküla, Kaja; Napa, Aita; Vaher, Ulvi; Õiglane-Šlik, Eve; Rein, Reet; Kolk, Anneli; Traat, Aili; Uibo, Raivo

    2013-07-01

    Glutamic acid decarboxylase autoantibodies (GADA) and anti-cardiolipin autoantibodies (ACA) have been detected in adult subjects with epilepsy, though the functional implications of these findings are a matter of debate. This study aimed to determine the prevalence of GADA and ACA and to investigate their clinical significance in pediatric subjects with newly-diagnosed epilepsy. For this purpose GADA and ACA were assessed by enzyme-linked immunosorbent assays in 208 pediatric patients with newly-diagnosed epilepsy and 128 controls. The clinical data (results of electroencephalography, magnetic resonance imaging, 6-month outcome etc.) was compared to antibody test results. Our study revealed GADA in 14 (6.7%) patients with epilepsy and in 1 (0.8%) control, which was a statistically significant difference (P=0.010; Chi-square test). The GADA-positive and -negative patients had similar clinical characteristics. The prevalence of ACA in patients with epilepsy (6.3%) was not significantly different than controls (2.6%). These results suggest that GADA is associated with epilepsy in a subgroup of newly-diagnosed pediatric patients. Further studies are required to determine the prognostic significance and pathogenic role of GADA among pediatric subjects with epilepsy.

  1. Impaired β cell function in Chinese newly diagnosed type 2 diabetes mellitus with hyperlipidemia.

    PubMed

    Ma, Yuhang; Wang, Yufan; Huang, Qianfang; Ren, Qian; Chen, Su; Zhang, Aifang; Zhao, Li; Zhen, Qin; Peng, Yongde

    2014-01-01

    The objective is to explore the effects of hyperlipidemia on β cell function in newly diagnosed type 2 diabetes mellitus (T2DM). 208 patients were enrolled in the study and were divided into newly diagnosed T2DM with hyperlipidemia (132 patients) and without hyperlipidemia (76 patients). Demographic data, glucose levels, insulin levels, lipid profiles, homeostasis model assessment for β cell function index (HOMA-β ), homeostasis model assessment for insulin resistance index (HOMA-IR), and quantitative insulin-sensitivity check index (QUICKI) were compared between the two groups. We found that comparing with those of normal lipid levels, the subjects of newly diagnosed T2DM with hyperlipidemia were younger, and had declined HOMA-β . However, the levels of HOMA-β were comparable regardless of different lipid profiles (combined hyperlipidemia, hypertriglyceridemia, and hypercholesterolemia). Multiple stepwise linear regression analysis showed that high fasting plasma glucose (FPG), decreased fasting insulin level (FINS), and high triglyceride (TG) were independent risk factors of β cell dysfunction in newly diagnosed T2DM. Therefore, the management of dyslipidemia, together with glucose control, may be beneficial for T2DM with hyperlipidemia.

  2. 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.

  3. A Structured Group for Gay Men Newly Diagnosed with HIV/AIDS

    ERIC Educational Resources Information Center

    Smiley, Kristin A.

    2004-01-01

    The author presents a structured group model designed to help gay men newly diagnosed with HIV/AIDS. A facilitator's manual is included to outline the group's progression through eight sessions and to address the psychosocial concerns often ignited by an HIV or AIDS diagnosis. Suggestions for future group work are also provided.

  4. 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

  5. [Effects of stepped counseling intervention on quality of life among newly diagnosed HIV-positive patients].

    PubMed

    Hsiao, Ching-Fang; Chao, Shu-Ling; Tsai, Tsui-Ching; Chuang, Peing

    2004-04-01

    The purpose of this research was to understand how stepped counseling intervention affects quality of life in newly diagnosed HIV-positive patients. The study made use of quasi-experimental methodology that included a three-step interview process over 45 days. The theoretical framework supporting interviews with 32 newly diagnosed HIV-positive patients in northern Taiwan included a combination of rational-emotive therapy, cognitive-behavior therapy, and health education. Participants were divided into an experimental and control group of equal size. Data collection also included responses to the WHOQOL-HIV instrument at the beginning and end of each interview session. Responses were analyzed with the SPSS software package. The results showed a 25-point difference between pre- and post-test scores in the experimental group (SD = 3.2) and a 6 point difference in the control group (SD = 4.3). The results indicate that stepped counseling techniques are effective in helping this patient population to adjust to the physical, emotional, social, and environmental stresses associated with their newly diagnosis. The researchers suggest that stepped counseling be used with all newly diagnosed HIV-positive Taiwanese patients in all hospitals and clinics to promote adaptive abilities and to control the further spread of HIV.

  6. Corticosteroids increase protein breakdown and loss in newly diagnosed pediatric Crohn disease.

    PubMed

    Steiner, Steven J; Noe, Joshua D; Denne, Scott C

    2011-11-01

    Children with Crohn disease have altered growth and body composition. Previous studies have demonstrated decreased protein breakdown after either corticosteroid or anti-TNF-α therapy. The aim of this study was to evaluate whole body protein metabolism during corticosteroid therapy in children with newly diagnosed Crohn disease. Children with suspected Crohn disease and children with abdominal symptoms not consistent with Crohn disease underwent outpatient metabolic assessment. Patients diagnosed with Crohn disease and prescribed corticosteroid therapy returned in 2 wk for repeat metabolic assessment. Using the stable isotopes [d5] phenylalanine, [1-(13)C] leucine, and [(15)N(2)] urea, protein kinetics were determined in the fasting state. Thirty-one children (18 controls and 13 newly diagnosed with Crohn disease) completed the study. There were no significant differences in protein breakdown or loss between patients with Crohn disease at diagnosis and controls. After corticosteroid therapy in patients with Crohn disease, the rates of appearance of phenylalanine (32%) and leucine (26%) increased significantly, reflecting increased protein breakdown, and the rate of appearance of urea also increased significantly (273%), reflecting increased protein loss. Whole body protein breakdown and loss increased significantly after 2 wk of corticosteroid therapy in children with newly diagnosed Crohn disease, which may have profound effects on body composition.

  7. 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

  8. 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

    2015-08-06

    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.

  9. Molecular evidence for central nervous system involvement in children with newly diagnosed acute lymphoblastic leukemia.

    PubMed

    Januszkiewicz, D A; Nowak, J S

    1995-01-01

    Central nervous system (CNS) involvement in children with newly diagnosed acute lymphoblastic leukemia (ALL) would have profound implication for the prognosis and accurate stratification of CNS prophylactic therapy. Using PCR technique with specific primers for V, D and J segments of TCRD gene, the pattern of TCRD gene rearrangements in bone marrow lymphoblasts and in cells from cerebrospinal fluid (CSF) have been investigated. The study involved 21 children at the time of diagnosis with B-lineage ALL. In nine of 21 patients incomplete TCRDVD gene rearrangement has been found in CSF cells, which was identical to that observed in bone marrow of the same children. It can be concluded that at least in 43 per cent of all analysed cases, there were signs of CNS involvement in newly diagnosed ALL patients.

  10. MGMT inactivation and clinical response in newly diagnosed GBM patients treated with Gliadel.

    PubMed

    Grossman, Rachel; Burger, Peter; Soudry, Ethan; Tyler, Betty; Chaichana, Kaisorn L; Weingart, Jon; Olivi, Alessandro; Gallia, Gary L; Sidransky, David; Quiñones-Hinojosa, Alfredo; Ye, Xiaobu; Brem, Henry

    2015-12-01

    We examined the relationship between the O(6)-methylguanine-methyltransferase (MGMT) methylation status and clinical outcomes in newly diagnosed glioblastoma multiforme (GBM) patients who were treated with Gliadel wafers (Eisai, Tokyo, Japan). MGMT promoter methylation has been associated with increased survival among patients with GBM who are treated with various alkylating agents. MGMT promoter methylation, in DNA from 122 of 160 newly diagnosed GBM patients treated with Gliadel, was determined by a quantitative methylation-specific polymerase chain reaction, and was correlated with overall survival (OS) and recurrence-free survival (RFS). The MGMT promoter was methylated in 40 (32.7%) of 122 patients. The median OS was 13.5 months (95% confidence interval [CI] 11.0-14.5) and RFS was 9.4 months (95% CI 7.8-10.2). After adjusting for age, Karnofsky performance score, extent of resection, temozolomide (TMZ) and radiation therapy (RT), the newly diagnosed GBM patients with MGMT methylation had a 15% reduced mortality risk, compared to patients with unmethylated MGMT (hazard ratio 0.85; 95% CI 0.56-1.31; p=0.46). The patients aged over 70 years with MGMT methylation had a significantly longer median OS of 13.5 months, compared to 7.6 months in patients with unmethylated MGMT (p=0.027). A significant difference was also found in older patients, with a median RFS of 13.1 versus 7.6 months for methylated and unmethylated MGMT groups, respectively (p=0.01). Methylation of the MGMT promoter in newly diagnosed GBM patients treated with Gliadel, RT and TMZ, was associated with significantly improved OS compared to the unmethylated population. In elderly patients, methylation of the MGMT promoter was associated with significantly better OS and RFS.

  11. [Correlations between serum 25-hydroxyvitamin D and cytokines in patients newly diagnosed with systemic lupus erythematosus].

    PubMed

    Su, Jiang; Zhu, Jing; Dong, Wei; Long, Li; Long, Wubin; Chen, Xixi

    2016-12-01

    Objective To investigate the correlations between serum 25-hydroxyvitamin D (25-OH-VitD) and serum cytokines of interferon (IFN)-α2, interleukin(IL)-6, IL-10, and IL-17A in Chinese Han patients newly diagnosed with systemic lupus erythematosus (SLE). Methods This study recruited 86 Chinese patients newly diagnosed with SLE and 73 healthy volunteers. The serum 25-OH-VitD was detected using ELISA. The serum levels of IFN-α2, IL-6, IL-10 and IL-17A were detected using Luminex liquichip. The associations between serum 25-OH-VitD and serum cytokines, clinical manifestations and laboratory findings were analyzed using Spearman linear correlation analysis. Results The serum 25-OH-VitD was significantly lower in SLE patients than in healthy controls. The serum 25-OH-VitD was positively correlated with serum C3, negatively correlated with serum IL-17A and 24 hour urine protein excretion, but not obviously correlated with serum IFN-α2, IL-6 and IL-10. Conclusion The serum 25-OH-VitD decreases in Chinese patients newly diagnosed with SLE and it is negatively correlated with serum IL-17A.

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

    PubMed

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

    2016-07-14

    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.

  13. Bayesian network meta-analysis comparing five contemporary treatment strategies for newly diagnosed acute promyelocytic leukaemia.

    PubMed

    Wu, Fenfang; Wu, Di; Ren, Yong; Duan, Chongyang; Chen, Shangwu; Xu, Anlong

    2016-07-26

    Acute promyelocytic leukemia (APL) is a curable subtype of acute myeloid leukemia. The optimum regimen for newly diagnosed APL remains inconclusive. In this Bayesian network meta-analysis, we compared the effectiveness of five regimens-arsenic trioxide (ATO) + all-trans retinoic acid (ATRA), realgar-indigo naturalis formula (RIF) which contains arsenic tetrasulfide + ATRA, ATRA + anthracycline-based chemotherapy (CT), ATO alone and ATRA alone, based on fourteen randomized controlled trials (RCTs), which included 1407 newly diagnosed APL patients. According to the results, the ranking efficacy of the treatment, including early death and complete remission in the induction stage, was the following: 1. ATO/RIF + ATRA; 2. ATRA + CT; 3. ATO, and 4. ATRA. For long-term benefit, ATO/RIF + ATRA significantly improved overall survival (OS) (hazard ratio = 0.35, 95%CI 0.15-0.82, p = 0.02) and event-free survival (EFS) (hazard ratio = 0.32, 95%CI 0.16-0.61, p = 0.001) over ATRA + CT regimen for the low-to-intermediate-risk patients. Thus, ATO + ATRA and RIF + ATRA might be considered the optimum treatments for the newly diagnosed APL and should be recommended as the standard care for frontline therapy.

  14. Documentation of Antipsychotic Use and Indications for Newly Diagnosed, Nonaggressive Dementia Patients

    PubMed Central

    Dhawan, Nikhil; Steele, Avila B.; Morgan, Robert O.; Snow, A. Lynn; Davila, Jessica A.; Kunik, Mark E.

    2008-01-01

    Objective: The purpose of this study was to determine the prevalence of antipsychotic use among nonaggressive patients with newly diagnosed dementia and to examine indications for antipsychotic use. Method: Patients had to be veterans older than 60 years, newly diagnosed with dementia (ICD-9-CM criteria) from 2001 to 2004 at the Michael A. DeBakey Veterans Affairs Medical Center in Houston, Tex. Patients diagnosed more than 1 year before telephone screening, living in a nursing home or having a caregiver less than 8 hours a week, and/or having aggression, determined by caregiver response on the Ryden Aggression Scale, were excluded. Medical records of eligible participants were then evaluated on the basis of 5 questions: (1) Was the patient taking an antipsychotic? (2) Were neuropsychiatric symptoms documented, with or without antipsychotics? (3) Did the patient have comorbid psychiatric diagnoses? (4) Did the physician attempt to decrease or discontinue the antipsychotic? and (5) Did the physician attempt non-pharmacologic interventions? Results: A total of 173 patients were eligible for medical record evaluation. Of these, 29 (17%) had been prescribed antipsychotics. Depression, nighttime disturbance, and irritability were the most often documented neuropsychiatric symptoms; however, 31% of patients had no documented symptoms. Mood disorder was documented in 36% of patient records; however, 94 patients (54%) had no comorbid psychiatric disorder. Twelve nonpharmacologic interventions were documented for dementia symptoms. Only 2 attempts to discontinue or decrease antipsychotics for the 29 patients using them were documented. Conclusion: A sizable minority of newly diagnosed, nonaggressive dementia patients are taking antipsychotics. Physicians need greater education and awareness of the benefits of nonpharmacologic interventions. PMID:18458729

  15. Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma

    ClinicalTrials.gov

    2016-11-08

    Adult Ependymoblastoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Medulloblastoma; Adult Mixed Glioma; Adult Oligodendroglial Tumors; Adult Pineoblastoma; Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)

  16. Clinical, electrocardiographic and echocardiographic abnormalities in Latin American migrants with newly diagnosed Chagas disease 2005-2009, Barcelona, Spain.

    PubMed

    Valerio, L; Roure, S; Sabria, M; Balanzo, X; Valles, X; Seres, L

    2011-09-22

    Following Latin American migration, Chagas disease has inevitably appeared in non-endemic countries in Europe and elsewhere. New policies are necessary to prevent transmission in those countries but the long, often undetected chronic period of the early stages of the disease also renders epidemiological studies important. The main objective of our study was to determine the presence of clinical, electrocardiogram (ECG) and echocardiographic abnormalities in a population of Latin American migrants infected with Trypanosoma cruzi at the moment of diagnosis. We performed a hospital-based observational study of 100 adult patients with newly diagnosed Chagas infection between January 2005 and December 2009. Thirty-seven patients were classified within the Brazilian Consensus on Chagas cardiomyopathy early cardiac stages (A or B1) and 49 presented pathological findings (stage B2) according to the Panamerican Health Organization Classification. Overall, 49 patients showed ECG and/or echocardiographic alterations. The presence of ECG and ecocardiographic alterations were significantly associated (p=0.038). The most frequent ECG and echocardiographic findings were right bundle branch block (12 cases) and impaired left ventricular wall relaxation (24 cases), respectively. In conclusion, ECG and echocardiographic alterations coherent with Chagas cardiomyopathy were found in a large proportion of newly diagnosed Latin American migrants infected with T. cruzi. In the mid-term, Chagas disease might become an important cause of chronic cadiomyopathy in our attendance area.

  17. 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.

  18. EVALUATING THE ACCEPTABILITY AND FEASIBILITY OF PROJECT ACCEPT: AN INTERVENTION FOR YOUTH NEWLY DIAGNOSED WITH HIV

    PubMed Central

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

    2012-01-01

    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 Trials Network (ATN). The majority of participants identified as African American (78%). Feasibility and acceptability data demonstrated high rates of participation and high levels of satisfaction with the intervention program from both participants and staff. Exploratory outcome data demonstrated improved levels of HIV knowledge that were sustained over time (Cohen’s effect [d] d = .52) and improvements in peer (d = .35) and formal (d = .20) social support immediately postintervention. Gender differences emerged over time in the areas of depressive symptoms, family social support, self-efficacy for sexual discussion, and personalized stigma. Project ACCEPT appears to be an acceptable and feasible intervention to implement in clinical settings for youth newly diagnosed with HIV. PMID:21517662

  19. Resilience and Associated Factors among Mainland Chinese Women Newly Diagnosed with Breast Cancer

    PubMed Central

    Wu, Zijing; Liu, Ye; Li, Xuelian; Li, Xiaohan

    2016-01-01

    Purpose Resilience is the individual’s ability to bounce back from trauma. It has been studied for some time in the U.S., but few studies in China have addressed this important construct. In mainland China, relatively little is known about the resilience of patients in clinical settings, especially among patients with breast cancer. In this study, we aimed to evaluate the level of resilience and identify predictors of resilience among mainland Chinese women newly diagnosed with breast cancer. Methods A cross-sectional descriptive study was conducted with 213 mainland Chinese women newly diagnosed with breast cancer between November 2014 and June 2015. Participants were assessed with the Connor-Davidson Resilience Scale (CD-RISC), Social Support Rating Scale (SSRS), Medical Coping Modes Questionnaire (MCMQ, including 3 subscales: confrontation, avoidance, and acceptance-resignation), Herth Hope Index (HHI), and demographic and disease-related information. Descriptive statistics, bivariate analyses and multiple stepwise regression were conducted to explore predictors for resilience. Results The average score for CD-RISC was 60.97, ranging from 37 to 69. Resilience was positively associated with educational level, family income, time span after diagnosis, social support, confrontation, avoidance, and hope. However, resilience was negatively associated with age, body mass index (BMI), and acceptance-resignation. Multiple stepwise regression analysis indicated that hope (β = 0.343, P<0.001), educational level of junior college or above (β = 0.272, P<0.001), educational level of high school (β = 0.235, P<0.001), avoidance (β = 0.220, P<0.001), confrontation (β = 0.187, P = 0.001), and age (β = -0.108, P = 0.037) significantly affected resilience and explained 50.1% of the total variance in resilience. Conclusions Women with newly diagnosed breast cancer from mainland China demonstrated particularly low resilience level, which was predicted by hope educational

  20. Initial Treatment of Men With Newly Diagnosed Lower Urinary Tract Dysfunction in the Veterans Health Administration

    PubMed Central

    Erickson, Bradley A.; Lu, Xin; Vaughan-Sarrazin, Mary; Kreder, Karl J.; Breyer, Benjamin N.; Cram, Peter

    2014-01-01

    OBJECTIVE To examine initial treatments given to men with newly diagnosed lower urinary tract dysfunction (LUTD) within a large integrated health care system in the United States. METHODS We used data from 2003 to 2009 from the Veteran's Health Administration to identify newly diagnosed cases of LUTD using established ICD-9CM codes. Our primary outcome was initial LUTD treatment (3 months), categorized as watchful waiting (WW), medical therapy (MT), or surgical therapy (ST); our secondary outcome was pharmacotherapy class received. We used logistic regression models to examine patient, provider, and health system factors associated with receiving MT or ST when compared with WW. RESULTS There were 393,901 incident cases of LUTD, of which 58.0% initially received WW, 41.8% MT, and 0.2% ST. Of the MT men, 79.8% received an alpha-blocker, 7.7% a 5-alpha reductase inhibitor, 3.3% an anticholinergic, and 7.3% combined therapy (alpha-blocker and 5-alpha reductase inhibitor). In our regression models, we found that age (higher), race (white/black), income (low), region (northeast/south), comorbidities (greater), prostate-specific antigen (lower), and provider (nonurologist) were associated with an increased odds of receiving MT. We found that age (higher), race (white), income (low), region (northeast/south), initial provider (urologist), and prostate-specific antigen (higher) increased the odds of receiving ST. CONCLUSION Most men with newly diagnosed LUTD in the Veteran's Health Administration receive WW, and initial surgical treatment is rare. A large number of men receiving MT were treated with monotherapy, despite evidence that combination therapy is potentially more effective in the long-term, suggesting opportunities for improvement in initial LUTD management within this population. PMID:24286603

  1. Localized 1H NMR spectroscopy in fifty cases of newly diagnosed intracranial tumors

    SciTech Connect

    Demaerel, P.; Johannik, K.; Van Hecke, P.; Van Ongeval, C.; Verellen, S.; Marchal, G.; Wilms, G.; Plets, C.; Goffin, J.; Van Calenbergh, F. )

    1991-01-01

    Fifty patients with newly diagnosed, untreated intracranial tumors were examined with 1H nuclear magnetic resonance single-volume spectroscopy (MRS) using a 1.5 T whole-body MR system. Prior to the MRS, contrast enhanced MR and/or CT imaging studies were carried out. Histological verification was obtained in all patients except one. All tumor spectra revealed distinct abnormalities as compared with the normal brain spectra. Although most meningiomas showed a rather characteristic spectral pattern, generally features specific for the various tumor types were not observed. For instance, though a strong lactic acid signal was seen in most malignant tumors, this signal was also evident in five benign neoplasms.

  2. 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

  3. 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

  4. 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

  5. The Heterogeneity of Early Parkinson’s Disease: A Cluster Analysis on Newly Diagnosed Untreated Patients

    PubMed Central

    Amboni, Marianna; Picillo, Marina; Moccia, Marcello; Longo, Katia; Santangelo, Gabriella; De Rosa, Anna; Allocca, Roberto; Giordano, Flavio; Orefice, Giuseppe; De Michele, Giuseppe; Santoro, Lucio; Pellecchia, Maria Teresa; Barone, Paolo

    2013-01-01

    Background The variability in the clinical phenotype of Parkinson’s disease seems to suggest the existence of several subtypes of the disease. To test this hypothesis we performed a cluster analysis using data assessing both motor and non-motor symptoms in a large cohort of newly diagnosed untreated PD patients. Methods We collected data on demographic, motor, and the whole complex of non-motor symptoms from 100 consecutive newly diagnosed untreated outpatients. Statistical cluster analysis allowed the identification of different subgroups, which have been subsequently explored. Results The data driven approach identified four distinct groups of patients, we have labeled: 1) Benign Pure Motor; 2) Benign mixed Motor-Non-Motor; 3) Non-Motor Dominant; and 4) Motor Dominant. Conclusion Our results confirmed the existence of different subgroups of early PD patients. Cluster analysis revealed the presence of distinct subtypes of patients profiled according to the relevance of both motor and non-motor symptoms. Identification of such subtypes may have important implications for generating pathogenetic hypotheses and therapeutic strategies. PMID:23936396

  6. [The low prevalence of Helicobacter pylori gastritis in newly diagnosed inflammatory bowel disease children and adolescent].

    PubMed

    Sładek, Małgorzata; Jedynak-Wasowicz, Urszula; Wedrychowicz, Andrzej; Kowalska-Duplaga, Kinga; Pieczarkowski, Stanisław; Fyderek, Krzysztof

    2007-01-01

    Data concerning prevalence rate of Helicobacter pylori gastritis in inflammatory bowel disease (IBD) patients is conflicting. We had studied the prevalence of Hp gastritis in newly diagnosed inflammatory bowel disease children before any pharmacological treatment was introduced. Ninety four consecutive children with inflammatory bowel diseased were enrolled into study, mean age 12.9 +/- 3.75 years, including 50 with Crohn's Disease (CD) and 44 with ulcerative colitis (UC). One hundred and four patients (mean age 13.6 +/- 4.2 year) referred for diagnostic evaluation because of recurrent abdominal pain, matched for age, sex and socioeconomic status served as a control. The results revealed a highly statistically lower prevalence of Hp gastritis in children with IBD as compared with controls (9.6% vs. 38.4%, p < 0.0001). Significantly more often Hp gastritis occurred in CD than UC patients. There was no statistical difference in mean age of IBD onset between Hp gastritis positive and negative groups (14.3 +/- 3.75 vs. 13.6 +/- 4.3 yr) was found. Our results show that in newly diagnosed IBD children, Hp gastritis is not unusual, but the prevalence rate is significantly lower comparing to the control group. The low Hp gastritis rate is not related to medical treatment, since the patients were studied before any was introduced.

  7. The Initial Assessment of Daily Insulin Dose in Chinese Newly Diagnosed Type 2 Diabetes

    PubMed Central

    Zhou, Huan; Xu, Hua; Chen, Xie; Teng, Xiangyu; Liu, Qianjing; Liu, Wei

    2016-01-01

    Background. It has been well accepted that insulin therapy is the ideal treatment for newly diagnosed diabetic patients. However, there was no study about assessment of the initial insulin dosage in new onset Chinese patients with type 2 diabetes. Research Design and Methods. 65 newly diagnosed patients with type 2 diabetes (39 males/26 females; HbA1c ≥ 11.80 ± 0.22%) were investigated. All patients had random hyperglycaemia (at 21.8 ± 3.9 mmol/L) on the first day of admission and received insulin infusion intravenously (5 U/per hour). When the blood glucose level dropped to around 10 mmol/L, patients were then transferred to continuous subcutaneous insulin infusion (CSII). The reduction of blood glucose levels in response to per unit of insulin (RBG/RI) was recorded. The target glucose level was achieved in about 3 days. The total daily insulin dose (TDD) and basal insulin dose (TBD) were calculated. Results. TDD was 45.97 ± 1.28 units and TBD was 19.00 ± 0.54 units. TBD was about 40% of the total daily insulin requirement. There was a negative correlation between the ratio of RBG/RI and TDD. Conclusions. TDD was correlated with blood glucose reduction in response to intravenous insulin infusion in Chinese new onset patients with type 2 diabetes. PMID:26697503

  8. Stress, social support and negative affectivity in children with newly diagnosed cancer: a prospective transactional analysis.

    PubMed

    Varni, J W; Katz, E

    1997-12-01

    Conceptually-driven investigations on the potentially modifiable predictors of individual differences among children with newly-diagnosed cancer may facilitate the identification of pediatric cancer patients at risk for maladjustment during the profound adversity associated with this life-threatening disease and aversive biomedical treatment. Within a risk and resistance theoretical framework, perceived stress and social support were investigated concurrently and prospectively within an exploratory design as predictors of negative affectivity (anxiety and depressive symptoms composite construct) in newly-diagnosed pediatric cancer patients at Time 1 (within one month after diagnosis), Time 2 (6 months postdiagnosis), and Time 3 (9 months postdiagnosis). Hierarchical multiple regression analysis findings indicate that perceived stress and social support have direct and independent effects on negative affectivity principally at the 9-month time interval. These findings are discussed in terms of the cognitive-behavioral treatment implications for enhancing child adjustment during the transition from the initial cancer diagnosis and aversive biomedical treatment to subsequent school and social reintegration.

  9. Antipsychotic medications and dental caries in newly diagnosed schizophrenia: A nationwide cohort study.

    PubMed

    Hu, Kai-Fang; Chou, Yu-Hsiang; Wen, Yen-Hsia; Hsieh, Kun-Pin; Tsai, Jui-Hsiu; Yang, Pinchen; Yang, Yi-Hsin; Lin, Chun-Hung Richard

    2016-11-30

    We investigated the association between antipsychotic medications and the risk of dental caries in patients with schizophrenia. We enroled a nationwide cohort of patients with newly diagnosed schizophrenia within 1 year of dental caries development. Exposure to antipsychotics and other medications was categorised according to their type and duration, and the association between exposure and dental caries was assessed through logistic regressions. Of the 3610 patients with newly diagnosed schizophrenia, 2149 (59.5%) exhibited an incidence of treated dental caries. Logistic regression analysis identified a younger age, female sex, high income, a 2-year history of dental caries, and exposure to first-generation antipsychotics, and antihypertensives as independent risk factors for treated dental caries in patients with schizophrenia. Hyposalivation, the adverse effect of first-generation antipsychotics and antihypertensives, was associated with an increased risk of treated dental caries. However, hypersalivation from first-generation antipsychotics for dental caries was associated with a protective factor. These findings suggest that clinicians should pay attention to the aforementioned risk factors for dental caries in patients with schizophrenia, particularly while prescribing first-generation antipsychotics and antihypertensives to such patients.

  10. In vitro cellular drug resistance and prognosis in newly diagnosed childhood acute lymphoblastic leukemia.

    PubMed

    Kaspers, G J; Veerman, A J; Pieters, R; Van Zantwijk, C H; Smets, L A; Van Wering, E R; Van Der Does-Van Den Berg, A

    1997-10-01

    As an important determinant of the response to chemotherapy, measurements of cellular drug resistance may provide prognostically significant information, which could be useful for optimal risk-group stratification. The objective of this report is to determine the relation between in vitro resistance to 12 drugs, measured with the colorimetric methyl-thiazol-tetrazolium (MTT) assay, and long-term clinical response to chemotherapy in 152 children with newly diagnosed acute lymphoblastic leukemia. At risk-group stratified analyses, in vitro resistance to prednisolone, L-asparaginase, and vincristine were each significantly (P < .01) related to the probability of disease-free survival (pDFS) after combination chemotherapy. The combination of data for prednisolone, L-asparaginase, and vincristine provided a drug-resistance profile with prognostic independent significance superior to that of any single drug or any other factor. The 3-years pDFS was 100% for the group with the most sensitive profile, 20% of all patients, 84% (SE 6%) for the group with an intermediately sensitive profile, 40% of all patients, and 43% (SE 8%) for the remaining group with the most resistant profile (P < .001). In conclusion, the extent of in vitro cellular resistance to prednisolone, L-asparaginase, and vincristine, measured using the MTT assay, was significantly related to the clinical response to combination chemotherapy. Treatment failure in newly diagnosed childhood ALL can be predicted based on cellular drug resistance data.

  11. Current role of short-term intensive insulin strategies in newly diagnosed type 2 diabetes.

    PubMed

    Xu, Wen; Weng, Jianping

    2013-09-01

    Type 2 diabetes mellitus (T2DM) is a progressive disease characterized by worsening insulin resistance and a decline in β-cell function. Achieving good glycemic control becomes more challenging as β-cell function continues to deteriorate throughout the disease process. The traditional management paradigm emphasizes a stepwise approach, and insulin has generally been reserved as a final armament. However, mounting evidence indicates that short-term intensive insulin therapy used in the early stages of type 2 diabetes could improve β-cell function, resulting in better glucose control and more extended glycemic remission than oral antidiabetic agents. Improvements in insulin sensitivity and lipid profile were also seen after the early initiation of short-term intensive insulin therapy. Thus, administering short-term intensive insulin therapy to patients with newly diagnosed T2DM has the potential to delay the natural process of this disease, and should be considered when clinicians initiate treatment. Although the early use of insulin is advocated by some guidelines, the optimal time to initiate insulin therapy is not clearly defined or easily recognized, and a pragmatic approach is lacking. Herein we summarize the current understanding of early intensive insulin therapy in patients with newly diagnosed T2DM, focusing on its clinical benefit and problems, as well as possible biological mechanisms of action, and discuss our perspective.

  12. 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.

  13. A Comprehensive Survey of Institutional Patient/Family Educational Practices for Newly Diagnosed Pediatric Oncology Patients.

    PubMed

    Withycombe, Janice S; Andam-Mejia, Rachel; Dwyer, Annie; Slaven, Abigail; Windt, Katherine; Landier, Wendy

    Patient/family education is an important component of nursing practice and is essential to the care of children newly diagnosed with cancer. Practices regarding patient/family education in Children's Oncology Group (COG) treatment centers have not been well described. We used an Internet-based survey to determine current patient/family educational practices at COG institutions; participation rate was 90.5% (201/222). Patient/family education was delivered primarily by an individual (rather than a team) at 43% of institutions. Advanced practice nurses had primary responsibility for providing education at 32% of institutions. "Fever" was the most frequently reported topic considered mandatory for inclusion in education for newly diagnosed patients. More than half of institutions reported using checklists and/or end-of-shift reports to facilitate health care team communication regarding patient/family education, and 77% reported using the "teach-back" method of assessing readiness for discharge. Thirty-seven percent of institutions reported delays in hospital discharge secondary to the need for additional teaching. An understanding of current practices related to patient/family education is the first step in establishing effective interventions to improve and standardize educational practices in pediatric oncology.

  14. 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

  15. Comparative microRNA profiling in relation to urinary albumin excretion in newly diagnosed hypertensive patients.

    PubMed

    Parthenakis, F I; Marketou, M E; Kontaraki, J E; Maragoudakis, F; Maragkoudakis, S; Nakou, H; Roufas, K; Patrianakos, A; Chlouverakis, G; Malliaraki, N; Vardas, P E

    2016-11-01

    Microalbuminuria is an established early marker of endothelial dysfunction and damage. MicroRNAs (miRNAs) are emerging as essential modulators of cardiovascular physiology and disease. In the present study, we sought an association between the differential expression of related miRNAs in the peripheral blood mononuclear cells of untreated patients with newly diagnosed essential hypertension and the levels of urinary albumin excretion. We assessed the expression of the miRNAs miRNA-1, miRNA-133a, miRNA-26b, miRNA-208b, miRNA-499 and miRNA-21 in consecutive subjects with untreated newly diagnosed essential hypertension (aged 62.5±9.7 years) and with no indications of other organic heart disease. MiRNA expression levels in peripheral blood mononuclear cells were quantified by real-time reverse transcription-polymerase chain reaction. The prevalence of microalbuminuria was 9.8%. miRNA-208b and miRNA-133a were independently correlated with 24-h urinary albumin excretion. More specifically, a strong association was found between the gene expression levels of miRNA-208b in our patients' peripheral blood cells and urinary albumin (r=0.72, P<0.001). A similar association was found for miRNA-133a (r=0.372, P<0.001). In conclusion, miRNA-208b and miRNA-133a show distinct profiling in peripheral blood cells isolated from untreated patients with recently diagnosed essential hypertension. Their gene expression levels reveal a strong correlation with urinary albumin excretion levels. Our findings provide new perspectives on the development of a new generation of biomarkers for the better monitoring of end-organ damage in hypertension.

  16. 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…

  17. 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

  18. A pilot study of bevacizumab-based therapy in patients with newly diagnosed high-grade gliomas and diffuse intrinsic pontine gliomas.

    PubMed

    Hummel, Trent R; Salloum, Ralph; Drissi, Rachid; Kumar, Shiva; Sobo, Matthew; Goldman, Stewart; Pai, Ahna; Leach, James; Lane, Adam; Pruitt, David; Sutton, Mary; Chow, Lionel M; Grimme, Laurie; Doughman, Renee; Backus, Lori; Miles, Lili; Stevenson, Charles; Fouladi, Maryam; DeWire, Mariko

    2016-03-01

    Although bevacizumab has not proven effective in adults with newly diagnosed high-grade gliomas (HGG), feasibility in newly diagnosed children with diffuse intrinsic pontine gliomas (DIPG) or HGG has not been reported in a prospective study. In a safety and feasibility study, children and young adults with newly diagnosed HGG received radiotherapy (RT) with bevacizumab (10 mg/kg: days 22, 36) and temozolomide (75-90 mg/m(2)/day for 42 days) followed by bevacizumab (10 mg/kg, days 1, 15), irinotecan (125 mg/m(2), days 1, 15) and temozolomide (150 mg/m(2)/day days 1-5). DIPG patients did not receive temozolomide. Telomerase activity, quality of life (QOL), and functional outcomes were assessed. Among 27 eligible patients (15 DIPG, 12 HGG), median age 10 years (range 3-29 years), 6 discontinued therapy for toxicity: 2 during RT (grade 4 thrombocytopenia, grade 3 hepatotoxicity) and 4 during maintenance therapy (grade 3: thrombosis, hypertension, skin ulceration, and wound dehiscence). Commonest ≥grade 3 toxicities included lymphopenia, neutropenia and leukopenia. Grade 3 hypertension occurred in 2 patients. No intracranial hemorrhages occurred. For DIPG patients, median overall survival (OS) was 10.4 months. For HGG patients, 3-year progression free survival and OS were 33 % (SE ± 14 %) and 50 % (SE ± 14 %), respectively. All 3 tested tumor samples, demonstrated histone H3.3K27M (n = 2 DIPG) or G34R (n = 1 HGG) mutations. QOL scores improved over the course of therapy. A bevacizumab-based regimen is feasible and tolerable in newly diagnosed children and young adults with HGG and DIPG.

  19. 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

  20. Detection of Blastomyces dermatitidis antigen in patients with newly diagnosed blastomycosis.

    PubMed

    Bariola, J Ryan; Hage, Chadi A; Durkin, Michelle; Bensadoun, Eric; Gubbins, Paul O; Wheat, L Joseph; Bradsher, Robert W

    2011-02-01

    Blastomycosis is a serious and potentially fatal infection, and diagnosis can be difficult at times. We evaluated the diagnostic utility of a commercially available assay for detection of Blastomyces dermatitidis antigen, recently modified to permit quantitation, in subjects with newly diagnosed blastomycosis. Twenty-three of 27 (85.1%) subjects had detectable B. dermatitidis antigenuria. In 2 of these 23, positive results were obtained after concentration of the urine specimen. Nine of 11 (81.8%) subjects had detectable B. dermatitidis antigen in serum, including 3 subjects with negative results before treatment of serum with ethylenediaminetetraacetic acid (EDTA) and positive results after EDTA treatment. B. dermatitidis antigen was not detected in specimens from 50 control subjects but was detected in 15 patients with histoplasmosis. B. dermatitidis antigen was detected in most of the patients with blastomycosis and can be a useful tool for timely diagnosis.

  1. 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

  2. Cognition in patients with newly diagnosed brain metastasis: profiles and implications.

    PubMed

    Gerstenecker, Adam; Nabors, Louis B; Meneses, Karen; Fiveash, John B; Marson, Daniel C; Cutter, Gary; Martin, Roy C; Meyers, Christina A; Triebel, Kristen L

    2014-10-01

    Cognitive impairment is a common symptom in patients with brain metastasis, and significant cognitive dysfunction is prevalent in a majority of patients who are still able to engage in basic self-care activities. In the current study, the neurocognitive performance of 32 patients with brain metastasis and 32 demographically-matched controls was examined using a battery of standardized neuropsychological tests, with the goal of comprehensively examining the cognitive functioning of newly diagnosed brain metastasis patients. The cognition of all patients was assessed within 1 week of beginning treatment for brain metastasis. Results indicated impairments in verbal memory, attention, executive functioning, and language in relation to healthy controls. Performance in relation to appropriate normative groups was also examined. Overall, cognitive deficits were prevalent and memory was the most common impairment. Given that cognitive dysfunction was present in this cohort of patients with largely minimal functional impairment, these results have implications for patients, caregivers and health care providers treating patients with brain metastasis.

  3. Ophthalmic findings of newly diagnosed leprosy patients in Istanbul Leprosy Hospital, Turkey.

    PubMed

    Cakiner, T; Karaçorlu, M A

    1998-02-01

    The objective of this study was to detect ocular lesions of newly diagnosed leprosy cases admitted to Istanbul Leprosy Hospital. The patients were categorized according to sex, age, type of leprosy and duration of the disease. Their eyes were categorized as with or without ocular findings due to leprosy. The total number of patients was 21. The mean age was 22+/-4.6 years, the duration of the disease was 36.3+/-19.6 months. Madarosis was the most common finding in this group. It was found in 15 patients (71.4%, 95% confidence interval (CI) 47.8-88.7%). As a second common finding related to corneal alterations, 13 patients had nerve thickening (61.9%, 95% CI 38.4-81.8%). None of our patients had trichiasis, episcleritis, scleritis, cataract, iris atrophy, iris pearl, abnormal vitreous or retinal findings.

  4. Hypoactivation of reward motivational system in patients with newly diagnosed hypertension grade I-II.

    PubMed

    Aftanas, L I; Brak, I V; Gilinskaya, O M; Korenek, V V; Pavlov, S V; Reva, N V

    2014-08-01

    In patients with newly diagnosed untreated grade I-II hypertension, EEG oscillations were recorded under conditions activation of the two basic motivational systems, defensive motivational system and positive reinforcement system, evoked by recall of personally meaningful emotional events. The 64-channel EEG and cardiovascular reactivity (beat-by-beat technology) were simultaneously recorded. At rest, hypertensive patients had significantly reduced platelet serotonin concentrations in comparison with healthy individuals. The patients experiencing emotional activation were characterized by significantly lower intensity of positive emotions associated with more pronounced suppression of EEG activity in the delta (2-4 Hz) and theta (ranges of frequency 4-6 and 6-8 Hz) oscillators in the parieto-occipital cortex (zones P and PO) in both hemispheres of the brain. The findings attest to insufficient function of the brain serotonin system and hypoactivation of the reward/reinforcement system in patients with primary hypertension.

  5. Inverse Association of Plasma Chromium Levels with Newly Diagnosed Type 2 Diabetes: A Case-Control Study.

    PubMed

    Chen, Sijing; Jin, Xiaoling; Shan, Zhilei; Li, Shuzhen; Yin, Jiawei; Sun, Taoping; Luo, Cheng; Yang, Wei; Yao, Ping; Yu, Kaifeng; Zhang, Yan; Cheng, Qian; Cheng, Jinquan; Bao, Wei; Liu, Liegang

    2017-03-17

    Chromium has long been known as an enhancer of insulin action. However, the role of chromium in the development of type 2 diabetes mellitus (T2DM) in humans remains controversial. The current study aimed to examine the associations of plasma chromium levels with T2DM and pre-diabetes mellitus (pre-DM). We conducted a case-control study involving 1471 patients with newly diagnosed T2DM, 682 individuals with newly diagnosed pre-DM, and 2290 individuals with normal glucose tolerance in a Chinese population from 2009 to 2014. Plasma chromium was measured by inductively coupled plasma mass spectrometry. Plasma chromium levels were lower in the T2DM and pre-DM groups than in the control group (median: 3.68 μg/L, 3.61 μg/L, 3.97 μg/L, respectively, p < 0.001). After adjustment for potential confounding factors, the odds ratios (95% confidence interval) for T2DM across increasing quartiles of plasma chromium levels were 1 (referent), 0.67 (0.55-0.83), 0.64 (0.51-0.79), and 0.58 (0.46-0.73), respectively (p for trend <0.001). The corresponding odds ratios (95% confidence interval) for pre-DM were 1 (referent), 0.70 (0.54-0.91), 0.67 (0.52-0.88), and 0.58 (0.43-0.78), respectively (p for trend < 0.001). Our results indicated that plasma chromium concentrations were inversely associated with T2DM and pre-DM in Chinese adults.

  6. 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.

  7. Inverse Association of Plasma Chromium Levels with Newly Diagnosed Type 2 Diabetes: A Case-Control Study

    PubMed Central

    Chen, Sijing; Jin, Xiaoling; Shan, Zhilei; Li, Shuzhen; Yin, Jiawei; Sun, Taoping; Luo, Cheng; Yang, Wei; Yao, Ping; Yu, Kaifeng; Zhang, Yan; Cheng, Qian; Cheng, Jinquan; Bao, Wei; Liu, Liegang

    2017-01-01

    Chromium has long been known as an enhancer of insulin action. However, the role of chromium in the development of type 2 diabetes mellitus (T2DM) in humans remains controversial. The current study aimed to examine the associations of plasma chromium levels with T2DM and pre-diabetes mellitus (pre-DM). We conducted a case-control study involving 1471 patients with newly diagnosed T2DM, 682 individuals with newly diagnosed pre-DM, and 2290 individuals with normal glucose tolerance in a Chinese population from 2009 to 2014. Plasma chromium was measured by inductively coupled plasma mass spectrometry. Plasma chromium levels were lower in the T2DM and pre-DM groups than in the control group (median: 3.68 μg/L, 3.61 μg/L, 3.97 μg/L, respectively, p < 0.001). After adjustment for potential confounding factors, the odds ratios (95% confidence interval) for T2DM across increasing quartiles of plasma chromium levels were 1 (referent), 0.67 (0.55–0.83), 0.64 (0.51–0.79), and 0.58 (0.46–0.73), respectively (p for trend <0.001). The corresponding odds ratios (95% confidence interval) for pre-DM were 1 (referent), 0.70 (0.54–0.91), 0.67 (0.52–0.88), and 0.58 (0.43–0.78), respectively (p for trend < 0.001). Our results indicated that plasma chromium concentrations were inversely associated with T2DM and pre-DM in Chinese adults. PMID:28304331

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. Evolving antithrombotic treatment patterns for patients with newly diagnosed atrial fibrillation

    PubMed Central

    Camm, A John; Accetta, Gabriele; Ambrosio, Giuseppe; Atar, Dan; Bassand, Jean-Pierre; Berge, Eivind; Cools, Frank; Fitzmaurice, David A; Goldhaber, Samuel Z; Goto, Shinya; Haas, Sylvia; Kayani, Gloria; Koretsune, Yukihiro; Mantovani, Lorenzo G; Misselwitz, Frank; Oh, Seil; Turpie, Alexander G G; Verheugt, Freek W A; Kakkar, Ajay K

    2017-01-01

    Objective We studied evolving antithrombotic therapy patterns in patients with newly diagnosed non-valvular atrial fibrillation (AF) and ≥1 additional stroke risk factor between 2010 and 2015. Methods 39 670 patients were prospectively enrolled in four sequential cohorts in the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF): cohort C1 (2010–2011), n=5500; C2 (2011–2013), n=11 662; C3 (2013–2014), n=11 462; C4 (2014–2015), n=11 046. Baseline characteristics and antithrombotic therapy initiated at diagnosis were analysed by cohort. Results Baseline characteristics were similar across cohorts. Median CHA2DS2-VASc (cardiac failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled)-vascular disease, age 65–74 and sex category (female)) score was 3 in all four cohorts. From C1 to C4, the proportion of patients on anticoagulant (AC) therapy increased by almost 15% (C1 57.4%; C4 71.1%). Use of vitamin K antagonist (VKA)±antiplatelet (AP) (C1 53.2%; C4 34.0%) and AP monotherapy (C1 30.2%; C4 16.6%) declined, while use of non-VKA oral ACs (NOACs)±AP increased (C1 4.2%; C4 37.0%). Most CHA2DS2-VASc ≥2 patients received AC, and this proportion increased over time, largely driven by NOAC prescribing. NOACs were more frequently prescribed than VKAs in men, the elderly, patients of Asian ethnicity, those with dementia, or those using non-steroidal anti-inflammatory drugs, and current smokers. VKA use was more common in patients with cardiac, vascular, or renal comorbidities. Conclusions Since NOACs were introduced, there has been an increase in newly diagnosed patients with AF at risk of stroke receiving guideline-recommended therapy, predominantly driven by increased use of NOACs and reduced use of VKA±AP or AP alone. Trial registration number NCT01090362; Pre-results. PMID:27647168

  15. Incidence of Symptomatic Vertebral Fractures Among Newly Diagnosed Autoimmune Diseases Initiating Glucocorticoid Therapy

    PubMed Central

    Migita, Kiyoshi; Iwanaga, Nozomi; Imadachi, Shunsuke; Jiuchi, Yuka; Izumi, Yasumori; Tsuji, Yoshika; Kawahara, Chieko; Kawakami, Atsushi; Furukawa, Hiroshi; Tohma, Shigeto

    2015-01-01

    Abstract Few data are available regarding vertebral fracture risk in patients treated with corticosteroids including patients with interstitial lung disease (ILD). The aim of the present study was to identify risk factors for symptomatic vertebral fracture analyzed in patients with newly diagnosed autoimmune diseases. This was an observational cohort study conducted in the National Hospital Organization-EBM study group from 2006 to 2008. The study subjects were autoimmune disease patients who were newly treated with glucocorticoids (GCs). The primary endpoint was the first occurrence of vertebral fracture diagnosed by x-rays. Cox proportional-hazards regression was used to determine independent risk factors for vertebral fracture with covariates including sex, age, comorbidity, laboratory data, use of immunosuppressants, and dose of GCs. Survival was analyzed according to the Kaplan–Meier method and assessed by the log-rank test. Among 604 patients of mean age 59.5 years and mean GC dose 50.4 mg/d (first 1 months), 19 patient (3.1%) had at least 1 symptomatic vertebral fracture during 1.9 years of follow-up period. Cox regression model demonstrated that the relative risk for symptomatic vertebral fracture was independently higher in patient with ILD (hazard ratio [HR] = 2.86, 95% confidence interval [CI] = 1.10–7.42, P = 0.031) and in every 10-year increment of the age of disease onset (HR = 1.57, 95% CI = 1.09–2.26, P = 0.015). Kaplan–Meier analyses demonstrated that the incidence of vertebral fractures in patients with ILD was significantly higher in comparison with those without ILD. Our results indicate a higher risk of vertebral facture in patients with ILD and elderly patients during the initial GC treatment against autoimmune diseases. There is a need for further, even longer-term, prospective studies subjected patients with autoimmune disease, including ILD, under GC treatment. PMID:26166127

  16. (18)F-FET PET Uptake Characteristics in Patients with Newly Diagnosed and Untreated Brain Metastasis.

    PubMed

    Unterrainer, Marcus; Galldiks, Norbert; Suchorska, Bogdana; Kowalew, Lara-Caroline; Wenter, Vera; Schmid-Tannwald, Christine; Niyazi, Maximilian; Bartenstein, Peter; Langen, Karl-Josef; Albert, Nathalie L

    2017-04-01

    In patients with brain metastasis, PET using labeled amino acids has gained clinical importance, mainly regarding the differentiation of viable tumor tissue from treatment-related effects. However, there is still limited knowledge concerning the uptake characteristics in patients with newly diagnosed and untreated brain metastases. Hence, we evaluated the uptake characteristics in these patients using dynamic O-(2-(18)F-fluoroethyl)-l-tyrosine ((18)F-FET) PET. Methods: Patients with newly diagnosed brain metastases without prior local therapy and (18)F-FET PET scanning were retrospectively identified in 2 centers. Static and dynamic PET parameters (maximal/mean tumor-to-brain-ratio [TBRmax/TBRmean], biologic tumor volume [BTV], and time-activity curves with minimal time to peak [TTPmin]) were evaluated and correlated with MRI parameters (maximal lesion diameter, volume of contrast enhancement) and originating primary tumor. Results: Forty-five brain metastases in 30 patients were included. Forty of 45 metastases (89%) had a TBRmax ≥ 1.6 and were classified as (18)F-FET-positive (median TBRmax, 2.53 [range, 1.64-9.47]; TBRmean, 1.86 [range, 1.63-5.48]; and BTV, 3.59 mL [range, 0.04-23.98 mL], respectively). In 39 of 45 brain metastases eligible for dynamic analysis, a wide range of TTPmin was observed (median, 22.5 min; range, 4.5-47.5 min). All (18)F-FET-negative metastases had a diameter of ≤ 1.0 cm, whereas metastases with a > 1.0 cm diameter all showed pathologic (18)F-FET uptake, which did not correlate with lesion size. The highest variability of uptake intensity was observed within the group of melanoma metastases. Conclusion: Untreated metastases predominantly show increased (18)F-FET uptake, and only a third of metastases < 1.0 cm were (18)F-FET-negative, most likely because of scanner resolution and partial-volume effects. In metastases > 1.0 cm, (18)F-FET uptake intensity was highly variable and independent of tumor size (even intraindividually). (18

  17. Intention to Quit Smoking and Associated Factors in Smokers Newly Diagnosed with Pulmonary Tuberculosis

    PubMed Central

    Aryanpur, Mahshid; Mortaz, Esmaeil; Hosseini, Mostafa; Jamaati, Hmidreza; Tabarsi, Payam; Soori, Hamid; Heydari, Gholam Reza; Kazempour-Dizaji, Mehdi; Emami, Habib; Mozafarian, Alireza

    2016-01-01

    Background: Several studies have shown that smoking, as a modifiable risk factor, can affect tuberculosis (TB) in different aspects such as enhancing development of TB infection, activation of latent TB and its related mortality. Since willingness to quit smoking is a critical stage, which may lead to quit attempts, being aware of smokers’ intention to quit and the related predictors can provide considerable advantages. Materials and Methods: In this cross-sectional study, subjects were recruited via a multi-stage cluster sampling method. Sampling was performed during 2012–2014 among pulmonary TB (PTB) patients referred to health centers in Tehran implementing the directly observed treatment short course (DOTS) strategy and a TB referral center. Data analysis was conducted using SPSS version 22 and the factors influencing quit intention were assessed using bivariate regression and multiple logistic regression models. Results: In this study 1,127 newly diagnosed PTB patients were studied; from which 284 patients (22%) were current smokers. When diagnosed with TB, 59 (23.8%) smokers quit smoking. Among the remaining 189 (76.2%) patients who continued smoking, 52.4% had intention to quit. In the final multiple logistic regression model, living in urban areas (OR=8.81, P=0.003), having an office job (OR= 7.34, P=0.001), being single (OR=4.89, P=0.016) and a one unit increase in the motivation degree (OR=2.60, P<0.001) were found to increase the intention to quit smoking. Conclusion: The study found that PTB patients who continued smoking had remarkable intention to quit. Thus, it is recommended that smoking cessation interventions should be started at the time of TB diagnosis. Understanding the associated factors can guide the consultants to predict patients’ intention to quit and select the most proper management to facilitate smoking cessation for each patient. PMID:27403174

  18. 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.

  19. Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma: a multicenter, phase 2 study.

    PubMed

    Bringhen, Sara; Petrucci, Maria Teresa; Larocca, Alessandra; Conticello, Concetta; Rossi, Davide; Magarotto, Valeria; Musto, Pellegrino; Boccadifuoco, Luana; Offidani, Massimo; Omedé, Paola; Gentilini, Fabiana; Ciccone, Giovannino; Benevolo, Giulia; Genuardi, Mariella; Montefusco, Vittorio; Oliva, Stefania; Caravita, Tommaso; Tacchetti, Paola; Boccadoro, Mario; Sonneveld, Pieter; Palumbo, Antonio

    2014-07-03

    This multicenter, open-label phase 2 trial determined the safety and efficacy of carfilzomib, a novel and irreversible proteasome inhibitor, in combination with cyclophosphamide and dexamethasone (CCyd) in patients with newly diagnosed multiple myeloma (NDMM) ≥65 years of age or who were ineligible for autologous stem cell transplantation. Patients (N = 58) received CCyd for up to 9 28-day cycles, followed by maintenance with carfilzomib until progression or intolerance. After a median of 9 CCyd induction cycles (range 1-9), 95% of patients achieved at least a partial response, 71% achieved at least a very good partial response, 49% achieved at least a near complete response, and 20% achieved stringent complete response. After a median follow-up of 18 months, the 2-year progression-free survival and overall survival rates were 76% and 87%, respectively. The most frequent grade 3 to 5 toxicities were neutropenia (20%), anemia (11%), and cardiopulmonary adverse events (7%). Peripheral neuropathy was limited to grades 1 and 2 (9%). Fourteen percent of patients discontinued treatment because of adverse events, and 21% of patients required carfilzomib dose reductions. In summary, results showed high complete response rates and a good safety profile. This trial was registered at clinicaltrials.gov as #NCT01346787.

  20. Thalidomide, clarithromycin, lenalidomide and dexamethasone therapy in newly diagnosed, symptomatic multiple myeloma.

    PubMed

    Mark, Tomer M; Bowman, Isaac A; Rossi, Adriana C; Shah, Manan; Rodriguez, Melissa; Quinn, Ryann; Pearse, Roger N; Zafar, Faiza; Pekle, Karen; Jayabalan, David; Ely, Scott; Coleman, Morton; Chen-Kiang, Selina; Niesvizky, Ruben

    2014-12-01

    We studied T-BiRD (thalidomide [Thalomid(®)], clarithromycin [Biaxin(®)], lenalidomide [Revlimid(®)] and dexamethasone) in symptomatic, newly diagnosed multiple myeloma. In 28-day cycles, patients received dexamethasone 40 mg/day on days 1, 8, 15, 22, clarithromycin 500 mg twice daily on days 1-28; lenalidomide 25 mg/day on days 1-21; and thalidomide 100 mg/day (50 mg/day on days 1-7 of cycle 1 only) on days 1-28. Twenty-six patients received a median of 6 cycles (range 0-41). Overall response rate (ORR) was 80% for the group and 100% in 11 patients who underwent autologous stem cell transplantation as part of first-line therapy. The 4-year overall survival rate was 74.9%, and the median progression-free survival was 35.6 months. Eight patients discontinued due to regimen toxicity. Grade 3 non hematologic toxicity affected 12 patients (46.2%). T-BiRD is a highly active regimen with potential toxicity limitations. ClinicalTrials.gov identifier: NCT00538733.

  1. Educatin given to parents of children newly diagnosed with acute lymphoblastic leukemia: the parent's perspective.

    PubMed

    Aburn, Gemma; Gott, Meryn

    2014-01-01

    Over the last 30 years, diagnosis and treatment of childhood cancers have improved significantly due to medical research and advancements in technology. Increasingly, parents are taking on the role of providing "nursing" care for their children, including managing emergency situations as well as everyday treatment needs. This study investigated the perceptions and experiences of parents caring for newly diagnosed children with acute lymphoblastic leukemia (ALL) in relation to education given prior to the first discharge from hospital. Using a grounded theory approach, 12 parents of children with ALL from a tertiary pediatric hematology and oncology setting in New Zealand were interviewed using a semi-structured interview technique. Key findings of relevance to clinical practice include the importance of recognizing the emotional strain parents experience following diagnosis and the resultant impact upon how education is understood. Findings may also be applicable to other complex child health areas where education is provided, both in a local and international context. Understanding the family perspective is crucial to enabling clinicians to provide appropriate and informative education to children with ALL and their families.

  2. 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.

  3. 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.

  4. A guide for clinicians in the evaluation of emerging molecular diagnostics for newly diagnosed prostate cancer.

    PubMed

    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.

  5. 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

  6. Cognition in patients with newly diagnosed brain metastasis: profiles and implications

    PubMed Central

    Gerstenecker, Adam; Nabors, Louis B.; Meneses, Karen; Fiveash, John B.; Marson, Daniel C.; Cutter, Gary; Martin, Roy C.; Meyers, Christina A.; Triebel, Kristen L.

    2015-01-01

    Cognitive impairment is a common symptom in patients with brain metastasis, and significant cognitive dysfunction is prevalent in a majority of patients who are still able to engage in basic self-care activities. In the current study, the neurocognitive performance of 32 patients with brain metastasis and 32 demographically-matched controls was examined using a battery of standardized neuropsychological tests, with the goal of comprehensively examining the cognitive functioning of newly diagnosed brain metastasis patients. The cognition of all patients was assessed within 1 week of beginning treatment for brain metastasis. Results indicated impairments in verbal memory, attention, executive functioning, and language in relation to healthy controls. Performance in relation to appropriate normative groups was also examined. Overall, cognitive deficits were prevalent and memory was the most common impairment. Given that cognitive dysfunction was present in this cohort of patients with largely minimal functional impairment, these results have implications for patients, caregivers and health care providers treating patients with brain metastasis. PMID:25035099

  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. Skeletal, neuromuscular and fitness impairments among children with newly diagnosed acute lymphoblastic leukemia

    PubMed Central

    Ness, Kirsten K.; Kaste, Sue C.; Zhu, Liang; Pui, Ching-Hon; Jeha, Sima; Nathan, Paul C.; Inaba, Hiroto; Wasilewski-Masker, Karen; Shah, Durga; Wells, Robert J.; Karlage, Robyn E.; Robison, Leslie L.; Cox, Cheryl L.

    2014-01-01

    This study describes skeletal, neuromuscular and fitness impairments among 109 children (median age 10 (range 4–18) years, 65.1% male, 63.3% white) with acute lymphoblastic leukemia (ALL), enrolled on a physical activity trial from 2009 to 2013. Outcomes were measured 7-10 days after diagnosis and compared to age- and sex-specific expected values. Associations between function and HRQL were evaluated with logistic regression. Children low values for BMD z-scores/height (mean±standard error: −0.53±0.16 vs. 0.00±0.14, p <0.01), body mass index percentile (57.6±3.15 vs. 50.0±3.27%, p=0.02), quadriceps strength (201.9±8.3 vs. 236.1±5.4 Newtons, p<0.01), six minute walk distance (385.0±13.1 vs. 628.2±7.1 meters, p < 0.001), and Bruininks-Oseretsky Test of Motor Proficiency (23±2.5 vs. 50±3.4%, p < 0.001). Quadriceps weakness was associated with a 20.9-fold (95% CI 2.5–173.3) increase in poor physical HRQL. Children with newly diagnosed ALL have weakness and poor endurance and may benefit from early rehabilitation that includes strengthening and aerobic conditioning. PMID:25030039

  9. 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

  10. 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)

  11. Differences in vitamin D nutritional status between newly diagnosed cancer patients from rural or urban settings in Kentucky.

    PubMed

    Christopher, K L; Wiggins, A T; Van Meter, E M; Means, R T; Hayslip, J W; Roach, J P

    2013-01-01

    Although poor nutritional status and weight loss in cancer patients is known to affect outcomes, little is known about malnutrition differences based on geographic location. We investigated nutritional and inflammatory status of 220 newly diagnosed adults with solid tumors at the University of Kentucky's Markey Cancer Center during December 2008 through October 2011. Chi-square tests were used to determine any associations between suboptimal nutritional levels and rural-urban areas of residence. Out of the 13 lab values collected, the only significant difference between rural and urban participants was found for vitamin D resulting in more rural subjects (67.4%) having a suboptimal vitamin D status as compared to those residing in urban areas (53.3%, P = 0.04). Controlling for baseline demographics including age, race, sex, body mass index, nutritional status, and type of cancer, logistic regression analyses concluded those in rural areas had nearly a twofold increase in the odds of having a suboptimal vitamin D level compared to those in urban areas (odd's ratio = 1.97; 95% confidence interval = 1.04, 3.74). Further investigation into the rural-urban differences in vitamin D needs to be investigated in order to improve outcomes during cancer treatment.

  12. Role of MRD status in relation to clinical outcomes in newly diagnosed multiple myeloma patients: a meta-analysis.

    PubMed

    Landgren, O; Devlin, S; Boulad, M; Mailankody, S

    2016-12-01

    Driven by access to better drugs, on average, newly diagnosed multiple myeloma patients have over 10 years overall survival. Using modern combination therapies-with or without the addition of high-dose melphalan and autologous stem cell transplantation-up to 80% of patients reach a complete response. As a logical and necessary step forward, clinical studies have explored strategies to detect minimal residual disease (MRD) and its correlation with clinical outcomes. In this context, MRD has been proposed as a regulatory end point for drug approval in newly diagnosed multiple myeloma. To better define the role of MRD negativity in relation to clinical outcomes, we undertook a meta-analysis including published clinical trials of newly diagnosed multiple myeloma patients. We applied a random effects model which weighted studies using the inverse-variance method. Studies were combined on the scale of the logarithm of the hazard ratio (HR) and the corresponding s.d. We found that MRD negativity (versus positivity) was associated with better PFS (HR=0.35; 95% confidence interval (CI) 0.27-0.46; P<0.001) and overall survival (HR=0.48; 95% CI 0.33-0.70; P<0.001). Our results show that MRD negativity is a strong predictor of clinical outcomes, supportive of MRD becoming a regulatory end point for drug approval in newly diagnosed multiple myeloma.

  13. 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.

  14. 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…

  15. 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

  16. Repeatability of Standardized and Normalized Relative CBV in Patients with Newly Diagnosed Glioblastoma

    PubMed Central

    Prah, M.A.; Stufflebeam, S.M.; Paulson, E.S.; Kalpathy-Cramer, J.; Gerstner, E.R.; Batchelor, T.T.; Barboriak, D.P.; Rosen, B.R.; Schmainda, K.M.

    2015-01-01

    BACKGROUND AND PURPOSE For more widespread clinical use advanced imaging methods such as relative cerebral blood volume must be both accurate and repeatable. The aim of this study was to determine the repeatability of relative CBV measurements in newly diagnosed glioblastoma multiforme by using several of the most commonly published estimation techniques. MATERIALS AND METHODS The relative CBV estimates were calculated from dynamic susceptibility contrast MR imaging in double-baseline examinations for 33 patients with treatment-naïve and pathologically proved glioblastoma multiforme (men=20; mean age=55 years). Normalized and standardized relative CBV were calculated by using 6 common postprocessing methods. The repeatability of both normalized and standardized relative CBV, in both tumor and contralateral brain, was examined for each method with metrics of repeatability, including the repeatability coefficient and within-subject coefficient of variation. The minimum sample size required to detect a parameter change of 10% or 20% was also determined for both normalized relative CBV and standardized relative CBV for each estimation method. RESULTS When ordered by the repeatability coefficient, methods using postprocessing leakage correction and ΔR2*(t) techniques offered superior repeatability. Across processing techniques, the standardized relative CBV repeatability in normal-appearing brain was comparable with that in tumor (P = .31), yet inferior in tumor for normalized relative CBV (P = .03). On the basis of the within-subject coefficient of variation, tumor standardized relative CBV estimates were less variable (13%–20%) than normalized relative CBV estimates (24%– 67%). The minimum number of participants needed to detect a change of 10% or 20% is 118–643 or 30 –161 for normalized relative CBV and 109 –215 or 28 –54 for standardized relative CBV. CONCLUSIONS The ΔR2* estimation methods that incorporate leakage correction offer the best

  17. 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

  18. Relationship between radiologic patterns, pulmonary function values and bronchoalveolar lavage fluid cells in newly diagnosed sarcoidosis

    PubMed Central

    Zeleckienė, Ingrida; Matačiūnas, Mindaugas; Puronaitė, Roma; Jurgauskienė, Laimutė; Malickaitė, Radvilė; Strumilienė, Edita; Gruslys, Vygantas; Zablockis, Rolandas; Danila, Edvardas

    2017-01-01

    Background The aim of the present study was to identify specious radiologic and/or physiologic prognostic marker(s), which lead to optimize of the patient follow-up frequency. Methods Eighty consecutive patients with newly diagnosed pulmonary sarcoidosis. Patients underwent chest radiography, high-resolution computed tomography (HRCT) examination, pulmonary function tests (PFT), bronchoscopy with bronchoalveolar lavage (BAL) and lung biopsy, and bronchoalveolar lavage fluid (BALF) cell examination. Results The reduction in PFT values seen in radiological sarcoidosis stage III was greater than that seen in stages I and II. The percentage of neutrophils in the lungs was found to increase in stages II and III. PFT indices were correlated negatively with the consolidation and ground glass opacities CT scores, but not with the micronodule or macronodule scores. The rise in the percentage of BALF lymphocytes was associated with the restriction pattern of PFT. The diagnostic value of BALF for sarcoidosis was higher when the typical radiologic patterns of stage I disease were found and that smoking decreased the diagnostic value of CD4/CD8 ratio. Conclusions This study supports the opinion that the staging of the pulmonary sarcoidosis with chest X-rays is still valuable from the prognostic point of view, because significant correlations between the radiologic stages of sarcoidosis and PFT parameters were found. Chest HRCT was significantly superior to chest X-ray in detecting mediastinal and pulmonary parenchymal changes. However, the prognostic role of HRCT needs to be better investigated evaluating serial examinations. Only consolidation and ground glass scores (neither of which are frequently found in sarcoidosis) hold prognostic value, since these were negatively correlated with PFT parameters. PMID:28203410

  19. 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

  20. Boron neutron capture therapy for newly diagnosed glioblastoma multiforme: an assessment of clinical potential.

    PubMed

    Sköld, K; Gorlia, T; Pellettieri, L; Giusti, V; H-Stenstam, B; Hopewell, J W

    2010-07-01

    The purpose of this study was to assess the potential of boron neutron capture therapy (BNCT), with a 6-h infusion of the boron carrier l-boronophenylalanine as a fructose preparation (BPA-f), as first-line radiotherapy for newly diagnosed glioblastoma multiforme (GBM). Patient survival data from a Phase II study using BNCT were compared with retrospective data from the two arms of a Phase III study using conventional radiotherapy (RT) in the reference arm and using RT plus concomitant and adjuvant medication with temozolomide (TMZ) in the experimental arm, and were also compared with small subgroups of these patients for whom the methylation status of the MGMT (O(6)-methylguanine-DNA methyltransferase) DNA repair gene was known. Differences in the baseline characteristics, salvage therapy after recurrence and levels of severe adverse events were also considered. The results indicate that BNCT offers a treatment that is at least as effective as conventional RT alone. For patients with an unmethylated MGMT DNA repair gene, a possible clinical advantage of BNCT over RT/TMZ was suggested. BNCT is a single-day treatment, which is of convenience to patients, with mild side effects, which would offer an initial 6 weeks of good-quality life during the time when patients would otherwise be undergoing daily treatments with RT and TMZ. It is suggested that the use of BNCT with a 6-h infusion of BPA-f should be explored in a stratified randomised Phase II trial in which patients with the unmethylated MGMT DNA repair gene are offered BNCT in the experimental arm and RT plus TMZ in the reference arm.

  1. Endocan and Non-Dipping Circadian Pattern in Newly Diagnosed Essential Hypertension

    PubMed Central

    Bilgin, Murat; Akyel, Ahmet; Felekoğlu, Mehmet Ali; Nallbani, Ali; Özdemir, Şeyda; Erden, Gönül; Öztürk, Alpaslan; Doğan, Mehmet; Yeter, Ekrem

    2016-01-01

    Background and Objectives Non-dipper hypertension is frequently accompanied by endothelial dysfunction and activation. Previous studies suggested that endocan may be a novel endothelial dysfunction marker. This study aims to investigate the association between circadian blood pressure (BP) pattern and plasma endocan levels together with high-sensitivity C-reactive protein (hsCRP) in patients with newly diagnosed untreated hypertension. Subjects and Methods Twenty-four hour ambulatory blood pressure monitoring was recorded in 35 dipper, 35 non-dipper hypertensives and 35 healthy controls. Endocan levels were measured by enzyme-linked immunosorbent assay. Serum levels of hsCRP were also recorded. Results Despite similar daytime and 24-hour average BP values between dippers and non-dippers, statistically significant high nocturnal BP was accompanied by a non-dipping pattern (Systolic BP: 132±9 vs. 147±11 mmHg; Distolic BP: 80±7 vs. 91±9 mmHg, respectively, p<0.001 for both). Non-dipper patients demonstrated higher endocan levels compared to dippers and normotensives (367 (193-844) pg/mL, 254 (182-512) pg/mL and 237 (141-314) pg/ml, respectively, p<0.001). HsCRP levels were significantly higher in non-dippers than the other groups (p=0.013). In a multivariate logistic regression analysis, endocan (p=0.021) and hsCRP (p=0.044) were independently associated with a non-dipping pattern. Conclusion Elevated endocan levels were found in non-dipper groups. Endocan and hsCRP were found to be independently associated with a non-dipping pattern. We suggest that elevated levels of endocan in non-dipper hypertensive patients might be associated with a longer duration of exposure to high BP. These results point to the possible future role of endocan in selection of hypertensive patients at higher risk or target organ damage. PMID:27826342

  2. Baseline characteristics, chromosomal alterations, and treatment affecting prognosis of deletion 17p in newly diagnosed myeloma.

    PubMed

    Merz, Maximilian; Hielscher, Thomas; Seckinger, Anja; Hose, Dirk; Mai, Elias K; Raab, Marc S; Goldschmidt, Hartmut; Jauch, Anna; Hillengass, Jens

    2016-11-01

    Deletion 17p13, del(17p), is associated with poor outcome in myeloma but some patients show long-term survival. With the current study we intended to identify factors impacting outcome of such high risk patients. We analyzed 110 newly diagnosed, symptomatic patients with del(17p) detected by fluorescence in situ hybridization (FISH) in CD138-purified myeloma cells to identify prognostic factors for survival. Age >65 years, ISS III, and elevated LDH negatively impacted survival. Patients with subclonal (10-60% of plasma cells) del(17p) had longer progression-free survival (PFS) than patients with del(17p) in >60% of plasma cells (26 vs. 19 months, P = 0.03). Additional gain of 1q21 was associated with shorter PFS (17 vs. 25 months, P = 0.01). Hyperdiploidy did not ameliorate impact of del(17p), but gain 19q13 predicted longer PFS (30 vs. 18 months, P = 0.01) and overall survival (50 vs. 29 months, P = 0.01). Multivariate analysis in transplant eligible patients (≤65 years) revealed better survival for patients treated with upfront autologous transplantation (hazard ratio, [95% confidence interval]: 0.15 [0.04, 0.58], P = 0.006). Application of maintenance therapy was associated with better survival in transplant-eligible patients (0.30 [0.09, 0.99], P = 0.05). We demonstrate heterogeneous outcome of patients with del(17p) according to baseline characteristics and treatment. 19q13 should be included in routine FISH panel, since gains were associated with better survival. Am. J. Hematol. 91:E473-E477, 2016. © 2016 Wiley Periodicals, Inc.

  3. Correlates and outcomes of warfarin initiation in kidney transplant recipients newly diagnosed with atrial fibrillation

    PubMed Central

    Lenihan, Colin R.; Montez-Rath, Maria E.; Shen, Jenny I.; Scandling, John D.; Turakhia, Mintu P.; Chang, Tara I.; Winkelmayer, Wolfgang C.

    2015-01-01

    In the kidney transplant population with atrial fibrillation (AF), evidence regarding the effectiveness and safety of warfarin treatment is lacking. We used fee-for-service Medicare claims to identify kidney transplant recipients with newly diagnosed AF from the United States Renal Data System. Warfarin use within 30 days of AF diagnosis was ascertained from Medicare Part D prescription claims (2007–11) or using a validated algorithm (1997–2011). The study end points were (i) the composite of death, stroke or gastrointestinal bleed, (ii) death and (iii) death-censored graft failure. Warfarin user and non-user groups were balanced using inverse probability of treatment weighting and hazard ratios were (HRs) estimated using Cox regression. Among 718 subjects with an indication for anticoagulation, 24% initiated warfarin treatment within 30 days of AF diagnosis. Age was the only independent correlate of warfarin use [odds ratio = 1.02 per year; 95% confidence interval (95% CI) 1.01–1.04]. In the larger cohort of 6492 patients with AF, warfarin use [(23.5%) versus non-use (76.5%)] was associated with small and non-significant reductions in the composite of death, stroke or gastrointestinal bleed (HR = 0.92; 95% CI 0.83–1.02), death (HR = 0.92; 95% CI 0.82–1.02) and death-censored graft failure (HR = 0.90; 95% CI 0.76–1.08). Our study suggests the need for clinical trials of warfarin use in the kidney transplant population with AF. PMID:25335507

  4. 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

  5. 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

  6. 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

  7. 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

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

    ClinicalTrials.gov

    2016-10-19

    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

  9. 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

  10. Idarubicin and Cytarabine With or Without Bevacizumab in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

    ClinicalTrials.gov

    2013-01-23

    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 Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Childhood Acute Basophilic Leukemia; Childhood Acute Eosinophilic Leukemia; Childhood Acute Erythroleukemia (M6); Childhood Acute Megakaryocytic Leukemia (M7); Childhood Acute Monoblastic Leukemia (M5a); Childhood Acute Monocytic Leukemia (M5b); Childhood Acute Myeloblastic Leukemia With Maturation (M2); Childhood Acute Myeloblastic Leukemia Without Maturation (M1); Childhood Acute Myelomonocytic Leukemia (M4); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies

  11. 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

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

    ClinicalTrials.gov

    2017-02-13

    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

  13. 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

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

    ClinicalTrials.gov

    2017-01-17

    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

  15. Barriers to Care and 1-Year Mortality Among Newly Diagnosed HIV-Infected People in Durban, South Africa

    PubMed Central

    Coleman, Sharon M.; Giddy, Janet; Bogart, Laura M.; Chaisson, Christine E.; Ross, Douglas; Flash, Moses J. E.; Govender, Tessa; Walensky, Rochelle P.; Freedberg, Kenneth A.; Losina, Elena

    2017-01-01

    Background: Prompt entry into HIV care is often hindered by personal and structural barriers. Our objective was to evaluate the impact of self-perceived barriers to health care on 1-year mortality among newly diagnosed HIV-infected individuals in Durban, South Africa. Methods: Before HIV testing at 4 outpatient sites, adults (≥18 years) were surveyed regarding perceived barriers to care including (1) service delivery, (2) financial, (3) personal health perception, (4) logistical, and (5) structural. We assessed deaths via phone calls and the South African National Population Register. We used multivariable Cox proportional hazards models to determine the association between number of perceived barriers and death within 1 year. Results: One thousand eight hundred ninety-nine HIV-infected participants enrolled. Median age was 33 years (interquartile range: 27–41 years), 49% were females, and median CD4 count was 192/μL (interquartile range: 72–346/μL). One thousand fifty-seven participants (56%) reported no, 370 (20%) reported 1–3, and 460 (24%) reported >3 barriers to care. By 1 year, 250 [13%, 95% confidence interval (CI): 12% to 15%] participants died. Adjusting for age, sex, education, baseline CD4 count, distance to clinic, and tuberculosis status, participants with 1–3 barriers (adjusted hazard ratio: 1.49, 95% CI: 1.06 to 2.08) and >3 barriers (adjusted hazard ratio: 1.81, 95% CI: 1.35 to 2.43) had higher 1-year mortality risk compared with those without barriers. Conclusions: HIV-infected individuals in South Africa who reported perceived barriers to medical care at diagnosis were more likely to die within 1 year. Targeted structural interventions, such as extended clinic hours, travel vouchers, and streamlined clinic operations, may improve linkage to care and antiretroviral therapy initiation for these people. PMID:28060226

  16. 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.

  17. The utilization of Gleason grade as the primary criterion for ordering nuclear bone scan in newly diagnosed prostate cancer patients.

    PubMed

    Ritenour, Chad W M; Abbott, John T; Goodman, Michael; Alazraki, Naomi; Marshall, Fray F; Issa, Muta M

    2009-10-02

    Utilization of nuclear bone scans for staging newly diagnosed prostate cancer has decreased dramatically due to PSA-driven stage migration. The current criteria for performing bone scans are based on limited historical data. This study evaluates serum PSA and Gleason grade in predicting positive scans in a contemporary large series of newly diagnosed prostate cancer patients. Eight hundred consecutive cases of newly diagnosed prostate cancer over a 64-month period underwent a staging nuclear scan. All subjects had histologically confirmed cancer. The relationship between PSA, Gleason grade, and bone scan was examined by calculating series of crude, stratified, and adjusted odds ratios with corresponding 95% confidence intervals. Four percent (32/800) of all bone scans were positive. This proportion was significantly lower in patients with Gleason score or=8 (18.8%, p < 0.001). Among patients with Gleason score 30 ng/ml compared to or=8, the rate was significantly higher (27.9 vs. 0%) when PSA was >10 ng/ml compared to newly diagnosed prostate cancer patients. The PSA threshold for ordering bone scans should be adjusted according to Gleason score. For patients with Gleason scores 30 ng/ml. However, for patients with a high Gleason score (8-10), we recommend a bone scan if the PSA is >10 ng/ml.

  18. Resilience, self-efficacy, coping styles and depressive and anxiety symptoms in those newly diagnosed with multiple sclerosis.

    PubMed

    Tan-Kristanto, Stef; Kiropoulos, Litza A

    2015-01-01

    High levels of depressive and anxiety symptoms have been reported by individuals with multiple sclerosis (MS). This study examined the associations between resilience, self-efficacy and coping and depressive and anxiety symptoms and whether resilience, self-efficacy and coping were predictors of depressive and anxiety symptoms in patients newly diagnosed with MS. A sample of 129 individuals newly diagnosed with MS participated in this cross-sectional study and completed an online questionnaire assessing resilience, self-efficacy, coping and depressive and anxiety symptoms. Results revealed that depressive and anxiety symptoms were significantly associated with problem-focused, emotion-focused and avoidance coping strategies, resilience and self-efficacy. Anxiety symptoms were also significantly associated with employment status and level of disability. Results from hierarchical multiple regression revealed that the resilience subscale of personal competence, the avoidance coping style of substance use and emotion-focused coping styles of venting predicted depressive symptoms and uniquely accounted for 63.8% of the variance in the depression score, F (18, 124) = 10.36, p = .000. Level of disability and employment status accounted for 13.2% of the anxiety score and avoidance coping style of denial and emotion-focused coping style of humour accounted for 36.4% of the variance in the anxiety symptom score, F (15, 112) = 6.37, p = .000. Our findings suggest that resilience and avoidance and emotion-focused coping strategies are predictive of depressive symptoms and anxiety symptoms in those newly diagnosed with MS. Resilience and coping styles may be another target for interventions aimed at managing depressive and anxiety symptoms in those newly diagnosed with MS.

  19. Continuous Glucose Monitoring in Newly Diagnosed Type 2 Diabetes Patients Reveals a Potential Risk of Hypoglycemia in Older Men

    PubMed Central

    Li, Feng-fei; Liu, Bing-li; Zhu, Hong-hong; Li, Ting; Zhang, Wen-li; Su, Xiao-fei; Wu, Jin-dan; Wang, Xue-qin; Xu, Ning; Yu, Wei-Nan; Yuan, Qun; Qi, Guan-cheng; Ye, Lei; Lee, Kok-Onn

    2017-01-01

    Objectives. We performed continuous glucose monitoring (CGM) to define the features of patients with newly diagnosed type 2 diabetes (T2D) before and after Continuous Subcutaneous Insulin Infusion (CSII) therapy. Methods. This was a retrospective analysis. Newly diagnosed T2D patients (106) were admitted from eight centers in China. They were divided into a younger patient group (<60 years) and an older patient group (≥60 years). Each group was further divided into male and female patients. CSII therapy was maintained for 3 weeks after the glycemic target was reached. CGM was performed 2 times before and after completion of insulin treatment. Results. CGM data showed the expected significant improvement of mean amplitude glycemic excursion (MAGE) with CSII therapy. The older patients had lower hourly glucose concentrations from 0200 to 0700 o'clock compared to the younger patients at baseline. Surprisingly, in the older patient group, the male patients had a potential risk of hypoglycemia after CSII therapy, especially during periods from 2300 to 2400 and 0400 to 0600. Conclusions. Our data suggested that older male patients with newly diagnosed T2D may have lower nocturnal glucose concentrations. This may potentially increase the risk of nocturnal hypoglycemia during CSII therapy. This study was registered with Chinese Clinical Trial Registry, number CliCTR-TRC-11001218. PMID:28271075

  20. Prevalence and predictors of chronic kidney disease in newly diagnosed human immunodeficiency virus patients in Owerri, Nigeria

    PubMed Central

    Anyabolu, E. N.; Chukwuonye, I. I.; Arodiwe, E.; Ijoma, C. K.; Ulasi, I.

    2016-01-01

    Human immunodeficiency virus (HIV) infection is a common cause of chronic kidney disease (CKD) in Sub-Saharan Africa. This study aims at identifying the prevalence and predictors of CKD in newly diagnosed HIV patients in Owerri, South East Nigeria. This was a cross-sectional study consisting of 393 newly diagnosed HIV-seropositive subjects and 136 age- and sex-matched seronegative subjects as controls. CKD was defined as 24-hour urine protein (24-HUP) ≥0.3 g and/or glomerular filtration rate (GFR) < 60 ml/min. Subjects were recruited from the HIV clinic and the Medical Outpatient Department of Federal Medical Centre, Owerri. Clinical and anthropometric data were collected. Relevant investigations were performed, including HIV screening and relevant urine and blood investigations. The mean age of the HIV subjects was 38.84 ± 10.65 years. CKD was present in 86 (22.9%) HIV subjects and 11 (8.l %) controls. Low waist circumference (WC), high serum creatinine, high spot urine protein/creatinine ratio (SUPCR), high 24-HUP/creatinine Ratio (24-HUPCR), high 24-HUP/osmolality Ratio (24-HUPOR) predicted CKD in HIV subjects. CKD prevalence is high (22.9%) among newly diagnosed HIV patients in South East Nigeria. The predictors of CKD included WC, serum creatinine, SUPCR, 24-HUPCR, and 24-HUPOR. PMID:26937072

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

    ClinicalTrials.gov

    2017-04-04

    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; q22.1); RUNX1-RUNX1T1; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

  2. 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

  3. Racial Differences in Lifestyle Modification in Men with Newly Diagnosed Prostate Cancer

    DTIC Science & Technology

    2005-07-01

    affects of these changes on CaP prognosis. Interviews and biological samples will be collected over a period of 2 years from 125AA and 125CA diagnosed...interviews and biological samples will be collected over a period of 2 years from 125 AA and 125 CA age 40-80 years diagnosed with pathologist-confirmed...disease progression. Combining careful assessment of diet 4 and other behavioral CaP risk factors with the collection of biological samples will

  4. 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

  5. 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

  6. Management of newly diagnosed type 2 Diabetes Mellitus (T2DM) in children and adolescents.

    PubMed

    Copeland, Kenneth C; Silverstein, Janet; Moore, Kelly R; Prazar, Greg E; Raymer, Terry; Shiffman, Richard N; Springer, Shelley C; Thaker, Vidhu V; Anderson, Meaghan; Spann, Stephen J; Flinn, Susan K

    2013-02-01

    Over the past 3 decades, the prevalence of childhood obesity has increased dramatically in North America, ushering in a variety of health problems, including type 2 diabetes mellitus (T2DM), which previously was not typically seen until much later in life. The rapid emergence of childhood T2DM poses challenges to many physicians who find themselves generally ill-equipped to treat adult diseases encountered in children. This clinical practice guideline was developed to provide evidence-based recommendations on managing 10- to 18-year-old patients in whom T2DM has been diagnosed. The American Academy of Pediatrics (AAP) convened a Subcommittee on Management of T2DM in Children and Adolescents with the support of the American Diabetes Association, the Pediatric Endocrine Society, the American Academy of Family Physicians, and the Academy of Nutrition and Dietetics (formerly the American Dietetic Association). These groups collaborated to develop an evidence report that served as a major source of information for these practice guideline recommendations. The guideline emphasizes the use of management modalities that have been shown to affect clinical outcomes in this pediatric population. Recommendations are made for situations in which either insulin or metformin is the preferred first-line treatment of children and adolescents with T2DM. The recommendations suggest integrating lifestyle modifications (ie, diet and exercise) in concert with medication rather than as an isolated initial treatment approach. Guidelines for frequency of monitoring hemoglobin A1c (HbA1c) and finger-stick blood glucose (BG) concentrations are presented. Decisions were made on the basis of a systematic grading of the quality of evidence and strength of recommendation. The clinical practice guideline underwent peer review before it was approved by the AAP. This clinical practice guideline is not intended to replace clinical judgment or establish a protocol for the care of all children with T2

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. Initial linkage and subsequent retention in HIV care for a newly diagnosed HIV-infected cohort in Denver, Colorado.

    PubMed

    Gardner, Edward M; Daniloff, Elaine; Thrun, Mark W; Reirden, Daniel H; Davidson, Arthur J; Johnson, Steven C; Wilmoth, Ralph; Connick, Elizabeth; Burman, William J

    2013-01-01

    This is a retrospective cohort study of 352 newly diagnosed HIV-infected individuals in Denver, from 2005 to 2007. Utilizing data from 3 health care systems, 2 clinical trials units, and statewide Colorado HIV laboratory reporting databases, we tracked initial linkage to HIV care, retention in care, loss to follow-up, and transitions between HIV care providers. After more than 2.6 years of follow-up, 256 (73%) individuals linked to HIV care within 180 days. Of the 301 individuals who eventually linked to care, 168 (56%) had at least one 180-day gap in care, while 49 (16%) had a 360-day gap. Transitions in care were common, with 131 (37%) individuals accessing care from 2 different providers and 15% having evidence of living outside of Colorado. In this newly diagnosed HIV-infected cohort, linkage to care was slow and long-term retention in care was poor. Transitions between HIV care providers were common and may impair engagement in care over time. Out-of-state migration was frequent and may cause an underestimation of engagement in care.

  13. Deficiency of monoclonal antibody (Leu 7) defined NK cells in newly diagnosed insulin-dependent diabetes mellitus.

    PubMed

    Chandy, K G; Charles, M A; Buckingham, B; Waldeck, N; Kershnar, A; Gupta, S

    1984-01-01

    Peripheral blood from 11 newly diagnosed patients with insulin-dependent diabetes mellitus (IDDM) was studied for the proportion of monoclonal antibody (HNK 1, Leu 7) defined natural killer (NK) cells using a fluorescence-activated cell sorter analyzer. The proportion of Leu 7+ cells in patients with IDDM (7.0 +/- 4.0) was significantly (P less than 0.001) lower than in simultaneously studied healthy controls (16.8 +/- 7.0). A 2-yr-old boy with recent onset IDDM had a deficiency of Leu 7+ NK cells (6.1%), while his healthy identical twin had normal proportions of Leu 7+ cells (22.2%), when compared to a simultaneously studied healthy control. Two patients reexamined in remission and one other studied in remission alone, showed deficiency of Leu 7+ NK cells. This study demonstrates a quantitative deficiency of monoclonal antibody (Leu 7+) defined NK cells in newly diagnosed patients with IDDM that persists during remission of the disease and therefore appears to be independent of metabolic abnormality. The deficiency of NK cells may predispose genetically susceptible individuals to viral-induced islet cell injury, contributing to the pathogenesis of IDDM.

  14. 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

  15. 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.

  16. Positive choices: outcomes of a brief risk reduction intervention for newly HIV-diagnosed men who have sex with men.

    PubMed

    Sikkema, Kathleen J; Abler, Laurie; Hansen, Nathan B; Wilson, Patrick A; Drabkin, Anya S; Kochman, Arlene; MacFarlane, Jessica C; DeLorenzo, Allyson; Mayer, Gal; Watt, Melissa H; Nazareth, William

    2014-09-01

    Positive choices (PC), a brief sexual risk reduction intervention conducted with newly HIV-diagnosed men who have sex with men (MSM), was evaluated for preliminary efficacy. Participants were enrolled if they reported unprotected anal intercourse (UAI) in the three months prior to HIV diagnosis (n = 102). Three months after diagnosis, participants completed baseline assessments and were randomly assigned to receive the 3-session PC intervention or the comprehensive standard of care (C-SoC) at a community health center. Participants completed assessments at 3- (post intervention), 6-, and 9- months after baseline. Compared to C-SoC participants, PC participants significantly reduced the frequency of UAI with HIV serodiscordant (HIV negative or status unknown) partners over the 9-month follow-up period. No differences by condition were found in the frequency of UAI with all partners. The findings from this trial suggest that brief risk reduction approaches for newly-diagnosed MSM integrated into HIV care can benefit secondary HIV prevention efforts.

  17. Enzymatic activities of circulating plasma proteasomes in newly diagnosed multiple myeloma patients treated with carfilzomib, lenalidomide and dexamethasone.

    PubMed

    Manasanch, Elisabet E; de Larrea, Carlos Fernández; Zingone, Adriana; Steinberg, Seth M; Kwok, Mary; Tageja, Nishant; Bhutani, Manisha; Kazandjian, Dickran; Roschewski, Mark; Wu, Peter; Carter, George; Zuchlinski, Diamond; Mulquin, Marcia; Lamping, Liz; Costello, Rene; Burton, Deborah; Gil, Lindsay A; Figg, William D; Maric, Irina; Calvo, Katherine R; Yuan, Constance; Stetler-Stevenson, Maryalice; Korde, Neha; Landgren, Ola

    2017-03-01

    The proteasome inhibitor carfilzomib is highly effective in the treatment of multiple myeloma. It irreversibly binds the chymotrypsin-like active site in the β5 subunit of the 20S proteasome. Despite impressive response rates when carfilzomib is used in combination with immunomodulatory agents in newly diagnosed multiple myeloma patients; no biomarker exists to accurately predict response and clinical outcomes. We prospectively assessed the activity in peripheral blood of the chymotrypsin-like (CHYM), caspase-like (CASP) and trypsin-like (TRYP) proteolytic sites in 45 newly diagnosed multiple myeloma patients treated with eight cycles of carfilzomib, lenalidomide and dexamethasone (CRd) (NCT01402284). Samples were collected per protocol and proteasome activity measured through a fluorogenic assay. Median CHYM levels after one dose of carfilzomib decreased by >70%. CHYM and CASP activity decreased throughout treatment reaching a minimum after eight cycles of treatment. Higher levels of proteasome activity associated with higher disease burden (r > 0.30; p < 0.05) and higher disease stage (0.10 < p <0.20). No association was found with the probability of achieving a complete response, minimal residual disease negativity or time to best response. Further studies evaluating proteasome activity in malignant plasma cells may help elucidate how proteasome activity can be used as a biomarker in multiple myeloma.

  18. Initial evidence that blood-borne microvesicles are biomarkers for recurrence and survival in newly diagnosed glioblastoma patients.

    PubMed

    Evans, Sydney M; Putt, Mary; Yang, Xiang-Yang; Lustig, Robert A; Martinez-Lage, Maria; Williams, Dewight; Desai, Arati; Wolf, Ronald; Brem, Steven; Koch, Cameron J

    2016-04-01

    The purpose of this pilot study was to determine whether blood-borne microvesicles from newly diagnosed glioblastoma patients could be used as biomarkers. We collected 2.8 mL blood from 16 post-operative patients at the time that they were being simulated for chemoradiation therapy (radiation with concurrent temozolomide). Two additional samples were collected during chemoradiation therapy and a final sample was collected at the end of chemoradiation therapy. Patients continued with the therapy suggested by their physicians, based on tumor conference consensus and were followed for recurrence and overall survival. Microvesicles were isolated using serial centrifugation and stained for surface markers (Annexin V for phosphotidyl serine, CD41 for platelets, anti-EGFR for tumor cells, and CD235 for red blood cells). Flow cytometry analysis was performed. Our findings provide initial evidence that increases in Annexin V positive microvesicle levels during chemoradiation therapy are associated with earlier recurrence and shorter overall survival in newly diagnosed glioblastoma patients. The effect is dramatic, with over a four-fold increase in the hazard ratio for an individual at the 75th versus the 25th percentile. Moreover the pattern of Annexin V positive microvesicles remain significant after adjustment for confounding clinical variables that have previously been shown to be prognostic for recurrence and survival. Inclusion of neutrophil levels at the start of chemoradiation therapy in the model yielded the largest attenuation of the observed association. Further studies will be needed to verify and further investigate the association between these two entities.

  19. 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

  20. Cognitive Predictors of Understanding Treatment Decisions in Patients with Newly Diagnosed Brain Metastases

    PubMed Central

    Gerstenecker, Adam; Meneses, Karen; Duff, Kevin; Fiveash, John B.; Marson, Daniel C.; Triebel, Kristen L.

    2015-01-01

    Background Medical decision-making capacity is a higher-order functional skill that refers to a patient’s ability to make informed, sound decisions related to care and treatment. In a medical context, understanding is the most cognitively demanding consent standard and refers to a patient’s ability to comprehend information to the extent that informed decisions can be made. Methods The association between reasoning and cognition was examined using data from 41 patients with diagnosed brain metastasis. All diagnoses were made by a board-certified radiation oncologist and were verified histologically. In total, 41 demographically-matched, cognitively healthy controls were also included to aid in classifying patients with brain metastasis according to reasoning status (i.e., intact or impaired). Results Results indicate that measures of simple attention, verbal fluency, verbal memory, processing speed, and executive functioning were all associated with understanding, and that verbal memory and phonemic fluency were the primary cognitive predictors. Using these two primary predictors, equations can be constructed to predict the ability to understand treatment decisions in patients with brain metastasis. Conclusions Although preliminary, these data demonstrate how cognitive measures can estimate understanding as it relates to medical decision-making capacities in these patients. Clinically, these findings suggest that poor verbal memory and expressive language function could serve as “red flags” for reduced consent capacity in this patient population, and, thus, signal that a more comprehensive medical decision-making capacity evaluation is warranted. PMID:25735262

  1. Cognitive Predictors of Reasoning through Treatment Decisions in Patients with Newly Diagnosed Brain Metastases.

    PubMed

    Gerstenecker, Adam; Duff, Kevin; Meneses, Karen; Fiveash, John B; Nabors, Louis B; Triebel, Kristen L

    2015-07-01

    To examine the association between reasoning through medical treatment decisions and cognition in a sample of patients with brain metastasis. The association between reasoning and cognition was examined using data from 41 patients with diagnosed brain metastasis. All diagnoses were made by a board-certified radiation oncologist and were verified histologically. In total, 41 demographically matched, cognitively healthy controls were also included to aid in classifying patients with brain metastasis according to reasoning status (i.e., intact or impaired). Results indicate that measures of episodic memory and processing speed were associated with reasoning. Using these two predictors, actuarial equations were constructed that can be used to help screen for impaired reasoning ability in patients' with brain metastasis. The equations presented in this study have clinical significance as they can be used to help identify patients at risk for possessing a diminished ability to reason through medical treatment decisions and, thus, are in need of a more comprehensive evaluation of their medical decision-making capacity.

  2. Cognitive Predictors of Reasoning Through Treatment Decisions in Patients with Newly Diagnosed Brain Metastases

    PubMed Central

    Gerstenecker, Adam; Duff, Kevin; Meneses, Karen; Fiveash, John B.; Nabors, Louis B.; Triebel, Kristen L.

    2015-01-01

    Objective To examine the association between reasoning through medical treatment decisions and cognition in a sample of patients with brain metastasis. Methods The association between reasoning and cognition was examined using data from 41 patients with diagnosed brain metastasis. All diagnoses were made by a board-certified radiation oncologist and were verified histologically. In total, 41 demographically-matched, cognitively healthy controls were also included to aid in classifying patients with brain metastasis according to reasoning status (i.e., intact or impaired). Results Results indicate that measures of episodic memory and processing speed were associated with reasoning. Using these two predictors, actuarial equations were constructed that can be used to help screen for impaired reasoning ability in patients’ with brain metastasis. Conclusions The equations presented in this study have clinical significance as they can be used to help identify patients at risk for possessing a diminished ability to reason through medical treatment decisions and, thus, are in need of a more comprehensive evaluation of their medical decision-making capacity. PMID:26149751

  3. 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

  4. Relationship between obstructive sleep apnea severity and sleep, depression and anxiety symptoms in newly-diagnosed patients.

    PubMed

    Macey, Paul M; Woo, Mary A; Kumar, Rajesh; Cross, Rebecca L; Harper, Ronald M

    2010-04-16

    Obstructive sleep apnea (OSA) occurs in at least 10% of the population, and leads to higher morbidity and mortality; however, relationships between OSA severity and sleep or psychological symptoms are unclear. Existing studies include samples with wide-ranging comorbidities, so we assessed relationships between severity of OSA and common sleep and psychological disturbances in recently diagnosed OSA patients with minimal co-morbidities. We studied 49 newly diagnosed, untreated OSA patients without major co-morbidities such as mental illness, cardiovascular disease, or stroke; subjects were not using psychoactive medications or tobacco (mean +/- std age: 46.8+/-9.1 years; apnea/hyponea index [AHI]: 32.1+/-20.5 events/hour; female/male: 12/37; weight <125 kg). We evaluated relationships between the AHI and daytime sleepiness (Epworth Sleepiness Scale; ESS), sleep quality (Pittsburg Sleep Quality Index; PSQI), depressive symptoms (Beck Depression Inventory-II; BDI), and anxiety symptoms (Beck Anxiety Inventory; BAI), as well as sex and body mass index (BMI). AHI was similar in females and males. Mean levels of all symptoms were above normal thresholds, but AHI was not correlated with age, ESS, PSQI, BDI, or BAI; only BMI was correlated with OSA severity. No differences in mean AHI appeared when subjects were grouped by normal versus elevated values of ESS, PSQI, BDI, or BAI. Consistent with other studies, a strong link between OSA severity and psychological symptoms did not appear in these newly diagnosed patients, suggesting that mechanisms additional to the number and frequency of hypoxic events and arousals occurring with apneas contribute to adverse health effects in OSA. OSA patients presenting with mild or moderate severity, and no major co-morbidities will not necessarily have low levels of sleep or psychological disturbances.

  5. HIV-1 molecular epidemiology among newly diagnosed HIV-1 individuals in Hebei, a low HIV prevalence province in China

    PubMed Central

    Lu, Xinli; Kang, Xianjiang; Liu, Yongjian; Cui, Ze; Guo, Wei; Zhao, Cuiying; Li, Yan; Chen, Suliang; Li, Jingyun; Zhang, Yuqi; Zhao, Hongru

    2017-01-01

    New human immunodeficiency virus type 1 (HIV-1) diagnoses are increasing rapidly in Hebei. The aim of this study presents the most extensive HIV-1 molecular epidemiology investigation in Hebei province in China thus far. We have carried out the most extensive systematic cross-sectional study based on newly diagnosed HIV-1 positive individuals in 2013, and characterized the molecular epidemiology of HIV-1 based on full length gag-partial pol gene sequences in the whole of Hebei. Nine HIV-1 genotypes based on full length gag-partial pol gene sequence were identified among 610 newly diagnosed naïve individuals. The four main genotypes were circulating recombinant form (CRF)01_AE (53.4%), CRF07_BC (23.4%), subtype B (15.9%), and unique recombinant forms URFs (4.9%). Within 1 year, three new genotypes (subtype A1, CRF55_01B, CRF65_cpx), unknown before in Hebei, were first found among men who have sex with men (MSM). All nine genotypes were identified in the sexually contracted HIV-1 population. Among 30 URFs, six recombinant patterns were revealed, including CRF01_AE/BC (40.0%), CRF01_AE/B (23.3%), B/C (16.7%), CRF01_AE/C (13.3%), CRF01_AE/B/A2 (3.3%) and CRF01_AE/BC/A2 (3.3%), plus two potential CRFs. This study elucidated the complicated characteristics of HIV-1 molecular epidemiology in a low HIV-1 prevalence northern province of China and revealed the high level of HIV-1 genetic diversity. All nine HIV-1 genotypes circulating in Hebei have spread out of their initial risk groups into the general population through sexual contact, especially through MSM. This highlights the urgency of HIV prevention and control in China. PMID:28178737

  6. 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

  7. 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

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

    PubMed

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

    2016-09-01

    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.

  9. A case of newly diagnosed klippel trenaunay weber syndrome presenting with nephrotic syndrome.

    PubMed

    Cebeci, Egemen; Demir, Secil; Gursu, Meltem; Sumnu, Abdullah; Yamak, Mehmet; Doner, Barıs; Karadag, Serhat; Uzun, Sami; Behlul, Ahmet; Ozkan, Oktay; Ozturk, Savas

    2015-01-01

    Klippel Trenaunay Weber syndrome (KTWS) is a rare disease characterized by hemihypertrophy, variceal enlargement of the veins, and arteriovenous (AV) malformations. Renal involvement in KTWS is not known except in rare case reports. Herein, we present a case of KTWS with nephrotic syndrome. A 52-year-old male was admitted due to dyspnea and swelling of the body for the last three months. The pathological physical findings were diffuse edema, decreased lung sounds at the right basal site, increased diameter and decreased length of the left leg compared with the right one, diffuse variceal enlargements, and a few hemangiomatous lesions on the left leg. The pathological laboratory findings were hypoalbuminemia, hyperlipidemia, increased creatinine level (1.23 mg/dL), and proteinuria (7.6 g/day). Radiographic pathological findings were cystic lesions in the liver, spleen, and kidneys, splenomegaly, AV malformation on the left posterolateral thigh, and hypertrophy of the soft tissues of the proximal left leg. He was diagnosed to have KTWS with these findings. Renal biopsy was performed to determine the cause of nephrotic syndrome. The pathologic examination was consistent with focal segmental sclerosis (FSGS). He was started on oral methylprednisolone at the dosage of 1 mg/kg and began to be followedup in the nephrology outpatient clinic.

  10. Effects of sitagliptin as initial therapy in newly diagnosed elderly type 2 diabetics: A randomized controlled study

    PubMed Central

    Xiao, Xiaoyan; Cui, Xiaopei; Zhang, Jianbo; Han, Zhenxia; Xiao, Yu; Chen, Nan; Li, Baoying; Cheng, Mei; Gao, Haiqing; Tang, Kuanxiao

    2016-01-01

    The objective of this study was to investigate the characteristics of blood glycemic excursion, incretins and pancreatic hormone secretion in elderly people with newly diagnosed type 2 diabetes mellitus (T2DM) and to study the effects of sitagliptin on glycemic excursion in these subjects. A total of 129 newly diagnosed T2DM patients were enrolled in the study from March 2012 to August 2013. Clinical data, serum incretin, pancreatic hormone and continuous glucose monitoring data were collected. Among these subjects, elderly patients (NEDM) randomly received metformin combined with sitagliptin phosphate or glimepiride for 24 weeks. The blood glucose, glycosylated hemoglobin A1c (GHbA1c), serum incretins and pancreatic hormone levels were determined. During the oral glucose tolerance test (OGTT), 30 min insulin and C-peptide levels, 120 min insulin levels and ratio of the increases of insulin and blood glucose levels after 30 min of sugar loading (∆Ins30/∆Glu30) were significantly lower in elderly patients than in middle-aged patients (P<0.05). In addition, the glucagon elevation at 30 min was higher and the glucagon-like peptide-1 (GLP-1) at 30 min was lower in the elderly patients (P<0.05). Glucose excursion indices, including the standard deviation of the average blood glucose, intraday mean average glucose excursions (MAGE), and mean of daily differences (MODD), were significantly higher in the elderly patients (P<0.05). During the OGTT, insulin, C-peptide and ∆Ins30/∆Glu30 results at 30 min and GLP-1 levels at 120 min in NEDM subjects were significantly increased (P<0.05) and glucagon levels at 30 min was significantly lower after sitagliptin treatment (P<0.05) compared with glimepiride. Moreover, MAGE and MODD were significantly lower in the sitagliptin group after treatment compared to those in the glimepiride group (P<0.05). No severe hypoglycemia or cardiovascular diseases were observed. Strong blood glucose excursions occur in elderly patients with

  11. Establishing preference for unreliable reinforcement in adults with dual diagnoses.

    PubMed

    Rehfeldt, Ruth Anne; Randich, Lisette

    2003-08-01

    We evaluated the choice responding of three adults dually diagnosed with developmental and psychiatric disabilities using concurrent schedules of reinforcement. Specifically, participants were given a choice between a response option resulting in reliable reinforcement and a response option resulting in unreliable reinforcement. Our primary purpose was to shift preference from reliable to unreliable reinforcement via the systematic presentation of stimuli during delay intervals. A second purpose was to evaluate the effectiveness of intervening stimuli in shifting preference at differing delay-to-reinforcement intervals. Preference for unreliable reinforcement was first examined in the absence of stimulus presentations during delays, at three different delay values. Next, we aimed to establish preference for unreliable reinforcement by presenting pictures of reinforcers during delays preceding unreliable reinforcement. Preference was again examined at three different delay values. In the absence of stimulus presentations during delays, participants were shown to prefer reliable reinforcement, particularly at the longer delay value. When stimuli were presented during the delays, two of the three participants preferred unreliable reinforcement, particularly the longer the delay value. These results suggest that the presentation of intervening stimuli during delays may help facilitate tolerance for unreliable reinforcement.

  12. Psychological distress in newly diagnosed colorectal cancer patients following microsatellite instability testing for Lynch syndrome on the pathologist's initiative.

    PubMed

    Landsbergen, K M; Prins, J B; Brunner, H G; van Duijvendijk, P; Nagengast, F M; van Krieken, J H; Ligtenberg, M; Hoogerbrugge, N

    2012-06-01

    According to the Dutch Guideline on Hereditary Colorectal Cancer published in 2008, patients with recently diagnosed colorectal cancer (CRC) should undergo microsatellite instability (MSI) testing by a pathologist immediately after tumour resection if they are younger than 50 years, or if a second CRC has been diagnosed before the age of 70 years, owing to the high risk of Lynch syndrome (MIPA). The aim of the present MIPAPS study was to investigate general distress and cancer-specific distress following MSI testing. From March 2007 to September 2009, 400 patients who had been tested for MSI after newly diagnosed CRC were recruited from 30 Dutch hospitals. Levels of general distress (SCL-90) and cancer-specific distress (IES) were assessed immediately after MSI result disclosure (T1) and 6 months later (T2). Response rates were 23/77 (30%) in the MSI-positive patients and 58/323 (18%) in the MSI-negative patients. Levels of general distress and cancer-specific distress were moderate. In the MSI-positive group, 27% of the patients had high general distress at T1 versus 18% at T2 (p = 0.5), whereas in the MSI-negative group, these percentage were 14 and 18% (p = 0.6), respectively. At T1 and T2, cancer-specific distress rates in the MSI-positive group and MSI-negative group were 39 versus 27% (p = 0.3) and 38 versus 36% (p = 1.0), respectively. High levels of general distress were correlated with female gender, low social support and high perceived cancer risk. Moderate levels of distress were observed after MSI testing, similar to those found in other patients diagnosed with CRC. Immediately after result disclosure, high cancer-specific distress was observed in 40% of the MSI-positive patients.

  13. 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 ...

  14. Assessment of duration until initial treatment and its determining factors among newly diagnosed oral cancer patients

    PubMed Central

    Chiou, Shang-Jyh; Lin, Wender; Hsieh, Chi-Jeng

    2016-01-01

    Abstract Few studies have focused on the early treatment stages of cancer, and the impact of treatment delay on oncologic outcomes is poorly defined. We used oral cancer as an example to investigate the distribution of durations until initial treatment. This study was conducted using the National Health Insurance Research Database, which is linked to Taiwan's Cancer Registry and Death Registry databases. We defined “cutoff points for first-time treatment” according to a weekly schedule and sorted the patients into 2 groups based on whether their duration until initial treatment was longer or shorter than each cutoff. We then calculated the Kaplan–Meier estimator to determine the difference in survival rates between the 2 groups and performed logistic regression to identify determining factors. The average time between diagnosis and initial treatment was approximately 22.45 days. The average survival duration was 1363 days (standard deviation: 473.06 days). Oral cancer patients had no statistically significant differences in survival until a cutoff point of 3 weeks was used (with survival duration 71 days longer if initial treatment was received within 3 weeks). Patients with higher incomes or higher Charlson comorbidity index scores and patients treated at a hospital in a region with medium urbanization had lower likelihoods of treatment delay, whereas older patients were at higher risk of treatment delay. The attitudes, beliefs, and social contexts of oral cancer patients influence the treatment-seeking behaviors of these patients. Therefore, the government should advocate the merits of the referral system for cancer treatment or improve quality assurance for cancer diagnoses across different types of hospitals. Health authorities should also educate patients or use a case manager to encourage prompt treatment within 3 weeks and should provide screening and prevention services, particularly for high-risk groups, to reduce mortality risk. PMID:27977607

  15. Innate Immune Markers in Mothers and Fathers of Children Newly Diagnosed with Cancer

    PubMed Central

    Lutz Stehl, Meredith J.; Kazak, Anne E.; Hwang, Wei-Ting; Pai, Ahna L.H.; Reilly, Anne F.; Douglas, Steven D.

    2010-01-01

    Objective The diagnosis of a life-threatening illness in a child is one of the most stressful events imaginable for parents and is associated with increased anxiety and distress. Despite associations between stress and immune function in animal and human models, the immune function in caregivers of children at the time of a child-related potentially traumatic event, like cancer, is not known. Methods Nineteen parents (11 mothers, 8 fathers), representing six caregiver pairs, provided blood for natural killer (NK) cell count by flow cytometry and function assays [% NK whole blood, absolute NK whole blood, LU20 (lytic unit) peripheral blood mononuclear cells, LU20 NK cells] and completed self-report measures (acute stress) within 2 weeks of learning their child had cancer. The NK cell assay was also completed with a sample of healthy adults, the immune reference group. Results There were similar levels of NK cell activity between caregivers and the immune reference group. Immune level and psychological outcomes were not associated. LU20 peripheral blood mononuclear cells and LU20 NK cells were each correlated at r = 0.83 between mothers and fathers in the same family. Conclusions Although based on a small sample, these preliminary results suggest that knowledge about stress responses in parents of children with life-threatening illness may be important and provide novel data regarding the shared impact of stress on immune function within caregiver dyads. PMID:18679048

  16. 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.

  17. Concurrent intensive chemotherapy and imatinib before and after stem cell transplantation in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. Final results of the CSTIBES02 trial

    PubMed Central

    Ribera, Josep-Maria; Oriol, Albert; González, Marcos; Vidriales, Belén; Brunet, Salut; Esteve, Jordi; del Potro, Eloy; Rivas, Concepción; Moreno, Maria-José; Tormo, Mar; Martín-Reina, Victoria; Sarrá, Josep; Parody, Ricardo; de Oteyza, Jaime Pérez; Bureo, Encarna; Bernal, Maria-Teresa

    2010-01-01

    Background Imatinib, given concurrently or alternating with chemotherapy, has improved the response and survival of patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) but relapses are still frequent. The aim of this study was to evaluate the feasibility and results of giving imatinib concurrently with intensive chemotherapy, stem cell transplantation and post-transplant imatinib maintenance therapy in patients with newly diagnosed Ph+ ALL. Design and Methods This was a phase II study of patients with newly diagnosed Ph+ ALL given standard chemotherapy, together with imatinib (400 mg/day) until stem cell transplantation, followed by imatinib maintenance therapy for all patients regardless of the molecular status of the disease. Results Of the 30 patients included, 27 (90%) achieved complete remission, one was resistant to treatment and two died during induction therapy. The percentages of major and complete molecular responses were 86% and 21% after induction, and 81% and 65% after consolidation, respectively. Similar results were observed assessing minimal residual disease by flow cytometry. Of the 27 patients who achieved complete remission, 21 underwent stem cell transplantation (16 allogeneic, 5 autologous). Imatinib (400 mg/day) could be administered after transplantation for a median of 3.9 months in 12 patients, although it was interrupted in 10 patients (in 2 cases because of side effects of the drug). Nine patients relapsed, four before and five after stem cell transplantation and eight patients died of transplant-related causes. With a median follow-up of 4.1 years, the probabilities (95% CI) of disease-free and overall survival were 30% (15% to 45%) and 30% (16% to 45%), respectively. Conclusions These results confirm that imatinib is an effective first-line treatment for adult Ph+ ALL when given concurrently with chemotherapy, making stem cell transplantation feasible in a high proportion of patients. However, post

  18. Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea

    PubMed Central

    Kang, Shin-Hyuk; Lee, Jae Won; Chang, Jong-Hee; Kim, Jeong-Hoon; Lim, Young-Jin; Koh, Young-Cho; Chung, Yong-Gu; Kim, Jae-Min; Kim, Choong-Hyun

    2017-01-01

    Purpose Adoptive cell immunotherapy involves an ex vivo expansion of autologous cytokine-induced killer (CIK) cells before their reinfusion into the host. We evaluated the efficacy and safety of CIK cell immunotherapy with radiotherapy-temozolomide (TMZ) for the treatment of newly diagnosed glioblastomas. Experimental design In this multi-center, open-label, phase 3 study, we randomly assigned patients with newly diagnosed glioblastoma to receive CIK cell immunotherapy combined with standard TMZ chemoradiotherapy (CIK immunotherapy group) or standard TMZ chemoradiotherapy alone (control group). The efficacy endpoints were analyzed in the intention-to-treat set and in the per protocol set. Results Between December 2008 and October 2012, a total of 180 patients were randomly assigned to the CIK immunotherapy (n = 91) or control group (n = 89. In the intention-to-treat analysis set, median PFS was 8.1 months (95% confidence interval (CI), 5.8 to 8.5 months) in the CIK immunotherapy group, as compared to 5.4 months (95% CI, 3.3 to 7.9 months) in the control group (one-sided log-rank, p = 0.0401). Overall survival did not differ significantly between two groups. Grade 3 or higher adverse events, health-related quality of life and performance status between two groups did not show a significant difference. Conclusions The addition of CIK cells immunotherapy to standard chemoradiotherapy with TMZ improved PFS. However, the CIK immunotherapy group did not show evidence of a beneficial effect on overall survival. PMID:27690294

  19. Glipizide controlled-release tablets, with or without acarbose, improve glycaemic variability in newly diagnosed Type 2 diabetes.

    PubMed

    Bao, Yu-Qian; Zhou, Jian; Zhou, Mi; Cheng, Yi-Jia; Lu, Wei; Pan, Xiao-Ping; Tang, Jun-Ling; Lu, Hui-Juan; Jia, Wei-Ping

    2010-05-01

    1. The aim of the present study was to compare the effects of glipizide controlled-release (CR) tablets monotherapy with that of glipizide CR tablets plus acarbose on glycaemic variability in newly diagnosed Type 2 diabetes (T2DM) patients using a continuous glucose-monitoring system (CGMS). 2. Forty newly diagnosed T2DM patients whose glycated haemoglobin A1c (HbA1c) levels ranged from 7.0% to 9.8% were randomized to either monotherapy or combination therapy. Overall glycaemic control and blood glucose variability were evaluated by CGMS parameters. 3. After 8 weeks treatment, fasting and postprandial blood glucose, HbA1c, glycated albumin (GA), mean blood glucose (MBG), mean amplitude of glycaemic excursions (MAGE), postprandial incremental area under the curve (AUC(pp)) and homeostasis model assessment of insulin resistance decreased significantly in both groups (P < 0.01). There was also a significant decrease in the mean of daily differences (MODD) in the combination therapy group. Mean changes in MBG, MAGE, MODD and AUC(pp) were significantly greater in the combination therapy group than in the monotherapy group (all P < 0.01), whereas no significant differences were found in the mean changes of HbA1c and GA. Multivariate regression analysis showed that the decrement in AUC(pp) was significantly associated with decreases in MAGE. 4. In conclusion, glipizide CR tablets alone or in combination with acarbose can improve overall blood glucose levels and glycaemic variability. Combination therapy using glipizide CR tablets and acarbose was more effective in reducing intraday and day-to-day glycaemic variability than glipizide CR tablet monotherapy.

  20. Outcome of infants and young children with newly diagnosed ependymoma treated on the "Head Start" III prospective clinical trial.

    PubMed

    Venkatramani, Rajkumar; Ji, Lingyun; Lasky, Joseph; Haley, Kelley; Judkins, Alexander; Zhou, Shengmei; Sposto, Richard; Olshefski, Randal; Garvin, James; Tekautz, Tanya; Kennedy, Gloria; Rassekh, Shahrad Rod; Moore, Theodore; Gardner, Sharon; Allen, Jeffrey; Shore, Richard; Moertel, Christopher; Atlas, Mark; Dhall, Girish; Finlay, Jonathan

    2013-06-01

    This study investigates the outcome of children <10 years old with newly-diagnosed ependymoma treated on the prospective multinational "Head Start" III clinical trial. Between April 2004 and July 2009, 19 children with newly-diagnosed ependymoma were enrolled. All children were to receive five induction chemotherapy cycles followed by one consolidation cycle of myelo-ablative chemotherapy and autologous hematopoietic cell rescue. Children between 6 and 10 years of age or with residual tumor prior to consolidation were to receive irradiation thereafter. Median age of 19 children (8 female) was 20 months at diagnosis. Median follow up was 44 months. The primary site was infratentorial in 11 and supratentorial in 8 patients. Gross total resection was achieved in 10 patients. After induction chemotherapy, all three supratentorial ependymoma patients with residual disease achieved a complete response (CR), while only one of six infratentorial patients with residual disease achieved CR. Three infratentorial patients developed progressive disease during induction chemotherapy. All four infratentorial patients with residual disease who underwent autologous hematopoietic cell transplant, failed to achieve CR. Four patients received focal irradiation following chemotherapy. The 3-year event free survival (EFS) and overall survival (OS) for supratentorial ependymoma were 86 ± 13 % and 100 % respectively. The 3-year EFS and OS for infratentorial ependymoma were 27 ± 13 % and 73 ± 13 % respectively. The role of intensive induction and consolidation chemotherapy in deferring irradiation should be investigated further in children with supratentorial ependymoma with residual disease following surgery. This approach appears ineffective in children with infratentorial ependymoma in the absence of irradiation.

  1. A phase II study of conventional radiation therapy and thalidomide for supratentorial, newly-diagnosed glioblastoma (RTOG 9806).

    PubMed

    Alexander, Brian M; Wang, Meihua; Yung, W K Alfred; Fine, Howard A; Donahue, Bernadine A; Tremont, Ivo W; Richards, Ray S; Kerlin, Kevin J; Hartford, Alan C; Curran, Walter J; Mehta, Minesh P

    2013-01-01

    The Radiation Therapy Oncology Group (RTOG) initiated the single-arm, phase II study 9806 to determine the safety and efficacy of daily thalidomide with radiation therapy in patients with newly diagnosed glioblastoma. Patients were treated with thalidomide (200 mg daily) from day one of radiation therapy, increasing by 100-200 to 1,200 mg every 1-2 weeks until tumor progression or unacceptable toxicity. The median survival time (MST) of all 89 evaluable patients was 10 months. When compared with the historical database stratified by recursive partitioning analysis (RPA) class, this end point was not different [hazard ratio (HR) = 1.18; 95 % CI: 0.95-1.46; P = 0.93]. The MST of RPA class III and IV patients was 13.9 versus 12.5 months in controls (HR = 0.99; 95 % CI: 0.73-1.36; P = 0.48), and 4.3 versus 8.6 months in RPA class V controls (HR = 1.63, 95 % CI: 1.17-2.27; P = 0.99). In all, 34 % of patients discontinued thalidomide because of adverse events or refusal. The most common grade 3-4 toxicities were venous thrombosis, fatigue, skin reactions, encephalopathy, and neuropathy. In conclusion, thalidomide given simultaneously with radiation therapy was safe, but did not improve survival in patients with newly diagnosed glioblastoma.

  2. Clofarabine, Idarubicin, and Cytarabine (CIA) as Frontline Therapy for Patients ≤60 Years with Newly Diagnosed Acute Myeloid Leukemia (AML)

    PubMed Central

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

    2014-01-01

    Purpose To explore the combination of clofarabine, cytarabine, and idarubicin (CIA) in patients with newly diagnosed acute myeloid leukemia (AML) 40 years. Compared to historical patients treated with IA combination, the OS and EFS were significantly higher (P = 0.005, 0.0001, respectively) for CIA treated patients. In multivariate analysis, CIA retained its superior impact on OS and EFS compared to IA. Conclusion CIA is an effective combination for patients newly diagnosed AML. Patients ≤ 40 years had better OS and EFS. CIA achieved longer OS and EFS compared to IA alone. PMID:23877926

  3. 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.

  4. Outcome Predictors in Nonoperative Management of Newly Diagnosed Subacromial Impingement Syndrome: A Longitudinal Study

    PubMed Central

    TaheriAzam, Afshin; Sadatsafavi, Mohsen; Moayyeri, Alireza

    2005-01-01

    Abstract and Introduction Abstract Objective This prospective investigation is designed to determine the prognostic factors associated with the response to conservative therapy of subacromial impingement syndrome. Materials and Methods We treated 102 patients with subacromial impingement syndrome, diagnosed by physical examination and a subacromial lidocaine injection test, with a standardized conservative protocol. We followed the patients for a period of 12 months. Outcome was evaluated with Constant score and effects of 8 variables: Age, sex, pretreatment symptom duration, dominant shoulder, initial Constant score, active range of motion, acromion morphology, and acromial spur on patient outcomes were evaluated with univariate and multivariate analyses. Results Among 89 patients (44 men; mean age, 56.4 years) who finished the study, the mean difference between initial and final scores was 15.9 (95% confidence interval [CI]: 13.9–17.8). Three variables, the initial Constant score (b = .52, 95% CI: .28–.76), the duration of disease before treatment (b = −4.4, 95% CI: from −7.2 to −1.6), and acromial morphology (b = −5.3, 95% CI: from −9.8 to −.8) were found to be independent predictors of outcome (model R2 = .68). Conclusion Patients with more severe disease, a long duration of symptoms, and type II or III acromion may require more invasive therapeutic options as the first intervention. Introduction Subacromial impingement and rotator cuff tears are common causes of shoulder disability. For the first time, Neer[1] popularized the concept of this syndrome, and described it as impingement of the rotator cuff tendon below the anteroinferior part of the acromion. This impingement caused tendonitis and eventual tendon tear. He described a clinical sign in which pain was aggravated when the affected shoulder was placed in forward-flexed and internally rotated position. He also introduced an impingement test that evaluated pain relief in response to

  5. 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

  6. 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

  7. Diagnose

    NASA Astrophysics Data System (ADS)

    Schauer, Wolfgang

    Die Zunahme der Elektronik im Kraftfahrzeug, die Nutzung von Software zur Steuerung des Fahrzeugs und die erhöhte Komplexität moderner Einspritzsysteme stellen hohe Anforderungen an das Diagnosekonzept, die Überwachung im Fahrbetrieb (On-Board-Diagnose) und die Werkstattdiagnose (Bild 1). Basis der Werkstattdiagnose ist die geführte Fehlersuche, die verschiedene Möglichkeiten von Onboard- und Offboard-Prüfmethoden und Prüfgeräten verknüpft. Im Zuge der Verschärfung der Abgasgesetzgebung und der Forderung nach laufender Überwachung hat auch der Gesetzgeber die On-Board-Diagnose als Hilfsmittel zur Abgasüberwachung erkannt und eine herstellerunabhängige Standardisierung geschaffen. Dieses zusätzlich installierte System wird OBD-System (On Board Diagnostic System) genannt.

  8. 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.

  9. Long-term results of carmustine wafer implantation for newly diagnosed glioblastomas: a controlled propensity-matched analysis of a French multicenter cohort

    PubMed Central

    Pallud, Johan; Audureau, Etienne; Noel, Georges; Corns, Robert; Lechapt-Zalcman, Emmanuèle; Duntze, Julien; Pavlov, Vladislav; Guyotat, Jacques; Hieu, Phong Dam; Le Reste, Pierre-Jean; Faillot, Thierry; Litre, Claude-Fabien; Desse, Nicolas; Petit, Antoine; Emery, Evelyne; Voirin, Jimmy; Peltier, Johann; Caire, François; Vignes, Jean-Rodolphe; Barat, Jean-Luc; Langlois, Olivier; Dezamis, Edouard; Parraga, Eduardo; Zanello, Marc; Nader, Edmond; Lefranc, Michel; Bauchet, Luc; Devaux, Bertrand; Menei, Philippe; Metellus, Philippe

    2015-01-01

    Background The standard of care for newly diagnosed glioblastoma is maximal safe surgical resection, followed by chemoradiation therapy. We assessed carmustine wafer implantation efficacy and safety when used in combination with standard care. Methods Included were adult patients with (n = 354, implantation group) and without (n = 433, standard group) carmustine wafer implantation during first surgical resection followed by chemoradiation standard protocol. Multivariate and case-matched analyses (controlled propensity-matched cohort, 262 pairs of patients) were conducted. Results The median progression-free survival was 12.0 months (95% CI: 10.7–12.6) in the implantation group and 10.0 months (9.0–10.0) in the standard group and the median overall survival was 20.4 months (19.0–22.7) and 18.0 months (17.0–19.0), respectively. Carmustine wafer implantation was independently associated with longer progression-free survival in patients with subtotal/total surgical resection in the whole series (adjusted hazard ratio [HR], 0.76 [95% CI: 0.63–0.92], P = .005) and after propensity matching (HR, 0.74 [95% CI: 0.60–0.92], P = .008), whereas no significant difference was found for overall survival (HR, 0.95 [0.80–1.13], P = .574; HR, 1.06 [0.87–1.29], P = .561, respectively). Surgical resection at progression whether alone or combined with carmustine wafer implantation was independently associated with longer overall survival in the whole series (HR, 0.58 [0.44–0.76], P < .0001; HR, 0.54 [0.41–0.70], P < .0001, respectively) and after propensity matching (HR, 0.56 [95% CI: 0.40–0.78], P < .0001; HR, 0.46 [95% CI: 0.33–0.64], P < .0001, respectively). The higher postoperative infection rate in the implantation group did not affect survival. Conclusions Carmustine wafer implantation during surgical resection followed by the standard chemoradiation protocol for newly diagnosed glioblastoma in adults resulted in a significant progression-free survival

  10. Challenges with Diagnosing and Managing Sepsis in Older Adults

    PubMed Central

    Clifford, Kalin M.; Dy-Boarman, Eliza A.; Haase, Krystal K.; Maxvill, Kristen (Hesch); Pass, Steven; 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 as well as offers recommendations for monitoring and treating sepsis in the older adult population. PMID:26687340

  11. 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

  12. Effect of Poor Glycemic Control in Newly Diagnosed Patients with Smear-Positive Pulmonary Tuberculosis and Type-2 Diabetes Mellitus

    PubMed Central

    Mahishale, Vinay; Avuthu, Sindhuri; Patil, Bhagyashri; Lolly, Mitchelle; Eti, Ajith; Khan, Sujeer

    2017-01-01

    Background: There is growing evidence that diabetes mellitus (DM) is an important risk factor for tuberculosis (TB). A significant number of DM patients have poor glycemic control. This study was carried out to find the impact of poor glycemic control on newly diagnosed smear-positive pulmonary tuberculosis patients with type-2 diabetes mellitus in a tertiary care hospital. Methods: In a hospital-based prospective study, newly diagnosed smear-positive pulmonary TB with DM patients were classified as poorly controlled diabetes (HBA1C≥7%) and optimal control diabetics (HbA1c<7%). Patients were started on anti-TB treatment and followed for 2 years for severity and treatment outcome. ANOVA was used for numerical variables in the univariable analysis. Logistic regression analysis was used for multivariable analysis of treatment outcome. The significance level was kept at a P≤0.05. Results: A total of 630 individuals who met the inclusion criteria were analyzed; of which 423 patients had poor glycemic control (PGC) and 207 patients had optimal glycemic control (OGC). The average HbA1c was 10±2.6 and 5±1.50 in the PGC and OGC groups, respectively. The mean symptom score was significantly higher in the PGC group compared with patients in the OGC group (4.55±0.80 vs. 2.70±0.82, P<0.001). PGC was associated with more extensive lung disease, lung cavitation, and positive sputum smear at the baseline. In PGC, sputum smears were significantly more likely to remain positive after 2 months of treatment. PGC patients had significantly higher rates of treatment failure (adj. OR 0.72, 95% CI 0.58-0.74, P<0.001) and relapse (adj. OR 2.83, 95% CI 2.60-2.92, P<0.001). Conclusion: Poor glycemic control is associated with an increased risk of advanced and more severe TB disease in the form of lung cavitations, positive sputum smear, and slower smear conversion. It has a profound negative effect on treatment completion, cure, and relapse rates in patients with pulmonary

  13. 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

  14. 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

  15. [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

  16. A concurrent ultra-fractionated radiation therapy and temozolomide treatment: A promising therapy for newly diagnosed, inoperable glioblastoma.

    PubMed

    Beauchesne, P; Quillien, V; Faure, G; Bernier, V; Noel, G; Quetin, P; Gorlia, T; Carnin, C; Pedeux, R

    2016-03-15

    We report on a phase II clinical trial to determine the effect of a concurrent ultra-fractionated radiotherapy and temozolomide treatment in inoperable glioblastoma patients. A phase II study opened; patients over 18 years of age who were able to give informed consent and had histologically proven, newly diagnosed inoperable diagnosed and supratentorial glioblastoma were eligible. Three doses of 0.75 Gy spaced apart by at least 4 hr were delivered daily, 5 days a week for six consecutive weeks for a total of 67.5 Gy. Chemotherapy was administered during the same period, which consisted of temozolomide given at a dose of 75 mg/m(2) for 7 days a week. After a 4-week break, chemotherapy was resumed for up to six cycles of adjuvant temozolomide treatment, given every 28 days, according to the standard 5-day regimen. Tolerance and toxicity were the primary endpoints; survival and progression-free survival were the secondary endpoints. In total, 40 patients were enrolled in this study, 29 men and 11 women. The median age was 58 years, and the median Karnofsky performance status was 80. The concomitant ultra-fractionated radiotherapy and temozolomide treatment was well tolerated. Complete responses were seen in four patients, and partial responses were reported in seven patients. The median survival from the initial diagnosis was 16 months. Several long-term survivors were noted. Concurrent ultra-fractionated radiation therapy and temozolomide treatment are well accepted by the patients. The results showed encouraging survival rates for these unfavorable patients.

  17. Low Prevalence of Transmitted Drug Resistance in Patients Newly Diagnosed with HIV-1 Infection in Sweden 2003–2010

    PubMed Central

    Karlsson, Annika; Björkman, Per; Bratt, Göran; Ekvall, Håkan; Gisslén, Magnus; Sönnerborg, Anders; Mild, Mattias; Albert, Jan

    2012-01-01

    Transmitted drug resistance (TDR) is a clinical and epidemiological problem because it may contribute to failure of antiretroviral treatment. The prevalence of TDR varies geographically, and its prevalence in Sweden during the last decade has not been reported. Plasma samples from 1,463 patients newly diagnosed with HIV-1 infection between 2003 and 2010, representing 44% of all patients diagnosed in Sweden during this period, were analyzed using the WHO 2009 list of mutations for surveillance of TDR. Maximum likelihood phylogenetic analyses were used to determine genetic subtype and to investigate the relatedness of the sequences. Eighty-two patients showed evidence of TDR, representing a prevalence of 5.6% (95% CI: 4.5%–6.9%) without any significant time trends or differences between patients infected in Sweden or abroad. Multivariable logistic regression showed that TDR was positively associated with men who have sex with men (MSM) and subtype B infection and negatively associated with CD4 cell counts. Among patients with TDR, 54 (68%) had single resistance mutations, whereas five patients had multi-drug resistant HIV-1. Phylogenetic analyses identified nine significantly supported clusters involving 29 of the patients with TDR, including 23 of 42 (55%) of the patients with TDR acquired in Sweden. One cluster contained 18 viruses with a M41L resistance mutation, which had spread among MSM in Stockholm over a period of at least 16 years (1994–2010). Another cluster, which contained the five multidrug resistant viruses, also involved MSM from Stockholm. The prevalence of TDR in Sweden 2003–2010 was lower than in many other European countries. TDR was concentrated among MSM, where clustering of TDR strains was observed, which highlights the need for continued and improved measures for targeted interventions. PMID:22448246

  18. 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.

  19. 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…

  20. 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

    2016-03-03

    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.

  1. The Effects of Hospital Length of Stay on Readmissions for Children With Newly Diagnosed Acute Lymphoblastic Leukemia.

    PubMed

    Wedekind, Mary F; Dennis, Robyn; Sturm, Mollie; Koch, Terah; Stanek, Joseph; O'Brien, Sarah H

    2016-07-01

    Although regimens for induction therapy in children with acute lymphoblastic leukemia (ALL) are similar across the United States, typical practice with regard to inpatient length of stay (LOS) varies by institution. US children's hospitals were categorized by typical induction LOS; and readmissions, pediatric intensive care unit (PICU) admissions, and average adjusted charges were compared for the first 30 days from initial admission. Using Pediatric Health Information System data, we extracted ALL induction admissions from 2007 to 2013. We categorized hospitals into 3 categories based on median LOS: short (≤7 d), medium (8 to 15 d), or long (≥16 d). Median LOS varied from 5 to 31 days across hospitals. Thirty-day median inpatient costs per patient ranged from $32 K for short LOS, $40 K for medium LOS, and $47 K for long LOS. Compared with short LOS hospitals (n=14), medium LOS (n=8) and long LOS hospitals (n=8) had lower odds of PICU readmissions (odds ratio [OR], 0.68; P=0.0124 and OR, 0.31; P<0.001, respectively), and long LOS hospitals had lower odds of any readmission (OR, 0.44; P<0.0001). Average LOS for children with newly diagnosed ALL varies widely by institution. Children's hospitals that typically admit new ALL patients for >7 days have fewer PICU readmissions but substantial increase in total induction inpatient costs.

  2. Increased Blood Levels of Growth Factors, Proinflammatory Cytokines, and Th17 Cytokines in Patients with Newly Diagnosed Type 1 Diabetes.

    PubMed

    Alnek, Kristi; Kisand, Kalle; Heilman, Kaire; Peet, Aleksandr; Varik, Karin; Uibo, Raivo

    2015-01-01

    The production of several cytokines could be dysregulated in type 1 diabetes (T1D). In particular, the activation of T helper (Th) type 1 (Th1) cells has been proposed to underlie the autoimmune pathogenesis of the disease, although roles for inflammatory processes and the Th17 pathway have also been shown. Nevertheless, despite evidence for the role of cytokines before and at the onset of T1D, the corresponding findings are inconsistent across studies. Moreover, conflicting data exist regarding the blood cytokine levels in T1D patients. The current study was performed to investigate genetic and autoantibody markers in association with the peripheral blood cytokine profiles by xMap multiplex technology in newly diagnosed young T1D patients and age-matched healthy controls. The onset of young-age T1D was characterized by the upregulation of growth factors, including granulocyte macrophage-colony stimulating factor (GM-CSF) and interleukin (IL)-7, the proinflammatory cytokine IL-1β (but not IL-6 or tumor necrosis factor [TNF]-α), Th17 cytokines, and the regulatory cytokines IL-10 and IL-27. Ketoacidosis and autoantibodies (anti-IA-2 and -ZnT8), but not human leukocyte antigen (HLA) genotype, influenced the blood cytokine levels. These findings broaden the current understanding of the dysregulation of systemic levels of several key cytokines at the young-age onset of T1D and provide a further basis for the development of novel immunoregulatory treatments in this disease.

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

    PubMed Central

    Abler, Laurie; Watt, Melissa H.; Hansen, Nathan B.; Wilson, Patrick A.; Kochman, Arlene

    2015-01-01

    Abstract 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

  4. Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study.

    PubMed

    Suzuki, Kenshi; Shinagawa, Atsushi; Uchida, Toshiki; Taniwaki, Masafumi; Hirata, Hirokazu; Ishizawa, Kenichi; Matsue, Kosei; Ogawa, Yoshiaki; Shimizu, Takayuki; Otsuka, Maki; Matsumoto, Morio; Iida, Shinsuke; Terui, Yasuhito; Matsumura, Itaru; Ikeda, Takashi; Takezako, Naoki; Ogaki, Yumi; Midorikawa, Shuichi; Houck, Vanessa; Ervin-Haynes, Annette; Chou, Takaaki

    2016-05-01

    In the FIRST trial (MM-020), lenalidomide plus low-dose dexamethasone (Rd) reduced the risk of disease progression or death compared with combination melphalan-prednisone-thalidomide. As the FIRST trial did not include any Japanese patients, the efficacy and safety of continuous treatment with Rd was evaluated in 26 Japanese patients with newly diagnosed multiple myeloma (NDMM) in a single-arm, multicenter, open-label phase II trial (MM-025). Patients received lenalidomide on days 1-21 of each 28-day cycle, with a starting dose of 25 mg/day (dose adjusted for renal impairment), and 40 mg/day dexamethasone (dose adjusted for age) on days 1, 8, 15 and 22 of each 28-day cycle until disease progression or discontinuation for any reason. In the efficacy evaluable population, overall response rate was 87.5%, including 29.2% of patients who achieved a complete response/very good partial response. Median durations of response, progression-free survival and overall survival have not been reached. The most common grade 3-4 adverse events were neutropenia (23%) and anemia (19%). The efficacy and safety of Rd were consistent with data from larger studies, including the FIRST trial, thereby supporting the use of Rd continuous in Japanese patients with NDMM who are ineligible for stem cell transplantation.

  5. [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.

  6. High cereblon expression is associated with better survival in patients with newly diagnosed multiple myeloma treated with thalidomide maintenance.

    PubMed

    Broyl, Annemiek; Kuiper, Rowan; van Duin, Mark; van der Holt, Bronno; el Jarari, Laila; Bertsch, Uta; Zweegman, Sonja; Buijs, Arjan; Hose, Dirk; Lokhorst, Henk M; Goldschmidt, Hartmut; Sonneveld, Pieter

    2013-01-24

    Recently, cereblon (CRBN) expression was found to be essential for the activity of thalidomide and lenalidomide. In the present study, we investigated whether the clinical efficacy of thalidomide in multiple myeloma is associated with CRBN expression in myeloma cells. Patients with newly diagnosed multiple myeloma were included in the HOVON-65/GMMG-HD4 trial, in which postintensification treatment in 1 arm consisted of daily thalidomide (50 mg) for 2 years. Gene-expression profiling, determined at the start of the trial, was available for 96 patients who started thalidomide maintenance. In this patient set, increase of CRBN gene expression was significantly associated with longerprogression-free survival (P = .005). In contrast, no association between CRBN expression and survival was observed in the arm with bortezomib maintenance. We conclude that CRBN expression may be associated with the clinical efficacy of thalidomide. This trial has been registered at the Nederlands Trial Register (www.trialregister.nl) as NTR213; at the European Union Drug Regulating Authorities Clinical Trials (EudraCT) as 2004-000944-26; and at the International Standard Randomized Controlled Trial Number (ISRCTN) as 64455289.

  7. Examining perceived stigma of children with newly-diagnosed epilepsy and their caregivers over a two-year period.

    PubMed

    Rood, Jennifer E; Schultz, Janet R; Rausch, Joseph R; Modi, Avani C

    2014-10-01

    The purpose of this study was to examine the following: 1) the course of perceived epilepsy-related stigma among children newly diagnosed with epilepsy (n=39) and their caregivers (n=97) over a two-year period, 2) the influence of seizure absence/presence on children and caregivers' perception of epilepsy-related stigma, and 3) the congruence of child and caregiver perception of child epilepsy-related stigma. Participants completed a measure of perceived epilepsy-related stigma at three time points, and seizure status was collected at the final time point. Results indicated that both caregivers (t(1,76)=-2.57, p<.01) and children with epilepsy (t(1,29)=-3.37, p<.01) reported decreasing epilepsy-related stigma from diagnosis to two years postdiagnosis. No significant differences were found in caregiver and child reports of perceived stigma for children experiencing seizures compared with children who have been seizure-free for the past year. Results revealed poor caregiver-child agreement of perceived epilepsy-related stigma at all three time points. These data suggest that while children with epilepsy initially perceive epilepsy-related stigma at diagnosis, their perception of stigma decreases over time. Having a better understanding of the course of epilepsy-related stigma provides clinicians with information regarding critical times to support families with stigma reduction interventions.

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

    PubMed

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

    2015-10-01

    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.

  9. Serum Chemerin Levels are Associated with Visceral Adiposity, Independent of Waist Circumference, in Newly Diagnosed Type 2 Diabetic Subjects

    PubMed Central

    Cheon, Dae Young; Kang, Jun Goo; Lee, Seong Jin; Ihm, Sung Hee; Lee, Eun Jig; Choi, Moon Gi; Yoo, Hyung Joon

    2017-01-01

    Purpose Chemerin has been suggested to be linked to insulin resistance and type 2 diabetes mellitus (T2DM). However, the relationship between visceral adiposity and chemerin levels remains unclear in subjects with T2DM. In this study, we investigated the relationship between serum chemerin levels and visceral adiposity. Materials and Methods This study included 102 subjects newly diagnosed with T2DM. The relationships between serum chemerin levels and clinical and biochemical parameters were examined. Multiple linear regression analysis was performed to determine the predictable factors of serum chemerin levels. Results Serum chemerin levels showed significant positive correlations with body mass index (BMI), waist circumference (WC), visceral fat thickness (VFT), insulin levels, the homeostasis model assessment of insulin resistance, and levels of triglycerides (log-transformed) and high-sensitivity C-reactive protein, while showing significant negative correlations with high-density lipoprotein cholesterol. After adjusting for BMI and WC, VFT showed a significant relationship with serum chemerin levels (r=0.222, p=0.027). Moreover, VFT was an independent predictive factor of serum chemerin levels (β=0.242, p=0.041). Conclusion We demonstrated that chemerin is linked to metabolic syndrome components. Moreover, serum chemerin levels were associated significantly with obesity, especially visceral adipose tissue, in subjects with T2DM. PMID:28120562

  10. Simultaneous acute shoulder arthritis and multiple mononeuropathy in a newly diagnosed type 2 diabetes patient - First case report.

    PubMed

    Kotlęga, Dariusz; Gołąb-Janowska, Monika; Zaborowski, Grzegorz; Ciećwież, Sylwester; Nowacki, Przemysław

    Diabetes is a common disorder that leads to the musculoskeletal symptoms such as the shoulder arthritis. The involvement of peripheral nervous system is one of the troublesome for the patients as it provokes chronic sensory symptoms, lower motor neuron involvement and autonomic symptoms. In the course of the disease there has been several types of neuropathies described. A 41-year-old male patient was admitted to the internal medicine department because of the general weakness, malaise, polydypsia and polyuria since several days. The initial blood glucose level was 780mg/dl. During the first day the continuous insulin infusion was administered. On the next day when he woke up, the severe pain in the right shoulder with limited movement, right upper extremity weakness and burning pain in the radial aspect of this extremity appeared. On examination right shoulder joint movement limitation was found with the muscle weakness and sensory symptoms in the upper limbs. The clinical picture indicated on the right shoulder arthritis and the peripheral nervous system symptoms such as the right musculocutaneous, supraspinatus, right radial nerve and left radial nerve damage. We present a first case report of simultaneous, acute involvement of the shoulder joint and multiple neuropathy in a patient with newly diagnosed type 2 diabetes, presumably in the state of ketoacidosis.

  11. 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.

  12. 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

  13. 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

  14. 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,…

  15. 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.

  16. 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

  17. 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

  18. [The level of diabetic compensation and endogenous secretion of insulin in newly diagnosed diabetics. Prospective study: Part 1].

    PubMed

    Perusicová, J

    1999-10-01

    In a prospective study of newly detected diabetic patients in 1989-1991 the authors focused their attention on the evaluation of blood sugar levels and HbA1c during manifestation of DM and the amount of insulin secretion in relation to diabetes type 1 and 2 in adult patients. Part 1 of the paper reveals great differences in the fasting blood sugar level during manifestation of DM (26% of the group had a blood sugar level lower than 8.5 mmol/l and 14% above 15 mmol/l) even after 1-4 months treatment (3.8-17.2 mmol/l). Similar differences were found in HbA1c values (4.5-12.9%). High C-peptide levels revealed an incorrectly assessed diagnosis of type 1 diabetes in 16.7% diabetics and low C-peptide values on fasting and postporandial values were at variance with the diagnosis of type 2 diabetes in 6% of the group.

  19. Tobacco use prevalence, knowledge, and attitudes among newly diagnosed tuberculosis patients in Penang State and Wilayah Persekutuan Kuala Lumpur, Malaysia

    PubMed Central

    2010-01-01

    Background There is sufficient evidence to conclude that tobacco smoking is strongly linked to tuberculosis (TB) and a large proportion of TB patients may be active smokers. In addition, a previous analysis has suggested that a considerable proportion of the global burden of TB may be attributable to smoking. However, there is paucity of information on the prevalence of tobacco smoking among TB patients in Malaysia. Moreover, the tobacco-related knowledge, attitudes, and behaviors of TB patients who are smokers have not been previously explored. This study aimed to document the prevalence of smoking among newly diagnosed TB patients and to learn about the tobacco use knowledge and attitudes of those who are smokers among this population. Methods Data were generated on prevalence rates of smoking among newly diagnosed TB patients in the State of Penang from January 2008 to December 2008. The data were obtained based on a review of routinely collated data from the quarterly report on TB case registration. The study setting comprised of five healthcare facilities (TB clinics) located within Penang and Wilayah Persekutuan, Kuala Lumpur health districts in Malaysia, which were involved in a larger project, known as SCIDOTS Project. A 58-item questionnaire was used to assess the tobacco use knowledge, attitudes and behaviors of those TB patients who were smokers. Results Smoking status was determinant in 817 of 943 new cases of TB from January to December 2008. Of this, it was estimated that the prevalence rates of current- and ex-smoking among the TB patients were 40.27% (329/817) and 13.95% (114/817), respectively. The prevalence of ever-smoking among patients with TB was estimated to be 54,220 per 100,000 population. Of 120 eligible participants for the SCIDOTS Project, 88 responded to the survey (73.3% response rate) and 80 surveys were analyzed (66.7% usable rate). The mean (± SD) total score of tobacco use knowledge items was 4.23 ± 2.66 (maximum possible score

  20. 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.

  1. 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.

  2. Cyclophosphamide-based hematopoietic stem cell mobilization before autologous stem cell transplantation in newly diagnosed multiple myeloma.

    PubMed

    Tuchman, Sascha A; Bacon, Wendi A; Huang, Li-Wen; Long, Gwynn; Rizzieri, David; Horwitz, Mitchell; Chute, John P; Sullivan, Keith; Morris Engemann, Ashley; Yopp, Amanda; Li, Zhiguo; Corbet, Kelly; Chao, Nelson; Gasparetto, Cristina

    2015-06-01

    High-dose cyclophosphamide (Cy) is frequently employed for peripheral blood mobilization of hematopoietic stem cells before high-dose chemotherapy with autologous stem cell transplantation (ASCT) in multiple myeloma (MM). The benefit of mobilization with Cy over filgrastim (granulocyte colony-stimulating factor; G-CSF) alone is unclear. Between 2000 and 2008, 167 patients with newly diagnosed MM underwent single ASCT after melphalan conditioning at our institution. Seventy-three patients were mobilized with G-CSF alone, and 94 patients with Cy plus G-CSF (Cy+G-CSF). We retrospectively analyzed Cy's impact on both toxicity and efficacy. Mobilization efficiency was augmented by Cy; a mean total of 12 versus 5.8 × 10(6) CD34+ cells/kg were collected from patients mobilized with Cy+G-CSF versus G-CSF, respectively, (P < 0.01), over a mean of 1.6 versus 2.2 days of peripheral blood apheresis (p = 0.001). Mobilization-related toxicity was also, however, augmented by Cy; 14% of Cy+G-CSF patients were hospitalized because of complications versus none receiving G-CSF (P < 0.0001). Toxicity, including death, related to ASCT was similar between cohorts. Regarding long-term outcomes, multivariate analysis revealed no difference for Cy+G-CSF versus G-CSF (hazard ratio 0.8 for event-free survival [95% confidence interval {CI} 0.57-1.25] and 0.96 for overall survival [95% CI 0.61-1.54]). In summary, we show that mobilization with Cy increases toxicity without positively impacting long-term outcomes in MM. Our findings place into question Cy's benefit as a routine component of stem cell mobilization regimens in MM. Randomized trials are needed to elucidate the risks and benefits of Cy more definitively.

  3. 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.

  4. A Phase I Dose Escalation Study of Hypofractionated IMRT Field-in-Field Boost for Newly Diagnosed Glioblastoma Multiforme

    SciTech Connect

    Monjazeb, Arta M.; Ayala, Deandra; Jensen, Courtney; Case, L. Douglas; Bourland, J. Daniel; Ellis, Thomas L.; McMullen, Kevin P.; Chan, Michael D.; Tatter, Stephen B.; Lesser, Glen J.; Shaw, Edward G.

    2012-02-01

    Objectives: To describe the results of a Phase I dose escalation trial for newly diagnosed glioblastoma multiforme (GBM) using a hypofractionated concurrent intensity-modulated radiotherapy (IMRT) boost. Methods: Twenty-one patients were enrolled between April 1999 and August 2003. Radiotherapy consisted of daily fractions of 1.8 Gy with a concurrent boost of 0.7 Gy (total 2.5 Gy daily) to a total dose of 70, 75, or 80 Gy. Concurrent chemotherapy was not permitted. Seven patients were enrolled at each dose and dose limiting toxicities were defined as irreversible Grade 3 or any Grade 4-5 acute neurotoxicity attributable to radiotherapy. Results: All patients experienced Grade 1 or 2 acute toxicities. Acutely, 8 patients experienced Grade 3 and 1 patient experienced Grade 3 and 4 toxicities. Of these, only two reversible cases of otitis media were attributable to radiotherapy. No dose-limiting toxicities were encountered. Only 2 patients experienced Grade 3 delayed toxicity and there was no delayed Grade 4 toxicity. Eleven patients requiring repeat resection or biopsy were found to have viable tumor and radiation changes with no cases of radionecrosis alone. Median overall and progression-free survival for this cohort were 13.6 and 6.5 months, respectively. One- and 2-year survival rates were 57% and 19%. At recurrence, 15 patients received chemotherapy, 9 underwent resection, and 5 received radiotherapy. Conclusions: Using a hypofractionated concurrent IMRT boost, we were able to safely treat patients to 80 Gy without any dose-limiting toxicity. Given that local failure still remains the predominant pattern for GBM patients, a trial of dose escalation with IMRT and temozolomide is warranted.

  5. 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.

  6. Information Seeking and Satisfaction with Information Sources Among Spouses of Men with Newly Diagnosed Local-Stage Prostate Cancer.

    PubMed

    Bansal, Aasthaa; Koepl, Lisel M; Fedorenko, Catherine R; Li, Chunyu; Smith, Judith Lee; Hall, Ingrid J; Penson, David F; Ramsey, Scott D

    2017-02-25

    Information sources about prostate cancer treatment and outcomes are typically designed for patients. Little is known about the availability and utility of information for partners. The objectives of our study were to evaluate information sources used by partners to understand prostate cancer management options, their perceived usefulness, and the relationship between sources used and satisfaction with treatment experience. A longitudinal survey of female partners of men newly diagnosed with local-stage prostate cancer was conducted in three different geographic regions. Partners and associated patients were surveyed at baseline (after patient diagnosis but prior to receiving therapy) and at 12 months following diagnosis. Information sources included provider, literature, friends or family members, Internet websites, books, traditional media, and support groups. Utility of an information source was defined as whether the partner would recommend it to caregivers of other patients with local-stage prostate cancer. Our study cohort included 179 partner-patient pairs. At diagnosis, partners consulted an average of 4.6 information sources. Non-Hispanic white partners were more likely than others to use friends and family as an information source (OR = 2.44, 95% CI (1.04, 5.56)). More educated partners were less likely to use support groups (OR = 0.31, 95% CI (0.14, 0.71)). At 12-month follow-up, partners were less likely to recommend books (OR = 0.23, 95% CI (0.11, 0.49)) compared to baseline. Partners consulted a large number of information sources in researching treatment options for local-stage prostate cancer and the types of sources accessed varied by race/ethnicity and educational attainment. Additional resources to promote selection of high-quality non-provider information sources are warranted to enable partners to better aid patients in their treatment decision-making process.

  7. A Three-Variable Model Predicts Short Survival in Patients With Newly Diagnosed Metastatic Renal Cell Carcinoma

    PubMed Central

    Syed, Mohsan Ali; Nieder, Carsten

    2017-01-01

    Background Patients with metastatic renal cell carcinoma (mRCC) have variable survival outcomes. When discussing management approaches and providing information to patients and caregivers, it is important to have realistic perspectives, especially if the expected prognosis is very unfavorable. In the present study, factors predicting this endpoint were analyzed. Methods Data from 60 patients treated in routine clinical practice were evaluated. Unfavorable prognosis was defined as death within approximately 3 months from diagnosis of mRCC (maximum 3.5 months). Baseline factors including laboratory values and management approach were compared between the groups with short and longer survival. Results A total of 48 patients (80%) experienced ≥ 4 months survival (4+MS) and 10 (16.7%) experienced shorter survival (3MS). The others had short follow-up. Adverse prognostic factors that were significantly more frequent in the 3MS group were low hemoglobin, high lactate dehydrogenase and lack of systemic therapy. We used these three items to create a prognostic model: score 0 = no adverse factors, score 1 = one adverse factor, score 2 = two adverse factors, score 3 = three adverse factors. In the score 0 group, one out of 20 patients experienced 3MS (5%). In score 1, two out of 21 patients belonged to the 3MS group (9.5%). For score 2, the corresponding figure was four out of 14 patients (29%). In the score 3 group, three out of three patients experienced 3MS (100%) (P = 0.0001). Conclusions A simple model with three prognostic factors predicted survival of patients with newly diagnosed mRCC. Additional validation in other databases is warranted. PMID:28270887

  8. Response of circulating ghrelin levels to insulin therapy in children with newly diagnosed type 1 diabetes mellitus.

    PubMed

    Soriano-Guillén, Leandro; Barrios, Vicente; Lechuga-Sancho, Alfonso; Chowen, Julie A; Argente, Jesús

    2004-05-01

    Ghrelin is secreted primarily by the stomach, although other tissues such as the pancreas synthesize a minor proportion. The discovery of a new cell type that produces ghrelin in the human pancreas and that this organ expresses GHS-R opens new perspectives in the understanding of the control of glucose metabolism. We have studied 22 children with newly diagnosed type 1 diabetes mellitus at four different points: at diagnosis before insulin therapy, after 48-60 h of insulin therapy, and after 1 and 4 mo of insulin treatment. At each point circulating levels of ghrelin, leptin, IGF-I, IGF binding protein (IGFBP)-1, IGFBP-2, IGFBP-3, and glucose were determined. Ghrelin levels were significantly decreased at diagnosis (573 +/- 68 pg/mL, p < 0.01) compared with controls (867 +/- 38 pg/mL) and remained decreased after insulin therapy (d 2: 595 +/- 68 pg/mL; 1 mo: 590 +/- 61 pg/mL; 4 mo: 538 +/- 67 pg/mL) with no differences before or after insulin treatment. There was a negative correlation between ghrelin levels and body mass index at all of the study points, whereas a negative correlation between ghrelin and glucose concentrations was only observed after insulin therapy. No correlation between ghrelin and HbA1c was found at any point. A positive correlation between ghrelin and IGFBP-1 was found after insulin therapy, but no correlation with other members of the IGF system or leptin was found. In conclusion, these data could indicate a possible link between glucose concentrations and ghrelin; hence, the persisting low ghrelin levels in diabetic children may suggest a defensive mechanism against hyperglycemia.

  9. 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.

  10. Being hospitalized with a newly diagnosed chronic illness—A phenomenological study of children's lifeworld in the hospital

    PubMed Central

    Gjengedal, Eva

    2012-01-01

    The impact of a hospital environment on children has rarely been investigated. Recently, however, the perspective of hospitalized children has been taken into account. Being hospitalized and facing an illness represent a dramatic change in a child's daily life, and the quality of the environment may influence the child's experiences. The aim of this study was to investigate the experiences of children being hospitalized with newly diagnosed type 1 diabetes and to obtain an increased understanding of the environmental influences on the children's lifeworld. The study used a hermeneutic phenomenological approach. The design is a combination of observation of the participant, interviews, and photographs. Nine children, aged between 7 and 12 years, participated in the study. The data were collected between October 2008 and February 2010 and analysed in accordance with thematic analysis as described by van Manen. The children experienced change through recognition and adaptation. They perceived the environment as strange but still comfortable because of the “child-friendly” atmosphere, close contact with their relatives, and access to private space. The children were gradually able to adapt to their new life; they perceived their illness through bodily changes and developed practical skills and understanding. The findings underscored the necessity for an emphasis on the mutual relationship between the body and its environment. Bodily changes that occur during illness may lead to changes in one's perception of the environment. Children seem to be particularly affected when the body appears alien and the hospital environment is unfamiliar. A well-adapted environment, active involvement, and the incorporation of new habits are significant elements of gradually returning to a more familiar life. However, the child's new life requires alertness to the body's signals and acclimation to a demanding diabetes treatment regime. All these factors remind children of their body

  11. Regional changes in psychotropic use among Finnish persons with newly diagnosed Alzheimer’s disease in 2005-2011

    PubMed Central

    Voutilainen, Ari; Taipale, Heidi; Tanskanen, Antti; Lavikainen, Piia; Koponen, Marjaana; Tiihonen, Jari; Hartikainen, Sirpa

    2017-01-01

    Objectives To describe and compare temporal changes in prevalence and incidence of psychotropic use (antipsychotics, antidepressants and benzodiazepines and related drugs; BZDRs) in persons with newly diagnosed Alzheimer’s disease (AD) between university hospital districts of Finland during 2005–2011. Methods The MEDALZ study includes all community-dwellers of Finland who received a clinically verified AD diagnosis in 2005–2011 (N = 70,718). Prevalent and incident use of psychotropics among those who had received AD diagnosis less than one year ago were compared in 2005–2011. Results Regional differences in psychotropic use between university hospital districts were more evident in 2005 than 2011 for prevalent use of any psychotropic, antipsychotic and BZDRs and incident use of any psychotropic and antipsychotics. Regional differences in prevalent antidepressant use and incident BZDR use remained similar during the follow-up, while differences in incident antidepressant use increased during the follow-up. The prevalence of any psychotropic use in 2005 varied between 44.7–50.7% and between 45.0–47.9% in 2011. Incidence of any psychotropic use in 2005 was between 8.6–12.1% and 6.2–8.2% in 2011. In 2005, the distribution of incident psychotropic use followed a large scale spatial variation that, however, did not correspond to university hospital districts. During the study period from 2005 to 2011 the cyclic spatial variation disappeared. No sign of adjacent hospital districts being more or less closely related to each other compared to hospital districts in general was detected. Conclusions Except for antidepressants, regional differences in psychotropic use have mainly diminished between 2005 and 2011. Our findings highlight the importance of acknowledging regional differences in a country with relatively homogeneous healthcare system and conducting future studies assessing the reasons behind these differences. PMID:28278245

  12. 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.

  13. Mobile telecare system for intensive insulin treatment and patient education. First applications for newly diagnosed type 1 diabetic patients.

    PubMed

    Ładyzyński, P; Wójcicki, J M; Krzymień, J; Foltyński, P; Migalska-Musiał, K; Tracz, M; Karnafel, W

    2006-11-01

    The aim of the work was to develop and to evaluate the clinical efficiency of a mobile telecare system implementing teleconsultations based on the continuous transmission of patient-collected data directly to the physician and to the clinic. The developed TeleMed system consists of the patients' and the diabetologist's mobile units, the diabetologist's clinic and home workstations and the clinical server. The evaluation of the system was performed on a group of 13 newly diagnosed type 1 diabetic patients, during a single-arm study with 3-days run-in period, including a one-day intensive educational program, and 3-week study period, when the intensive insulin treatment was conducted without visits of patients to the clinic. The MBG dropped from 7.2 +/- 1.7 mmol/L before the study to 6.1 +/- 1.0 mmol/L in the third week of the study (P = 0.02) and the J-index from 30.2+/-19.2 to 19.7+/-7.7 (P = 0.04). Hemoglobin A1c decreased from 11.8 +/- 3.3% to 8.6 +/- 1.2% (P = 0.0002) in one month. The total daily insulin dose declined from 39.9 +/- 8.5 U to 20.0 +/- 9.6 U (P = 0.000006). The number of hypoglycemia episodes per patient per day decreased by 66% (P = 0.08) and the number of hyperglycemia episodes was reduced by 47% (P < 0.0001). The TeleMed facilitates not only efficient realization of the intensive insulin treatment but also successful remote patient training and education. No formal patient satisfaction study was done. However, some of the findings indicate that the application of the developed system increases patient self-confidence and quality of life.

  14. 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.

  15. 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.

  16. Survival in Patients With Severe Lymphopenia Following Treatment With Radiation and Chemotherapy for Newly Diagnosed Solid Tumors

    PubMed Central

    Grossman, Stuart A.; Ellsworth, Susannah; Campian, Jian; Wild, Aaron T.; Herman, Joseph M.; Laheru, Dan; Brock, Malcolm; Balmanoukian, Ani; Ye, Xiaobu

    2016-01-01

    Background The immune system plays an important role in cancer surveillance and therapy. Chemoradiation can cause severe treatment-related lymphopenia (TRL) (<500 cells/mm3) that is associated with reduced survival. Materials and Methods Data from 4 independent solid tumor studies on serial lymphocyte counts, prognostic factors, treatment, and survival were collected and analyzed. The data set included 297 patients with newly diagnosed malignant glioma (N=96), resected pancreatic cancer (N=53), unresectable pancreatic cancer (N=101), and non–small cell lung cancer (N=47). Results Pretreatment lymphocyte counts were normal in 83% of the patient population, and no patient had severe baseline lymphopenia. Two months after initiating chemoradiation, 43% developed severe and persistent lymphopenia (P=.001). An increased risk for death was attributable to TRL in each cancer cohort (gliomas: hazard rate [HR], 1.8; 95% CI, 1.13–2.87; resected pancreas: HR, 2.2; 95% CI, 1.17–4.12; unresected pancreas: HR, 2.9; 95% CI, 1.53–5.42; and lung: HR, 1.7; 95% CI, 0.8–3.61) and in the entire study population regardless of pathologic findings (HR, 2.1; 95% CI, 1.54–2.78; P<.0001). Severe TRL was observed in more than 40% of patients 2 months after initiating chemoradiation, regardless of histology or chemotherapy regimen, and was independently associated with shorter survival from tumor progression. Conclusions Increased attention and research should be focused on the cause, prevention, and reversal of this unintended consequence of cancer treatment that seems to be related to survival in patients with solid tumors. PMID:26483062

  17. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts

    PubMed Central

    Seymour, John F.; Butrym, Aleksandra; Wierzbowska, Agnieszka; Selleslag, Dominik; Jang, Jun Ho; Kumar, Rajat; Cavenagh, James; Schuh, Andre C.; Candoni, Anna; Récher, Christian; Sandhu, Irwindeep; Bernal del Castillo, Teresa; Al-Ali, Haifa Kathrin; Martinelli, Giovanni; Falantes, Jose; Noppeney, Richard; Stone, Richard M.; Minden, Mark D.; McIntyre, Heidi; Songer, Steve; Lucy, Lela M.; Beach, C. L.; Döhner, Hartmut

    2015-01-01

    This multicenter, randomized, open-label, phase 3 trial evaluated azacitidine efficacy and safety vs conventional care regimens (CCRs) in 488 patients age ≥65 years with newly diagnosed acute myeloid leukemia (AML) with >30% bone marrow blasts. Before randomization, a CCR (standard induction chemotherapy, low-dose ara-c, or supportive care only) was preselected for each patient. Patients then were assigned 1:1 to azacitidine (n = 241) or CCR (n = 247). Patients assigned to CCR received their preselected treatment. Median overall survival (OS) was increased with azacitidine vs CCR: 10.4 months (95% confidence interval [CI], 8.0-12.7 months) vs 6.5 months (95% CI, 5.0-8.6 months), respectively (hazard ratio [HR] was 0.85; 95% CI, 0.69-1.03; stratified log-rank P = .1009). One-year survival rates with azacitidine and CCR were 46.5% and 34.2%, respectively (difference, 12.3%; 95% CI, 3.5%-21.0%). A prespecified analysis censoring patients who received AML treatment after discontinuing study drug showed median OS with azacitidine vs CCR was 12.1 months (95% CI, 9.2-14.2 months) vs 6.9 months (95% CI, 5.1-9.6 months; HR, 0.76; 95% CI, 0.60-0.96; stratified log-rank P = .0190). Univariate analysis showed favorable trends for azacitidine compared with CCR across all subgroups defined by baseline demographic and disease features. Adverse events were consistent with the well-established safety profile of azacitidine. Azacitidine may be an important treatment option for this difficult-to-treat AML population. This trial was registered at www.clinicaltrials.gov as #NCT01074047. PMID:25987659

  18. Sex partner meeting places over time among newly HIV diagnosed men who have sex with men (MSM) in Baltimore, Maryland

    PubMed Central

    Jennings, Jacky M.; Reilly, Meredith L.; Perin, Jamie; Schumacher, Christina; Sharma, Megha; Safi, Amelia Greiner; Fields, Errol L.; Muvva, Ravikiran; Nganga-Good, Carolyn; Chaulk, Patrick

    2015-01-01

    Background Sex partner meeting places may be important locales to access men who have sex with men (MSM) and implement targeted human immunodeficiency virus (HIV) control strategies. These locales may change over time, but temporal evaluations have not been performed. Methods The objectives of this study were to describe the frequency of report of MSM sex partner meeting places over time, and to compare frequently reported meeting places in the past five years and past year among newly HIV diagnosed MSM in Baltimore City, Maryland. Public health HIV surveillance data including partner services information was obtained for this study from the Baltimore City Health Department from May 2009 to June 2014. Results 869 sex partner meeting places were reported, including 306 unique places. Bars/clubs (31%) and internet-based sites (38%) were the most frequently reported meeting place types. Over the five year period, the percentage of bars/clubs decreased over time and the percentage of internet-based sites increased over time. Among bars/clubs, 4/5 of those most frequently reported in the past five years were also most frequently reported in the most recent year. Among internet-based sites, 3/5 of those most frequently reported in the past five years were also in the top five most frequently reported in the past year. Conclusion This study provides a richer understanding of sex partner meeting places reported by MSM over time and information to health departments on types of places to access a population at high risk for HIV transmission. PMID:26372926

  19. 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.

  20. 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

    2017-01-27

    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

  1. Newly Emerging Feeding Difficulties in a 33-Year-Old Adult With CHARGE Syndrome

    PubMed Central

    Hudson, Alexandra; Blake, Kim

    2016-01-01

    Feeding and swallowing difficulties are common among individuals with CHARGE syndrome. Many children require gastrostomy tube feeding in their early years and often undergo a delay in feeding and oral-motor skill development. There is little information available on adults with CHARGE syndrome, and the feeding difficulties they face. The present case describes newly emerging mouth over-stuffing feeding behaviors and feeding difficulties in a 33-year-old adult with CHARGE syndrome who had not undergone feeding therapy since childhood. PMID:26668685

  2. In newly diagnosed breast cancer, screening MRI of the contralateral breast detects mammographically occult cancer, even in elderly women: the mayo clinic in Florida experience.

    PubMed

    Bernard, Johnny Ray; Vallow, Laura A; DePeri, Elizabeth R; McNeil, Rebecca B; Feigel, Deborah G; Amar, Surabhi; Buskirk, Steven J; Perez, Edith A

    2010-01-01

    The role of magnetic resonance imaging (MRI) in patients with newly diagnosed breast cancer is somewhat controversial. The purpose of this study was to evaluate the prevalence of synchronous, occult contralateral breast cancer detected by MRI but not by mammography or clinical breast examination in women with newly diagnosed breast cancer, including those aged 70 years or older at our institution. MRI results for women with newly diagnosed breast cancer who underwent bilateral breast MRI after negative mammography and clinical examination between February 2003 and November 2007 at Mayo Clinic in Florida were reviewed. The prevalence of pathologically confirmed contralateral carcinoma diagnosed solely by MRI was determined and analyzed in the context of age, family history, menopausal status, breast density, and primary-tumor characteristics. Logistic regression was used to explore the association between contralateral carcinoma and potential patient risk factors. A total of 425 women were evaluated, of whom 129 (30%) were aged 70 years or older. A contralateral biopsy was recommended and performed solely on the basis of MRI in 72 of the 425 women (17%). Sixteen of these 72 women (22%) had pathologically confirmed carcinoma, including seven in the older subgroup. The prevalence of clinically and mammographically occult contralateral carcinoma detected by MRI was 3.8% (16/425) overall and 5.4% (7/129) in the group of older women. When potential risk factors for contralateral breast cancer were evaluated, postmenopausal status was the only significant predictor of contralateral cancer detected by MRI (p = 0.016). We concluded that contralateral breast screening with MRI should be considered in postmenopausal women with newly diagnosed breast cancer, even those aged 70 years or older at diagnosis.

  3. 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

  4. Phase II study of thalidomide and radiation in children with newly diagnosed brain stem gliomas and glioblastoma multiforme.

    PubMed

    Turner, Christopher D; Chi, Susan; Marcus, Karen J; MacDonald, Tobey; Packer, Roger J; Poussaint, Tina Young; Vajapeyam, Sridhar; Ullrich, Nicole; Goumnerova, Liliana C; Scott, R Michael; Briody, Caitlin; Chordas, Christine; Zimmerman, Mary Ann; Kieran, Mark W

    2007-03-01

    A phase II study was conducted to assess the efficacy of administering daily thalidomide concomitantly with radiation and continuing for up to 1 year following radiation in children with brain stem gliomas (BSG) or glioblastoma multiforme (GBM). Secondary objectives were to obtain preliminary evidence of biologic activity of thalidomide and to evaluate toxicities from chronic administration of thalidomide in this population. Thirteen patients (2-14 years old) with newly diagnosed BSG (12 patients) or GBM (one patient) were enrolled between July 1999 and June 2000. All patients received focal radiotherapy to a total dose of 5,580 cGy. Thalidomide was administered once daily beginning on the first day of radiation and continued for 12 months or until the patient came off study. The starting dose was 12 mg/kg (rounded down to the nearest 50 mg) and was increased by 20% weekly, if tolerated, to 24 mg/kg or 1,000 mg (whichever was lower). Advanced imaging techniques and urine and serum analysis for anti-angiogenic markers were performed in some patients in an attempt to correlate changes with clinical effect of therapy. No patients completed the planned 12 months of thalidomide therapy and all have since died of disease progression. The median duration of therapy was 5 months (range 2-11 months). Nine patients came off study for progressive disease (PD), three patients due to toxicity and one patient withdrew consent. Several patients on this study required more extended courses of high dose steroids than would have been otherwise expected for this population due to significant peritumoral edema and necrosis. No consistent pattern emerged from the biologic correlative studies from 11 patients. However, advanced imaging with techniques such as MR spectroscopy, MR perfusion and 18-fluorodeoxyglucose positron emission tomography (FDG-PET) were helpful in distinguishing growing tumor from treatment effect and necrosis in some patients. The median time to progression (TTP

  5. 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

  6. 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

  7. 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

  8. Trend, characteristics, and pharmacotherapy of adults diagnosed with attention-deficit/hyperactivity disorder: a nationwide survey in Taiwan

    PubMed Central

    Cheng, Yu-Shian; Shyu, Yu-Chiau; Lee, Sheng-Yu; Yuan, Shin-Sheng; Yang, Chun-Ju; Yang, Kang-Chung; Lee, Tung-Liang; Wang, Liang-Jen

    2017-01-01

    Objective Attention-deficit/hyperactivity disorder (ADHD) in adults may result in functional impairment warranting clinical interventions. However, few studies have investigated the diagnosis and treatment rates of adult ADHD in non-Caucasian ethnic groups. This study used nationwide population-based data to investigate the rate of diagnosis, associated characteristics, and pharmacological treatment for adult ADHD in Taiwan. Methods Adults (age ≥18 years) newly diagnosed with ADHD (n=5,397) between January 2000 and December 2011 were enrolled from the National Health Insurance database in Taiwan. All patients were monitored until December 31, 2011. Patients who received treatment with immediate-release methylphenidate (IR-MPH), osmotic release oral system-methylphenidate (OROS-MPH), and atomoxetine (ATX) were analyzed. Results The cumulative prevalence of adult ADHD was 0.028%, and the incidence increased 10.9-fold from 2000 to 2011. The male to female ratio was 1.16, and 74.9% of the patients had the inattentive type. Overall, 55% of the patients received drug therapy for ADHD, and the average treatment duration was 478.3 days. Of the total patients, 50.4%, 13.3%, and 1.7% were prescribed with IR-MPH, OROS-MPH, and ATX, for a mean duration of 453.9, 327.7, and 161.4 days, respectively. Conclusion This population-based study showed an increasing trend in the diagnosis rate of adult ADHD; however, this rate is still low compared with Western countries. Approximately 45% of the adult patients with ADHD never received medication for their ADHD. Continuous efforts are needed to increase public awareness of adult ADHD. PMID:28280346

  9. 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

  10. 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

  11. Posttraumatic stress mediates the relationship between childhood victimization and current mental health burden in newly incarcerated adults.

    PubMed

    Greene, Carolyn A; Ford, Julian D; Wakefield, Dorothy B; Barry, Lisa C

    2014-10-01

    The purpose of this study was to evaluate the interrelationship among childhood abuse and traumatic loss, posttraumatic stress symptoms (PTSS), and Axis I psychiatric disorders other than PTSD among newly incarcerated adults, and to test a proposed model in which the severity of PTSS mediates the relationship between childhood abuse/loss and adult psychiatric disorders. Four hundred sixty-five male and female inmates participated in a structured clinical research interview. Four types of interpersonal potentially traumatic experiences (physical abuse, sexual abuse, emotional abuse, and traumatic loss) were assessed for occurrence prior to the age of 18 years old. Current psychiatric disorders and PTSS were also assessed by structured interview. Negative binomial regression was used to evaluate the association between the cumulative number of types of childhood abuse/loss experienced and number of current Axis I disorders, and to test the mediation model. Approximately half of the sample (51%) experienced 1 or more types of childhood abuse/loss, and 30% of the sample had at least one psychiatric disorder other than PTSD. For both men and women, childhood physical abuse and childhood sexual abuse were independently associated with psychiatric morbidity, and an increasing number of types of childhood trauma experienced was associated with an increase in the number of current Axis I diagnoses. However, these associations were no longer statistically significant when severity of PTSS was added to the model, providing support for the proposed mediation model. Implications for secondary prevention services for at-risk inmates are discussed.

  12. [Early detection of MRD in peripheral blood after induction chemotherapy of newly diagnosed patients with AML and its correlation with curative effects].

    PubMed

    Zhong, Xu-Shu; Lan, Fei; Cui, Xu; Jiang, Neng-Gang; Zhu, Huan-Ling; Jia, Yong-Qian

    2013-02-01

    The purpose of this study was to detect the minimal residual disease (MRD) in peripheral blood of newly diagnosed patients with acute myeloid leukemia (AML) on day 8 of induction chemotherapy and analyze the correlation between day 8 MRD (D8RD) and therapeutic effectiveness. 29 adult patients (13 males and 16 females, aged 16 - 75 years, median 41 years) with AML diagnosed and treated in West China Hospital from September 2009 to June 2010 were analyzed and followed up in the study. The leukemia-associated aberrant immunophenotype (LAIP) of all the patients were detected by multiparameter flow cytometry (FCM) before therapy. The level of MRD in the peripheral blood at day 8 of induction chemotherapy was detected by FCM based on the LAIP. The overall survival curve was drawn by calculation using Kaplan-Meier method using, and the comparison between different groups was carried out by Log-rank test. The results indicated that after first course therapy, the levels of peripheral D8RD in 7 out of 29 AML cases were lower than 0.01% (negative group), and that in another 22 cases were higher than 0.01% (0.08% - 55%, positive group). The sex, age, WBC, LDH, percentage of bone marrow blasts at diagnosis in these groups were not statistically different. 6 cases achieved CR (86%) in D8RD negative group, and also 6 cases achieved CR (27%) in D8RD positive group, CR rate in D8RD negative group was higher than in D8RD positive group (86% vs 27%, P < 0.05). The median follow-up of 29 cases lasted for 15 months; the 1-year overall survival rate of D8RD negative and D8RD positive groups was 100% and 39.4%, respectively (P < 0.01). It is concluded that MRD level in peripheral blood at day 8 of induction chemotherapy is an early index to predict clinical efficacy of induction therapy in AML.

  13. Critical review of the addition of tumor treating fields (TTFields) to the existing standard of care for newly diagnosed glioblastoma patients.

    PubMed

    Mehta, M; Wen, P; Nishikawa, R; Reardon, D; Peters, K

    2017-03-01

    Since 2005, the standard of care for patients with newly diagnosed glioblastoma (GBM) has consisted of maximal resection followed by radiotherapy plus daily temozolomide (TMZ), followed by maintenance TMZ. In patients selected for clinical trials, median overall survival (OS) and progression-free survival (PFS) with this regimen is 15-17 months and 6-7 months, respectively. There have been various, largely unsuccessful attempts to improve on this standard of care. With the FDA approval of the tumor-treating fields (TTFields) device, Optune, for recurrent GBM (2011), and the more recent EF-14 interim trial results and approval for newly diagnosed GBM patients, several questions have arisen. A roundtable of experts was convened at the 2015 ASCO meeting to engage in an open conversation and debate of the EF-14 results presented at that meeting and their implications for neuro-oncology practice and clinical research. In October 2015, subsequent to the roundtable discussion, TTFields received FDA approval for newly diagnosed GBM.

  14. Open Trial of an Acceptance-Based Behavior Therapy Intervention to Engage Newly Diagnosed HIV Patients in Care: Rationale and Evidence of Feasibility and Acceptability.

    PubMed

    Moitra, Ethan; Chan, Philip A; Stein, Michael D

    2015-09-01

    Successful linkage and retention in care of newly diagnosed individuals in the United States remains a significant gap in the HIV care continuum. This study assessed the acceptability and feasibility of an acceptance-based behavior therapy (ABBT) intervention to engage patients newly diagnosed with HIV in medical care. Nine patients were recruited over 4 months for this brief ABBT intervention, which consisted of two brief sessions, each lasting less than 20 min. The intervention was developed to promote psychological acceptance of the HIV diagnosis, thereby increasing patients' willingness to make informed disclosure of their status. Eight patients completed a 1-month follow-up assessment, and all approved of the intervention and its components. Over the 1-month period, participants showed increased acceptance, reduced perceptions of HIV stigmatization, and increased disclosure of HIV status to social supports. This pilot study provided support for the continued investigation of ABBT as an adjunctive intervention for newly diagnosed HIV patients who are at high-risk of dropping out of HIV care.

  15. Patients With Newly Diagnosed Hypertension Treated With the Renin Angiotensin Receptor Blocker Azilsartan Medoxomil vs Angiotensin-Converting Enzyme Inhibitors: The Prospective EARLY Registry.

    PubMed

    Schmieder, Roland E; Potthoff, Sebastian A; Bramlage, Peter; Baumgart, Peter; Mahfoud, Felix; Buhck, Hartmut; Ouarrak, Taoufik; Ehmen, Martina; Senges, Jochen; Gitt, Anselm K

    2015-12-01

    For patients with newly diagnosed hypertension, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) are usually the first-line therapies. There is, however, no real-life data regarding the relative clinical effectiveness and tolerability of either drug class. The prospective registry, Treatment With Azilsartan Compared to ACE Inhibitors in Antihypertensive Therapy (EARLY), was conducted to evaluate the effectiveness of the ARB azilsartan medoxomil (AZL-M) vs ACE inhibitors in real-world patients. Of the 1153 patients with newly diagnosed hypertension who were included in the registry, 789 were prescribed AZL-M and 364 were prescribed an ACE inhibitor. After multivariate adjustment, AZL-M was found to provide superior blood pressure reduction and better target blood pressure (<140/90 mm Hg) achievement. The proportion of patients with adverse events was not statistically different between groups. The authors conclude that in newly diagnosed hypertensive patients, AZL-M provides superior blood pressure control with a similar safety profile compared with ACE inhibitors.

  16. Nilotinib as frontline therapy for patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase: results from the Japanese subgroup of ENESTnd.

    PubMed

    Nakamae, Hirohisa; Shibayama, Hirohiko; Kurokawa, Mineo; Fukuda, Tetsuya; Nakaseko, Chiaki; Kanda, Yoshinobu; Nagai, Tadashi; Ohnishi, Kazunori; Maeda, Yasuhiro; Matsuda, Akira; Amagasaki, Taro; Yanada, Masamitsu

    2011-05-01

    Recent results from the phase 3 ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients) study have demonstrated superiority of nilotinib over imatinib for the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (CML-CP). Here, we report results from the Japanese subset of patients in ENESTnd, and assess whether results in this subpopulation are consistent with the overall study population. Seventy-nine Japanese patients with CML-CP were randomized to receive nilotinib 300 mg twice daily (BID) (n = 30), nilotinib 400 mg BID (n = 24) or imatinib 400 mg once daily (QD) (n = 25). Major molecular response rates at 12 months, the primary endpoint, were at least twice as high for nilotinib 300 mg BID (57%) and nilotinib 400 mg BID (50%) compared with imatinib 400 mg QD (24%). No patient on nilotinib progressed, while one patient progressed on imatinib. Both drugs were generally well tolerated and discontinuations due to adverse events were comparable among treatment arms. The results in the subpopulation of Japanese patients from ENESTnd closely mirror the results of the overall population, and support the use of nilotinib at 300 mg BID in Japanese patients with newly diagnosed CML-CP.

  17. Transspinal direct current stimulation modulates migration and proliferation of adult newly born spinal cells in mice.

    PubMed

    Samaddar, Sreyashi; Vazquez, Kizzy; Ponkia, Dipen; Toruno, Pedro; Sahbani, Karim; Begum, Sultana; Abouelela, Ahmed; Mekhael, Wagdy; Ahmed, Zaghloul

    2017-02-01

    Direct current electrical fields have been shown to be a major factor in the regulation of cell proliferation, differentiation, migration, and survival, as well as in the maturation of dividing cells during development. During adulthood, spinal cord cells are continuously produced in both animals and humans, and they hold great potential for neural restoration following spinal cord injury. While the effects of direct current electrical fields on adult-born spinal cells cultured ex vivo have recently been reported, the effects of direct current electrical fields on adult-born spinal cells in vivo have not been characterized. Here, we provide convincing findings that a therapeutic form of transspinal direct current stimulation (tsDCS) affects the migration and proliferation of adult-born spinal cells in mice. Specifically, cathodal tsDCS attracted the adult-born spinal cells, while anodal tsDCS repulsed them. In addition, both tsDCS polarities caused a significant increase in cell number. Regarding the potential mechanisms involved, both cathodal and anodal tsDCS caused significant increases in expression of brain-derived neurotrophic factor, while expression of nerve growth factor increased and decreased, respectively. In the spinal cord, both anodal and cathodal tsDCS increased blood flow. Since blood flow and angiogenesis are associated with the proliferation of neural stem cells, increased blood flow may represent a major factor in the modulation of newly born spinal cells by tsDCS. Consequently, we propose that the method and novel findings presented in the current study have the potential to facilitate cellular, molecular, and/or bioengineering strategies to repair injured spinal cords.NEW & NOTEWORTHY Our results indicate that transspinal direct current stimulation (tsDCS) affects the migratory pattern and proliferation of adult newly born spinal cells, a cell population which has been implicated in learning and memory. In addition, our results suggest a

  18. 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…

  19. Engagement-in-care during the first 5 years after HIV diagnosis: data from a cohort of newly HIV-diagnosed individuals in a large US city.

    PubMed

    Rowan, Sarah E; Burman, William J; Johnson, Steven C; Connick, Elizabeth; Reirden, Daniel; Daniloff, Elaine; Gardner, Edward M

    2014-09-01

    Initial descriptions of the HIV engagement continuum are limited by short-term follow-up and incomplete data. We evaluated engagement in a newly HIV-diagnosed cohort. Our goals were to assess long-term engagement-in-care, evaluate the effects of out-of-state migration on engagement estimates, and determine whether engagement has improved in more recently diagnosed individuals. This is a retrospective cohort study of individuals newly HIV-diagnosed at two large HIV care centers in the Denver metropolitan area from 2005 to 2009. Clinical data were obtained from three public HIV providers and two clinical trial groups. For statewide evaluation, we used mandated laboratory reporting databases for CD4 lymphocyte counts and HIV-1 RNA levels. From 2005 to 2009, 615 individuals were diagnosed with HIV. By 18 months after HIV diagnosis, 84% of the cohort had linked to care, 73% were retained in care, 49% were prescribed antiretroviral therapy, and 36% had viral suppression. By 5 years after HIV diagnosis, 55% of the cohort were retained in care, 37% had viral suppression, 15% had moved out of state, and 3% were deceased. When censoring for outmigration and death, 66% of the cohort were retained in care and 45% of the cohort had viral suppression 5 years after HIV diagnosis. Engagement-in-care 18 months after diagnosis was better in individuals diagnosed more recently. Retention in care declined while viral suppression increased over time after HIV diagnosis. Accounting for outmigration and death significantly increased estimates of engagement-in-care. Performance in the engagement continuum 18 months after diagnosis improved significantly in individuals more recently diagnosed with HIV.

  20. 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

  1. Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas

    ClinicalTrials.gov

    2016-12-20

    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

  2. Sexuality Among Middle-Aged and Older Adults With Diagnosed and Undiagnosed Diabetes

    PubMed Central

    Lindau, Stacy Tessler; Tang, Hui; Gomero, Ada; Vable, Anusha; Huang, Elbert S.; Drum, Melinda L.; Qato, Dima M.; Chin, Marshall H.

    2010-01-01

    OBJECTIVE To describe sexual activity, behavior, and problems among middle-age and older adults by diabetes status. RESEARCH DESIGN AND METHODS This was a substudy of 1,993 community-residing adults, aged 57–85 years, from a cross-sectional, nationally representative sample (N = 3,005). In-home interviews, observed medications, and A1C were used to stratify by diagnosed diabetes, undiagnosed diabetes, or no diabetes. Logistic regression was used to model associations between diabetes conditions and sexual characteristics, separately by gender. RESULTS The survey response rate was 75.5%. More than 60% of partnered individuals with diagnosed diabetes were sexually active. Women with diagnosed diabetes were less likely than men with diagnosed diabetes (adjusted odds ratio 0.28 [95% CI 0.16–0.49]) and other women (0.63 [0.45–0.87]) to be sexually active. Partnered sexual behaviors did not differ by gender or diabetes status. The prevalence of orgasm problems was similarly elevated among men with diagnosed and undiagnosed diabetes compared with that for other men, but erectile difficulties were elevated only among men with diagnosed diabetes (2.51 [1.53 to 4.14]). Women with undiagnosed diabetes were less likely to have discussed sex with a physician (11%) than women with diagnosed diabetes (19%) and men with undiagnosed (28%) or diagnosed (47%) diabetes. CONCLUSIONS Many middle-age and older adults with diabetes are sexually active and engage in sexual behaviors similarly to individuals without diabetes. Women with diabetes were more likely than men to cease all sexual activity. Older women with diabetes are as likely to have sexual problems but are significantly less likely than men to discuss them. PMID:20802158

  3. Sensory deprivation disrupts homeostatic regeneration of newly generated olfactory sensory neurons after injury in adult mice.

    PubMed

    Kikuta, Shu; Sakamoto, Takashi; Nagayama, Shin; Kanaya, Kaori; Kinoshita, Makoto; Kondo, Kenji; Tsunoda, Koichi; Mori, Kensaku; Yamasoba, Tatsuya

    2015-02-11

    Although it is well known that injury induces the generation of a substantial number of new olfactory sensory neurons (OSNs) in the adult olfactory epithelium (OE), it is not well understood whether olfactory sensory input influences the survival and maturation of these injury-induced OSNs in adults. Here, we investigated whether olfactory sensory deprivation affected the dynamic incorporation of newly generated OSNs 3, 7, 14, and 28 d after injury in adult mice. Mice were unilaterally deprived of olfactory sensory input by inserting a silicone tube into their nostrils. Methimazole, an olfactotoxic drug, was also injected intraperitoneally to bilaterally ablate OSNs. The OE was restored to its preinjury condition with new OSNs by day 28. No significant differences in the numbers of olfactory marker protein-positive mature OSNs or apoptotic OSNs were observed between the deprived and nondeprived sides 0-7 d after injury. However, between days 7 and 28, the sensory-deprived side showed markedly fewer OSNs and mature OSNs, but more apoptotic OSNs, than the nondeprived side. Intrinsic functional imaging of the dorsal surface of the olfactory bulb at day 28 revealed that responses to odor stimulation were weaker in the deprived side compared with those in the nondeprived side. Furthermore, prevention of cell death in new neurons 7-14 d after injury promoted the recovery of the OE. These results indicate that, in the adult OE, sensory deprivation disrupts compensatory OSN regeneration after injury and that newly generated OSNs have a critical time window for sensory-input-dependent survival 7-14 d after injury.

  4. Origin, migration and fate of newly generated neurons in the adult rodent piriform cortex.

    PubMed

    Shapiro, Lee A; Ng, Kwan L; Kinyamu, Richard; Whitaker-Azmitia, Patricia; Geisert, Eldon E; Blurton-Jones, Mathew; Zhou, Qun-Yong; Ribak, Charles E

    2007-09-01

    Newly generated neurons are continuously added to the olfactory epithelium and olfactory bulbs of adult mammals. Studies also report newly generated neurons in the piriform cortex, the primary cortical projection site of the olfactory bulbs. The current study used BrdU-injection paradigms, and in vivo and in vitro DiI tracing methods to address three fundamental issues of these cells: their origin, migratory route and fate. The results show that 1 day after a BrdU-injection, BrdU/DCX double-labeled cells appear deep to the ventricular subependyma, within the white matter. Such cells appear further ventral and caudal in the ensuing days, first appearing in the rostral piriform cortex of mice at 2 days after the BrdU-injection, and at 4 days in the rat. In the caudal piriform cortex, BrdU/DCX labeled cells first appear at 4 days after the injection in mice and 7 days in rats. The time it takes for these cells to appear in the piriform cortex and the temporal distribution pattern suggest that they migrate from outside this region. DiI tracing methods confirmed a migratory route to the piriform cortex from the ventricular subependyma. The presence of BrdU/NeuN labeled cells as early as 7 days after a BrdU injection in mice and 10 days in the rat and lasting as long as 41 days indicates that some of these cells have extended survival durations in the adult piriform cortex.

  5. 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…

  6. 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…

  7. 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)

  8. 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…

  9. 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…

  10. 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…

  11. 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,…

  12. 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…

  13. 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…

  14. Busulfan, Melphalan, Topotecan Hydrochloride, and a Stem Cell Transplant in Treating Patients With Newly Diagnosed or Relapsed Solid Tumor

    ClinicalTrials.gov

    2016-11-04

    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

  15. 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

  16. 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

  17. HIV-1 subtype distribution and its demographic determinants in newly diagnosed patients in Europe suggest highly compartmentalized epidemics

    PubMed Central

    2013-01-01

    Background Understanding HIV-1 subtype distribution and epidemiology can assist preventive measures and clinical decisions. Sequence variation may affect antiviral drug resistance development, disease progression, evolutionary rates and transmission routes. Results We investigated the subtype distribution of HIV-1 in Europe and Israel in a representative sample of patients diagnosed between 2002 and 2005 and related it to the demographic data available. 2793 PRO-RT sequences were subtyped either with the REGA Subtyping tool or by a manual procedure that included phylogenetic tree and recombination analysis. The most prevalent subtypes/CRFs in our dataset were subtype B (66.1%), followed by sub-subtype A1 (6.9%), subtype C (6.8%) and CRF02_AG (4.7%). Substantial differences in the proportion of new diagnoses with distinct subtypes were found between European countries: the lowest proportion of subtype B was found in Israel (27.9%) and Portugal (39.2%), while the highest was observed in Poland (96.2%) and Slovenia (93.6%). Other subtypes were significantly more diagnosed in immigrant populations. Subtype B was significantly more diagnosed in men than in women and in MSM > IDUs > heterosexuals. Furthermore, the subtype distribution according to continent of origin of the patients suggests they acquired their infection there or in Europe from compatriots. Conclusions The association of subtype with demographic parameters suggests highly compartmentalized epidemics, determined by social and behavioural characteristics of the patients. PMID:23317093

  18. 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

  19. 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.

  20. Predictive value of pretreatment positron emission tomography/computed tomography in patients with newly diagnosed extranodal natural killer/T-cell lymphoma.

    PubMed

    Bai, Bing; Huang, Hui-Qiang; Cai, Qi-Chun; Fan, Wei; Wang, Xiao-Xiao; Zhang, Xu; Lin, Ze-Xiao; Gao, Yan; Xia, Yun-Fei; Guo, Ying; Cai, Qing-Qing; Jiang, Wen-Qi; Lin, Tong-Yu

    2013-03-01

    The role of (18)Fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) in extranodal natural killer/T-cell lymphoma (ENKL) is not well established. This study aimed to investigate the prognostic role of the pretreatment maximum standardized uptake value (SUV(max)) on PET/CT in patients with newly diagnosed ENKL. Among 364 consecutive patients with newly diagnosed ENKL, 81 patients were included and reviewed. The impact of SUV(max) on survival and the relationship between SUV(max) and other clinicopathological parameters were analyzed. The median SUV(max) was 14.6 (range 2.0-45.4). The optimal cutoff value of SUV(max) to predict overall survival (OS) was 15. Patients with high SUV(max) (SUVmax >15) were associated with bulky disease (P < 0.001), local invasion (P = 0.030), high score of Korean Prognostic Index (KPI, P = 0.046), resistance to primary treatment (P = 0.014), poor OS (P < 0.001), and unfavorable progression-free survival (P < 0.001). With a median follow-up of 25.0 months, the median OS was 63.0 months (range 2.0-99.0 months). Multivariate analyses revealed the following independent prognostic factors for OS: age >60 years (P = 0.001), stage III-IV (P = 0.023), SUV(max) >15 (P = 0.020), and bulky disease (>5 cm) (P = 0.002). By using the SUV(max), patients in most subgroups stratified by the KPI or the International Prognostic Index (IPI) were further discriminated in OS with significant statistical difference. Our results suggest the pretreatment SUV(max) is predictive of prognosis in patients with newly diagnosed ENKL. The SUV(max) may provide additional prognostic information for IPI and KPI.

  1. Risk factors for second primary neoplasia of esophagus in newly diagnosed head and neck cancer patients: a case–control study

    PubMed Central

    2013-01-01

    Background The prevalence of esophageal neoplasia in head and neck (H&N) cancer patients is not low; however, routine esophageal surveillance is not included in staging of newly-diagnosed H&N cancers. We aimed to investigate the risk factors for synchronous esophageal neoplasia and the impact of endoscopy on management of H&N cancer patients. Methods A total of 129 newly diagnosed H&N cancer patients who underwent endoscopy with white-light imaging, narrow-band imaging (NBI) with magnifying endoscopy (ME), and chromoendoscopy with 1.5% Lugol’s solution, before definite treatment were enrolled prospectively. Results 60 esophageal lesions were biopsied from 53 (41.1%) patients, including 11 low-grade, 14 high-grade intraepithelial neoplasia and 12 invasive carcinoma in 30 (23.3%) patients. Alcohol consumption [odds ratio (OR) 5.90, 95% confidence interval (CI) 1.23-26.44], advanced stage (stage III and IV) of index H&N cancers (OR 2.98, 95% CI 1.11-7.99), and lower body mass index (BMI) (every 1-kg/m2 increment with OR 0.87, 95% CI 0.76-0.99) were independent risk factors for synchronous esophageal neoplasia. NBI with ME was the ideal screening tool (sensitivity, specificity, and accuracy of 97.3%, 94.1%, and 96.3%, respectively, for detection of dysplastic and cancerous esophageal lesions). The treatment strategy was modified after endoscopy in 20 (15.5%) patients. The number needed to screen was 6.45 (95% CI 4.60-10.90). Conclusions NBI-ME surveillance of esophagus should be done in newly-diagnosed H&N cancer patients, especially those with alcohol drinking, lower BMI, and advanced stage of primary tumor. PMID:24456340

  2. 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

  3. Fatigue is highly associated with poor health-related quality of life, disability and depression in newly-diagnosed patients with inflammatory bowel disease, independent of disease activity

    PubMed Central

    Cohen, B L; Zoëga, H; Shah, S A; LeLeiko, N; Lidofsky, S; Bright, R; Flowers, N; Law, M; Moniz, H; Merrick, M; Sands, B E

    2014-01-01

    Background Fatigue is common in Crohn's disease (CD) and ulcerative colitis (UC). Data on fatigue in newly diagnosed patients are unavailable. Aim To report prevalence of fatigue in newly diagnosed CD and UC patients and examine its association with health-related quality of life (HRQOL), depression and disability. Methods The Ocean State Crohn's and Colitis Area Registry (OSCCAR) is a statewide cohort of newly diagnosed inflammatory bowel disease patients in Rhode Island. Fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue Scale. Patients were administered instruments measuring HRQOL, overall disability and work impairment, and depression. Results Fatigue was prevalent in 26.4% of 220 subjects. Cohen's d effect sizes for fatigue were large: Short-Form 36 Health Survey mental health component (CD 1.5, UC 1.4) and physical health component (CD 1.4, UC 1.4), EuroQol-5D valuation of current health state (CD 1.2, UC 1.0), Inflammatory Bowel Disease Questionnaire (CD 1.9, UC 1.6) and Patient Health Questionnaire depression scale (CD 1.8, UC 1.7). Fatigued patients reported more work impairment (Score difference: CD 29.5%, UC 23.8%) and activity impairment (score difference: CD 32.3%, UC 25.7%) on the Work Productivity and Activity Impairment Questionnaire. Fatigue's association with all scores remained highly significant despite controlling for disease activity. Conclusions Fatigue is strongly associated with poor HRQOL, disability and depression similarly in CD and UC even when controlling for disease activity. Fatigue's association with a wide range of patient-reported outcome measures suggests that monitoring fatigue is a simple way to screen for overall disruption in patient life. PMID:24612278

  4. Serial analysis of 3D H-1 MRSI for patients with newly diagnosed GBM treated with combination therapy that includes bevacizumab.

    PubMed

    Nelson, Sarah J; Li, Yan; Lupo, Janine M; Olson, Marram; Crane, Jason C; Molinaro, Annette; Roy, Ritu; Clarke, Jennifer; Butowski, Nicholas; Prados, Michael; Cha, Soonmee; Chang, Susan M

    2016-10-01

    Interpretation of changes in the T1- and T2-weighted MR images from patients with newly diagnosed glioblastoma (GBM) treated with standard of care in conjunction with anti-angiogenic agents is complicated by pseudoprogression and pseudoresponse. The hypothesis being tested in this study was that 3D H-1 magnetic resonance spectroscopic imaging (MRSI) provides estimates of levels of choline, creatine, N-acetylaspartate (NAA), lactate and lipid that change in response to treatment and that metrics describing these characteristics are associated with survival. Thirty-one patients with newly diagnosed GBM and being treated with radiation therapy (RT), temozolomide, erlotinib and bevacizumab were recruited to receive serial MR scans that included 3-D lactate edited MRSI at baseline, mid-RT, post-RT and at specific follow-up time points. The data were processed to provide estimates of metrics representing changes in metabolite levels relative to normal appearing brain. Cox proportional hazards analysis was applied to examine the relationship of these parameters with progression free survival (PFS) and overall survival (OS). There were significant reductions in parameters that describe relative levels of choline to NAA and creatine, indicating that the treatment caused a decrease in tumor cellularity. Changes in the levels of lactate and lipid relative to the NAA from contralateral brain were consistent with vascular normalization. Metabolic parameters from the first serial follow-up scan were associated with PFS and OS, when accounting for age and extent of resection. Integrating metabolic parameters into the assessment of patients with newly diagnosed GBM receiving therapies that include anti-angiogenic agents may be helpful for tracking changes in tumor burden, resolving ambiguities in anatomic images caused by non-specific treatment effects and for predicting outcome.

  5. 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

  6. Body composition as an indicator of the nutritional status in children with newly diagnosed ulcerative colitis and Crohn’s disease – a prospective study

    PubMed Central

    Binkowska-Bury, Monika; Korczowski, Bartosz

    2016-01-01

    Introduction The prevalence of nutritional status disorders in children with ulcerative colitis (UC) is much lower than in the case of Crohn’s disease (CD). The largest variability in the components of body composition occurs at the time of a new diagnosis and in periods of disease exacerbation. Aim Assessment of body composition in children with UC and CD. Material and methods The preliminary study included 59 children with inflammatory bowel disease (IBD) (34 children with UC vs. 25 children with CD) aged 4–18 years. The final analysis included 26 newly diagnosed children (16 children with UC vs. 10 children with CD). The evaluation of body composition was conducted by means of BIA-101 bioimpedance analyser. Results Decreased values of lean mass were found in children with newly diagnosed IBD (UC: 41.13 kg vs. control group: 42.06 kg; CD: 35.50 kg vs. control group: 45.50 kg). After a year interval, an increase in fat (UC 1: 7.67 kg vs. UC 2: 10.33 kg; CD 1: 7.36 kg vs. CD 2: 9.47 kg) as well as lean body mass (UC 1: 35.22 kg vs. UC 2: 39.00 kg; CD 1: 35.99 kg vs. CD 2: 42.41 kg) was found in children. Conclusions Children with newly diagnosed IBD were highly vulnerable to nutritional status disturbances. The increase in fat and lean body mass in an annual interval may be due to the treatment regime and control of the children.

  7. 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

  8. PSMA-PET/CT-Positive Paget Disease in a Patient with Newly Diagnosed Prostate Cancer: Imaging and Bone Biopsy Findings.

    PubMed

    Froehner, Michael; Toma, Marieta; Zöphel, Klaus; Novotny, Vladimir; Laniado, Michael; Wirth, Manfred P

    2017-01-01

    A 67-year-old man diagnosed with Gleason score 4 + 5 = 9 clinically localized prostate cancer with (68)Ga-labeled prostate-specific membrane antigen-targeted ligand positron emission tomography/computed tomography (PSMA-PET/CT) positive Paget bone disease is described. Immunohistochemical staining revealed weak PSMA positivity of the bone lesion supporting the hypothesis that neovasculature might explain positive PSMA-PET/CT findings in Paget disease.

  9. PSMA-PET/CT-Positive Paget Disease in a Patient with Newly Diagnosed Prostate Cancer: Imaging and Bone Biopsy Findings

    PubMed Central

    Toma, Marieta; Zöphel, Klaus; Novotny, Vladimir; Laniado, Michael

    2017-01-01

    A 67-year-old man diagnosed with Gleason score 4 + 5 = 9 clinically localized prostate cancer with 68Ga-labeled prostate-specific membrane antigen-targeted ligand positron emission tomography/computed tomography (PSMA-PET/CT) positive Paget bone disease is described. Immunohistochemical staining revealed weak PSMA positivity of the bone lesion supporting the hypothesis that neovasculature might explain positive PSMA-PET/CT findings in Paget disease.

  10. Experiences of older adult women diagnosed with attention deficit hyperactivity disorder.

    PubMed

    Henry, Erin; Jones, Sally Hill

    2011-01-01

    Attention Deficit Hyperactivity Disorder (ADHD), usually diagnosed in children, is known to persist into adulthood. However, the research has not examined the disorder in older adults. This article describes a preliminary qualitative study of the experiences of women over age 62 who were diagnosed with ADHD after the age of 60. Participants reported experiencing peer rejection, feeling different, and a tendency to become advocates for others. Although they reported difficulties in work and relationships, they also described finding creative solutions to their attention problems. Diagnosis and treatment appears to have assisted with self-acceptance and appreciation of the strengths of having ADHD.

  11. Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

    ClinicalTrials.gov

    2017-02-07

    B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; BCR-ABL1 Fusion Protein Expression; Minimal Residual Disease; Philadelphia Chromosome Positive; T Acute Lymphoblastic Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia

  12. 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.

  13. Validation of the Effectiveness and Safety of Temozolomide during and after Radiotherapy for Newly Diagnosed Glioblastomas: 10-year Experience of a Single Institution.

    PubMed

    Joo, Jin-Deok; Kim, Hansol; Kim, Young-Hoon; Han, Jung Ho; Kim, Chae-Yong

    2015-11-01

    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.

  14. Clinical Characteristics of Patients with Newly Diagnosed Diabetic Macular Edema in Turkey: A Real-Life Registry Study—TURK-DEM

    PubMed Central

    Ozdek, Sengul; Ozmert, Emin; Ulay, Esat; Nomak, Gulsah

    2017-01-01

    Purpose. To evaluate the clinical and diagnostic characteristics of patients with newly diagnosed diabetic macular edema (DME) in Turkey in a real-life setting. Methods. A total of 945 consecutive patients (mean (SD) age: 61.3 (9.9) years, 55.2% male) with newly diagnosed DME were included. Data on patient demographics, comorbidities, ocular history, ophthalmic examination findings including type of DME, central macular thickness (CMT) via time domain (TD) and spectral domain (SD) optical coherence tomography (OCT), and planned treatments were recorded. Results. OCT (98.8%) and fundoscopy (92.9%) were the two most common diagnostic methods. Diffuse and focal DMEs were detected in 39.2% and 36.9% of cases, respectively. Laser photocoagulation (32.1%) and antivascular endothelial growth factors (anti-VEGF; 31.8%) were the most commonly planned treatments. The median CMT in the right eye was significantly greater in untreated than in treated patients [376.5 μm (range: 160–840) versus 342 μm (range: 146–999) (p = 0.002)] and in the left eye [370 μm (range: 201–780) versus 329 μm (range: 148–999) (p < 0.001)]. Conclusions. This study is the first large-scale real-life registry of DME patients in Turkey. SD-OCT and fundoscopy were the most common diagnostic methods. Laser photocoagulation and anti-VEGF therapy were the most common treatments. PMID:28316835

  15. Lenalidomide: a review of its continuous use in patients with newly diagnosed multiple myeloma not eligible for stem-cell transplantation.

    PubMed

    McCormack, Paul L

    2015-05-01

    Lenalidomide (Revlimid(®)) is a second-generation immunomodulatory drug structurally related to thalidomide, with improved efficacy and tolerability, for which the label in the EU was recently expanded to include continuous therapy in patients with previously untreated multiple myeloma not eligible for stem-cell transplantation. In randomized, controlled clinical trials, continuous lenalidomide therapy, either in combination with dexamethasone (FIRST trial) or as maintenance monotherapy following induction with melphalan/prednisone/lenalidomide (MM-015 trial), significantly improved progression-free survival (PFS) compared with induction therapy alone (with non-lenalidomide- or lenalidomide-containing regimens) in patients with newly diagnosed multiple myeloma not eligible for stem-cell transplantation. The improvements in PFS with continuous lenalidomide were reflected in improved health-related quality-of-life measures. An overall survival benefit was observed in the FIRST trial, but not in the MM-015 trial. Continuous lenalidomide and continuous thalidomide regimens displayed similar efficacy, but lenalidomide was associated with significantly less toxicity than thalidomide. Continuous use of lenalidomide did not appear to negatively impact on the drug's tolerability and did not increase the incidence of neutropenia or second primary malignancy compared with shorter-term use. The incidence of most adverse events began to reduce after about 18 months of therapy. In conclusion, continuous lenalidomide regimens provide an effective longer-term treatment option in patients with newly diagnosed multiple myeloma ineligible for stem-cell transplantation.

  16. Evaluation of Baseline CD4+ T Cell Counts and ART Requirement in Newly Diagnosed HIV Seropositive Individuals in a Tertiary Care Hospital of Northern India

    PubMed Central

    Bhattar, Sonali; Mehra, Bhanu; Rawat, Deepti

    2016-01-01

    Introduction Antiretroviral Therapy (ART) has changed the outlook of Human Immune-deficiency Virus (HIV)/Acquired Immuno Deficiency Syndrome (AIDS) patients worldwide. Aim To analyse the trends in baseline CD4+ T cell counts and ART requirements in newly diagnosed HIV seropositive individuals in a Tertiary care hospital of Northern India. Materials and Methods Out of 1263 HIV seropositive clients identified from January 2012 to June 2014, the baseline CD4+ T cell counts of only those 470 clients were analysed, who registered at the linked ART centre. Results The mean baseline CD4+ count of the study group was 249.77±216.0cells/mm3 and that of male and female were 300.31±240.47cells/mm3 and 232.38±204.25cells/mm3 respectively. A total of 259 of 334 (77.54%) HIV reactive males, 83 of 130 (63.85%) HIV reactive females and overall 348 of 470 (74.04%) required antiretroviral treatment on enrolment. Conclusion In the present study, about three-fourth of newly diagnosed HIV positive Indian patients required initiation of ART at registration. The relatively low baseline CD4+ T cell counts in this population highlights the need for timely baseline CD4+ counts testing of HIV positive patients and the urgency of initiating treatment in HIV reactive individuals in Indian health care settings. PMID:28050367

  17. Phase 1/2 study of carfilzomib plus melphalan and prednisone in patients aged over 65 years with newly diagnosed multiple myeloma.

    PubMed

    Moreau, Philippe; Kolb, Brigitte; Attal, Michel; Caillot, Denis; Benboubker, Lotfi; Tiab, Mourad; Touzeau, Cyrille; Leleu, Xavier; Roussel, Murielle; Chaleteix, Carine; Planche, Lucie; Chiffoleau, Anne; Fortin, June; Avet-Loiseau, Hervé; Mary, Jean-Yves; Hulin, Cyrille; Facon, Thierry

    2015-05-14

    This phase 1/2 dose-escalation study investigated the combination of carfilzomib with melphalan and prednisone (CMP) in patients aged >65 years with newly diagnosed multiple myeloma (MM). Melphalan and prednisone were administered orally on days 1 to 4; carfilzomib was IV administered on days 1, 2, 8, 9, 22, 23, 29, and 30 of a 42-day cycle. Patients received up to 9 cycles of CMP. In the phase 1 dose-escalation portion, the primary objectives were to determine the incidence of dose-limiting toxicities during the first cycle of CMP treatment to define the maximal tolerated dose (MTD) of carfilzomib. In the phase 2 portion, the primary objective was to evaluate the overall response rate (ORR) of CMP. In the phase 1 portion of the study, 24 patients received CMP at carfilzomib dosing levels of 20 mg/m(2), 27 mg/m(2), 36 mg/m(2), and 45 mg/m(2). The MTD was established as 36 mg/m(2). In the phase 2 portion of the study, 44 patients were enrolled at the MTD. Among 50 efficacy-evaluable patients treated at the MTD, the ORR was 90%. The projected 3-year overall survival rate was 80%. The combination of CMP was observed to be effective in elderly patients with newly diagnosed MM. This trial was registered at www.clinicaltrials.gov as #NCT01279694 (Eudract identifier 2010-019462-92).

  18. Reduced CA2–CA3 Hippocampal Subfield Volume Is Related to Depression and Normalized by l-DOPA in Newly Diagnosed Parkinson’s Disease

    PubMed Central

    Györfi, Orsolya; Nagy, Helga; Bokor, Magdolna; Moustafa, Ahmed A.; Rosenzweig, Ivana; Kelemen, Oguz; Kéri, Szabolcs

    2017-01-01

    Hippocampal dysfunctions may play an important role in the non-motor aspects of Parkinson’s disease (PD), including depressive and cognitive symptoms. Fine structural alterations of the hippocampus and their relationship with symptoms and medication effects are unknown in newly diagnosed PD. We measured the volume of hippocampal subfields in 35 drug-naïve, newly diagnosed PD patients without cognitive impairment and 30 matched healthy control individuals. Assessments were performed when the patients did not receive medications and after a 24-week period of l-DOPA treatment. We obtained a T1-weighted 3D magnetization-prepared rapid acquisition gradient echo image at each assessment. FreeSurfer v6.0 was used for image analysis. Results revealed a selectively decreased CA2–CA3 volume in non-medicated PD patients, which was normalized after the 24-week treatment period. Higher depressive symptoms were associated with smaller CA2–CA3 volumes. These results indicate that the CA2–CA3 subfield is structurally affected in the earliest stage of PD in the absence of cognitive impairment. This structural anomaly, normalized by l-DOPA, is related to depressive non-motor symptoms. PMID:28367136

  19. Comparing efficacy and survivals of initial treatments for elderly patients with newly diagnosed multiple myeloma: a network meta-analysis of randomized controlled trials

    PubMed Central

    Liu, Xiaoping; Chen, Jiarui; He, Yuncen A; Meng, Xiangyu; Li, Kaili; He, Colin K; Liu, Shangqin

    2017-01-01

    Objective The aim of this study was to evaluate the efficacy and clinical outcome of initial therapies for elderly patients with multiple myeloma (MM). Methods Randomized controlled trials (RCTs) were obtained through a comprehensive search. Response rate, progression-free survival (PFS) and overall survival (OS) were the interested outcome measures. Network meta-analysis (NMA) using graph theory methodology to construct an NMA model, and sensitivity analysis were performed. Results Nineteen RCTs containing 7,235 participants and 17 treatments were included in the NMA. As compared to the classic melphalan plus prednisone (MP) regimen, the majority of other initial regimens showed higher rates of complete response/near complete response, overall response rate (ORR) and better PFS as well as OS. These four outcomes favored the two lenalidomide plus dexamethasone regimens (continuous lenalidomide and 18 cycles of lenalidomide plus dexamethasone), especially continuous lenalidomide plus dexamethasone regimen, over the majority of other regimens including the two established standard treatments (MP plus thalidomide or bortezomib) for elderly patients with newly diagnosed MM. Conclusion Continuous lenalidomide plus dexamethasone ranked as the best regimen in terms of ORR and OS for the treatment of elderly patients with newly diagnosed MM. PMID:28053546

  20. 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.

  1. Factors affecting linkage to care and engagement in care for newly diagnosed HIV-positive adolescents within fifteen adolescent medicine clinics in the United States.

    PubMed

    Philbin, Morgan M; Tanner, Amanda E; DuVal, Anna; Ellen, Jonathan M; Xu, Jiahong; Kapogiannis, Bill; Bethel, Jim; Fortenberry, J Dennis

    2014-08-01

    Early linkage to care and engagement in care are critical for initiation of medical interventions. However, over 50 % of newly diagnosed persons do not receive HIV-related care within 6 months of diagnosis. We evaluated a linkage to care and engagement in care initiative for HIV-positive adolescents in 15 U.S.-based clinics. Structural and client-level factors (e.g. demographic and behavioral characteristics, clinic staff and location) were evaluated as predictors of successful linkage and engagement. Within 32 months, 1,172/1,679 (69.8 %) of adolescents were linked to care of which 1,043/1,172 (89 %) were engaged in care. Only 62.1 % (1,043/1,679) of adolescents were linked and engaged in care. Linkage to care failure was attributed to adolescent, provider, and clinic-specific factors. Many adolescents provided incomplete data during the linkage process or failed to attend appointments, both associated with failure to linkage to care. Additional improvements in HIV care will require creative approaches to coordinated data sharing, as well as continued outreach services to support newly diagnosed adolescents.

  2. Adjustment to Acute Leukemia: The Impact of Social Support and Marital Satisfaction on Distress and Quality of Life Among Newly Diagnosed Patients and Their Caregivers.

    PubMed

    Pailler, Megan E; Johnson, Teresa M; Kuszczak, Sarah; Attwood, Kristopher M; Zevon, Michael A; Griffiths, Elizabeth; Thompson, James; Wang, Eunice S; Wetzler, Meir

    2016-09-01

    Little is known about the specific patterns of adjustment among newly diagnosed acute leukemia patients and their caregivers. This study examined the trajectories of patient and caregiver distress over time as well as the extent to which marital satisfaction and social support moderated these trajectories among those with significant-other caregivers. Forty six patient-caregiver dyads provided ratings at four time points: within 1 week of diagnosis (T1), 2 week follow-up (T2), 6 week follow-up (T3) and 12 week follow-up (T4). As anticipated, patients and caregivers reported higher levels of distress around the time of diagnosis than they did during subsequent time points. Marital satisfaction was a significant predictor of distress among patients, whereas among caregivers, social support predicted distress and quality of life. Results support the inclusion of relational variables such as social support and relationship satisfaction in the assessment of newly diagnosed patients and families in order to best identify those at risk for distress over time.

  3. Diagnostic and treatment considerations when newly diagnosed breast cancer coincides with pregnancy: a case report and review of literature.

    PubMed

    Nye, Lauren; Huyck, Timothy K; Gradishar, William J

    2012-02-01

    Breast cancer is the most common malignancy associated with pregnancy and is a rare but well-recognized complication. It is hypothesized that as more women continue to delay childbearing, the incidence of breast cancer in pregnancy will increase. Because of the lack of clinical experience with breast cancer in the setting of pregnancy, given its relative infrequency, many patients and physicians believe the diagnosis puts the life of the mother at odds with that of the fetus, but available data suggest that termination of the pregnancy does not improve the outcome for pregnant women with breast cancer. Often diagnosis is delayed because neither patient nor physician suspects malignancy. This report presents a recent case of a young primigravid woman with a newly appreciated breast mass seen at Northwestern University Feinberg School of Medicine as a means of discussing diagnostic considerations, therapeutic options, and supportive care available to the practitioner when managing a pregnant patient with breast cancer.

  4. 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

  5. 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.

  6. Transmitted HIV Type 1 drug resistance and Non-B subtypes prevalence among seroconverters and newly diagnosed patients from 1992 to 2005 in Italy.

    PubMed

    Riva, Chiara; Lai, Alessia; Caramma, Ilaria; Corvasce, Stefano; Violin, Michela; Dehò, Lorenzo; Prati, Francesca; Rossi, Cristina; Colombo, Maria Chiara; Capetti, Amedeo; Franzetti, Marco; Rossini, Valeria; Tambussi, Giuseppe; Ciccozzi, Massimo; Suligoi, Barbara; Mussini, Cristina; Rezza, Giovanni; Balotta, Claudia

    2010-01-01

    The patterns of transmitted drug-resistant (TDR) HIV-1 variants, non-B subtype spread, and epidemiological trends were evaluated either in seroconverters or in newly diagnosed individuals in Italy over a 13-year period. We analyzed 119 seroconverters, enrolled from 1992 to 2003 for the CASCADE study, and 271 newly diagnosed individuals of the SPREAD study (2002-2005), of whom 42 had a known seroconversion date. Overall, TDR was 15.1% in the CASCADE and 12.2% in the SPREAD study. In the 1992-2003 period, men having sex with men (MSMs) and heterosexuals (HEs) were 48.7% and 36.8%, respectively; TDR was found to be higher in MSMs compared to HEs (78.9% vs. 21%, p = 0.006). The same groups were 39.1% and 53.3% in the SPREAD study; however, no association was detected between modality of infection and TDR. Overall, 9.2% and 22.1% of individuals harbored a non-B clade virus in the CASCADE and SPREAD study, respectively. As evidence of onward transmission, 40% (24/60) of non-B variants were carried by European individuals in the latter study; among these patients the F1 subtype was highly prevalent (p = 0.00001). One of every eight patients who received a diagnosis of HIV-1 in recent years harbored a resistant variant, reinforcing the arguments for baseline resistance testing to customize first-line therapy in newly infected individuals. The spread of non-B clades may act as a dilution factor of TDR concealing the proportion of TDR in seroconverters and MSMs.

  7. Recruitment approaches to identifying newly diagnosed HIV infection among African American men who have sex with men.

    PubMed

    Ellen, J M; McCree, D H; Muvva, R; Chung, S-E; Miazad, R M; Arrington-Sanders, R; Jones, K; Burnett, P; Fichtenberg, C

    2013-05-01

    To determine effectiveness of alternate venue testing (AVT), social network strategy (SNS) and provider referral (PR) for identifying previously undiagnosed HIV-infected 18-64-year-old African American men who have sex with men (AA MSM) by a health department. For AVT, staff used a mobile clinic to conduct HIV testing. For PR, staff solicited contact information from HIV-infected AA MSM, located contacts and offered HIV testing. For SNS, HIV-positive AA MSM recruited network associates for HIV testing. Two hundred and eighteen self-identified AA MSM were tested through AVT (25.2% HIV positivity) of whom 20 were newly identified HIV-positive. Fourteen HIV-positive men participated in SNS; 22 AA MSM contacts were recruited through SNS, eight (36.4%) were HIV positive and none were new positives. Two HIV-infected men participated in the PR strategy, yielding two AA MSM sex partners (one previously positive). The results suggest the need for health departments to consider using several complimentary strategies for identifying previously undiagnosed HIV infections in AA MSM in urban environments such as Baltimore.

  8. Radiation combined with temozolomide contraindicated for young adults diagnosed with anaplastic glioma

    PubMed Central

    Cai, Jinquan; You, Gan; Wang, Yinyan; Qiu, Xiaoguang; Li, Shouwei; Wu, Chenxing; Yao, Kun; Li, Wenbin; Peng, Xiaoxia; Zhang, Wei; Jiang, Tao

    2016-01-01

    Purpose Age is a major prognostic factor for malignant gliomas. However, few studies have investigated the management of gliomas in young adults. We determined the role of survival and treatment in young adults with advanced gliomas in a large population from the Chinese Glioma Genome Atlas (CGGA). Methods This study included 726 adults (age ≥ 18) with histologically proven anaplastic glioma or glioblastoma multiforme (GBM). The overall and progression-free survival was determined in young (age < 50) and older groups (age ≥ 50). Results The study included an older group (OP) of 264 patients and a younger group (YP) of 462patients. In the OP group with GBM and anaplastic glioma, patients treated with RT combined with temozolomide (TMZ) manifested significantly longer OS and PFS compared with patients assigned to RT alone (P < 0.05). In contrast, the YP group diagnosed with anaplastic glioma failed to show any survival advantage with RT plus TMZ compared with RT alone. Conclusions We observed no survival benefit in young adults (age < 50) with anaplastic glioma when treated with TMZ combined with RT. Our findings warrant further investigation of younger patients diagnosed with anaplastic glioma treated with radiotherapy plus TMZ chemotherapy. PMID:27590514

  9. Severe vitamin C deficiency in a child newly diagnosed with T-cell ALL due to nutrient gap.

    PubMed

    Harris-Janz, Sydney; Johnston, Donna; Halton, Jacqueline

    2016-01-28

    A 10-year-old boy developed a perifollicular rash during interim maintenance of T-Cell acute lymphoblastic leukaemia. Differential diagnoses included drug reaction and inflammatory process. Before diagnosis, the patient had a limited diet--low in vegetables and fruits--due to selective eating, with later anorexia and taste aversions due to chemotherapy treatment. Despite nutritional counselling and starting a multivitamin, the patient incurred severe weight loss (18.5% of his usual body weight). Serum levels of ascorbic acid were non-detectable, at <5 μmol/L, indicative of vitamin C deficiency. The patient began vitamin C supplementation containing 125 mg ascorbic acid three times a day for 7 days, then 125 mg once daily for 3 months to normalise serum vitamin C. After ascorbic acid treatment was completed, the patient started a complete multivitamin and made efforts to eat fruits and vegetables rich in vitamin C. His serum ascorbic acid concentrations normalised to 52 μmol/L 3 months after receiving supplementation.

  10. 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.

  11. 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

  12. Pediatric phase II trials of poly-ICLC in the management of newly diagnosed and recurrent brain tumors.

    PubMed

    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

    2014-08-01

    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.

  13. Alogliptin as an initial therapy in patients with newly diagnosed, drug naïve type 2 diabetes: a randomized, control trial.

    PubMed

    Kutoh, Eiji; Ukai, Yasuhiro

    2012-06-01

    The objectives of this study is to evaluate the efficacy and safety of alogliptin versus very low fat/calorie traditional Japanese diet (non-inferiority trial) as an initial therapy for newly diagnosed, drug naïve subjects with type 2 diabetes (T2DM). Study design was prospective, randomized, non-double-blind, controlled trial. The study was conducted at outpatient units of municipal hospital. Patients were newly diagnosed, drug naïve patients who visited the outpatient units. The patients randomly received 12.5-25 mg/day alogliptin (n = 25) or severe low calorie traditional Japanese diet (n = 26). The procedure of this trial was assessed by the consolidated standards of reporting trials statement. The primary end point was the change of HbA1c at 3 months. Secondary end points included the changes of fasting blood glucose, insulin, homeostasis model assessment-R (HOMA-R), HOMA-B, body mass index (BMI), and lipid parameters. Similar, significant reductions of HbA1c levels were observed in both groups (from 10.51 to 8.74% for alogliptin and from 10.01 to 8.39% for traditional Japanese diet) without any clinically significant adverse events. In the alogliptin group, some subjects (16%) had mild hypoglycemic evens which could be managed by taking glucose drinks by themselves. HOMA-B significantly increased in both groups with varying degrees, whereas HOMA-R significantly decreased only in the Japanese diet group. Atherogenic lipids, such as, total cholesterol, non-high density lipoprotein cholesterol, and low density lipoprotein cholesterol levels significantly decreased in both groups. BMI had no change in the alogliptin group, whereas it significantly decreased in the Japanese diet group. (1) Concerning its glycemic efficacy, alogliptin is effective and non-inferior to traditional Japanese diet as an initial therapeutic option for newly diagnosed T2DM. However, regarding the reductions of body weight and insulin resistance, traditional Japanese diet is

  14. 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

    2016-08-08

    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.

  15. The complexity of atrial fibrillation newly diagnosed after ischemic stroke and transient ischemic attack: advances and uncertainties

    PubMed Central

    Cerasuolo, Joshua O.; Cipriano, Lauren E.; Sposato, Luciano A.

    2017-01-01

    Purpose of review Atrial fibrillation is being increasingly diagnosed after ischemic stroke and transient ischemic attack (TIA). Patient characteristics, frequency and duration of paroxysms, and the risk of recurrent ischemic stroke associated with atrial fibrillation detected after stroke and TIA (AFDAS) may differ from atrial fibrillation already known before stroke occurrence. We aim to summarize major recent advances in the field, in the context of prior evidence, and to identify areas of uncertainty to be addressed in future research. Recent findings Half of all atrial fibrillations in ischemic stroke and TIA patients are AFDAS, and most of them are asymptomatic. Over 50% of AFDAS paroxysms last less than 30 s. The rapid initiation of cardiac monitoring and its duration are crucial for its timely and effective detection. AFDAS comprises a heterogeneous mix of atrial fibrillation, possibly including cardiogenic and neurogenic types, and a mix of both. Over 25 single markers and at least 10 scores have been proposed as predictors of AFDAS. However, there are considerable inconsistencies across studies. The role of AFDAS burden and its associated risk of stroke recurrence have not yet been investigated. Summary AFDAS may differ from atrial fibrillation known before stroke in several clinical dimensions, which are important for optimal patient care strategies. Many questions remain unanswered. Neurogenic and cardiogenic AFDAS need to be characterized, as it may be possible to avoid some neurogenic cases by initiating timely preventive treatments. AFDAS burden may differ in ischemic stroke and TIA patients, with distinctive diagnostic and treatment implications. The prognosis of AFDAS and its risk of recurrent stroke are still unknown; therefore, it is uncertain whether AFDAS patients should be treated with oral anticoagulants. PMID:27984303

  16. Clinical Characteristics of Diabetic Ketoacidosis in Children with Newly Diagnosed Type 1 Diabetes in Addis Ababa, Ethiopia: A Cross-Sectional Study

    PubMed Central

    Turago, Muluken Gizaw; Tegegne, Balewgizie Sileshi

    2017-01-01

    Background Diabetic ketoacidosis (DKA) is one of the most serious acute complications of type 1 diabetes (T1D) and the leading cause of morbidity and mortality in children with T1D. This study was aimed at assessing the prevalence and associated factors of DKA in children with newly diagnosed T1D in Addis Ababa. Methods A hospital based cross-sectional study was conducted in selected hospitals in Addis Ababa. Children below the age of 12 years with DKA who were admitted to the pediatric ward in the selected hospitals between January 2009 and December 2014 and the residence of Addis Ababa were included. DKA was defined as children below the age of 12 years who have blood glucose level ≥250mg/dl, ketonuria, and ketonemia and diagnosed being T1D patient for the first time. Descriptive statistics was performed using frequency distribution, mean, median, tables, and graphs. Logistic regression analysis was used to identify independent factors associated with the prevalence of DKA in children with newly diagnosed T1D. Results Of 395 DKA patients who were hospitalized during the five-year period, 142(35.8%) presented with DKA at first diagnosis of diabetes. On the other hand 253 (64.2%) children with DKA had longstanding T1D. Independent factors associated with DKA include: Age category 2–4.49years, 7–9.49 years and ≥9.5years (Adjusted odd ratio (AOR) = 3.14[1.21,8.06]), 3.44(1.39,8.49) and 4.02(1.68,9.60), respectively); parents’ knowledge on the sign and symptoms of DKA (AOR = 0.51[0.27, 0.95]); sign and symptoms of DKA before the onset of DKA (AOR = 0.35[0.21, 0.59]) and infection prior to DKA onset (AOR = 3.45[1.97, 6.04]). Conclusions The overall proportion of children diagnosed with DKA and new onset of T1D in Addis Ababa was high. In particular, children between 9–12 years of age and children whose parents did not know the sign and symptoms of DKA had a high risk of DKA at primary diagnosis of T1D. PMID:28135278

  17. Newly Diagnosed Colonic Adenocarcinoma: The Presenting Sign in a Young Woman with Undiagnosed Crohn's Disease in the Absence of Primary Sclerosing Cholangitis and a Normal Microsatellite Instability Profile

    PubMed Central

    2017-01-01

    Ulcerative colitis has long been linked with an increased risk for colonic adenocarcinoma, whereas Crohn's disease (CD) has recently been reported to pose a similar increased risk. We report a 33-year-old healthy female with no family history who presented with abdominal pain and a colon mass. Histopathology revealed a moderately differentiated adenocarcinoma extending through the muscularis propria with metastatic lymph nodes and intact mismatch repair proteins by immunohistochemical expression and gene sequencing. The nonneoplastic grossly uninvolved background mucosa showed marked crypt distortion, crypt abscesses, CD-like lymphoid hyperplasia, transmural inflammation, and reactive epithelial atypia. Additional patient questioning revealed frequent loose stools since she was a teenager leading to diagnosis of a previously undiagnosed CD without primary sclerosing cholangitis (PSC). The adenocarcinoma is suspected to be related to the underlying CD. Newly diagnosed adenocarcinoma in a young female as the presenting sign for CD in the absence of PSC is extremely rare. PMID:28255489

  18. 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.

  19. Patterns of colonic involvement at initial presentation in ulcerative colitis: a retrospective study of 46 newly diagnosed cases.

    PubMed

    Robert, Marie E; Skacel, Mark; Ullman, Thomas; Bernstein, Charles N; Easley, Kirk; Goldblum, John R

    2004-07-01

    Studies have shown that rectal sparing and patchiness develop in treated and longstanding ulcerative colitis (UC), making the distinction from Crohn colitis increasingly difficult after treatment is initiated. However, no histologic studies of the incidence of rectal sparing in adults at UC onset have been performed. Colectomy specimens from 46 patients with classic UC histologic features and no Crohn disease features were identified. Biopsy specimens obtained before medical therapy were retrieved and examined blindly by 2 pathologists, along with appropriate control samples. Slides were scored for chronicity (crypt branching, subcryptal plasma cells, lamina propria plasma cells) and activity (cryptitis, crypt abscesses, epithelial injury). In 28 cases, only rectal biopsy specimens were taken; for 16, rectal and at least 1 proximal biopsy specimen were taken. All cases showed rectal involvement; none had rectal sparing at initial biopsy. Of 16 cases with rectal and more proximal biopsy specimens, 5 (31%) showed relative rectal sparing (lower scores in rectum than in more proximal sites). In 16 cases with rectal and more proximal biopsy specimens, chronicity and activity scores were higher in the rectum than in more proximal sites (P = .01; chronicity and activity). The mean overall chronicity score decreased in a linear manner from rectum to cecum. The rectum is involved and shows evidence of chronicity and activity at disease onset in UC, using colectomy as the gold standard for diagnosis. Because rectal sparing at UC onset has been reported, a prospective study using uniform biopsy protocols is needed to establish the true incidence of rectal sparing at presentation.

  20. 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.

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

    PubMed Central

    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.

    2014-01-01

    activation 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. PMID:25080285

  2. 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

  3. 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.

  4. Efficacy and Tolerability of Solifenacin 5 mg Fixed Dose in Korean Children with Newly Diagnosed Idiopathic Overactive Bladder: a Multicenter Prospective Study

    PubMed Central

    2017-01-01

    We investigated the efficacy and tolerability of solifenacin 5 mg fixed dose in children with newly diagnosed idiopathic overactive bladder (OAB). A total of 34 children (male/female patients = 16/18) aged under 13 years (mean age: 7.2 ± 2.3; range: 5–12) who were newly diagnosed with OAB from January 2012 to September 2014 were prospectively evaluated with open-label protocol. All patients were treated with solifenacin 5 mg fixed dose once daily for at least 4 weeks. The efficacy and tolerability of solifenacin were evaluated 4, 8, and 12 weeks after the initiation of treatment. The mean voiding frequency during daytime was decreased from 9.4 ± 3.0 to 6.5 ± 2.3 times after the 12-week treatment (P < 0.001). The mean total OAB symptom score (OABSS) decreased from 7.7 ± 4.2 to 3.1 ± 3.1 after the 12-week treatment (P < 0.001). The urgency and urgency urinary incontinence (UUI) domains significantly improved from the 12-week treatment, and complete resolution of urgency occurred in 38.9% of patients and the percentage of children with UUI among urgent patients decreased from 79.4% to 57.1%. According to 3-day voiding diaries, the average bladder capacity increased from 90.4 ± 44.4 to 156.2 ± 67.3 mL (P < 0.001). Drug-induced adverse effects (AEs) were reported in 7 patients (20.6%). Our results indicate that solifenacin 5 mg fixed dose is effective against OAB symptoms, and its tolerability is acceptable without significant AEs in children with OAB. PMID:28049246

  5. Effect of the early intensive multifactorial therapy on the cardiovascular risk in patients with newly diagnosed type 2 diabetes: an observational, prospective study

    PubMed Central

    STEFAN, RAMONA MARIA; NITA, CRISTINA; CRACIUN, ANCA; RUSU, ADRIANA; HANCU, NICOLAE

    2015-01-01

    Background and aims We assessed if early intensive interventions improve the glycemic control and the modifiable cardiovascular diseases risk factors in Romanian patients with newly diagnosed type-2 diabetes during the first year follow-up period. Patients and methods This was an observational, prospective study: 69 subjects were included in the analysis; each of them received intensive multi-factorial pharmacologic treatment and therapeutic education targeting hyperglycemia, weight, hypertension and dyslipidemia. Disease monitoring was done at months 0, 1, 3, 6 and 12 by assessment of anthropometric measurements, arterial blood pressure and biochemical parameters. The cardiovascular diseases risk factors were calculated using the United Kingdom Prospective Diabetes Study Risk Engine. Results The mean age at diagnosis was 53.61±10.66 years. All anthropometric variables (body weight, body mass index, waist circumference, visceral fat area, percentage of body fat), except for skeletal muscle mass, significantly decreased overtime. The majority of the biochemical parameters significantly decreased overtime. The non-fatal/fatal coronary heart disease risk significantly decreased at month 12 (9.74 [p<0.05] and 4.84 [p<0.05], respectively) compared to month 0 (19.66 and 11.10, respectively); a similar trend of the non-fatal/fatal stroke (risk at month 12, 8.30 [p<0.05] and 1.04 [p<0.05], respectively, while at month 0, 7.89 and 1.38, respectively) was recorded. Conclusions Early multi-factorial treatment and intensive lifestyle interventions in patients newly diagnosed with type-2 diabetes could decrease with approximately 50% the rate of cardiovascular disease risk. PMID:26528067

  6. 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.

  7. 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

  8. Multicentric and contralateral invasive tumors identified with pre-op MRI in patients newly diagnosed with ductal carcinoma in situ of the breast.

    PubMed

    Hollingsworth, Alan B; Stough, Rebecca G

    2012-09-01

    Preoperative breast MRI in newly diagnosed cancer patients has several potential benefits. Improved survival for patients with invasive disease as the index lesion is unlikely to be one of these benefits, given what is known from variations in locoregional management in the historic conservation trials. However, this may not be the case for patients with ductal carcinoma in situ (DCIS), as the discovery of unsuspected invasive cancer located elsewhere from the biopsy-proven DCIS could result in decreased survival if left undetected and untreated. In support of this hypothesis, a previous observational study of a large cohort of DCIS patients revealed the development of invasive cancer to be the most common event after unilateral DCIS treatment, occurring in 3.9%, mostly in the opposite breast. These cancers appeared on mammography or clinical exam within a short time frame (median 2.9 years) and were associated with a diminution in survival. Given these second events occurring so soon after DCIS treatment, it must be considered that invasive cancers were present elsewhere, but mammographically occult, at the time of DCIS diagnosis. To examine this possibility, 288 consecutive patients with newly diagnosed DCIS underwent preoperative MRI, with the discovery of separate foci of invasive cancer, either multicentric or contralateral, occurring in 3.5% of patients, a similar incidence to the short-term observational study. These "elsewhere" invasive cancers are presented here with details of pathology such that both Stage I and Stage II disease can be seen as clinically significant, with the usual stage-based survival implications.

  9. Advanced vertebral fracture among newly diagnosed children with acute lymphoblastic leukemia: results of the Canadian Steroid-Associated Osteoporosis in the Pediatric Population (STOPP) research program.

    PubMed

    Halton, Jacqueline; Gaboury, Isabelle; Grant, Ronald; Alos, Nathalie; Cummings, Elizabeth A; Matzinger, Maryann; Shenouda, Nazih; Lentle, Brian; Abish, Sharon; Atkinson, Stephanie; Cairney, Elizabeth; Dix, David; Israels, Sara; Stephure, David; Wilson, Beverly; Hay, John; Moher, David; Rauch, Frank; Siminoski, Kerry; Ward, Leanne M

    2009-07-01

    Vertebral compression is a serious complication of childhood acute lymphoblastic leukemia (ALL). The prevalence and pattern of vertebral fractures, as well as their relationship to BMD and other clinical indices, have not been systematically studied. We evaluated spine health in 186 newly diagnosed children (median age, 5.3 yr; 108 boys) with ALL (precursor B cell: N = 167; T cell: N = 19) who were enrolled in a national bone health research program. Patients were assessed within 30 days of diagnosis by lateral thoraco-lumbar spine radiograph, bone age (also used for metacarpal morphometry), and BMD. Vertebral morphometry was carried out by the Genant semiquantitative method. Twenty-nine patients (16%) had a total of 75 grade 1 or higher prevalent vertebral compression fractures (53 thoracic, 71%; 22 lumbar). Grade 1 fractures as the worst grade were present in 14 children (48%), 9 patients (31%) had grade 2 fractures, and 6 children (21%) had grade 3 fractures. The distribution of spine fracture was bimodal, with most occurring in the midthoracic and thoraco-lumbar regions. Children with grade 1 or higher vertebral compression had reduced lumbar spine (LS) areal BMD Z-scores compared with those without (mean +/- SD, -2.1 +/- 1.5 versus -1.1 +/- 1.2; p < 0.001). LS BMD Z-score, second metacarpal percent cortical area Z-score, and back pain were associated with increased odds for fracture. For every 1 SD reduction in LS BMD Z-score, the odds for fracture increased by 80% (95% CI: 10-193%); the presence of back pain had an OR of 4.7 (95% CI: 1.5-14.5). These results show that vertebral compression is an under-recognized complication of newly diagnosed ALL. Whether the fractures will resolve through bone growth during or after leukemia chemotherapy remains to be determined.

  10. Respiratory pharmacotherapy use in patients newly diagnosed with chronic obstructive pulmonary disease in a primary care setting in the UK: a retrospective cohort study.

    PubMed

    Wurst, Keele E; Shukla, Amit; Muellerova, Hana; Davis, Kourtney J

    2014-09-01

    This retrospective cohort study aimed to analyze the prescribing practices of general practitioners treating patients with newly diagnosed chronic obstructive pulmonary disease (COPD), and to assess characteristics associated with initial pharmacotherapy. Patients were identified in the General Practice Research Database, a population-based UK electronic medical record (EMR) with data from January 1, 2008 to December 31, 2009. Patient characteristics, prescribed COPD pharmacotherapies (≤12 months before diagnosis and within 3 months following diagnosis), co-morbidities, hospitalizations, and events indicative of a possible COPD exacerbation (≤12 months before diagnosis) were analyzed in 7881 patients with newly diagnosed COPD. Most patients (64.4%) were prescribed COPD pharmacotherapy in the 12 months before diagnosis. Following diagnosis, COPD pharmacotherapy was prescribed within 3 months in 85.0% of patients. Short-acting bronchodilators alone (22.9%) or inhaled corticosteroids + long-acting beta-2 agonists (ICS+LABA, 22.1%) were prescribed most frequently. Compared with other pharmacotherapies, the prevalence of severe airflow limitation was highest in patients prescribed ICS+LABA+long-acting muscarinic antagonists (LAMA). Moderate-to-severe dyspnea was identified most frequently in patients prescribed a LAMA-containing regimen. Patients prescribed an ICS-containing regimen had a higher prevalence of asthma or possible exacerbations recorded in the EMR than those not prescribed ICS. In conclusion, pharmacotherapy prescribed at initial COPD diagnosis varied by disease severity indicators as assessed by airflow limitation, dyspnea, history of asthma, and possible exacerbations. Frequent prescription of COPD pharmacotherapies before the first-recorded COPD diagnosis indicates a delay between obstructive lung disease presentation in primary care practice and assignment of a medical diagnosis.

  11. Impact of β-thalassemia trait carrier state on cardiovascular risk factors and metabolic profile in patients with newly diagnosed hypertension.

    PubMed

    Triantafyllou, A I; Vyssoulis, G P; Karpanou, E A; Karkalousos, P L; Triantafyllou, E A; Aessopos, A; Farmakis, D T

    2014-05-01

    Thalassemia minor (Tm), the β-thalassemia carrier state, is followed by favorable lipidemic profile and seems to protect against myocardial infarction mainly in men. However, the cardiovascular risk factor (CRF) and metabolic profile of these subjects has not been thoroughly addressed, although it is not known whether gender differences are involved. We evaluated CRFs, metabolic parameters and risk-prediction equations along with renal function and selected echocardiographic indices in 23,680 consecutive subjects, that is, 11,192 women and 12,488 men, with newly diagnosed hypertension according to the presence or absence of Tm. Of 23,680 patients, 548 (2.3%) had Tm. Compared with patients without Tm, Tm cases had similar gender distribution, age, body mass index and blood pressure. Besides having a better lipidemic profile, Tm patients were less frequently smokers (25% vs. 32%, P<0.001), had a lower prevalence of metabolic syndrome (26% vs. 39%, P<0.001) and lower HeartSCORE and INTERHEART scores (P<0.001). Tm patients also had lower levels of fibrinogen and plasminogen activator inhibitor-1 (P<0.001), lower serum creatinine and higher estimated glomerular filtration rate (P<0.001), lower prevalence of left ventricular hypertrophy (35% vs. 48%, P<0.001) and higher total and mid-wall fractional shortening (P=0.03 and <0.001, respectively). Most of these differences were consistent in both genders, whereas the HeartSCORE and the echo indices were significantly better in Tm only in women. Among patients with newly diagnosed hypertension, those with Tm have a better overall CRF and metabolic profile, beyond the well-known differences in serum lipids. Compared with men, women seem to be at least equally protected.

  12. 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.

  13. 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

  14. 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.

  15. Prevalence of adult Huntington's disease in the UK based on diagnoses recorded in general practice records

    PubMed Central

    Evans, Stephen JW; Douglas, Ian; Rawlins, Michael D; Wexler, Nancy S; Tabrizi, Sarah J; Smeeth, Liam

    2013-01-01

    Background and purpose The prevalence of Huntington's disease (HD) in the UK is uncertain. Recently, it has been suggested that the prevalence may be substantially greater than previously reported. This study was undertaken to estimate the overall UK prevalence in adults diagnosed with HD, using data from primary care. Methods The electronic medical records of patients aged 21 years or more, with recorded diagnoses of HD, were retrieved from the UK's General Practice Research Database. Prevalence was estimated from the number of persons with recorded diagnoses of HD, on 1 July each year, between 1990 and 2010. This number was divided by the total number of persons registered with participating general practices on that same date. These data were also used to estimate both age specific prevalence and prevalence in various regions of the UK. Results A total of 1136 patients diagnosed with HD, aged 21 years or more, were identified from the database. The estimated prevalence (expressed per 100 000 population) rose from 5.4 (95% CI 3.8 to 7.5) in 1990 to 12.3 (95% CI 11.2 to 13.5) in 2010. Although an increased prevalence was observed within every age group, the most dramatic was in older patients. Age specific prevalence was highest in the 51–60 year age range (15.8 95% CI 9.0 to 22.3). The prevalence of adult HD was lowest in the London region (5.4 (95% CI 3.0 to 8.9)) and highest in the North East of England (18.3 (95% CI 8.6 to 34.6)) and Scotland (16.1 (95% CI 10.8 to 22.9)). Conclusions The prevalence of diagnosed HD is clearly substantially higher in the UK than suggested from previous studies. By extrapolation to the UK as a whole, it is estimated that there are more than 5700 people, aged 21 years or more, with HD. There has also been a surprising doubling of the HD population between 1990 and 2010. Many factors may have caused this increase, including more accurate diagnoses, better and more available therapies and an improved life expectancy

  16. Comparison of PG-SGA, SGA and body-composition measurement in detecting malnutrition among newly diagnosed lung cancer patients in stage IIIB/IV and benign conditions.

    PubMed

    Li, Rong; Wu, Jing; Ma, Meili; Pei, Jun; Song, Yiyi; Zhang, Xueyan; Han, Baohui

    2011-09-01

    Assessment tools and body-composition measurements are useful in diagnosing malnutrition. Which one is better for lung disease patients is unclear. The objectives of the present study are: to assess relationships between different methods of nutritional measurements in lung diseases patients; to determine which one is better in diagnosing malnutrition for lung disease patients; and to determine whether lung cancer patients can be differentiated from benign lung disease patients using different measurements. A total of 96 newly diagnosed primary lung cancer patients in stage IIIB/IV and 52 benign lung disease patients nutritional status were assessed according to the SGA, the scored PG-SGA, and serum albumin, prealbumin, transferrin, hemoglobin, total lymphocyte count, body mass index (BMI), and weight. A total of 40% of lung cancer patients were severely malnourished, with men or elder having a higher rate of malnutrition. Significantly lower values of weight, BMI, total lymphocyte count, transferrin, prealbumin and serum albumin were found for them. Age, sex, weight, weight half year ago and prealbumin are in the regression equation to predict them. For benign lung disease patients, 21.2% were severely malnourished with significantly lower values of weight and transferrin. Age and prealbumin are in the equation to predict severely malnourished benign lung disease patients. The highest receiver operation characteristic area under the curve was found for the PG-SGA score, BMI and weight. PG-SGA global rating, age and iron-transferring protein are in the equation for predicting disease status. The SGA and PG-SGA are appropriate for identifying malnutrition in lung disease patients. Lung cancer patients can be differentiated from benign conditions by PG-SGA.

  17. 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

  18. Addressing Structural Barriers to HIV Care among Triply Diagnosed Adults: Project Bridge Oakland.

    PubMed

    Powers, Christina; Comfort, Megan; Lopez, Andrea M; Kral, Alex H; Murdoch, Owen; Lorvick, Jennifer

    2017-03-14

    People who are "triply diagnosed" with HIV, mental health issues, and substance-related disorders face tremendous barriers connecting to and remaining in HIV care. Authors of this article implemented Project Bridge Oakland (PBO), an intervention based on harm reduction and trauma-informed care, to help maintain continuity of care for triply diagnosed adults through cycles of criminal justice involvement. From August 2011 to December 2014, a clinical social worker and an HIV physician provided intensive case management for 19 clients living in Oakland, California. By working with clients across a multitude of community, clinic, and correctional spaces while maintaining a low threshold for services, the social worker was able to engage a severely marginalized population in HIV care. This article details the PBO strategies for assisting with a wide range of services needed for community stabilization, navigating criminal justice involvement, and establishing a therapeutic relationship through mundane practices such as eating and waiting for appointments. This article illustrates how programs aimed at stabilizing triply diagnosed clients in the community and connecting them to HIV care require coordination among providers, outreach to engage clients, ample time to work with them, and flexibility to account for the complexities of their day-to-day lives and experiences.

  19. Understanding Prostate Cancer: Newly Diagnosed

    MedlinePlus

    ... tumor cells. The higher the score, the more aggressive the tumor. The cells are scored on a ... Gleason scores (2 – 4) tend to be less aggressive, while cancers with higher Gleason scores (7 – 10) ...

  20. 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 ... medical treatment for mental ills. Don't let yourself become isolated. Pick ...

  1. The Prognosis of Anti-Angiogenesis Treatments Combined with Standard Therapy for Newly Diagnosed Glioblastoma: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Ciccone, Natalia; Wang, Xingdong; Zhang, Hengzhu

    2016-01-01

    Background and Purpose Although bevacizumab (BV) has been approved as second-line therapy for recurrent glioblastoma (GB), the efficacy and safety of BV for patients with newly diagnosed GB remain unclear. Methodology/Principal Findings We systematically searched electronic databases (PubMed, EMBASE, OVID, etc.) to identify related studies published from January 1966 and August 2016. Eight randomized controlled trials including a total of 2,185 patients with GB were included. We found that the median progression-free survival (PFS) was higher in the BV group than in the standard therapy (ST) group (pooled hazard ratio, 0.73; 95%CI, 0.62–0.86; P = 0.0001). Compared with ST, BV improved the PFS rate at 6 months (OR 3.33, 95% CI 2.73–4.06, p<0.00001) and 12 months (OR 2.10, 95% CI 1.74–2.54, p<0.00001). There were no significant differences in median overall survival between the BV and ST groups (OR, 1.01; 95%CI, 0.83–1.23; P = 0.95). The BV group had higher survival rates at 6 months (OR, 1.41; 95% CI, 1.09–1.84; P = 0.01) and 12 months (OR, 1.23; 95% CI, 1.02–1.48; P = 0.03), but a low survival rate at the 36-month follow-up (OR, 0.57; 95% CI, 0.32–0.98; P = 0.04). For the incidence of adverse events, three adverse outcomes were found to be significantly different between BV and ST groups, including hypertension (8.37% vs. 1.62%, p<0.000001), proteinuria (7.65% vs. 0%, p<0.001), and fatigue (14.54% vs. 9.01%, p = 0.05). Conclusions/Significance Our study indicates that combination of BV with ST for newly diagnosed GB did not improve the median overall survival but result in longer median PFS, maintaining the quality of life and functional status. However, the long-term use of BV is associated with a higher incidence of adverse events and mortality. Study Registration This research was registered at PROSPERO. (Registration Number: CRD42016038247). PMID:28005980

  2. Effect of intensive insulin therapy on first-phase insulin secretion in newly diagnosed type 2 diabetic patients with a family history of the disease

    PubMed Central

    LI, QING; WANG, LUAN; XIAO, LIN; WANG, ZHONGCHAO; WANG, FANG; YU, XIAOLONG; YAN, SHENGLI; WANG, YANGANG

    2015-01-01

    Intensive insulin treatment is known to improve β-cell function in the majority of patients with newly diagnosed type 2 diabetes mellitus (T2DM), and family history (FH) is known to be an important independent risk factor for T2DM. Thus, the aim of the present study was to investigate the difference in first-phase insulin secretion and the effect of intensive insulin therapy on the improvement of β-cell function between T2DM patients with and without a FH of diabetes. Patients with newly diagnosed T2DM and healthy controls were divided into groups according to their FH of diabetes. Improvement in β-cell function was evaluated with an arginine stimulation test after two weeks of continuous subcutaneous insulin infusion (CSII). Compared with the control group, the level of fasting insulin and the homeostasis model assessment of insulin resistance (HOMA2-IR) were higher in the DM group, while the homeostasis model assessment of β-cell insulin secretion (HOMA2-%β) and the first-phase peak ratio were lower (P<0.05). In addition, the first-phase peak ratio in the FH- control group was higher compared with that in the FH+ control group (P=0.023). Following CSII, all the patients achieved excellent blood glucose control in 6.2±3.6 days, without severe adverse effects. In the DM groups, the fasting insulin level and HOMA2-IR were lower, while the HOMA2-%β and first-phase peak ratio were higher, when compared with the values prior to treatment, particularly in the FH- DM group. The HOMA2-%β in the FH+ DM group was lower compared with the FH- DM group (P=0.027). Therefore, T2DM patients with and without a FH of the disease were shown to have a good response to CSII in the improvement of insulin resistance and β-cell function; however, the improvements were less significant in patients with a FH compared with patients without a FH of diabetes. PMID:25574243

  3. Effect of Linagliptin on Glycemic Control in Chinese Patients with Newly-Diagnosed, Drug-Naïve Type 2 Diabetes Mellitus: A Randomized Controlled Trial.

    PubMed

    Wu, Wenjun; Li, Ying; Chen, Xiong; Lin, Dini; Xiang, Songying; Shen, Feixia; Gu, Xuemei

    2015-09-09

    BACKGROUND This study aimed to evaluate the efficacy and safety of linagliptin (a novel dipeptidyl peptidase (DPP)-4 inhibitor) on glucose metabolism and β-cell function in Chinese patients with newly-diagnosed, drug-naïve type 2 diabetes mellitus (T2DM). MATERIAL AND METHODS Newly-diagnosed and drug-naïve T2DM patients were enrolled. After 4-week lifestyle modulation and 2-week placebo run-in, 57 patients were randomized to double-blind treatment with linagliptin (n=34) or placebo (n=23). The primary endpoint was the change from baseline in glycosylated hemoglobin A1c (HbA1c) after 24 weeks. Fasting plasma glucose (FPG), 2-h postprandial plasma glucose (2h-PPG), fasting insulin, proinsulin-to-insulin ratio, homeostasis model assessment of insulin resistance (HOMA-IR), and homeostasis model assessment of β-cell function (HOMA-β) were also evaluated. RESULTS Baseline characteristics were similar between the 2 groups. Compared with placebo, linagliptin therapy resulted in a significant decrease in HbA1C (-1.2±0.7% vs. -0.4±0.4%, P<0.001), FBG (-0.98±1.17 vs. -0.32±0.51 mmol/L, P=0.011, and 2h-PPG (-2.02±0.94 vs. -0.97±0.63 mmol/L, P<0.001). Significant differences were observed for the proinsulin/insulin ratio (P<0.001) and HOMA-β index (P=0.001). Rates of adverse events were similar between the 2 groups (30.3% vs. 27.3%). All adverse events were mild. One patient discontinued participation due to pregnancy. CONCLUSIONS Linagliptin treatment resulted in a significant and clinically meaningful improvement of glycemic control in drug-naïve Chinese patients with T2DM, as well as improved parameters of b-cell function. Linagliptin had an excellent safety profile.

  4. Circulating CD4+CD161+ T Lymphocytes Are Increased in Seropositive Arthralgia Patients but Decreased in Patients with Newly Diagnosed Rheumatoid Arthritis

    PubMed Central

    Chalan, Paulina; Huitema, Minke G.; Abdulahad, Wayel H.; Bijzet, Johan; Brouwer, Elisabeth; Boots, Annemieke M. H.

    2013-01-01

    Improved understanding of the immune events discriminating between seropositive arthralgia and clinical synovitis is of key importance in rheumatology research. Ample evidence suggests a role for Th17 cells in rheumatoid arthritis. We hypothesized that CD4+CD161+ cells representing Th17 lineage cells may be modulated prior to or after development of clinical synovitis. Therefore, in a cross-sectional study, we investigated the occurrence of CD4+CD161+ T-cells in seropositive arthralgia patients who are at risk for developing rheumatoid arthritis and in newly diagnosed rheumatoid arthritis patients. In a prospective study, we evaluated the effect of methotrexate treatment on circulating CD4+CD161+ T-cells. Next, we assessed if these cells can be detected at the level of the RA joints. Precursor Th17 lineage cells bearing CD161 were found to be increased in seropositive arthralgia patients. In contrast, circulating CD4+CD161+T-cells were decreased in newly diagnosed rheumatoid arthritis patients. The decrease in CD4+CD161+ T-cells correlated inversely with C-reactive protein and with the 66 swollen joint count. Methotrexate treatment led to normalization of CD4+CD161+ T-cells and reduced disease activity. CD4+CD161+ T cells were readily detected in synovial tissues from both early and late-stage rheumatoid arthritis. In addition, synovial fluid from late-stage disease was found to be enriched for CD4+CD161+ T-cells. Notably, synovial fluid accumulated CD4+CD161+T-cells showed skewing towards the Th1 phenotype as evidenced by increased interferon-γ expression. The changes in peripheral numbers of CD4+CD161+ T-cells in seropositive arthralgia and early rheumatoid arthritis and the enrichment of these cells at the level of the joint predict a role for CD4+CD161+ T-cells in the early immune events leading to clinical synovitis. Our findings may add to the development of RA prediction models and provide opportunities for early intervention. PMID:24223933

  5. Advanced Vertebral Fracture among Newly Diagnosed Children with Acute Lymphoblastic Leukemia: Results of the Canadian STeroid-associated Osteoporosis in the Pediatric Population (STOPP) Research Program

    PubMed Central

    Halton, J.; Gaboury, I.; Grant, R.; Alos, N.; Cummings, E. A.; Matzinger, M.; Shenouda, N.; Lentle, B.; Abish, S.; Atkinson, S.; Cairney, E.; Dix, D.; Israels, S.; Stephure, D.; Wilson, B.; Hay, J.; Moher, D.; Rauch, F.; Siminoski, K.; Ward, L.M.

    2013-01-01

    Vertebral compression is a serious complication of childhood acute lymphoblastic leukemia (ALL). The prevalence and pattern of vertebral fractures, as well as their relationship to bone mineral density (BMD) and other clinical indices, have not been systematically studied. We evaluated spine health in 186 newly diagnosed children (median age 5.3 years, 108 boys) with ALL (precursor B cell: N=167; T-cell: N=19), who were enrolled in a national bone health research program. Patients were assessed within 30 days of diagnosis by lateral thoraco-lumbar spine radiograph, bone age (also used for metacarpal morphometry) and BMD. Vertebral morphometry was carried out by the Genant semi-quantitative method. Twenty-nine patients (16%) had a total of 75 grade 1 or higher prevalent vertebral compression fractures (53 thoracic, 71%; 22 lumbar). Grade 1 fractures as the worst grade were present in 14 children (48%), 9 patients (31%) had grade 2 fractures, and 6 children (21%) had grade 3 fractures. The distribution of spine fracture was bi-modal, with most occurring in the mid-thoracic and thoraco-lumbar regions. Children with grade 1 or higher vertebral compression had reduced lumbar spine (LS) areal BMD Z-scores compared to those without (mean±SD, −2.1±1.5 vs. −1.1±1.2; P < 0.001). LS BMD Z-score, second metacarpal percent cortical area Z-score, and back pain were associated with increased odds for fracture. For every 1 SD reduction in LS BMD Z-score, the odds for fracture increased by 80% (95% CI 10% to 193%); the presence of back pain had an odds ratio of 4.7 (95% CI, 1.5 to 14.5). These results show that vertebral compression is an under-recognized complication of newly diagnosed ALL. Whether the fractures will resolve through bone growth during or after leukemia chemotherapy remains to be determined. PMID:19210218

  6. 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

  7. 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

  8. Association of Diffusion and Anatomic Imaging Parameters with Survival for Patients with Newly Diagnosed Glioblastoma Participating in Two Different Clinical Trials1

    PubMed Central

    Wen, Qiuting; Jalilian, Laleh; Lupo, Janine M.; Li, Yan; Roy, Ritu; Molinaro, Annette M.; Chang, Susan M.; Prados, Michael; Butowski, Nicholas; Clarke, Jennifer; Nelson, Sarah J.

    2015-01-01

    PURPOSE: To evaluate the time course and association with survival of anatomic lesion volumes and diffusion imaging parameters for patients with newly diagnosed glioblastoma who were treated with radiation and concurrently with either temozolomide and enzastaurin (TMZ+enza cohort) or temozolomide, erlotonib, and bevaciumab (TMZ+erl+bev cohort). MATERIALS AND METHODS: Regions of interest corresponding to the contrast-enhancing and hyperintense lesions on T2-weighted images were generated. Diffusion-weighted images were processed to provide maps of apparent diffusion coefficient, fractional anisotropy, and longitudinal and radial eigenvalues. Histograms of diffusion values were generated and summary statistics calculated. Cox proportional hazards models were employed to assess the association of representative imaging parameters with survival with adjustments for age, Karnofsky performance status, and extent of resection. RESULTS: Although progression-free survival was significantly longer for the TMZ+erl+bev cohort (12.8 vs 7.3 months), there was no significant difference in overall survival between the two populations (17.0 vs 17.8 months). The median contrast-enhancing lesion volumes decreased from 6.3 to 1.9 cm3 from baseline to the postradiotherapy scan for patients in the TMZ+enza cohort and from 2.8 to 0.9cm3 for the TMZ+erl+bev cohort. Changes in the T2 lesion volumes were only significant for the latter cohort (26.5 to 11.9 cm3). The median apparent diffusion coefficient and related diffusion parameters were significantly increased for the TMZ+enza cohort (1054 to 1225 μm2/s). More of the anatomic parameters were associated with survival for the TMZ+enza cohort, whereas more diffusion parameters were associated with survival for the TMZ+erl+bev cohort. CONCLUSION: The early changes in anatomic and diffusion imaging parameters and their association with survival reflected differences in the mechanisms of action of the treatments that were being given. This

  9. Diagnosis-Specific Prognostic Factors, Indexes, and Treatment Outcomes for Patients With Newly Diagnosed Brain Metastases: A Multi-Institutional Analysis of 4,259 Patients

    SciTech Connect

    Sperduto, Paul W.; Chao, Samuel T.; Sneed, Penny K.

    2010-07-01

    Purpose: Controversy endures regarding the optimal treatment of patients with brain metastases (BMs). Debate persists, despite many randomized trials, perhaps because BM patients are a heterogeneous population. The purpose of the present study was to identify significant diagnosis-specific prognostic factors and indexes (Diagnosis-Specific Graded Prognostic Assessment [DS-GPA]). Methods and Materials: A retrospective database of 5,067 patients treated for BMs between 1985 and 2007 was generated from 11 institutions. After exclusion of the patients with recurrent BMs or incomplete data, 4,259 patients with newly diagnosed BMs remained eligible for analysis. Univariate and multivariate analyses of the prognostic factors and outcomes by primary site and treatment were performed. The significant prognostic factors were determined and used to define the DS-GPA prognostic indexes. The DS-GPA scores were calculated and correlated with the outcomes, stratified by diagnosis and treatment. Results: The significant prognostic factors varied by diagnosis. For non-small-cell lung cancer and small-cell lung cancer, the significant prognostic factors were Karnofsky performance status, age, presence of extracranial metastases, and number of BMs, confirming the original GPA for these diagnoses. For melanoma and renal cell cancer, the significant prognostic factors were Karnofsky performance status and the number of BMs. For breast and gastrointestinal cancer, the only significant prognostic factor was the Karnofsky performance status. Two new DS-GPA indexes were thus designed for breast/gastrointestinal cancer and melanoma/renal cell carcinoma. The median survival by GPA score, diagnosis, and treatment were determined. Conclusion: The prognostic factors for BM patients varied by diagnosis. The original GPA was confirmed for non-small-cell lung cancer and small-cell lung cancer. New DS-GPA indexes were determined for other histologic types and correlated with the outcome, and

  10. 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

  11. 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.

  12. "When we are together I feel at home." Types and sources of social support among youth newly diagnosed with HIV in Kenya: implications for intervention.

    PubMed

    Lypen, Kathryn D; Lockwood, Nicole M; Shalabi, Firas; Harper, Gary W; Ngugi, Elizabeth

    2015-01-01

    Social support helps youth manage psychosocial stress. Though many studies have investigated the role of social support in helping youth in developed countries cope with their HIV status, such research is lacking among youth living in sub-Saharan African countries, including Kenya. The importance of research on youth living with HIV in Kenya is enhanced given young people's unique developmental stages and the HIV prevalence rate of 8.8% among Kenyans aged 25 to 29 years. To gain further insight, qualitative focus group interviews were conducted with 53 youth aged 18 to 27 years who lived in the informal urban settlement of Kibera in Nairobi, Kenya. A phenomenological approach was used to analyse the data from which four major types of social support were identified: 1) emotional; 2) informational; 3) appraisal; and 4) instrumental. Within each of these overarching themes more specific sub-themes were identified. The youth also reported receiving social support from eight main sources: 1) family; 2) friends; 3) clinicians and clinical services; 4) counsellors; 5) support groups; 6) religious sources; 7) partners; and 8) other. These findings suggest that various forms of social support, provided by diverse sources, which may fall outside of those commonly involved in interventions, can help youth living with HIV cope with their diagnosis and promote healthy lifestyles. Future research should investigate the roles and interactions of different types and sources of support, specifically as they relate to interventions aiming to ameliorate the experiences of youth newly diagnosed with HIV.

  13. 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

  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. Online screening for distress, the 6th vital sign, in newly diagnosed oncology outpatients: randomised controlled trial of computerised vs personalised triage

    PubMed Central

    Carlson, L E; Waller, A; Groff, S L; Zhong, L; Bultz, B D

    2012-01-01

    Background: This randomised controlled trial examined the impact of screening for distress followed by two different triage methods on clinically relevant outcomes over a 12-month period. Methods: Newly diagnosed patients attending a large tertiary cancer centre were randomised to one of the two conditions: (1) screening with computerised triage or (2) screening with personalised triage, both following standardised clinical triage algorithms. Patients completed the Distress Thermometer, Pain and Fatigue Thermometers, the Psychological Screen for Cancer (PSSCAN) Part C and questions on resource utilisation at baseline, 3, 6 and 12 months. Results: In all, 3133 patients provided baseline data (67% of new patients); with 1709 (54.5%) retained at 12 months (15.4% deceased). Mixed effects models revealed that both groups experienced significant decreases in distress, anxiety, depression, pain and fatigue over time. People receiving personalised triage and people reporting higher symptom burden were more likely to access services, which was subsequently related to greater decreases in distress, anxiety and depression. Women may benefit more from personalised triage, whereas men may benefit more from a computerised triage model. Conclusion: Screening for distress is a viable intervention that has the potential to decrease symptom burden up to 12 months post diagnosis. The best model of screening may be to incorporate personalised triage for patients indicating high levels of depression and anxiety while providing computerised triage for others. PMID:22828610

  16. Relationships between glucose excursion and the activation of oxidative stress in patients with newly diagnosed type 2 diabetes or impaired glucose regulation.

    PubMed

    Zheng, Fenping; Lu, Weina; Jia, Chengfang; Li, Hong; Wang, Zhou; Jia, Weiping

    2010-02-01

    The effect of glucose excursions on oxidative stress is an important topic in diabetes research. We investigated this relationship by analyzing markers of oxidative stress and glycemic data from a continuous glucose monitoring system (CGMS) in 30 individuals with normal glucose regulation (NGR), 27 subjects with impaired glucose regulation (IGR), and 27 patients with newly diagnosed type 2 diabetes (T2DM). We compared the mean amplitude of glycemic excursion (MAGE), mean postprandial glucose excursion (MPPGE), and mean postprandial incremental area under the curve (IAUC) with plasma levels of oxidative stress markers 8-iso-PGF2α, 8-OH-dG, and protein carbonyl content in the study subjects. Patients with T2DM or IGR had significantly higher glucose excursions and plasma levels of oxidative stress markers compared to normal controls (P < 0.01 or 0.05). Multiple linear regression analyses showed significant relationships between MAGE and plasma 8-iso-PGF2α, and between MPPGE and plasma 8-OH-dG in patients with IGR or T2DM (P < 0.01 or 0.05). Furthermore, 2h-postprandial glucose level and IAUC were related to plasma protein carbonyl content in the study cohort including T2DM and IGR (P < 0.01). We demonstrate that glucose excursions in subjects with IGR and T2DM trigger the activation of oxidative stress.

  17. Variations in the role of social support on disclosure among newly diagnosed HIV-infected people who inject drugs in Vietnam

    PubMed Central

    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

  18. The Psychosocial Assessment Tool (PAT2.0): Psychometric Properties of a Screener for Psychosocial Distress in Families of Children Newly Diagnosed with Cancer

    PubMed Central

    Pai, Ahna L. H.; Patiño-Fernández, Anna Maria; McSherry, Mary; Beele, David; Alderfer, Melissa A.; Reilly, Anne T.; Hwang, Wei-Ting; Kazak, Anne E.

    2010-01-01

    Purpose Psychometric properties of the Psychosocial Assessment Tool 2.0 (PAT2.0), a brief screener for psychosocial risk in families of children with cancer, are presented. Methods Female (N =132) and male (N =72) caregivers of 141 children newly diagnosed with cancer completed the PAT2.0 and measures of child behavior symptoms, anxiety, acute stress, and family functioning to establish validity. Internal consistency and test–retest reliability of the PAT2.0 were also examined. Results Internal consistency and two-week test–retest for the PAT2.0 Total score was strong. Validity for the PAT2.0 was supported by significant correlations between the PAT2.0 subscales and measures of corresponding constructs. PAT2.0 Total scores were correlated with acute stress and child behavior symptoms for both mothers and fathers. Receiver-Operating Characteristic curves provided preliminary support for the proposed cutoffs. Conclusion The PAT2.0 Total score is a useful screening tool for family psychosocial risk in the pediatric oncology population. PMID:17609228

  19. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial.

    PubMed

    Lu, Jin; Lee, Jae H; Huang, Shang-Yi; Qiu, Lugui; Lee, Je-Jung; Liu, Ting; Yoon, Sung-Soo; Kim, Kihyun; Shen, Zhi X; Eom, Hyeon S; Chen, Wen M; Min, Chang K; Kim, Hyo J; Lee, Jeong O; Kwak, Jae Y; Yiu, Wai; Chen, Guang; Ervin-Haynes, Annette; Hulin, Cyrille; Facon, Thierry

    2017-03-01

    The phase 3 FIRST (Frontline Investigation of REVLIMID + Dexamethasone Versus Standard Thalidomide) trial demonstrated that lenalidomide plus low-dose dexamethasone (Rd) until disease progression (Rd continuous) is an effective treatment option for transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Given genetic differences between Asian and Western populations, this subanalysis of the FIRST trial examined the safety and efficacy of Rd (given continuously or for 18 cycles [Rd18]) and MPT (melphalan, prednisone, thalidomide) in 114 Asian patients from Mainland China, South Korea and Taiwan. Efficacy and safety with Rd continuous in Asian patients were consistent with those in the overall study population. The overall response rates were 77·8% for Rd continuous, 57·5% for MPT and 65·8% for Rd18. The risk of progression or death was reduced by 39% with Rd continuous versus MPT and by 35% with Rd continuous versus Rd18. Rd continuous improved the 3-year survival rate compared with MPT (70·2% vs. 56·4%) and Rd18 (58·1%). Common grade 3/4 adverse events in the Rd continuous and MPT arms were neutropenia (25·0% vs. 43·6%), infection (19·4% vs. 28·2%) and anaemia (19·4% vs. 15·4%), respectively. Thromboembolic event rates were low, and no second primary malignancies were observed. Rd continuous is safe and effective in transplant-ineligible Asian patients with NDMM.

  20. Updated survival analysis of two sequential prospective trials of R-MACLO-IVAM followed by maintenance for newly diagnosed mantle cell lymphoma.

    PubMed

    Hosein, Peter J; Sandoval-Sus, Jose D; Goodman, Deborah; Arteaga, Alexandra Gomez; Reis, Isildinha; Hoffman, James; Stefanovic, Alexandra; Rosenblatt, Joseph D; Lossos, Izidore S

    2015-06-01

    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 MCL 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.

  1. Abnormal Glucose Tolerance, White Blood Cell Count, and Telomere Length in Newly Diagnosed, Antidepressant-Naïve Patients with Depression

    PubMed Central

    Garcia-Rizo, Clemente; Fernandez-Egea, Emilio; Miller, Brian J.; Oliveira, Cristina; Justicia, Azucena; Griffith, Jeffrey K.; Heaphy, Christopher M.; Bernardo, Miguel; Kirkpatrick, Brian

    2012-01-01

    Chronic mood disorders have been associated with a shortened telomere, a marker of increased mortality rate and ageing, and impaired cellular immunity. However, treatment may confound these relationships. We examined the relationship of glucose tolerance, white blood cell count and telomere length to depression in newly diagnosed, antidepressant-naïve patients. Subjects with major depression (n=15), and matched healthy control subjects (n=70) underwent a two-hour oral glucose tolerance test and evaluation of blood cell count and telomere content. The depression group had significantly higher two-hour glucose concentrations and a lower lymphocyte count than control subjects (respective means [SD] for two-hour glucose were 125.0 mg/dL [67.9] vs 84.6 [25.6] (p<.001); for lymphocyte count 2.1 × 109/L [0.6] vs. 2.5 ×109/L [0.7] p=.028).Telomere content was significantly shortened in the depression group (87.9 [7.6]) compared to control subjects (101.0 [14.3]; p<0.01). Abnormal glucose tolerance, lymphopenia and a shortened telomere are present early in the course of depression independently of the confounding effect of antidepressant treatment, supporting the concept of major depression as an accelerated ageing disease. PMID:23207109

  2. The incremental effect of obstructive sleep apnea syndrome on right and left ventricular myocardial performance in newly diagnosed essential hypertensive subjects.

    PubMed

    Gao, Jing; Hua, Qi; Li, Jing; Wang, Cai-Rong

    2009-03-01

    Obstructive sleep apnea syndrome (OSAS) may predispose patients to congestive heart failure, suggesting a deleterious effect of OSAS on myocardial contractility. We investigated whether essential hypertensive individuals with OSAS are characterized by decreased right and left ventricular myocardial performance. Our study population consisted of 45 consecutive patients with newly diagnosed untreated stage I-II essential hypertension suffering from OSAS (35 men, aged 49+/-8 years) and 48 hypertensives without OSAS, matched for age, sex, level of blood pressure, heart rate, body mass index and smoking status. All subjects underwent polysomnography and echocardiography. Right and left ventricular functions were evaluated using the myocardial performance index (MPI). Right and left ventricular functions were altered in hypertensives with OSAS. The mean right MPI was 0.26+/-0.11 in hypertensives without OSAS and 0.51+/-0.16 in hypertensives with OSAS (P<0.01). The mean left MPI values were 0.29+/-0.07 and 0.44+/-0.13, respectively (P<0.01). Right and left MPI correlated positively and significantly with apnea-hypopnea index (rho=0.40, P=0.002).OSAS is associated with impaired right and left ventricular function. These phenomena were independent of hypertension.

  3. Association between coefficients of variation of the R-R intervals on electrocardiograms and post-challenge hyperglycemia in patients with newly diagnosed type 2 diabetes.

    PubMed

    Nakade, Yusuke; Takamura, Toshinari; Sakurai, Masaru; Misu, Hirofumi; Nagata, Mitsuko; Nanbu, Yuko; Oe, Hiroyasu; Takamura, Toshiji; Sakai, Yoshio; Kaneko, Shuichi; Wada, Takashi

    2011-08-02

    The aim of the present study was to examine whether there is a relationship between autonomic function and post-challenge hyperglycemia in patients with type 2 diabetes. Subjects included 122 Japanese patients newly diagnosed with type 2 diabetes. Autonomic nerve function was assessed using coefficients of variation of the R-R intervals on electrocardiograms (CVRR). Unlike anthropometry, insulin secretion and insulin resistance, age (r = -0.209, P < 0.021) and post-challenge plasma glucose at 120 min (PG120; r = -0.219, P < 0.015) were the only variables significantly correlated with CVRR. Age was not significantly correlated with PG120. In multiple regression analyses, CVRR Z-score, but not age, was significantly correlated with PG120. The present results suggest that autonomic function affects post-challenge blood glucose levels independently of age. (J Diabetes Invest,doi: 10.1111/j.2040-1124.2010.00098.x, 2011).

  4. 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

  5. A steroid-independent regimen of bortezomib, liposomal doxorubicin and thalidomide demonstrate high response rates in newly diagnosed multiple myeloma patients

    PubMed Central

    Sher, Taimur; Ailawadhi, Sikander; Miller, Kena C.; Manfredi, Debbie; Wood, Margaret; Tan, Wei; Wilding, Gregory; Czuczman, Myron S.; Hernandez-Ilizaliturri, Francisco J.; Hong, Fredrick; Sood, Raman; Soniwala, Saif; Lawrence, William; Jamshed, Saad; Masood, Aisha; Iancu, Daniel; Lee, Kelvin; Chanan-Khan, Asher

    2014-01-01

    Novel agents have provided new a foundation for multiple myeloma therapies. When combined with other anti-myeloma agents, these compounds significantly enhance clinical efficacy. High-dose steroids are frequently used in anti-myeloma combination regimens; however, the doses employed are often poorly tolerated, especially in patients with concurrent comorbid conditions. We hypothesized that a steroid-independent combination regimen could be developed without significant compromise of efficacy. The availability of such a regimen will be important for patients whose concurrent ailments make them poor candidates for steroid containing anti-myeloma regimens. A phase II single institute, non-randomized clinical trial was conducted to investigate a novel steroid-free three-drug combination of bortezomib (V), pegylated liposomal doxorubicin (D), and thalidomide (T), the VDT regimen. Forty-three newly diagnosed multiple myeloma patients requiring treatment were enrolled on this study. The overall response rate and complete response (CR) + near complete response (nCR) rate was 78% and 35%, respectively. Median time to progression was 29.5 months. Fatigue, rash, neuropathy, constipation and infections were the most common side effects. We concluded that VDT is a tolerable and an effective regimen capable of inducing high response rates and can be employed in patients considered to be poor candidates for steroid-based treatment regimens. PMID:21554260

  6. 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

  7. 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.

  8. 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.

  9. Gait analysis of teenagers and young adults diagnosed with autism and severe verbal communication disorders

    PubMed Central

    Weiss, Michael J.; Moran, Matthew F.; Parker, Mary E.; Foley, John T.

    2013-01-01

    Both movement differences and disorders are common within autism spectrum disorders (ASD). These differences have wide and heterogeneous variability among different ages and sub-groups all diagnosed with ASD. Gait was studied in a more homogeneously identified group of nine teenagers and young adults who scored as “severe” in both measures of verbal communication and overall rating of Autism on the Childhood Autism Rating Scales (CARS). The ASD individuals were compared to a group of typically developing university undergraduates of similar ages. All participants walked a distance of 6-meters across a GAITRite (GR) electronic walkway for six trials. The ASD and comparison groups differed widely on many spatiotemporal aspects of gait including: step and stride length, foot positioning, cadence, velocity, step time, gait cycle time, swing time, stance time, and single and double support time. Moreover, the two groups differed in the percentage of the total gait cycle in each of these phases. The qualitative rating of “Body Use” on the CARS also indicated severe levels of unusual body movement for all of the ASD participants. These findings demonstrate that older teens and young adults with “severe” forms of Verbal Communication Impairments and Autism differ widely in their gait from typically developing individuals. The differences found in the current investigation are far more pronounced compared to previous findings with younger and/or less severely involved individuals diagnosed with ASD as compared to typically developing controls. As such, these data may be a useful anchor-point in understanding the trajectory of development of gait specifically and motor functions generally. PMID:23730274

  10. In-hospital Mobility Variations across Primary Diagnoses among Older Adults

    PubMed Central

    Valiani, Vincenzo; Gao, Shiyao; Chen, Zhiguo; Swami, Sunil; Harle, Christopher A.; Lipori, Gigi; Sourdet, Sandrine; Wu, Samuel; Nayfield, Susan G.; Sabbá, Carlo; Pahor, Marco; Manini, Todd M.

    2016-01-01

    Objectives To examine the relationship between primary diagnoses and mobility impairment and recovery among hospitalized older adults. Design Prospective cohort study. Setting UF Health Shands Hospital, an 852-bed level I trauma center located in Gainesville, Florida. Participants 18,551 older adults (≥65 years) with 29,148 hospitalizations between 1/2009 and 4/2014. Measurements Incident and discharge mobility impairment and recovery were assessed using the Braden activity subscale score that was recorded by the nursing staff at every shift change–approximately three times per day. Primary diagnosis ICD-9 codes were used as predictors and re-categorized by using the Agency for Health Care Research and Quality Clinical Classification Software. Results Out of the 15,498 hospital records where the patient was initially observed to “walk frequently”, 3,186 (20.6%) developed incident mobility impairment (chair-fast or bedfast). Primary diagnoses with a surgical or invasive procedure were the most prevalent (77.2 %) among the hospital observations with incident mobility impairment; otherwise primary diagnoses without surgery were much more associated with discharge mobility impairment (59%). The highest incidence of mobility impairment occurred in patients with heart valve disorders and aortic and peripheral/visceral artery aneurysms (6.24 and 6.05 events per 30 person-days, respectively); septicemia showed the highest incidence rate for mobility limitation at discharge (0.94 events per 30 person-days). Mobility impairment was observed in 13,650 (46.8% of total) records at admission and 5,930 (43.44%) were observed to recover to a state of walking occasionally or frequently. Osteoarthritis and cancer of gastrointestinal organs/peritoneum had the highest incidence rate for mobility recovery (7.68 and 5.63 events per 30 person-days respectively). Conclusions Approximately 1 out of 5 patients who were mobile at admission became significantly impaired during

  11. Neuropathological diagnoses and clinical correlates in older adults in Brazil: A cross-sectional study

    PubMed Central

    Suemoto, Claudia K.; Ferretti-Rebustini, Renata E. L.; Cippiciani, Tarcila M.; Farfel, Jose M.; Chiavegatto Filho, Alexandre; Naslavsky, Michel Satya; Pasqualucci, Carlos A.; Jacob-Filho, Wilson; Nitrini, Ricardo

    2017-01-01

    Background Clinicopathological studies are important in determining the brain lesions underlying dementia. Although almost 60% of individuals with dementia live in developing countries, few clinicopathological studies focus on these individuals. We investigated the frequency of neurodegenerative and vascular-related neuropathological lesions in 1,092 Brazilian admixed older adults, their correlation with cognitive and neuropsychiatric symptoms, and the accuracy of dementia subtype diagnosis. Methods and findings In this cross-sectional study, we describe clinical and neuropathological variables related to cognitive impairment in 1,092 participants (mean age = 74 y, 49% male, 69% white, and mean education = 4 y). Cognitive function was investigated using the Clinical Dementia Rating (CDR) and the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); neuropsychiatric symptoms were evaluated using the Neuropsychiatric Inventory (NPI). Associations between neuropathological lesions and cognitive impairment were investigated using ordinal logistic regression. We developed a neuropathological comorbidity (NPC) score and compared it to CDR, IQCODE, and NPI scores. We also described and compared the frequency of neuropathological diagnosis to clinical diagnosis of dementia subtype. Forty-four percent of the sample met criteria for neuropathological diagnosis. Among these participants, 50% had neuropathological diagnoses of Alzheimer disease (AD), and 35% of vascular dementia (VaD). Neurofibrillary tangles (NFTs), hippocampal sclerosis, lacunar infarcts, hyaline atherosclerosis, siderocalcinosis, and Lewy body disease were independently associated with cognitive impairment. Higher NPC scores were associated with worse scores in the CDR sum of boxes (β = 1.33, 95% CI 1.20–1.46), IQCODE (β = 0.14, 95% CI 0.13–0.16), and NPI (β = 1.74, 95% CI = 1.33–2.16). Compared to neuropathological diagnoses, clinical diagnosis had high sensitivity to AD and high

  12. 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

  13. 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

  14. 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.

  15. 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

  16. 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

  17. 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

  18. Lenalidomide-prednisone induction followed by lenalidomide-melphalan-prednisone consolidation and lenalidomide-prednisone maintenance in newly diagnosed elderly unfit myeloma patients.

    PubMed

    Falco, P; Cavallo, F; Larocca, A; Rossi, D; Guglielmelli, T; Rocci, A; Grasso, M; Siez, M L M; De Paoli, L; Oliva, S; Molica, S; Mina, R; Gay, F; Benevolo, G; Musto, P; Omedè, P; Freilone, R; Bringhen, S; Carella, A M; Gaidano, G; Boccadoro, M; Palumbo, A

    2013-03-01

    This multicenter phase II trial evaluated the safety and efficacy of lenalidomide-prednisone (RP) induction, followed by lenalidomide-melphalan-prednisone (MPR) consolidation and RP maintenance in elderly unfit newly diagnosed myeloma patients. Patients received four 28-day RP induction courses (lenalidomide 25 mg/day on days 1-21 and prednisone 50 mg three times/week), followed by six 28-day MPR consolidation cycles (melphalan 2 mg, prednisone 50 mg three times/week and lenalidomide 10-15 mg/day on days 1-21), and maintenance with lenalidomide (10 mg/day on days 1-21 every 28 days) plus prednisone (25 mg three times/week). Forty-six patients were enrolled. Median age was 75 years, 59% of patients had at least one comorbidity and 35% at least two. Partial response rate was 80%, including 29% very good partial response. Median time to progression was 19.6 months, median progression-free survival was 18.4 months and 2-year overall survival was 80%. At the tolerated consolidation dose (melphalan 25 mg/month and lenalidomide 10 mg/day), the most frequent grade 3 adverse events were neutropenia (36.4%), anemia (12.1%), cutaneous reactions (18.2%) and infections (12.1%). Grade 4 neutropenia occurred in 12.1% of patients. In conclusion, RP induction followed by MPR consolidation and RP maintenance showed a manageable safety profile, and reduced the risk of severe hematological toxicity in unfit elderly myeloma patients.

  19. 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

    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

    2015-09-01

    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. 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. Forty eligible patients were entered and 32 completed protocol treatment. With a median follow-up time of 8.7 years (range 1.1-10.1), median progression-free survival (PFS) is 5.8 years (95 % CI 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. 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.

  20. Marine n-3 polyunsaturated fatty acids affect the blood pressure control in patients with newly diagnosed hypertension - a 1-year follow-up study.

    PubMed

    Bagge, Carina N; Strandhave, Charlotte; Skov, Charlotte M; Svensson, My; Schmidt, Erik B; Christensen, Jeppe H

    2017-02-28

    Marine long-chained n-3 polyunsaturated fatty acids (PUFA) are recognized for their cardio-protective effects, including potential lowering of blood pressure. We hypothesized that higher habitual fish intake and n-3 PUFA plasma levels were associated with lower blood pressure and being less likely to receive antihypertensive medication after one-year follow-up. In this prospective study of 115 patients, we assessed 24 h ambulatory and central blood pressure, plasma phospholipid fatty acid composition using gas chromatography and participants completed a food frequency questionnaire, including fish-eating habits. All measurements were repeated at one-year follow-up. At baseline, patients consuming fish ≥2 times per month for dinner had significantly higher plasma levels of total marine n-3 PUFA, docosahexaenoic acid and eicosapentaenoic acid as well as significantly lower central blood pressure and a trend towards lower peripheral blood pressure. At follow-up, 21 patients (18%) without antihypertensive medication had significantly higher plasma levels of n-3 PUFA, docosahexaenoic acid and eicosapentaenoic acid as well as a higher, but still acceptable 24 h ambulatory blood pressure (137/85 mmHg) compared to subjects receiving antihypertensive medication. The untreated group was more prone to take fish oil capsules and increased their plasma levels of n-3 PUFA compared to baseline. In patients with newly diagnosed, untreated hypertension, regular fish consumption was accompanied by lower blood pressure. After one year, patients without antihypertensive medication were characterized by a significant increase and higher plasma levels of n-3 PUFA. This supports a blood pressure-lowering effect and suggests an increase in marine n-3 PUFA intake as part of non-pharmacological treatment of hypertension.

  1. Neurocognitive function and quality of life in patients with newly diagnosed brain metastasis after treatment with intra-operative cesium-131 brachytherapy: a prospective trial.

    PubMed

    Pham, Anthony; Yondorf, Menachem Z; Parashar, Bhupesh; Scheff, Ronald J; Pannullo, Susan C; Ramakrishna, Rohan; Stieg, Philip E; Schwartz, Theodore H; Wernicke, A Gabriella

    2016-03-01

    Intraoperative permanent Cesium-131 (Cs-131) brachytherapy can provide a viable alternative to WBRT with excellent response rates and minimal toxicity. This study reports the results of the prospective trial of the impact of intraoperative Cs-131 on neurocognitive function and quality of life (QoL) in patients with resected brain metastases. Between 2010 and 2012, 24 patients with newly diagnosed metastasis to the brain were accrued on a prospective protocol and treated with Cs-131 brachytherapy seeds after surgical resection. Physicians administered the mini-mental status examination (MMSE) and functional assessment of cancer therapy-brain (FACT-Br) questionnaire to all patients before treatment and again every 2 months for the duration of 6 months with additional follow-up again at 12 months. Wilcoxon rank sum test was used to analyze statistically significant changes in MMSE over time and paired t test was used to analyze changes in FACT-BR. There was a statistical improvement in overall FACT-BR score at 4 and 6 months of follow-up when compared to baseline (162 vs. 143, P = 0.004; 164 vs. 143, P = 0.005 respectively) with a non-significant trend toward improvement at 2 and 12 months (154 vs. 143, P = 0.067; 159 vs. 149, P = 0.4). MMSE score was statistically improved at 4 and up to 12 months compared to pre-treatment MMSE (30 vs. 29, P = 0.017; 30 vs. 29, P = 0.001 respectively). Patients with brain metastasis who received intra-operative permanent Cs-131 brachytherapy implants saw an improvement of their neurocognitive status and self-assessment of QoL. In addition to the excellent local control of metastasis, this approach may contribute to the improvements in cognitive function and QOL.

  2. The intriguing effects of time to glycemic goal in newly diagnosed type 2 diabetes after short-term intensive insulin therapy.

    PubMed

    Cheng, Lin; Xu, Mingtong; Lin, Xiuhong; Tang, Juying; Qi, Yiqin; Wan, Yan; Pan, Xiaofang; Chen, Xiaoyun; Ren, Meng; Yan, Li

    2016-08-31

    Short-term intensive insulin therapy is effective for type 2 diabetes because it offers the potential to achieve excellent glycemic control and improve β-cell function. We observed that the time to glycemic goal (TGG) was adjustable. Original data of 138 newly diagnosed type 2 diabetic patients received intensive insulin therapy by continuous subcutaneous insulin infusion for 2-3 weeks were retrospectively collected. Subjects underwent an intravenous glucose tolerance test (IVGTT) and an oral glucose tolerance test (OGTT) pre and post treatment. The glycemic goal was achieved within 6 (4-8) days. Patients were divided into two groups by TGG above (TGG-slow) and below (TGG-fast) the median value. Patients in both groups had significantly better glycemic control. Compared with TGG-fast, TGG-slow required a few more total insulin and performed more improvement of HOMA-β and IVGTT-AUCIns, but less improvement of HOMA-IR and QUICKI. Multiple linear regression analysis revealed that TGG was always an explanatory variable for the changes (HOMA-β, IVGTT-AUCIns, HOMA-IR and QUICKI). The hypoglycemia prevalence was lower in TGG-slow (1.48% vs. 3.40%, P<0.01). Multivariate logistic regression analysis indicated that individuals in TGG-slow had a lower risk of hypoglycemia (adjusted OR, 0.700; 95% CI, 0.567-0.864; P<0.05). Multiple linear regression analysis confirmed that the ratio of the incremental insulin to glucose responses over the first 30 min during OGTT (ΔIns30/ΔG30), average insulin dose before achieving targets, initial insulin dose and LDL-c were independent predictors for TGG. It is intriguing to hypothesize that patients with fast time to glycemic goal benefit more in improving insulin sensitivity, but patients with slow time benefit more in improving β-cell function and reducing the risk of hypoglycemia.

  3. A phase I/II trial of hydroxychloroquine in conjunction with radiation therapy and concurrent and adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme.

    PubMed

    Rosenfeld, Myrna R; Ye, Xiaobu; Supko, Jeffrey G; Desideri, Serena; Grossman, Stuart A; Brem, Steven; Mikkelson, Tom; Wang, Daniel; Chang, Yunyoung C; Hu, Janice; McAfee, Quentin; Fisher, Joy; Troxel, Andrea B; Piao, Shengfu; Heitjan, Daniel F; Tan, Kay-See; Pontiggia, Laura; O'Dwyer, Peter J; Davis, Lisa E; Amaravadi, Ravi K

    2014-08-01

    Preclinical studies indicate autophagy inhibition with hydroxychloroquine (HCQ) can augment the efficacy of DNA-damaging therapy. The primary objective of this trial was to determine the maximum tolerated dose (MTD) and efficacy of HCQ in combination with radiation therapy (RT) and temozolomide (TMZ) for newly diagnosed glioblastoma (GB). A 3 + 3 phase I trial design followed by a noncomparative phase II study was conducted in GB patients after initial resection. Patients received HCQ (200 to 800 mg oral daily) with RT and concurrent and adjuvant TMZ. Quantitative electron microscopy and immunoblotting were used to assess changes in autophagic vacuoles (AVs) in peripheral blood mononuclear cells (PBMC). Population pharmacokinetic (PK) modeling enabled PK-pharmacodynamic correlations. Sixteen phase I subjects were evaluable for dose-limiting toxicities. At 800 mg HCQ/d, 3/3 subjects experienced Grade 3 and 4 neutropenia and thrombocytopenia, 1 with sepsis. HCQ 600 mg/d was found to be the MTD in this combination. The phase II cohort (n = 76) had a median survival of 15.6 mos with survival rates at 12, 18, and 24 mo of 70%, 36%, and 25%. PK analysis indicated dose-proportional exposure for HCQ. Significant therapy-associated increases in AV and LC3-II were observed in PBMC and correlated with higher HCQ exposure. These data establish that autophagy inhibition is achievable with HCQ, but dose-limiting toxicity prevented escalation to higher doses of HCQ. At HCQ 600 mg/d, autophagy inhibition was not consistently achieved in patients treated with this regimen, and no significant improvement in overall survival was observed. Therefore, a definitive test of the role of autophagy inhibition in the adjuvant setting for glioma patients awaits the development of lower-toxicity compounds that can achieve more consistent inhibition of autophagy than HCQ.

  4. Circulating plasma cells in newly diagnosed symptomatic multiple myeloma as a possible prognostic marker for patients with standard-risk cytogenetics.

    PubMed

    Vagnoni, Davide; Travaglini, Fosco; Pezzoni, Valerio; Ruggieri, Miriana; Bigazzi, Catia; Dalsass, Alessia; Mestichelli, Francesca; Troiani, Emanuela; Falcioni, Sadia; Mazzotta, Serena; Natale, Annalisa; Angelini, Mario; Ferretti, Silvia; Angelini, Stefano; Galieni, Piero

    2015-08-01

    Detection of circulating plasma cells (PCs) in multiple myeloma (MM) patients is a well-known prognostic factor. We evaluated circulating PCs by flow cytometry (FC) in 104 patients with active MM at diagnosis by gating on CD38(+)  CD45(-) cells and examined their relationship with cytogenetic risk. Patients had an average follow-up of 36 months. By using a receiver operating characteristics analysis, we estimated the optimal cut-off of circulating PCs for defining poor prognosis to be 41. Patients with high-risk cytogenetics (n = 24) had poor prognosis, independently of circulating PC levels [PC < 41 vs. PC ≥ 41: overall survival (OS) = 0% vs. OS = 17%, P = not significant (n.s.); progression-free survival (PFS) = 0% vs. 17%, P = n.s.]. Patients with standard-risk cytogenetics (n = 65) showed a better prognosis when associated with a lower number of circulating PCs (PC < 41 vs. PC ≥ 41: OS = 62% vs. 24%, P = 0·008; PFS = 48% vs. 21%, P = 0·001). Multivariate analysis on the subgroup with standard-risk cytogenetics confirmed that the co-presence of circulating PCs ≥ 41, older age, Durie-Salmon stage >I and lack of maintenance adversely affected PFS, while OS was adversely affected only by lactate dehydrogenase, older age and lack of maintenance. Our results indicate that the quantification of circulating PCs by a simple two-colour FC analysis can provide useful prognostic information in newly diagnosed MM patients with standard-risk cytogenetics.

  5. Bendamustine, bortezomib and prednisone for the treatment of patients with newly diagnosed multiple myeloma: results of a prospective phase 2 Spanish/PETHEMA trial

    PubMed Central

    Mateos, María-Victoria; Oriol, Albert; Rosiñol, Laura; de Arriba, Felipe; Puig, Noemí; Martín, Jesús; Martínez-López, Joaquín; Echeveste, María Asunción; Sarrá, Josep; Ocio, Enrique; Ramírez, Gemma; Martínez, Rafael; Palomera, Luis; Payer, Angel; Iglesias, Rebeca; de la Rubia, Javier; Alegre, Adrian; Chinea, Ana Isabel; Bladé, Joan; Lahuerta, Juan José; Miguel, Jesús-F. San

    2015-01-01

    Bendamustine is a bifunctional alkylating agent with proven activity in myeloma. In this study 60 newly diagnosed myeloma patients were given bendamustine plus bortezomib and prednisone in a regimen consisting of one cycle of bortezomib twice weekly for 6 weeks (1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32), plus bendamustine (90 mg/m2 on days 1 and 4) and prednisone. The following cycles included bortezomib once weekly. Patients who were transplant candidates proceeded to stem cell collection after four cycles and the transplant was performed after six cycles. Patients who were not candidates for transplantation received up to nine cycles. Forty-two patients were transplant candidates and after six cycles, 50% achieved at least a very good partial response, with 24% having complete responses; 35 proceeded to a transplant, and the complete response rate was 54%. Seventeen patients continued up to nine cycles, and 57% achieved at least a very good partial response, including 26% with complete responses. The 2-year progression-free survival and overall survival rates were 62% and 86%, respectively. The safety profile was manageable, but stem cell mobilization was compromised in 35% of patients. In summary, this combination is effective in untreated patients, with an acceptable toxicity profile, but given the introduction of second-generation novel agents and monoclonal antibodies, the combination will probably be better reserved for relapsing patients, in whom stem cell collection is not needed, while cost-effective combinations with non-cross-resistant drugs continue to represent a medical need. This trial was registered with ClinicalTrials.gov, number NCT01376401. PMID:25911554

  6. 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

  7. Prevalence of hepatitis C virus and human immunodeficiency virus in a group of patients newly diagnosed with active tuberculosis in Porto Alegre, Southern Brazil

    PubMed Central

    Costi, Cintia; Grandi, Tarciana; Halon, Maria Laura; Silva, Márcia Susana Nunes; da Silva, Cláudia Maria Dornelles; Gregianini, Tatiana Schäffer; Possuelo, Lia Gonçalves; Jarczewski, Carla Adriane; Niel, Christian; Rossetti, Maria Lucia Rosa

    2017-01-01

    BACKGROUND Porto Alegre is the Brazilian state capital with second highest incidence of tuberculosis (TB) and the highest proportion of people infected with human immunodeficiency virus (HIV) among patients with TB. Hepatitis C virus (HCV) infection increases the risk of anti-TB drug-induced hepatotoxicity, which may result in discontinuation of the therapy. OBJECTIVES The aim of this study was (i) to estimate prevalence of HCV and HIV in a group of patients newly diagnosed with active TB in a public reference hospital in Porto Alegre and (ii) to compare demographic, behavioural, and clinical characteristics of patients in relation to their HCV infection status. METHODS One hundred and thirty-eight patients with TB were tested for anti-HCV antibody, HCV RNA, and anti-HIV1/2 antibody markers. HCV RNA from real-time polymerase chain reaction (PCR)-positive samples was submitted to reverse transcription and PCR amplification. The 5′ non-coding region of the HCV genome was sequenced, and genotypes of HCV isolates were determined. FINDINGS Anti-HCV antibody, HCV RNA, and anti-HIV antibodies were detected in 27 [20%; 95% confidence interval (CI), 13-26%], 17 (12%; 95% CI, 7-18%), and 34 (25%; 95% CI, 17-32%) patients, respectively. HCV isolates belonged to genotypes 1 (n = 12) and 3 (n = 4). Some characteristics were significantly more frequent in patients infected with HCV. Among them, non-white individuals, alcoholics, users of illicit drugs, imprisoned individuals, and those with history of previous TB episode were more commonly infected with HCV (p < 0.05). MAIN CONCLUSIONS HCV screening, including detection of anti-HCV antibody and HCV RNA, will be important to improving the management of co-infected patients, given their increased risk of developing TB treatment-related hepatotoxicity. PMID:28327789

  8. Blood-Brain Barrier Disruption and Intra-Arterial Methotrexate-Based Therapy for Newly Diagnosed Primary CNS Lymphoma: A Multi-Institutional Experience

    PubMed Central

    Angelov, Lilyana; Doolittle, Nancy D.; Kraemer, Dale F.; Siegal, Tali; Barnett, Gene H.; Peereboom, David M.; Stevens, Glen; McGregor, John; Jahnke, Kristoph; Lacy, Cynthia A.; Hedrick, Nancy A.; Shalom, Edna; Ference, Sandra; Bell, Susan; Sorenson, Lisa; Tyson, Rose Marie; Haluska, Marianne; Neuwelt, Edward A.

    2009-01-01

    Purpose Primary CNS lymphoma (PCNSL) is confined to the CNS and/or the eyes at presentation and is usually initially treated with intravenous methotrexate-based chemotherapy and whole-brain radiotherapy (WBRT). However, the intact blood-brain barrier (BBB) can limit diffusion of methotrexate into brain and tumor. With BBB disruption (BBBD), enhanced drug delivery to the tumor can be achieved. Patients and Methods This report summarizes the multi-institutional experience of 149 newly diagnosed (with no prior WBRT) patients with PCNSL treated with osmotic BBBD and intra-arterial (IA) methotrexate at four institutions from 1982 to 2005. In this series, 47.6% of patients were age ≥ 60 years, and 42.3% had Karnofsky performance score (KPS) less than 70 at diagnosis. Results The overall response rate was 81.9% (57.8% complete; 24.2% partial). Median overall survival (OS) was 3.1 years (25% estimated survival at 8.5 years). Median progression-free survival (PFS) was 1.8 years, with 5-year PFS of 31% and 7-year PFS of 25%. In low-risk patients (age < 60 years and KPS ≥ 70), median OS was approximately 14 years, with a plateau after approximately 8 years. Procedures were generally well tolerated; focal seizures (9.2%) were the most frequent side effect and lacked long-term sequelae. Conclusion This large series of patients treated over a 23-year period demonstrates that BBBD/IA methotrexate-based chemotherapy results in successful and durable tumor control and outcomes that are comparable or superior to other PCNSL treatment regimens. PMID:19451444

  9. High levels of periostin correlate with increased fracture rate, diffuse MRI pattern, abnormal bone remodeling and advanced disease stage in patients with newly diagnosed symptomatic multiple myeloma

    PubMed Central

    Terpos, E; Christoulas, D; Kastritis, E; Bagratuni, T; Gavriatopoulou, M; Roussou, M; Papatheodorou, A; Eleutherakis-Papaiakovou, E; Kanellias, N; Liakou, C; Panagiotidis, I; Migkou, M; Kokkoris, P; Moulopoulos, L A; Dimopoulos, M A

    2016-01-01

    Periostin is an extracellular matrix protein that is implicated in the biology of normal bone remodeling and in different cancer cell growth and metastasis. However, there is no information on the role of periostin in multiple myeloma (MM). Thus, we evaluated periostin in six myeloma cell lines in vitro; in the bone marrow plasma and serum of 105 newly diagnosed symptomatic MM (NDMM) patients and in the serum of 23 monoclonal gammopathy of undetermined significance (MGUS), 33 smoldering MM (SMM) patients, 30 patients at the plateau phase post-first-line therapy, 30 patients at first relapse and 30 healthy controls. We found high levels of periostin in the supernatants of myeloma cell lines compared with ovarian cancer cell lines that were not influenced by the incubation with the stromal cell line HS5. In NDMM patients the bone marrow plasma periostin was almost fourfold higher compared with the serum levels of periostin and correlated with the presence of fractures and of diffuse magnetic resonance imaging pattern of marrow infiltration. Serum periostin was elevated in NDMM patients compared with healthy controls, MGUS and SMM patients and correlated with advanced disease stage, high lactate dehydrogenase, increased activin-A, increased bone resorption and reduced bone formation. Patients at first relapse had also elevated periostin compared with healthy controls, MGUS and SMM patients, while even patients at the plateau phase had elevated serum periostin compared with healthy controls. These results support an important role of periostin in the biology of myeloma and reveal periostin as a possible target for the development of antimyeloma drugs. PMID:27716740

  10. 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.

  11. 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

  12. Panobinostat as part of induction and maintenance for elderly patients with newly diagnosed acute myeloid leukemia: phase Ib/II panobidara study.

    PubMed

    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

    2015-10-01

    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/m(2) iv days 1-3) plus cytarabine (100 mg/m(2) 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.

  13. Geriatric Assessment to Predict Survival and Risk of Serious Adverse Events in Elderly Newly Diagnosed Multiple Myeloma Patients: A Multicenter Study in China

    PubMed Central

    Zhong, Yu-Ping; Zhang, Yi-Zhuo; Liao, Ai-Jun; Li, Su-Xia; Tian, Chen; Lu, Jin

    2017-01-01

    Background: Elderly multiple myeloma (MM) patients often tend to suffer a variety of diseases, so the treatment of choice is very difficult for the elderly myeloma patients. The overall survival (OS) time and side effects with elderly patients are unclear in China. The study tried to find out the role of geriatric assessment in the Chinese elderly MM. Methods: We retrospectively analyzed the data of 628 newly diagnosed patients from six hospitals from June 2011 to June 2013. A geriatric assessment had been performed to assess comorbidities, cognitive, and physical status for these patients. The primary endpoint was to evaluate different physical states of elderly patients with OS time and treatment-related side effects. Results: An additive scoring system (range: 0–5), based on age, Katz's Activity of Daily Living (ADL) and Lawton's Instrumental Activity of Daily Living (IADL) ≤5 and Charlson Comorbidity Index (CCI) was developed to identify three groups: fit (score = 0); intermediate-fitness (score = 1); and frail (score ≥2). The 3-year OS was 63% in fit patients, 63% in intermediate-fitness patients, and 49% in frail patients ≥3 hematologic adverse events (AEs) were documented in 45 (35.4%) fit, 34 (34%) intermediate-fitness, and 121 (30.2%) frail patients. The risk of a grade ≥3 hematologic AEs was not significantly increase in intermediate-fitness (hazard ratios [HR]: 0.99, 95% confidence interval [CI]: 0.54–1.47, P = 1.000) and in frail patients (HR: 1.16, 95% CI: 0.70–1.93, P = 0.558) compared with fit ones. Conclusions: MM occurs earlier in life and being advanced when the diagnosis is made in the mainland of China. The overall survival in frailty with International Staging System (ISS) II/III was the worst in all patients. PMID:28091402

  14. Proton Magnetic Resonance Spectroscopic Imaging in Newly Diagnosed Glioblastoma: Predictive Value for the Site of Postradiotherapy Relapse in a Prospective Longitudinal Study

    SciTech Connect

    Laprie, Anne Catalaa, Isabelle; Cassol, Emmanuelle; McKnight, Tracy R.; Berchery, Delphine; Marre, Delphine; Bachaud, Jean-Marc; Berry, Isabelle; Moyal, Elizabeth Cohen-Jonathan

    2008-03-01

    Purpose: To investigate the association between magnetic resonance spectroscopic imaging (MRSI)-defined, metabolically abnormal tumor regions and subsequent sites of relapse in data from patients treated with radiotherapy (RT) in a prospective clinical trial. Methods and Materials: Twenty-three examinations were performed prospectively for 9 patients with newly diagnosed glioblastoma multiforme studied in a Phase I trial combining Tipifarnib and RT. The patients underwent magnetic resonance imaging (MRI) and MRSI before treatment and every 2 months until relapse. The MRSI data were categorized by the choline (Cho)/N-acetyl-aspartate (NAA) ratio (CNR) as a measure of spectroscopic abnormality. CNRs corresponding to T1 and T2 MRI for 1,207 voxels were evaluated before RT and at recurrence. Results: Before treatment, areas of CNR2 (CNR {>=}2) represented 25% of the contrast-enhancing (T1CE) regions and 10% of abnormal T2 regions outside T1CE (HyperT2). The presence of CNR2 was often an early indicator of the site of relapse after therapy. In fact, 75% of the voxels within the T1CE+CNR2 before therapy continued to exhibit CNR2 at relapse, compared with 22% of the voxels within the T1CE with normal CNR (p < 0.05). The location of new contrast enhancement with CNR2 corresponded in 80% of the initial HyperT2+CNR2 vs. 20.7% of the HyperT2 voxels with normal CNR (p < 0.05). Conclusion: Metabolically active regions represented a small percentage of pretreatment MRI abnormalities and were predictive for the site of post-RT relapse. The incorporation of MRSI data in the definition of RT target volumes for selective boosting may be a promising avenue leading to increased local control of glioblastomas.

  15. Transmitted drug resistance is still low in newly diagnosed human immunodeficiency virus type 1 CRF06_cpx-infected patients in Estonia in 2010.

    PubMed

    Avi, Radko; Huik, Kristi; Pauskar, Merit; Ustina, Valentina; Karki, Tõnis; Kallas, Eveli; Jõgeda, Ene-Ly; Krispin, Tõnu; Lutsar, Irja

    2014-03-01

    The presence of transmitted drug resistance (TDR) in treatment-naive HIV-1-positive subjects is of concern, especially in the countries of the former Soviet Union in which the number of subjects exposed to antiretrovirals (ARV) has exponentially increased during the past decade. We assessed the rate of TDR among newly diagnosed subjects in Estonia in 2010 and compared it to that in 2008. The study included 325 subjects (87% of all subjects tested HIV positive from January 1 to December 31, 2010). Of the 244 sequenced viral genomic RNA in the reverse transcriptase (RT) region 214 were CRF06_cpx, nine were subtype A1, three (one each) were subtype B and subtype C, CRF02_AG, and CRF03_AB; 15 viruses remained unclassified as putative recombinant forms between CRF06_cpx and subtype A1. HIV-1 TDR mutations in 2010 and 2008 (n=145) occurred at similar frequency in 4.5% (95% CI 2.45; 7.98) and 5.5% (95% CI 1.8; 9.24) of the patients, respectively. In 2010, 2.5% (6/244) of the sequences harbored nonnucleoside reverse transcriptase inhibitor (NNRTI) (K103N and K101E), 1.6% (4/244) nucleoside reverse transcriptase inhibitor (NRTI) (M41L, M184I, and K219E), and 0.4% (1/244) protease inhibitor (PI) (V82A) mutations. Our findings indicate that in spite of the increased consumption of ARVs the rate of TDR in Estonia has remained unchanged over the past 3 years. Similar stabilizing or even decreasing trends have been described in Western Europe and North America albeit at higher levels and in different socioeconomic backgrounds.

  16. The effect of single course high dose dexamethasone on CD28/CTLA-4 balance in the treatment of patients with newly diagnosed primary immune thrombocytopenia

    PubMed Central

    Guo, Xinhong; Yasen, Halida; Zhao, Fang; Wang, Lei; Sun, Mingling; Pang, Nannan; Wang, Xiujuan; Zhang, Ying; Ding, Jianbing; Ma, Xiumin

    2016-01-01

    To evaluate the effect of a single course of high dose dexamethasone (HD-DXM) on CD28 and CTLA-4 expression in patients with newly-diagnosed primary immune thrombocytopenia (ITP). Twenty-8 ITP patients (18 females and 10 males, age range 18–65 years, median age 38.5 years) enrolled in this study and 26 healthy volunteers (19 women and 7 men, age range 16–66 years, median age 37 years) served as a control group. The patients were treated with HD-DXM (40 mg/day) for 4 consecutive days. CD28 and CTLA-4 expression was assessed by flow cytometry once-monthly for 6 months. Plasma levels of the cytokines IFN-γ and IL-10 were determined by enzyme-linked immunosorbent assay. One month after treatment, a platelet response was observed in 23 (82%) of the patients. The response rates over the next 5 months were 71%, 57%, 53%, 46%, and 39%, chronologically. We observed a significant decrease in CD28 expression after the first month (34.7 ± 4.8% vs. 44.5 ± 4.4% before treatment), after which the CD28 levels gradually increased. In contrast, CTLA-4 expression increased after the first month (3.2 ± 0.5% vs. 0.8 ± 0.4 before treatment), after which the CTLA-4 levels gradually decreased. Similar dynamic changes were seen in the levels of IFN-γ and IL-10. The dynamic changes of CD28 and CTLA-4 were consistent with those of IFN-γ and IL-10 and with the effectiveness of HD-DXM in the treatment of ITP. Our results suggest that a disturbed CD28/CTLA-4 balance may contribute to the immunopathogenesis of ITP. PMID:26211942

  17. 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

  18. 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

  19. Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

    ClinicalTrials.gov

    2017-04-04

    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

  20. 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);…

  1. 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

  2. Add-on bevacizumab can prevent early clinical deterioration and prolong survival in newly diagnosed partially resected glioblastoma patients with a poor performance status

    PubMed Central

    Hata, Nobuhiro; Yoshimoto, Koji; Hatae, Ryusuke; Kuga, Daisuke; Akagi, Yojiro; Sangatsuda, Yuhei; Suzuki, Satoshi O; Shono, Tadahisa; Mizoguchi, Masahiro; Iihara, Koji

    2017-01-01

    Purpose The AVAglio trial established the beneficial effect of add-on bevacizumab (BEV) for the treatment of newly diagnosed glioblastomas (nd-GBMs) that led to the approval of BEV for the treatment of these patients in Japan. However, the rationality of using BEV as a first-line treatment for nd-GBMs remains controversial. The purpose of this study was to analyze the outcomes of a case series of nd-GBM patients. Patients and methods The outcomes of 69 nd-GBM patients treated after 2006 were retrospectively analyzed. Clinical and genetic analyses were performed, and estimates of progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan–Meier method. Since add-on BEV therapy was only used for partially resected GBMs (pr-GBMs) after its approval in 2013, the patients were subdivided into 3 treatment groups: Type I, partial removal with temozolomide (TMZ)/BEV and concurrent radiotherapy (CCRT); Type II, partial removal with TMZ and CCRT; and Type III, gross total removal with TMZ and CCRT. Results The PFS rate of Type I patients was significantly higher than that of Type II patients (P=0.014), but comparable to that of Type III patients. Differences in OS rates between Type I and Type II patients were less apparent (P=0.075), although the median OS of Type I patients was ~8 months higher than that of Type II patients (17.4 vs 9.8 months, respectively). The clinical deterioration rate during initial treatment was significantly (P=0.024) lower in Type I than in Type II patients (7.7% vs 47.4%, respectively). Differences in OS rates between Type I and Type II patients with a poor performance status (PS) were significant (P=0.017). Conclusion Our findings suggest that add-on BEV can prevent early clinical deterioration of pr-GBM patients and contribute to a prolonged survival, especially for those with a poor PS. PMID:28176936

  3. Phase 1/2 Trials of Temozolomide, Motexafin Gadolinium, and 60-Gy Fractionated Radiation for Newly Diagnosed Supratentorial Glioblastoma Multiforme: Final Results of RTOG 0513

    SciTech Connect

    Brachman, David G.; Pugh, Stephanie L.; Ashby, Lynn S.; Thomas, Theresa A.; Dunbar, Erin M.; Narayan, Samir; Robins, H. Ian; Bovi, Joseph A.; Rockhill, Jason K.; Won, Minhee; Curran, Walter P.

    2015-04-01

    Purpose: The purpose of phase 1 was to determine the maximum tolerated dose (MTD) of motexafin gadolinium (MGd) given concurrently with temozolomide (TMZ) and radiation therapy (RT) in patients with newly diagnosed supratentorial glioblastoma multiforme (GBM). Phase 2 determined whether this combination improved overall survival (OS) and progression-free survival (PFS) in GBM recursive partitioning analysis class III to V patients compared to therapies for recently published historical controls. Methods and Materials: Dose escalation in phase 1 progressed through 3 cohorts until 2 of 6 patients experienced dose-limiting toxicity or a dose of 5 mg/kg was reached. Once MTD was established, a 1-sided 1-sample log-rank test at significance level of .1 had 85% power to detect a median survival difference (13.69 vs 18.48 months) with 60 deaths over a 12-month accrual period and an additional 18 months of follow-up. OS and PFS were estimated using the Kaplan-Meier method. Results: In phase 1, 24 patients were enrolled. The MTD established was 5 mg/kg, given intravenously 5 days a week for the first 10 RT fractions, then 3 times a week for the duration of RT. The 7 patients enrolled in the third dose level and the 94 enrolled in phase 2 received this dose. Of these 101 patients, 87 were eligible and evaluable. Median survival time was 15.6 months (95% confidence interval [CI]: 12.9-17.6 months), not significantly different from that of the historical control (P=.36). Median PFS was 7.6 months (95% CI: 5.7-9.6 months). One patient (1%) experienced a grade 5 adverse event possibly related to therapy during the concurrent phase, and none experience toxicity during adjuvant TMZ therapy. Conclusions: Treatment was well tolerated, but median OS did not reach improvement specified by protocol compared to historical control, indicating that the combination of standard RT with TMZ and MGd did not achieve a significant survival advantage.

  4. Copy number neutral loss of heterozygosity at 17p and homozygous mutations of TP53 are associated with complex chromosomal aberrations in patients newly diagnosed with myelodysplastic syndromes.

    PubMed

    Svobodova, Karla; Zemanova, Zuzana; Lhotska, Halka; Novakova, Milena; Podskalska, Lucie; Belickova, Monika; Brezinova, Jana; Sarova, Iveta; Izakova, Silvia; Lizcova, Libuse; Berkova, Adela; Siskova, Magda; Jonasova, Anna; Cermak, Jaroslav; Michalova, Kyra

    2016-03-01

    Complex karyotypes are seen in approximately 20% of patients with myelodysplastic syndromes (MDS) and are associated with a high risk of transformation to acute myeloid leukemia and poor outcomes in patients. Copy number neutral loss of heterozygosity (CN-LOH, i.e., both copies of a chromosomal pair or their parts originate from one parent) might contribute to increased genomic instability in the bone-marrow cells of patients with MDS. The pathological potential of CN-LOH, which arises as a clonal aberration in a proportion of somatic cells, consists of tumor suppressor gene and oncogene homozygous mutations. The aim of our study was to evaluate the frequency of CN-LOH at 17p in bone-marrow cells of newly diagnosed MDS patients with complex chromosomal aberrations and to assess its correlation with mutations in the TP53 gene (17p13.1). CN-LOH was detected in 40 chromosomal regions in 21 (29%) of 72 patients analyzed. The changes in 27 of the 40 regions identified were sporadic. The most common finding was CN-LOH of the short arm of chromosome 17, which was detected in 13 (18%) of 72 patients. A mutational analysis confirmed the homozygous mutation of TP53 in all CN-LOH 17p patients, among which two frameshift mutations are not registered in the International Agency for Research on Cancer TP53 Database. CN-LOH 17p correlated with aggressive disease (median overall survival 4 months) and was strongly associated with a complex karyotype in the cohort studied, which might cause rapid disease progression in high-risk MDS. No other CN-LOH region previously recorded in MDS or AML patients (1p, 4q, 7q, 11q, 13q, 19q, 21q) was detected in our cohort of patients with complex karyotype examined at the diagnosis of MDS. The LOH region appeared to be balanced (i.e., with no DNA copy number change) when examined with conventional and molecular cytogenetic methods. Therefore, a microarray that detects single-nucleotide polymorphisms is an ideal method with which to identify and

  5. Relationship of Bowel MR Imaging to Health-related Quality of Life Measures in Newly Diagnosed Pediatric Small Bowel Crohn Disease.

    PubMed

    Dillman, Jonathan R; Carlos, Ruth C; Smith, Ethan A; Davenport, Matthew S; De Matos Maillard, Vera; Adler, Jeremy

    2016-08-01

    Purpose To determine if utility measures of health-related quality of life (HRQOL) in pediatric small bowel Crohn disease (a) change in response to infliximab therapy, (b) correlate with proxy parent or guardian assessments, and (c) correlate with magnetic resonance (MR) imaging and laboratory markers of intestinal active inflammation. Materials and Methods This prospective single-center cohort study was approved by the institutional review board and was compliant with HIPAA. Parental informed consent and subject assent were obtained from all study participants. Twenty-six children with newly diagnosed small bowel Crohn disease receiving infliximab therapy were prospectively enrolled. All subjects underwent measurement of HRQOL utilities (visual analog scale [VAS], time trade-off [TTO], and standard gamble [SG]), MR enterography, and laboratory assessment at baseline and 6 months later. The Wilcoxon signed-rank test was used to compare paired nonparametric data; Spearman correlation (ρ) was used to assess bivariate relationships. Results The median VAS score was 47.5 (interquartile range [IQR]: 20.0-52.2) before infliximab therapy and 83.0 (IQR: 62.0-92.0) at follow-up (P = .0003). There was positive correlation between subject and parent or guardian change in VAS score between baseline and follow-up (ρ = 0.71; P = .0006). The authors identified significant negative correlations between VAS score and MR imaging bowel wall arterial phase enhancement after contrast material administration at baseline (ρ = -0.57, P = .0032) as well as between change in VAS score and change in bowel wall enhancement in the arterial phase at contrast-enhanced MR imaging over time (ρ = -0.51, P = .02). No correlations between VAS score and laboratory inflammatory markers were identified. Conclusion VAS assessment of HRQOL changes over time in response to infliximab therapy in children with small bowel Crohn disease. There are statistically significant correlations between child

  6. A higher frequency of CD4(+)CXCR5(+) T follicular helper cells in patients with newly diagnosed Henoch-Schönlein purpura nephritis.

    PubMed

    Zhang, Zhihui; Zhao, Songchen; Zhang, Li; Crew, Rebecca; Zhang, Nan; Sun, Xiguang; Jiang, Yanfang

    2016-03-01

    T follicular helper (TFH) cells play an important role in the humoral immune responses. The aim of this study was to examine the frequency of different subsets of CD4(+)CXCR5(+) TFH cells and B cells in patients with new-onset Henoch-Schönlein purpura nephritis (HSPN). The numbers of different subsets of CD4(+)CXCR5(+) TFH cells, B cells and the constituents of serum cytokines were detected in a total of 25 patients with newly diagnosed HSPN before and after treatment, and in 14 healthy controls (HC). The potential connection of these cells with the clinical characteristics in HSPN patients was analyzed. The numbers of circulating CD4(+)CXCR5(+), CD4(+)CXCR5(+)ICOS(+) and CD4(+)CXCR5(+)PD-1(+) TFH cells, CD86(+)CD19(+), CD38(+)CD19(+) B cells and serum IL-2, IL-4, IL-17A, IL-21 and IFN-γ were significantly higher in HSPN patients (p<0.05) than in HC. Before and after treatment the numbers of CD4(+)CXCR5(+) TFH cells were negatively correlated with the values of eGFR (r=-0.7162, p<0.05; r=-0.732, p<0.05, respectively). Similarly the numbers of CD4(+)CXCR5(+)PD-1(+) TFH cells were negatively correlated with 24-h urinary proteins (r=-0.4013, p<0.05; r=-0.7857, p<0.05, respectively), and the numbers of CD4(+)CXCR5(+)ICOS(+) TFH cells were positively correlated with the levels of serum IL-21 (r=0.5186, p<0.05; r=0.8503, p<0.05, respectively) and 24-h urinary protein (r=0.6045, p<0.05; r=0.833, p<0.05, respectively) in these patients, regardless of treatment. Following treatment the numbers of CD4(+)CXCR5(+), CD4(+)CXCR5(+)PD-1(+), and CD4(+)CXCR5(+)ICOS(+) TFH cells, as well as serum levels of IL-21 were significantly reduced, however IL-4 levels were noticeably increased (p<0.05). A higher frequency of circulating CD4(+)CXCR5(+) TFH cells existed in patients with HSPN and may be a viable therapeutic target.

  7. Suppression of the noninvolved pair of the myeloma isotype correlates with poor survival in newly diagnosed and relapsed/refractory patients with myeloma

    PubMed Central

    Milosavljevic, Dejan; Berlanga, Oscar; Zojer, Niklas; Hübl, Wolfgang; Fritz, Veronique; Harding, Stephen

    2016-01-01

    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. Am. J. Hematol. 91:295–301, 2016. © 2015 The Authors. American Journal of Hematology Published by Wiley Periodicals, Inc. PMID:26662888

  8. The use of rituximab in newly diagnosed patients with systemic lupus erythematosus: long-term steroid saving capacity and clinical effectiveness

    PubMed Central

    Gracia-Tello, Borja; Ezeonyeji, Amara; Isenberg, David

    2017-01-01

    Background Previous reports indicate that treating patients with lupus (SLE) at or close to the time of diagnosis successfully without using any, or minimal, corticosteroids by using B-cell depletion (BCD) is possible in the short-term. It is not however known whether using BCD is as effective or reduces corticosteroid use in the long-term. We report the long-term (up to 7 years) use of BCD with respect to its steroid-saving capacity and clinical effectiveness in newly diagnosed SLE. Methods Sixteen female patients with SLE were treated at, or shortly after diagnosis, with BCD therapy (BCDT) minimising the routine use of oral steroids. Post-treatment, most patients were given hydroxychloroquine (n=14) and azathioprine (n=10). The British Isles Lupus Assessment Group (BILAG) disease activity index was used for clinical assessment. Serum antidouble-stranded DNA (dsDNA) antibodies, complement (C3), erythrocyte sedimentation rate (ESR), circulating B lymphocytes (CD19+) and total inmmunoglobulins were tested every 2–6 months (average of 4.5 years) (SD 2) post-treatment. Disease activity and steroid requirement were compared with three patients with SLE treated conventionally, each matched for ethnicity, sex, age, clinical features, disease duration at diagnosis and follow-up period. Results All patients given rituximab achieved BCD. The mean number of flares during follow-up (new BILAG A or B) was 2.63 (SD 3) in the BCDT group and 4 (SD 3.6) in the controls (NS, p=0.14). Post-BCDT, mean anti-dsDNA antibody level fell from 1114 U/mL (SD 1699.3) to 194 (SD 346.7) at 18 months (p=0.043), mean serum ESR fell by >70% at 6 months maintained during follow-up and serum C3 level normalised in 8 patients. The mean cumulative prednisolone dose at 60 months for the patients who underwent BCDT (n=11) was 4745.67 mg (SD 6090 mg) vs 12 553.92 mg (SD 12 672 mg) for the controls (p=0.01). Conclusions Early treatment of patients with SLE with BCDT is safe

  9. Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

    ClinicalTrials.gov

    2017-03-27

    Acute Biphenotypic Leukemia; de Novo Myelodysplastic Syndrome; Previously Treated Myelodysplastic Syndrome; Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndrome; Untreated Adult Acute Myeloid Leukemia

  10. 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.

  11. Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm

    ClinicalTrials.gov

    2016-12-27

    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); Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Refractory Anemia With Excess Blasts; Untreated Adult Acute Myeloid Leukemia; Myeloproliferative Neoplasm With 10% Blasts or Higher

  12. GDP (Gemcitabine, Dexamethasone, and Cisplatin) Is Highly Effective and Well-Tolerated for Newly Diagnosed Stage IV and Relapsed/Refractory Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type

    PubMed Central

    Wang, Jing-jing; Dong, Mei; He, Xiao-hui; Li, Ye-xiong; Wang, Wei-hu; Liu, Peng; Yang, Jian-liang; Gui, Lin; Zhang, Chang-gong; Yang, Sheng; Zhou, Sheng-yu; Shi, Yuan-kai

    2016-01-01

    Abstract This study was conducted to evaluate the effectiveness and tolerance of GDP (gemcitabine, dexamethasone, and cisplatin) regimen in patients with newly diagnosed stage IV and relapsed/refractory extranodal natural killer/T-cell lymphoma, nasal type (ENKTL). The study enrolled 41 ENKTL patients who received GDP regimen at the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College between January 2008 and January 2015. The disease status was newly diagnosed stage IV in 15 patients and relapsed/refractory in 26 patients. The median number of cycles of chemotherapy per patient was 6 (range, 2–8 cycles). The overall response rate and complete-remission rate were 83.0% (34/41) and 41.5% (17/41), respectively. After a median follow-up of 16.2 months, 1-year progression-free survival rate and 1-year overall survival rate for the whole cohort were 54.5% and 72.7%. Grade 3 to 4 adverse events included neutropenia (34.1%), thrombocytopenia (19.5%), and anemia (14.6%). Our study has suggested high efficacy and low toxicity profile of GDP regimen in patients with newly diagnosed stage IV and relapsed/refractory ENKTL. PMID:26871836

  13. Sources and prevalence of self-reported asthma diagnoses in adults in urban and rural settings of Bangladesh.

    PubMed

    Bartlett, Emily; Parr, John; Lindeboom, Wietze; Khanam, Masuma Akter; Koehlmoos, Tracy Pérez

    2013-01-01

    This study provides data on the sources of asthma diagnoses in the adult Bangladeshi population in urban and rural settings. The paper also reports the prevalence of self-reported asthma diagnoses and associated socio-demographic factors. A cross-sectional study was conducted in three communities: two rural settings and one urban setting, with a total sample size of 32,665 subjects. Pre-existing surveillance data provided individual socio-demographic factors. Provider categories were based on previous research describing provider plurality in Bangladesh. Descriptive statistics, univariate regression and multivariate regression analyses were performed. Bachelor of Medicine, Bachelor of Surgery (MBBS) generalists provided the largest proportion of diagnoses in both urban (54.6%) and rural (42.4%) sites. The largest proportion of non-MBBS-trained healthcare workers providing diagnoses of asthma was spiritual healers (13.3%) in the urban settings and village doctors (42.4%) in rural settings. The overall prevalence of self-reported asthma diagnoses was 5.0% in the urban population and 3.5% in the rural population. The results highlight the importance of non-MBBS doctors in serving the healthcare needs of the Bangladeshi population. This study reveals a higher prevalence of self-reported asthma diagnoses in the urban setting than in rural ones, which is consistent with international literature on the topic.

  14. 18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas

    ClinicalTrials.gov

    2017-01-30

    Adult Anaplastic Ependymoma; Adult Anaplastic Oligodendroglioma; Adult Brain Stem Glioma; Adult Diffuse Astrocytoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Mixed Glioma; Adult Oligodendroglioma; Adult Pilocytic Astrocytoma; Adult Pineal Gland Astrocytoma; Adult Subependymal Giant Cell Astrocytoma; Childhood High-grade Cerebellar Astrocytoma; Childhood High-grade Cerebral Astrocytoma; Childhood Low-grade Cerebellar Astrocytoma; Childhood Low-grade Cerebral Astrocytoma; Recurrent Adult Brain Tumor; Recurrent Childhood Anaplastic Astrocytoma; Recurrent Childhood Anaplastic Oligoastrocytoma; Recurrent Childhood Anaplastic Oligodendroglioma; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Diffuse Astrocytoma; Recurrent Childhood Fibrillary Astrocytoma; Recurrent Childhood Gemistocytic Astrocytoma; Recurrent Childhood Giant Cell Glioblastoma; Recurrent Childhood Glioblastoma; Recurrent Childhood Gliomatosis Cerebri; Recurrent Childhood Gliosarcoma; Recurrent Childhood Oligoastrocytoma; Recurrent Childhood Oligodendroglioma; Recurrent Childhood Pilomyxoid Astrocytoma; Recurrent Childhood Protoplasmic Astrocytoma; Recurrent Childhood Subependymal Giant Cell Astrocytoma; Recurrent Childhood Visual Pathway and Hypothalamic Glioma; Recurrent Childhood Visual Pathway Glioma; Untreated Childhood Anaplastic Astrocytoma; Untreated Childhood Anaplastic Oligoastrocytoma; Untreated Childhood Anaplastic Oligodendroglioma; Untreated Childhood Brain Stem Glioma; Untreated Childhood Cerebellar Astrocytoma; Untreated Childhood Cerebral Astrocytoma; Untreated Childhood Diffuse Astrocytoma; Untreated Childhood Fibrillary Astrocytoma; Untreated Childhood Gemistocytic Astrocytoma; Untreated Childhood Giant Cell Glioblastoma; Untreated Childhood Glioblastoma; Untreated Childhood Gliomatosis Cerebri; Untreated Childhood Gliosarcoma; Untreated Childhood

  15. Phase I/II Study of Neurosurgical Resection and Intra-operative Cesium-131 Radio-isotope Brachytherapy in Patients with Newly Diagnosed Brain Metastases

    PubMed Central

    Wernicke, A. Gabriella; Yondorf, Menachem Z; Peng, Luke; Trichter, Samuel; Nedialkova, Lucy; Sabbas, Albert; Khulidzhanov, Fridon; Parashar, Bhupesh; Nori, Dattatreyudu; Chao, K.S. Clifford; Christos, Paul; Pannullo, Susan; Boockvar, John A.; Stieg, Phillip; Schwartz, Theodore H.

    2014-01-01

    Object Resected brain metastases have a high rate of local recurrence without adjuvant therapy. Adjuvant whole brain radiotherapy (WBRT) remains the standard of care with the rate of local control >90%. However, WBRT is delivered over 10–15 days, which can delay other therapy and is associated with acute and long-term toxicities. Intra-operative permanent Cesium-131 (Cs-131) implants can be performed at the time of surgery, thereby avoiding any additional therapy. We evaluate the safety, feasibility and efficacy of a novel treatment approach of brain metastases with a permanent intra-operative Cs-131 brachytherapy. Methods After IRB approval, 24 patients with a newly diagnosed metastasis to the brain (n=24) were accrued on a prospective protocol between 2010 and 2012. There were 10 frontal, 7 parietal, 4 cerebellar, 2 occipital, and 1 temporal metastases. Histology included lung (16), breast (2), kidney (2), melanoma (2), colon (1), and cervix (1). Cs-131 stranded seeds were placed as a permanent volume implant. Prescription dose was 80Gy at 5mm depth from the resection cavity surface. Distant metastases were treated with stereotactic radiosurgery (SRS) or WBRT, depending on the number of lesions. Primary end point was resection cavity freedom from progression (FFP). Secondary end points included distant metastases FFP, median survival, overall survival (OS), and toxicity. Results Median follow-up was 19.3 months (range, 12.89 – 29.57 months). Median age was 65 years (range, 45–84 years). Median volume of resected tumor was 10.31 cc (range, 1.77 - 87.11 cc). Median number of seeds employed was 12 (range, 4–35) with median activity per seed of 3.82 mCi (range, 3.31–4.83 mCi) and total activity of 46.91 mCi (range, 15.31–130.70 mCi). Local recurrence FFP was 100%. There was 1 adjacent leptomeningeal recurrence, resulting in a 1-year regional FFP of 93.8% (95% CI = 63.2%, 99.1%). Distant metastasis FFP was 48.4% (95% CI = 26.3%, 67.4%). Median OS was 9

  16. Use of Hospital-based Services among Young Adults with Behavioral Health Diagnoses Before and After Health Insurance Expansions

    PubMed Central

    Golberstein, Ezra; Zaha, Rebecca; Greenfield, Shelly F.; Beardslee, William R.; Busch, Susan H.

    2014-01-01

    Importance Young adults have high levels of behavioral health needs but often lack health insurance. Recent health reforms have increased coverage, but it is unclear how use of hospital-based care changed after expanding insurance. Objective To evaluate the association between health insurance coverage expansions and use of hospital-based care among young adults with behavioral health diagnoses. Design Quasi-experimental analyses of hospital inpatient and emergency department use from 2003–2009 based on hospital discharge data, comparing differential changes in service use among young adults with behavioral health diagnoses in Massachusetts versus other states before and after Massachusetts’ 2006 health reform. Setting Hospital inpatient departments in the U.S. and emergency departments in Massachusetts and Maryland. Participants Population-based sample of inpatient admissions (n=12,821,746 across 7 years) nationwide and emergency department visits (n=6,756,303 across 7 years) from Maryland and Massachusetts for 12 to 25 year olds. Main Outcomes and Measures Inpatient admission rates per 1000 population for primary diagnosis of any behavioral health disorder, by diagnosis; emergency department visit rates per 1000 population by behavioral health diagnosis; and insurance coverage for discharges. Results After 2006, uninsurance among 19 to 25 year olds in Massachusetts fell from 26% to 10% (16 percentage points; 95% CI, 13–20). Young adults experienced relative declines in inpatient admission rates of 2.0 per 1000 for primary diagnoses of any behavioral health disorder (95% CI, 0.8