Car Crashes and Central Disorders of Hypersomnolence: A French Study.

PubMed

Pizza, Fabio; Jaussent, Isabelle; Lopez, Regis; Pesenti, Carole; Plazzi, Giuseppe; Drouot, Xavier; Leu-Semenescu, Smaranda; Beziat, Severine; Arnulf, Isabelle; Dauvilliers, Yves

2015-01-01

Drowsiness compromises driving ability by reducing alertness and attentiveness, and delayed reaction times. Sleep-related car crashes account for a considerable proportion of accident at the wheel. Narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) are rare central disorders of hypersomnolence, the most severe causes of sleepiness thus being potential dangerous conditions for both personal and public safety with increasing scientific, social, and political attention. Our main objective was to assess the frequency of recent car crashes in a large cohort of patients affected with well-defined central disorders of hypersomnolence versus subjects from the general population. We performed a cross-sectional study in French reference centres for rare hypersomnia diseases and included 527 patients and 781 healthy subjects. All participants included needed to have a driving license, information available on potential accident events during the last 5 years, and on potential confounders; thus analyses were performed on 282 cases (71 IH, 82 NT2, 129 NT1) and 470 healthy subjects. Patients reported more frequently than healthy subjects the occurrence of recent car crashes (in the previous five years), a risk that was confirmed in both treated and untreated subjects at study inclusion (Untreated, OR = 2.21 95%CI = [1.30-3.76], Treated OR = 2.04 95%CI = [1.26-3.30]), as well as in all disease categories, and was modulated by subjective sleepiness level (Epworth scale and naps). Conversely, the risk of car accidents of patients treated for at least 5 years was not different to healthy subjects (OR = 1.23 95%CI = [0.56-2.69]). Main risk factors were analogous in patients and healthy subjects. Patients affected with central disorders of hypersomnolence had increased risk of recent car crashes compared to subjects from the general population, a finding potentially reversed by long-term treatment.

Car Crashes and Central Disorders of Hypersomnolence: A French Study

PubMed Central

Lopez, Regis; Pesenti, Carole; Plazzi, Giuseppe; Drouot, Xavier; Leu-Semenescu, Smaranda; Beziat, Severine; Arnulf, Isabelle; Dauvilliers, Yves

2015-01-01

Background Drowsiness compromises driving ability by reducing alertness and attentiveness, and delayed reaction times. Sleep-related car crashes account for a considerable proportion of accident at the wheel. Narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) are rare central disorders of hypersomnolence, the most severe causes of sleepiness thus being potential dangerous conditions for both personal and public safety with increasing scientific, social, and political attention. Our main objective was to assess the frequency of recent car crashes in a large cohort of patients affected with well-defined central disorders of hypersomnolence versus subjects from the general population. Methods We performed a cross-sectional study in French reference centres for rare hypersomnia diseases and included 527 patients and 781 healthy subjects. All participants included needed to have a driving license, information available on potential accident events during the last 5 years, and on potential confounders; thus analyses were performed on 282 cases (71 IH, 82 NT2, 129 NT1) and 470 healthy subjects. Results Patients reported more frequently than healthy subjects the occurrence of recent car crashes (in the previous five years), a risk that was confirmed in both treated and untreated subjects at study inclusion (Untreated, OR = 2.21 95%CI = [1.30–3.76], Treated OR = 2.04 95%CI = [1.26–3.30]), as well as in all disease categories, and was modulated by subjective sleepiness level (Epworth scale and naps). Conversely, the risk of car accidents of patients treated for at least 5 years was not different to healthy subjects (OR = 1.23 95%CI = [0.56–2.69]). Main risk factors were analogous in patients and healthy subjects. Conclusion Patients affected with central disorders of hypersomnolence had increased risk of recent car crashes compared to subjects from the general population, a finding potentially reversed by long-term treatment. PMID:26052938

Annotated bibliography of Chamaecypans nootkatensis.

Treesearch

P.E Hennon; A.S. Harris

1997-01-01

Some 680 citations from literature treating Chamaecypans nootkatensis are listed alphabetically by author in this bibliography. Most citations are followed by a short summary. A subject index is included.

Supplement Analysis for the Transmission System Vegetation Management Program FEIS (DOE/EIS-0285/SA-108), Satsop-Aberdeen #2

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tippetts, Greg P.

2002-09-05

Vegetation Management along the Satsop-Aberdeen #2 230kV transmission line corridor from structure 1/1 through structure 11/5. BPA proposes to remove unwanted vegetation along the right-of- way, access roads and around tower structures along the subject transmission line corridors. Approximately 11 miles of right-of-way will be treated using selective and non-selective methods that include hand cutting, mowing and herbicide treatments. Approximately 0.8 miles of access roads will be cleared using selective and non-selective methods that include hand cutting, mowing and herbicide treatments. Tower sites will be treated using selective and non-selective methods that include hand cutting, mowing and herbicide treatments. Vegetationmore » management is required for unimpeded operation and maintenance of the subject transmission line. See Section 1of the attached checklist for a complete description of the proposal.« less

Reoperation following open reduction and plate fixation of displaced mid-shaft clavicle fractures.

PubMed

Ashman, Bradley D; Slobogean, Gerard P; Stone, Trevor B; Viskontas, Darius G; Moola, Farhad O; Perey, Bertrand H; Boyer, Dory S; McCormack, Robert G

2014-10-01

Operative fixation of displaced, mid-shaft clavicle fractures has become an increasingly common practice. With this emerging trend, data describing patient outcomes with longer follow-up are necessary. We retrospectively reviewed the medical records of subjects treated with plate fixation for displaced mid-shaft clavicle fractures from 2003 to 2009 at a Level I trauma hospital. All subjects were greater than 12 months post-index surgery. Treatment involved ORIF with either a low-contact dynamic compression plate (LCDC) or a contoured plate (pre-contoured or pelvic reconstruction plate). Our primary outcome was reoperation for any indication. 143 subjects were included. The mean age was 36 ± 14 years and the mean time to reoperation or chart review was 33 months. Contoured plates were used in 64% of cases and LCDC plates were used in the remaining subjects. Twenty-nine subjects (20%) underwent reoperation: 23.5% of subjects treated with LCDC plates and 18.5% of subjects treated with contoured plates (p=0.52). Indications for reoperation included implant irritation (n=25), implant failure (n=2), and non-union (n=2). There was near statistically significant association with reoperation and female gender (p=0.05) but no association between reoperation and age (p=0.14), fracture class (p=0.53), plate type (p=0.49), or plate location (p=0.93). The mean QuickDASH score for the population surveyed was 8.8 (5.5-12.1; 95% CI) with near statistically significant and clinically relevant difference between those considering reoperation and those not 22.3 (8.6-36.0; 95% CI) versus 6.7 (3.6-9.8; 95% CI). This study represents a large series of displaced clavicle fractures treated with open reduction and plate fixation. Reoperation following plate fixation is relatively common, but primarily due to implant irritation. No difference in reoperation rates between plate types or location could be detected in our current sample size. Also, excellent functional outcomes continue to be observed several years after clavicle fracture fixation. Copyright © 2014 Elsevier Ltd. All rights reserved.

[Use of the EvalObs® adherence scale in an unselected French population of treated subjects with antihypertensive, hypolipemiants or oral antidiabetics medications: The FLAHS 2017 adherence survey].

PubMed

Girerd, X; Hanon, O; Vaïsse, B

2018-06-01

A Visual Analog Scale (VAS) is useful for diagnosing medication nonadherence and its validity has been evaluated using electronic pillbox as the gold standard. We have developed the EvaLobs ® scale for use on paper or on smartphone and the aim of the study was to administrate the scale among FLAHS 2017 participants treated for an hypertension, a dyslipidemia or diabetes. In subjects treated with antihypertensive medications, participants completed the 6-item Girerd Scale and EvaLobs ® . The French League Against Hypertension Survey (FLAHS) are carried out by self-questionnaire sent by mail to individuals from the French Kantar Health sampling frame (representative panel of the population living in metropolitan France). In 2017, FLAHS was conducted in 4783 subjects aged 35 and over. The EvaLobs ® has a scale from 0 to 15 and the use instruction is "how many days have you taken the drug in the past 15 days". A score>12 indicates a "good compliance". The 6-item Girerd scale was also completed. "Good adherence" was determined for a score of 0 to 2 and "nonadherence" for a score of 3 or more. The agreement between EvaLobs ® and the 6-item Girerd scale was evaluated in treated hypertensives. The survey included 4783 subjects with 1308 treated hypertensives, 942 subjects treated with lipid-lowering drugs and 405 subjects treated with anti-diabetics. EVALOBS ® indicates "Good adherence" in 96% of subjects and the 6 questions questionnaire indicates "good adherence" in 95% of subjects. An excellent agreement is noted in 93.8%. An EvaLobs ® score indicating nonadherence or an absence of response to EvaLobs ® is observed in 3.6% [CI 95, 2.5-4.7] of hypertensives, in 6.0% [CI 95, 3.9-8.1] of diabetics and in 8.2% [CI 95, 6.5-9.9] of dyslipidemic patients. In the population living in France and in unselected patients treated for metabolic disease or hypertension, non-adherence is lowest for antihypertensive medications and highest for statins. EvaLobs ® , which shows good agreement with an adherence questionnaire, is a quick and simple tool for assessing adherence. The smartphone app EvaLobs ® is available for free on Google play and the Apple store. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Esomeprazole treatment of frequent heartburn: two randomized, double-blind, placebo-controlled trials.

PubMed

Peura, David A; Traxler, Barry; Kocun, Christopher; Lind, Tore

2014-07-01

To determine the efficacy of a 14-day regimen of esomeprazole 20 mg for the treatment of frequent heartburn in subjects who are likely to self-treat with over-the-counter medications without consulting a health care provider. Adults with frequent heartburn ≥ 2 days per week in the past 4 weeks were randomly assigned to 14-day double-blind treatment with esomeprazole 20 mg once daily or placebo in 2 identical multicenter studies (ClinicalTrials.gov identifiers: NCT01370525, NCT01370538). The primary efficacy outcome was percentage of heartburn-free 24-hour days across 14 days. Secondary efficacy outcomes included heartburn resolution, defined as heartburn ≤ 2 days over 14 days, and percentages of subjects reporting ≤ 1 day with heartburn in the first and final weeks of treatment. Subjects recorded data in daily self-assessment diaries. The percentage of heartburn-free 24-hour days over 14 days was significantly higher (P < 0.0001) in subjects receiving esomeprazole 20 mg compared with placebo in study 1 (N = 331; 46.13% vs. 33.07%, respectively) and study 2 (N = 320; 48.00% vs 32.75%, respectively). Significantly more subjects treated with esomeprazole 20 mg had heartburn resolution over 14 days and in the first and final weeks compared with placebo. Within the first 4 days, the proportion of subjects with heartburn-free days was significantly greater with esomeprazole 20 mg versus placebo. Treatment was generally well tolerated, with a safety pattern consistent with the known profile for esomeprazole. A 14-day regimen of esomeprazole 20 mg once daily was effective for treating frequent heartburn in subjects who are likely to self-treat with over-the-counter medications.

Comparison of Cisatracurium Versus Atracurium in Early ARDS.

PubMed

Moore, Leanne; Kramer, Charles Joseph; Delcoix-Lopes, Sophie; Modrykamien, Ariel M

2017-07-01

Administration of cisatracurium in severe ARDS decreases in-hospital mortality. Whether clinical outcomes are cisatracurium-specific or related with all neuromuscular blockers is unknown. This study aimed to compare outcomes in severe ARDS patients treated with cisatracurium versus atracurium. Patients admitted in ICUs with a diagnosis of severe ARDS and treated with neuromuscular blocking agents within 72 h of diagnosis were included. Subjects treated with cisatracurium versus atracurium were compared. The primary outcome was improvement in oxygenation, defined as the difference of P aO 2 /F IO 2 at 72 h post-initiation of neuromuscular blocking agents. Secondary outcomes were ventilator-free days at day 28, ICU and hospital lengths of stay, and hospital mortality. Seventy-six subjects with ARDS were included in the study. Eighteen subjects (24%) were treated with atracurium, whereas 58 (76%) were treated with cisatracurium. Equivalent dosages of sedation and analgesia as well as use of brain function monitoring technology were similar between both groups. There were no differences in clinical outcomes. Specifically, improvement of P aO 2 /F IO 2 was a median (interquartile range [IQR]) of 65 (25-162) in the atracurium group and 66 (IQR 16-147) in the cisatracurium group ( P = .65). Ventilator-free days at day 28 were 13 d (IQR 0-22 d) and 15 d (IQR 8-21 d) in the atracurium and cisatracurium groups, respectively ( P = .72). ICU length or stay was 18 d (IQR 8-34 d) in the atracurium group and 15 d (IQR 9-22 d) in the cisatracurium group ( P = .34). In-hospital mortality was 50% for the atracurium population and 62% for the cisatracurium group ( P = .42) CONCLUSIONS: Among subjects with early severe ARDS, the utilization of atracurium versus cisatracurium within 72 h of admission was not associated with significant differences in clinical outcomes. Copyright © 2017 by Daedalus Enterprises.

Surgical treatment is effective in severe cases of exercise-induced laryngeal obstruction: A follow-up study.

PubMed

Norlander, Katarina; Johansson, Henrik; Jansson, Christer; Nordvall, Lennart; Nordang, Leif

2015-01-01

Surgery is an effective treatment in severe cases of supraglottic exercise-induced laryngeal obstruction (E-ILO). Conservatively treated subjects and subjects tested negative for E-ILO, who still experience breathing problems 1-3 years after diagnosis, tend to adjust their physical activity to a greater extent than surgically treated subjects. To investigate how symptoms and level of physical activity change over time in patients with E-ILO who have undergone surgery, patients with E-ILO treated conservatively and patients who tested negative for laryngeal obstruction at continuous laryngoscopy exercise-test (CLE-test). Patients referred for exercise-induced breathing difficulties answered questionnaires at diagnostic CLE-test and at follow-up. Questions regarded exercise-induced breathing problems, current physical activity level, and medical history of asthma and perennial allergy. Out of 84 invited subjects, 59 (70%) answered both questionnaires. Surgically treated subjects had less breathing problems at follow-up compared with conservatively treated subjects and subjects who tested negative (p < 0.001). None of the surgically treated subjects were less physically active or had changed sport due to exercise-induced dyspnoea, whereas 41.7% of the conservatively treated subjects had made such adjustments (p < 0.001).

Prospective Study Evaluating IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm: Interim Results from the First 145 Subjects with Cervical Dystonia.

PubMed

Fernandez, Hubert H; Pagan, Fernando; Danisi, Fabio; Greeley, David; Jankovic, Joseph; Verma, Amit; Sethi, Kapil; Pappert, Eric J

2013-01-01

We report the interim results from XCiDaBLE, a large, prospective, observational "naturalistic" study evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or BLEpharospasm in the United States. Subjects (≥ 18 years old) with cervical dystonia (CD) are followed for two treatment cycles and monitored via Interactive Voice/Web Response. The subject's physician must have chosen to treat with incobotulinumtoxinA prior to and independent of enrollment in this study. Subject-reported scales include the Subject Global Impression-Severity and Improvement and Cervical Dystonia Impact Profile (CDIP-58), and Work Productivity and Quality of Life (QoL) are assessed by means of an employment questionnaire and work history and the SF-12v2 Health Survey (SF-12v2). Subjects are seen by the investigator for three visits, which include a baseline visit (including the first injection), a second injection visit, and a final study visit (12 weeks after the second injection). This ongoing study includes 145 subjects with a diagnosis of CD. The majority were female (82.3%) and white (91.0%) and had previously been treated with botulinum toxins (77.2%). There were 106 employed at the time of disease onset, but 12.6 years later only 44% were still employed at the time of enrolment into the study, and 20% were either receiving or seeking disability benefits. The mean total dose/treatment of CD was 225.2 units for the first injection. The CDIP-58 total score was significantly improved 4 weeks after the first injection compared to baseline (p≤0.0001). Most subjects noted improvement in their global impression assessment. No new or unexpected adverse events occurred. The results from these interim analyses confirm previous controlled, single-dose studies of incobotulinumtoxinA in terms of efficacy and safety.

Prospective Study Evaluating IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm: Interim Results from the First 145 Subjects with Cervical Dystonia

PubMed Central

Fernandez, Hubert H.; Pagan, Fernando; Danisi, Fabio; Greeley, David; Jankovic, Joseph; Verma, Amit; Sethi, Kapil; Pappert, Eric J.

2013-01-01

Background We report the interim results from XCiDaBLE, a large, prospective, observational “naturalistic” study evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or BLEpharospasm in the United States. Methods Subjects (≥ 18 years old) with cervical dystonia (CD) are followed for two treatment cycles and monitored via Interactive Voice/Web Response. The subject's physician must have chosen to treat with incobotulinumtoxinA prior to and independent of enrollment in this study. Subject-reported scales include the Subject Global Impression-Severity and Improvement and Cervical Dystonia Impact Profile (CDIP-58), and Work Productivity and Quality of Life (QoL) are assessed by means of an employment questionnaire and work history and the SF-12v2 Health Survey (SF-12v2). Subjects are seen by the investigator for three visits, which include a baseline visit (including the first injection), a second injection visit, and a final study visit (12 weeks after the second injection). Results This ongoing study includes 145 subjects with a diagnosis of CD. The majority were female (82.3%) and white (91.0%) and had previously been treated with botulinum toxins (77.2%). There were 106 employed at the time of disease onset, but 12.6 years later only 44% were still employed at the time of enrolment into the study, and 20% were either receiving or seeking disability benefits. The mean total dose/treatment of CD was 225.2 units for the first injection. The CDIP-58 total score was significantly improved 4 weeks after the first injection compared to baseline (p≤0.0001). Most subjects noted improvement in their global impression assessment. No new or unexpected adverse events occurred. Discussion The results from these interim analyses confirm previous controlled, single-dose studies of incobotulinumtoxinA in terms of efficacy and safety. PMID:23724362

A controlled, randomized, delayed-start study of rasagiline in early Parkinson disease.

PubMed

2004-04-01

Treatment with rasagiline mesylate, an irreversible monoamine oxidase type B inhibitor, improves symptoms of early Parkinson disease (PD). Preclinical studies suggest that this compound may also modify the progression of PD. To compare the effects of early and later initiation of rasagiline on progression of disability in patients with PD. Double-blind, parallel-group, randomized, delayed-start clinical trial. Four hundred four subjects with early PD, not requiring dopaminergic therapy, enrolled at 32 sites in the United States and Canada. Subjects were randomized to receive rasagiline, 1 or 2 mg/d, for 1 year or placebo for 6 months followed by rasagiline, 2 mg/d, for 6 months. Change in total Unified Parkinson's Disease Rating Scale score from baseline to 12 months. Three hundred seventy-one subjects were included in the 1-year efficacy analysis. Subjects treated with rasagiline, 2 mg/d, for 1 year had a 2.29-unit smaller increase in mean adjusted total Unified Parkinson's Disease Rating Scale score compared with subjects treated with placebo for 6 months followed by rasagiline, 2 mg/d, for 6 months (P =.01). The mean adjusted difference between the placebo/rasagiline, 2 mg/d, group and those receiving rasagiline, 1 mg/d, for 1 year was -1.82 unit on the Unified Parkinson's Disease Rating Scale score (P =.05). Subjects treated with rasagiline, 2 and 1 mg/d, for 12 months showed less functional decline than subjects whose treatment was delayed for 6 months.

Peer Collaboration: The Case for Treating the Dyad as the Unit of Analysis.

ERIC Educational Resources Information Center

Tudge, Jonathan

In a study of peer collaboration among children, the case is made for treating the dyad, rather than the individual, as the unit of analysis. Subjects included 154 children aged 5 to 9 years from a broad range of social classes. Children worked in 14 problems (representing 6 types of problems) predicting the movement of a balance beam. Children…

Effect of comorbid tics on a clinically meaningful response to 8-week open-label trial of fluoxetine in obsessive compulsive disorder.

PubMed

Husted, David S; Shapira, Nathan A; Murphy, Tanya K; Mann, Giselle D; Ward, Herbert E; Goodman, Wayne K

2007-01-01

Currently, there are limited published data evaluating the effects of tics on serotonin reuptake inhibitor (SRI) monotherapy responses in treating obsessive-compulsive disorder (OCD). One retrospective case-controlled analysis of OCD patients treated with SRI monotherapy showed lesser improvement in OCD symptoms in patients with tics than those without. However, more recently there were preliminary reports of OCD subjects treated with SRI monotherapy which did not demonstrate poorer response in subjects with tics or Tourette's Syndrome (TS). The specific aim of this study was to investigate whether the presence of comorbid chronic tics affected "clinically meaningful improvement" [McDougle, C.J., Goodman, W.K., Leckman, J.F., Barr, L.C., Heninger, G.R., Price, L.H., 1993. The efficacy of fluvoxamine in obsessive-compulsive disorder: effects of comorbid chronic tic disorder. Journal of Clinical Psychopharmacology 13, 354-358] of OCD in an 8-week open-label trial of fluoxetine monotherapy. Seventy-four adult subjects (13 patients with comorbid chronic tics and 61 patients without tics) with a primary DSM-IV OCD diagnosis were treated with up to 40mg fluoxetine for 8 weeks and had at least one post-baseline evaluation. The results indicate that there was a significant response by time in both fluoxetine-with-tic subjects and fluoxetine-without-tic subjects. Additionally, there were 3 (23.0%) OCD subjects with tics who had clinically meaningful improvement versus 16 (26.2%) OCD subjects without tics that demonstrated similar levels of improvement. These findings indicate that OCD patients with or without chronic tic disorders did not have a differential response to an 8-week open-label trial of fluoxetine. Limitations include the relatively low number of tic subjects and the open-label nature of the study. Additional data are needed on how comorbid tics may affect SRI treatment response in OCD.

Effect of positive airway pressure therapy on seizure control in patients with epilepsy and obstructive sleep apnea.

PubMed

Pornsriniyom, Darakul; Kim, Hu won; Bena, James; Andrews, Noah D; Moul, Douglas; Foldvary-Schaefer, Nancy

2014-08-01

Previous studies suggest that treatment for obstructive sleep apnea (OSA) in patients with epilepsy can improve seizure control. We investigated the effect of positive airway pressure (PAP) therapy on seizures in adults with epilepsy referred to the Cleveland Clinic for polysomnography (PSG) from 1997 to 2010. Seizure outcome at baseline and 1 year later was compared in patients with no OSA (apnea-hypopnea index [AHI] <5), patients with PAP-treated OSA, and patients with untreated OSA. One hundred thirty-two subjects (age: 40.2±13 (18-76) years, 65.4% female) were included. Seventy-six (57.6%) subjects had OSA; of these, 43 (56.6%) were on PAP therapy, and 33 (43.4%) were not on PAP therapy (either PAP-intolerant or refused therapy). Of the group with PAP-treated OSA, 83.7% were adherent (use ≥4 h/night at least 5 nights/week). The percentage of subjects with ≥50% seizure reduction and the mean percentage of seizure reduction were significantly greater in the group with PAP-treated OSA (73.9%; 58.5%) than in subjects with untreated OSA (14.3%; 17.0%). There were significantly more subjects with successful outcomes (with ≥50% seizure reduction or seizure-free at both baseline and follow-up) in the group with PAP-treated OSA (83.7%) than in the groups with no OSA (53.6%) and untreated OSA (39.4%). After adjusting for age, gender, body mass index, AHI, and epilepsy duration, we found that the odds of successful outcomes in subjects in the group with PAP-treated OSA were 9.9 and 3.91 times those of the groups with untreated OSA and no OSA, respectively. The group with PAP-treated OSA had 32.3 times the odds of having a ≥50% seizure reduction compared with the group with untreated OSA and 6.13 times compared with the group with no OSA. Positive airway pressure therapy appears to produce beneficial effects on seizures in adult patients with epilepsy and OSA. Copyright © 2014 Elsevier Inc. All rights reserved.

Elevated homocysteine levels in human immunodeficiency virus-infected patients under antiretroviral therapy: A meta-analysis

PubMed Central

Deminice, Rafael; Silva, Talita Capoani Vieira; de Oliveira, Vitor Hugo Fernando

2015-01-01

AIM: To evaluate the association between the levels of homocysteine (Hcy), folate, vitamin B12 in human immunodeficiency virus (HIV)-infected patients who were treated with antiretroviral therapy (ART) or not treated with ART. METHODS: The PubMed and Scielo databases were searched. Eligible studies regarding plasma Hcy level in HIV-infected patients were firstly identified. After careful analysis by two independent researches, the identified articles were included in the review according to two outcomes (1) Hcy, folate and vitamin B12 blood concentration in HIV-infected subjects vs health controls and; (2) Hcy blood concentration in HIV-infected subjects under ART vs not treated with ART. RevMan (version 5.2) was employed for data synthesis. RESULTS: A total of 12 studies were included in outcome 1 (1649 participants, 932 cases and 717 controls). Outcome 1 meta-analysis demonstrated higher plasma Hcy (2.05 µmol/L; 95%CI: 0.10 to 4.00, P < 0.01) and decreased plasma folate concentrations (-2.74 ng/mL; 95%CI: -5.18 to -0.29, P < 0.01) in HIV-infected patients compared to healthy controls. No changes in vitamin B12 plasma concentration were observed between groups. All studies included in the outcome 2 meta-analysis (1167 participants; 404 HIV-infected exposed to ART and 757 HIV-infected non-ART patients) demonstrated higher mean Hcy concentration in subjects HIV-infected under ART compared to non-ART HIV subjects (4.13 µmol/L; 95%CI: 1.34 to 6.92, P < 0.01). CONCLUSION: This meta-analysis demonstrated that the levels of Hcy and folate, but not vitamin B12, were associated with HIV infection. In addition, Hcy levels were higher in HIV-infected patients who were under ART compared to HIV-infected patients who were not exposed to ART. Our results suggest that hyperhomocysteinemia should be included among the several important metabolic disturbances that are associated with ART in patients with HIV infection. PMID:25964880

Association between physical exercise and quality of erection in men with ischaemic heart disease and erectile dysfunction subjected to physical training.

PubMed

Kałka, Dariusz; Domagała, Zygmunt; Dworak, Jacek; Womperski, Krzysztof; Rusiecki, Lesław; Marciniak, Wojciech; Adamus, Jerzy; Pilecki, Witold

2013-01-01

In addition to a beneficial effect on exercise tolerance and an associated reduction of global cardiovascular risk, modification of physical activity has a positive effect on the quality of life, reducing, among other things, the severity of erectile dysfunction (ED). The specific nature of sexual activity, which combines the need to maintain appropriate exercise tolerance and good erection quality, prompted us to evaluate the association between exercise tolerance and severity of ED in an intervention group of subjects with ischaemic heart disease (IHD) and ED in the context of cardiac rehabilitation (CR). A total of 138 men treated invasively for IHD (including 99 treated with percutaneous coronary intervention and 39 treated with coronary artery bypass grafting) who scored 21 or less in the initial IIEF-5 test were investigated. Subjects were randomised into two groups. The study group included 103 subjects (mean age 62.07 ± 8.59 years) who were subjected to a CR cycle. The control group included 35 subjects (mean age 61.43 ± 8.81 years) who were not subjected to any CR. All subjects filled out an initial and final IIEF-5 questionnaire and were evaluated twice with a treadmill exercise test. The CR cycle was carried out for a period of 6 months and included interval endurance training on a cycle ergometer (three times a week) and general fitness exercises and resistance training (twice a week). The CR cycle in the study group resulted in a statistically significant increase in exercise tolerance (7.15 ± 1.69 vs. 9.16 ± 1.84 METs,p < 0.05) and an increase in erection quality (12.51 ± 5.98 vs. 14.39 ± 6.82, p < 0.05) which was not observed in the control group. A significant effect of age on a progressive decrease in exercise tolerance and erection quality was found in the study group. Exercise tolerance and erection quality were also negatively affected by hypertension and smoking. A significant correlation between exercise tolerance and erection quality prior to the rehabilitation cycle indicates better erection quality in patients with better effort tolerance. The improvement in exercise tolerance did not correlate significantly with initial exercise tolerance or age of the subjects. In contrast, a significantly higher increase in erection quality was observed in younger subjects with the lowest baseline severity of ED.The relative increase in exercise tolerance in the group subjected to CR was significantly higher than the relative increase in erection quality but these two effects were not significantly correlated with each other. 1. In subjects with IHD and ED, erection quality is significantly correlated with exercise tolerance. 2. Exercise training had a positive effect on both exercise tolerance and erection quality but the size of these two effects was different and they ran independently of each other.

Mosaic HIV envelope immunogenic polypeptides

DOE Office of Scientific and Technical Information (OSTI.GOV)

Korber, Bette T. M.; Gnanakaran, S.; Perkins, Simon

Disclosed herein are mosaic HIV envelope (Env) polypeptides that can elicit an immune response to HIV (such as cytotoxic T cell (CTL), helper T cell, and/or humoral responses). Also disclosed are sets of the disclosed mosaic Env polypeptides, which include two or more (for example, three) of the polypeptides. Also disclosed herein are methods for treating or inhibiting HIV in a subject including administering one or more of the disclosed immunogenic polypeptides or compositions to a subject infected with HIV or at risk of HIV infection. In some embodiments, the methods include inducing an immune response to HIV in amore » subject comprising administering to the subject at least one (such as two, three, or more) of the immunogenic polypeptides or at least one (such as two, three, or more) nucleic acids encoding at least one of the immunogenic polypeptides disclosed herein.« less

EVALUATION OF FULL-FIELD ELECTRORETINOGRAM REDUCTIONS AFTER OCRIPLASMIN TREATMENT

PubMed Central

Benz, Matthew S.; Miller, Daniel M.; Antoszyk, Andrew N.; Markoff, Joseph; Kozma, Petra; Meunier, Esmeralda; Sergott, Robert C.

2018-01-01

Purpose: To explore a possible association between full-field electroretinograms with vitreomacular adhesion resolution and best-corrected visual acuity as part of the prospective, randomized, double-masked, sham-controlled Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) trial studying ocriplasmin. Methods: The ERG substudy enrolled 62 of 220 OASIS subjects (randomized 2:1) and analyzed full-field electroretinograms and their association with both vitreomacular adhesion resolution and best-corrected visual acuity from baseline through Month 24. Electroretinogram reductions were defined as acute full-field electroretinogram reductions in amplitude of ≥40% from baseline occurring at postinjection Day 7 or Day 28. Results: In the ocriplasmin group, 16/40 (40%) subjects developed ERG reductions, compared to 1/21 (4.8%) in the sham group; 13/16 (81.3%) and 1/1 (100%) resolved by study end, respectively. A total of 11/16 (68.8%) ocriplasmin-treated subjects with ERG reductions achieved vitreomacular adhesion resolution, compared to those without (9/24, 37.5%). The ocriplasmin-treated subjects with ERG reductions also gained more letters on average (11.3 vs. 9.3 letters) from baseline and had a difference of 6.7 letters in mean best-corrected visual acuity by study end compared to those without ERG reductions. Conclusion: Ocriplasmin-treated subjects with ERG reductions had a higher rate of vitreomacular adhesion resolution and showed better visual improvement than their counterparts without ERG reductions or sham subjects by study end. PMID:28198785

Antimicrobial Treatment of Asymptomatic Bacteriuria in Healthy Ambulatory Subjects.

ERIC Educational Resources Information Center

Zhanel, George G.

1990-01-01

The treatment of urinary tract infections is discussed. Specific issues considered include the definition of asymptomatic bacteriuria, the prevalence of asymptomatic bacteriuria, the controversies of who should be treated, and antimicrobial treatment of asymptomatic bacteriuria. (MLW)

[The assessment of the clinical effectiveness of fenspiride for the treatment of acute obstruction of the Eustachian tube].

PubMed

Fedin, A V

2015-01-01

The objective of the present study was to estimate the clinical effectiveness of fenspiride used to correct the obstruction of the Eustachian tube in 80 patients presenting with acute tubootitis and exudative otitis media. The algorithm of the examination included the evaluation of the severity of subjective clinical symptoms based on the relevant analog-visual scale, results of tonal audiometry, and tympanometry. The control group was comprised of 34 patients treated with antibacterial preparations, topical decongestants, and transtubal administration of glucocorticoids. The study group included 46 patients who received fenspiride at a dose of 80 mg thrice daily in addition to the above pharmacotherapy. The severity of clinical symptoms in the patients treated with fenspiride decreased faster than in the control subjects. The frequency analysis of dynamics of the air-bone gaps on the audiometric curves revealed the significantly more intensive recovery of the hearing function in the patients treated by basal pharmacotherapy in the combination with fenspiride. Type A tympanograms predominated on day 7 after the onset of the conservative treatment with the use of fenspiride whereas type C tympanograms continued to predominate in the patients of the control group. It is concluded that the introduction of fenspiride into combined therapy of acute tubootitis and exudative otitis media promotes the normalization of the ventilation and drainage functions and relieves the severity of subjective clinical symptoms.

10 CFR 35.604 - Surveys of patients and human research subjects treated with a remote afterloader unit.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Surveys of patients and human research subjects treated... Stereotactic Radiosurgery Units § 35.604 Surveys of patients and human research subjects treated with a remote... shall survey the patient or the human research subject and the remote afterloader unit with a portable...

10 CFR 35.604 - Surveys of patients and human research subjects treated with a remote afterloader unit.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Surveys of patients and human research subjects treated... Stereotactic Radiosurgery Units § 35.604 Surveys of patients and human research subjects treated with a remote... shall survey the patient or the human research subject and the remote afterloader unit with a portable...

10 CFR 35.604 - Surveys of patients and human research subjects treated with a remote afterloader unit.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Surveys of patients and human research subjects treated... Stereotactic Radiosurgery Units § 35.604 Surveys of patients and human research subjects treated with a remote... shall survey the patient or the human research subject and the remote afterloader unit with a portable...

10 CFR 35.604 - Surveys of patients and human research subjects treated with a remote afterloader unit.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Surveys of patients and human research subjects treated... Stereotactic Radiosurgery Units § 35.604 Surveys of patients and human research subjects treated with a remote... shall survey the patient or the human research subject and the remote afterloader unit with a portable...

10 CFR 35.604 - Surveys of patients and human research subjects treated with a remote afterloader unit.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Surveys of patients and human research subjects treated... Stereotactic Radiosurgery Units § 35.604 Surveys of patients and human research subjects treated with a remote... shall survey the patient or the human research subject and the remote afterloader unit with a portable...

Treating nailbiting: a comparative analysis of mild aversion and competing response therapies.

PubMed

Silber, K P; Haynes, C E

1992-01-01

This study compared two methods of treating nail-biting. One method involved the use of a mild aversive stimulus in which subjects painted a bitter substance on their nails, and the other required the subject to perform a competing response whenever they had the urge to bite or found themselves biting their nails. Both methods included self-monitoring of the behaviour, and a third group of subjects performed self-monitoring alone as a control condition. The study lasted four weeks. Twenty-one subjects, seven per group, participated. Both methods resulted in significant improvements in nail length, with the competing response method showing the most beneficial effect. There was no significant improvement for the control group. The competing response condition also yielded significant improvements along other dimensions such as degree of skin damage and subjects own ratings of their control over their habit. These were not seen for the other two conditions. The benefits of this abridged version of Azrin and Nunn's (Behaviour Research and Therapy, 11, 619-628, 1973) habit reversal method in terms of treatment success, use of therapist time and client satisfaction, are discussed.

Study protocol and overview of the literature on long-term health and quality of life outcomes in patients treated in adolescence for scoliosis with therapeutic exercises.

PubMed

Plaszewski, Maciej; Kotwicki, Tomasz; Chwala, Wieslaw; Terech, Jacek; Cieśliński, Igor

2015-01-01

Scoliosis, the most prevalent orthopaedic condition affecting children and adolescents, may have lasting physical, psychological and social consequences. With limited evidence-base, scoliosis-specific exercise therapies are an option. An overview of the subject and description of a long-term follow-up study including adults who in adolescence were treated with a scoliosis-specific exercise programme investigating the association of the exercise regime with present physical activity, physical functioning and subjective wellbeing. To the authors' best knowledge, this is the first long-term outcome study on scoliosis-specific exercises, in opposition to a number of studies in adults who were braced or treated surgically in adolescence. Observational, registry-based case-control study. Adult subjects who in adolescence were treated with an exercise programme or were under observation are invited. Spine and trunk deformity, respiratory function, physical capacity and trunk muscles' function are measured. Health-related quality of life with generic and condition-specific instruments, general mental health, depression and anxiety symptoms, disability due to low back problems and physical activity are assessed. The report is believed to provide the readers with an overview of this controversial aspect of rehabilitation, and that the proposed protocol will assist researchers designing their studies.

The Effects of 2′-O-Methoxyethyl Containing Antisense Oligonucleotides on Platelets in Human Clinical Trials

PubMed Central

Baker, Brenda F.; Witztum, Joseph L.; Kwoh, T. Jesse; Pham, Nguyen C.; Salgado, Nelson; McEvoy, Bradley W.; Cheng, Wei; Hughes, Steven G.; Bhanot, Sanjay; Geary, Richard S.

2017-01-01

A thorough analysis of clinical trial data in the Ionis integrated safety database (ISDB) was performed to determine if there is a class effect on platelet numbers and function in subjects treated with 2′-O-methoxyethyl (2′MOE)-modified antisense oligonucleotides (ASOs). The Ionis ISDB includes over 2,600 human subjects treated with 16 different 2′MOE ASOs in placebo-controlled and open-label clinical trials over a range of doses up to 624 mg/week and treatment durations as long as 4.6 years. This analysis showed that there is no class generic effect on platelet numbers and no incidence of confirmed platelet levels below 50 K/μL in subjects treated with 2′MOE ASOs. Only 7 of 2,638 (0.3%) subjects treated with a 2′MOE ASO experienced a confirmed postbaseline (BSLN) platelet count between 100 and 50 K/μL. Three of sixteen 2′MOE ASOs had >10% incidence of platelet decreases >30% from BSLN, suggesting that certain sequences may associate with clinically insignificant platelet declines. Further to these results, we found no evidence that 2′MOE ASOs alter platelet function, as measured by the lack of clinically relevant bleeding in the presence or absence of other drugs that alter platelet function and/or number and by the results from trials conducted with the factor XI (FXI) ASO. PMID:28145801

Treating speech subsystems in childhood apraxia of speech with tactual input: the PROMPT approach.

PubMed

Dale, Philip S; Hayden, Deborah A

2013-11-01

Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT; Hayden, 2004; Hayden, Eigen, Walker, & Olsen, 2010)-a treatment approach for the improvement of speech sound disorders in children-uses tactile-kinesthetic- proprioceptive (TKP) cues to support and shape movements of the oral articulators. No research to date has systematically examined the efficacy of PROMPT for children with childhood apraxia of speech (CAS). Four children (ages 3;6 [years;months] to 4;8), all meeting the American Speech-Language-Hearing Association (2007) criteria for CAS, were treated using PROMPT. All children received 8 weeks of 2 × per week treatment, including at least 4 weeks of full PROMPT treatment that included TKP cues. During the first 4 weeks, 2 of the 4 children received treatment that included all PROMPT components except TKP cues. This design permitted both between-subjects and within-subjects comparisons to evaluate the effect of TKP cues. Gains in treatment were measured by standardized tests and by criterion-referenced measures based on the production of untreated probe words, reflecting change in speech movements and auditory perceptual accuracy. All 4 children made significant gains during treatment, but measures of motor speech control and untreated word probes provided evidence for more gain when TKP cues were included. PROMPT as a whole appears to be effective for treating children with CAS, and the inclusion of TKP cues appears to facilitate greater effect.

Pyridostigmine in postpolio syndrome: no decline in fatigue and limited functional improvement

PubMed Central

Horemans, H; Nollet, F; Beelen, A; Drost, G; Stegeman, D; Zwarts, M; Bussmann, J; de Visser, M; Lankhorst, G

2003-01-01

Objectives: To investigate the effect of pyridostigmine on fatigue, physical performance, and muscle function in subjects with postpoliomyelitis syndrome. Methods: 67 subjects with increased fatigue and new weakness in one quadriceps muscle showing neuromuscular transmission defects, were included in a randomised, double blind, placebo controlled trial of 60 mg pyridostigmine four times a day for 14 weeks. Primary outcome was fatigue (on the "energy" category of the Nottingham health profile). Secondary outcomes included two minute walking distance and quadriceps strength and jitter. Motor unit size of the quadriceps was studied as a potential effect modifier. The primary data analysis compared the changes from baseline in the outcomes in the last week of treatment between groups. Results: 31 subjects treated with pyridostigmine and 31 subjects treated with placebo completed the trial. No significant effect of pyridostigmine was found on fatigue. The walking distance improved more in the pyridostigmine group than in the placebo group (by 7.2 m (6.0%); p<0.01). Subgroup analysis showed that a significant improvement in walking performance was only found in subjects with normal sized motor units. Quadriceps strength improved more in the pyridostigmine group than in the placebo group (by 6.7 Nm (7.2%); p = 0.15). No effect of pyridostigmine was found on jitter. Conclusions: Pyridostigmine in the prescribed dose did not reduce fatigue in subjects with postpoliomyelitis syndrome. However, it may have a limited beneficial effect on physical performance, especially in subjects with neuromuscular transmission defects in normal sized motor units. PMID:14638885

Effects of fexofenadine and hydroxyzine on brake reaction time during car-driving with cellular phone use.

PubMed

Tashiro, Manabu; Horikawa, Etsuo; Mochizuki, Hideki; Sakurada, Yumiko; Kato, Motohisa; Inokuchi, Takatoshi; Ridout, Fran; Hindmarch, Ian; Yanai, Kazuhiko

2005-10-01

Antihistamines are a mainstay treatment for allergic rhinitis; however, many older agents cause adverse events, including sedation and central nervous system (CNS) impairment. Research has shown sedating effects of antihistamines on driving; currently, no known study has examined whether cellular phone usage while driving further compounds impairment in individuals administered antihistamines. The aim of this study was to examine this endpoint. In a randomized, double-blind, placebo-controlled, three-way crossover study, healthy volunteers received fexofenadine HCl 120 mg, hydroxyzine HCl 30 mg and placebo. Brake reaction time (BRT) was used to examine driving performance across four conditions: driving only; driving while completing simple calculations; complex calculations; and conversing on a cellular phone. Subjective sedation assessments were also conducted. Brake reaction time with and without cellular phone usage in fexofenadine-treated subjects did not differ significantly from placebo in any condition. In contrast, hydroxyzine-treated subjects were significantly more sedated and had slower BRTs, suggesting slower hazard recognition and brake application, compared with the fexofenadine and placebo groups in all conditions. Importantly, cellular phone operation was an additive factor, increasing BRTs in hydroxyzine-treated volunteers. Fexofenadine did not impair CNS function in subjects involved in a divided attention task of driving and cellular phone operation. Copyright (c) 2005 John Wiley & Sons, Ltd.

26 CFR 1.1441-5 - Withholding on payments to partnerships, trusts, and estates.

Code of Federal Regulations, 2010 CFR

2010-04-01

... subject to withholding (as defined in § 1.1441-2(a)) that a withholding agent may treat as made to a U.S... withholding (as defined in § 1.1441-2(a)) that is includible in the gross income of a partner that is a... net income is an amount subject to withholding (as defined in § 1.1441-2(a)). A U.S. simple trust...

[Surgical treatment of polycystic ovary syndrome].

PubMed

Warenik-Szymankiewicz, A; Grotowski, W; Halerz-Nowakowska, B; Maciejewska, M

1999-05-01

This analysis includes 67 cases of diagnosed polycystic ovary syndrome, which were treated by surgical procedure (ovarian wedge resection). Subjects to assessment were: efficacy of treatment by mean of menstrual cycle regulation and influence of wedge resection on patients hormonal profile.

Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures(e–Pub ahead of print)(LOE Classification)

PubMed Central

LaFrance, W.C.; Keitner, G.I.; Papandonatos, G.D.; Blum, A.S.; Machan, J.T.; Ryan, C.E.; Miller, I.W.

2010-01-01

Objective: There have been few treatment trials for psychogenic nonepileptic seizures (PNES). Some psychotherapies have been shown to improve PNES and comorbid symptom outcomes. We evaluated a pharmacologic intervention to test the hypothesis that sertraline would reduce PNES. Methods: We conducted a pilot, double-blind, randomized, placebo-controlled trial in an academic medical hospital with epilepsy center outpatients. Subjects aged 18 to 65 years diagnosed with video-EEG–confirmed PNES were treated with flexible-dose sertraline or placebo over 12 weeks. Seizure calendars and symptom scales were charted prospectively. Secondary outcome measures included psychiatric symptom scales and psychosocial variables. Results: Thirty-eight subjects enrolled, and 26 (68%) completed the trial. Thirty-three subjects with nonzero nonepileptic seizure rates at baseline were included in intent-to-treat analysis of the primary outcome. Subjects assigned to the sertraline arm experienced a 45% reduction in seizure rates from baseline to final visit (p = 0.03) vs an 8% increase in placebo (p = 0.78). Secondary outcome scales revealed no significant between-group differences in change scores from baseline to final visit, after adjustment for differences at baseline. Conclusions: PNES were reduced in patients treated with a serotonin selective reuptake inhibitor, whereas those treated with placebo slightly increased. This study provides feasibility data for a larger-scale study. Level of evidence: This study provides Class II evidence that flexible-dose sertraline up to a maximum dose of 200 mg is associated with a nonsignificant reduction in PNES rate compared with a placebo control arm (risk ratio 0.51, 95% confidence interval 0.25–1.05, p = 0.29), adjusting for differences at baseline. GLOSSARY AED = antiepileptic drug; CI = confidence interval; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th edition; ES = epileptic seizures; ITT = intent to treat; PNES = psychogenic nonepileptic seizures; PTSD = posttraumatic stress disorder; QOL = quality of life; RCT = randomized controlled trial; RIH = Rhode Island Hospital; RR = risk ratio; SSRI = serotonin selective reuptake inhibitor; vEEG = video-EEG. PMID:20739647

Treatment with Selective Serotonin Reuptake Inhibitors and Mirtapazine Results in Differential Brain Activation by Visual Erotic Stimuli in Patients with Major Depressive Disorder

PubMed Central

Kim, Won; Jin, Bo-Ra; Yang, Wan-Seok; Lee, Kyuong-Uk; Juh, Ra-Hyung; Ahn, Kook-Jin; Chung, Yong-An

2009-01-01

Objective The objective of this study was to identify patterns of brain activation elicited by erotic visual stimuli in patients treated with either Selective Serotonin Reuptake Inhibitors (SSRIs) or mirtazipine. Methods Nine middle-aged men with major depressive disorder treated with an SSRI and ten middle-aged men with major depressive disorder treated with mirtazapine completed the trial. Ten subjects with no psychiatric illness were included as a control group. We conducted functional brain magnetic resonance imaging (fMRI) while a film alternatively played erotic and non-erotic contents for 14 minutes and 9 seconds. Results The control group showed activation in the occipitotemporal area, anterior cingulate gyrus, insula, orbitofrontal cortex, and caudate nucleus. For subjects treated with SSRIs, the intensity of activity in these regions was much lower compared to the control group. Intensity of activation in the group treated with mirtazapine was less than the control group but grea-ter than those treated with SSRIs. Using subtraction analysis, the SSRI group showed significantly lower activation than the mirtazapine group in the anterior cingulate gyrus and the caudate nucleus. Conclusion Our study suggests that the different rates of sexual side effects between the patients in the SSRI-treated group and the mirtazapine-treated group may be due to different effects on brain activation. PMID:20046380

Treatment with selective serotonin reuptake inhibitors and mirtapazine results in differential brain activation by visual erotic stimuli in patients with major depressive disorder.

PubMed

Kim, Won; Jin, Bo-Ra; Yang, Wan-Seok; Lee, Kyuong-Uk; Juh, Ra-Hyung; Ahn, Kook-Jin; Chung, Yong-An; Chae, Jeong-Ho

2009-06-01

The objective of this study was to identify patterns of brain activation elicited by erotic visual stimuli in patients treated with either Selective Serotonin Reuptake Inhibitors (SSRIs) or mirtazipine. Nine middle-aged men with major depressive disorder treated with an SSRI and ten middle-aged men with major depressive disorder treated with mirtazapine completed the trial. Ten subjects with no psychiatric illness were included as a control group. We conducted functional brain magnetic resonance imaging (fMRI) while a film alternatively played erotic and non-erotic contents for 14 minutes and 9 seconds. The control group showed activation in the occipitotemporal area, anterior cingulate gyrus, insula, orbitofrontal cortex, and caudate nucleus. For subjects treated with SSRIs, the intensity of activity in these regions was much lower compared to the control group. Intensity of activation in the group treated with mirtazapine was less than the control group but grea-ter than those treated with SSRIs. Using subtraction analysis, the SSRI group showed significantly lower activation than the mirtazapine group in the anterior cingulate gyrus and the caudate nucleus. Our study suggests that the different rates of sexual side effects between the patients in the SSRI-treated group and the mirtazapine-treated group may be due to different effects on brain activation.

Mapping the maintenance stage of recovery: a qualitative study among treated and non-treated former alcohol dependents in Poland.

PubMed

Klingemann, Justyna Iwona

2012-01-01

The study provides an in-depth qualitative understanding of the maintenance stage when recovering from alcohol dependence with a focus on the broader social context of change of addictive behaviour. It explores the recovery as a subjective process within the abstinence-oriented Polish treatment system organized on the basis of the Minnesota model and is probes for group differences between treated and non-treated populations. The study is based on qualitative data from a media-recruited sample of 29 treated and non-treated former alcohol dependents (ICD-10) in Warsaw/Poland 2006/2007. They reported a recovery time of at least 2 years (M(recovery) = 11, SD = 9). In-depth, semi-structured interviews were analysed according to the problem-centred interview method using ATLAS.ti software. A wide range of maintenance strategies potentially contributing to the stabilization of recovery from alcohol dependence was identified. However, from the respondents' point of view, the change process is contingent upon the subjective weighing of specific maintenance factors and the importance attributed to their interplay. This includes time management as well as one's ability to invest available resources and strengths in shaping and pursuing personal goals. More commonalities than differences can be observed between groups during the maintenance stage, regardless of respondents' type of the pathway out of addiction. However, when confronting professional concepts of recovery with subjective accounts, only a subgroup conforms to the invasive, potentially normative definitions of recovery, while others do not link their recovery with identity transformation.

Protein-protein interaction network of gene expression in the hydrocortisone-treated keloid.

PubMed

Chen, Rui; Zhang, Zhiliang; Xue, Zhujia; Wang, Lin; Fu, Mingang; Lu, Yi; Bai, Ling; Zhang, Ping; Fan, Zhihong

2015-01-01

In order to explore the molecular mechanism of hydrocortisone in keloid tissue, the gene expression profiles of keloid samples treated with hydrocortisone were subjected to bioinformatics analysis. Firstly, the gene expression profiles (GSE7890) of five samples of keloid treated with hydrocortisone and five untreated keloid samples were downloaded from the Gene Expression Omnibus (GEO) database. Secondly, data were preprocessed using packages in R language and differentially expressed genes (DEGs) were screened using a significance analysis of microarrays (SAM) protocol. Thirdly, the DEGs were subjected to gene ontology (GO) function and KEGG pathway enrichment analysis. Finally, the interactions of DEGs in samples of keloid treated with hydrocortisone were explored in a human protein-protein interaction (PPI) network, and sub-modules of the DEGs interaction network were analyzed using Cytoscape software. Based on the analysis, 572 DEGs in the hydrocortisone-treated samples were screened; most of these were involved in the signal transduction and cell cycle. Furthermore, three critical genes in the module, including COL1A1, NID1, and PRELP, were screened in the PPI network analysis. These findings enhance understanding of the pathogenesis of the keloid and provide references for keloid therapy. © 2015 The International Society of Dermatology.

Continuous High-Frequency Oscillation Therapy in Invasively Ventilated Pediatric Subjects in the Critical Care Setting.

PubMed

Morgan, Stephen; Hornik, Christoph P; Patel, Niyati; Williford, Walter L; Turner, David A; Cheifetz, Ira M

2016-11-01

Continuous high-frequency oscillation (CHFO) creates a pressure gradient in the small airways that accelerates expiratory flow. The intended use of CHFO therapy is to facilitate secretion removal and treat atelectasis. Our objective was to assess the feasibility, safety, and efficacy of CHFO in the mechanically ventilated pediatric population. After institutional review board approval, we retrospectively reviewed medical records of mechanically ventilated children treated with CHFO (the MetaNeb system) at our institution from July 1, 2007 through August 31, 2012. Patients supported with extracorporeal membrane oxygenation were excluded. We evaluated changes in ventilator settings in subjects with ventilator data documented within 6 h pre- and post-treatment. We evaluated arterial blood gas (ABG) results for individual treatments, comparing ABG results within 8 h pre-therapy to ABG results within 3 h post-treatment. Oxygen index and P aO 2 /F IO 2 were calculated. Demographic data, blood pressure, heart rate, and development of new air leak while being treated with CHFO were recorded. Pre- and post-CHFO measurements were compared using Wilcoxon signed-rank testing. Our cohort included 59 invasively ventilated subjects. Median age was 2 y (range 1 month to 19 y), and median weight was 14 kg (2-81 kg). We evaluated data on 528 total treatments (range per subject 1-39 treatments). Peak inspiratory pressure significantly decreased with CHFO, whereas other parameters, including P aCO 2 and breathing frequency, remained stable. There was no significant change in systolic blood pressure, diastolic blood pressure, or heart rate following treatment with CHFO. One subject (2%) developed a clinically insignificant pneumothorax during CHFO. CHFO is feasible and seems safe in our cohort of mechanically ventilated pediatric subjects. The rate of pneumothorax was consistent with that seen in similar pediatric ICU populations. These preliminary results suggest that CHFO may be beneficial by improving lung compliance in pediatric subjects with secretion-induced atelectasis. Prospective clinical studies are needed to further evaluate the clinical efficacy and safety of CHFO in children receiving invasive mechanical ventilation. Copyright © 2016 by Daedalus Enterprises.

Late effects of early growth hormone treatment in Down syndrome.

PubMed

Myrelid, Å; Bergman, S; Elfvik Strömberg, M; Jonsson, B; Nyberg, F; Gustafsson, J; Annerén, G

2010-05-01

Down syndrome (DS) is associated with short stature and psychomotor delay. We have previously shown that growth hormone (GH) treatment during infancy and childhood normalizes growth velocity and improves fine motor skill performance in DS. The aim of this study was to investigate late effects of early GH treatment on growth and psychomotor development in the DS subjects from the previous trial. Twelve of 15 adolescents with DS (3 F) from the GH group and 10 of 15 controls (5 F) participated in this follow-up study. Fifteen other subjects with DS (6 F) were included as controls in anthropometric analyses. Cognitive function was assessed with the Leiter International Performance Scale-Revised (Leiter-R) and selected subtests of the Wechsler Intelligence Scale for Children, Third edition (WISC-III). The Bruininks-Oseretsky Test of Motor Proficiency, Second edition (BOT-2), was used to assess general motor ability. Although early GH treatment had no effect on final height, the treated subjects had a greater head circumference standard deviation score (SDS) than the controls (-1.6 SDS vs. -2.2 SDS). The adolescents previously treated with GH had scores above those of the controls in all subtests of Leiter-R and WISC-III, but no difference in Brief IQ-score was seen between the groups. The age-adjusted motor performance of all subjects was below -2 SD, but the GH-treated subjects performed better than the controls in all but one subtest. The combined finding of a greater head circumference SDS and better psychomotor performance indicates that DS subjects may benefit from early GH treatment.

Ketamine Patient Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active Comparator Controlled, Blinded, Pilot Trial

DTIC Science & Technology

2017-01-11

patient- controlled analgesia per the primary treating team. Four subjects in the ketamine group and one subject in the hydromorphone group withdrew...occurred more frequently in the ketamine group , although this was not statistically significant (40% vs. 0%, P=0.090). Ketamine patient- controlled ...breakthrough IV morphine equivalents between groups . 4.0 RESULTS 4.1 Participants Due to unanticipated barriers to enrollment, including a

Weather/temperature-sensitive vasomotor rhinitis may be refractory to intranasal corticosteroid treatment.

PubMed

Jacobs, Robert; Lieberman, Philip; Kent, Edward; Silvey, MaryJane; Locantore, Nicholas; Philpot, Edward E

2009-01-01

Vasomotor rhinitis (VMR) is a common but poorly understood disorder of which there are two major subgroups: VMR(w/t), triggered by weather/temperature and VMR(ir), triggered by airborne irritants. No specific biological pathways or specific treatments for VMR(w/t) or VMR(ir) have been identified. However, intranasal corticosteroids (INSs) are effective in treating many forms of nonallergic rhinitis that include these conditions. A recently introduced INS with established efficacy in allergic rhinitis and enhanced affinity, fluticasone furoate, may possess the potency and safety profile required to treat chronic VMR(w/t). Two replicate studies (FFR30006 and FFR30007) were conducted in six countries to evaluate the efficacy and safety of fluticasone furoate nasal spray in subjects with VMR(w/t). After a 7- to 14-day screening period, subjects (n = 699) with symptomatic VMR(w/t) received fluticasone furoate, 110 mug q.d. or placebo for 4 weeks in these two randomized, double-blind, parallel-group studies. Subjects rated their nasal symptoms (congestion, rhinorrhea, and postnasal drip) twice daily on a 4-point categorical scale and evaluated their overall response to treatment at study end. Fluticasone furoate did not significantly improve daily reflective total nasal symptom scores, the primary end point, versus placebo (p = 0.259) and there was no improvement in any other measure of efficacy. The active treatment was well tolerated. Fluticasone furoate was not effective in treating subjects with a newly defined condition, weather-sensitive VMR. These unexpected results suggest that VMR(w/t) is a distinct subgroup of VMR that is refractory to treatment with INSs. Additional study of other treatments for VMR(w/t) (including INSs) is warranted.

The impact of disease activity and tumour necrosis factor-α inhibitor therapy on cytokine levels in juvenile idiopathic arthritis.

PubMed

Walters, H M; Pan, N; Lehman, T J A; Adams, A; Kalliolias, G D; Zhu, Y S; Santiago, F; Nguyen, J; Sitaras, L; Cunningham-Rundles, S; Walsh, T J; Toussi, S S

2016-06-01

The aim of this study was to evaluate prospectively cytokine levels and disease activity in juvenile idiopathic arthritis (JIA) patients treated with and without tumour necrosis factor (TNF)-α inhibitors. TNF-α inhibitor-naive JIA subjects were followed prospectively for 6 months. Cytokine levels of TNF-α, interleukin (IL)-1β, IL-6, IL-8, IL-10 and IL-17 were measured at baseline for JIA subjects and healthy controls (HCs). Cytokine levels were then measured at four time-points after initiation of TNF-α inhibition for anti-TNF-α-treated (anti-TNF) JIA subjects, and at two subsequent time-points for other JIA (non-TNF) subjects. JIA disease activity by Childhood Health Assessment Questionnaire (CHAQ) disability index/pain score and physician joint count/global assessment was recorded. Sixteen anti-TNF, 31 non-TNF and 16 HCs were analysed. Among JIA subjects, those with higher baseline disease activity (subsequent anti-TNFs) had higher baseline TNF-α, IL-6 and IL-8 than those with lower disease activity (non-TNFs) (P < 0·05). TNF-α and IL-10 increased, and IL-6 and IL-8 no longer remained significantly higher after TNF-α inhibitor initiation in anti-TNF subjects. Subgroup analysis of etanercept versus adalimumab-treated subjects showed that TNF-α and IL-17 increased significantly in etanercept but not adalimumab-treated subjects, despite clinical improvement in both groups of subjects. JIA subjects with increased disease activity at baseline had higher serum proinflammatory cytokines. TNF-α inhibition resulted in suppression of IL-6 and IL-8 in parallel with clinical improvement in all anti-TNF-treated subjects, but was also associated with elevated TNF-α and IL-17 in etanercept-treated subjects. © 2016 British Society for Immunology.

Homeostatic and Circadian Abnormalities in Sleep and Arousal in Gulf War Syndrome

DTIC Science & Technology

2014-10-01

These expanded criteria include allows subjects with obstructive sleep apnea (OSA) provided the disorder is currently treated. We have also allowed for...individuals in this age range with a BMI > 35 will have sleep apnea , which is why they were originally excluded, but in light of our changed criteria for...OSA, we expect to recruit many participants in this BMI-range with treated sleep apnea . We anticipate that these relaxed exclusion criteria will

Efficacy and safety of flavocoxid compared with naproxen in subjects with osteoarthritis of the knee- a subset analysis.

PubMed

Levy, Robert; Khokhlov, Alexander; Kopenkin, Sergey; Bart, Boris; Ermolova, Tatiana; Kantemirova, Raiasa; Mazurov, Vadim; Bell, Marjorie; Caldron, Paul; Pillai, Lakshmi; Burnett, Bruce

2010-12-01

twice-daily flavocoxid, a cyclooxygenase and 5-lipoxygenase inhibitor with potent antioxidant activity of botanical origin, was evaluated for 12 weeks in a randomized, double-blind, active-comparator study against naproxen in 220 subjects with moderate-severe osteoarthritis (OA) of the knee. As previously reported, both groups noted a significant reduction in the signs and symptoms of OA with no detectable differences in efficacy between the groups when the entire intent-to-treat population was considered. This post-hoc analysis compares the efficacy of flavocoxid to naproxen in different subsets of patients, specifically those related to age, gender, and disease severity as reported at baseline for individual response parameters. in the original randomized, double-blind study, 220 subjects were assigned to receive either flavocoxid (500 mg twice daily) or naproxen (500 mg twice daily) for 12 weeks. In this subgroup analysis, primary outcome measures including the Western Ontario and McMaster Universities OA index and subscales, timed walk, and secondary efficacy variables, including investigator global assessment for disease and global response to treatment, subject visual analog scale for discomfort, overall disease activity, global response to treatment, index joint tenderness and mobility, were evaluated for differing trends between the study groups. subset analyses revealed some statistically significant differences and some notable trends in favor of the flavocoxid group. These trends became stronger the longer the subjects continued on therapy. These observations were specifically noted in older subjects (>60 years), males and in subjects with milder disease, particularly those with lower subject global assessment of disease activity and investigator global assessment for disease and faster walking times at baseline. initial analysis of the entire intent-to-treat population revealed that flavocoxid was as effective as naproxen in managing the signs and symptoms of OA of the knee. Detailed analyses of subject subsets demonstrated distinct trends in favor of flavocoxid for specific groups of subjects.

Vascular risk factors promote conversion from mild cognitive impairment to Alzheimer disease.

PubMed

Li, J; Wang, Y J; Zhang, M; Xu, Z Q; Gao, C Y; Fang, C Q; Yan, J C; Zhou, H D

2011-04-26

Growing evidence suggests that vascular risk factors (VRF) contribute to cognitive decline. The aim of this study was to investigate the impact of VRF on the conversion from mild cognitive impairment (MCI) to Alzheimer disease (AD) dementia. A total of 837 subjects with MCI were enrolled at baseline and followed up annually for 5 years. The incidence of AD dementia was investigated. A mixed random effects regression model was used to analyze the association between VRF and the progression of MCI assessed with Mini-Mental State Examination and instrumental Activities of Daily Living. Cox proportional hazard models were used to identify the association between VRF and dementia conversion, and to examine whether treatment of VRF can prevent dementia conversion. At the end of the follow-up, 298 subjects converted to AD dementia, while 352 remained MCI. Subjects with VRF had a faster progression in cognition and function relative to subjects without. VRF including hypertension, diabetes, cerebrovascular diseases, and hypercholesterolemia increased the risk of dementia conversion. Those subjects with MCI in whom all VRF were treated had a lower risk of dementia than those who had some VRF treated. Treatment of individual VRF including hypertension, diabetes, and hypercholesterolemia was associated with the reduced risk of AD conversion. VRF increased the risk of incident AD dementia. Treatment of VRF was associated with a reduced risk of incident AD dementia. Although our findings are observational, they suggest active intervention for VRF might reduce progression in MCI to AD dementia.

Mobilization with movement and kinesiotaping compared with a supervised exercise program for painful shoulder: results of a clinical trial.

PubMed

Djordjevic, Olivera C; Vukicevic, Danijela; Katunac, Ljiljana; Jovic, Stevan

2012-07-01

The purpose of this study was to compare the efficacy of Mobilization with Movement (MWM) and kinesiotaping (KT) techniques with a supervised exercise program in participants with patients with shoulder pain. Twenty subjects with shoulder pain were included if subjects were diagnosed by the referring physician with either rotator cuff lesion with impingement syndrome or impingement shoulder syndrome. Participants were randomly assigned to 1 of 2 groups after clinical and radiologic assessment: group 1 was treated with MWM and KT techniques, whereas group 2 was treated with a supervised exercise program. The main outcome measures were active pain-free shoulder abduction and flexion tested on days 0, 5, and 10. Improvement in active pain-free shoulder range of motion was significantly higher in the group treated with MWM and KT. Repeated-measures analysis of variance indicated significant effects of treatment, time, and treatment×time interaction. This study suggests that MWM and KT may be an effective and useful treatment in range of motion augmentation of subjects with rotator cuff lesion and impingement syndrome or impingement shoulder syndrome. Copyright © 2012 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Neuraminidase inhibitor therapy in a military population.

PubMed

Fairchok, Mary P; Chen, Wei-Ju; Arnold, John C; Schofield, Christina; Danaher, Patrick J; McDonough, Erin A; Ottolini, Martin; Mor, Deepika; Ridore, Michelande; Burgess, Timothy H; Millar, Eugene V

2015-06-01

Although neuraminidase inhibitors (NI) are the mainstay of treatment for influenza infection, prescribing practice for these agents is not well described. Additionally, benefit is contested. We examined provider prescriptions of NI during the 2009 pandemic and post-pandemic periods. We also evaluated the effectiveness of NI in reducing severity of influenza infection. Data on NI prescription and severity of influenza infection were compiled in healthy pediatric and adult beneficiaries enrolled in a prospective study of influenza like illness conducted at five military medical centers over five years. Subjects underwent nasal swabs to determine viral etiology of their infection. Demographic, medication and severity data were collected. Subjects with positive influenza were included. Two hundred sixty three subjects were influenza positive [38% [H1N1] pdm09, 38.4% H3N2, and 20.5% B); 23.9% were treated with NI. NI were initiated within 48h in 63% of treated subjects. Although NI use increased over the five years of the study, early use declined. Most measures for severity of illness were not significantly reduced with NI; adults treated within 48h had only a modest reduction in duration and severity of some of their symptoms. NI use in our population is increasing, but early use is not. NI use resulted in no reduction in complications of illness. Resolution of symptoms and reduction in severity of some symptoms were slightly better in adults who were treated early. These modest benefits do not support routine treatment with NI in otherwise healthy individuals with influenza. Copyright © 2015 Elsevier B.V. All rights reserved.

Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars.

PubMed

Prager, Welf; Gauglitz, Gerd G

2018-06-14

An occlusive overnight intensive patch medical device (OIP) containing onion extract and allantoin has been developed for preventing and treating dermatologic scars and keloids. Here, we examined the efficacy and safety of the OIP for post-dermatologic surgery scars. This was an intra-individual randomized, observer-blind, controlled study in adults with post-dermatologic surgery scars. Two scars per subject were randomized to no treatment or overnight treatment with the OIP for 12-24 weeks. Scar quality was assessed using the Patient and Observer Scar Assessment Scale (POSAS) and a Global Aesthetic Improvement Scale. A total of 125 subjects were included. The decrease in observer-assessed POSAS from baseline was significantly greater for treated than untreated scars at week 6 (p < 0.001) and 24 (p = 0.001). The decrease in patient-assessed POSAS was significantly greater for the treated scar than the untreated scar at week 12 (p = 0.017) and 24 (p = 0.014). Subject- and investigator-evaluated Global Aesthetic Improvement Scale scores were higher for the treated than the untreated scar at all visits. All subjects considered the global comfort of the OIP to be good or very good, and no safety concerns were identified. This study confirmed that the OIP safely promotes scar healing after minor dermatologic surgery. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The innovative potential of Lactobacillus rhamnosus LR06, Lactobacillus pentosus LPS01, Lactobacillus plantarum LP01, and Lactobacillus delbrueckii Subsp. delbrueckii LDD01 to restore the "gastric barrier effect" in patients chronically treated with PPI: a pilot study.

PubMed

Del Piano, Mario; Anderloni, Andrea; Balzarini, Marco; Ballarè, Marco; Carmagnola, Stefania; Montino, Franco; Orsello, Marco; Pagliarulo, Michela; Tari, Roberto; Soattini, Liliana; Sforza, Filomena; Mogna, Luca; Mogna, Giovanni

2012-10-01

Gastroesophageal reflux disease is a very widespread condition. In Europe, it is estimated that about 175 million people suffer from this disease and have to chronically take drugs to increase gastric pH. The proton pump inhibitors (PPIs) such as omeprazole, lansoprazole, and esomeprazole are the most widely used drug typology in this regard. However, the inhibition of normal gastric acid secretion has important side effects, the most important being bacterial overgrowth in the stomach and duodenum with a concentration of >10⁵ viable cells/mL. As a major consequence of this, many harmful or even pathogenic bacteria contained in some foods could survive the gastric transit and colonize either the stomach itself, the duodenum, or the gut, where they could establish acute and even chronic infections with unavoidable consequences for the host's health. In other words, the "gastric barrier effect" is strongly reduced or even disrupted. To date, there are no real strategies to deal with this widespread, although still relatively little known, problem. The aim of this study was to confirm the gastric bacterial overgrowth in long-term PPI consumers and to assess the efficacy of some probiotic bacteria, belonging to both genera Lactobacillus and Bifidobacterium, in the reduction of gastric and duodenal bacterial overgrowth, therefore partially restoring the gastric barrier effect against foodborne pathogenic bacteria. For this purpose, probiotics with a strong demonstrated inhibitory activity on gram-negative bacteria, such as Escherichia coli, were tested in a human intervention trial involving a total of 30 subjects treated with PPIs for either 3 to 12 consecutive months (short-term) or >12 consecutive months (long-term). An additional 10 subjects not taking PPIs were enrolled and used as a control group representing the general population. Four selected probiotics Probiotical SpA (Novara, Italy), namely Lactobacillus rhamnosus LR06 (DSM 21981), Lactobacillus pentosus LPS01 (DSM 21980), Lactobacillus plantarum LP01 (LMG P-21021), and Lactobacillus delbrueckii subsp. delbrueckii LDD01 (DSM 22106) were administered for 10 days to 10 subjects treated with PPIs for >12 months (group B). In the 60 mg formulation, N-acetylcysteine was included as well in light of its well-known mechanical effects on bacterial biofilms. Gastroscopies were performed at the beginning of the study (d0) in all the groups (A, B, C, and D) and after 10 days (d10) in group B only; that is, at the end of probiotics intake. The total viable cells and total Lactobacillus were quantified in gastric juice and duodenal brushing material from all subjects. The results were compared among all the groups and with the control subjects (group D) to confirm the bacterial overgrowth. A comparison was made also between d0 and d10 in group B to quantify the efficacy of the 4 probiotics administered for 10 days. Fecal samples were collected from all groups at d0, including subjects not treated with PPIs, and in group B only at d10. Specific bacterial classes, namely enterococci, total coliforms, E. coli, molds, and yeasts were quantified in all fecal specimens. The results collected confirmed the strong bacterial overgrowth in the stomach and duodenum of people treated with PPIs compared with subjects with a normal intragastric acidity. It is also worth noting that the bacterial cell counts in subjects who underwent a long-term treatment with a PPI were greater than the results from subjects taking these drugs for 3 to 12 months. The intake of 4 specific probiotic strains with a marked antagonistic activity towards 5 E. coli bacteria, including the enterohaemorrhagic O157:H7 strain, and an effective amount of N-acetylcysteine (NAC) was able to significantly reduce bacterial overgrowth in long-term PPI-treated subjects. Total lactobacilli represented the major percentage of bacterial counts, thus demonstrating the ability of such bacteria to colonize the stomach and the duodenum, at least temporarily, and to consequently restore the gastric barrier effect. A significant decrease in fecal enterococci, total coliforms, E. coli, molds, and yeasts in subjects treated with PPIs was recorded at the end of probiotics supplementation (d10) compared with baseline (d0) in group B. This is a further confirmation of the barrier effect also exerted at the stomach level. PPIs are the most widely sold and used drugs in the world. However, the chronic use of these pharmacological molecules exposes the subject to the risk of foodborne infections as most pathogens are able to survive the gastric transit in a condition of significantly decreased acidity.

Gastrin Receptor-Avid Peptide Conjugates

DOEpatents

Hoffman, Timothy J.; Volkert, Wynn A.; Li, Ning; Sieckman, Gary; Higginbotham, Chrys-Ann

2005-07-26

A compound for use as a therapeutic or diagnostic radiopharmaceutical includes a group capable of complexing a medically useful metal attached to a moiety which is capable of binding to a gastrin releasing peptide receptor. A method for treating a subject having a neoplastic disease includes administering to the subject an effective amount of a radiopharmaceutical having a metal chelated with a chelating group attached to a moiety capable of binding to a gastrin releasing peptide receptor expressed on tumor cells with subsequent internalization inside of the cell. A method of forming a therapeutic or diagnostic compound includes reacting a metal synthon with a chelating group covalently linked with a moiety capable of binding a gastrin releasing peptide receptor.

Gastrin receptor-avid peptide conjugates

DOEpatents

Hoffman, Timothy J.; Volkert, Wynn A.; Li, Ning; Sieckman, Gary; Higginbotham, C. A.

2001-01-01

A compound for use as a therapeutic or diagnostic radiopharmaceutical includes a group capable of complexing a medically useful metal attached to a moiety which is capable of binding to a gastrin releasing peptide receptor. A method for treating a subject having a neoplastic disease includes administering to the subject an effective amount of a radiopharmaceutical having a metal chelated with a chelating group attached to a moiety capable of binding to a gastrin releasing peptide receptor expressed on tumor cells with subsequent internalization inside of the cell. A method of forming a therapeutic or diagnostic compound includes reacting a metal synthon with a chelating group covalently linked with a moiety capable of binding a gastrin releasing peptide receptor.

Gastrin receptor-avid peptide conjugates

DOEpatents

Hoffman, Timothy J.; Volkert, Wynn A.; Sieckman, Gary; Smith, Charles J.; Gali, Hariprasad

2006-06-13

A compound for use as a therapeutic or diagnostic radiopharmaceutical includes a group capable of complexing a medically useful metal attached to a moiety which is capable of binding to a gastrin releasing peptide receptor. A method for treating a subject having a neoplastic disease includes administering to the subject an effective amount of a radiopharmaceutical having a metal chelated with a chelating group attached to a-moiety capable of binding to a gastrin releasing peptide receptor expressed on tumor cells with subsequent internalization inside of the cell. A method of forming a therapeutic or diagnostic compound includes reacting a metal synthon with a chelating group covalently linked with a moiety capable of binding a gastrin releasing peptide receptor.

Gastrin receptor-avid peptide conjugates

DOEpatents

Hoffman, Timothy J.; Volkert, Wynn A.; Li, Ning; Sieckman, Gary; Higginbotham, Chrys-Ann

2006-12-12

A compound for use as a therapeutic or diagnostic radiopharmaceutical includes a group capable of complexing a medically useful metal attached to a moiety which is capable of binding to a gastrin releasing peptide receptor. A method for treating a subject having a neoplastic disease includes administering to the subject an effective amount of a radiopharmaceutical having a metal chelated with a chelating group attached to a moiety capable of binding to a gastrin releasing peptide receptor expressed on tumor cells with subsequent internalization inside of the cell. A method of forming a therapeutic or diagnostic compound includes reacting a metal synthon with a chelating group covalently linked with a moiety capable of binding a gastrin releasing peptide receptor.

26 CFR 1.527-6 - Inclusion of certain amounts in the gross income of an exempt organization which is not a...

Code of Federal Regulations, 2013 CFR

2013-04-01

... an exempt function, it may be subject to tax. There is included in the gross income of such... function. The amount included will be treated as political organization taxable income. (b) Exempt function expenditures—(1) Directly related expenses. (i) Except as provided in this section, the term exempt function...

26 CFR 1.527-6 - Inclusion of certain amounts in the gross income of an exempt organization which is not a...

Code of Federal Regulations, 2012 CFR

2012-04-01

... an exempt function, it may be subject to tax. There is included in the gross income of such... function. The amount included will be treated as political organization taxable income. (b) Exempt function expenditures—(1) Directly related expenses. (i) Except as provided in this section, the term exempt function...

26 CFR 1.527-6 - Inclusion of certain amounts in the gross income of an exempt organization which is not a...

Code of Federal Regulations, 2011 CFR

2011-04-01

... an exempt function, it may be subject to tax. There is included in the gross income of such... function. The amount included will be treated as political organization taxable income. (b) Exempt function expenditures—(1) Directly related expenses. (i) Except as provided in this section, the term exempt function...

26 CFR 1.527-6 - Inclusion of certain amounts in the gross income of an exempt organization which is not a...

Code of Federal Regulations, 2014 CFR

2014-04-01

... an exempt function, it may be subject to tax. There is included in the gross income of such... function. The amount included will be treated as political organization taxable income. (b) Exempt function expenditures—(1) Directly related expenses. (i) Except as provided in this section, the term exempt function...

Efficacy and safety of a low-level laser device in the treatment of male and female pattern hair loss: a multicenter, randomized, sham device-controlled, double-blind study.

PubMed

Jimenez, Joaquin J; Wikramanayake, Tongyu C; Bergfeld, Wilma; Hordinsky, Maria; Hickman, Janet G; Hamblin, Michael R; Schachner, Lawrence A

2014-04-01

Male and female pattern hair loss are common, chronic dermatologic disorders with limited therapeutic options. In recent years, a number of commercial devices using low-level laser therapy have been promoted, but there have been little peer-reviewed data on their efficacy. To determine whether treatment with a low-level laser device, the US FDA-cleared HairMax Lasercomb®, increases terminal hair density in both men and women with pattern hair loss. Randomized, sham device-controlled, double-blind clinical trials were conducted at multiple institutional and private practices. A total of 146 male and 188 female subjects with pattern hair loss were screened. A total of 128 male and 141 female subjects were randomized to receive either a lasercomb (one of three models) or a sham device in concealed sealed packets, and were treated on the whole scalp three times a week for 26 weeks. Terminal hair density of the target area was evaluated at baseline and at 16- and 26-week follow-ups, and analyzed to determine whether the hypothesis formulated prior to data collection, that lasercomb treatment would increase terminal hair density, was correct. The site investigators and the subjects remained blinded to the type of device they dispensed/received throughout the study. The evaluator of masked digital photographs was blinded to which trial arm the subject belonged. Seventy-eight, 63, 49, and 79 subjects were randomized in four trials of 9-beam lasercomb treatment in female subjects, 12-beam lasercomb treatment in female subjects, 7-beam lasercomb treatment in male subjects, and 9- and 12-beam lasercomb treatment in male subjects, compared with the sham device, respectively. Nineteen female and 25 male subjects were lost to follow-up. Among the remaining 122 female and 103 male subjects in the efficacy analysis, the mean terminal hair count at 26 weeks increased from baseline by 20.2, 20.6, 18.4, 20.9, and 25.7 per cm2 in 9-beam lasercomb-treated female subjects, 12-beam lasercomb-treated female subjects, 7-beam lasercomb-treated male subjects, and 9- and 12-beam lasercomb-treated male subjects, respectively, compared with 2.8 (p<0.0001), 3.0 (p<0.0001), 1.6 (p=0.0017), 9.4 (p=0.0249), and 9.4 (p=0.0028) in sham-treated subjects (95% confidence interval). The increase in terminal hair density was independent of the age and sex of the subject and the lasercomb model. Additionally, a higher percentage of lasercomb-treated subjects reported overall improvement of hair loss condition and thickness and fullness of hair in self-assessment, compared with sham-treated subjects. No serious adverse events were reported in any subject receiving the lasercomb in any of the four trials. We observed a statistically significant difference in the increase in terminal hair density between lasercomb- and sham-treated subjects. No serious adverse events were reported. Our results suggest that low-level laser treatment may be an effective option to treat pattern hair loss in both men and women. Additional studies should be considered to determine the long-term effects of low-level laser treatment on hair growth and maintenance, and to optimize laser modality.

45 CFR 2553.44 - May cost reimbursements received by a RSVP volunteer be subject to any tax or charge, treated as...

Code of Federal Regulations, 2014 CFR

2014-10-01

... volunteer be subject to any tax or charge, treated as wages or compensation, or affect eligibility to... VOLUNTEER PROGRAM Eligibility, Cost Reimbursements and Volunteer Assignments § 2553.44 May cost reimbursements received by a RSVP volunteer be subject to any tax or charge, treated as wages or compensation, or...

45 CFR 2553.44 - May cost reimbursements received by a RSVP volunteer be subject to any tax or charge, treated as...

Code of Federal Regulations, 2013 CFR

2013-10-01

... volunteer be subject to any tax or charge, treated as wages or compensation, or affect eligibility to... VOLUNTEER PROGRAM Eligibility, Cost Reimbursements and Volunteer Assignments § 2553.44 May cost reimbursements received by a RSVP volunteer be subject to any tax or charge, treated as wages or compensation, or...

45 CFR 2553.44 - May cost reimbursements received by a RSVP volunteer be subject to any tax or charge, treated as...

Code of Federal Regulations, 2011 CFR

2011-10-01

... volunteer be subject to any tax or charge, treated as wages or compensation, or affect eligibility to... VOLUNTEER PROGRAM Eligibility, Cost Reimbursements and Volunteer Assignments § 2553.44 May cost reimbursements received by a RSVP volunteer be subject to any tax or charge, treated as wages or compensation, or...

45 CFR 2553.44 - May cost reimbursements received by a RSVP volunteer be subject to any tax or charge, treated as...

Code of Federal Regulations, 2012 CFR

2012-10-01

... volunteer be subject to any tax or charge, treated as wages or compensation, or affect eligibility to... VOLUNTEER PROGRAM Eligibility, Cost Reimbursements and Volunteer Assignments § 2553.44 May cost reimbursements received by a RSVP volunteer be subject to any tax or charge, treated as wages or compensation, or...

78 FR 58154 - Importation of Litchi Fruit From Australia

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-23

... treated with irradiation and subject to inspection. If irradiation is applied outside the United States... required irradiation treatment. If irradiation is to be applied upon arrival in the United States, the... systems approach that includes requirements for monitoring and oversight, irradiation treatment of the...

Inappropriate usage of dietary supplements in patients by miscommunication with physicians in Japan.

PubMed

Chiba, Tsuyoshi; Sato, Yoko; Nakanishi, Tomoko; Yokotani, Kaori; Suzuki, Sachina; Umegaki, Keizo

2014-11-26

Recently, people have used dietary supplements not only for nutritional supplementation, but also for treatment of their diseases. However, use of dietary supplements to treat diseases, especially with medications, may cause health problems in patients. In this study, we investigated use of dietary supplements in patients in Japan. This survey was conducted from January to December 2012, and was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about dietary supplements. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using dietary supplements, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses. The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used dietary supplements to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using dietary supplements concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention dietary supplement use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with dietary supplements. Communication between patients and physicians is important to avoid health problems associated with the use of dietary supplements.

Inappropriate Usage of Dietary Supplements in Patients by Miscommunication with Physicians in Japan

PubMed Central

Chiba, Tsuyoshi; Sato, Yoko; Nakanishi, Tomoko; Yokotani, Kaori; Suzuki, Sachina; Umegaki, Keizo

2014-01-01

Recently, people have used dietary supplements not only for nutritional supplementation, but also for treatment of their diseases. However, use of dietary supplements to treat diseases, especially with medications, may cause health problems in patients. In this study, we investigated use of dietary supplements in patients in Japan. This survey was conducted from January to December 2012, and was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about dietary supplements. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using dietary supplements, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses. The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used dietary supplements to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using dietary supplements concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention dietary supplement use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with dietary supplements. Communication between patients and physicians is important to avoid health problems associated with the use of dietary supplements. PMID:25431879

Long-term skeletal and dental effects and treatment timing for functional appliances in Class II malocclusion.

PubMed

Franchi, Lorenzo; Pavoni, Chiara; Faltin, Kurt; McNamara, James A; Cozza, Paola

2013-03-01

To analyze the long-term skeletal and dentoalveolar effects and to evaluate treatment timing of Class II treatment with functional appliances followed by fixed appliances. A group of 40 patients (22 females and 18 males) with Class II malocclusion consecutively treated either with a Bionator or an Activator followed by fixed appliances was compared with a control group of 20 subjects (9 females and 11 males) with untreated Class II malocclusion. Lateral cephalograms were available at the start of treatment (mean age 10 years), end of treatment with functional appliances (mean age 12 years), and long-term observation (mean age 18.6 years). The treated sample also was divided into two groups according to skeletal maturity. The early-treatment group was composed of 20 subjects (12 females and 8 males) treated before puberty, while the late-treatment group included 20 subjects (10 females and 10 males) treated at puberty. Statistical comparisons were performed with analysis of variance followed by Tukey's post hoc tests. Significant long-term mandibular changes (Co-Gn) in the treated group (3.6 mm over the controls) were associated with improvements in the skeletal sagittal intermaxillary relationship, overjet, and molar relationship (∼3.0-3.5 mm). Treatment during the pubertal peak was able to produce significantly greater increases in total mandibular length (4.3 mm) and mandibular ramus height (3.1 mm) associated with a significant advancement of the bony chin (3.9 mm) when compared with treatment before puberty. Treatment of Class II malocclusion with functional appliances appears to be more effective at puberty.

Altered frontocortical, cerebellar, and basal ganglia activity in adjuvant-treated breast cancer survivors 5-10 years after chemotherapy.

PubMed

Silverman, Daniel H S; Dy, Christine J; Castellon, Steven A; Lai, Jasmine; Pio, Betty S; Abraham, Laura; Waddell, Kari; Petersen, Laura; Phelps, Michael E; Ganz, Patricia A

2007-07-01

To explore the relationship of regional cerebral blood flow and metabolism with cognitive function and past exposure to chemotherapy for breast cancer. Subjects treated for breast cancer with adjuvant chemotherapy remotely (5-10 years previously) were studied with neuropsychologic testing and positron emission tomography (PET), and were compared with control subjects who had never received chemotherapy. [O-15] water PET scans was acquired during performance of control and memory-related tasks to evaluate cognition-related cerebral blood flow, and [F-18] fluorodeoxyglucose (FDG) PET scans were acquired to evaluate resting cerebral metabolism. PET scans were analyzed by statistical parametric mapping and region of interest methods of analysis. During performance of a short-term recall task, modulation of cerebral blood flow in specific regions of frontal cortex and cerebellum was significantly altered in chemotherapy-treated subjects. Cerebral activation in chemotherapy-treated subjects differed most significantly from untreated subjects in inferior frontal gyrus, and resting metabolism in this area correlated with performance on a short-term memory task previously found to be particularly impaired in chemotherapy-treated subjects. In examining drug-class specific effects, metabolism of the basal ganglia was significantly decreased in tamoxifen + chemotherapy-treated patients compared with chemotherapy-only breast cancer subjects or with subjects who had not received chemotherapy, while chemotherapy alone was not associated with decreased basal ganglia activity relative to untreated subjects. Specific alterations in activity of frontal cortex, cerebellum, and basal ganglia in breast cancer survivors were documented by functional neuroimaging 5-10 years after completion of chemotherapy.

Late sequelae in children treated for brain tumors and leukemia.

PubMed

Jereb, B; Korenjak, R; Krzisnik, C; Petric-Grabnar, G; Zadravec-Zaletel, L; Anzic, J; Stare, J

1994-01-01

Forty-two survivors treated at an age of 2-16 years for brain tumors or leukemia were, 4-21 years after treatment, subjected to an extensive follow-up investigation, including physical examination and interview; 35 of them also had endocrinological and 33 psychological evaluation. Hormonal deficiencies were found in about two-thirds of patients and were most common in those treated for brain tumors. The great majority had verbal intelligence quotient (VIQ) within normal range. Also, the performance intelligence quotients (PIQ) were normal in most patients. However, the results suggested that the primary intellectual capacity in children treated for cancer was not being fully utilized, their PIQ being on the average higher than their VIQ; this tendency was especially pronounced in the leukemia patients.

Drivers of costs associated with reperfusion therapy in acute stroke: the Interventional Management of Stroke III Trial.

PubMed

Simpson, Kit N; Simpson, Annie N; Mauldin, Patrick D; Hill, Michael D; Yeatts, Sharon D; Spilker, Judith A; Foster, Lydia D; Khatri, Pooja; Martin, Renee; Jauch, Edward C; Kleindorfer, Dawn; Palesch, Yuko Y; Broderick, Joseph P

2014-06-01

The Interventional Management of Stroke (IMS) III study tested the effect of intravenous tissue-type plasminogen activator (tPA) alone when compared with intravenous tPA followed by endovascular therapy and collected cost data to assess the economic implications of the 2 therapies. This report describes the factors affecting the costs of the initial hospitalization for acute stroke subjects from the United States. Prospective cost analysis of the US subjects was treated with intravenous tPA alone or with intravenous tPA followed by endovascular therapy in the IMS III trial. Results were compared with expected Medicare payments. The adjusted cost of a stroke admission in the study was $35 130 for subjects treated with endovascular therapy after intravenous tPA treatment and $25 630 for subjects treated with intravenous tPA alone (P<0.0001). Significant factors related to costs included treatment group, baseline National Institutes of Health Stroke Scale, time from stroke onset to intravenous tPA, age, stroke location, and comorbid diabetes mellitus. The mean cost for subjects who had routine use of general anesthesia as part of endovascular therapy was $46 444 when compared with $30 350 for those who did not have general anesthesia. The costs of embolectomy for IMS III subjects and patients from the National Inpatient Sample cohort exceeded the Medicare diagnosis-related group payment in ≥75% of patients. Minimizing the time to start of intravenous tPA and decreasing the use of routine general anesthesia may improve the cost-effectiveness of medical and endovascular therapy for acute stroke. http://www.clinicaltrials.gov. Unique identifier: NCT00359424. © 2014 American Heart Association, Inc.

Efficacy of botulinum toxin in treating myofascial pain in bruxers: a controlled placebo pilot study.

PubMed

Guarda-Nardini, Luca; Manfredini, Daniele; Salamone, Milena; Salmaso, Luigi; Tonello, Stefano; Ferronato, Giuseppe

2008-04-01

The present investigation is a preliminary double-blind, controlled placebo, randomized clinical trial with a six month follow-up period. The study aimed to assess the efficacy of type A botulinum toxin (Botox, Allergan, Inc. Irvine, CA) to treat myofascial pain symptoms and to reduce muscle hyperactivity in bruxers. Twenty patients (ten males, ten females; age range 25-45) with a clinical diagnosis of bruxism and myofascial pain of the masticatory muscles were enrolled in a double-blind, controlled placebo, randomized clinical trial, with a treatment group (ten subjects treated with botulinum toxin injections- BTX-A) and a control group (ten subjects treated with saline placebo injections). A number of objective and subjective clinical parameters (pain at rest and during chewing; mastication efficiency; maximum nonassisted and assisted mouth opening, protrusive and laterotrusive movements; functional limitation during usual jaw movements; subjective efficacy of the treatment; tolerance of the treatment) were assessed at baseline time and at one week, one month, and six months follow-up appointments. Descriptive analysis showed that improvements in both objective (range of mandibular movements) and subjective (pain at rest; pain during chewing) clinical outcome variables were higher in the Botox treated group than in the placebo treated subjects. Patients treated with BTX-A had a higher subjective improvement in their perception of treatment efficacy than the placebo subjects. Differences were not significant in some cases due to the small sample size. Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers, and provided pilot data which need to be confirmed by further research using larger samples.

A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris.

PubMed

Parish, Lawrence Charles; Parish, Jennifer L; Routh, Hirak B; Avakian, Edward; Olayinka, Babajide; Pappert, Eric J; Plaum, Stefan; Fleischer, Alan B; Hardas, Bhushan

2011-10-01

Naftifine HCl 2% cream (NAFT-2%) is a topical allylamine antifungal preparation under development in the U.S. The objective of this randomized, double-blind, vehicle-controlled study was to evaluate the efficacy and safety of a two-week course of once-daily NAFT-2% vs. vehicle in the treatment of Tinea cruris ("jock itch"). A total of 334 subjects with T. cruris were enrolled and randomly assigned to NAFT-2% (n=166) or vehicle (n=168), which was applied once daily for 14 days. Efficacy and safety were evaluated at week 2 (end of treatment) and week 4. Efficacy measures included complete cure, treatment effectiveness, mycological cure, clinical cure, and clinical success and were analyzed only in subjects with a positive potassium hydroxide (KOH) and dermatophyte culture at baseline (n=75, naftifine; n=71, vehicle). Safety was assessed by adverse events and changes from baseline in clinical status and laboratory studies. At week 4, 25 percent of naftifine-treated subjects achieved complete cure vs. three percent of vehicle subjects and 72 percent achieved mycological cure vs. 16 percent of vehicle treated subjects (one-sided, P<0.001). Treatment effectiveness was achieved in 60 percent of NAFT-2% subjects vs. 10 percent of vehicle subjects (one-sided, P<0.001). Clinical cure rate and clinical success rate were 33 percent and 84 percent in NAFT-2% subjects, respectively vs. 10 percent and 46 percent in vehicle subjects (both P is less than 0.001, 2-sided). Week 2 efficacy response rates in NAFT-2% subjects were all lower than at week 4 but were significantly higher than week 2 vehicle-treated counterparts (P<0.025). Treatment-related AE occurred in 11 subjects (7 NAFT-2%, 4 vehicle) during the study. The most common AE in both groups were contact dermatitis (2 NAFT-2%), pruritus (2 vehicle), and application site reaction (1 per group). NAFT-2% applied once daily for two weeks (one-half the treatment duration for naftifine 1% cream) is efficacious and safe for the treatment of T. cruris.

Aeronautical engineering: A special bibliography with indexes, supplement 49

NASA Technical Reports Server (NTRS)

1974-01-01

The bibliography contains 368 abstract citations of reports, journal articles, and other documents concerned with the engineering and theoretical aspects of design, construction, evaluation, testing, operation, and performance of aircraft (including aircraft engines) and associated components, equipment, and systems. Research and development in aerodynamics, aeronautics, and ground support equipment are also treated. Subject, personal, and contract number indexes are included for ease of access.

Patterns of drug abuse among drug users with regular and irregular attendance for treatment as detected by comprehensive UHPLC-HR-TOF-MS.

PubMed

Sundström, Mira; Pelander, Anna; Simojoki, Kaarlo; Ojanperä, Ilkka

2016-01-01

The most severe consequences of drug abuse include infectious diseases, overdoses, and drug-related deaths. As the range of toxicologically relevant compounds is continually changing due to the emergence of new psychoactive substances (NPS), laboratories are encountering analytical challenges. Current immunoassays are insufficient for determining the whole range of the drugs abused, and a broad-spectrum screening method is therefore needed. Here, the patterns of drug abuse in two groups of drug users were studied from urine samples using a comprehensive screening method based on high-resolution time-of-flight mass spectrometry. The two groups comprised drug abusers undergoing opioid maintenance treatment (OMT) or drug withdrawal therapy and routinely visiting a rehabilitation clinic, and drug abusers with irregular attendance at a harm reduction unit (HRU) and suspected of potential NPS abuse. Polydrug abuse was observed in both groups, but was more pronounced among the HRU subjects with a mean number of concurrent drugs per sample of 3.9, whereas among the regularly treated subjects the corresponding number was 2.1. NPS and pregabalin were more frequent among HRU subjects, and their abuse was always related to drug co-use. The most common drug combination for an HRU subject included amphetamine, cannabis, buprenorphine, benzodiazepine, and alpha-pyrrolidinovalerophenone. A typical set of drugs for treated subjects was buprenorphine, benzodiazepine, and occasionally amphetamine. Abuse of several concurrent drugs poses a higher risk of drug intoxication and a threat of premature termination of OMT. Since the subjects attending treatment used fewer concurrent drugs, this treatment could be valuable in reducing polydrug abuse. Copyright © 2015 John Wiley & Sons, Ltd.

An Analysis of the Effects of Phenytoin in Treating Motion Sickness and the Effects of Motion Sickness on the Human Electroencephalogram

DTIC Science & Technology

1990-12-01

ears ( tinnitus ) and/or a reduced auditory acuity resulted from the dosing. These side effects have been shown to 29 occur in some subjects as a result of...examinations. 5. Complete blood count (CBC). 6. Blood biochemistry screen (Chem 18 including liver function tests). 7. Blood cholesterol and lipids . 8. Chest X...blood lipids and cholesterol, chest X-ray, urinalysis, visual acuity test, vestibular evaluation and liver function studies. Subjects will then take

In vivo viability of stored red blood cells derived from riboflavin plus ultraviolet light-treated whole blood.

PubMed

Cancelas, Jose A; Rugg, Neeta; Fletcher, Dana; Pratt, P Gayle; Worsham, D Nicole; Dunn, Susan K; Marschner, Susanne; Reddy, Heather L; Goodrich, Raymond P

2011-07-01

A novel system using ultraviolet (UV) light and riboflavin (Mirasol System, CaridianBCT Biotechnologies) to fragment nucleic acids has been developed to treat whole blood (WB), aiming at the reduction of potential pathogen load and white blood cell inactivation. We evaluated stored red blood cell (RBC) metabolic status and viability, in vitro and in vivo, of riboflavin/UV light-treated WB (IMPROVE study). The study compared recovery and survival of RBCs obtained from nonleukoreduced WB treated using three different UV light energies (22, 33, or 44 J/mL(RBC)). After treatment, WB from 12 subjects was separated into components and tested at the beginning and end of component storage. After 42 days of storage, an aliquot of RBCs was radiolabeled and autologously reinfused into subjects for analysis of 24-hour recovery and survival of RBCs. Eleven subjects completed the in vivo study. No device-related adverse events were observed. By Day 42 of storage, a significant change in the concentrations of sodium and potassium was observed. Five subjects had a 24-hour RBC recovery of 75% or more with no significant differences among the energy groups. RBC t(1/2) was 24 ± 9 days for the combined three groups. Significant correlations between 24-hour RBC recovery and survival, hemolysis, adenosine triphosphate (ATP), and CO(2) levels were observed. This study shows that key RBC quality variables, hemolysis, and ATP concentration may be predictive of their 24-hour recovery and t(1/2) survival. These variables will now be used to assess modifications to the system including storage duration, storage temperature, and appropriate energy dose for treatment. © 2011 American Association of Blood Banks.

[USE OF QuantiFERON® TB-GOLD IN-TUBE IN A CONTACT INVESTIGATION TO DETERMINE THE ONSET OF TUBERCULOSIS WITH OR WITHOUT LATENT TUBERCULOSIS INFECTION TREATMENT].

PubMed

Matsumoto, Kenji; Komukai, Jun; Tsuda, Yuko; Furukawa, Kanae; Saito, Kazumi; Hirota, Satoshi; Koda, Shinichi; Kasai, Sachi; Shimouchi, Akira

2016-02-01

QuantiFERON® TB-Gold In-Tube (3G) testing was performed on tuberculosis-positive index cases and their contacts. The purpose of this study was to evaluate the relationship between 3G test results and the subsequent development of tuberculosis, and to identify effective strategies to prevent the onset of tuberculosis. Index cases and their contacts were subjected to 3G testing in a contact investigation in Osaka City in 2011-2012. For index cases, sputum smears were tested, and the infecting organism was identified. For the contacts, the following information was collected: age, results of 3G testing, presence or absence of latent tuberculosis infection (LTBI) treatment, and onset of tuberculosis disease within 2 years of follow-up from the last contact with the index cases. (1) There were 830 index cases, including 774 subjects with pulmonary tuberculosis (93.3%) and 3 with laryngeal tuberculosis (0.4%). From sputum smear tests, 726 patients (87.5%) were determined to be 3G positive, and 83 (10.0%) were determined to be 3G negative. (2) In total, 2,644 contacts were subjected to 3G testing. Of these, 2,072 patients (78.4%) tested negative, 196 (7.4%) showed an equivocal result, and 375 (14.2%) tested positive. Their mean ages were 33.7, 38.0, and 38.8 years, respectively, showing significant differences in tuberculosis status according to age (P < 0.001). (3) Among the 2,072 3G-negative contacts, tuberculosis developed in 2 (0.1%) of 2063. None of these contacts was treated for LTBI. Among the 375 3G-positive contacts, tuberculosis developed in 36 (36.0%) of 100 subjects that were not LTBI treated, while tuberculosis developed in 3 (1.1 %) of 275 subjects that were LTBI treated. A significant difference in the incidence of tuberculosis between treated and untreated 3G-positive contacts was observed (P < 0.001). Tuberculosis developed in a high proportion of 3G-positive contacts that were not LTBI treated, suggesting the need for preventive management of 3G-positive contacts.

Vehicle-Controlled, Phase 2 Clinical Trial of a Sustained-Release Dexamethasone Intracanalicular Insert in a Chronic Allergen Challenge Model.

PubMed

Torkildsen, Gail; Abelson, Mark B; Gomes, Paul J; McLaurin, Eugene; Potts, Susan L; Mah, Francis S

2017-03-01

To evaluate the efficacy and safety of a sustained-release dexamethasone intracanalicular insert (Dextenza™) in a model of allergic conjunctivitis. This was a randomized, double-masked, vehicle-controlled, Phase 2 study. Subjects had to have a positive conjunctival allergen challenge (CAC) reaction to allergen (bilateral +2 itching and redness on 5-point, 0-4 scales) at Visit 1, and for 2 of 3 time points on subsequent visits. Subjects who met entry criteria were randomized to receive Dextenza or PV (vehicle insert). Challenges occurred over 42 days, with efficacy assessed at 14 (primary endpoint visit), 28, and 40 days postinsertion. Outcome measures included the evaluation of ocular itching, redness, tearing, chemosis, eyelid swelling, rhinorrhea, and congestion. Twenty-eight subjects completed the study in the Dextenza group and 31 in the vehicle group. At 14 days postinsertion, Dextenza was statistically superior to PV, with least square mean differences for ocular itching of -0.76, -0.97, and -0.87 at 3, 5, and 7 min post-CAC, and for conjunctival redness of -0.46, -0.66, and -0.68 at 7, 15, and 20 min post-CAC. Clinical significance, defined as a 1-U decrease from PV, was not met for primary efficacy. Secondary endpoints, including number of subjects reporting itching and conjunctival redness, indicated superior performance of Dextenza compared with vehicle. Eleven Dextenza-treated (35.5%) and 10 vehicle-treated (30.3%) subjects each experienced a single adverse event. This Phase 2 study demonstrated preliminary efficacy and safety data of Dextenza for treatment of allergic conjunctivitis.

A naturally-inspired, curcumin-based lecithin formulation (Meriva® formulated as the finished product Algocur®) alleviates the osteo-muscular pain conditions in rugby players.

PubMed

Di Pierro, F; Zacconi, P; Bertuccioli, A; Togni, S; Eggenhoffner, R; Giacomelli, L; Scaltrini, S

2017-11-01

Curcumin is one of the most investigated phytochemical products because of its low toxicity and its broad spectrum of bioactivity, including anti-inflammatory and analgesic properties. A new delivery form of curcumin, resorting to phosphatidylcholine (Meriva®, formulated as the finished product Algocur®) has been developed to increase its bioavailability. In this study, we tested the efficacy and safety of a Meriva®-based product in rugby players suffering by different osteo-muscular pain conditions PATIENTS AND METHODS: In this pilot study, 50 male rugby players with osteo-muscular pain due to traumatic injuries, physical overload or acute episode of chronic pain were recruited and treated with conventional analgesic drugs (n = 25) or Meriva®-based product (n = 25) for a maximum of 10 days. The pain perception and the functio laesa were evaluated at baseline and after 1, 3, 6, 10 and 20 days from the initiation of the treatment protocol. Treatment tolerability, compliance, and adverse events were also reported. During the study, the analgesic effect decreased in both treated group compared to baseline, starting from the third day of treatment. Similarly, the impaired physical function evaluated after 3, 6, 10 and 20 days improved in Meriva®-based product treated group and in subjects treated with conventional analgesic drugs, compared to the baseline condition. The percentage of excellent adherence to treatment or tolerability was higher in the Meriva®-based product treated group. Only 1 (4%) subject treated with Meriva®-based product experienced adverse events whereas 4 (16%) subjects treated with conventional analgesic drugs reported gastric pain as an adverse event. Despite the small sample size and the group heterogeneity, this study suggests that the naturally-derived, curcumin-based delivery form, Meriva® (formulated as the finished product Algocur®), could represent a promising safe, analgesic remedy in painful osteo-muscular conditions associated with intense, high impact, physical activities.

Laser Surface Preparation and Bonding of Aerospace Structural Composites

NASA Technical Reports Server (NTRS)

Belcher, Marcus A.; Wohl, Christopher J.; Connell, John W.

2009-01-01

A Nd:YAG laser was used to etch patterns conducive to adhesive bonding onto CFRP surfaces. These were compared to typical pre-bonding surface treatments including grit blasting, manual abrasion, and peel ply. Laser treated composites were then subjected to optical microscopy, contact angle measurements, and post-bonding mechanical testing.

Consumer Health. Bibliographies on Educational Topics No. 5.

ERIC Educational Resources Information Center

ERIC Clearinghouse on Teacher Education, Washington, DC.

This document is the fifth in the series, BIBLIOGRAPHIES ON EDUCATIONAL TOPICS (BETS), providing topical searches of ERIC literature in the scope areas of teacher education and health education, physical education, and recreation education. Here, the subject of consumer health is treated bibliographically. Included are topics dealing with the wise…

Research Considerations in Ethical Education.

ERIC Educational Resources Information Center

Hogan, Robert

The author purports the need to treat moral education as a serious academic subject and suggests ways educators can manage it in an intellectually defensible way. Ethical education must avoid indoctrination, yet it should not be a mere training in philosophical ethics. The domain of moral education should include four partially interdependent…

Safety and efficacy of combined use of 4-hydroxyanisole (mequinol) 2%/tretinoin 0.01% solution and sunscreen in solar lentigines.

PubMed

Ortonne, Jean Paul; Camacho, Francisco; Wainwright, Nicholas; Bergfelt, Louise; Westerhof, Wiete; Roseeuw, Diane

2004-10-01

The objective of this open-label, noncontrolled study was to evaluate the safety of a combination solution containing 4-hydroxyanisole (mequinol) 2%/tretinoin 0.01% (Solagé) with a sunscreen in the treatment of solar lentigines. The study included a total of 406 subjects for a treatment period up to 24 weeks. Efficacy was evaluated clinically by grading the pigmentation level of the treated areas on the face and forearms. A total of 378 subjects were included in the safety population. Of the 173 subjects with skin-related and treatment-related adverse events, severity was reported as mild in 79 subjects, moderate in 71, and severe in 23. Hypopigmentation was observed in 4 subjects and had definitively resolved in 3 of these subjects at the end of the study or after treatment had been discontinued. Halo hypopigmentation was reported in 16 subjects. No allergic reactions were observed. Efficacy evaluation was based on data for 370 subjects. A total of 325 (88%) subjects had facial target lesions almost clear to clear, and a total of 298 (81%) subjects had forearm target lesions almost clear to clear. Our study shows that the mequinol 2%/tretinoin 0.01% solution is effective, convenient, and safe in the treatment of solar lentigines.

Cryotherapy and Topical Minocycline as Adjunctive Measures to Control Pain After Third Molar Surgery: An Exploratory Study

PubMed Central

Gelesko, Savannah; Long, Leann; Faulk, Jan; Phillips, Ceib; Dicus, Carolyn; White, Raymond P.

2013-01-01

Purpose To assess the impact of cryotherapy or topical minocycline on patients’ perceptions of recovery from pain after third molar surgery in an exploratory comparative-effectiveness study. Patients and Methods Subjects aged at least 14 years who were having all 4 third molars removed were enrolled in 3 separate institutional review board–approved studies. Study groups included subjects treated with a passively applied cold wrap for 24 hours postoperatively, subjects treated with topical minocycline during surgery, and subjects enrolled in a nonconcurrent comparison group who had received neither topical minocycline nor directed cryotherapy. Third molar surgery was performed in all cases by trained surgeons using the same protocol. An exact Kruskal-Wallis test was used to compare the distributions of the worst and average pain scores and a Fisher exact test to compare verbal responses from Gracely pain scales among the 3 groups for postsurgical days (PSDs) 1 to 3. Results This study comprised 51 cryotherapy subjects (2005–2009), 63 minocycline subjects (2003–2004), and 92 comparison-group subjects (2002–2006) who were treated at academic centers and in community practices across the United States (N = 206). Demographic descriptors were similar among all groups. For PSDs 1 through 3 (unadjusted), the highest scores for worst pain (6–7 [out of 7] on Likert-type scale) were reported less frequently in each of the study groups than in subjects in the comparison group, although the numbers of subjects reporting the highest scores were few. The distribution of pain outcomes was significantly different among the 3 groups for worst pain and affective words on PSD 1 (P = .04 for both). However, the small number of subjects who reported the highest pain scores precluded adequate multivariate statistical analyses for all outcomes on PSD 1 to 3. Conclusions Data from this exploratory study suggest that adjunctive therapy to decrease postoperative pain—cryotherapy or topical minocycline—might be effective at moderating the patient’s highest pain levels after third molar surgery. The topic should be studied further in a multicenter, prospective, randomized trial. PMID:21802812

Restoration of normal sperm characteristics in hypoprolactinemic infertile men treated with metoclopramide and exogenous human prolactin.

PubMed

Ufearo, C S; Orisakwe, O E

1995-09-01

We investigated the effects of induced increase in prolactin levels on spermatogenesis in 20 infertile men with hypoprolactinemia using exogenous human prolactin (hPRL) and metoclopramide. The subjects were selected from a population of 175 infertile men in whom the prevalence of hypoprolactinemia was 33.14%. Mean basal plasma prolactin was 2.79 +/- 0.62 ng.ml-1 in the infertile men and 9.57 +/- 2.14 ng.ml-1 in the normal control subjects. At the sixteenth week, mean plasma prolactin was 9.41 +/- 1.3 ng.ml-1 in subjects treated with exogenous hPRL and 5.2 +/- 0.7 ng.ml-1 in subjects treated with metoclopramide. Mean basal sperm concentration was approximately 8.8 million per milliliter in the infertile men and 41.5 million per milliliter in the normal control subjects. Mean sperm concentration was approximately 37 million per milliliter in subjects treated with exogenous hPRL, whereas the peak mean value was 23 million per milliliter in subjects treated with metoclopramide for 16 weeks. At basal conditions, the mean percentages of abnormal sperm were 66.75% +/- 14.93% and 21.36% +/- 4.78% in infertile and normal subjects, respectively. In subjects treated with exogenous hPRL and metoclopramide, the mean percentage of abnormal sperm were 24.7% and 31%, respectively, at week 16. Mean plasma prolactin, mean sperm concentration and the mean percentage of abnormal sperm were 3.3 +/- 1.4 ng.ml-1, 7 million per milliliter, and 60.5, respectively, in the infertile subjects after drug withdrawal at week 14. In normal control subjects, there was no significant difference (p = 0.01) in the plecebo effect. We therefore conclude that the low prolactin levels in this group of infertile men may be one of the primary causes of their infertility.

Doppler echocardiographic analysis of left ventricular filling in treated hypertensive patients.

PubMed

Phillips, R A; Coplan, N L; Krakoff, L R; Yeager, K; Ross, R S; Gorlin, R; Goldman, M E

1987-02-01

Early detection and prevention of cardiac dysfunction is an important goal in the management of hypertensive patients. In this study, Doppler echocardiography was used to evaluate the pattern of left ventricular diastolic filling in 38 subjects: 18 treated hypertensive patients (blood pressure 141 +/- 17/83 +/- 10 mm Hg, mean +/- SD) without other coronary risk factors and 20 risk-free normotensive subjects of similar age (47 +/- 10 and 49 +/- 13 years, respectively). Peak velocity of late left ventricular filling due to the atrial contraction was greater in hypertensive compared with normotensive subjects (69 +/- 14 versus 52 +/- 13 cm/s; p less than 0.001). Peak velocity of late filling was significantly greater in hypertensive versus normotensive subjects in those aged 50 years or younger and those older than age 50 (65 +/- 12 versus 50 +/- 11; p less than 0.01 and 75 +/- 15 versus 56 +/- 15 cm/s; p less than 0.05, respectively). In hypertensive subjects, peak velocity of late filling did not correlate with routine indexes of hypertensive heart disease (including posterior wall thickness and left ventricular mass), systolic and diastolic blood pressure or duration of hypertension. These results indicate that increased velocity of late left ventricular filling may be independent of left ventricular hypertrophy and persist despite effective blood pressure control.

A Prospective Study of Axillary Hair Reduction in Patients Treated With Microwave Technology.

PubMed

Brauer, Jeremy A; Neckman, Julia P; Zelickson, Brian; Vasily, David B; Geronemus, Roy G

2017-04-01

Removing unwanted body hair is a growing trend in society today, and there are many laser-based devices for hair reduction. There are some limitations to those methods, including the lack of efficacy for lighter color hair. The objective was to quantify hair reduction in the axillae after treatment with a noninvasive microwave energy device. A prospective, multicenter study was performed at 3 private dermatology clinics. Fifty-six adult subjects seeking axillary hair reduction were enrolled and treated with the device in 1 or 2 treatment sessions 3 months apart at various energy levels, and followed for 12 months. The primary analysis was monitoring reduction of hair counts from baseline to follow-up visits. A subject assessment of overall satisfaction, odor ratings, and sweat reduction ratings was provided at follow-up visits. Fifty-six subjects received treatment, with an average total underarm hair reduction of approximately 70% for both light and dark hair. Percentage of patients with hair reduction of 30% or more was significantly higher than 50% at all follow-up visits. Half of treated subjects reported expected mild transient post-treatment effects such as localized edema, discomfort, and bruising. Other reported events were mild. This clinical study provides evidence for safe and permanent axillary hair reduction, showing stable average reduction that lasted through the year of follow-up. Most notably, the study has shown the treatment's efficacy for reduction of light-colored axillary hair.

Inocoterone and acne. The effect of a topical antiandrogen: results of a multicenter clinical trial.

PubMed

Lookingbill, D P; Abrams, B B; Ellis, C N; Jegasothy, B V; Lucky, A W; Ortiz-Ferrer, L C; Savin, R C; Shupack, J L; Stiller, M J; Zone, J J

1992-09-01

Because acne is androgen dependent, antiandrogen therapy might improve the condition. Inocoterone acetate (RU 882) is a nonsteroidal antiandrogen that binds to the androgen receptor and has antiandrogenic activity in animal models. To test its topical effect on acne, 126 male subjects with facial acne completed a 16-week, multi-center, double-blind study in which the twice-daily application of a 10% solution of inocoterone was compared with vehicle solution. Baseline and monthly examinations included acne lesion counts and general and endocrine laboratory tests. Inflammatory papules and pustules showed greater reduction in the inocoterone-treated subjects than in the subjects treated with vehicle. This difference achieved statistical significance by week 12 (24% reduction vs 10%) and week 16 (26% reduction vs 13%) and, with longitudinal analysis, throughout the course of the study. Global assessments and changes in comedo counts and sebum excretion rates were not significantly different between the groups. No serious adverse reactions were encountered. In this double-blind study of 126 male subjects with acne, a topical solution of the antiandrogen inocoterone, compared with vehicle, produced a modest but statistically significant reduction in the number of inflammatory acne lesions.

Occupancy of striatal and extrastriatal dopamine D2/D3 receptors by olanzapine and haloperidol.

PubMed

Kessler, Robert M; Ansari, Mohammad Sib; Riccardi, Patrizia; Li, Rui; Jayathilake, Karuna; Dawant, Benoit; Meltzer, Herbert Y

2005-12-01

There have been conflicting reports as to whether olanzapine produces lower occupancy of striatal dopamine D(2)/D(3) receptor than typical antipsychotic drugs and preferential occupancy of extrastriatal dopamine D(2)/D(3) receptors. We performed [(18)F] fallypride PET studies in six schizophrenic subjects treated with olanzapine and six schizophrenic subjects treated with haloperidol to examine the occupancy of striatal and extrastriatal dopamine receptors by these antipsychotic drugs. [(18)F] setoperone PET studies were performed in seven olanzapine-treated subjects to determine 5-HT(2A) receptor occupancy. Occupancy of dopamine D(2)/D(3) receptors by olanzapine was not significantly different from that seen with haloperidol in the putamen, ventral striatum, medial thalamus, amygdala, or temporal cortex, that is, 67.5-78.2% occupancy; olanzapine produced no preferential occupancy of dopamine D(2)/D(3) receptors in the ventral striatum, medial thalamus, amygdala, or temporal cortex. There was, however, significantly lower occupancy of substantia nigra/VTA dopamine D(2)/D(3) receptors in olanzapine-treated compared to haloperidol-treated subjects, that is, 40.2 vs 59.3% (p=0.0014, corrected for multiple comparisons); in olanzapine-treated subjects, the substantia nigra/VTA was the only region with significantly lower dopamine D(2)/D(3) receptor occupancy than the putamen, that is, 40.2 vs 69.2% (p<0.001, corrected for multiple comparison). Occupancy of 5-HT(2A) receptors was 85-93% in the olanzapine- treated subjects. The results of this study demonstrated that olanzapine does not produce preferential occupancy of extrastriatal dopamine D(2)/D(3) receptors but does spare substantia nigra/VTA receptors. Sparing of substantia nigra/VTA dopamine D(2)/D(3) receptor occupancy may contribute to the low incidence of extrapyramidal side effects in olanzapine-treated patients.

Omalizumab facilitates rapid oral desensitization for peanut allergy.

PubMed

MacGinnitie, Andrew J; Rachid, Rima; Gragg, Hana; Little, Sara V; Lakin, Paul; Cianferoni, Antonella; Heimall, Jennifer; Makhija, Melanie; Robison, Rachel; Chinthrajah, R Sharon; Lee, John; Lebovidge, Jennifer; Dominguez, Tina; Rooney, Courtney; Lewis, Megan Ott; Koss, Jennifer; Burke-Roberts, Elizabeth; Chin, Kimberly; Logvinenko, Tanya; Pongracic, Jacqueline A; Umetsu, Dale T; Spergel, Jonathan; Nadeau, Kari C; Schneider, Lynda C

2017-03-01

Peanut oral immunotherapy is a promising approach to peanut allergy, but reactions are frequent, and some patients cannot be desensitized. The anti-IgE medication omalizumab (Xolair; Genentech, South San Francisco, Calif) might allow more rapid peanut updosing and decrease reactions. We sought to evaluate whether omalizumab facilitated rapid peanut desensitization in highly allergic patients. Thirty-seven subjects were randomized to omalizumab (n = 29) or placebo (n = 8). After 12 weeks of treatment, subjects underwent a rapid 1-day desensitization of up to 250 mg of peanut protein, followed by weekly increases up to 2000 mg. Omalizumab was then discontinued, and subjects continued on 2000 mg of peanut protein. Subjects underwent an open challenge to 4000 mg of peanut protein 12 weeks after stopping study drug. If tolerated, subjects continued on 4000 mg of peanut protein daily. The median peanut dose tolerated on the initial desensitization day was 250 mg for omalizumab-treated subjects versus 22.5 mg for placebo-treated subject. Subsequently, 23 (79%) of 29 subjects randomized to omalizumab tolerated 2000 mg of peanut protein 6 weeks after stopping omalizumab versus 1 (12%) of 8 receiving placebo (P < .01). Twenty-three subjects receiving omalizumab versus 1 subject receiving placebo passed the 4000-mg food challenge. Overall reaction rates were not significantly lower in omalizumab-treated versus placebo-treated subjects (odds ratio, 0.57; P = .15), although omalizumab-treated subjects were exposed to much higher peanut doses. Omalizumab allows subjects with peanut allergy to be rapidly desensitized over as little as 8 weeks of peanut oral immunotherapy. In the majority of subjects, this desensitization is sustained after omalizumab is discontinued. Additional studies will help clarify which patients would benefit most from this approach. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

PubMed Central

Hosseini, Kamran; Walters, Thomas; DaVanzo, Robert; Lindstrom, Richard L

2016-01-01

Purpose The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075%) compared with DuraSite® vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery. Methods A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15. Results At Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001). At each of the postsurgical time points (Days 1, 8, 15, and 29), proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively) had no pain (a VAS score of 0) compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively), and at each time point, these differences in proportions were statistically significant (P<0.001). More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4%) compared to those in the vehicle group (54/85; 63.5%). There were no new safety signals reported. Conclusion Bromfenac 0.075% in DuraSite is safe, well tolerated, and effective at reducing inflammation and preventing pain associated with cataract surgery. PMID:27920490

In Vitro Activity of Delafloxacin and Microbiological Response against Fluoroquinolone-Susceptible and Nonsusceptible Staphylococcus aureus Isolates from Two Phase 3 Studies of Acute Bacterial Skin and Skin Structure Infections

PubMed Central

Lawrence, L.; Quintas, M.; Woosley, L.; Flamm, R.; Tseng, C.; Cammarata, S.

2017-01-01

ABSTRACT Delafloxacin is an investigational anionic fluoroquinolone antibiotic with broad-spectrum in vitro activity, including activity against Gram-positive organisms, Gram-negative organisms, atypical organisms, and anaerobes. The in vitro activity of delafloxacin and the percent microbiological response in subjects infected with fluoroquinolone-susceptible and nonsusceptible Staphylococcus aureus isolates were determined from two global phase 3 studies of delafloxacin versus vancomycin plus aztreonam in patients with acute bacterial skin and skin structure infections (ABSSSI). Patients from 23 countries, predominately the United States but also Europe, South America, and Asia, were enrolled. The microbiological intent-to-treat (MITT) population included 1,042 patients from which 685 S. aureus isolates were submitted for identification and susceptibility testing per CLSI guidelines at the central laboratory (JMI Laboratories, North Liberty, IA). The comparator fluoroquinolone antibiotics included levofloxacin and ciprofloxacin. Nonsusceptibility to these antibiotics was determined using CLSI breakpoints. S. aureus isolates were 33.7% levofloxacin nonsusceptible (LVX-NS). The delafloxacin MIC90 values against levofloxacin-nonsusceptible S. aureus, methicillin-resistant S. aureus (MRSA), and methicillin-susceptible S. aureus isolates were all 0.25 μg/ml. Delafloxacin demonstrated high rates of microbiological response against LVX-NS isolates as well as isolates with documented mutations in the quinolone resistance-determining region (QRDR). S. aureus was eradicated or presumed eradicated in 98.4% (245/249) of delafloxacin-treated patients. Similar eradication rates were observed for delafloxacin-treated subjects with levofloxacin-nonsusceptible S. aureus isolates (80/81; 98.8%) and MRSA isolates (70/71; 98.6%). Microbiological response rates of 98.6% were observed with delafloxacin-treated subjects with S. aureus isolates with the S84L mutation in gyrA and the S80Y mutation in parC, the most commonly observed mutations in global phase 3 studies. The data suggest that delafloxacin could be a good option for the treatment of infections caused by S. aureus isolates causing ABSSSI, including MRSA isolates, where high rates of ciprofloxacin and levofloxacin nonsusceptibility are observed. (The phase 3 studies described in this paper have been registered at ClinicalTrials.gov under identifiers NCT01984684 and NCT01811732.) PMID:28630189

In Vitro Activity of Delafloxacin and Microbiological Response against Fluoroquinolone-Susceptible and Nonsusceptible Staphylococcus aureus Isolates from Two Phase 3 Studies of Acute Bacterial Skin and Skin Structure Infections.

PubMed

McCurdy, S; Lawrence, L; Quintas, M; Woosley, L; Flamm, R; Tseng, C; Cammarata, S

2017-09-01

Delafloxacin is an investigational anionic fluoroquinolone antibiotic with broad-spectrum in vitro activity, including activity against Gram-positive organisms, Gram-negative organisms, atypical organisms, and anaerobes. The in vitro activity of delafloxacin and the percent microbiological response in subjects infected with fluoroquinolone-susceptible and nonsusceptible Staphylococcus aureus isolates were determined from two global phase 3 studies of delafloxacin versus vancomycin plus aztreonam in patients with acute bacterial skin and skin structure infections (ABSSSI). Patients from 23 countries, predominately the United States but also Europe, South America, and Asia, were enrolled. The microbiological intent-to-treat (MITT) population included 1,042 patients from which 685 S. aureus isolates were submitted for identification and susceptibility testing per CLSI guidelines at the central laboratory (JMI Laboratories, North Liberty, IA). The comparator fluoroquinolone antibiotics included levofloxacin and ciprofloxacin. Nonsusceptibility to these antibiotics was determined using CLSI breakpoints. S. aureus isolates were 33.7% levofloxacin nonsusceptible (LVX-NS). The delafloxacin MIC 90 values against levofloxacin-nonsusceptible S. aureus , methicillin-resistant S. aureus (MRSA), and methicillin-susceptible S. aureus isolates were all 0.25 μg/ml. Delafloxacin demonstrated high rates of microbiological response against LVX-NS isolates as well as isolates with documented mutations in the quinolone resistance-determining region (QRDR). S. aureus was eradicated or presumed eradicated in 98.4% (245/249) of delafloxacin-treated patients. Similar eradication rates were observed for delafloxacin-treated subjects with levofloxacin-nonsusceptible S. aureus isolates (80/81; 98.8%) and MRSA isolates (70/71; 98.6%). Microbiological response rates of 98.6% were observed with delafloxacin-treated subjects with S. aureus isolates with the S84L mutation in gyrA and the S80Y mutation in parC , the most commonly observed mutations in global phase 3 studies. The data suggest that delafloxacin could be a good option for the treatment of infections caused by S. aureus isolates causing ABSSSI, including MRSA isolates, where high rates of ciprofloxacin and levofloxacin nonsusceptibility are observed. (The phase 3 studies described in this paper have been registered at ClinicalTrials.gov under identifiers NCT01984684 and NCT01811732.). Copyright © 2017 McCurdy et al.

Course of serological tests in treated subjects with chronic Trypanosoma cruzi infection: a systematic review and meta-analysis of individual participant data.

PubMed

Sguassero, Yanina; Roberts, Karen N; Harvey, Guillermina B; Comandé, Daniel; Ciapponi, Agustín; Cuesta, Cristina B; Danesi, Emmaría; Aguiar, Camila; Andrade, Ana L; Castro, Ana Mde; Lana, Marta de; Escribà, Josep M; Fabbro, Diana L; Fernandes, Cloé D; Meira, Wendell Sf; Flores-Chávez, María; Hasslocher-Moreno, Alejandro M; Jackson, Yves; Lacunza, Carlos D; Machado-de-Assis, Girley F; Maldonado, Marisel; Monje-Rumi, María M; Molina, Israel; Martín, Catalina Muñoz-San; Murcia, Laura; Castro, Cleudson Nery de; Silveira, Celeste An; Negrette, Olga Sánchez; Segovia, Manuel; Solari, Aldo; Steindel, Mário; Streiger, Mirtha L; Bilbao, Ninfa Vera de; Zulantay, Inés; Sosa-Estani, Sergio

2018-06-04

To determine the course of serological tests in subjects with chronic T. cruzi infection treated with antitrypanosomal drugs. We conducted a systematic review and meta-analysis using individual participant data. Survival analysis and Cox proportional hazards regression model with a random effect to adjust for covariates were applied. The protocol was registered at www.crd.york.ac.uk/PROSPERO (CRD42012002162). We included 27 studies (1296 subjects) conducted in eight countries. The risk of bias was low for all domains in 17 studies (63.0%). We assessed 913 subjects (149 seroreversion events, 83.7% censored data) for ELISA, 670 subjects (134 events, 80.0% censored) for IIF, and 548 subjects (99 events, 82.0% censored) for IHA. A higher probability of seroreversion was observed in subjects aged 1-19 years compared to adults at a shorter time span. The chance of seroreversion also varied according to the country where the infection might have been acquired. For instance, the pooled adjusted hazard ratio between children/adolescents and adults for IIF test was 1.54 (95% CI 0.64-3.71) and 9.37 (3.44-25.50) in some countries of South America and Brazil, respectively. The disappearance of anti-T. cruzi antibodies was demonstrated along the follow-up. An interaction between age at treatment and country setting was shown. Copyright © 2018. Published by Elsevier Ltd.

Virtual Reality Therapy for the Treatment of Alcohol Dependence: A Preliminary Investigation With Positron Emission Tomography/Computerized Tomography.

PubMed

Son, Ji Hyun; Lee, Sang Hoon; Seok, Ju Won; Kee, Baik Seok; Lee, Hyun Woong; Kim, Hyung Joon; Lee, Tae Kyung; Han, Doug Hyun

2015-07-01

Virtual reality therapy (VRT) uses multimodal stimulation that includes visual, auditory, olfactory, and gustatory stimuli. The aim of this study was to assess the effectiveness of VRT in treating subjects with alcohol dependence (AD) by evaluating changes in brain metabolism. The VRT protocol consisted of three steps: relaxation, presentation of a high-risk situation, and presentation of an aversive situation. Twelve alcohol-dependent subjects underwent 10 sessions of VRT. The alcohol-dependent subjects were assessed with 18F-fluorodeoxyglucose positron emission tomography images before and after VRT, whereas the control group underwent imaging according to the same protocol only at baseline. Compared with the healthy control group, AD subjects showed higher metabolism in the right lentiform nucleus and right temporal lobe (BA20) at baseline (P(FDR < .05) = .026). In addition, the metabolism in the left anterior cingulate was lower in subjects with AD (P(uncorr) = .001). After VRT, alcohol-dependent subjects showed decreased brain metabolism in the right lentiform nucleus (P(FDR < .05) = .026) and right temporal lobe (BA38, P(FDR < .05) = .032) relative to that at baseline. Our results suggest a neurobiological imbalance, notably, a high sensitivity to stimuli, in the limbic system in subjects with AD. Furthermore, we determined that metabolism decreased in the basal ganglia after VRT, which may explain the limbic-regulated responses of reward and regulation. Therefore, we tentatively recommend VRT to treat AD through its regulating effect on limbic circuits.

75 FR 73140 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... categories of participants: Customers, broker-dealers, market makers (including specialists, Registered... respect to all-or-none orders, which will be treated like customer orders), 1033(e), 1064.02 (except professional orders will be considered customer orders subject to facilitation), and 1080.08 as well as Options...

Broadcast Journalism; An Introduction to News Writing.

ERIC Educational Resources Information Center

Hall, Mark W.

The important features of writing news for radio and television are covered in this book. Ways to write colorful, accurate, and timely stories are explained with the emphasis on the differences between broadcast and newspaper stories. Other subjects treated are sources of news (including explanations of how the Associated Press copy works and how…

Positive Effectiveness of Tafamidis in Delaying Disease Progression in Transthyretin Familial Amyloid Polyneuropathy up to 2 Years: An Analysis from the Transthyretin Amyloidosis Outcomes Survey (THAOS).

PubMed

Mundayat, Rajiv; Stewart, Michelle; Alvir, Jose; Short, Sarah; Ong, Moh-Lim; Keohane, Denis; Rill, Denise; Sultan, Marla B

2018-04-09

The effectiveness of tafamidis for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP) was evaluated using data from the Transthyretin Amyloidosis Outcomes Survey (THAOS) registry. Subjects receiving tafamidis (n = 252) were compared with untreated subjects in a non-randomized, matched cohort analysis. Subjects were matched with up to four untreated controls by genetic mutation, region of birth, and mean treatment propensity score. The matched, treated sample consisted predominantly of subjects with the Val30Met genotype (92.5%), from Portugal, and with a mean age of 40.4 years. Over the course of the 2-year follow-up period, subjects treated with tafamidis showed significantly less deterioration on the Neuropathy Impairment Score for Lower Limbs (p < 0.001) and its subscales (p < 0.023) compared with untreated subjects. There was significantly less deterioration among tafamidis-treated subjects compared with untreated subjects on the Norfolk Quality of Life scale (p < 0.001). There were no significant differences observed in functional (assessed by Karnofsky Performance Status Scale score) or nutritional (assessed by modified body mass index) status between the treated and untreated groups. The primary model which examined survival from baseline using the matched cohort was not able to yield estimates of the hazard ratio, as there were no deaths in the tafamidis-treated subjects. These findings support the results from clinical trials and strengthen evidence of the effectiveness of tafamidis beyond conventional clinical trials. ClinicalTrials.gov: NCT00628745 FUNDING: Pfizer.

Eculizumab for dense deposit disease and C3 glomerulonephritis.

PubMed

Bomback, Andrew S; Smith, Richard J; Barile, Gaetano R; Zhang, Yuzhou; Heher, Eliot C; Herlitz, Leal; Stokes, M Barry; Markowitz, Glen S; D'Agati, Vivette D; Canetta, Pietro A; Radhakrishnan, Jai; Appel, Gerald B

2012-05-01

The principle defect in dense deposit disease and C3 glomerulonephritis is hyperactivity of the alternative complement pathway. Eculizumab, a monoclonal antibody that binds to C5 to prevent formation of the membrane attack complex, may prove beneficial. In this open-label, proof of concept efficacy and safety study, six subjects with dense deposit disease or C3 glomerulonephritis were treated with eculizumab every other week for 1 year. All had proteinuria >1 g/d and/or AKI at enrollment. Subjects underwent biopsy before enrollment and repeat biopsy at the 1-year mark. The subjects included three patients with dense deposit disease (including one patient with recurrent dense deposit disease in allograft) and three patients with C3 glomerulonephritis (including two patients with recurrent C3 glomerulonephritis in allograft). Genetic and complement function testing revealed a mutation in CFH and MCP in one subject each, C3 nephritic factor in three subjects, and elevated levels of serum membrane attack complex in three subjects. After 12 months, two subjects showed significantly reduced serum creatinine, one subject achieved marked reduction in proteinuria, and one subject had stable laboratory parameters but histopathologic improvements. Elevated serum membrane attack complex levels normalized on therapy and paralleled improvements in creatinine and proteinuria. Clinical and histopathologic data suggest a response to eculizumab in some but not all subjects with dense deposit disease and C3 glomerulonephritis. Elevation of serum membrane attack complex before treatment may predict response. Additional research is needed to define the subgroup of dense deposit disease/C3 glomerulonephritis patients in whom eculizumab therapy can be considered.

Dyslipidemia and cardiovascular disease risk factor management in HIV-1-infected subjects treated with HAART in the Spanish VACH cohort.

PubMed

Pere, Domingo; Ignacio, Suarez-Lozano; Ramón, Teira; Fernando, Lozano; Alberto, Terrón; Pompeyo, Viciana; Juan, González; M José, Galindo; Paloma, Geijo; Antonio, Vergara; Jaime, Cosín; Esteban, Ribera; Bernardino, Roca; M Luisa, Garcia-Alcalde; Trinitario, Sánchez; Ferran, Torres; Juan Ramón, Lacalle; Myriam, Garrido

2008-01-01

There is increasing evidence that metabolic adverse effects associated with antiretroviral therapy may translate into an increased cardiovascular risk in HIV-1-infected patients. To determine the prevalence of risk factors for cardiovascular disease (CVD) among HIV-1-infected persons, and to investigate any association between them, stage of HIV-1 disease, and use of antiretroviral therapies. Multicentric, cross-sectional analysis of CVD risk factors of treated patients in the VACH cohort. The data collected includes: demographic variables, cigarette smoking, diabetes mellitus, hypertension, dyslipidemia, body mass index, stage of HIV-1 infection, and antiretroviral therapy. The analysis included 2358 patients. More than 18% of the study population was at an age of appreciable risk of CVD. 1.7% had previous CVD and 59.2% were smokers. Increased prevalence of elevated total cholesterol was observed among subjects receiving an NNRTI but no PI [odds ratio (OR), 3.34; 95% confidence interval (CI), 1.77-6.31], PI but no NNRTI (OR, 4.04; 95% CI, 2.12-7.71), or NNRTI + PI (OR, 17.77; 95% CI, 7.24-43.59) compared to patients treated only with nucleoside reverse transcriptase inhibitors (NRTI). Higher CD4 cell count, lower plasma HIV-1 RNA levels, clinical signs of lipodystrophy, longer exposure times to NNRTI and PI, and older age were all also associated with elevated cholesterol levels. The use of lipid lowering agents was very low among our patients. Patients in the VACH cohort present multiple known risk factors for CVD, and a very low rate of lipid lowering therapy use. NNRTI and/or PI-based antiretroviral therapies are associated with the worst lipid profile. This is more frequent in older subjects with greater CD4 counts and controlled HIV-1 replication.

Effect of sensory training of the posterior thigh on trunk control and upper extremity functions in stroke patients.

PubMed

Dogru Huzmeli, Esra; Yildirim, Sibel Aksu; Kilinc, Muhammed

2017-04-01

Some studies show that sensorial rehabilitation is effective on functionality. The aim of this study is to investigate the effect of sensory training of the posterior thigh on the functionality of upper extremity and trunk control in stroke patients. Thirteen subjects (53.23 ± 6.82 years) were included in the intervention group and 13 subjects (58.69 ± 5.94 years) in the control group. The control and intervention groups were treated for ten sessions. The control group was treated only with neurodevelopmental treatment, and the intervention group was treated with sensorial training on the posterior thigh in addition to the neurodevelopmental treatment. Subjects were evaluated three times, pre- and post-treatment and 10 days after finishing the treatment. Trunk control was assessed by the Trunk Impairment Scale, reaching function by the Functional Reach Test, balance by the Berg Balance Test, upper extremity symptom and disability severity by the Disabilities of the Arm, Shoulder, Hand and Minnesota, independence level in daily living activities by the Barthel Index, and sensory function of the posterior thigh by sensorial tests. In the post-treatment assessment, it was found that the intervention group was better than the control group in the parameter of functional reach while sitting (p < 0.005). In the third assessment, reaching while sitting and independence level were better in the intervention group than the control group (p < 0.005). There was no difference in sensorial assessment between the groups. Sensory training of the posterior thigh should be included in the rehabilitation programme of stroke patients.

Effect of ezetimibe on the prevalence of cholelithiasis.

PubMed

Stein, Assaf; Hermoni, Doron; Elis, Avishay; Konikoff, Fred M

2012-10-28

To investigate the prevalence of cholelithiasis among patients treated with ezetimibe. A retrospective, case-control study based on computerized medical records from patients of the Clalit Health Services, Sharon-Shomron region, from 2000 to 2009. Patients 20-85 years of age, who had been treated with ezetimibe and statins or statins only for at least 6 mo, and who had an abdominal ultrasound were included in the study. Collected data included age, gender, ezetimibe treatment duration, presence of hypothyroidism or diabetes, and existence of cholelithiasis as determined by ultrasound. Excluded were subjects after gallbladder resection, with hemolysis, myeloproliferative or inflammatory bowel diseases, and those treated with ursodeoxycholic acid and fibrates. Patients treated with statins and ezetimibe (study group) were compared to patients treated with statins only (control group). The study group included 25 patients and the control group 168. All patients in the study were treated with statins. The study group included 13 males (52%) and 12 females (48%), the control group 76 males (45%) and 92 (55%) females (P = 0.544). The groups did not differ in age (mean age: 68 ± 8 years, range 53-85 years vs mean age: 71 ± 8 years, range 51-85 years; P = 0.153) or in the rate of diabetic and hypothyroid patients [11 (44%) vs 57 (33%), P = 0.347 in the study group and 5 (20%) vs 23 (14%), P = 0.449 in the control group, respectively]. Patients in the study group were treated with ezetimibe for an average of 798 ± 379 d. Cholelithiasis was found in 4 (16%) patients in the study group and in 33 (20%) patients in the control group (P = 0.666). Ezetimibe does not appear to influence the prevalence of gallstones.

Antiretroviral drug resistance and phylogenetic diversity of HIV-1 in Chile.

PubMed

Ríos, Maritza; Delgado, Elena; Pérez-Alvarez, Lucía; Fernández, Jorge; Gálvez, Paula; de Parga, Elena Vázquez; Yung, Verónica; Thomson, Michael M; Nájera, Rafael

2007-06-01

This study reports the analysis of human immunodeficiency virus type 1 (HIV-1) protease (PR) and reverse transcriptase (RT) coding sequences from 136 HIV-1-infected subjects from Chile, 66 (49%) of them under antiretroviral (ARV) treatment. The prevalence of mutations conferring high or intermediate resistance levels to ARVs was 77% among treated patients and 2.5% among drug-naïve subjects. The distribution of resistance prevalence in treated patients by drug class was 61% to nucleoside RT inhibitors, 84% to nonnucleoside RT inhibitors, and 46% to PR inhibitors. Phylogenetic analysis revealed that 115 (85%) subjects were infected with subtype B viruses, 1 with a subtype F1 virus, and 20 (15%) carried BF intersubtype recombinants. Most BF recombinants grouped into two clusters, one related to CRF12_BF, while the other could represent a new circulating recombinant form (CRF). In conclusion, this is the first report analysing the prevalence of ARV resistance which includes patients under HAART from Chile. Additionally, phylogenetic analysis of the PR-RT coding sequences reveals the presence of BF intersubtype recombinants. (c) 2007 Wiley-Liss, Inc.

Nonspecific eating disorders - a subjective review.

PubMed

Michalska, Aneta; Szejko, Natalia; Jakubczyk, Andrzej; Wojnar, Marcin

2016-01-01

The aim of this paper was to characterise nonspecific eating disorders (other than anorexia nervosa and bulimia nervosa). The Medline database was searched for articles on nonspecific eating disorders. The following disorders were described: binge eating disorder (BED), pica, rumination disorder, avoidant/restrictive food intake disorder, night eating syndrome (NES), sleep-related eating disorder (SRED), bigorexia, orthorexia, focusing on diagnosis, symptoms, assessment, comorbidities, clinical implications and treatment. All of the included disorders may have dangerous consequences, both somatic and psychological. They are often comorbid with other psychiatric disorders. Approximately a few percent of general population can be diagnosed with each disorder, from 0.5-4.7% (SRED) to about 7% (orthorexia). With the growing literature on the subject and changes in DSM-5, clinicians recognise and treat those disorders more often. More studies have to be conducted in order to differentiate disorders and treat or prevent them appropriately.

Factors associated with falling in early, treated Parkinson's disease: The NET-PD LS1 cohort.

PubMed

Chou, Kelvin L; Elm, Jordan J; Wielinski, Catherine L; Simon, David K; Aminoff, Michael J; Christine, Chadwick W; Liang, Grace S; Hauser, Robert A; Sudarsky, Lewis; Umeh, Chizoba C; Voss, Tiffini; Juncos, Jorge; Fang, John Y; Boyd, James T; Bodis-Wollner, Ivan; Mari, Zoltan; Morgan, John C; Wills, Anne-Marie; Lee, Stephen L; Parashos, Sotirios A

2017-06-15

Recognizing the factors associated with falling in Parkinson's disease (PD) would improve identification of at-risk individuals. To examine frequency of falling and baseline characteristics associated with falling in PD using the National Institute of Neurological Disorders and Stroke (NINDS) Exploratory Trials in PD Long-term Study-1 (NET-PD LS-1) dataset. The LS-1 database included 1741 early treated PD subjects (median 4year follow-up). Baseline characteristics were tested for a univariate association with post-baseline falling during the trial. Significant variables were included in a multivariable logistic regression model. A separate analysis using a negative binomial model investigated baseline factors on fall rate. 728 subjects (42%) fell during the trial, including at baseline. A baseline history of falls was the factor most associated with post-baseline falling. Men had lower odds of post-baseline falling compared to women, but for men, the probability of a post-baseline fall increased with age such that after age 70, men and women had similar odds of falling. Other baseline factors associated with a post-baseline fall and increased fall rate included the Unified PD Rating Scale (UPDRS) Activities of Daily Living (ADL) score, total functional capacity (TFC), baseline ambulatory capacity score and dopamine agonist monotherapy. Falls are common in early treated PD. The biggest risk factor for falls in PD remains a history of falling. Measures of functional ability (UPDRS ADL, TFC) and ambulatory capacity are novel clinical risk factors needing further study. A significant age by sex interaction may help to explain why age has been an inconsistent risk factor for falls in PD. Copyright © 2017 Elsevier B.V. All rights reserved.

Addition of High-Dose Cytarabine to Fludarabine-Based Conditioning for Hematopoietic Stem Cell Transplantation for Treating Fanconi Anemia Patients with Advanced Myeloid Malignancy: A Single-Center Experience and Literature Review.

PubMed

Aoki, Takahiro; Koh, Katsuyoshi; Ikeda, Yuhachi; Sekinaka, Yujin; Akiyama, Kosuke; Mori, Makiko; Arakawa, Yuki; Hanada, Ryoji

2016-09-01

The complication of Fanconi anemia (FA) with acute leukemia is rare and challenging to treat because of high relapse rates, despite the improved outcome of hematopoietic stem cell transplantation with fludarabine-based conditioning for treating FA patients with hematological abnormalities. We added high-dose cytarabine to fludarabine-based conditioning to promote an enhanced antitumor effect and successfully subjected 4 patients with FA, including 3 with acute leukemia, to hematopoietic stem cell transplantation. All patients remain alive without treatment-related mortality or evidence of disease. Adding high-dose cytarabine to fludarabine-based conditioning may be tolerable and effective for treating FA patients with acute leukemia. Copyright © 2016 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis.

PubMed

Tonstad, Serena; Davies, Simon; Flammer, Martina; Russ, Cristina; Hughes, John

2010-04-01

Varenicline (Chantix), Champix) has shown efficacy and tolerability as an aid to smoking cessation. In postmarketing surveillance, neuropsychiatric symptoms have appeared; however, their incidence and causal relationship to varenicline is not known. We assessed the incidence and relative risk (RR) of psychiatric disorders in ten randomized, double-blind, placebo-controlled trials of varenicline for smoking cessation. All smoking cessation phase II, III and IV randomized controlled clinical trials of varenicline versus placebo completed as of 31 December 2008, on file with the manufacturer (Pfizer, Inc.), were included. All studies have been published. All 3091 participants who received at least one dose of varenicline and all 2005 participants who received placebo were included in this analysis. These were men and women smoking > or =10 cigarettes/day, aged 18-75 years and without current psychiatric disease who received varenicline or placebo for 6 (one study), 12 (eight studies) or 52 (one study) weeks. Adverse events were recorded at each study visit and classified according to standard Medical Dictionary for Regulatory Activities (MedDRA) terms (version 11.0). The incidence of psychiatric disorders other than solely sleep disorders and disturbances was 10.7% in subjects treated with varenicline and 9.7% in subjects treated with placebo, with an RR of 1.02 (95% CI 0.86, 1.22). The RRs (95% CI) versus placebo of psychiatric adverse events with an incidence > or =1% in the varenicline group were 0.86 (0.67, 1.12) for anxiety disorders and symptoms, 0.76 (0.42, 1.39) for changes in physical activity, 1.42 (0.96, 2.08) for depressed mood disorders and disturbances, 1.21 (0.79, 1.83) for mood disorders and disturbances not elsewhere classified and 1.70 (1.50, 1.92) for sleep disorders and disturbances. There were no cases of suicidal ideation or behaviour in varenicline-treated subjects in the ten placebo-controlled studies analysed. However, among three trials that were excluded from the analysis because of their open-label design, two cases of suicidal ideation and one completed suicide were reported in patients who had been treated with varenicline. With the exception of sleep disorders and disturbances, there was no evidence of dose-responsivity. There was no significant increase in overall psychiatric disorders, other than sleep disorders and disturbances, in varenicline-treated subjects in this sample of smokers without current psychiatric disorders. Ongoing studies are testing the use of varenicline in psychiatric patients.

Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder: A Double-Blind, Placebo-Controlled Trial.

PubMed

Phillips, Katharine A; Keshaviah, Aparna; Dougherty, Darin D; Stout, Robert L; Menard, William; Wilhelm, Sabine

2016-09-01

Body dysmorphic disorder is common, distressing, and often severely impairing. Serotonin reuptake inhibitors appear efficacious, but the few existing pharmacotherapy studies were short term (≤4 months), and no relapse prevention studies or continuation phase studies have been conducted to the authors' knowledge. The authors report results from the first relapse prevention study in body dysmorphic disorder. Adults (N=100) with DSM-IV body dysmorphic disorder received open-label escitalopram for 14 weeks (phase 1); 58 responders were then randomized to double-blind continuation treatment with escitalopram versus switch to placebo for 6 months (phase 2). Reliable and valid outcome measures were utilized. In phase 1, 67.0% of treated subjects and 81.1% of subjects who completed phase 1 responded to escitalopram. Body dysmorphic disorder severity (in both the intent-to-treat and the completer groups) and insight, depressive symptoms, psychosocial functioning, and quality of life significantly improved from baseline to end of phase 1. In phase 2, time to relapse was significantly longer with escitalopram than with placebo treatment (hazard ratio=2.72, 95% CI=1.01-8.57). Phase 2 relapse proportions were 18% for escitalopram and 40% for placebo. Among escitalopram-treated subjects, body dysmorphic disorder severity significantly decreased over time during the continuation phase, with 35.7% of subjects showing further improvement. There were no significant group differences in body dysmorphic disorder severity or insight, depressive symptoms, psychosocial functioning, or quality of life. Continuation-phase escitalopram delayed time to relapse, and fewer escitalopram-treated subjects relapsed than did placebo-treated subjects. Body dysmorphic disorder severity significantly improved during 6 additional months of escitalopram treatment following acute response; more than one-third of escitalopram-treated subjects experienced further improvement.

Photodynamic therapy using chlorophyll-a in the treatment of acne vulgaris: a randomized, single-blind, split-face study.

PubMed

Song, Byong Han; Lee, Dong Hun; Kim, Byung Chul; Ku, Sang Hyeon; Park, Eun Joo; Kwon, In Ho; Kim, Kwang Ho; Kim, Kwang Joong

2014-10-01

Chlorophyll-a is a novel photosensitizer recently tested for the treatment of acne vulgaris. We sought to evaluate the clinical efficacy and safety of chlorophyll-a photodynamic therapy used for acne treatment. Subjects with acne on both sides of the face were included. Eight treatment sessions were performed over a 4-week duration. Half of the face was irradiated using a blue and red light-emitting diode after topical application of chlorophyll-lipoid complex. The other half underwent only light-emitting diode phototherapy. The lesion counts and acne severity were assessed by a blinded examiner. Sebum secretion, safety, and histologic changes were also evaluated. In total, 24 subjects completed the study. Facial acne improved on both treated sides. On the chlorophyll-a photodynamic therapy-treated side, there were significant reductions in acne lesion counts, acne severity grades, and sebum levels compared with the side treated with light-emitting diode phototherapy alone. The side effects were tolerable in all the cases. All the subjects were of Asian descent with darker skin types, which may limit the generalizability of the study. A chlorophyll-a arm alone is absent, as is a no-treatment arm. We suggest that chlorophyll-a photodynamic therapy for the treatment of acne vulgaris can be effective and safe with minimal side effects. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Executive function impairment in early-treated PKU subjects with normal mental development.

PubMed

Leuzzi, V; Pansini, M; Sechi, E; Chiarotti, F; Carducci, Cl; Levi, G; Antonozzi, I

2004-01-01

Executive functions were studied in 14 early and continuously treated PKU subjects (age 10.8 years, range 8-13) in comparison with controls matched for IQ, sex, age and socioeconomic status. Brain MRI examination was normal in all PKU patients. Neuropsychological evaluation included Wisconsin Card Sorting Test, Rey-Osterreith Complex Figure Test, Elithorn's Perceptual Maze Test, Weigl's Sorting Test, Tower of London, Visual Search and Motor Motor Learning Test. Whatever the IQ, PKU subjects performed worse than controls in tests exploring executive functions. Subgrouping the PKU subjects according to the quality of dietary control for the entire follow-up period (using 400 micromol/L as cut-off value for blood phenylalanine (Phe) concentration) showed that patients with worse dietary control performed more poorly than both the PKU group with the best dietary control and the control group. However, a mild impairment of executive functions was still found in PKU patients with a good dietary control (Phe <400 micromol/L) compared to controls. Concerning the PKU group as a whole, no linear correlation was found between neuropsychological performance and historical and concurrent biochemical parameters. We conclude that (a) PKU patients, even when treated early, rigorously and continuously, show an impairment of frontal lobe functions; (b) a protracted exposure to moderately high levels of Phe can affect frontal lobe functions independently of the possible effect of the same exposure on IQ; (c) in order to reduce the risk of frontal lobe dysfunction, the target of dietary therapy should be to maintain blood Phe concentration below 400 micromol/L.

Conflicting interests, social justice and proxy consent to research.

PubMed

Pullman, Daryl

2002-10-01

Historically the primary role of the Institutional Review Board (IRB) has been "to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research" (U.S. FDA, 1996). However, there is much to suggest that IRBs have been unable to fulfil this mandate, particularly in regard to the matter of informed consent. Part of the problem in this regard is that the competing interests of other stakeholders often undermine the IRB's capacity to serve the best interests of research subjects. This paper proposes an alternative view of the role of the IRB. It begins by treating the interests of other stakeholders as legitimate matters of concern for IRBs. Hence the process established to review and monitor human research should be treated as an exercise in social justice in which the interests of all legitimate stakeholders must be represented and considered. A variation of Rawls' (1971) heuristic "the veil of ignorance" is employed to explore the dynamic relationship between knowledge and interests that ensues when the role of the IRB is characterized in this manner. Inadequacies in the informed consent process are taken as illustrative of the inability of IRBs as they are presently construed to attend to the interests of research subjects. The major normative implication of the analysis offered here is that the role of the IRB must be expanded to include the granting of a provisional proxy consent on behalf of prospective research subjects. This provision is necessary, it is argued, if the interests of research subjects are to be fairly assessed by IRBs as a matter of social justice. It is necessary as well to ensure that an adequate standard of informed consent is attained. Somewhat paradoxically it is argued that the interests of research subjects are better served when treated as one among a number of competing sets of interests the IRB must serve, rather than as the primary concern of the IRB.

Selective lateral laser thyroarytenoid myotomy for adductor spasmodic dysphonia.

PubMed

Hussain, A; Shakeel, M

2010-08-01

Selective lateral laser thyroarytenoid myotomy is a conceptually sound, simple, minimally invasive, repeatable and predictable new surgical procedure for treating adductor spasmodic dysphonia. This paper aims to introduce and describe the surgical technique, and to present a clinical case series and its outcomes. A prospective, clinical case series treated with selective lateral laser thyroarytenoid myotomy, with follow up of 2.5 years. Pre- and post-operative data were collected prospectively for patients undergoing selective lateral laser thyroarytenoid myotomy. These data included patient demographics, previous interventions for adductor spasmodic dysphonia, technical aspects of surgery and clinical outcome. Outcome data included clinical assessment, voice handicap index, need for further intervention, and patient satisfaction assessed by subjective improvement (detailed subjectively by the patients themselves and objectively using the Glasgow benefit inventory). Four patients (two men and two women; mean age 65 years; age range 41-80 years) were included. The mean duration of adductor spasmodic dysphonia was 11 years. All patients had previously been treated with botulinum toxin A. All patients reported improvement in voice quality, fluency, sustainability and elimination of voice breaks over 2.5 years' follow up. Clinical assessment revealed no alteration in mucosal wave, and complete relief of hyperadduction was observed on phonation. No patients required supplementary botulinum toxin treatment during follow up. Selective lateral laser thyroarytenoid myotomy seems to represent a curative procedure for adductor spasmodic dysphonia, a chronic, debilitating condition. This procedure is conceptually simple, minimally invasive and repeatable. It also seems to offer a safe and lasting alternative to botulinum toxin therapy.

Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy.

PubMed

Kereiakes, Dean J; Yeh, Robert W; Massaro, Joseph M; Driscoll-Shempp, Priscilla; Cutlip, Donald E; Steg, P Gabriel; Gershlick, Anthony H; Darius, Harald; Meredith, Ian T; Ormiston, John; Tanguay, Jean-François; Windecker, Stephan; Garratt, Kirk N; Kandzari, David E; Lee, David P; Simon, Daniel I; Iancu, Adrian Corneliu; Trebacz, Jaroslaw; Mauri, Laura

2015-10-01

This study sought to compare rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE) (composite of death, myocardial infarction, or stroke) after coronary stenting with drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who participated in the DAPT (Dual Antiplatelet Therapy) study, an international multicenter randomized trial comparing 30 versus 12 months of dual antiplatelet therapy in subjects undergoing coronary stenting with either DES or BMS. Despite antirestenotic efficacy of coronary DES compared with BMS, the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Many clinicians perceive BMS to be associated with fewer adverse ischemic events and to require shorter-duration dual antiplatelet therapy than DES. Prospective propensity-matched analysis of subjects enrolled into a randomized trial of dual antiplatelet therapy duration was performed. DES- and BMS-treated subjects were propensity-score matched in a many-to-one fashion. The study design was observational for all subjects 0 to 12 months following stenting. A subset of eligible subjects without major ischemic or bleeding events were randomized at 12 months to continued thienopyridine versus placebo; all subjects were followed through 33 months. Among 10,026 propensity-matched subjects, DES-treated subjects (n = 8,308) had a lower rate of stent thrombosis through 33 months compared with BMS-treated subjects (n = 1,718, 1.7% vs. 2.6%; weighted risk difference -1.1%, p = 0.01) and a noninferior rate of MACCE (11.4% vs. 13.2%, respectively, weighted risk difference -1.8%, p = 0.053, noninferiority p < 0.001). DES-treated subjects have long-term rates of stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT00977938). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Trends in population blood pressure and determinant factors for population blood pressure.

PubMed

Andersen, Ulla Overgaard

2017-03-01

Strategies to reduce the burden of blood pressure attributable diseases require knowledge of secular trend in PBP and its determinants. The issues were investigated in the Copenhagen City Heart Study. The design of CCHS is a repeated measures study. Such designs are uniquely suited to studying changes of an outcome and what risk factors may be associated with that outcome. Repeated measures studies are very well suited for trend analysis by using mixed effect analyses. SBP decreased about 2 mmHg in 25 years. The risk factors age, gender and BMI were found valid as determinant factors for secular trends in SBP. In addition, the following factors were identified: household income and the interactions ''gender*age'' and ''survey*age''. The interaction ''gender*age'' stated that the difference between SBP in the two genders was great in the young individuals and diminished by age. The interaction ''survey*age'' stated that SBP in the young individuals decreased more with survey than SBP in the older individuals. Thus, the 20 years old subjects in survey 2, 3 and 4 have lower SBP than the 20 years old subjects in preceding surveys. The slopes were less steep in higher ages. In the group of elderly and old subjects the trend is partly explained by treatment bias because more and more subjects leave the untreated group and start treatment. The factor ''household income'' was significant only in the female population and stated that high-income women had lower SBP and a more beneficial secular trend in SBP than low-income women. Marital status, self-reported physical exercise and alcohol intake were not significant factors. A number of factors, that are interesting in relation to SBP, were not included in the CCHS and therefore not investigated. Among them are salt intake, childhood factors, genetic factors and the DASH diet. A survival study was performed to investigate the mortality rate in relation to SBP changes during the observation period. A Cox regression analysis was used in this study. The survival study demonstrated that SBP was a significant variable in survival models for all age groups. There was a decrease in mortality rate in young to middle-aged individuals. The mortality rate that is associated with a particular value of SBP did not change. Thus, it was concluded that SBP was as dangerous as it has always been and that the reduction in mortality rate was most pronounced in the age classes that also experienced the greatest reduction in blood pressure. During the observation period the number of treated individuals in the population increased from 6.5% to 18.1%. About 50% of the population was hypertensive (SBP ≥ 140 mmHg or treated with antihypertensive medication). The value of SBPtreated was used as an indicator for hypertension control in the treated population. Hypertension control is a collection of topics that includes guidelines, available medicine, physicians attitude towards hypertension treatment, systematic control, patient awareness and patient compliance. The analysis of trends in SPB in treated hypertensives showed that SBP treated decreased 9.2 mmHg in 25 years. The result may be ascribed to improvements in treatment but may also be caused by a change in start-to-treat practice: If hypertensives start treatment at an increasingly lower SBP threshold then SBP treated will decrease without improvements in treatment. Therefore the start-to-treat practice was evaluated by SBP threshold . A change in SBP threshold was not observed. Thus, the 9.2 mmHg decrease in SBP treated may represent improvements in treatment. ''Age'' was a significant factor for SBP treated . This result demonstrated that elderly and old individuals were treated less successful than young and middle-aged individuals. Subjects diagnosed with ischemic heart disease constitute a group with a more advantageous slope than subjects with other diagnoses (stroke, IHD in combination with stroke, and hypertension alone). Self-reported physical exercise, gender, alcohol intake, household income and family structure were not significant as variables in the decreasing SBP among treated hypertensives. Thus, the papers in this thesis described SBP trends in the untreated and in the treated part of a population. Different patient-related factors were identified as determinant factors for trends in the two groups. The determinant factors are the explanatory variables most associated with trends in SBP. The determinant factors were different for the two groups (except for age).

Management of Patient Experience With ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat.

PubMed

Dover, Jeffrey S; Kenkel, Jeffrey M; Carruthers, Alastair; Lizzul, Paul F; Gross, Todd M; Subramanian, Meenakshi; Beddingfield, Frederick C

2016-11-01

ATX-101 (deoxycholic acid injection; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was recently approved for submental fat (SMF) reduction in the United States (Kybella) and Canada (Belkyra). The pivotal trials supporting these approvals revealed that ATX-101 is associated with common injection-site treatment reactions consistent with its mechanism of action and administration procedure. The purpose of this study was to evaluate 4 patient experience management paradigms targeting the common injection-site adverse events of pain, swelling/edema, and bruising after a single treatment session with ATX-101. In this double-blind, parallel-group, exploratory Phase 3b study (ClinicalTrials.gov identifier: NCT02007434), subjects with moderate to severe SMF were randomized 4:1 within each paradigm to receive ATX-101 2 mg/cm or placebo. In Paradigm 1, subjects received a cold pack application to the treatment area. In Paradigm 2, in addition to cold pack application, subjects were treated with topical lidocaine and injectable lidocaine containing epinephrine. In Paradigm 3, in addition to the interventions of Paradigm 2, subjects received loratadine and ibuprofen. Subjects in Paradigm 4 received the same interventions in Paradigm 3, plus application of a chin strap. Eighty-three subjects were treated. In ATX-101-treated subjects, peak pain occurred within 1 to 5 minutes of treatment, with median values at these time points ranging from 21.4 to 35.7 mm on a 100-mm pain visual analog scale ("mild"). Pain ratings reduced substantially by 15 minutes; at 4 hours after injection, pain was characterized as mild tenderness or mild achiness. Compared with cold alone, treatment with topical and injectable lidocaine reduced median peak pain by 17%. Addition of ibuprofen and loratadine resulted in a total reduction in pain by 40%. Peak swelling/edema in ATX-101-treated subjects was "modest," with mean values ≤1.7 (on a 0-5 scale) across all paradigms. Swelling/edema was not substantially mitigated by the interventions, including ibuprofen, loratidine, and the use of a chin strap. Bruising associated with ATX-101 treatment was confined to the treatment area, with mean values between 1.0 and 1.4 on a 0-to-5 scale. Bruising was modestly reduced by injectable lidocaine with epinephrine. Results from this study support the safety of ATX-101 for SMF reduction, and demonstrate that pain and bruising associated with ATX-101 treatment can be mitigated by a series of simple measures.

Use of respiratory medication in five Latin American cities: The PLATINO study.

PubMed

Montes de Oca, Maria; Tálamo, Carlos; Perez-Padilla, Rogelio; Lopez, Maria Victorina; Muiño, Adriana; Jardim, José Roberto B; Valdivia, Gonzalo; Pertuzé, Julio; Moreno, Dolores; Halbert, Ronald J; Menezes, Ana Maria B

2008-10-01

There is scanty information regarding respiratory medication prescription pattern in Latin America. We examined the use of bronchodilators and corticosteroids in a population-based study conducted in five Latin American cities. Medication use was derived from questions regarding the use of medication "to help breathing" within the previous 12 months, type of medicine, and frequency of use. To minimize the possibility of overdiagnosis, we used postbronchodilator FEV(1)/FVC<0.70 plus FEV(1)<80% as the definition of obstruction. Interviews were completed in 5571 subjects from 6711 eligible individuals, and spirometry was performed in 5314 subjects. There were 360 (6.5%) treated subjects and 5211 not treated. Treated subjects were more likely to be older, women, unemployed, have higher tobacco consumption, higher body mass index, higher FEV(1) reversibility and airway obstruction. They were also more likely to report prior spirometry, prior diagnosis of COPD, asthma or tuberculosis, and more respiratory symptoms. Over half of treated subjects had neither obstruction nor FEV(1) reversibility, and approximately 30% reported no prior diagnosis of asthma or COPD. Prior respiratory diagnoses and wheezing were more strongly associated with treatment than objective measures of airway obstruction. The use of bronchodilators and/or corticosteroids is common in the general population aged 40 years or older, with over one-half of treated subjects using them without being obstructed.

Remote Sensing Applied to Geology (Latest Citations from the Aerospace Database)

NASA Technical Reports Server (NTRS)

1996-01-01

The bibliography contains citations concerning the use of remote sensing in geological resource exploration. Technologies discussed include thermal, optical, photographic, and electronic imaging using ground-based, aerial, and satellite-borne devices. Analog and digital techniques to locate, classify, and assess geophysical features, structures, and resources are also covered. Application of remote sensing to petroleum and minerals exploration is treated in a separate bibliography. (Contains 50-250 citations and includes a subject term index and title list.)

A 1-year multicenter randomized double-blind comparison of repaglinide and glyburide for the treatment of type 2 diabetes. Dutch and German Repaglinide Study Group.

PubMed

Wolffenbuttel, B H; Landgraf, R

1999-03-01

Repaglinide is a newly developed oral blood glucose-lowering agent that exerts its effect by stimulating insulin secretion. This multicenter study was designed to compare the efficacy and safety of this drug with glyburide in a 1-year randomized double-blind study of outpatients with type 2 diabetes. A total of 424 subjects (154 women, 270 men) participated and had the following characteristics: age, 61 +/- 9 years; duration of diabetes. 8 years (range 0.5-35); BMI, 28.3 +/- 3.5 kg/m2; HbA1c, 7.1 +/- 1.4%; and fasting plasma glucose, 10.8 +/- 3.1 mmol/l. The majority of the subjects (91%) were previously treated with sulfonylurea, alone or in combination with metformin. The patients were randomized to a 2:1 ratio of repaglinide (0.5-4 mg t.i.d.) or glyburide (1.75-10.5 mg daily) treatment. The study protocol included a screening visit to assess patient eligibility; a titration period of 6-8 weeks, during which the dosages of repaglinide and glyburide were optimized; and a subsequent 12-month treatment period on fixed, optimal dosages. The trial was completed by 320 subjects, 211 (74%) in the repaglinide and 109 (78%) in the glyburide group. HbA1c initially decreased in both groups and then increased during the second half-year of the maintenance period to a similar extent in the repaglinide and glyburide subjects (0.58 and 0.45% vs. at screening, respectively). In the small group of subjects who previously controlled their condition with diet only (n = 37), a sustained improvement of metabolic control could be observed with both drugs, which was slightly better with glyburide than with repaglinide (theta HbA1c -2.4 vs. -1.0%; P < 0.05). The same trends were seen with fasting plasma glucose. There were no changes in serum lipids. Over the course of the study, 15% of the repaglinide-treated and 13% of glyburide-treated subjects withdrew due to adverse events, mostly hyperglycemia. No differences in adverse events between both drugs were reported. There were no differences in incidences of hypoglycemia. Repaglinide is a safe and efficacious oral blood glucose-lowering agent, with a potency similar to that of glyburide. Its rapid onset of action and hepatic clearance allows meal-related administration, including in subjects with impaired kidney function.

Gait symmetry and hip strength in women with developmental dysplasia following hip arthroplasty compared to healthy subjects: A cross-sectional study.

PubMed

Leijendekkers, Ruud A; Marra, Marco A; Kolk, Sjoerd; van Bon, Geert; Schreurs, B Wim; Weerdesteyn, Vivian; Verdonschot, Nico

2018-01-01

Untreated unilateral developmental dysplasia of the hip (DDH) results in asymmetry of gait and hip strength and may lead to early osteoarthritis, which is commonly treated with a total hip arthroplasty (THA). There is limited knowledge about the obtained symmetry of gait and hip strength after the THA. The objectives of this cross-sectional study were to: a) identify asymmetries between the operated and non-operated side in kinematics, kinetics and hip strength, b) analyze if increased walking speed changed the level of asymmetry in patients c) compare these results with those of healthy subjects. Women (18-70 year) with unilateral DDH who had undergone unilateral THA were eligible for inclusion. Vicon gait analysis system was used to collect frontal and sagittal plane kinematic and kinetic parameters of the hip joint, pelvis and trunk during walking at comfortable walking speed and increased walking speed. Furthermore, hip abductor and extensor muscle strength was measured. Six patients and eight healthy subjects were included. In the patients, modest asymmetries in lower limb kinematics and kinetics were present during gait, but trunk lateral flexion asymmetry was evident. Patients' trunk lateral flexion also differed compared to healthy subjects. Walking speed did not significantly influence the level of asymmetry. The hip abduction strength asymmetry of 23% was not statistically significant, but the muscle strength of both sides were significantly weaker than those of healthy subjects. In patients with a DDH treated with an IBG THA modest asymmetries in gait kinematics and kinetics were present, with the exception of a substantial asymmetry of the trunk lateral flexion. Increased walking speed did not result in increased asymmetries in gait kinematics and kinetics. Hip muscle strength was symmetrical in patients, but significantly weaker than in healthy subjects. Trunk kinematics should be included as an outcome measure to assess the biomechanical benefits of the THA surgery after DDH.

Psyllium fiber improves glycemic control proportional to loss of glycemic control: a meta-analysis of data in euglycemic subjects, patients at risk of type 2 diabetes mellitus, and patients being treated for type 2 diabetes mellitus.

PubMed

Gibb, Roger D; McRorie, Johnson W; Russell, Darrell A; Hasselblad, Vic; D'Alessio, David A

2015-12-01

A number of health benefits are associated with intake of soluble, viscous, gel-forming fibers, including reduced serum cholesterol and the attenuation of postprandial glucose excursions. We assess the effects of psyllium, which is a soluble, gel-forming, nonfermented fiber supplement, on glycemic control in patients who were being treated for type 2 diabetes mellitus (T2DM) and in patients who were at risk of developing T2DM. A comprehensive search was performed of available published literature (Scopus scientific database) and clinical records stored by Procter & Gamble with the use of key search terms to identify clinical studies that assessed the glycemic effects of psyllium in nondiabetic, pre-T2DM, and T2DM patients. We identified 35 randomized, controlled, clinical studies that spanned 3 decades and 3 continents. These data were assessed in 8 meta-analyses. In patients with T2DM, multiweek studies (psyllium dosed before meals) showed significant improvement in both the fasting blood glucose (FBG) concentration (-37.0 mg/dL; P < 0.001) and glycated hemoglobin (HbA1c) [-0.97% (-10.6 mmol/mol); P = 0.048]. Glycemic effects were proportional to baseline FBG; no significant glucose lowering was observed in euglycemic subjects, a modest improvement was observed in subjects with pre-T2DM, and the greatest improvement was observed in subjects who were being treated for T2DM. These data indicate that psyllium would be an effective addition to a lifestyle-intervention program. The degree of psyllium's glycemic benefit was commensurate with the loss of glycemic control. Because the greatest effect was seen in patients who were being treated for T2DM, additional studies are needed to determine how best to incorporate psyllium into existing prevention and treatment algorithms with concomitant hypoglycemic medications. © 2015 American Society for Nutrition.

Excimer laser calibration system.

PubMed

Gottsch, J D; Rencs, E V; Cambier, J L; Hall, D; Azar, D T; Stark, W J

1996-01-01

Excimer laser photoablation for refractive and therapeutic keratectomies has been demonstrated to be feasible and practicable. However, corneal laser ablations are not without problems, including the delivery and maintenance of a homogeneous beam. We have developed an excimer laser calibration system capable of characterizing a laser ablation profile. Beam homogeneity is determined by the analysis of a polymethylmethacrylate (PMMA)-based thin-film using video capture and image processing. The ablation profile is presented as a color-coded map. Interpolation of excimer calibration system analysis provides a three-dimensional representation of elevation profiles that correlates with two-dimensional scanning profilometry. Excimer calibration analysis was performed before treating a monkey undergoing phototherapeutic keratectomy and two human subjects undergoing myopic spherocylindrical photorefractive keratectomy. Excimer calibration analysis was performed before and after laser refurbishing. Laser ablation profiles in PMMA are resolved by the excimer calibration system to .006 microns/pulse. Correlations with ablative patterns in a monkey cornea were demonstrated with preoperative and postoperative keratometry using corneal topography, and two human subjects using video-keratography. Excimer calibration analysis predicted a central-steep-island ablative pattern with the VISX Twenty/Twenty laser, which was confirmed by corneal topography immediately postoperatively and at 1 week after reepithelialization in the monkey. Predicted central steep islands in the two human subjects were confirmed by video-keratography at 1 week and at 1 month. Subsequent technical refurbishing of the laser resulted in a beam with an overall increased ablation rate measured as microns/pulse with a donut ablation profile. A patient treated after repair of the laser electrodes demonstrated no central island. This excimer laser calibration system can precisely detect laser-beam ablation profiles. The calibration system correctly predicted central islands after excimer photoablation in a treated monkey cornea and in two treated human subjects. Detection of excimer-laser-beam ablation profiles may be useful for precise calibration of excimer lasers before human photorefractive and therapeutic surgery.

The effect of testosterone on cardiometabolic risk factors in atorvastatin-treated men with late-onset hypogonadism.

PubMed

Krysiak, Robert; Gilowski, Wojciech; Okopień, Bogusław

2016-02-01

By reducing LDL cholesterol levels, statins may decrease androgen production. This study was aimed at investigating whether testosterone treatment has an impact on cardiometabolic risk factors in statin-treated men with late-onset hypogonadism (LOH). The study included 31 men with LOH who had been treated for at least 6 months with atorvastatin (20-40mg daily). On the basis of patient preference, atorvastatin-treated patients were divided into two matched groups of patients: receiving intramuscular testosterone enanthate (100mg weekly, n=16) and not treated with this hormone (n=15). Plasma lipids, glucose homeostasis markers, as well as plasma levels of androgens, uric acid, high-sensitivity C-reactive protein (hsCRP), homocysteine, and fibrinogen were assessed before and after 4 months of therapy. Compared with the control age-, weight, and lipid-matched statin-naïve subjects with LOH (n=12), atorvastatin-treated patients were characterized by decreased levels of testosterone, hsCRP, and homocysteine. In patients not receiving testosterone therapy, plasma lipids, glucose homeostasis markers, as well as plasma levels of the investigated risk factors remained at the similar levels throughout the whole period of atorvastatin treatment. In atorvastatin-naïve patients, testosterone increased its plasma levels and decreased HDL cholesterol. Apart from an increase in testosterone levels, if administered to atorvastatin-treated subjects with LOH, testosterone reduced plasma levels of LDL cholesterol, uric acid, hsCRP, homocysteine, and fibrinogen, as well as improved insulin sensitivity. Our study may suggest the clinical benefits associated with combination therapy with a statin and testosterone in elderly men with LOH. Copyright © 2015 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Eculizumab for Dense Deposit Disease and C3 Glomerulonephritis

PubMed Central

Smith, Richard J.; Barile, Gaetano R.; Zhang, Yuzhou; Heher, Eliot C.; Herlitz, Leal; Stokes, M. Barry; Markowitz, Glen S.; D’Agati, Vivette D.; Canetta, Pietro A.; Radhakrishnan, Jai; Appel, Gerald B.

2012-01-01

Summary Background and objectives The principle defect in dense deposit disease and C3 glomerulonephritis is hyperactivity of the alternative complement pathway. Eculizumab, a monoclonal antibody that binds to C5 to prevent formation of the membrane attack complex, may prove beneficial. Design, setting, participants, & measurements In this open-label, proof of concept efficacy and safety study, six subjects with dense deposit disease or C3 glomerulonephritis were treated with eculizumab every other week for 1 year. All had proteinuria >1 g/d and/or AKI at enrollment. Subjects underwent biopsy before enrollment and repeat biopsy at the 1-year mark. Results The subjects included three patients with dense deposit disease (including one patient with recurrent dense deposit disease in allograft) and three patients with C3 glomerulonephritis (including two patients with recurrent C3 glomerulonephritis in allograft). Genetic and complement function testing revealed a mutation in CFH and MCP in one subject each, C3 nephritic factor in three subjects, and elevated levels of serum membrane attack complex in three subjects. After 12 months, two subjects showed significantly reduced serum creatinine, one subject achieved marked reduction in proteinuria, and one subject had stable laboratory parameters but histopathologic improvements. Elevated serum membrane attack complex levels normalized on therapy and paralleled improvements in creatinine and proteinuria. Conclusions Clinical and histopathologic data suggest a response to eculizumab in some but not all subjects with dense deposit disease and C3 glomerulonephritis. Elevation of serum membrane attack complex before treatment may predict response. Additional research is needed to define the subgroup of dense deposit disease/C3 glomerulonephritis patients in whom eculizumab therapy can be considered. PMID:22403278

Demographic Characteristics, Phenomenology, Comorbidity, and Family History in 200 Individuals With Body Dysmorphic Disorder

PubMed Central

Phillips, Katharine A.; Menard, William; Fay, Christina; Weisberg, Risa

2005-01-01

The authors examined characteristics of body dysmorphic disorder in the largest sample for which a wide range of clinical features has been reported. The authors also compared psychiatrically treated and untreated subjects. Body dysmorphic disorder usually began during adolescence, involved numerous body areas and behaviors, and was characterized by poor insight, high comorbidity rates, and high rates of functional impairment, suicidal ideation, and suicide attempts. There were far more similarities than differences between the currently treated and untreated subjects, although the treated subjects displayed better insight and had more comorbidity. PMID:16000674

Self-esteem evaluation in children and adolescents suffering from ADHD.

PubMed

Mazzone, Luigi; Postorino, Valentina; Reale, Laura; Guarnera, Manuela; Mannino, Valeria; Armando, Marco; Fatta, Laura; De Peppo, Lavinia; Vicari, Stefano

2013-01-01

Several recent studies investigated the relationship between self-esteem and ADHD, however, the results are still controversial. In the present study we analyze the characteristics of self-esteem in a sample of children and adolescents suffering from ADHD, with a particular focus on the relationship between ADHD symptoms severity and treatment strategies. A total of 85 patients with ADHD (44 drug-free and 41 drug-treated, 23 of which atomoxetine-treated and 18 Methylphenidate-treated) and 26 healthy controls were enrolled in the study in order to evaluate self-esteem using the Self-esteem Multidimensional Test (TMA). ADHD subjects revealed lower scores on all self-esteem domains compared to controls. Both ADHD drug-free (47.1%) and ADHD drug-treated (44.1%) groups showed significantly higher rates of subjects in the pathological range as compared to normal control group (8.8%) (p <.001) with a higher percentage of subjects in the pathological range. Among ADHD drug-treated subjects, the methylphenidate group showed higher self-esteem scores as compared to the atomoxetine group. A lower self-esteem profile is more common in subjects suffering from ADHD than in healthy controls, suggesting the importance of an early detection of psychological well-being in these children in order to reduce the ADHD symptoms long-term impacts.

Self-Esteem Evaluation in Children and Adolescents Suffering from ADHD

PubMed Central

Mazzone, Luigi; Postorino, Valentina; Reale, Laura; Guarnera, Manuela; Mannino, Valeria; Armando, Marco; Fatta, Laura; De Peppo, Lavinia; Vicari, Stefano

2013-01-01

Background: Several recent studies investigated the relationship between self-esteem and ADHD, however, the results are still controversial. In the present study we analyze the characteristics of self-esteem in a sample of children and adolescents suffering from ADHD, with a particular focus on the relationship between ADHD symptoms severity and treatment strategies. Methods: A total of 85 patients with ADHD (44 drug-free and 41 drug-treated, 23 of which atomoxetine-treated and 18 Methylphenidate-treated) and 26 healthy controls were enrolled in the study in order to evaluate self-esteem using the Self-esteem Multidimensional Test (TMA). Results: ADHD subjects revealed lower scores on all self-esteem domains compared to controls. Both ADHD drug-free (47.1%) and ADHD drug-treated (44.1%) groups showed significantly higher rates of subjects in the pathological range as compared to normal control group (8.8%) (p <.001) with a higher percentage of subjects in the pathological range. Among ADHD drug-treated subjects, the methylphenidate group showed higher self-esteem scores as compared to the atomoxetine group. Conclusion: A lower self-esteem profile is more common in subjects suffering from ADHD than in healthy controls, suggesting the importance of an early detection of psychological well-being in these children in order to reduce the ADHD symptoms long-term impacts. PMID:23878614

Processing of whey modulates proliferative and immune functions in intestinal epithelial cells.

PubMed

Nguyen, Duc Ninh; Sangild, Per T; Li, Yanqi; Bering, Stine B; Chatterton, Dereck E W

2016-02-01

Whey protein concentrate (WPC) is often subjected to heat treatment during industrial processing, resulting in protein denaturation and loss of protein bioactivity. We hypothesized that WPC samples subjected to different degrees of thermal processing are associated with different levels of bioactive proteins and effects on proliferation and immune response in intestinal epithelial cells (IEC). The results showed that low-heat-treated WPC had elevated levels of lactoferrin and transforming growth factor-β2 compared with that of standard WPC. The level of aggregates depended on the source of whey, with the lowest level being found in WPC derived from acid whey. Following acid activation, WPC from acid whey enhanced IEC proliferation compared with WPC from sweet whey or nonactivated WPC. Low-heat-treated WPC from acid whey induced greater secretion of IL-8 in IEC than either standard WPC from acid whey or low-heat-treated WPC from sweet whey. Following acid activation (to activate growth factors), low-heat-treated WPC from sweet whey induced higher IL-8 levels in IEC compared with standard WPC from sweet whey. In conclusion, higher levels of bioactive proteins in low-heat-treated WPC, especially from acid whey, may enhance proliferation and cytokine responses of IEC. These considerations could be important to maintain optimal bioactivity of infant formulas, including their maturational and immunological effects on the developing intestine. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

The Effect of the Association between Donepezil and Choline Alphoscerate on Behavioral Disturbances in Alzheimer's Disease: Interim Results of the ASCOMALVA Trial.

PubMed

Carotenuto, Anna; Rea, Raffaele; Traini, Enea; Fasanaro, Angiola Maria; Ricci, Giovanna; Manzo, Valentino; Amenta, Francesco

2017-01-01

Behavioral and psychological symptoms of dementia (BPSD) are a group of psychological reactions, psychiatric symptoms, and behaviors commonly found in Alzheimer's disease (AD). Four clusters of BPSD have been described: mood disorders (depression, anxiety, and apathy), psychotic symptoms (delusions and hallucinations), aberrant motor behaviors (pacing, wandering, and other purposeless behaviors), and inappropriate behaviors (agitation, disinhibition, and euphoria). Most of them are attributed to acetylcholine deficiency. To evaluate if a higher amount of acetylcholine obtained by associating donepezil and choline alphoscerate might have a favorable effect on BPSD. BPSD were measured at baseline and after 24 months in 113 mild/moderate AD patients, included in the double-blind randomized trial ASCOMALVA, by the Neuropsychiatric Inventory (NPI). Two matched groups were compared: group A treated with donepezil (10 mg/day) plus choline alphoscerate (1200 mg/day), and group B treated with donepezil (10 mg/day) plus placebo. Data of NPI revealed a significant decrease of BPSD severity and distress of the caregiver in patients of group A compared with group B. Mood disorders (depression, anxiety and apathy) were significantly decreased in subjects treated with donepezil and choline alphoscerate, while their severity and frequency was increased in the other group. Patients treated with donepezil plus choline alphoscerate showed a lower level of behavioral disturbances than subjects treated with donepezil only, suggesting that the association can have beneficial effects.

Safety and effectiveness of hyaluronic acid fillers in skin of color.

PubMed

Grimes, Pearl E; Thomas, Jane A; Murphy, Diane K

2009-09-01

To assess the safety and effectiveness of hyaluronic acid (HA) fillers in skin of color. Two prospective studies followed up subjects with Fitzpatrick skin phototypes of IV, V, or VI for 24 weeks after dermal filler injections. In a double-blind, randomized study, subjects were injected with one of three high concentration (24 mg/mL) HA fillers (Juvéderm Ultra, Ultra Plus, and 30) in one nasolabial fold and Zyplast collagen in the other. In an open-label, randomized study, subjects received one of three low concentration (5.5 mg/mL) HA fillers (Hylaform, Hylaform Plus, and Captique) in both nasolabial folds. A total of 160 subjects (a subset of 439 study subjects) were randomized and treated with one of the three high concentration fillers, and 119 subjects were randomized and treated with one of the three low concentration fillers. For subjects treated with the high concentration fillers there were no occurrences of hypersensitivity or hypertrophic scarring, and no increased incidence of hyperpigmentation or hypopigmentation in non-Caucasian vs. Caucasian subjects. For subjects treated with the low concentration fillers there were no occurrences of keloid formation, hypertrophic scarring, hypopigmentation, hypersensitivity, and three instances of mild hyperpigmentation. For all of the fillers the majority of subjects maintained >/=1 point improvement in nasolabial fold severity scores through 24 weeks. All of the HA fillers were well tolerated in individuals with skin of color and demonstrated effectiveness throughout the 24 week period. Furthermore, the fillers provided smooth, natural-looking wrinkle correction in darker skin types.

THE USE OF TRIGGER POINT DRY NEEDLING AND INTRAMUSCULAR ELECTRICAL STIMULATION FOR A SUBJECT WITH CHRONIC LOW BACK PAIN: A CASE REPORT

PubMed Central

2013-01-01

Study Design: Case Report. Background and Purpose: Myofascial trigger points (MTrPs) are widely accepted by clinicians and researchers as a primary source of regional neuromusculoskeletal pain. Trigger point dry needling (TrP‐DN) is an invasive procedure that involves stimulation of MTrPs using an monofilament needle. The purpose of this case report is to report the outcomes of TrP‐DN and intramuscular electrical stimulation (IES) as a primary treatment intervention in a subject with chronic low back pain. Case Description: The subject was a 30‐year‐old female, active duty military, who was referred to physical therapy for low back and right posterolateral hip pain. She noticed symptoms after suffering a lumbar flexion injury while picking up a barbell during weight training. Physical examination demonstrated findings that supported the diagnosis of lumbar segmental instability with a right hip stability dysfunction. Objective findings included a multi‐segmental flexion movement pattern dysfunction and MTrPs in the right gluteus maximus and gluteus medius muscles with deep palpation. The subject was treated with TrP‐DN and IES for a total of two visits. Bilateral L3 and L5 multifidus and right gluteus maximus and medius muscles were treated, along with implementing a home exercise program consisting of core stability exercises. Outcomes: The subject reported no existing pain and disability on the Numerical Pain Rating Scale and Oswestry Disability Questionnaire and a large perceived change in recovery on the Global Rating of Change at final follow‐up. Physical examination was normal, demonstrating no observed impairments or functional limitations, including normal multi‐segmental flexion and no MTrPs with deep palpation. Discussion: The subject was able to return to full military active duty without any physical limitations and resumed pre‐injury activity levels, including the ability to resume all activities without pain. There is much promise regarding the use of TrP‐DN with IES intervention for the treatment of lumbar and/or hip stability dysfunction. Future research is recommended to determine if TrP‐DN intervention, with and without IES, is effective for other body regions and long‐term subject outcomes. Level of Evidence: Level 4. PMID:23593553

Perceived relaxation as a function of restorative yoga combined with Reiki for cancer survivors.

PubMed

DiScipio, William J

2016-08-01

Twenty-six cancer survivor volunteers participated in a study of the efficacy of perceived relaxation after performing restorative yoga combined with Reiki. Subjects scoring high ratings of Meaning and Peace in life demonstrated greater perception of depth of relaxation. A comparison of subjects receiving concurrent Reiki (19) and restorative yoga with those who only received restorative yoga (7) showed that Reiki subjects experienced greater perceived depth of relaxation than subjects who were not afforded the Reiki intervention. Non-Reiki participants also showed more difficulty overcoming intrusive fearful thoughts than the Reiki group. Clinical implications suggest that patients should be screened and treated for trauma-like symptoms including intrusive thoughts linked to anxiety and depression before referral to complementary programs that offer meditative or relaxation interventions. Copyright © 2016 Elsevier Ltd. All rights reserved.

Impact of bromocriptine-QR therapy on cardiovascular outcomes in type 2 diabetes mellitus subjects on metformin.

PubMed

Chamarthi, Bindu; Ezrokhi, Michael; Rutty, Dean; Cincotta, Anthony H

2016-11-01

Type 2 diabetes mellitus (T2DM) is associated with a substantially increased risk of cardiovascular disease (CVD). Bromocriptine-QR (B-QR), a quick release sympatholytic dopamine D 2 receptor agonist, is a FDA-approved therapy for T2DM which may provide CVD risk reduction. Metformin is considered to be an agent with a potential cardioprotective benefit. This large placebo controlled clinical study assessed the impact of B-QR addition to existing metformin therapy on CVD outcomes in T2DM subjects. 1791 subjects (1208 B-QR; 583 placebo) on metformin ± another anti-diabetes therapy at baseline derived from the Cycloset Safety Trial, a 12-month, randomized, multicenter, placebo-controlled, double-blind study in T2DM, were included in this study. The primary CVD endpoint evaluated was treatment impact on CVD event rate, prespecified as a composite of time to first myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina/congestive heart failure. Impact on glycemic control was evaluated as a secondary analysis. The composite CVD end point occurred in 16/1208 B-QR treated (1.3%) and 18/583 placebo treated (3.1%) subjects resulting in a 55% CVD hazard risk reduction (intention-to-treat, Cox regression analysis; HR: 0.45 [0.23-0.88], p = 0.028). Kaplan-Meier curves demonstrated a significantly lower cumulative incidence rate of the CVD endpoint in the B-QR treatment group (Log-Rank p = 0.017). In subjects with poor glycemic control (HbA1c ≥ 7.5) at baseline, B-QR therapy relative to placebo resulted in a significant mean %HbA1c reduction of -0.59 at week 12 and -0.51 at week 52 respectively (p < 0.001 for both) and a 10 fold higher percent of subjects achieving HbA1c goal of ≤7% by week 52 (B-QR 30%, placebo 3%; p = 0.003). These findings suggest that in T2DM subjects on metformin, BQR therapy may represent an effective strategy for reducing CVD risk. Cycloset Safety Trial registration: ClinicalTrials.gov Identifier: NCT00377676.

[Research update of effectiveness and mechanism of essential fatty acids in treating dry eye].

PubMed

Liu, Y; Liang, Q F

2017-03-11

Topical anti-inflammatory therapy has become the significant way of treating dry eye so far. However, as the long-term use of routine anti-inflammatory medications are restricted from their side effects, it is inevitable to explore safer and more effective alternatives. Essential fatty acids have proven to be anti-inflammatory systemically, which makes it possible to treat dry eye. Clinical trials have demonstrated that supplementation with either ω-3 or ω-6 essential fatty acids or both has multifactorial efficacies including improvement of subjective symptoms, alleviation of inflammation of ocular surface and eyelid margin, prolongation of tear break-up time and increase of tear flow secretion. Besides anti-inflammation effects, several basic researches have revealed that other mechanisms of essential fatty acids treating dry eye might lie in the corneal epithelial healing and tear secretion promotion. This review puts emphasis on the effectiveness, feasibility and mechanism of treating dry eye with essential fatty acids. (Chin J Ophthalmol, 2017, 53: 225-229) .

Clinical efficacy of fidarestat, a novel aldose reductase inhibitor, for diabetic peripheral neuropathy: a 52-week multicenter placebo-controlled double-blind parallel group study.

PubMed

Hotta, N; Toyota, T; Matsuoka, K; Shigeta, Y; Kikkawa, R; Kaneko, T; Takahashi, A; Sugimura, K; Koike, Y; Ishii, J; Sakamoto, N

2001-10-01

The purpose of this study was to evaluate the efficacy of fidarestat, a novel aldose reductase (AR) inhibitor, in a double-blind placebo controlled study in patients with type 1 and type 2 diabetes and associated peripheral neuropathy. A total of 279 patients with diabetic neuropathy were treated with placebo or fidarestat at a daily dose of 1 mg for 52 weeks. The efficacy evaluation was based on change in electrophysiological measurements of median and tibial motor nerve conduction velocity, F-wave minimum latency, F-wave conduction velocity (FCV), and median sensory nerve conduction velocity (forearm and distal), as well as an assessment of subjective symptoms. Over the course of the study, five of the eight electrophysiological measures assessed showed significant improvement from baseline in the fidarestat-treated group, whereas no measure showed significant deterioration. In contrast, in the placebo group, no electrophysiological measure was improved, and one measure significantly deteriorated (i.e., median nerve FCV). At the study conclusion, the fidarestat-treated group was significantly improved compared with the placebo group in two electrophysiological measures (i.e., median nerve FCV and minimal latency). Subjective symptoms (including numbness, spontaneous pain, sensation of rigidity, paresthesia in the sole upon walking, heaviness in the foot, and hypesthesia) benefited from fidarestat treatment, and all were significantly improved in the treated versus placebo group at the study conclusion. At the dose used, fidarestat was well tolerated, with an adverse event profile that did not significantly differ from that seen in the placebo group. The effects of fidarestat-treatment on nerve conduction and the subjective symptoms of diabetic neuropathy provide evidence that this treatment alters the progression of diabetic neuropathy.

The efficacy of three different mask styles on a PAP titration night.

PubMed

Ebben, Matthew R; Oyegbile, Temitayo; Pollak, Charles P

2012-06-01

This study compared the efficacy of three different masks, nasal pillows, nasal masks and full face (oronasal) masks, during a single night of titration with continuous positive airway pressure (CPAP). Fifty five subjects that included men (n=33) and women (n=22) were randomly assigned to one of three masks and underwent a routine titration with incremental CPAP applied through the different masks. CPAP applied through the nasal pillows and nasal mask was equally effective in treating mild, moderate, and severe sleep apnea. However, CPAP applied through the oronasal mask required a significantly higher pressure compared to nasal masks to treat moderately severe (2.8 cm of H(2)O ± 2.1 SD) and severe (6.0 cm of H(2)O ± 3.2 SD) obstructive sleep apnea. CPAP applied with either nasal mask was effective in treating mild, moderate, and severe sleep apnea. The oronasal mask required significantly higher pressures in subjects with moderate to severe disease. Therefore, when changing from a nasal to an oronasal mask, a repeat titration is required to ensure effective treatment of sleep apnea, especially in patients with moderate to severe disease. Copyright © 2012 Elsevier B.V. All rights reserved.

Impaired vibrotactile sense in children and adolescents with type 1 diabetes - Signs of peripheral neuropathy.

PubMed

Ising, Erik; Dahlin, Lars B; Elding Larsson, Helena

2018-01-01

To investigate whether multi-frequency vibrometry can identify individuals with elevated vibration perception thresholds (VPTs), reflecting impaired vibrotactile sense, among children and adolescents with type 1 diabetes. In 72 pediatric patients with type 1 diabetes, VPTs were evaluated for seven frequencies on two sites of the hand, and five frequencies on two sites of the foot. Z-scores, based on previously collected reference data, were calculated. Perception to light touch was investigated using monofilaments. Subjects' characteristics were analyzed in comparison to normal and impaired vibrotactile sense. Subjects' median age, disease duration and age at disease onset were 12.8, 5.3 and 6.9 years, respectively. A total of 13 out of 72 (18%) subjects had impaired vibrotactile sense on at least one foot site. Impaired vibrotactile sense was more common among subjects treated with multiple daily insulin injections (MDI) compared to subjects treated with continuous subcutaneous insulin infusion (CSII) (p = 0.013). Age at disease onset was higher among subjects with impaired vibrotactile sense (p = 0.046). No significant correlations were found with gender, HbA1c or duration of diabetes. Impaired vibrotactile sense, mirroring diabetic peripheral neuropathy, was found in 1/5 of the children and adolescents in the study, and was more common in patients treated with MDI than in subjects treated with CSII.

Neuropathic pain is not adequately treated in the older general population: Results from the KORA F4 survey.

PubMed

Meisinger, Christa; Bongaerts, Brenda W C; Heier, Margit; Amann, Ute; Kowall, Bernd; Herder, Christian; Rückert-Eheberg, Ina-Maria; Rathmann, Wolfgang; Ziegler, Dan

2018-05-24

We evaluated the pharmacological treatment of distal sensorimotor polyneuropathy (DSPN) among older subjects from the general population. The study included subjects aged 61 to 82 years from the KORA F4 survey (2006-2008). DSPN was defined as the presence of bilaterally impaired foot-vibration perception and/or bilaterally impaired foot-pressure sensation. Pain intensity was assessed with the painDETECT questionnaire. From the included 1076 older persons, 172 (16%) persons reported pain in the lower extremities and DSPN was present in 150 (14%) subjects. Forty-eight people with pain in the lower extremities reported DSPN. Only 38% of the subjects with DSPN reporting an average pain level of ≥4 during the past 4 weeks received medical treatment, predominantly nonsteroidal anti-inflammatory drugs (NSAIDs 20% and opioids 12%). The medication of choice for neuropathic pain, antidepressants, anticonvulsants, and opioids was relatively being underused. However, opioids and neuropathy preparations were prescribed preferably for subjects with painful DSPN. In the older general population, only a small proportion of subjects with painful DSPN receive analgesic pharmacotherapy. Although not recommended by guidelines for the treatment of neuropathic pain, NSAIDs were the most frequently used class of analgesic drugs. Copyright © 2018 John Wiley & Sons, Ltd.

Lidocaine patches reduce pain in trauma patients with rib fractures.

PubMed

Zink, Karen A; Mayberry, John C; Peck, Ellen G; Schreiber, Martin A

2011-04-01

Rib fracture pain is notoriously difficult to manage. The lidocaine patch is effective in other pain scenarios with an excellent safety profile. This study assesses the efficacy of lidocaine patches for treating rib fracture pain. A prospectively gathered cohort of patients with rib fracture was retrospectively analyzed for use of lidocaine patches. Patients treated with lidocaine patches were matched to control subjects treated without patches. Subjective pain reports and narcotic use before and after patch placement, or equivalent time points for control subjects, were gathered from the chart. All patients underwent long-term follow-up, including a McGill Pain Questionnaire (MPQ). Twenty-nine patients with lidocaine patches (LP) and 29 matched control subjects (C) were analyzed. During the 24 hours before patch placement, pain scores and narcotic use were similar (LP 5.3, C 4.6, P = 0.19 and LP 51, C 32 mg morphine, P = 0.17). In the 24 hours after patch placement, LP patients had a greater decrease in pain scores (LP 1.2, C 0.0, P = 0.01) with no change in narcotic use (LP -8.4, C 0.5-mg change in morphine, P = 0.25). At 60 days, LP patients had a lower MPQ pain score (LP 7.7, C 12.2, P < 0.01), although only one patient was still using a patch. There was no difference in time to return to baseline activity (LP 73, C 105 days, P = 0.16) and no adverse events. Lidocaine patches are a safe, effective adjunct for rib fracture pain. Lidocaine patches resulted in a sustained reduction in pain, outlasting the duration of therapy.

Fluoxetine increases suicide ideation less than placebo during treatment of adults with minor depressive disorder.

PubMed

Garlow, Steven J; Kinkead, Becky; Thase, Michael E; Judd, Lewis L; Rush, A John; Yonkers, Kimberly A; Kupfer, David J; Frank, Ellen; Schettler, Pamela J; Rapaport, Mark Hyman

2013-09-01

Some reports suggest an increase in suicide ideations and behaviors in patients treated with antidepressants. This is an analysis of the impact of fluoxetine on suicide ideations in outpatients with minor depressive disorder. Research subjects were adult outpatients with minor depressive disorder (N = 162), who received fluoxetine or placebo in a prospective, 12-week, double-blind randomized trial. The research participants were evaluated weekly with standard rating scales that included four suicide-related items: item 3 of the Hamilton Rating Scale for Depression (HRSD), item 18 of Inventory of Depressive Symptomatology (IDS-C), and items 15 and 59 of the Hopkins Symptom Checklist (SCL-90). Clinically significant intensification of suicide ideation was defined as an increase of ≥2 points on any of these items. Overall 60/162 subjects (37%) had an increase of ≥1 point during treatment and 17/162 (10.5%) of ≥2 points on at least one suicide item, with 12/81 (14.8%) placebo and 5/81 (6.2%) fluoxetine-treated subjects having a ≥2 point gain. Of the study participants with baseline suicide ideation, 9/22 (40.9%) placebo and 3/24 (12.5%) fluoxetine treated had ≥2 point increase (p = 0.04). Survival analysis revealed that subjects on placebo were significantly more likely (p = 0.050) to experience a ≥2 point increase on one or more item, a difference that emerged early and continued throughout the 12-week trial. Compared to placebo, fluoxetine was not associated with a clinically significant increase in suicide ideation among adults with minor depressive disorder during 12 weeks of treatment. Copyright © 2013 Elsevier Ltd. All rights reserved.

Fluoxetine Increases Suicide Ideation Less than Placebo During Treatment of Adults with Minor Depressive Disorder

PubMed Central

Garlow, Steven J.; Kinkead, Becky; Thase, Michael E.; Judd, Lewis L.; Rush, A. John; Yonkers, Kimberly A.; Kupfer, David J.; Frank, Ellen; Schettler, Pamela J.; Rapaport, Mark Hyman

2013-01-01

Objective Some reports suggest an increase in suicide ideations and behaviors in patients treated with antidepressants. This is an analysis of the impact of fluoxetine on suicide ideations in outpatients with Minor Depressive Disorder. Methods Research subjects were adult outpatients with Minor Depressive Disorder (N=162), who received fluoxetine or placebo in a prospective, 12-week, double blind randomized trial. The research participants were evaluated weekly with standard rating scales that included 4 suicide-related items; item 3 of the Hamilton Rating Scale for Depression (HRSD), item 18 of Inventory of Depressive Symptomatology (IDS-C), and items 15 and 59 of the Hopkins Symptom Checklist (SCL-90). Clinically significant intensification of suicide ideation was defined as an increase of ≥2 on any of these items. Results Overall 60/162 subjects (37%) had an increase of ≥1 point during treatment and 17/162 (10.5%) of ≥2 points on at least one suicide item, with 12/81 (14.8%) placebo and 5/81 (6.2%) fluoxetine treated subjects having a ≥2 point gain. Of the study participants with baseline suicide ideation, 9/22 (40.9%) placebo and 3/24 (12.5%) fluoxetine treated had ≥2 point increase (p=0.04). Survival analysis revealed that subjects on placebo were significantly more likely (p=0.050) to experience a ≥2 point increase on one or more item, a difference that emerged early and continued throughout the 12-week trial. Conclusions Compared to placebo, fluoxetine was not associated with a clinically significant increase in suicide ideation among adults with Minor Depressive Disorder during 12 weeks of treatment. PMID:23786912

Oculomotor Deficits after Chemotherapy in Childhood

PubMed Central

Einarsson, Einar-Jón; Patel, Mitesh; Petersen, Hannes; Wiebe, Thomas; Magnusson, Måns; Moëll, Christian; Fransson, Per-Anders

2016-01-01

Advances in the diagnosis and treatment of pediatric malignancies have substantially increased the number of childhood cancer survivors. However, reports suggest that some of the chemotherapy agents used for treatment can cross the blood brain barrier which may lead to a host of neurological symptoms including oculomotor dysfunction. Whether chemotherapy at young age causes oculomotor dysfunction later in life is unknown. Oculomotor performance was assessed with traditional and novel methods in 23 adults (mean age 25.3 years, treatment age 10.2 years) treated with chemotherapy for a solid malignant tumor not affecting the central nervous system. Their results were compared to those from 25 healthy, age-matched controls (mean age 25.1 years). Correlation analysis was performed between the subjective symptoms reported by the chemotherapy treated subjects (CTS) and oculomotor performance. In CTS, the temporal control of the smooth pursuit velocity (velocity accuracy) was markedly poorer (p<0.001) and the saccades had disproportionally shorter amplitude than normal for the associated saccade peak velocity (main sequence) (p = 0.004), whereas smooth pursuit and saccade onset times were shorter (p = 0.004) in CTS compared with controls. The CTS treated before 12 years of age manifested more severe oculomotor deficits. CTS frequently reported subjective symptoms of visual disturbances (70%), unsteadiness, light-headedness and that things around them were spinning or moving (87%). Several subjective symptoms were significantly related to deficits in oculomotor performance. To conclude, chemotherapy in childhood or adolescence can result in severe oculomotor dysfunctions in adulthood. The revealed oculomotor dysfunctions were significantly related to the subjects’ self-perception of visual disturbances, dizziness, light-headedness and sensing unsteadiness. Assessments of oculomotor function may, thus, offer an objective method to track and rate the level of neurological complications following chemotherapy. PMID:26815789

Subjective Memory Immediately Following Electroconvulsive Therapy.

PubMed

Brus, Ole; Nordanskog, Pia; Båve, Ullvi; Cao, Yang; Hammar, Åsa; Landén, Mikael; Lundberg, Johan; Nordenskjöld, Axel

2017-06-01

The aims of the present study were to describe the short-term rate of subjective memory worsening (SMW) and identify factors of importance for SMW in a large clinical sample treated for depression with electroconvulsive therapy (ECT). This register-based study included 1212 patients from the Swedish National Quality Register for ECT. Subjective memory worsening was defined as a 2-point worsening on the memory item of the Comprehensive Psychopathological Rating Scale from before to within 1 week after treatment. Associations between patient characteristics and treatment factors were examined using logistic regression. Subjective memory worsening was experienced in 26%. It was more common in women than in men (31% vs 18%; P < 0.001) and more common in patients aged 18 to 39 years than in patients 65 years or older (32% vs 22%; P = 0.008). Patients with less subjective memory disturbances before ECT had a greater risk of SMW. Patients in remission after ECT had a lower risk of SMW. A brief pulse width stimulus gave higher risk of SMW compared with ultrabrief pulse (odds ratio, 1.61; 95% confidence interval, 1.05-2.47). Subjective memory worsening is reported by a minority of patients. However, young women are at risk of experiencing SMW. Ultrabrief pulse width stimulus could be considered for patients treated with unilateral electrode placement who experience SMW. Each patient should be monitored with regard to symptoms and adverse effects, and treatment should be adjusted on an individual basis to maximize the clinical effect and with efforts to minimize the cognitive adverse effects.

Antiherpes virus-specific treatment and cognition in schizophrenia: a test-of-concept randomized double-blind placebo-controlled trial.

PubMed

Prasad, Konasale M; Eack, Shaun M; Keshavan, Matcheri S; Yolken, Robert H; Iyengar, Satish; Nimgaonkar, Vishwajit L

2013-07-01

To test our hypothesis that valacyclovir, an antiherpes virus-specific medication, added to antipsychotics (APs) would improve cognitive performance and psychopathology among schizophrenia subjects exposed to neurotropic herpes simplex virus, type 1 (HSV1). Using a double-blind placebo-controlled design, we randomized 24 HSV1-seropositive schizophrenia subjects to receive either valacyclovir (n = 12) or placebo (n = 12) for 18 weeks in addition to stable doses of APs. Valacyclovir dose was stabilized at 1.5 g twice daily orally. At each visit, subjects were evaluated for severity of psychopathology and side effects using standardized scales and a study-specific semistructured checklist. A computerized neurocognitive battery validated on both schizophrenia and healthy subjects was administered at baseline and follow-up. Intent-to-treat analysis, using linear regression models that included all randomized subjects, were used to examine differential changes in cognition and psychopathology scores over 18 weeks between valacyclovir and placebo, accounting for placebo response. Valacyclovir group improved in verbal memory, working memory, and visual object learning compared with placebo group. The effect sizes (Cohen's d) were 0.79 for working memory, 1.14 for immediate verbal memory, and 0.97 for the visual object learning. Psychotic symptom severity did not improve. Supplemental valacyclovir may alleviate impairments in cognitive domains that are often observed in schizophrenia but not psychotic symptoms in those exposed to HSV1. If replicated, this approach could provide a novel strategy to treat cognitive impairments in a subgroup of schizophrenia subjects who can be reliably identified using a blood test.

Aspirin alone and combined with a statin suppresses eicosanoid formation in human colon tissue.

PubMed

Gottschall, Heike; Schmöcker, Christoph; Hartmann, Dirk; Rohwer, Nadine; Rund, Katharina; Kutzner, Laura; Nolte, Fabian; Ostermann, Annika I; Schebb, Nils Helge; Weylandt, Karsten H

2018-05-01

Eicosanoids, including prostaglandins (PGs) and thromboxanes, are broadly bioactive lipid mediators and increase colon tumorigenesis possibly through chronic inflammatory mechanisms. Epidemiological and experimental data suggest that acetylsalicylic acid (ASA) helps prevent colorectal cancer (CRC), possibly through cyclooxygenase (COX)-mediated suppression of eicosanoid, particularly PGE 2 , formation. Recent studies suggest that statins prevent CRC and improve survival after diagnosis. We identified patients on ASA and/or statin treatment undergoing routine colonoscopy and measured eicosanoid levels in colonic mucosa with targeted metabolomics technology (LC-MS/MS). ASA-treated individuals (n = 27) had significantly lower tissue eicosanoid levels of most COX-derived metabolites than untreated individuals (n = 31). In contrast, COX-derived lipid metabolites tended to be higher in patients with statin treatment (n = 7) as compared with those not receiving statins (n = 24). This effect was not discernible in subjects treated with ASA and statins (n = 11): Individuals treated with both drugs showed a pronounced suppression of COX-derived eicosanoids in colon tissue, even compared with subjects treated with ASA alone. Our data from a routine clinical setting support the hypothesis that ASA and statins could inhibit CRC development via lipid mediator modification. Further studies should directly investigate the effect of dual ASA and statin treatment on colon tumorigenesis in humans. Copyright © 2018 by the American Society for Biochemistry and Molecular Biology, Inc.

5-Day versus 10-Day Course of Fluoroquinolones in Outpatient Males with a Urinary Tract Infection (UTI).

PubMed

Mospan, Geoffrey A; Wargo, Kurt A

Current guidelines classify urinary tract infections (UTIs) in males as complicated and recommend longer treatment than for UTIs in females. The objective of this study is to demonstrate that males with UTIs may be successfully treated with an outpatient 5-day course of levofloxacin. Data were obtained from a previously conducted clinical trial (www.clinicaltrials.gov identifier NCT00210886), a multicenter, double-blind, randomized, noninferiority study comparing levofloxacin 750 mg intravenously/by mouth once daily for 5 days and ciprofloxacin 400/500 mg intravenously/by mouth twice daily for 10 days in complicated UTI (cUTI). The current study was a post hoc, subgroup analysis of male and female subjects with cUTI. Subjects were stratified into groups based on sex and antibiotic received. The subjects were analyzed at the end of therapy (EOT) and post therapy (PT) for clinical success rates, defined as no further need for antimicrobial treatment. Totals of 427 patients (224 male, 203 female) and 350 patients (189 male, 161 female) were included in the modified intent-to-treat (mITT) population and microbiologically evaluable (ME) populations, respectively. Clinical success rates between males and females were not statistically different between antibiotic groups in either the mITT or ME populations at EOT or PT. This study demonstrates that males with UTI may be treated with a shorter course of antimicrobial therapy for UTI than previously recommended. © Copyright 2016 by the American Board of Family Medicine.

Efficacy of Guanfacine Extended Release in the Treatment of Combined and Inattentive Only Subtypes of Attention-Deficit/Hyperactivity Disorder

PubMed Central

Kollins, Scott H.; Wigal, Timothy L.

2012-01-01

Abstract Background Extended-release guanfacine (GXR) is approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6–17 years. This post-hoc analysis further examines the effects of GXR on hyperactivity-impulsivity and inattentiveness. Method Data from two large double-blind placebo-controlled pivotal trials of GXR in the treatment of ADHD were analyzed. Using the pooled population to provide sufficient sample size and associated statistical power, the impact of GXR treatment on core ADHD symptoms was examined by comparing ADHD Rating Scale IV (ADHD-RS-IV) total scores in the overall GXR and placebo groups in subjects with each of the three ADHD subtypes. ADHD-RS-IV Hyperactivity-Impulsivity and Inattentiveness subscale scores in the overall study population by randomized dose group (vs. placebo) were also examined. Results The full analysis set included 631 subjects aged 6–17 years (GXR: n=490; placebo: n=141). Among subjects with the predominantly inattentive subtype of ADHD, differences in least squares (LS) mean reductions from baseline in ADHD-RS-IV total scores were significantly greater in GXR-treated subjects (n=127) than in placebo-treated subjects (n=38) at treatment weeks 3 through 5 and end point (p≤0.020). Among subjects with combined type ADHD, differences in LS mean ADHD-RS-IV total score reductions from baseline were significantly greater in the GXR group (n=354) than in the placebo group (n=100) at treatment weeks 1 through 5 and end point (p≤0.011). The dearth of predominantly hyperactive-impulsive type subjects (n=12) precluded analysis of this subgroup. Each randomized GXR dose group in each trial demonstrated significantly greater reductions from baseline in ADHD-RS-IV Hyperactivity-Impulsivity and Inattentiveness subscale scores than did the respective placebo group at end point (p≤0.05 for all). Conclusions The results support the use of GXR in the treatment of core ADHD symptoms as defined in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision, including hyperactivity, impulsivity, and inattention. PMID:22612526

The creatine kinase response to eccentric exercise with atorvastatin 10 mg or 80 mg.

PubMed

Kearns, Amy K; Bilbie, Cherie L; Clarkson, Priscilla M; White, C Michael; Sewright, Kim A; O'Fallon, Kevin S; Gadarla, Mamatha; Thompson, Paul D

2008-09-01

Hydroxy-methyl-glutaryl co-enzyme A (HMG-CoA) reductase inhibitors or statins are well tolerated by most patients, but can produce a variety of skeletal muscle problems including myalgia, creatine kinase (CK) elevations and clinically important rhabdomyolysis. We have previously demonstrated that the CK response to downhill walking is greater in statin compared to placebo treated subjects. This study examined the CK response to downhill walking in subjects treated with low and high dose of atorvastatin. 79 subjects with LDL cholesterol>100mg/dL were randomly assigned to atorvastatin 10mg (N=42) or 80 mg (N=37) for 5 weeks. Subjects performed a downhill walking exercise during the fifth week of treatment. Leg muscle soreness, plasma CK and CK-MB levels were measured daily for 4 days following the exercise. CK, CK-MB and muscle soreness increased above pre-exercise levels in all subjects after the exercise. There were no differences in the CK, CK-MB or soreness response between the high and low dose treatment groups at any time point. The downhill walking model of muscle injury does not distinguish between high and low dose atorvastatin therapy either because this test is insensitive to differences among statin doses or because there is no difference in muscle injury between these two drug doses with this statin. Clinicians should be aware, however, that exercise can increase CK levels with even low dose statin therapy.

PTH(1-34) for the Primary Prevention of Postthyroidectomy Hypocalcemia: The THYPOS Trial.

PubMed

Palermo, Andrea; Mangiameli, Giuseppe; Tabacco, Gaia; Longo, Filippo; Pedone, Claudio; Briganti, Silvia Irina; Maggi, Daria; Vescini, Fabio; Naciu, Anda; Lauria Pantano, Angelo; Napoli, Nicola; Angeletti, Silvia; Pozzilli, Paolo; Crucitti, Pierfilippo; Manfrini, Silvia

2016-11-01

There are no studies evaluating teriparatide for prevention of post-thyroidectomy hypocalcemia. Our objective was to evaluate whether teriparatide can prevent postsurgical hypocalcemia and shorten the hospitalization in subjects at high risk of hypocalcemia following thyroid surgery. This was a prospective phase II randomized open-label trial. This trial was set on a surgical ward. Twenty-six subjects (six males, 20 females) with intact PTH lower than10 pg/ml 4 hours after thyroidectomy were included. Subjects were randomized (1:1) to receive SC administration of 20 mcg of teriparatide every 12 hours until the discharge (treatment group) or to follow standard clinical care (control group). Adjusted serum calcium, duration of hospitalization, and calcium/calcitriol supplementation were measured. Overall, the incidence of hypocalcemia was 3/13 in treatment group and 11/13 in the control group (P = .006). Treated patients had a lower risk of hypocalcemia than controls (relative risk, 0.26 [95% confidence interval, 0.09-0.723)]). The median duration of hospitalization was 3 days (interquartile range, 1) in control subjects and 2 days (interquartile range, 0) in treated subjects (P = .012). One month after discharge, 10/13 subjects in the treatment group had stopped calcium carbonate supplements, while only 5/13 in the control group had discontinued calcium. The ANOVA for repeated measures showed a significant difference in calcium supplements between groups at 1-month visit (P = .04) as well as a significant difference between discharge and 1-month visit in the treatment group (P for interaction time group = .04) Conclusions: Teriparatide may prevent postsurgical hypocalcemia, shorten the duration of hospitalization, and reduce the need for calcium and vitamin D supplementation after discharge in high risk subjects after thyroid surgery.

Safety and efficacy of fimasartan in Mexican patients with grade 1-2 essential hypertension.

PubMed

Cardona-Muñoz, Ernesto G; López-Alvarado, Agustín; Conde-Carmona, Ignacio; Sánchez-Mejorada, Gerardo; Pascoe-González, Sara; Banda-Elizondo, Ramiro G; García-Castillo, Armando; González-Gálvez, Guillermo; Velasco-Sánchez, Raúl G; Vidrio-Velázquez, Maricela; Leiva-Pons, José L; Villeda-Espinosa, Efraín; Guerra-López, Arturo; Esturau-Santalo, Ramón M

To evaluate efficacy and safety of 60mg and 120mg Fimasartan (FMS) alone or combined with 12.5mg hydrochlorothiazide (HCTZ) in a Mexican population. A six month, treat-to-target, open study was conducted on subjects with grade 1-2 hypertension. The subjects were initially treated with 60mg FMS once daily. In week 8, those with Diastolic Blood Pressure (DBP) <90mmHg continued on the same FMS dose during the rest of the study, while those with DBP ≥90mmHg were randomised to either 120mg FMS or 60mg FMS + 12.5mg HCTZ once daily. In week 12, randomised subjects with DBP ≥90mmHg received 120mg FMS+12.5mg HCTZ, while those achieving target continued with their assigned treatment until the end of the study. FMS 60mg (n=272) decreased both DBP and Systolic Blood Pressure (SBP) by 11.3±8.9 (p<.0001) and 16.0±14.1 (p<.0001)mmHg, respectively, with 75.4% of subjects reaching the treatment target. Subjects assigned to FMS 120mg, FMS 60mg+HCTZ 12.5mg, or FMS 120mg+HCTZ 12.5mg once daily, showed significant reductions in DBP and SBP with their assigned treatment. At the end of the study, 237/272 subjects (87.1%) achieved a DBP<90mmHg and an SBP<140mmHg. The most frequently reported adverse reactions included headache (3.7%), dry mouth (1.1%), transient liver enzyme increase (1.1%), and dizziness (0.7%). Fimasartan is safe and effective in Mexican subjects with grade 1-2 essential hypertension. Copyright © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.

Effect of salt intake on blood pressure in patients receiving antihypertensive therapy: Shimane CoHRE Study.

PubMed

Ito, Tomoko; Takeda, Miwako; Hamano, Tsuyoshi; Kijima, Tsunetaka; Yamasaki, Masayuki; Isomura, Minoru; Yano, Shozo; Shiwaku, Kuninori; Nabika, Toru

2016-03-01

Salt intake is recognized as an important risk factor for hypertension in the general population. On the other hand, the availability of various classes of antihypertensive drugs means that it is generally not considered crucial to control the salt intake of hypertensive patients. In this study, we evaluated whether blood pressure (BP) was correlated with 24-hour salt intake in patients receiving antihypertensive therapy. A total of 1496 consecutive participants undergoing health screening examinations were recruited. Subjects were divided into two groups according to their antihypertensive medications checked on prescriptions: 1005 subjects without antihypertensive therapy (untreated subjects) and 491 subjects with antihypertensive therapy (treated subjects). The 24-hour urinary sodium excretion (24h-uNa), a surrogate marker for daily salt intake, was estimated with the formula proposed by Tanaka et al. in 2002. Univariate analysis indicated that 24h-uNa was positively correlated with the systolic BP of both untreated and treated subjects. This was confirmed by multiple linear regression analysis after adjustment for confounding factors (untreated subjects: partial regression coefficient β=1.45 ± 0.26, p<0.001; treated subjects: β=0.75 ± 0.27, p=0.01). Salt intake was also correlated with the pulse pressure in both treated subjects (β=0.55 ± 0.24, p=0.02) and untreated subjects (β=0.93 ± 0.19, p<0.001). These results suggest the importance of reducing salt intake in hypertensive patients on pharmacotherapy, as well as in the general population. Further studies of hypertensive patients employing 24-h urine collection are warranted to confirm the present findings. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin: results of a randomized controlled trial.

PubMed

Glickman, Marc; Gheissari, Ali; Money, Samuel; Martin, John; Ballard, Jeffrey L

2002-03-01

An experimental polymeric sealant (CoSeal [Cohesion Technologies, Palo Alto, Calif]) provides equivalent anastomotic sealing to Gelfoam (Upjohn, Kalamazoo, Mich)/thrombin during surgical placement of prosthetic vascular grafts. Randomized controlled trial. Nine university-affiliated medical centers. One hundred forty-eight patients scheduled for implantation of polytetrafluoroethylene grafts, mainly for infrainguinal revascularization procedures or the creation of dialysis access shunts, who were treated randomly with either an experimental intervention (n = 74) or control (n = 74). Following polytetrafluoroethylene graft placement, anastomotic suture hole bleeding was treated intraoperatively in all control subjects with Gelfoam/thrombin. Subjects in the experimental group had the polymeric sealant applied directly to the suture lines without concomitant manual compression. Primary treatment success was defined as the proportion of subjects in each group that achieved complete anastomotic sealing within 10 minutes. The proportion of subjects that achieved immediate sealing and the time required to fully inhibit suture hole bleeding also were compared between treatment groups. Overall 10-minute sealing success was equivalent (86% vs 80%; P =.29) between experimental and control subjects, respectively. However, subjects treated with CoSeal achieved immediate anastomotic sealing at more than twice the rate of subjects treated with Gelfoam/thrombin (47% vs 20%; P<.001). Consequently, the median time needed to inhibit bleeding in control subjects was more than 10 times longer than for experimental subjects (16.5 seconds vs 189.0 seconds; P =.01). Strikingly similar findings for all comparisons were observed separately for subgroups of subjects having infrainguinal bypass grafting and for those undergoing placement of dialysis access shunts. The experimental sealant offers equivalent anastomotic sealing performance compared with Gelfoam/thrombin, but it provides this desired effect in a significantly more rapid time frame.

Care manager to control cardiovascular risk factors in primary care: the Raffaello cluster randomized trial.

PubMed

Deales, A; Fratini, M; Romano, S; Rappelli, A; Penco, M; Perna, G Piero; Beccaceci, G; Borgia, R; Palumbo, W; Magi, M; Vespasiani, G; Bronzini, M; Musilli, A; Nocciolini, M; Mezzetti, A; Manzoli, L

2014-05-01

This cluster randomized trial evaluated the efficacy of a disease and care management (D&CM) model in cardiovascular (CVD) prevention in primary care. Eligible subjects had ≥ 1 among: blood pressure ≥ 140/90 mmHg; glycated hemoglobin ≥ 7%; LDL-cholesterol ≥ 160 or ≥ 100 mg/dL (primary or secondary prevention, respectively); BMI ≥ 30; current smoking. The D&CM intervention included a teamwork including nurses as care managers for the implementation of tailored care plans. Control group was allocated to usual-care. The main outcome was the proportion of subjects achieving recommended clinical targets for ≥ 1 of uncontrolled CVD risk factors at 12-month. During 2008-2009 we enrolled 920 subjects in the Abruzzo/Marche regions, Italy. Following the exclusion of L'Aquila due to 2009 earthquake, final analyses included 762 subjects. The primary outcome was achieved by 39.1% (95%CI: 34.2-44.2) and 25.2% (95%CI: 20.9-29.9) of subjects in the intervention and usual-care group, respectively (p < 0.001). The D&CM intervention significantly increased the proportion of subjects who achieved clinical targets for both diabetes and hypertension, with no differences in hypercholesterolemia, smoking status and obesity. The D&CM intervention was effective in controlling cardiovascular risk factors, in particular hypertension and diabetes. Numbers needed to treat were small. Such intervention may deserve further consideration in clinical practice. ACTRN12611000813987. Copyright © 2013 Elsevier B.V. All rights reserved.

Low-dose oral isotretinoin versus topical retinoic acid for photoaging: a randomized, comparative study.

PubMed

Bagatin, Edileia; Guadanhim, Lilia R S; Enokihara, Milvia M S S; Sanudo, Adriana; Talarico, Sérgio; Miot, Helio A; Gibson, Lawrence

2014-01-01

Oral isotretinoin (ISO) is the only drug which promotes prolonged remission or cure of severe acne. It also has other properties, supporting its use for non-acne indications. Retinoic acid (RA) is gold standard treatment for photoaging. ISO for photoaging treatment was reported in non-controlled trials as alternative to RA, which causes skin irritation. To compare clinical, histological, and immunohistochemical effects of low-dose ISO and 0.05% topical RA to treat photoaging. Randomized, comparative, evaluator-blinded, single-center study. Twenty-four healthy, Caucasian, 50 to 75-year-old men and women (menopausal or sterilized) with advanced photoaging were included. Twelve subjects received ISO, 20 mg/day, and 12 subjects were treated with RA cream, for six months; both treatments were administered every other day, and moisturizer and sunscreen were also used. Outcome measures included patient assessments, blinded photographic evaluations, Life Quality Index, histological (HE, Verhoeff) and immunohistochemical (p53, collagen type I) evaluations, adverse events, liver function, lipid profile, and blood count. Statistical analysis with generalized estimating equations and repeated measures ANOVA tests was used. Eleven subjects in each group completed the study. Patient and photographic assessments showed overall improvement in skin appearance. Quality-of-life scores were reduced for all subjects. Histological analysis revealed corneal layer diminution, epidermal thickness increase, and elastosis reduction. Immunohistochemical findings revealed significant epidermal p53 reduction and dermal collagen 1 increase. No differences were found between groups; laboratory tests showed no significant alterations. Despite being safe and effective, low-dose ISO was not superior to 0.05% RA for advanced photoaging treatment. © 2013 The International Society of Dermatology.

Development of Age-Related Macular Degeneration (AMD) in the Fellow Eye of Patients with AMD Treated by Treat-and-Extend Intravitreal Therapy with Aflibercept.

PubMed

Mimura, Kensuke; Matsumoto, Hidetaka; Morimoto, Masahiro; Akiyama, Hideo

2018-01-01

To evaluate the development of neovascular age-related macular degeneration (nAMD) in the fellow eye in patients with unilateral nAMD treated by a treat-and-extend (TAE) regimen with intravitreal aflibercept injections. We retrospectively studied 104 patients with treatment-naïve unilateral nAMD. We assessed best-corrected visual acuity (BCVA) and exudative changes in the treated eyes and development of nAMD in the fellow eye for 2 years. The subjects included 46 patients with typical AMD (tAMD), 44 with polypoidal choroidal vasculopathy (PCV), and 14 with retinal angiomatous proliferation (RAP). BCVA was significantly improved after the loading phase in all subtypes. Forty-six patients (44.2%) had no recurrence within 2 years after the loading phase, including 12 (26.1%) with tAMD, 23 (52.2%) with PCV, and 11 (78.6%) with RAP (p < 0.01). Eleven patients (10.6%) developed nAMD in the fellow eye within 2 years, including 4 (8.7%) with tAMD, 0 (0%) with PCV, and 7 (50.0%) with RAP (p < 0.001). Patients with RAP had significantly more frequent development of nAMD in the fellow eye compared to other subtypes, while they showed significantly less recurrence during the TAE regimen with intravitreal aflibercept injections. Development of nAMD in the fellow eye should be monitored in RAP when the injection interval is extended. © 2017 S. Karger AG, Basel.

Bisphosphonate ISS Flight Experiment

NASA Technical Reports Server (NTRS)

LeBlanc, Adrian; Matsumoto, Toshio; Jones, Jeffrey; Shapiro, Jay; Lang, Thomas; Shackleford, Linda; Smith, Scott M.; Evans, Harlan; Spector, Elizabeth; Ploutz-Snyder, Robert;

Understanding regulations affecting pet foods.

PubMed

Dzanis, David A

2008-08-01

In the United States, pet foods are subject to regulation at both the federal and the state levels. The US Food and Drug Administration has jurisdiction over all animal feeds (including pet foods, treats, chews, supplements, and ingredients) in interstate commerce, which includes imported products. Many states adopt and enforce at least in part the Association of American Feed Control Officials Model Bill and Model Regulations for Pet Food and Specialty Pet Food. Thus, all pet foods in multi-state distribution are subject to a host of labeling requirements covering aspects such as product names, ingredient lists, nutrient content guarantees, and nutritional adequacy statements. Ingredients must be GRAS (generally recognized as safe) substances, approved food additives, or defined by Association of American Feed Control Officials for their intended use. Pet food labels may not bear claims that are false or misleading or that state or imply use for the treatment or prevention of disease. Pet foods that are found to be adulterated or misbranded may be subject to seizure or other enforcement actions.

Incidence of retinopathy in chronic hepatitis C patients treated with pegylated interferon alpha 2a and ribavirin combination therapy

PubMed Central

Kashif, Muhammad; Saleem, Muhammad Khurram; Farooka, Imran Khan; Husnain, Amina; Siddiqui, Arif Mahmood

2015-01-01

Objectives: The objective of this study was to determine the incidence of retinopathy in chronic hepatitis C patients treated with Pegylated interferon alpha 2a and Ribavirin. Methods: This descriptive case series study was conducted in Medical Unit II of the Jinnah Hospital Lahore from September 2012 to February 2013. One hundred chronic hepatitis C patients visiting Medical Unit II outpatient department fulfilling inclusion criteria were selected for this study via non probability purposive sampling. Patients were started on pegylated interferon and ribavirin combination therapy. Subjects were subjected to dilated eye fundoscopic examination at the start of therapy and then after three months of the therapy. Results: One hundred patients were included in this study. Out of these 100 patients 5% developed retinopathy whereas fundus examination was normal in rest of the patients. Conclusion: Interferon therapy can lead to retinopathy. Periodic fundoscopic examinations help in early detection and prevent progression to permanent visual loss. PMID:25878638

Incidence of retinopathy in chronic hepatitis C patients treated with pegylated interferon alpha 2a and ribavirin combination therapy.

PubMed

Kashif, Muhammad; Saleem, Muhammad Khurram; Farooka, Imran Khan; Husnain, Amina; Siddiqui, Arif Mahmood

2015-01-01

The objective of this study was to determine the incidence of retinopathy in chronic hepatitis C patients treated with Pegylated interferon alpha 2a and Ribavirin. This descriptive case series study was conducted in Medical Unit II of the Jinnah Hospital Lahore from September 2012 to February 2013. One hundred chronic hepatitis C patients visiting Medical Unit II outpatient department fulfilling inclusion criteria were selected for this study via non probability purposive sampling. Patients were started on pegylated interferon and ribavirin combination therapy. Subjects were subjected to dilated eye fundoscopic examination at the start of therapy and then after three months of the therapy. One hundred patients were included in this study. Out of these 100 patients 5% developed retinopathy whereas fundus examination was normal in rest of the patients. Interferon therapy can lead to retinopathy. Periodic fundoscopic examinations help in early detection and prevent progression to permanent visual loss.

The Gluten-Free, Casein-Free Diet in Autism: Results of a Preliminary Double Blind Clinical Trial

ERIC Educational Resources Information Center

Elder, Jennifer Harrison; Shankar, Meena; Shuster, Jonathan; Theriaque, Douglas; Burns, Sylvia; Sherrill, Lindsay

2006-01-01

This study tested the efficacy of a gluten-free and casein-free (GFCF) diet in treating autism using a randomized, double blind repeated measures crossover design. The sample included 15 children aged 2-16 years with autism spectrum disorder. Data on autistic symptoms and urinary peptide levels were collected in the subjects' homes over the 12…

Outcome of Endodontically Treated Cracked Teeth

DTIC Science & Technology

2016-06-01

condition associated with pain during chewing and with temperature changes. According to the American Association of Endodontists (AAE), a cracked...stress that localized at the center groove and cervical region of the molar model under equivalent loads. A higher, unfavorable, tensile stress was...dilemma. The diagnosis is primarily based on a patient’s subjective symptoms and chief complaint. These can include the presence of pain during

Prazosin for Treatment of Patients With PTSD and Comorbid Alcohol Dependence

DTIC Science & Technology

2013-07-01

treat individuals with comorbid AD and TSD. The use of an alpha-! adrenergic receptor antagonist represents a novel approach to treatment that may... adrenergic ~ceptor antagonist that has been used successfully in the treatment of trauma nightmares and sleep disturbance in combat veterans with TSD, and...stressor, presented randomly. Outcome measures include self-reported measures of alcohol craving and anxiety . Subjects are subsequently randomized

Decreasing recurrent bowel obstructions, improving quality of life with physiotherapy: Controlled study.

PubMed

Rice, Amanda D; Patterson, Kimberley; Reed, Evette D; Wurn, Belinda F; Robles, Kristen; Klingenberg, Bernhard; Weinstock, Leonard B; Pratt, Janey Sa; King, C Richard; Wurn, Lawrence J

2018-05-21

To compare (1) quality of life and (2) rate of recurrent small bowel obstructions (SBO) for patients treated with novel manual physiotherapy vs no treatment. One hundred and three subjects (age 19-89) with a history of recurrent adhesive SBO were treated with a manual physiotherapy called the Clear Passage Approach (CPA) which focused on decreasing adhesive crosslinking in abdominopelvic viscera. Pre- and post-therapy data measured recurring obstructions and quality of life, using a validated test sent 90 d after therapy. Results were compared to 136 untreated control subjects who underwent the same measurements for subjects who did not receive any therapy, which is the normal course for patients with recurring SBO. Comparison of the groups allowed us to assess changes when the physiotherapy was added as an adjunct treatment for patients with recurring SBO. Despite histories of more prior hospitalizations, obstructions, surgeries, and years impacted by bowel issues, the 103 CPA-treated subjects reported a significantly lower rate of repeat SBO than 136 untreated controls (total obstructions P = 0.0003; partial obstructions P = 0.0076). Subjects treated with the therapy demonstrated significant improvements in five of six total domains in the validated Small Bowel Obstruction Questionnaire (SBO-Q). Domains of diet, pain, gastrointestinal symptoms, quality of life (QOL) and pain severity when compared to post CPA treatment were significantly improved ( P < 0.0001). The medication domain was not changed in the CPA treated group ( P = 0.176). CPA physical therapy was effective for patients with adhesive SBO with significantly lower recurrence rate, improvement in reported symptoms and overall quality of life of subjects.

Essential Hypertension: Cardiovascular Response to Breath Hold Combined with Exercise.

PubMed

Hoffmann, U; Urban, P; Koschate, J; Drescher, U; Pfister, R; Michels, G

2015-07-01

Essential hypertension (EH) is a widespread disease and might be prevalent in apnea divers and master athletes. Little is known about the influence of EH and the antihypertensive drugs (AHD) on cardiovascular reactions to combined breath hold (BH) and exercise. In this pilot study, healthy divers (HCON) were compared with treated hypertensive divers with regard to heart rate (HR) and mean blood-pressure (MAP) responses to BH, exercise and the combination of both. Ten subjects with EH and ten healthy divers were tested. 3 different 20 s stimuli were applied: BH combined with 30 W or 150 W and 150 W without BH. The time-charts during the stress intervals and during recovery were compared. Subjects treated with an angiotensin-converting enzyme (ACE) inhibitor showed higher changes for MAP values if breath hold was performed. HR responses were obviously changed if a β-blocker was part of the medication. One subject showed extreme MAP responses to all stimuli and conspicuous HR if BH was involved. The modulation of HR-/MAP-response in EH subjects depends on the mechanisms of antihypertensive agents. The combination of an ACE inhibitor and a β-blocker may give the best protection. It is recommended to include short apnea tests in the fitness-to-dive examination to individually predict potential endangerment. © Georg Thieme Verlag KG Stuttgart · New York.

Epstein-Barr and other herpesvirus infections in patients with early onset type 1 diabetes treated with daclizumab and mycophenolate mofetil.

PubMed

Loechelt, Brett J; Boulware, David; Green, Michael; Baden, Lindsey R; Gottlieb, Peter; Krause-Steinrauf, Heidi; Weinberg, Adriana

2013-01-01

We assessed the morbidity of herpesviruses in patients with type 1 diabetes mellitus (T1D) enrolled in immunosuppressive treatment studies. Epstein-Barr virus (EBV), cytomegalovirus (CMV), herpes simplex virus (HSV), and varicella zoster virus (VZV) infections were monitored in 126 participants of a randomized, double-blind, placebo-controlled study of daclizumab (DZB) and mycophenolate mofetil (MMF) including DZB(+)MMF(+), DZB(-)MMF(+), DZB(+)MMF(-), and DZB(-)MMF(-). During the 2-year follow-up, herpesviral infections were monitored clinically, by serology and blood DNA polymerase chain reaction. Among 57 baseline EBV-seronegative participants, 9 developed EBV primary infections, including 2 with infectious mononucleosis syndrome. There were no appreciable differences in the course of the primary EBV infections across treatment groups. Among 69 baseline EBV-seropositive participants, 22 had virologic reactivations, including 1 symptomatic DZB(-)MMF(+) subject. Compared with 7 DZB(-)MMF(-) EBV reactivators, the 9 DZB(+)MMF(+) reactivators tended to have more prolonged viremia (11.4 vs 4.4 months; P = .06) and higher cumulative viral burden (14.2 vs 12.5 log EBV copies/mL; P = .06). Four of 85 baseline CMV-seronegative subjects developed asymptomatic primary CMV infections. There were no CMV reactivations. Of 30 baseline HSV-seropositive subjects, 8 developed ≥1 episode of herpes labialis; 1 subject had a primary HSV infection; and 1 subject without baseline serology information had a new diagnosis of genital HSV. There were no significant differences in the incidence of HSV recurrences across treatment groups. Of 100 baseline VZV-seropositive subjects, 1 DZB(-)MMF(-) subject developed herpes zoster and 1 DZB(-)MMF(+) subject had Bell's palsy possibly related to VZV. The use of DZB alone or in combination with MMF was not associated with increased morbidity due to herpesviruses. NCT00100178.

[The subjective quality of life of patients with schizophrenia: influence of psychopathology and patients' expectations. A comparative study].

PubMed

Salomé, F; Petitjean, F; Germain, C; Demant, J-C

2004-01-01

Most studies on the quality of life (Qol) of patients with schizophrenia deal with objective living conditions and how they are perceived by hospitalized patients. The few studies that compare Qol for patients treated in part time services with the Qol of ambulatory patients do not show any significant difference in terms of subjective Qol. Some stu-dies evaluate the influence of psychopathology and needs (or expectations) on the subjective Qol in these groups of patients. Available data indicate that the general well-being is influenced by psychopathology (positive, negative or depressive symptoms) and unmet needs in ambulatory patients. They also show that subjective Qol in certain life domains (social relations, family relations, leisure, health, law and security) is influenced by negative symptoms, anxiety and depression in patients treated in part-time services. The aim of this study is to compare the objective and subjective Qol of patients with schizophrenia treated in part time services (day hospital and day care center) to the Qol of out-patients treated on a purely ambulatory basis (out patient clinic). We studied the Qol of 2 groups of 30 patients with schizophrenia (ICD 10 criteria) treated in various centers. The first group was made of ambulatory patients, the second one was constituted of patients treated in a day hospital or a day care center. Patients were matched for age, duration of illness, number of hospitalizations. The instruments used for rating were the following: Clinical Global Impression (CGI), Global Assessment of Functioning (GAF), Positive And Negative Symptoms Scale (PANSS), Drug Attitude Inventory (DAI-10). The Qol was measured with a french version of the Lancashire Quality Of Life Profile (LQOLP) (Salomé, Germain, Petitjean, Demant and Boyer, 2000). This instrument measures the objective Qol as well as the subjective Qol. It does possess satisfying psychometric properties and offers the possibility to establish Qol profiles. All Qol ratings were carried out by a clinician who was not involved in the treatment of the patients. When the 2 groups are compared our results indicate that ambulatory patients are less symptomatic, have a better level of functioning and a better objective Qol in such domains as: finances, living situation, family relations and health. There is no significant difference in terms of anxiety and depression as measured by the respective items of the PANSS. Patients treated in part-time services present higher scores of positive symptoms. Our results indicate that there is no significant difference for subjective Qol variables between the two groups, except for general well-being, that tends to be higher in ambulatory patients. When exploring the influence of clinical data on the Qol in each group, we find negative correlations in ambulatory patients between various domains of subjective Qol and illness severity (law and security, family relations, social relations, general well-being), global functioning (family relations, social relation, health) and positive symptoms (living conditions, law and security, family relations, social relations, health). In this same group, the subjective Qol for family relations is significantly correlated with several expectations in terms of Qol improvement (leisure, social relations, family relations, transport, work). In these patients, the subjective Qol for social relations is also significantly correlated with their expectations in terms of Qol improvement (work, money, lodging, affective relations, transport). There is no significant correlation between subjective Qol and expectations in patients treated in part-time services. Our results indicate that part time services treat schizophrenic patients with a lower level of global functioning and a higher level of symptom severity compared with ambulatory patients. These results confirm other studies that show no significant difference between these 2 groups in terms of subjective Qol. The subjective Qol in the field of relations (family and social) in ambulatory patients seems particularly sensitive to illness severity, positive symptoms and global functioning level. This has also been reported by other studies. In patients treated in part-time services, the subjective Qol, particularly for living conditions and security, seems sensitive to anxiety and depression. This has also been shown by other studies. Finally, our results underline the importance of patients' expectations in terms of subjective Qol, particularly in the field of relations (family and social) for ambulatory patients.

Adverse cardiovascular outcomes between insulin-treated and non-insulin treated diabetic patients after percutaneous coronary intervention: a systematic review and meta-analysis.

PubMed

Bundhun, Pravesh Kumar; Li, Nuo; Chen, Meng-Hua

2015-10-07

Type 2 diabetes mellitus (DM) patients have worse adverse cardiovascular outcomes after Percutaneous Coronary Intervention (PCI). However, the adverse cardiovascular outcomes between insulin-treated and non-insulin treated DM patients have been a subject of debate. We sought to compare the short-term (<1 year) and long-term (≥1 year) cardiovascular outcomes between insulin-treated and non-insulin treated DM patients after PCI. Medline and Embase databases were searched for studies by typing 'diabetes and percutaneous coronary intervention/PCI' or 'insulin-treated and non-insulin treated diabetes mellitus and PCI'. Endpoints included adverse cardiovascular outcomes reported in these DM patients during the corresponding follow-up periods. Odd Ratio (OR) with 95% confidence interval (CI) was used to express the pooled effect on discontinuous variables and the pooled analyses were performed with RevMan 5.3. 21 studies have been included in this meta-analysis consisting of a total of 21,759 diabetic patients (6250 insulin-treated and 15,509 non-insulin treated DM patients). Short term mortality, myocardial infarction, target lesion revascularization, major adverse cardiac effects and, stent thrombosis were significantly higher in insulin-treated diabetic patients (OR 1.69, 95% CI 1.40-2.04, p < 0.00001), (OR 1.40, 95% CI 1.16-1.70, p = 0.0005), (OR 1.37, 95% CI 1.06-1.76, p = 0.02), (OR 1.46, 95% CI 1.22-1.76, p < 0.0001) and (OR 1.66, 95% CI 1.16-2.38, p = 0.005) respectively. Long-term cardiovascular outcomes were also significantly higher in insulin-treated DM patients. Insulin treatment in these DM patients was associated with a significantly higher short and long-term adverse cardiovascular outcomes after PCI compared to those DM patients not treated by insulin therapy.

Annoyance judgements of aircraft with and without acoustically treated nacelles

NASA Technical Reports Server (NTRS)

Borsky, P. N.; Leonard, S.

1973-01-01

A series of subjective response laboratory tests were conducted to determine the effectiveness of reducing aircraft noise by treating the aircraft engine nacelles with acoustically absorbent material. A total of 108 subjects participated in the magnitude estimation tests. The subjects were selected from persons who had previously been interviewed and classified according to selected psychological characteristics. The subjects lived in three general areas located at three specified distances from New York's Kennedy Airport. The aircraft signals used in the tests consisted of tape recordings of the landing approach noise of a B-727 aircraft under normal operating conditions. These recordings were electronically altered to simulate an aircraft with acoustically treated nacelles to achieve noise reductions of approximately 6 EPNdB and 12 EPNdB. The results from these tests indicate that significant reductions in annoyance resulted from the synthesized nacelle treatments.

Pediatric Ventilator-Associated Infections: The Ventilator-Associated INfection Study.

PubMed

Willson, Douglas F; Hoot, Michelle; Khemani, Robinder; Carrol, Christopher; Kirby, Aileen; Schwarz, Adam; Gedeit, Rainer; Nett, Sholeen T; Erickson, Simon; Flori, Heidi; Hays, Spencer; Hall, Mark

2017-01-01

Suspected ventilator-associated infection is the most common reason for antibiotics in the PICU. We sought to characterize the clinical variables associated with continuing antibiotics after initial evaluation for suspected ventilator-associated infection and to determine whether clinical variables or antibiotic treatment influenced outcomes. Prospective, observational cohort study conducted in 47 PICUs in the United States, Canada, and Australia. Two hundred twenty-nine pediatric patients ventilated more than 48 hours undergoing respiratory secretion cultures were enrolled as "suspected ventilator-associated infection" in a prospective cohort study, those receiving antibiotics of less than or equal to 3 days were categorized as "evaluation only," and greater than 3 days as "treated." Demographics, diagnoses, comorbidities, culture results, and clinical data were compared between evaluation only and treated subjects and between subjects with positive versus negative cultures. PICUs in 47 hospitals in the United States, Canada, and Australia. All patients undergoing respiratory secretion cultures during the 6 study periods. None. Treated subjects differed from evaluation-only subjects only in frequency of positive cultures (79% vs 36%; p < 0.0001). Subjects with positive cultures were more likely to have chronic lung disease, tracheostomy, and shorter PICU stay, but there were no differences in ventilator days or mortality. Outcomes were similar in subjects with positive or negative cultures irrespective of antibiotic treatment. Immunocompromise and higher Pediatric Logistic Organ Dysfunction scores were the only variables associated with mortality in the overall population, but treated subjects with endotracheal tubes had significantly lower mortality. Positive respiratory cultures were the primary determinant of continued antibiotic treatment in children with suspected ventilator-associated infection. Positive cultures were not associated with worse outcomes irrespective of antibiotic treatment although the lower mortality in treated subjects with endotracheal tubes is notable. The necessity of continuing antibiotics for a positive respiratory culture in suspected ventilator-associated infection requires further study.

Consensus Report of the Coalition for Clinical Research—Self-Monitoring of Blood Glucose

PubMed Central

Klonoff, David C.; Bergenstal, Richard; Blonde, Lawrence; Boren, Suzanne Austin; Church, Timothy S.; Gaffaney, Jenifer; Jovanovič, Lois; Kendall, David M.; Kollman, Craig; Kovatchev, Boris P.; Leippert, Claudia; DDG, Diabetesberaterin; Owens, David R.; Polonsky, William H.; Reach, Gérard; Renard, Eric; Riddell, Michael C.; Rubin, Richard R.; Schnell, Oliver; Siminiero, Linda M.; Vigersky, Robert A.; Wilson, Darrell M.; Wollitzer, Alison Okada

2008-01-01

The Coalition for Clinical Research—Self-Monitoring of Blood Glucose Scientific Board, a group of nine academic clinicians and scientists from the United States and Europe, convened in San Francisco, California, on June 11–12, 2008, to discuss the appropriate uses of self-monitoring of blood glucose (SMBG) and the measures necessary to accurately assess the potential benefit of this practice in noninsulin-treated type 2 diabetes mellitus (T2DM). Thirteen consultants from the United States, Europe, and Canada from academia, practice, and government also participated and contributed based on their fields of expertise. These experts represent a range of disciplines that include adult endocrinology, pediatric endocrinology, health education, mathematics, statistics, psychology, nutrition, exercise physiology, and nursing. This coalition was organized by Diabetes Technology Management, Inc. Among the participants, there was consensus that: protocols assessing the performance of SMBG in noninsulin treated T2DM must provide the SMBG intervention subjects with blood glucose (BG) goals and instructions on how to respond to BG data in randomized controlled trials (RCTs);intervention subjects in clinical trials of SMBG-driven interventions must aggressively titrate their therapeutic responses or lifestyle changes in response to hyperglycemia;control subjects in clinical trials of SMBG must be isolated from SMBG-driven interventions and not be contaminated by physician experience with study subjects receiving a SMBG intervention;the best endpoints to measure in a clinical trial of SMBG in T2DM include delta Hemoglobin A1c levels, hyperglycemic events, hypoglycemic events, time to titrate noninsulin therapy to a maximum necessary dosage, and quality of life indices;either individual randomization or cluster randomization may be appropriate methods for separating control subjects from SMBG intervention subjects, provided that precautions are taken to avoid bias and that the sample size is adequate;treatment algorithms for assessing SMBG in T2DM may include a dietary, exercise, and/or medication intervention, which are all titratable according to the SMBG values;the medical literature contains very little information about the performance of SMBG in T2DM from RCTs in which treatment algorithms were used for dysglycemic values; andresearch on the performance of SMBG in T2DM based on sound scientific principles and clinical practices is needed at this time. PMID:19885292

Visual symptoms and retinal straylight after laser peripheral iridotomy: the Zhongshan Angle-Closure Prevention Trial.

PubMed

Congdon, Nathan; Yan, Xixi; Friedman, David S; Foster, Paul J; van den Berg, Thomas J T P; Peng, Michelle; Gangwani, Rita; He, Mingguang

2012-07-01

To assess the impact of laser peripheral iridotomy (LPI) on forward-scatter of light and subjective visual symptoms and to identify LPI parameters influencing these phenomena. Cohort study derived from a randomized trial, using an external control group. Chinese subjects initially aged 50 or older and 70 years or younger with bilateral narrow angles undergoing LPI in 1 eye selected at random, and age- and gender-matched controls. Eighteen months after laser, LPI-treated subjects underwent digital iris photography and photogrammetry to characterize the size and location of the LPI, Lens Opacity Classification System III cataract grading, and measurement of retinal straylight (C-Quant; OCULUS, Wetzlar, Germany) in the treated and untreated eyes and completed a visual symptoms questionnaire. Controls answered the questionnaire and underwent straylight measurement and (in a random one-sixth sample) cataract grading. Retinal straylight levels and subjective visual symptoms. Among 230 LPI-treated subjects (121 [58.8%] with LPI totally covered by the lid, 43 [19.8%] with LPI partly covered by the lid, 53 [24.4%] with LPI uncovered by the lid), 217 (94.3%) completed all testing, as did 250 (93.3%) of 268 controls. Age, gender, and prevalence of visual symptoms did not differ between treated subjects and controls, although nuclear (P<0.01) and cortical (P = 0.03) cataract were less common among controls. Neither presenting visual acuity nor straylight score differed between the treated and untreated eyes among all treated persons, nor among those (n = 96) with LPI partially or totally uncovered. Prevalence of subjective glare did not differ significantly between participants with totally covered LPI (6.61%; 95% confidence interval [CI], 3.39%-12.5%), partially covered LPI (11.6%; 95% CI, 5.07%-24.5%), or totally uncovered LPI (9.43%; 95% CI, 4.10%-10.3%). In regression models, only worse cortical cataract grade (P = 0.01) was associated significantly with straylight score, and no predictors were associated with subjective glare. None of the LPI size or location parameters were associated with straylight or subjective symptoms. These results suggests that LPI is safe regarding measures of straylight and visual symptoms. This randomized design provides strong evidence that treatment programs for narrow angles would be unlikely to result in important medium-term visual disability. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Protocolized fluid therapy in brain-dead donors: The multi-center randomized MOnIToR trial

PubMed Central

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S.; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-01-01

BACKGROUND Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multi-center randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases organs transplanted. METHODS We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A “protocol-guided fluid therapy” algorithm targeting cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor and our primary analysis was intention-to-treat. Secondary analyses included: 1) modified intention-to-treat where only subjects able to receive the intervention were included, and 2) twelve-month survival in transplant recipients. The study was stopped early. RESULTS We enrolled 556 donors; 279 protocolized care, 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76% of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor, (95%CI: 3.14-3.63) with protocolized care, compared to usual care 3.29 (95%CI: 3.04-3.54) (mean difference, 0.1, 95%CI: -0.25 to 0.45; p=0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95%CI: 3.23-3.8) but was not statistically significant (mean difference, 0.23, 95%CI: -0.15-0.61; p=0.23). Among the 1430 recipients of organs from study subjects, with data available, 56 deaths (7.8%) occurred in the protocolized care arm and 56 (7.9%) in the usual care arm in the first year (Hazard Ratio: 0.97, p=0.86). CONCLUSIONS In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor. PMID:25583616

Burning mouth syndrome: controversial place as a symptom of Oro-dental pathology

PubMed Central

Coculescu, EC; Manole, G; Coculescu, BI; Purcărea, VL

2015-01-01

As defined by WHO experts, disease involves a change of the physical, mental and social welfare, generating chronic stress condition if unresolved. One of the symptoms almost constantly found in any condition is pain. This feeling manifests differently depending on the subjective perception. The burning mouth syndrome (BMS) is included in such a framework. The BMS is considered as one of the characteristic states of chronic stress syndromes associated with nonspecific clinical manifestations and requires special medical attention in terms of assessing and treating the condition. However, the insufficient knowledge of its etiopathogenic mechanisms requires comprehensive research undertaken on such a subject. PMID:26361508

Burning mouth syndrome: controversial place as a symptom of Oro-dental pathology.

PubMed

Coculescu, E C; Manole, G; Coculescu, B I; Purcărea, V L

2015-01-01

As defined by WHO experts, disease involves a change of the physical, mental and social welfare, generating chronic stress condition if unresolved. One of the symptoms almost constantly found in any condition is pain. This feeling manifests differently depending on the subjective perception. The burning mouth syndrome (BMS) is included in such a framework. The BMS is considered as one of the characteristic states of chronic stress syndromes associated with nonspecific clinical manifestations and requires special medical attention in terms of assessing and treating the condition. However, the insufficient knowledge of its etiopathogenic mechanisms requires comprehensive research undertaken on such a subject.

Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome.

PubMed

Inoue, Yuichi; Hirata, Koichi; Hayashida, Kenichi; Hattori, Nobutaka; Tomida, Takayuki; Garcia-Borreguero, Diego

2013-01-10

The present study aimed to examine the long-term efficacy and safety of rotigotine treatment for restless legs syndrome (RLS), as well as the rate of clinically significant augmentation, in a 1-year open-label study of Japanese subjects. Japanese patients with RLS who had been treated with rotigotine or placebo in a double-blind trial were enrolled in a 1-year, open-label, uncontrolled extension study and treated with rotigotine at a dose of up to 3 mg/24 h after an 8-week titration phase. Outcomes included International Restless Legs Syndrome Study Group rating scale (IRLS scale), Pittsburgh Sleep Quality Index (PSQI), safety, and investigator-/expert panel-assessed augmentation (including Augmentation Severity Rating Scale). Overall, 185 patients entered the open-label study and 133 completed the study. IRLS and PSQI total scores improved throughout the 52-week treatment period (IRLS, from 23.2±5.1 to 7.8±7.6 and PSQI, from 8.0±3.1 to 5.0±2.9). Treatment-emergent adverse events were mild to moderate in severity, and included application site reactions (52.4%) and nausea (28.6%). Clinically significant augmentation occurred in five patients (2.7%). These results indicate a good long-term efficacy of rotigotine for treating RLS, with a relatively low risk of clinically significant augmentation. Copyright © 2012 Elsevier Inc. All rights reserved.

Severe difficulties with word recognition in noise after platinum chemotherapy in childhood, and improvements with open-fitting hearing-aids.

PubMed

Einarsson, Einar-Jón; Petersen, Hannes; Wiebe, Thomas; Fransson, Per-Anders; Magnusson, Måns; Moëll, Christian

2011-10-01

To investigate word recognition in noise in subjects treated in childhood with chemotherapy, study benefits of open-fitting hearing-aids for word recognition, and investigate whether self-reported hearing-handicap corresponded to subjects' word recognition ability. Subjects diagnosed with cancer and treated with platinum-based chemotherapy in childhood underwent audiometric evaluations. Fifteen subjects (eight females and seven males) fulfilled the criteria set for the study, and four of those received customized open-fitting hearing-aids. Subjects with cisplatin-induced ototoxicity had severe difficulties recognizing words in noise, and scored as low as 54% below reference scores standardized for age and degree of hearing loss. Hearing-impaired subjects' self-reported hearing-handicap correlated significantly with word recognition in a quiet environment but not in noise. Word recognition in noise improved markedly (up to 46%) with hearing-aids, and the self-reported hearing-handicap and disability score were reduced by more than 50%. This study demonstrates the importance of testing word recognition in noise in subjects treated with platinum-based chemotherapy in childhood, and to use specific custom-made questionnaires to evaluate the experienced hearing-handicap. Open-fitting hearing-aids are a good alternative for subjects suffering from poor word recognition in noise.

CD8 T-Cell Expansion and Inflammation Linked to CMV Coinfection in ART-treated HIV Infection

PubMed Central

Freeman, Michael L.; Mudd, Joseph C.; Shive, Carey L.; Younes, Souheil-Antoine; Panigrahi, Soumya; Sieg, Scott F.; Lee, Sulggi A.; Hunt, Peter W.; Calabrese, Leonard H.; Gianella, Sara; Rodriguez, Benigno; Lederman, Michael M.

2016-01-01

Background. Persistent CD8 T-cell expansion, low CD4/CD8 T-cell ratios, and heightened inflammation persist in antiretroviral therapy (ART)-treated human immunodeficiency virus (HIV) infection and are associated with increased risk of morbid outcomes. We explored the role of cytomegalovirus (CMV) infection in CD8 lymphocytosis and inflammation in ART-treated HIV infection. Methods. Absolute CD4 and CD8 T-cell counts were abstracted from clinical records and compared among 32 HIV-infected CMV-seronegative subjects, 126 age, CD4 and gender-matched HIV-infected CMV-seropositive subjects, and among 21 HIV-uninfected controls (9 CMV-negative, 12 CMV-positive). Plasma inflammatory indices were measured in a subset by ELISA. Results. Median CD8 counts/µL were higher in HIV-positive/CMV-positive patients (795) than in HIV-positive/CMV-negative subjects (522, P = .006) or in healthy controls (451, P = .0007), whereas CD8 T-cell counts were similar to controls' levels in HIV-positive/CMV-negative subjects. Higher plasma levels of IP-10 (P = .0011), TNF-RII (P = .0002), and D-dimer (P = .0444) were also found in coinfected patients than in HIV-positive/CMV-negative subjects. Conclusions. CMV infection is associated with higher CD8 T-cell counts, resultant lower CD4/CD8 ratios, and increased systemic inflammation in ART-treated HIV infection. CMV infection may contribute to risk for morbid outcomes in treated HIV infection. PMID:26400999

Spacecraft technology. [development of satellites and remote sensors

NASA Technical Reports Server (NTRS)

1975-01-01

Developments in spacecraft technology are discussed with emphasis on the Explorer satellite program. The subjects considered include the following: (1) nutational behavior of the Explorer-45 satellite, (2) panoramic sensor development, (3) onboard camera signal processor for Explorer satellites, and (4) microcircuit development. Information on the zero gravity testing of heat pipes is included. Procedures for cleaning heat treated aluminum heat pipes are explained. The development of a five-year magnetic tape, an accurate incremental angular encoder, and a blood freezing apparatus for leukemia research are also discussed.

Goal management training of executive functions in patients with spina bifida: a randomized controlled trial.

PubMed

Stubberud, Jan; Langenbahn, Donna; Levine, Brian; Stanghelle, Johan; Schanke, Anne-Kristine

2013-07-01

Executive dysfunction causes significant real-life disability for patients with spina bifida (SB). However, no previous research has been directed toward the amelioration of executive functioning deficits amongst persons with SB. Goal Management Training (GMT) is a compensatory cognitive rehabilitation approach, addressing underlying deficits in sustained attention to improve executive function. GMT has received empirical support in studies of other patient groups. The purpose of the present study was to determine the efficacy of GMT in treating subjects with SB, using inpatient intervention periods. We hypothesized post-intervention changes in scores on neuropsychological measures to reflect improved attentional control, including sustained attention and inhibitory control. Thirty-eight adult subjects with SB were included in this randomized controlled trial. Inclusion was based upon the presence of executive functioning complaints. Experimental subjects (n = 24) received 21 hr of GMT, with efficacy of GMT being compared to results of subjects in a wait-list condition (n = 14). All subjects were assessed at baseline, post-intervention, and at 6-month follow-up. Findings indicated superior effects of GMT on domain-specific neuropsychological measures and on a functional "real-life" measure, all lasting at least 6 months post-treatment. These results show that deficits in executive functioning can be ameliorated in patients with congenital brain dysfunction.

Overweight, obesity and features of metabolic syndrome in children with diabetes treated with insulin pump therapy.

PubMed

Łuczyński, Włodzimierz; Szypowska, Agnieszka; Głowińska-Olszewska, Barbara; Bossowski, Artur

2011-07-01

There has been no specific evaluation of atherogenic risk factors in children with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII). We, therefore, studied the prevalence of overweight/obesity and metabolic syndrome among these patients. Five hundred children with T1DM treated with CSII and multiple daily insulin (MDI) regimen were included in the study. Anthropometric data/physical examination, data concerning diabetes, and a lipid profile were assessed in this group, and compared with respect to treatment method (CSII vs. MDI). Almost one-third (30.2%) of the children were overweight/obese. The body mass index (BMI) values at the time of the present evaluation were significantly higher in comparison with the BMI values 3-6 months after the diagnosis. Dyslipidemia was recognized in 51.6%, hypertension in 4.8%, and the metabolic syndrome in 3.2%. of the subjects. The overweight/obese children differed from their normal-weight counterparts with respect to metabolic control, the incidence of hypertension, dyslipidemia, and metabolic syndrome. The girls showed higher prevalence of overweight/obesity and higher BMI values compared to the boys. The children treated with CSII had the same prevalence of overweight/obesity, but a lower incidence of dyslipidemia, and a better metabolic control compared to the children treated with MDI regimen. Our study shows a high prevalence of overweight/obesity and dyslipidemia in children with T1DM including those treated with an insulin pump.

Extra-corporeal blood access, sensing, and radiation methods and apparatuses

NASA Technical Reports Server (NTRS)

Castle, Kent D. (Inventor)

1993-01-01

The described invention is related to extra-corporeal blood access and radiation methods and apparatuses and, in particular, to subjecting flowing blood to energy in variety of forms, including radiation, electromagnetic force fields or atomic particles. It is directed to methods and apparatuses for accessing flowing blood and for subjecting the blood to electrical conductive, electrostatic or electromagnetic fields or for radiating the blood with some type of radiation, e.g., radio waves, ultrasonic or audio waves, microwaves, IR rays, visible light, UV radiation, x-rays, alpha, beta or gamma rays. An apparatus is employed which includes one or more access ports or windows for radiating blood and/or for sensing/analyzing blood. This invention is useful for killing viruses and bacteria in blood, monitoring blood for medical purposes, genetic modification of blood, and analyzing and/or treating blood components.

The efficacy of cryolipolysis treatment on arms and inner thighs.

PubMed

Wanitphakdeedecha, Rungsima; Sathaworawong, Angkana; Manuskiatti, Woraphong

2015-11-01

Cryolipolysis has emerged as a new non-invasive body contouring method using controlled cooling to selectively destroy fat cells. Previous studies demonstrated the safety and efficacy of cryolipolysis for the reduction of localized subcutaneous fat on abdomen and flanks. Recently, the new flat cup vacuum applicator has been developed to treat localized subcutaneous fat on arms and inner thighs. The objective of this study was to determine the efficacy of non-invasive cryolipolysis for body contouring with a flat cup vacuum applicator on arms and inner thighs. Twenty females with excess localized subcutaneous fat on arms or inner thighs received a single cryolipolysis treatment. Forty treatment areas have been treated including 10 arms and 30 inner thighs. Subjects were evaluated using standardized photographs and measurements of body weight and circumference of arms or inner thighs at baseline, 3-month, and 6-month follow-up visits. Physicians' evaluation and patient's satisfaction of clinical improvement were also measured. Of all 20 subjects, 17 (10 arms and 24 inner thighs) completed the treatment protocol and attended all follow-up visits. Three subjects were withdrawn from the study, 1 subject could not complete the treatment session due to pain and numbness during treatment, 1 subject became pregnant after treatment, and the other subject could not attend all required follow-up visits. There was significant circumference reduction of 0.41 and 0.72 cm at 3-month and 6-month follow-up visits (p = 0.017), respectively. Most of the patients were rated to have 1-25% improvement at 6 months after treatment and were satisfied with the treatment outcome. The new cryolipolysis flat cup vacuum applicator provided beneficial effects for circumferential reduction of arms and inner thighs.

An assessment of anti-schistosomal treatment on physical work capacity.

PubMed

Awad El Karim, M A; Collins, K J; Sukkar, M Y; Omer, A H; Amin, M A; Doré, C

1981-04-01

Acting as their own controls, village subjects from the Gezira are of the Sudan with relatively high levels of schistosomiasis infection were first tested in an exercise laboratory in Khartoum and the tests were then repeated after a period of about 1 yr during which time the subjects were treated with hycanthone and periodically monitored to ensure that they had remained free of the disease. In the meantime they were also given anti-malarial prophylaxis. Laboratory tests showed a significant improvement in physiological work capacity of up to 20% after treatment compared with untreated controls. An overall improvement in pulmonary function, particularly forced vital capacity, was observed as well as a significant increase in mean haemoglobin concentration by 1.1 g/100 ml of blood in the treated group. Apart from these improvements in physical working capacity, the treated subjects subjectively felt better after the exercise tests, as expressed by the disappearance of fatiguability.

Stable Meniscal Tears Left In Situ at the Time of Arthroscopic Anterior Cruciate Ligament Reconstruction: A Systematic Review.

PubMed

Rothermich, Marcus A; Cohen, Jared A; Wright, Rick

2016-04-01

Meniscal tears can be incidentally encountered at the time of anterior cruciate ligament (ACL) reconstruction. In these cases, the surgeon has several treatment options that include benign neglect, debridement, trephination, and repair. The authors performed a systematic review of the literature studying the various treatment options for meniscal tears discovered at the time of ACL reconstruction. This systematic review included eight articles that had relevant data regarding benign neglect compared with debridement, trephination, or repair of incidentally encountered meniscal tears. Combined data from these studies resulted in a total of 646 meniscal tears treated with benign neglect with follow-up information available. Importantly, there were differences in reoperation rates between medial and lateral meniscal tears left in situ. However, stable medial and lateral meniscal tears treated with benign neglect did not have different subjective or objective outcomes than those treated with surgical intervention. This systematic review concludes that when stable meniscal tears are encountered at the time of arthroscopic ACL reconstruction, benign neglect can be used for a successful outcome. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Gut microbiota in MS: possible influence of immunomodulators

PubMed Central

Cantarel, Brandi L.; Waubant, Emmanuelle; Chehoud, Christel; Kuczynski, Justin; DeSantis, Todd Z.; Warrington, Janet; Venkatesan, Arun; Fraser, Claire M.; Mowry, Ellen M.

2015-01-01

Objectives Differences in gut bacteria have been described in several autoimmune disorders. In this exploratory pilot study, we compared gut bacteria in multiple sclerosis patients and healthy controls and evaluated the influence of glatiramer acetate and vitamin D treatment on the microbiota. Methods Subjects were otherwise healthy white women with or without relapsing-remitting multiple sclerosis who were vitamin D insufficient. Multiple sclerosis patients were untreated or were receiving glatiramer acetate. Subjects collected stool at baseline and after 90 days of vitamin D3 (5,000 IU/day) supplementation. The abundance of operational taxonomic units was evaluated by hybridization of 16S rRNA to a DNA microarray. Results While there was overlap of gut bacterial communities, the abundance of some operational taxonomic units, including Faecalibacterium, was lower in multiple sclerosis patients. Glatiramer acetate-treated MS subjects showed differences in community composition compared to untreated subjects, including Bacteroidaceae, Faecalibacterium, Ruminococcus, Lactobacillaceae, Clostridium, and Other Clostridiales. Compared to the other groups, untreated multiple sclerosis subjects had an increase in the Akkermansia, Faecalibacterium, and Coprococcus genera after vitamin D supplementation. Conclusions While overall bacterial communities were similar, specific operational taxonomic units differed between healthy and multiple sclerosis subjects. Glatiramer acetate and vitamin D supplementation were associated with differences or changes in the microbiota. This study was exploratory, and larger studies are needed to confirm these preliminary results. PMID:25775034

Effects of bariatric surgery on gout incidence in the Swedish Obese Subjects study: a non-randomised, prospective, controlled intervention trial.

PubMed

Maglio, Cristina; Peltonen, Markku; Neovius, Martin; Jacobson, Peter; Jacobsson, Lennart; Rudin, Anna; Carlsson, Lena M S

2017-04-01

To assess the long-term effect of bariatric surgery on the incidence of gout and hyperuricaemia in participants of the Swedish Obese Subjects (SOS) study. This report includes 1982 subjects who underwent bariatric surgery and 1999 obese controls from the SOS study, a prospective intervention trial designed to assess the effect of bariatric surgery compared with conventional treatment. None of the subjects had gout at baseline. An endpoint on gout incidence was created based on information on gout diagnosis and use of gout medications through national registers and questionnaires. Median follow-up for the incidence of gout was about 19 years for both groups. Moreover, the incidence of hyperuricaemia over up to 20 years was examined in a subgroup of participants having baseline uric acid levels <6.8 mg/dL. Bariatric surgery was associated with a reduced incidence of gout compared with usual care (adjusted HR 0.60, 95% CI 0.48 to 0.75, p<0.001). The difference in absolute risk between groups was 3 percentage points at 15 years, and the number of subjects needed to be treated by bariatric surgery to prevent one incident gout event was 32 (95% CI 22 to 59). The effect of bariatric surgery on gout incidence was not influenced by baseline risk factors, including body mass index. During follow-up, the surgery group had a lower incidence of hyperuricaemia (adjusted HR 0.47, 95% CI 0.39 to 0.58, p<0.001). The difference in absolute risk between groups was 12 percentage points at 15 years, and the number of participants needed to be treated by bariatric surgery to prevent hyperuricaemia was 8 (95% CI 6 to 13). Bariatric surgery prevents gout and hyperuricaemia in obese subjects. NCT01479452; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder: A Double-Blind Placebo-Controlled Trial

PubMed Central

Phillips, Katharine A.; Keshaviah, Aparna; Dougherty, Darin; Stout, Robert L.; Menard, William; Wilhelm, Sabine

2016-01-01

Objective Body dysmorphic disorder (BDD) is common, distressing, and often severely impairing. Serotonin-reuptake inhibitors (SRIs) appear efficacious for BDD, but the few existing pharmacotherapy studies were short-term (≤4 months), and no relapse prevention studies or continuation phase studies have been conducted. We report results from the first BDD relapse prevention study. Method Adults (N=100) with DSM-IV BDD received open-label escitalopram for 14 weeks (Phase 1); 58 responders were then randomized to double-blind continuation treatment with escitalopram versus switch to placebo for six months (Phase 2). Reliable and valid outcome measures were utilized. Results Phase 1: Overall, 67.0% of treated subjects and 81.1% of completers were escitalopram responders (p’s<0.0001). BDD severity, BDD-related insight, depressive symptoms, psychosocial functioning, and quality of life significantly improved from baseline to end of Phase 1 (all p's<0.0001). Phase 2: Time to relapse was significantly longer for subjects receiving escitalopram than those receiving placebo (hazard ratio=2.72, 95% CI [1.01, 8.57], p=0.049). Phase 2 relapse proportions were 18% for escitalopram versus 40% for placebo. In escitalopram-treated subjects, BDD severity significantly decreased over time during the continuation treatment phase (p=0.036); further improvement occurred in 35.7% of the escitalopram group. There were no significant group differences in BDD severity, insight, depressive symptoms, psychosocial functioning, or quality of life. Conclusions Continuation-phase escitalopram delayed time to relapse, and fewer escitalopram-treated subjects relapsed compared with placebo-treated subjects. BDD severity significantly further improved during six additional months of escitalopram treatment following acute response; more than one-third of escitalopram-treated subjects had further improvement during continuation phase treatment. PMID:27056606

The restoration of the vaginal microbiota after treatment for bacterial vaginosis with metronidazole or probiotics.

PubMed

Ling, Zongxin; Liu, Xia; Chen, Weiguang; Luo, Yueqiu; Yuan, Li; Xia, Yaxian; Nelson, Karen E; Huang, Shaolei; Zhang, Shaoen; Wang, Yuezhu; Yuan, Jieli; Li, Lanjuan; Xiang, Charlie

2013-04-01

Whether or not treatment with antibiotics or probiotics for bacterial vaginosis (BV) is associated with a change in the diversity of vaginal microbiota in women was investigated. One hundred fifteen women, consisting of 30 healthy subjects, 30 BV-positive control subjects, 30 subjects with BV treated with a 7-day metronidazole regimen, and 25 subjects with BV treated with a 10-day probiotics regimen, were analyzed to determine the efficacy and disparity of diversity and richness of vaginal microbiota using 454 pyrosequencing. Follow-up visits at days 5 and 30 showed a greater BV cure rate in the probiotics-treated subjects (88.0 and 96 %, respectively) compared to the metronidazole-treated subjects (83.3 and 70 %, respectively [p = 0.625 at day 5 and p = 0.013 at day 30]). Treatment with metronidazole reduced the taxa diversity and eradicated most of the BV-associated phylotypes, while probiotics only suppressed the overgrowth and re-established vaginal homeostasis gradually and steadily. Despite significant interindividual variation, the microbiota of the actively treated groups or participants constituted a unique profile. Along with the decrease in pathogenic bacteria, such as Gardnerella, Atopobium, Prevotella, Megasphaera, Coriobacteriaceae, Lachnospiraceae, Mycoplasma, and Sneathia, a Lactobacillus-dominated vaginal microbiota was recovered. Acting as vaginal sentinels and biomarkers, the relative abundance of Lactobacillus and pathogenic bacteria determined the consistency of the BV clinical and microbiologic cure rates, as well as recurrent BV. Both 7-day intravaginal metronidazole and 10-day intravaginal probiotics have good efficacy against BV, while probiotics maintained normal vaginal microbiota longer due to effective and steady vaginal microbiota restoration, which provide new insights into BV treatment.

Emotional memory and migraine: effects of amitriptyline and sex related difference.

PubMed

Gasbarri, Antonella; Arnone, Benedetto; Pompili, Assunta; Cifariello, Agata; Marini, Carmine; Tavares, M Clotilde; Tomaz, Carlos

2008-05-16

Many studies suggest that emotional arousal improves memory storage. The aim of this study was to evaluate the effects of emotional content on explicit memory in untreated cephalalgic patients and in migraineurs treated with the antidepressant amitriptyline. We utilized an adaptation of two versions of the same story, with different arousing properties (neutral or emotional), which have been already employed in experiments involving the enhancing effects of emotions on memory retention. Subjects of the present study were healthy subjects and cephalalgic patients, suffering from migraine headache, which included untreated migraineurs and migraineurs treated with the antidepressant amitriptyline. The findings of our experiments suggest that chronic migraine is related to memory impairment. Taking into account that migraine is associated with major depression, in the present research the effect of the antidepressant amitriptyline was also evaluated. Our results showed that amitriptyline has an impairment effect on memory. In fact, the untreated migraineurs, compared to treated, recalled the most emotional phase of the arousal story significantly better. Then, our data suggest that amitriptyline prevents the enhancing effects of emotional content on memory processes. Moreover, in agreement with our previous data, this study suggests the existence of gender differences in the processing of emotional stimuli and underscores the importance of sex on emotional memory mechanisms.

Effect of diabetic retinopathy and panretinal photocoagulation on retinal nerve fiber layer and optic nerve appearance.

PubMed

Lim, Michele C; Tanimoto, Suzana A; Furlani, Bruno A; Lum, Brent; Pinto, Luciano M; Eliason, David; Prata, Tiago S; Brandt, James D; Morse, Lawrence S; Park, Susanna S; Melo, Luiz A S

2009-07-01

To determine if panretinal photocoagulation (PRP) alters retinal nerve fiber layer (RNFL) thickness and optic nerve appearance. Patients with diabetes who did and did not undergo PRP and nondiabetic control subjects were enrolled in a prospective study. Participants underwent optical coherence tomography of the peripapillary retina and optic nerve. Stereoscopic optic nerve photographs were graded in a masked fashion. Ninety-four eyes of 48 healthy individuals, 89 eyes of 55 diabetic patients who did not undergo PRP, and 37 eyes of 24 subjects with diabetes who underwent PRP were included in this study. Eyes that had been treated with PRP had thinner peripapillary RNFL compared with the other groups; this was statistically significantly different in the inferior (P = .004) and nasal (P = .003) regions. Optic nerve cupping did not increase with severity of disease classification, but the proportion of optic nerves graded as suspicious for glaucoma or as having nonglaucomatous optic neuropathy did (P = .008). These grading categories were associated with thinner RNFL measurements. Diabetic eyes that have been treated with PRP have thinner RNFL than nondiabetic eyes. Optic nerves in eyes treated with PRP are more likely to be graded as abnormal, but their appearance is not necessarily glaucomatous and may be related to thinning of the RNFL.

Garment Selection for Cleanrooms and Controlled Environments for Spacecraft

DTIC Science & Technology

1991-04-01

visually undetectable, making it diffi- cult for a worker to select a treated garment. The optimal solution has been to weave a grid of synthetic coated ...make the base fabric static-dis- sipative must be selected carefully. Nylon- coated conductive yarns are readily subject to acid attack, while...Cations (+ ) which must be eliminated from garments include sodium, potassium, lithi- um, aluminum, boron , and arsenic. The standard mtwhod for

Increased mortality associated with treated active tuberculosis in HIV-infected adults in Tanzania

PubMed Central

Kabali, Conrad; Mtei, Lillian; Brooks, Daniel R.; Waddell, Richard; Bakari, Muhammad; Matee, Mecky; Arbeit, Robert D.; Pallangyo, Kisali; von Reyn, C. Fordham; Horsburgh, C. Robert

2013-01-01

SUMMARY Active tuberculosis (TB) among HIV-infected patients, even when successfully treated, may be associated with excess mortality. We conducted a prospective cohort study nested in a randomized TB vaccine trial to compare mortality between HIV-infected patients diagnosed and treated for TB (TB, n=77) and HIV-infected patients within the same CD4 range, who were not diagnosed with or treated for active TB (non-TB, n=308) in the period 2001–2008. Only twenty four subjects (6%) were on antiretroviral therapy at the beginning of this study. After accounting for covariate effects including use of antiretroviral therapy, isoniazid preventive therapy, and receipt of vaccine, we found a four-fold increase in mortality in TB patients compared with non-TB patients (adjusted Hazard Ratio 4.61; 95% Confidence Interval (CI): 1.63, 13.05). These findings suggest that treatment for TB alone is not sufficient to avert the excess mortality associated with HIV-related TB and that prevention of TB may provide a mortality benefit. PMID:23523641

Methods for assisting recovery of damaged brain and spinal cord and treating various diseases using arrays of x-ray microplanar beams

DOEpatents

Dilmanian, F Avraham [Yaphank, NY; Anchel, David J [Rocky Point, NY; Gaudette, Glenn [Holden, MA; Romanelli, Pantaleo [Monteroduni, IT; Hainfeld, James [Shoreham, NY

2010-06-29

A method of assisting recovery of an injury site of the central nervous system (CNS) or treating a disease includes providing a therapeutic dose of X-ray radiation to a target volume through an array of parallel microplanar beams. The dose to treat CNS injury temporarily removes regeneration inhibitors from the irradiated site. Substantially unirradiated cells surviving between beams migrate to the in-beam portion and assist recovery. The dose may be staggered in fractions over sessions using angle-variable intersecting microbeam arrays (AVIMA). Additional doses are administered by varying the orientation of the beams. The method is enhanced by injecting stem cells into the injury site. One array or the AVIMA method is applied to ablate selected cells in a target volume associated with disease for palliative or curative effect. Atrial fibrillation is treated by irradiating the atrial wall to destroy myocardial cells while continuously rotating the subject.

Conservative Approach in Patients with Pemphigus Gingival Vulgaris: A Pilot Study of Five Cases

PubMed Central

Gambino, Alessio; Carbone, Mario; Arduino, Paolo G.; Carbone, Lucio; Broccoletti, Roberto

2014-01-01

Objectives. The aim of this pilot study was to describe the clinical efficacy of a conservative oral hygiene protocol in patients affected by gingival pemphigus vulgaris (PV) applied in a case series. Methods. Subjects suffering from PV with gingival localisation and slightly responsive to conventional treatment with systemic corticosteroids and immunosuppressive drugs were selected among individuals treated in the Unit of Oral Medicine Section of the University of Turin. Five subjects received nonsurgical periodontal therapy, over a 7-day period, including oral hygiene instructions; patients were instructed about domiciliary oral hygiene maintenance and instructions were reinforced at each visit and personalised if necessary. Clinical outcome variables were recorded at baseline (before starting) and 16 weeks after intervention, including full mouth plaque score (FMPS), bleeding scores (FMBS), probing pocket depth (PPD), oral pemphigus clinical score (OPCS), and patient related outcomes (visual analogue score of pain). Results. Five patients were treated and, after finishing the proposed therapy protocol, a statistical significant reduction was observed for FMBS (P = 0.043) and OPCS (P = 0.038). Conclusions. Professional oral hygiene procedures with nonsurgical therapy are related to an improvement of gingival status and a decrease of gingival bleeding in patients affected by PV with specific gingival localization. PMID:25505912

Trismus following different treatment modalities for head and neck cancer: a systematic review of subjective measures.

PubMed

Loh, Sook Y; Mcleod, Robert W J; Elhassan, Hassan A

2017-07-01

The aim of this review was to compare systematically the subjective measure of trismus between different interventions to treat head and neck cancer, particularly those of the oropharynx. Using The Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) Guidelines, Six databases were searched for the text using various terms which include "oropharyngeal/head and neck cancer", "trismus/mouth opening" and the various treatment modalities. Included in the review were clinical studies (> or =10 patients). Three observers independently assessed the papers identified. Among the six studies reviewed, five showed a significantly worst outcome with regard to the quality-of-life questionnaire scores for a radiotherapy or surgery and radiotherapy (RT) ± chemotherapy or chemoradiotherapy when compared to surgery alone. Only one study showed no significant difference between surgery alone and other treatment modalities. Subjective quality-of-life measures are a concurrent part of modern surgical practice. Although subjective measures were utilised to measure post operative trismus successfully, there was no consensus as to which treatment modality had overall better outcomes, with conflicting studies in keeping with the current debate in this field. Larger and higher quality studies are needed to compare all three treatment modalities.

The temporal limits of cognitive change from music therapy in elderly persons with dementia or dementia-like cognitive impairment: a randomized controlled trial.

PubMed

Bruer, Robert A; Spitznagel, Edward; Cloninger, C Robert

2007-01-01

This study explored the temporal limits of cognitive change from an intention-to-treat with group music therapy. Elderly cognitively-impaired psychiatric inpatients (N = 28) participated in an 8-week randomized control trial using a crossover design. Once a week, subjects were assigned either to music therapy or a control treatment (age-appropriate movie). The Mini-Mental State Exam (MMSE) assessed cognition 3 times every week: prior to the intervention, immediately after the mid-afternoon intervention, and the morning following the intervention. Comparisons between conditions included weekly changes in individual subject's MMSE scores from weekly baseline to both the 2 follow-ups and the following week's baseline. Significant next morning improvements in MMSE scores were found within intent-to-treat music therapy cases as compared to control cases. While all the subjects in this study were cognitively impaired, only 17 had been formally diagnosed with dementia. Based on a Cochrane Collaboration suggestion that music therapy studies within geriatric populations look specifically at the treatment of dementia, a final generalized estimating equation model considered only the change within the 17 dementia-diagnosed subjects. Immediately after the intervention, MMSE scores in the dementia-diagnosed subjects assigned to music therapy improved 2.00 points compared to the dementia-diagnosed subjects assigned to the control group (Z = 1.99, p < .05). Next-day MMSE test scores in the dementia-diagnosed subjects assigned to music therapy showed average improvements of 3.69 points compared to the control subjects (Z = 3.38, p < .001). By the following week, no significant cognitive differences remained between the two groups. It was concluded that a reasonable music therapy intervention facilitated by a trained and accredited music therapist significantly improved next-morning cognitive functioning among dementia patients. With many music therapists working in geriatric settings, more research is justified to both replicate this study and provide better guidance into the effective use of music therapy in the treatment of dementia.

Effect of Class III bone anchor treatment on airway.

PubMed

Nguyen, Tung; De Clerck, Hugo; Wilson, Michael; Golden, Brent

2015-07-01

To compare airway volumes and minimum cross-section area changes of Class III patients treated with bone-anchored maxillary protraction (BAMP) versus untreated Class III controls. Twenty-eight consecutive skeletal Class III patients between the ages of 10 and 14 years (mean age, 11.9 years) were treated using Class III intermaxillary elastics and bilateral miniplates (two in the infra-zygomatic crests of the maxilla and two in the anterior mandible). The subjects had cone beam computed tomographs (CBCTs) taken before initial loading (T1) and 1 year out (T2). Twenty-eight untreated Class III patients (mean age, 12.4 years) had CBCTs taken and cephalograms generated. The airway volumes and minimum cross-sectional area measurements were performed using Dolphin Imaging 11.7 3D software. The superior border of the airway was defined by a plane that passes through the posterior nasal spine and basion, while the inferior border included the base of the epiglottis to the lower border of C3. From T1 to T2, airway volume from BAMP-treated subjects showed a statistically significant increase (1499.64 mm(3)). The area in the most constricted section of the airway (choke point) increased slightly (15.44 mm(2)). The airway volume of BAMP patients at T2 was 14136.61 mm(3), compared with 14432.98 mm(3) in untreated Class III subjects. Intraexaminer correlation coefficients values and 95% confidence interval values were all greater than .90, showing a high degree of reliability of the measurements. BAMP treatment did not hinder the development of the oropharynx.

Intima-Media Thickness in the Carotid and Femoral Arteries for Detection of Arteriosclerosis in Human Immunodeficiency Virus-Positive Individuals.

PubMed

Godoi, Emmanuelle Tenório Albuquerque Madruga; Brandt, Carlos Teixeira; Lacerda, Heloisa Ramos; Godoi, Jocelene Tenório Albuquerque Madruga; Oliveira, Dinaldo Cavalcanti de; Costa, Gabriela Farias Araujo Sousa; Santos Junior, Gerson Gomes Dos; Leite, Kaliene Maria Estevão; Godoi, Juannicelle Tenório Albuquerque Madruga; Vasconcelos, Adriana Ferraz de

2017-01-01

The prevalence of atherosclerosis is higher in HIV-positive people, who also experience it earlier than the general population. To assess and compare the prevalence of atherosclerosis evaluated by the intima-media thickness of carotid and femoral arteries, and by the ankle-brachial pressure index (ABPI) in HIV patients treated or not treated with protease inhibitors (PIs) and controls. Eighty HIV+ subjects (40 using PIs and 40 not using PIs) and 65 controls were included in the study. Atherosclerosis was diagnosed by (carotid and femoral) ITM measurement and ABPI. Classical risk factors for atherosclerosis and HIV were compared between the groups by statistical tests. A p ≤ 0.05 was considered significant. An IMT > P75 or the presence of plaque was higher in the HIV+ than in the control group (37.5% vs 19%, p = 0.04). Comparative analysis showed a significant difference (p=0.014) in carotid IMT between HIV+ with PIs (0.71 ± 0.28 mm), without PIs 0.63 ± 0.11 mm and, and controls (0.59 ± 0.11 mm). There was no significant difference in femoral IMT between the groups or in ABPI between HIV+ subjects and controls. However, a significant difference (p=0.015) was found between HIV+ patients not treated with PIs (1.17 [1.08 - 1.23]), and controls 1.08 [1.07 - 1.17]). In HIV patients, atherosclerosis is more prevalent and seems to occur earlier with particular characteristics compared with HIV-negative subjects.

Epigenetics modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA study.

PubMed

Marin, Jose M; Artal, Jorge; Martin, Teresa; Carrizo, Santiago J; Andres, Marta; Martin-Burriel, Inmaculada; Bolea, Rosa; Sanz, Arianne; Varona, Luis; Godino, Javier; Gallego, Begoña; Garcia-Erce, Jose A; Villar, Isabel; Gil, Victoria; Forner, Marta; Cubero, Jose P; Ros, Luis

2014-07-12

Obstructive sleep apnea (OSA) is associated with increased risk for cardiovascular morbidity and mortality. Epidemiological and animal models studies generate hypotheses for innovative strategies in OSA management by interfering intermediates mechanisms associated with cardiovascular complications. We have thus initiated the Epigenetics modification in Obstructive Sleep Apnea (EPIOSA) study (ClinicalTrials.gov identifier: NCT02131610). EPIOSA is a prospective cohort study aiming to recruit 350 participants of caucasian ethnicity and free of other chronic or inflammatory diseases: 300 patients with prevalent OSA and 50 non-OSA subjects. All of them will be follow-up for at least 5 years. Recruitment and study visits are performed in single University-based sleep clinic using standard operating procedures. At baseline and at each one year follow-up examination, patients are subjected to a core phenotyping protocol. This includes a standardized questionnaire and physical examination to determine incident comorbidities and health resources utilization, with a primary focus on cardiovascular events. Confirmatory outcomes information is requested from patient records and the regional Department of Health Services. Every year, OSA status will be assessed by full sleep study and blood samples will be obtained for immediate standard biochemistry, hematology, inflammatory cytokines and cytometry analysis. For biobanking, aliquots of serum, plasma, urine, mRNA and DNA are also obtained. Bilateral carotid echography will be performed to assess subclinical atherosclerosis and atherosclerosis progression. OSA patients are treated according with national guidelines. EPIOSA will enable the prospective evaluation of inflammatory and epigenetics mechanism involved in cardiovascular complication of treated and non-treated patients with OSA compared with non OSA subjects.

Prognosis of white-coat and masked hypertension: International Database of HOme blood pressure in relation to Cardiovascular Outcome.

PubMed

Stergiou, George S; Asayama, Kei; Thijs, Lutgarde; Kollias, Anastasios; Niiranen, Teemu J; Hozawa, Atsushi; Boggia, José; Johansson, Jouni K; Ohkubo, Takayoshi; Tsuji, Ichiro; Jula, Antti M; Imai, Yutaka; Staessen, Jan A

2014-04-01

Home blood pressure monitoring is useful in detecting white-coat and masked hypertension and is recommended for patients with suspected or treated hypertension. The prognostic significance of white-coat and masked hypertension detected by home measurement was investigated in 6458 participants from 5 populations enrolled in the International Database of HOme blood pressure in relation to Cardiovascular Outcomes. During a median follow-up of 8.3 years, 714 fatal plus nonfatal cardiovascular events occurred. Among untreated subjects (n=5007), cardiovascular risk was higher in those with white-coat hypertension (adjusted hazard ratio 1.42; 95% CI [1.06-1.91]; P=0.02), masked hypertension (1.55; 95% CI [1.12-2.14]; P<0.01) and sustained hypertension (2.13; 95% CI [1.66-2.73]; P<0.0001) compared with normotensive subjects. Among treated patients (n=1451), the cardiovascular risk did not differ between those with high office and low home blood pressure (white-coat) and treated controlled subjects (low office and home blood pressure; 1.16; 95% CI [0.79-1.72]; P=0.45). However, treated subjects with masked hypertension (low office and high home blood pressure; 1.76; 95% CI [1.23-2.53]; P=0.002) and uncontrolled hypertension (high office and home blood pressure; 1.40; 95% CI [1.02-1.94]; P=0.04) had higher cardiovascular risk than treated controlled patients. In conclusion, white-coat hypertension assessed by home measurements is a cardiovascular risk factor in untreated but not in treated subjects probably because the latter receive effective treatment on the basis of their elevated office blood pressure. In contrast, masked uncontrolled hypertension is associated with increased cardiovascular risk in both untreated and treated patients, who are probably undertreated because of their low office blood pressure.

Tolerance of Volume Control Noninvasive Ventilation in Subjects With Amyotrophic Lateral Sclerosis.

PubMed

Martínez, Daniel; Sancho, Jesús; Servera, Emilio; Marín, Julio

2015-12-01

Noninvasive ventilation (NIV) tolerance has been identified as an independent predictor of survival in amyotrophic lateral sclerosis (ALS). Volume control continuous mandatory ventilation (VC-CMV) NIV has been associated with poor tolerance. The aim of this study was to determine the tolerance of subjects with ALS to VC-CMV NIV. This was a prospective study involving subjects with ALS who were treated with VC-CMV NIV. Respiratory and functional parameters were recorded when the subjects began ventilatory support. NIV tolerance was evaluated after 3 months. Eighty-seven subjects with ALS were included. After 3 months, 80 subjects (92%) remained tolerant of NIV. Tolerant subjects presented greater survival (median 22.0 months, 95% CI 14.78-29.21) than intolerant subjects (median 6.0 months, 95% CI 0.86-11.13) (P = .03). The variables that best predicted NIV tolerance were mechanically assisted cough peak flow (P = .01) and percentage of time spent with SpO2 < 90% at night while on NIV (P = .03) CONCLUSIONS: VC-CMV NIV provides high rates of NIV tolerance in subjects with ALS. Mechanically assisted cough peak flow and percentage of time spent with SpO2 < 90% at night while using NIV are the 2 factors associated with tolerance of VC-CMV NIV in subjects with ALS. Copyright © 2015 by Daedalus Enterprises.

Effectiveness of an intensive, school-based intervention for teen mothers.

PubMed

Key, Janice D; Gebregziabher, Mulugeta G; Marsh, Linda D; O'Rourke, Kathleen M

2008-04-01

This study evaluated the effectiveness of a secondary teen pregnancy prevention intervention that includes school-based social work services coordinated with comprehensive health care for teen mothers and their children. A prospective cohort study compared subsequent births to teen mothers followed for at least 24 months or until age 20 years (whichever was longer) compared with matched subjects from state data. Analyses were based on intent to treat and included chi(2), survival, and cost-benefit analysis. Subjects included 63 girls (97% eligible, 99% African-American, mean age 16 years). A propensity-matched comparison group (n = 252) did not differ from subjects. Participation in program components was good: (1) group meetings: 76%; (2) case management: 95%; (3) coordinated medical care: 63%. The majority of subjects used contraception (93%), with greater use of medroxyprogesterone associated with participation in coordinated medical care (80% vs. 50%, p = .0145). Subsequent births were more common in the comparison group (33%) than among subjects (17%) (p = .001), and survival curves were significantly different (p = .007) (hazard ratio = 2.5). There was a trend toward fewer births with increased participation in medical care (p = .08) and case management (p = .08) but not with group meetings. Cost savings were calculated as $19,097 per birth avoided or $5,055 per month. The intervention was effective in reducing subsequent births to teens; however selection bias of school enrollment cannot be excluded by this study. The cost savings of delayed births outweigh the expenses of this intensive model.

The Effect of Combination Antiviral Therapy in the Treatment of Hepatitis C on the Occurrence of Depressive Disorder in Patients Treated for Hepatitis C in the Republic of Srpska.

PubMed

Banjac, Visnja; Zivlak-Radulovic, Nera; Miskovic, Mirjana

2016-04-01

The current standard treatment of chronic hepatitis C in Bosnia and Herzegovina consists of pegylated interferon alpha in combination with ribavirin. Interferon therapy has many psychiatric side effects, with depressive symptomatology being most prominent. The aim of the study was to establish the frequency and severity of depression in patients with chronic hepatitis C during two months of the aforementioned therapy. The overall sample consisted of 46 subjects, divided into three subgroups, aged 18 to 65. The study population consisted of subjects treated for chronic hepatitis C (n = 15), subjects infected but not treated for chronic hepatitis C (n = 15), and healthy controls (n = 16). The assessment and level of depression were based on the Structural clinical interview (SCID), Montgomery-Asberg Depression Rating Scale and Zung Self-Rating Depression Scale. The assessments were conducted before interferon therapy (on the day 0), after 4 and 8 weeks of therapy. Regarding its frequency, MADRS scoring showed that the number of depressed subjects receiving therapy increased after 8 weeks (46.7%). There was statistical significance between the subgroups after 4 and 8 weeks. Likewise, the ZUNG scale showed that the number of depressed subjects receiving therapy increased after 8 weeks (73.3%). There was statistical significance between the subgroups on the day 0, after 4 and 8 weeks. Depression was significantly more frequent in chronic hepatitis C subjects treated with interferon alpha in combination with ribavirin than in subjects in the group without therapy. Mild depression was most prevalent.

The effects of ketamine on sexual behavior, anxiety, and locomotion in female rats.

PubMed

Guarraci, Fay A; Gonzalez, Chantal M F; Lucero, Devon; Womble, Paige D; Abdel-Rahim, Heba; DeVore, Jennie; Kunkel, Marcela Nicole; Quadlander, Emma; Stinnett, Morgan; Boyette-Davis, Jessica

2018-02-01

The present study characterized the effects of ketamine on sexual behavior and anxiety in female rats. In Experiment 1, female subjects received an injection of ketamine (10.0mg/kg) or saline 30min prior to a sexual partner-preference test during which each female subject was given the opportunity to interact with a female stimulus or a sexually vigorous male stimulus. Immediately afterwards, female subjects were tested for locomotion in an open field test. Ketamine-treated subjects spent significantly more time with the male stimulus than saline-treated subjects. No other measures of mating behavior (i.e., paced mating behavior, lordosis) were affected by ketamine. Ketamine also had no effect on locomotion. In Experiment 2, female subjects received an injection of ketamine (10.0mg/kg), or saline daily for 10days to investigate the possibility that sexual dysfunction emerges only after repeated exposure. Similar to the results of Experiment 1, ketamine-treated subjects spent significantly more time with the male stimulus than saline-treated subjects. Chronic ketamine treatment also decreased the likelihood of leaving the male after mounts, without affecting any other measures of sexual behavior. Chronic ketamine had no effect on locomotion. In Experiment 3, female subjects received an injection of ketamine (10.0mg/kg) or saline and were tested for anxiety in an elevated plus maze test and for locomotion in an open field test. Acute ketamine had no effect on anxiety or locomotion. In Experiment 4, female subjects received an injection of ketamine (10.0mg/kg) or saline daily for 10days to investigate the possibility that anxiety emerges only after repeated exposure. Chronic ketamine exposure had no effect on any measure of anxiety. However, chronic ketamine exposure increased locomotion. The results from these experiments indicate that unlike other medications prescribed for depression, neither acute nor chronic ketamine treatment causes anxiety or disruption of sexual behavior. Copyright © 2018 Elsevier Inc. All rights reserved.

Effect on adult height of pubertal growth hormone retesting and withdrawal of therapy in patients with previously diagnosed growth hormone deficiency.

PubMed

Zucchini, Stefano; Pirazzoli, Piero; Baronio, Federico; Gennari, Monia; Bal, Milva Orquidea; Balsamo, Antonio; Gualandi, Stefano; Cicognani, Alessandro

2006-11-01

GH replacement therapy in GH-deficient (GHD) patients is usually continued until adult height despite the fact that most of these subjects display a normal secretion when retested at the end of growth. Puberty is the most likely time for normalization of GH secretion. The objectives of this study are to establish the characteristics and the percentage of the subjects with isolated GHD who normalized secretion at puberty and to compare their statural outcomes with those of the subjects with persistent deficiency treated also after retesting. This was a prospective, nonrandomized, open-label study conducted in a university research hospital. Sixty-nine subjects (40 male, 29 female) with a diagnosis before puberty of isolated GHD by means of arginine and l-dopa tests were reevaluated with the same tests after at least 2 yr of therapy and after puberty onset. If GH peak at retesting was more than 10 microg/liter, therapy was withdrawn. Percentage and characteristics of normalized subjects at retesting, outcome of treatment in the subjects treated or untreated to adult height, and factors predictive of growth outcome were measured. At retesting, 44 subjects (63.7%) confirmed a GH peak less than 10 microg/liter (24 of 40 male and 20 of 29 female). Apart from a less delayed bone age at diagnosis in females, the subjects with confirmed GHD were not different at diagnosis from the other group for height deficit at diagnosis, first year growth response to GH, age and height at puberty onset, height, and IGF-I at retesting. Mean adult height was 165.1 +/- 4.5 cm in the male group treated until adult height vs. 164.0 +/- 3.4 cm in the group who suspended therapy at retesting. Mean adult height was 153.2 +/- 4.1 cm in the female group treated until adult height vs. 152.9 +/- 5.2 cm in the group that suspended therapy at retesting. As regards the parameters expressing the final outcome, the only difference was found in the mean increment adult height-target height sd score in favor of the male group treated until adult height. In both sexes, therapy duration and GH levels at diagnosis and at retesting were unrelated to adult height parameters and to height increments during the period of observation. One third of our GHD subjects diagnosed before puberty presented a normal secretion at puberty. The withdrawal of GH therapy in these subjects after retesting was not associated with a catch down growth, and they obtained an adult height similar to those obtained by the GHD subjects treated until adult height. It seems convenient, in subjects with nonsevere GHD, to retest GH secretion at midpuberty and to withdraw treatment for the subjects that are no longer deficient.

Periodontal disease in children and adolescents of Latin America.

PubMed

Botero, Javier E; Rösing, Cassiano Kuchenbecker; Duque, Andres; Jaramillo, Adriana; Contreras, Adolfo

2015-02-01

Periodontal diseases are a group of infectious diseases that mainly include gingivitis and periodontitis. Gingivitis is the most prevalent form of periodontal disease in subjects of all ages, including children and adolescents. Less frequent types of periodontal disease include aggressive periodontitis, acute necrotizing ulcerative gingivitis and various diseases of herpesviral and fungal origin. This review aimed to retrieve relevant information from Latin America on the prevalence of periodontal diseases among children and adolescents of the region. Gingivitis was detected in 35% of young Latin American subjects and showed the highest frequencies in Colombia (77%) and Bolivia (73%) and the lowest frequency in Mexico (23%). The frequency of gingivitis in subjects from other Latin American countries was between 31% and 56%. Periodontitis may affect <10% of the young population in Latin America, but the data are based on only a few studies. A more precise assessment of the distribution and severity of periodontal disease in children and adolescents of Latin America may help policy makers and dentists to institute more effective public health measures to prevent and treat the disease at an early age to avoid major damage to the permanent dentition. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A Novel Treatment of Fear of Flying Using a Large Virtual Reality System.

PubMed

Czerniak, Efrat; Caspi, Asaf; Litvin, Michal; Amiaz, Revital; Bahat, Yotam; Baransi, Hani; Sharon, Hanania; Noy, Shlomo; Plotnik, Meir

2016-04-01

Fear of flying (FoF), a common phobia in the developed world, is usually treated with cognitive behavioral therapy, most efficiently when combined with exposure methods, e.g., virtual reality exposure therapy (VRET). We evaluated FoF treatment using VRET in a large motion-based VR system. The treated subjects were seated on a moving platform. The virtual scenery included the interior of an aircraft and a window view to the outside world accompanied by platform movements simulating, e.g., takeoff, landing, and air turbulence. Relevant auditory stimuli were also incorporated. Three male patients with FoF underwent a clinical interview followed by three VRETs in the presence and with the guidance of a therapist. Scores on the Flight Anxiety Situation (FAS) and Flight Anxiety Modality (FAM) questionnaires were obtained on the first and fourth visits. Anxiety levels were assessed using the subjective units of distress (SUDs) scale during the exposure. All three subjects expressed satisfaction regarding the procedure and did not skip or avoid any of its stages. Consistent improvement was seen in the SUDs throughout the VRET session and across sessions, while patients' scores on the FAS and FAM showed inconsistent trends. Two patients participated in actual flights in the months following the treatment, bringing 12 and 16 yr of avoidance to an end. This VR-based treatment includes critical elements for exposure of flying experience beyond visual and auditory stimuli. The current case reports suggest VRET sessions may have a meaningful impact on anxiety levels, yet additional research seems warranted.

Randomized Trial of Clitoral Vacuum Suction Versus Vibratory Stimulation in Neurogenic Female Orgasmic Dysfunction.

PubMed

Alexander, Marcalee; Bashir, Khurram; Alexander, Craig; Marson, Lesley; Rosen, Raymond

2018-02-01

To examine the safety and efficacy of using a clitoral vacuum suction device (CVSD) versus vibratory stimulation (V) to treat orgasmic dysfunction in women with multiple sclerosis (MS) or spinal cord injury (SCI). Randomized clinical trial. Two academic medical centers. Women (N=31) including 20 with MS and 11 with SCI. A 12-week trial of the use of a CVSD versus V. Female Sexual Function Inventory (FSFI) and Female Sexual Distress Scale (FSDS). Twenty-three women (18 MS, 5 SCI) completed the study including 13 of 16 randomized to CVSD and 10 of 15 randomized to V. There was a statistically significant increase in total FSFI score (P=.011), desire (P=.009), arousal (P=.009), lubrication (P=.008), orgasm (P=.012), and satisfaction (P=.049), and a significant decrease in distress as measured by FSDS (P=.020) in subjects using the CVSD. In subjects who used V, there was a statistically significant increase in the orgasm subscale of the FSFI (P=.028). Subjects using the CVSD maintained improvements 4 weeks after treatment. CVSD is safe and overall efficacious to treat female neurogenic sexual dysfunction related to MS and SCI. V is also safe and efficacious for female neurogenic orgasmic dysfunction; however, results were limited to the active treatment period. Because of ease of access and cost, clinicians can consider use of V for women with MS or SCI with orgasmic dysfunction. CVSD is recommended for women with multiple sexual dysfunctions or for whom V is ineffective. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A comparative trial of psychotherapy and pharmacotherapy for "pure" dysthymic patients.

PubMed

Markowitz, John C; Kocsis, James H; Bleiberg, Kathryn L; Christos, Paul J; Sacks, Michael

2005-12-01

Psychotherapy of "pure" dysthymic disorder remains understudied. This article reports outcomes of an acute randomized trial of 94 subjects treated for 16 weeks with either interpersonal psychotherapy (IPT), brief supportive psychotherapy (BSP), sertraline, or sertraline plus IPT. Recruited by clinical referral and advertising, subjects met DSM-IV criteria for early onset dysthymic disorder, with no episode of major depression in the prior six months. They were randomly assigned to one of four 16-week treatments, with options for crossover or continuation treatment. Results were analyzed from the intention-to-treat sample by ANCOVA, controlling for baseline depressive severity. Subjects improved in all conditions over time, with the cells including sertraline pharmacotherapy showing superiority over psychotherapy alone for response and remission. Response rates were 58% for sertraline alone, 57% for combined treatment, 35% for IPT, and 31% for BSP. The study was underpowered and may have employed too "active" a control condition. Follow-up data were unobtainable. In this acute trial for "pure" dysthymic disorder, sertraline with or without IPT showed advantages relative to IPT and BSP. Methodological difficulties may have limited differential outcome findings. This study bolsters a small but growing literature on the treatment of dysthymic disorder, suggesting that pharmacotherapy may acutely benefit patients more than psychotherapy.

The expression of cholesterol metabolism genes in monocytes from HIV-infected subjects suggests intracellular cholesterol accumulation.

PubMed

Feeney, Eoin R; McAuley, Nuala; O'Halloran, Jane A; Rock, Clare; Low, Justin; Satchell, Claudette S; Lambert, John S; Sheehan, Gerald J; Mallon, Patrick W G

2013-02-15

Human immunodeficiency virus (HIV) infection is associated with increased cardiovascular risk and reduced high-density lipoprotein cholesterol (HDL-c). In vitro, HIV impairs monocyte-macrophage cholesterol efflux, a major determinant of circulating HDL-c, by increasing ABCA1 degradation, with compensatory upregulation of ABCA1 messenger RNA (mRNA). We examined expression of genes involved in cholesterol uptake, metabolism, and efflux in monocytes from 22 HIV-positive subjects on antiretroviral therapy (ART-Treated), 30 untreated HIV-positive subjects (ART-Naive), and 22 HIV-negative controls (HIV-Neg). HDL-c was lower and expression of ABCA1 mRNA was higher in ART-Naive subjects than in both ART-Treated and HIV-Neg subjects (both P < .01), with HDL-c inversely correlated with HIV RNA (ρ = -0.52; P < .01). Expression of genes involved in cholesterol uptake (LDLR, CD36), synthesis (HMGCR), and regulation (SREBP2, LXRA) was significantly lower in both ART-Treated and ART-Naive subjects than in HIV-Neg controls. In vivo, increased monocyte ABCA1 expression in untreated HIV-infected patients and normalization of ABCA1 expression with virological suppression by ART supports direct HIV-induced impairment of cholesterol efflux previously demonstrated in vitro. However, decreased expression of cholesterol sensing, uptake, and synthesis genes in both untreated and treated HIV infection suggests that both HIV and ART affect monocyte cholesterol metabolism in a pattern consistent with accumulation of intramonocyte cholesterol.

Efficacy of amoxicillin with and without decongestant-antihistamine for otitis media with effusion in children. Results of a double-blind, randomized trial.

PubMed

Mandel, E M; Rockette, H E; Bluestone, C D; Paradise, J L; Nozza, R J

1987-02-19

In a randomized, double-blind, placebo-controlled trial involving 518 infants and children who had otitis media with effusion ("secretory" otitis media), we evaluated the efficacy of a two-week course of amoxicillin (40 mg per kilogram of body weight per day) with and without a four-week course of an oral decongestant-antihistamine combination. Among the 474 subjects who were evaluated at the four-week end point, the rate of resolution of middle-ear effusion was twice as high in those treated with amoxicillin, either with or without the decongestant-antihistamine, as in those who received placebo (P less than 0.001), but 69.8 percent of the amoxicillin-treated subjects still had effusion. Among both the amoxicillin-treated subjects and the placebo-treated subjects, resolution was more likely in those with initially unilateral effusion, in those who had had effusion for eight weeks or less, and in those without an upper respiratory tract infection at the four-week end point. Side effects were reported more often in subjects who received decongestant-antihistamine than in those who did not. Among the subjects without effusion at the four-week end point, recurrent effusion developed in approximately half those in both the amoxicillin and placebo groups during the subsequent three months. We conclude that in infants and children with otitis media with effusion, amoxicillin treatment increases to some extent the likelihood of resolution.

Clinical Evaluation of a Microwave Device for Treating Axillary Hyperhidrosis

PubMed Central

Hong, H Chih-Ho; Lupin, Mark; O'Shaughnessy, Kathryn F

2012-01-01

Background A third-generation microwave-based device has been developed to treat axillary hyperhidrosis by selectively heating the interface between the skin and underlying fat where the sweat glands reside. Materials and Methods Thirty-one (31) adults with primary axillary hyperhidrosis were enrolled. All subjects had one to three procedure sessions over a 6-month period to treat both axillae fully. Efficacy was assessed using the Hyperhidrosis Disease Severity Scale (HDSS), gravimetric weight of sweat, and the Dermatologic Life Quality Index (DLQI), a dermatology-specific quality-of-life scale. Subject safety was assessed at each visit. Subjects were followed for 12 months after all procedure sessions were complete. Results At the 12-month follow-up visit, 90.3% had HDSS scores of 1 or 2, 90.3% had at least a 50% reduction in axillary sweat from baseline, and 85.2% had a reduction of at least 5 points on the DLQI. All subjects experienced transient effects in the treatment area such as swelling, discomfort, and numbness. The most common adverse event (12 subjects) was the presence of altered sensation in the skin of the arm that resolved in all subjects. Conclusion The device tested provided efficacious and durable treatment for axillary hyperhidrosis. PMID:22452511

Photodynamic therapy for actinic cheilitis: a systematic review.

PubMed

Yazdani Abyaneh, Mohammad-Ali; Falto-Aizpurua, Leyre; Griffith, Robert D; Nouri, Keyvan

2015-02-01

Actinic cheilitis (AC) is a premalignant lesion of the lips that can progress to squamous cell carcinoma and metastasize. Actinic cheilitis is difficult to treat because surgical treatments have significant adverse effects whereas less invasive procedures have uncertain efficacy. Photodynamic therapy (PDT) may offer a noninvasive yet effective treatment option for AC. To systematically review the safety and efficacy of PDT for AC. The terms "photodynamic," "actinic," "solar," "cheilitis," and "cheilosis" were used in combinations to search the PubMed database. Studies were considered for inclusion based on eligibility criteria, and specific data were extracted from all studies. The authors identified 15 eligible case series encompassing a total of 242 treated subjects. Among studies that evaluated subjects for complete clinical response, 139 of 223 subjects (62%) showed complete response at final follow-ups ranging from 3 to 30 months. Among studies that evaluated subjects for histological outcome, 57 of 121 subjects (47%) demonstrated histological cure at final follow-ups ranging from 1.5 to 18 months. Cosmetic outcomes were good to excellent in the majority of subjects, and adverse events were well tolerated. Photodynamic therapy is safe and has the potential to clinically and histologically treat AC, with a need for future randomized controlled trials.

Default mode network connectivity distinguishes chemotherapy-treated breast cancer survivors from controls

PubMed Central

Kesler, Shelli R.; Wefel, Jeffrey S.; Hosseini, S. M. Hadi; Cheung, Maria; Watson, Christa L.; Hoeft, Fumiko

2013-01-01

Breast cancer (BC) chemotherapy is associated with cognitive changes including persistent deficits in some individuals. We tested the accuracy of default mode network (DMN) resting state functional connectivity patterns in discriminating chemotherapy treated (C+) from non–chemotherapy (C−) treated BC survivors and healthy controls (HC). We also examined the relationship between DMN connectivity patterns and cognitive function. Multivariate pattern analysis was used to classify 30 C+, 27 C−, and 24 HC, which showed significant accuracy for discriminating C+ from C− (91.23%, P < 0.0001) and C+ from HC (90.74%, P < 0.0001). The C− group did not differ significantly from HC (47.06%, P = 0.60). Lower subjective memory function was correlated (P < 0.002) with greater hyperplane distance (distance from the linear decision function that optimally separates the groups). Disrupted DMN connectivity may help explain long-term cognitive difficulties following BC chemotherapy. PMID:23798392

Double propensity-score adjustment: A solution to design bias or bias due to incomplete matching.

PubMed

Austin, Peter C

2017-02-01

Propensity-score matching is frequently used to reduce the effects of confounding when using observational data to estimate the effects of treatments. Matching allows one to estimate the average effect of treatment in the treated. Rosenbaum and Rubin coined the term "bias due to incomplete matching" to describe the bias that can occur when some treated subjects are excluded from the matched sample because no appropriate control subject was available. The presence of incomplete matching raises important questions around the generalizability of estimated treatment effects to the entire population of treated subjects. We describe an analytic solution to address the bias due to incomplete matching. Our method is based on using optimal or nearest neighbor matching, rather than caliper matching (which frequently results in the exclusion of some treated subjects). Within the sample matched on the propensity score, covariate adjustment using the propensity score is then employed to impute missing potential outcomes under lack of treatment for each treated subject. Using Monte Carlo simulations, we found that the proposed method resulted in estimates of treatment effect that were essentially unbiased. This method resulted in decreased bias compared to caliper matching alone and compared to either optimal matching or nearest neighbor matching alone. Caliper matching alone resulted in design bias or bias due to incomplete matching, while optimal matching or nearest neighbor matching alone resulted in bias due to residual confounding. The proposed method also tended to result in estimates with decreased mean squared error compared to when caliper matching was used.

Double propensity-score adjustment: A solution to design bias or bias due to incomplete matching

PubMed Central

2016-01-01

Propensity-score matching is frequently used to reduce the effects of confounding when using observational data to estimate the effects of treatments. Matching allows one to estimate the average effect of treatment in the treated. Rosenbaum and Rubin coined the term “bias due to incomplete matching” to describe the bias that can occur when some treated subjects are excluded from the matched sample because no appropriate control subject was available. The presence of incomplete matching raises important questions around the generalizability of estimated treatment effects to the entire population of treated subjects. We describe an analytic solution to address the bias due to incomplete matching. Our method is based on using optimal or nearest neighbor matching, rather than caliper matching (which frequently results in the exclusion of some treated subjects). Within the sample matched on the propensity score, covariate adjustment using the propensity score is then employed to impute missing potential outcomes under lack of treatment for each treated subject. Using Monte Carlo simulations, we found that the proposed method resulted in estimates of treatment effect that were essentially unbiased. This method resulted in decreased bias compared to caliper matching alone and compared to either optimal matching or nearest neighbor matching alone. Caliper matching alone resulted in design bias or bias due to incomplete matching, while optimal matching or nearest neighbor matching alone resulted in bias due to residual confounding. The proposed method also tended to result in estimates with decreased mean squared error compared to when caliper matching was used. PMID:25038071

Patent Ductus Arteriosus Therapy: Impact on Neonatal and 18-Month Outcome

PubMed Central

Madan, Juliette C.; Kendrick, Douglas; Hagadorn, James I.; Frantz, Ivan D.

2009-01-01

OBJECTIVE The purpose of this work was to evaluate therapy for patent ductus arteri-osus as a risk factor for death or neurodevelopmental impairment at 18 to 22 months, bronchopulmonary dysplasia, or necrotizing enterocolitis in extremely low birth weight infants. METHODS We studied infants in the National Institute of Child Health and Human Development Neonatal Research Network Generic Data Base born between 2000 and 2004 at 23 to 28 weeks’ gestation and at <1000-g birth weight with patent ductus arteriosus. Patent ductus arteriosus therapy was evaluated as a risk factor for outcomes in bivariable and multivariable analyses. RESULTS Treatment for subjects with patent ductus arteriosus (n = 2838) included 403 receiving supportive treatment only, 1525 treated with indomethacin only, 775 with indomethacin followed by secondary surgical closure, and 135 treated with primary surgery. Patients who received supportive therapy for patent ductus arteriosus did not differ from subjects treated with indomethacin only for any of the outcomes of interest. Compared with indomethacin treatment only, patients undergoing primary or secondary surgery were smaller and more premature. When compared with indomethacin alone, primary surgery was associated with increased adjusted odds for neurodevelopmental impairment and bronchopulmonary dysplasia in multivariable logistic regression. Secondary surgical closure was associated with increased odds for neurodevelopmental impairment and increased adjusted odds for bronchopulmonary dysplasia but decreased adjusted odds for death. Risk of necrotizing enterocolitis did not differ among treatments. Indomethacin prophylaxis did not significantly modify these results. CONCLUSIONS Our results suggest that infants treated with primary or secondary surgery for patent ductus arteriosus may be at increased risk for poor short- and long-term outcomes compared with those treated with indomethacin. Prophylaxis with indomethacin in the first 24 hours of life did not modify the subsequent outcomes of patent ductus arteriosus therapy. PMID:19171637

Peripheral mRNA expression of pluripotency markers in bipolar disorder and the effect of long-term lithium treatment.

PubMed

Ferensztajn-Rochowiak, Ewa; Tarnowski, Maciej; Samochowiec, Jerzy; Michalak, Michal; Ratajczak, Mariusz Z; Rybakowski, Janusz K

2016-10-01

The aim was to evaluate the peripheral mRNA expression of pluripotency master transcriptional factors such as octamer-binding transcription factor 4 (Oct4), sex-determining region Y-box 2 (Sox2) and homeobox protein Nanog, in patients with bipolar disorder (BD), and the effect of long-term lithium treatment. Fifteen BD patients (aged 53±7years) not treated with lithium, with duration of illness>10years, 15 BD patients (aged 55±6years) treated with lithium for 8-40 years (mean 16years) and 15 control subjects (aged 50±5years) were included. Assessment of the mRNA levels of pluripotency markers (Oct-4, Sox 2 and Nanog) was performed, using the Real-time quantitative reverse transcription PCR (RQ-PCR) procedure, and the number of CD34+ very small embryonic-like stem cells (VSELs) was measured by flow cytometric analysis. In those BD patients not treated with lithium the expression of all three pluripotency genes was significantly higher than that in the control subjects. Oct-4, Sox2 and Nanog also positively correlated with the number of CD34+ VSELs/[ul] in this group. In the lithium-treated patients the mRNA levels of Nanog were significantly higher than in the control individuals and correlated with the number and % of CD34+ VSELs. The overexpression of the pluripotency master transcriptional factors in patients with a long duration of BD not treated with lithium, may contribute to the pathogenesis of the illness and make them potential biological markers of BD. Long-term lithium treatment may attenuate these excessive regenerative processes, especially in relation to the transcription factors Oct-4 and Sox2. Copyright © 2016. Published by Elsevier Urban & Partner Sp. z o.o.

Inhibition of Tumor Necrosis Factor Improves Sleep Continuity in Patients with Treatment Resistant Depression and High Inflammation

PubMed Central

Weinberger, Jeremy F.; Raison, Charles L.; Rye, David B.; Montague, Amy R.; Woolwine, Bobbi J.; Felger, Jennifer C.; Haroon, Ebrahim; Miller, Andrew H.

2014-01-01

Blockade of the inflammatory cytokine tumor necrosis factor (TNF) in depressed patients with increased inflammation has been associated with decreased depressive symptoms. Nevertheless, the impact of TNF blockade on sleep in depressed patients has not been examined. Accordingly, sleep parameters were measured using polysomnography in 36 patients with treatment resistant major depression at baseline and 2 weeks after 3 infusions (week 8) of either the TNF antagonist infliximab (n=19) or placebo (n=17). Markers of inflammation including c-reactive protein (CRP) and TNF and its soluble receptors were assessed along with depression measured by the 17-item Hamilton Depression Rating Scale. No differences in sleep parameters were found as a function of infliximab treatment over time. Nevertheless, Wake After Sleep Onset (WASO), the spontaneous arousal index and sleep period time significantly decreased, and sleep efficiency significantly increased, from baseline to week 8 in infliximab-treated patients with high (CRP>5mg/L)(n=9) versus low inflammation (CRP≤5mg/L)(n=10), controlling for changes in scores of depression. Stage 2 sleep also significantly decreased in infliximab-treated patients with high versus low inflammation. Decreases in soluble TNF receptor 1 significantly correlated with decreases in WASO and increases in sleep efficiency in infliximab-treated subjects with high inflammation. Placebo-treated subjects exhibited no sleep changes as a function of inflammation, and no correlations between inflammatory markers and sleep parameters in placebo-treated patients were found. These data suggest that inhibition of inflammation may be a viable strategy to improve sleep alterations in patients with depression and other disorders associated with increased inflammation. PMID:25529904

An herbal supplement containing Ma Huang-Guarana for weight loss: a randomized, double-blind trial.

PubMed

Boozer, C N; Nasser, J A; Heymsfield, S B; Wang, V; Chen, G; Solomon, J L

2001-03-01

To examine in overweight humans the short-term safety and efficacy for weight loss of an herbal supplement containing Ma Huang, Guarana and other ingredients. An 8 week randomized, double-blind placebo controlled study of a herbal dietary supplement (72 mg/day ephedrine alkaloids and 240 mg/day caffeine). Overweight men and women (body mass index, > or =29 and < or =35 kg/m2). The primary outcome variable was body weight change. Secondary variables included anthropometric, metabolic and cardiovascular changes. Sixty-seven subjects were randomized to either placebo (n=32) or active Ma Huang/Guarana (n=35). Twenty-four subjects in each group completed the study. Active treatment produced significantly (P<0.006) greater loss of weight (X+/-s.d.,-4.0+/-3.4 kg) and fat (-2.1+/-3.0% fat) over the 8-week treatment period than did placebo (-0.8+/-2.4 kg and 0.2+/-2.3% fat). Active treatment also produced greater reductions in hip circumference and serum triglyceride levels. Eight of the 35 actively treated subjects (23%) and none of the 32 placebo-treated control subjects withdrew from the protocol because of potential treatment-related effects. Dry mouth, insomnia and headache were the adverse symptoms reported most frequently by the herbal vs placebo group at the final evaluation visit. This herbal mixture of Ma Huang and Guarana effectively promoted short-term weight and fat loss. Safety with long-term use requires further investigation.

Emergency department treatment of viral gastritis using intravenous ondansetron or dexamethasone in children.

PubMed

Stork, Christine M; Brown, Kathleen M; Reilly, Tracey H; Secreti, LaLaina; Brown, Lawrence H

2006-10-01

To compare the efficacy of intravenous ondansetron or dexamethasone compared with intravenous fluid therapy alone in children presenting to the emergency department with refractory vomiting from viral gastritis who had failed attempts at oral hydration. This double-blind, randomized, controlled trial was performed in a tertiary care pediatric emergency department. Children aged 6 months to 12 years presenting with more than three episodes of vomiting in the past 24 hours, mild/moderate dehydration, and failed oral hydration were included. Patients with other medical causes were excluded. Subjects were randomized to dexamethasone 1 mg/kg (15 mg maximum), ondansetron 0.15 mg/kg, or placebo (normal saline [NS], 10 mL). All subjects also received intravenous NS at 10-20 mL/kg/hr. Oral fluid tolerance was evaluated at two and four hours. Those not tolerating oral fluids at four hours were admitted. Discharged patients were evaluated at 24 and 72 hours for vomiting and repeat health care visits. The primary study outcome was hospitalization rates between the groups. Data were analyzed using chi-square test, Kruskal-Wallis test, Mantel-Haenszel test, and analysis of variance, with p < 0.05 considered significant. A total of 166 subjects were enrolled; data for analysis were available for 44 NS-treated patients, 46 ondansetron-treated patients, and 47 dexamethasone-treated patients. Hospital admission occurred in nine patients (20.5%) receiving placebo (NS alone), two patients (4.4%) receiving ondansetron, and seven patients (14.9%) receiving dexamethasone, with ondansetron significantly different from placebo (p = 0.02). Similarly, at two hours, more ondansetron-treated patients (39 [86.6%]) tolerated oral hydration than NS-treated patients (29 [67.4%]; relative risk, 1.28; 95% confidence interval = 1.02 to 1.68). There were no differences in number of mean episodes of vomiting or repeat visits to health care at 24 and 72 hours in the ondansetron, dexamethasone, or NS groups. In children with dehydration secondary to vomiting from acute viral gastritis, ondansetron with intravenous rehydration improves tolerance of oral fluids after two hours and reduces the hospital admission rate when compared with intravenous rehydration with or without dexamethasone.

The Effect of Botulinum Toxin A Injections in the Spine Muscles for Cerebral Palsy Scoliosis, Examined in a Prospective, Randomized Triple-blinded Study.

PubMed

Wong, Christian; Pedersen, Søren Anker; Kristensen, Billy B; Gosvig, Kasper; Sonne-Holm, Stig

2015-12-01

A prospective, randomized triple-blinded cross-over design treating with either botulinum toxin A (BXT) or saline (NaCl). To examine the efficacy of BTX treatment in cerebral palsy scoliosis (CPS). Intramuscular injections with BTX have been used off label in treating CPS. 1 prospective study has been conducted, demonstrating in both radiological and clinical improvement, whereas showing no side effects or complications. Subjects (brace-treated CPS between 2 and 18 yr) were injected using ultrasonic-guidance with either NaCl or BTX in selected spine muscles with 6 mo intervals (block randomization, sealed envelope). Radiographs of the spine and clinical follow-up were captured before and 6 weeks after each injection. Primary outcome parameter was radiological change in Cobb angle, where a 7° change was regarded as an effect (1 SD). Radiological parameters were measured before and 6 weeks after treatment by 3 experienced doctors separately. Moreover, clinical results were evaluated by the pediatric quality of life score and systematic open questioning of the parents about the child's wellbeing. Subjects, researchers, and monitors were blinded during the trial. Appropriate permissions (2008-004584-19) and no funding were obtained. 16 cerebral palsy patients (GFMCS III-V) with CPS were consecutively included, whereas 6 patients were excluded. There were no drop-outs to follow-up, but 1 possible serious adverse event of pneumonia resulting in death was recorded and the study was terminated. No significant radiological or clinical changes were detected when compared with NaCl injections using Wilcoxon matched pair signed-rank test. No positive radiological or clinical effects were demonstrated by this treatment, except for the parent's initial subjective but positive appraisal of the effect. However, the study was terminated due to 1 possible severe adverse event and scheduled numbers needed to treat (hence power) were not reached. 1.

The efficacy of anti-PD-1/PD-L1 therapy and its comparison with EGFR-TKIs for advanced non-small-cell lung cancer.

PubMed

Sheng, Zhixin; Zhu, Xu; Sun, Yanhua; Zhang, Yanxia

2017-08-22

To better understand the efficacy and safety of anti-PD-1/PD-L1 therapy (atezolizumab, pembrolizumab, nivolumab) in patients with previously treated advanced non-small-cell lung cancer (NSCLC). The Cochrane Controlled Trial Register, Embase, Medline, and the Science Citation Index were searched for prospective published reports of atezolizumab, pembrolizumab, nivolumab in previously treated patients with advanced NSCLC. Finally, we identified 14 prospective published reports including four trials of atezolizumab covering 542 subjects, three trials of pembrolizumab covering 1566 subjects, seven trials of nivolumab covering 1678 subjects. When compared to docetaxel, anti-PD-1/PD-L1 therapy could significantly improve overall survival (hazard ratio [HR] 0.67, P<0.001) and progression-free survival (HR 0.83, P=0.002) for previously treated patients with advanced NSCLC. Anti-PD-1/PD-L1 therapy produced an overall response rate of 19% in the 2374 evaluable patients. When using docetaxel as the common comparator, indirect comparison of anti-PD-1/PD-L1 therapy versus EGFR-TKIs showed progression-free survival benefit (HR 0.62, P<0.001) and overall survival benefit (HR 0.60, P<0.001) for those patients with EGFR wild-type. Meanwhile, for those EGFR mutant patients, indirect comparison indicated that anti-PD-1/PD-L1 therapy was inferior to EGFR-TKIs therapy in terms of progression-free survival (HR 3.20, P<0.001), but no survival difference (HR 1.30, P=0.18). Anti-PD-1/PD-L1 therapy could produce progression-free survival and overall survival improvement over docetaxel for patients with previously treated NSCLC. For EGFR wild-type patients, anti-PD-1/PD-L1 therapy seemed to prolong progression-free survival and overall survival when compared to EGFR-TKIs. Meanwhile, for these EGFR mutant patients, anti-PD-1/PD-L1 therapy was inferior to EGFR-TKIs therapy in terms of progression-free survival.

Effect of phosphate supplementation on oxygen delivery at high altitude

NASA Astrophysics Data System (ADS)

Jain, S. C.; Singh, M. V.; Rawal, S. B.; Sharma, V. M.; Divekar, H. M.; Tyagi, A. K.; Panwar, M. R.; Swamy, Y. V.

1987-09-01

In the present communication, effect of low doses of phosphate supplementation on short-term high altitude adaptation has been examined. Studies were carried out in 36 healthy, male, sea-level residents divided in a double blind fashion into drug and placebo treated groups. 3.2 mmol of phosphate were given orally to each subject of the drug treated group once a day for 4 days on arrival at an altitude of 3,500 m. Sequential studies were done in the subjects in both groups on the 3rd, 7th, 14th and 21st day of their altitude stay. Haemoglobin, haematocrit, erythrocyte and reticulocyte counts increased to the similar extent in both groups. Blood pH, pO2 and adenosine tri-phosphate (ATP) did not differ between the two groups. On 3rd day of the altitude stay, inorganic phosphate and 2,3-diphosphoglycerate (2,3 DPG) levels in the drug treated group increased significantly as compared to the placebo group. No significant difference in inorganic phosphate and 2,3 DPG was observed later on in the two groups. Psychological and clinical tests also indicated that the drug treated subjects felt better as compared to the placebo treated subjects. The present study suggests that low doses of phosphate increases circulating 2,3-DPG concentration which in turn brings about beneficial effect towards short term high altitude adaptation.

Evaluation of materials proposed for use in space flight

NASA Technical Reports Server (NTRS)

Duncan, W. C.

1981-01-01

The cutaneous primary irritancy and allergenicity potential of cotton shirts/fabrics treated with flame retardants were evaluated in order to establish their suitability for spacecraft crew use. Twenty-five volunteer human subjects were patch tested on the back utilizing standard methodology, with both treated and untreated cotton fabric. The fabric was treated with tetrakis (hydroxymethyl) phosphonium hydroxide and subsequently cured with gaseous ammonia. The final treatment comprised adding on dicyandiamine phosphoric acid. None of the individuals experienced primary irritant or allergic reactions attributable to the fabric during induction or challenge patch testing. Likewise, there were no reactions to treated or untreated fabric patches placed on ten subjects of the usage panel at the conclusion of the study.

Large Deformation Dynamic Three-Dimensional Coupled Finite Element Analysis of Soft Biological Tissues Treated as Biphasic Porous Media

DTIC Science & Technology

2014-11-01

response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and...over time , when a bipha- sic soft tissue is subjected to dynamic loading. Also, after the initial transient, the variation of solid skeleton stresses...will be naturally calculated as the fluid phase pressure dissipates over time . This is important for developing physiologically- relevant degradation

Effectiveness of Gotu Kola Extract 750 mg and 1000 mg Compared with Folic Acid 3 mg in Improving Vascular Cognitive Impairment after Stroke

PubMed Central

Wibowo, Samekto

2016-01-01

This study aimed to determine the effectiveness of gotu kola (Centella asiatica) in improving cognitive function in patients with vascular cognitive impairment (VCI). This study uses a quasi-experimental design. Subjects in this study were patients with poststroke cognitive impairment who were treated at two hospitals in Yogyakarta, Indonesia. The number of subjects was 48: 17 subjects were treated with 1000 mg/day of gotu kola extract, 17 subjects treated with 750 mg/day of gotu kola extract, and 14 subjects treated with 3 mg/day of folic acid for 6 weeks. A Montreal Cognitive Assessment-Indonesian version (MoCA-Ina) was conducted at the beginning of treatment and after 6 weeks of therapy. It was found that all trials effectively improved poststroke VCI based on MoCA-Ina scores over the course of the study. There is no significant difference in ΔMoCA-Ina (score at the 6th week of treatment − score at the beginning) mean score among the three groups, indicating that gotu kola is as effective as folic acid in improving poststroke VCI. Gotu kola was shown to be more effective than folic acid in improving memory domain. This study suggested that gotu kola extract is effective in improving cognitive function after stroke. PMID:27340413

Effectiveness of Gotu Kola Extract 750 mg and 1000 mg Compared with Folic Acid 3 mg in Improving Vascular Cognitive Impairment after Stroke.

PubMed

Farhana, Kun Marisa; Malueka, Rusdy Ghazali; Wibowo, Samekto; Gofir, Abdul

2016-01-01

This study aimed to determine the effectiveness of gotu kola (Centella asiatica) in improving cognitive function in patients with vascular cognitive impairment (VCI). This study uses a quasi-experimental design. Subjects in this study were patients with poststroke cognitive impairment who were treated at two hospitals in Yogyakarta, Indonesia. The number of subjects was 48: 17 subjects were treated with 1000 mg/day of gotu kola extract, 17 subjects treated with 750 mg/day of gotu kola extract, and 14 subjects treated with 3 mg/day of folic acid for 6 weeks. A Montreal Cognitive Assessment-Indonesian version (MoCA-Ina) was conducted at the beginning of treatment and after 6 weeks of therapy. It was found that all trials effectively improved poststroke VCI based on MoCA-Ina scores over the course of the study. There is no significant difference in ΔMoCA-Ina (score at the 6th week of treatment - score at the beginning) mean score among the three groups, indicating that gotu kola is as effective as folic acid in improving poststroke VCI. Gotu kola was shown to be more effective than folic acid in improving memory domain. This study suggested that gotu kola extract is effective in improving cognitive function after stroke.

Uniqueness of the anterior dentition three-dimensionally assessed for forensic bitemark analysis.

PubMed

Franco, A; Willems, G; Souza, Phc; Coucke, W; Thevissen, P

2017-02-01

The uniqueness of the human dentition (UHD) is an important concept in the comparative process in bitemark analysis. During this analysis, the incisal edges of the suspects' teeth are matched with the bitemarks collected from the victim's body or crime scenes. Despite playing an essential part to exclude suspects, the UHD contained in the involved incisal tooth edges remains an assumption on bitemark level. The present study was aimed, first, to investigate three-dimensionally (3D) the UHD within different quantities of dental material from the incisal edges; second, to test these outcomes in a bidimensional (2D) simulation. Four-hundred forty-five dental casts were collected to compose 4 study groups: I - randomly-selected subjects, II - orthodontically treated subjects, III - twins and IV - orthodontically treated twins. Additionally, 20 dental casts were included to create threshold groups on subjects from whom the dental impressions were taken at 2 different moments (Group V). All the dental casts were digitalized with an automated motion device (XCAD 3D ® (XCADCAM Technology ® , São Paulo, SP, Brazil). The digital cast files (DCF) were integrated in Geomagic Studio ® (3D Systems ® , Rock Hill, SC, USA) software package (GS) for cropping, automated superimposition and pair-wise comparisons. All the DCF were cropped remaining 3 mm (part 1), 2 mm (part 2) and 1 mm (part 3) from the incisal edges of the anterior teeth. For a 2D validation, slices of 1 mm, not including incisal edges (part 4), were also cropped. These procedures were repeated in Group V, creating specific thresholds for each of the study parts. The 4 study groups were compared with its respective threshold using ANOVA test with statistical significance of 5%. Groups I, II and III did not differ from the corresponding threshold (Group V) in all study parts (p > 0.05). Scientific evidence to support the UHD was not observed in the current study. Bitemark analysis should not be disregarded but considered carefully when the suspects present similar dental alignment and morphology, such as in orthodontically treated subjects and twins, respectively. Copyright © 2017 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

Associations of HbA1c and educational level with risk of cardiovascular events in 32,871 drug-treated patients with Type 2 diabetes: a cohort study in primary care.

PubMed

Östgren, C J; Sundström, J; Svennblad, B; Lohm, L; Nilsson, P M; Johansson, G

2013-05-01

To explore the association of HbA1c and educational level with risk of cardiovascular events and mortality in patients with Type 2 diabetes. A cohort of 32 871 patients with Type 2 diabetes aged 35 years and older identified by extracting data from electronic patient records for all patients who had a diagnosis of Type 2 diabetes and had glucose-lowering agents prescribed between 1999 and 2009 at 84 primary care centres in Sweden. Associations of mean HbA1c levels and educational level with risks of cardiovascular events and all-cause mortality were analysed. The associations of HbA1c with risk of all-cause and cardiovascular mortality were J-shaped, with the lowest risk observed for cardiovascular mortality at an HbA1c level of 51 mmol/mol (6.8%) for subjects on oral agents and 56 mmol/mol (7.3%) in insulin-treated patients. The lowest risk observed for all-cause mortality was at an HbA1c level of 51 mmol/mol (6.8%) for subjects on oral agents and 56 mmol/mol (7.3%) in insulin-treated patients. There was an increased risk for cardiovascular death [hazard ratio 1.6 (1.2-2.1), P = 0.0008] at the lowest HbA1c decile for subjects in the low education category. For subjects with higher education there was no evident J curve for cardiovascular death [hazard ratio 1.2 (0.8-1.6), P = 0.3873]. Our results lend support to the recent American Diabetes Association/ European Association for the Study of Diabetes position statement that emphasizes the importance of additional factors, including the propensity for hypoglycaemia, which should influence HbA1c targets and treatment choices for individual patients. (Clinical Trials Registry No; NCT 01121315). © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

Efficacy and safety of prophylaxis with once-weekly BAY 79-4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients. A randomised, active-controlled, double-blind study.

PubMed

Powell, Jerry; Martinowitz, Uri; Windyga, Jerzy; Di Minno, Giovanni; Hellmann, Andrzej; Pabinger, Ingrid; Maas Enriquez, Monika; Schwartz, Lawrence; Ingerslev, Jørgen

2012-11-01

The benefits of prophylaxis of haemophilia A patients regarding joint health and quality-of-life are well established. However, adherence to an up to every-other-day infusion regimen is a barrier to widespread adoption of prophylaxis. BAY 79-4980 is an investigational drug consisting of rFVIII-FS (sucrose-formulated recombinant FVIII) reconstituted with liposome solvent. Previous clinical studies showed extended protection from bleeding after a single injection of BAY 79-4980 (13.3 ± 6.2 days) compared with rFVIII-FS (7.2 ± 1.7 days). The effect of once-a-week prophylaxis with BAY 79-4980 (35 IU/kg) compared with three times-per-week rFVIII-FS (25 IU/kg) in previously treated, severe haemophilia A patients was evaluated in a 52-week, double-blind, two-arm, randomised, controlled study. The primary and secondary endpoints were protection from total bleeds and joint bleeds, respectively. Short- and long-term safety and tolerability of BAY 79-4980 including effects on lipid levels were assessed. A total of 139 and 131 subjects were evaluable for safety and efficacy analyses, respectively. A large difference in efficacy between treatment groups was observed with 72.1% (49/68) in the rFVIII-FS control group demonstrating <9 bleeds/year compared with 38.1% (24/63) of BAY 79-4980-treated subjects. A similar difference was seen in annualised joint bleeds, with 43 subjects (63.2%) in the control group demonstrating <5 joint bleeds/year compared with 24 subjects (38.1%) treated with BAY 79-4980. The distribution of bleeds seven days post-prophylactic treatment with BAY 79-4980 showed that 61% of bleeds occurred after day 4 post dosing. There were no safety concerns identified. The investigational treatment arm was prematurely discontinued due to failure to achieve the primary endpoint.

Metabolic fate and distribution of [{sup 14}C]1,3-dichloropropene in carrot, lettuce, radish, tomato, and wheat

DOE Office of Scientific and Technical Information (OSTI.GOV)

Barnkow, D.E.; Byrne, S.L.; Huskin, M.A.

1996-10-01

This study examined the nature of the radioactive residue in carrot, lettuce, radish, tomato, and wheat grown in soil treated with uniformly {sup 14}C-labeled cis- and trans-1,3-dichloropropene (1,3-D). Each crop was grown in soil treated at or above the maximum use rate. Carrot root and top, lettuce, radish root and top, tomato fruit and vine, and wheat forage, straw and grain were harvested, processed, and analyzed. The {sup 14}C residues were subjected to sequential extraction with diethyl ether and aqueous acetonitrile. The residues that remained were subjected to extraction, fractionation, and hydrolysis with buffer, enzymes, acid, alkali, and strong oxidizingmore » agents. Analyses of the solubilized residues demonstrated that no detectable parent, 1,3-D, or the putative metabolites 3-chloroallyl alcohol and 3-chloroacrylic acid were present. The components of the extractable residue included most major plant constituents (i.e., protein, pigments, organic acids, sucrose, cellulose, and lignin). Thus, natural incorporation of the {sup 14}C-label into natural plant biochemicals is demonstrated.« less

Ziprasidone and amisulpride effectively treat negative symptoms of schizophrenia: results of a 12-week, double-blind study.

PubMed

Olié, Jean-Pierre; Spina, Edoardo; Murray, Stephen; Yang, Ruoyong

2006-05-01

We compared the efficacy of ziprasidone and amisulpride in the treatment of negative symptoms and overall psychopathology in subjects who had chronic schizophrenia with predominantly negative symptoms. This multicentre, 12-week, double-blind study randomly assigned subjects with predominantly negative-symptom schizophrenia [i.e. Positive and Negative Syndrome Scale (PANSS) Negative Subscale score >or=6 points greater than Positive Subscale score] to ziprasidone (40-80 mg b.i.d.; n=60) or amisulpride (50-100 mg b.i.d.; n=63). The primary efficacy variable was the change from baseline in PANSS Negative Subscale score. Secondary efficacy variables included change in scores for PANSS Total, Global Assessment of Functioning, Brief Psychiatric Rating Scale derived from PANSS Total and Core, Clinical Global Impression (CGI)-Severity and CGI-Improvement. For the change in PANSS Negative Subscale score, a ratio to assess the equivalence of the treatment groups was calculated from the least squares mean changes from baseline, with equivalence claimed if the lower limit of the 95% confidence interval of the ratio exceeded 0.60. Mean daily dose, adjusted for differential numbers of subjects and differential days between visits, was 118.0 mg for ziprasidone and 144.7 mg for amisulpride. Mean PANSS Negative Subscale scores improved over the 12-week treatment period for intent-to-treat subjects, evaluable subjects (subjects with >or=4 weeks of double-blind treatment and no protocol deviations) and completers in both treatment groups. Ziprasidone demonstrated efficacy comparable to amisulpride in improving negative symptoms and global psychopathology. The groups demonstrated comparable improvements in secondary efficacy variables. Both agents were generally well tolerated, with comparably low incidences of movement disorders. In subjects with negative symptom-prominent schizophrenia, ziprasidone in mean daily doses of 118 mg was equivalent to amisulpride in mean daily doses of 148 mg in ameliorating negative symptoms and comparable in improving overall psychopathology and global illness severity.

Long-term efficacy and safety of blonanserin in patients with first-episode schizophrenia: a 1-year open-label trial.

PubMed

Ninomiya, Yuriko; Miyamoto, Seiya; Tenjin, Tomomi; Ogino, Shin; Miyake, Nobumi; Kaneda, Yasuhiro; Sumiyoshi, Tomiki; Yamaguchi, Noboru

2014-12-01

The purpose of this study was to evaluate the long-term effectiveness and safety of blonanserin, a second-generation antipsychotic drug developed in Japan, in patients with first-episode schizophrenia. Twenty-three antipsychotic-naïve patients with first-episode schizophrenia were treated within an open-label, 1-year, prospective trial of blonanserin (2-24 mg/day). Clinical evaluations were conducted at baseline and 2, 6, and 12 months after the start of treatment. The main outcome measures were changes in subjective well-being and subjective quality of life, as assessed by the Subjective Well-being under Neuroleptic treatment scale Short form-Japanese version and the Schizophrenia Quality of Life Scale-Japanese version, respectively. Secondary outcome measures included the Positive and Negative Syndrome Scale, the Brief Assessment of Cognition in Schizophrenia-Japanese version, laboratory tests, bodyweight, and extrapyramidal symptoms. Fourteen patients (60.9%) remained on the study at 1 year. In the intention-to-treat analysis, significant improvements were observed in several subscales on the Subjective Well-being under Neuroleptic treatment scale Short form-Japanese version, the Schizophrenia Quality of Life Scale-Japanese version, and the Brief Assessment of Cognition in Schizophrenia-Japanese version, and in all factor scores on the Positive and Negative Syndrome Scale. Improvement in depressive symptoms with blonanserin treatment was positively correlated with improvements in subjective well-being and subjective quality of life, as well as verbal memory. No significant changes were noted for any safety measure during the 1-year study period. Blonanserin was well tolerated and effective for the treatment of first-episode schizophrenia in terms of subjective wellness, cognition, and a wide range of pathological symptoms. Further large-scale studies are warranted to confirm our findings. © 2014 The Authors. Psychiatry and Clinical Neurosciences © 2014 Japanese Society of Psychiatry and Neurology.

Treatment of resistant glomerular diseases with adrenocorticotropic hormone gel: a prospective trial.

PubMed

Bomback, Andrew S; Canetta, Pietro A; Beck, Laurence H; Ayalon, Rivka; Radhakrishnan, Jai; Appel, Gerald B

2012-01-01

Adrenocorticotropic hormone (ACTH) has shown promising results in glomerular diseases resistant to conventional therapies, but the reported data have solely been from retrospective, observational studies. In this prospective, open-label study (NCT01129284), 15 subjects with resistant glomerular diseases were treated with ACTH gel (80 units subcutaneously twice weekly) for 6 months. Resistant membranous nephropathy (MN), minimal change disease (MCD), and focal segmental glomerulosclerosis (FSGS) were defined as failure to achieve sustained remission of proteinuria off immunosuppressive therapy with at least 2 treatment regimens; resistant IgA nephropathy was defined as >1 g/g urine protein:creatinine ratio despite maximally tolerated RAAS blockade. Remission was defined as stable or improved renal function with ≥50% reduction in proteinuria to <0.5 g/g (complete remission) or 0.5-3.5 g/g (partial remission). The study included 5 subjects with resistant idiopathic MN, 5 subjects with resistant MCD (n = 2)/FSGS (n = 3), and 5 subjects with resistant IgA nephropathy. Two resistant MN subjects achieved partial remission on ACTH therapy, although 3 achieved immunologic remission of disease (PLA(2)R antibody disappeared by 4 months of therapy). One subject with resistant FSGS achieved complete remission on ACTH; one subject with resistant MCD achieved partial remission but relapsed within 4 weeks of stopping ACTH. Two subjects with resistant IgA nephropathy demonstrated >50% reductions in proteinuria while on ACTH, with proteinuria consistently <1 g/g by 6 months. Three of 15 subjects reported significant steroid-like adverse effects with ACTH, including weight gain and hyperglycemia, prompting early termination of therapy without any clinical response. ACTH gel is a promising treatment for resistant glomerular diseases and should be studied further in controlled trials against currently available therapies for resistant disease. Copyright © 2012 S. Karger AG, Basel.

Non-invasive high-intensity focused ultrasound for UV-induced hyperpigmentation in Fitzpatrick skin types III and IV: a prospective, randomized, controlled, evaluator-blinded trial.

PubMed

Vachiramon, Vasanop; Jurairattanaporn, Natthachat; Harnchoowong, Sarawin; Chayavichitsilp, Pamela

2018-02-01

Skin hyperpigmentation is a frequently encountered problem, particularly in darker skin types. Unfortunately, standard treatments for this condition have shown disappointing results. High-intensity focused ultrasound (HIFU) is commonly indicated for skin laxity, but recently was used to treat UV-induced hyperpigmentation in animal models. This study is aimed to evaluate the efficacy and safety of high-intensity focused ultrasound for UVB-induced hyperpigmentation in human subjects. A randomized, evaluator-blinded pilot study was conducted on 20 subjects. Each subject was induced three hyperpigmentary spots by local broadband UVB. After 2 weeks, each spot was randomly allocated to control, low-energy, and high-energy HIFU. Subjects were instructed to follow up weekly for a duration of 1 month. Lightness index measurements, mean improvement scores, subjects' satisfaction, pain scores, and side effects were evaluated. All 20 subjects completed the study. Fourteen subjects had Fitzpatrick (FPT) skin type III and six subjects had FPT skin type IV. Twelve subjects showed greater improvement at control sites while eight subjects showed greater improvement at HIFU-treated sites. In FPT skin type III, HIFU appeared to be inferior to control in both lightness index and mean improvement scores, but in FPT skin type IV, HIFU had greater lightness index improvement and higher improvement scores than control. Side effects were more frequent in high-energy-treated areas. Focused ultrasound may be offered in some patients with hyperpigmentary conditions. More research is needed to determine proper energy settings for optimal outcome.

High Current Anxiety Symptoms, But Not a Past Anxiety Disorder Diagnosis, are Associated with Impaired Fear Extinction

PubMed Central

Duits, Puck; Cath, Danielle C.; Heitland, Ivo; Baas, Johanna M. P.

2016-01-01

Although impaired fear extinction has repeatedly been demonstrated in patients with anxiety disorders, little is known about whether these impairments persist after treatment. The current comparative exploratory study investigated fear extinction in 26 patients treated for their anxiety disorder in the years preceding the study as compared to 17 healthy control subjects. Fear-potentiated startle and subjective fear were measured in a cue and context fear conditioning paradigm within a virtual reality environment. Results indicated no differences in fear extinction between treated anxiety patients and control subjects. However, scores on the Beck Anxiety Inventory across all participants revealed impaired extinction of fear potentiated startle in subjects with high compared to low anxiety symptoms over the past week. Taken together, this exploratory study found no support for impaired fear extinction in treated anxiety patients, and implies that current anxiety symptoms rather than previous patient status determine the success of extinction. PMID:26955364

Virological Failure and HIV-1 Drug Resistance Mutations among Naive and Antiretroviral Pre-Treated Patients Entering the ESTHER Program of Calmette Hospital in Cambodia

PubMed Central

Limsreng, Setha; Him, Sovanvatey; Nouhin, Janin; Hak, Chanroeurn; Srun, Chanvatey; Viretto, Gerald; Ouk, Vara; Delfraissy, Jean Francois; Ségéral, Olivier

2014-01-01

Introduction In resource limited settings, patients entering an antiretroviral therapy (ART) program comprise ART naive and ART pre-treated patients who may show differential virological outcomes. Methods This retrospective study, conducted in 2010–2012 in the HIV clinic of Calmette Hospital located in Phnom Penh (Cambodia) assessed virological failure (VF) rates and patterns of drug resistance of naive and pre-treated patients. Naive and ART pre-treated patients were included when a Viral Load (VL) was performed during the first year of ART for naive subjects or at the first consultation for pre-treated individuals. Patients showing Virological failure (VF) (>1,000 copies/ml) underwent HIV DR genotyping testing. Interpretation of drug resistance mutations was done according to 2013 version 23 ANRS algorithms. Results On a total of 209 patients, 164 (78.4%) were naive and 45 (21.5%) were ART pre-treated. Their median initial CD4 counts were 74 cells/mm3 (IQR: 30–194) and 279 cells/mm3 (IQR: 103–455) (p<0.001), respectively. Twenty seven patients (12.9%) exhibited VF (95% CI: 8.6–18.2%), including 10 naive (10/164, 6.0%) and 17 pre-treated (17/45, 37.8%) patients (p<0.001). Among these viremic patients, twenty-two (81.4%) were sequenced in reverse transcriptase and protease coding regions. Overall, 19 (86.3%) harbored ≥1 drug resistance mutations (DRMs) whereas 3 (all belonging to pre-treated patients) harbored wild-types viruses. The most frequent DRMs were M184V (86.3%), K103N (45.5%) and thymidine analog mutations (TAMs) (40.9%). Two (13.3%) pre-treated patients harbored viruses that showed a multi-nucleos(t)ide resistance including Q151M, K65R, E33A/D, E44A/D mutations. Conclusion In Cambodia, VF rates were low for naive patients but the emergence of DRMs to NNRTI and 3TC occurred relatively quickly in this subgroup. In pre-treated patients, VF rates were much higher and TAMs were relatively common. HIV genotypic assays before ART initiation and for ART pre-treated patients infection should be considered as well. PMID:25166019

Electrocardiographic Changes in Children and Adolescents Treated with Ziprasidone: A Prospective Study.

ERIC Educational Resources Information Center

McElfresh, Adeline; Scahill, Lawrence; State, Matthew; Martin, Andres

2005-01-01

Objective: To assess the electrocardiographic safety profile of low-dose ziprasidone ([less than or equal to]40 mg/day) among pediatric outpatients treated for up to 6 months. Method: This was a prospective, open-label trial involving 20 subjects with a mean age of 13.2 [+ or -] 3.0 years. Subjects received a mean ziprasidone dose of 30 [+ or -]…

Impaired bone remodeling in children with osteogenesis imperfecta treated and untreated with bisphosphonates: the role of DKK1, RANKL, and TNF-α.

PubMed

Brunetti, G; Papadia, F; Tummolo, A; Fischetto, R; Nicastro, F; Piacente, L; Ventura, A; Mori, G; Oranger, A; Gigante, I; Colucci, S; Ciccarelli, M; Grano, M; Cavallo, L; Delvecchio, M; Faienza, M F

2016-07-01

In this study, we investigated the bone cell activity in patients with osteogenesis imperfecta (OI) treated and untreated with neridronate. We demonstrated the key role of Dickkopf-1 (DKK1), receptor activator of nuclear factor-κB ligand (RANKL), and tumor necrosis factor alpha (TNF-α) in regulating bone cell of untreated and treated OI subjects. These cytokines could represent new pharmacological targets for OI. Bisphosphonates are widely used in the treatment of children with osteogenesis imperfecta (OI) with the objective of reducing the risk of fractures. Although bisphosphonates increase bone mineral density in OI subjects, the effects on fracture incidence are conflicting. The aim of this study was to investigate the mechanisms underlying bone cell activity in subjects with mild untreated forms of OI and in a group of subjects with severe OI treated with cycles of intravenous neridronate. Sclerostin, DKK1, TNF-α, RANKL, osteoprotegerin (OPG), and bone turnover markers were quantified in serum of 18 OI patients (12 females, mean age 8.86 ± 3.90), 8 of which were receiving cyclic intravenous neridronate, and 21 sex- and age-matched controls. The effects on osteoblastogenesis and OPG expression of media conditioned by the serum of OI patients and anti-DKK1 neutralizing antibody were evaluated. Osteoclastogenesis was assessed in cultures from patients and controls. DKK1 and RANKL levels were significantly increased both in untreated and in treated OI subjects with respect to controls. The serum from patients with high DKK1 levels inhibited both osteoblast differentiation and OPG expression in vitro. High RANKL and low OPG messenger RNA (mRNA) levels were found in lymphomonocytes from patients. High amounts of TNF-α were expressed by monocytes, and an elevated percentage of circulating CD11b-CD51/CD61+ osteoclast precursors was observed in patients. Our study demonstrated the key role of DKK1, RANKL, and TNF-α in regulating bone cell activity of subjects with OI untreated and treated with bisphosphonates. These cytokines could represent new pharmacological targets for OI patients.

Ultrasound visual feedback treatment and practice variability for residual speech sound errors

PubMed Central

Preston, Jonathan L.; McCabe, Patricia; Rivera-Campos, Ahmed; Whittle, Jessica L.; Landry, Erik; Maas, Edwin

2014-01-01

Purpose The goals were to (1) test the efficacy of a motor-learning based treatment that includes ultrasound visual feedback for individuals with residual speech sound errors, and (2) explore whether the addition of prosodic cueing facilitates speech sound learning. Method A multiple baseline single subject design was used, replicated across 8 participants. For each participant, one sound context was treated with ultrasound plus prosodic cueing for 7 sessions, and another sound context was treated with ultrasound but without prosodic cueing for 7 sessions. Sessions included ultrasound visual feedback as well as non-ultrasound treatment. Word-level probes assessing untreated words were used to evaluate retention and generalization. Results For most participants, increases in accuracy of target sound contexts at the word level were observed with the treatment program regardless of whether prosodic cueing was included. Generalization between onset singletons and clusters was observed, as well as generalization to sentence-level accuracy. There was evidence of retention during post-treatment probes, including at a two-month follow-up. Conclusions A motor-based treatment program that includes ultrasound visual feedback can facilitate learning of speech sounds in individuals with residual speech sound errors. PMID:25087938

Determination of minimal clinically important change in early and advanced Parkinson's disease.

PubMed

Hauser, Robert A; Auinger, Peggy

2011-04-01

Two common primary efficacy outcome measures in Parkinson's disease (PD) are change in Unified Parkinson's Disease Rating Scale (UPDRS) scores in early PD and change in "off" time in patients with motor fluctuations. Defining the minimal clinically important change (MCIC) in these outcome measures is important to interpret the clinical relevance of changes observed in clinical trials and other situations. We analyzed data from 2 multicenter, placebo-controlled, randomized clinical trials of rasagiline; TEMPO studied 404 early PD subjects, and PRESTO studied 472 levodopa-treated subjects with motor fluctuations. An anchor-based approach using clinical global impression of improvement (CGI-I) was used to determine MCIC for UPDRS scores and daily "off" time. MCIC was defined as mean change in actively treated subjects rated minimally improved on CGI-I. Receiver operating characteristic (ROC) curves defined optimal cutoffs discriminating between changed and unchanged subjects. MCIC for improvement in total UPDRS score (parts I-III) in early PD was determined to be -3.5 points based on mean scores and -3.0 points based on ROC curves. In addition, we found an MCIC for reduction in "off" time of 1.0 hours as defined by mean reduction in "off" time in active treated subjects self-rated as minimally improved on CGI-I minus mean reduction in "off" time in placebo-treated subjects self-rated as unchanged (1.9-0.9 hours). We hypothesize that many methodological factors can influence determination of the MCIC, and a range of values is likely to emerge from multiple studies. Copyright © 2011 Movement Disorder Society.

Patient-reported quality of life in a randomized placebo-controlled trial of naltrexone/bupropion for obesity.

PubMed

Kolotkin, R L; Chen, S; Klassen, P; Gilder, K; Greenway, F L

2015-10-01

Weight loss is associated with improved quality of life in some, but not all, weight loss trials. We evaluated changes at 56 weeks in quality of life, measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, in a pooled analysis of patient-level data from four randomized controlled Phase 3 studies of naltrexone/bupropion (NB32 or Contrave®). The total number of subjects was 3362 (NB32 = 2043; placebo = 1319; mean body mass index = 36.3 kg m(2); mean age = 46). Improvements in IWQOL-Lite Total Score were greater in subjects treated with NB32 (11.9 points [SE 0.3]) vs. placebo (8.2 points [SE 0.3]; P < 0.001), corresponding to weight reductions of 7.0% (SE 0.2) and 2.3% (SE 0.2), respectively. Greater improvements were also observed for NB32 vs. placebo on all five subscale scores of the IWQOL-Lite. Fifty per cent of NB32-treated subjects achieved clinically meaningful improvements in IWQOL-Lite Total Score vs. 32.3% of placebo-treated subjects (odds ratio, 95% confidence interval; 2.09, 1.79-2.44). Subjects losing the most weight (≥ 15% of baseline weight) experienced the greatest improvement in IWQOL-Lite Total Score (19.3 points [SE 0.7] for NB32 and 18.7 points [SE 1.3] for placebo; P = 0.624). Improved quality of life was associated with weight reduction and was achieved in more subjects treated with NB32 than placebo. © 2015 World Obesity.

Brief Report: Soluble CD163 in CMV-Infected and CMV-Uninfected Subjects on Virologically Suppressive Antiretroviral Therapy in the ICONA Cohort.

PubMed

Vita, Serena; Lichtner, Miriam; Marchetti, Giulia; Mascia, Claudia; Merlini, Esther; Cicconi, Paola; Vullo, Vincenzo; Viale, Pierluigi; Costantini, Andrea; DʼArminio Monforte, Antonella

2017-03-01

To contribute to the understanding of the role played by cytomegalovirus (CMV) in sustaining monocyte/macrophage-mediated immune activation in antiretroviral therapy treated HIV-infected subjects. We selected 23 CMV-uninfected and 46 CMV-infected HIV+ subjects, matched for age, CD4 nadir, HIV infection duration, and viral hepatitis serostatus. All subjects were on successful antiretroviral therapy since at least 1 year. A group of 16 healthy donors with similar age and sex was also included. Plasma levels of tumor necrosis factor-alpha, interleukin-6, sCD163, sCD14, and CMV immunoglobulin G levels were measured in duplicate with human enzyme-linked immunosorbent assay kits. We found significantly higher sCD163 plasma levels in HIV+CMV+ compared with HIV+CMV- subjects and healthy donors. This augmentation was confirmed also when subjects positive for hepatitis C virus-Ab were excluded from analysis. Interestingly, a correlation between anti-CMV immunoglobulin G levels and sCD163, tumor necrosis factor-alpha, interleukin-6, and sCD14 in HIV+CMV+ subjects was found. CMV coinfection could be a major driver of monocyte/macrophage activation in virally suppressed HIV+ individuals and might explain the increased risk of non-AIDS morbidity/mortality in HIV/CMV-coinfected subjects.

Safety of Repeated-Dose Intratympanic Injections with AM-101 in Acute Inner Ear Tinnitus.

PubMed

Staecker, Hinrich; Morelock, Michael; Kramer, Timothy; Chrbolka, Pavel; Ahn, Joong Ho; Meyer, Thomas

2017-09-01

Objective To evaluate the safety and tolerability of repeated intratympanic administration of the gel-formulated NMDA receptor antagonist AM-101 in acute patients with inner ear tinnitus. Study Design Prospective, double-blind, randomized, placebo-controlled study. Setting Sixty-nine secondary and tertiary sites in North America, Europe, and Asia. Subjects and Methods In total, 343 subjects with persistent acute tinnitus after traumatic cochlear injury or otitis media were randomized to receive 3 intratympanic doses of either AM-101 0.87 mg/mL or placebo over 3 to 5 days. They were followed for 84 days. The primary safety end point was the incidence of a clinically meaningful hearing deterioration from baseline to study day 35. Further safety assessments included tympanic membrane closure rates, analysis of adverse events, hematology, blood chemistry, and vital signs. In addition, data were collected on applied anesthetics and injection techniques. Results The treatment was well tolerated, with no intervention-related serious adverse events. The incidence of clinically meaningful hearing deterioration was low, comparable between treatment groups ( P = .82 for the primary safety end point) and not different between treated and untreated ears in unilaterally treated subjects. The rate of treatment and procedure-related adverse events was similar among treatment groups. The tympanic membrane was closed in 92% of subjects within 1 week and in all subjects by study day 84. Blood values and vital signs were inconspicuous. Conclusion Repeated intratympanic injections of AM-101 over a 3- to 5-day period appear to be safe and well tolerated, demonstrating the ability to potentially use this delivery approach over longer time periods.

Efficacy and safety of treatment with an anti-m2e monoclonal antibody in experimental human influenza.

PubMed

Ramos, Eleanor L; Mitcham, Jennifer L; Koller, Teri D; Bonavia, Aurelio; Usner, Dale W; Balaratnam, Ganesh; Fredlund, Paul; Swiderek, Kristine M

2015-04-01

The efficacy of TCN-032, a human monoclonal antibody targeting a conserved epitope on M2e, was explored in experimental human influenza. Healthy volunteers were inoculated with influenza A/Wisconsin/67/2005 (H3N2) and received a single dose of the study drug, TCN-032, or placebo 24 hours later. Subjects were monitored for symptoms, viral shedding, and safety, including cytokine measurements. Oseltamivir was administered 7 days after inoculation. Although the primary objective of reducing the proportion of subjects developing any grade ≥2 influenza symptom or pyrexia, was not achieved, TCN-032-treated subjects showed 35% reduction (P = .047) in median total symptom area under the curve (days 1-7) and 2.2 log reduction in median viral load area under the curve (days 2-7) by quantitative polymerase chain reaction (P = .09) compared with placebo-treated subjects. TCN-032 was safe and well tolerated with no additional safety signals after administration of oseltamivir. Serum cytokine levels (interferon γ, tumor necrosis factor α, and interleukin 8 and 10) were similar in both groups. Genotypic and phenotypic analyses showed no difference between virus derived from subjects after TCN-032 treatment and parental strain. These data indicate that TCN-032 may provide immediate immunity and therapeutic benefit in influenza A infection, with no apparent emergence of resistant virus. TCN-032 was safe with no evidence of immune exacerbation based on serum cytokine expression. Clinicaltrials.gov registry number. NCT01719874. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Mechanistic correlates of clinical responses to omalizumab in the setting of oral immunotherapy for milk allergy.

PubMed

Frischmeyer-Guerrerio, Pamela A; Masilamani, Madhan; Gu, Wenjuan; Brittain, Erica; Wood, Robert; Kim, Jennifer; Nadeau, Kari; Jarvinen, Kirsi M; Grishin, Alexander; Lindblad, Robert; Sampson, Hugh A

2017-10-01

In our recent clinical trial, the addition of omalizumab to oral immunotherapy (OIT) for milk allergy improved safety, but no significant clinical benefit was detected. We sought to investigate mechanisms by which omalizumab modulates immunity in the context of OIT and to identify baseline biomarkers that predict subgroups of patients most likely to benefit from omalizumab. Blood was obtained at baseline and multiple time points during a placebo-controlled trial of OIT for milk allergy in which subjects were randomized to receive omalizumab or placebo. Immunologic outcomes included measurement of basophil CD63 expression and histamine release and casein-specific CD4 + regulatory T-cell proliferation. Biomarkers were analyzed in relationship to measurements of safety and efficacy. Milk-induced basophil CD63 expression was transiently reduced in whole blood samples from both omalizumab- and placebo-treated subjects. However, IgE-dependent histamine release increased in washed cell preparations from omalizumab- but not placebo-treated subjects. No increase in regulatory T-cell frequency was evident in either group. Subjects with lower rates of adverse reactions, regardless of arm, experienced better clinical outcomes. Pre-OIT basophil reactivity positively associated with occurrence of symptoms during OIT, whereas the baseline milk IgE/total IgE ratio correlated with the likelihood of achieving sustained unresponsiveness. A combination of baseline basophil and serologic biomarkers defined a subset of patients in which adjunctive therapy with omalizumab was associated with attainment of sustained unresponsiveness and a reduction in adverse reactions. Combining omalizumab therapy with milk OIT led to distinct alterations in basophil reactivity but not T-cell responses. Baseline biomarkers can identify subjects most likely to benefit from adjunctive therapy with omalizumab. Copyright © 2017 American Academy of Allergy, Asthma & Immunology. All rights reserved.

Emotional Reactivity and Regulation Following Citalopram Therapy in Children and Adolescents with Anxiety Disorders.

PubMed

Carthy, Tal; Benaroya-Milshtein, Noa; Valevski, Avi; Apter, Alan

2017-02-01

Emotional dysregulation is an important element in the pathophysiology of childhood anxiety disorders and can distinguish anxious subjects from controls. Treatment with selective serotonin inhibitors (SSRIs) has been found to lessen anxiety, but its effects on emotional reactivity and regulation are less documented. The aim of the study was to prospectively assess changes in emotional reactivity and regulation in response to citalopram in children and adolescents with anxiety disorders, with special focus on the mechanism of reappraisal. The sample included 70 children and adolescents (38 boys, 32 girls) 10-17 years of age, divided into three groups: Those with anxiety disorder treated with citalopram for 8 weeks (n = 35); untreated subjects with anxiety disorder on the waiting list for cognitive behavioral therapy (CBT) (n = 15); and subjects without anxiety disorder (controls) (n = 20). Emotional reactivity and regulation (i.e., reappraisal), were assessed at baseline and after 8 weeks (follow-up) with validated computer-based instruments, Reactivity and Regulation-Situations (REAR-S) and Reactivity and Regulation-Images (REAR-I). Citalopram-treated subjects showed significantly greater improvement in reappraisal ability than CBT-waitlisted subjects. Improvement in the ability to reappraise threatening images correlated significantly with the decrease in anxiety. There was a decrease in negative emotional reactivity between assessments, which was positively correlated with clinical improvement. Higher intensity of baseline reactivity (on the REAR-S) predicted more severe symptoms at follow-up. Citalopram therapy improves reappraisal ability in children and adolescents with anxiety. However, the improvement in other examined emotional reactivity indices occurred in both medicated and waitlisted groups. It is possible that these findings may have implications for understanding the pathophysiology of anxiety in children and adolescents.

Long-term outcome of individuals treated with oral insulin: diabetes prevention trial-type 1 (DPT-1) oral insulin trial.

PubMed

Vehik, Kendra; Cuthbertson, David; Ruhlig, Holly; Schatz, Desmond A; Peakman, Mark; Krischer, Jeffrey P

2011-07-01

To evaluate the long-term intervention effects of oral insulin on the development of type 1 diabetes and to assess the rate of progression to type 1 diabetes before and after oral insulin treatment was stopped in the Diabetes Prevention Trial-Type 1 (DPT-1). The follow-up included subjects who participated in the early intervention of oral insulin (1994-2003) to prevent or delay type 1 diabetes. A telephone survey was conducted in 2009 to determine whether diabetes had been diagnosed and, if not, an oral glucose tolerance test (OGTT), hemoglobin A1c (HbA1c), and autoantibody levels were obtained on all subjects who agreed to participate. Of 372 subjects randomized, 97 developed type 1 diabetes before follow-up; 75% of the remaining 275 subjects were contacted. In the interim, 77 subjects had been diagnosed with type 1 diabetes and 54 of the remainder have had an OGTT; 10 of these were diagnosed with type 1 diabetes, subsequently. Among individuals meeting the original criteria for insulin autoantibodies (IAAs) (≥80 nU/mL), the overall benefit of oral insulin remained significant (P=0.05). However, the hazard rate in this group increased (from 6.4% [95% CI 4.5-9.1] to 10.0% [7.1-14.1]) after cessation of therapy, which approximated the rate of individuals treated with placebo (10.2% [7.1-14.6]). Overall, the oral insulin treatment effect in individuals with confirmed IAA≥80 nU/mL appeared to be maintained with additional follow-up; however, once therapy stopped, the rate of developing diabetes in the oral insulin group increased to a rate similar to that in the placebo group.

Staphylococcus Aureus Prevention Strategies in Cardiac Surgery: A Cost-Effectiveness Analysis.

PubMed

Hong, Jonathan C; Saraswat, Manoj K; Ellison, Trevor A; Magruder, J Trent; Crawford, Todd; Gardner, Julia M; Padula, William V; Whitman, Glenn J

2018-01-01

Cardiac surgery patients colonized with Staphylococcus aureus have a greater risk of surgical site infection (SSI). The purpose of this study was to evaluate the cost-effectiveness of decolonization strategies to prevent SSIs. We compared three decolonization strategies: universal decolonization (UD), all subjects treated; targeted decolonization (TD), only S aureus carriers treated; and no decolonization (ND). Decolonization included mupirocin, chlorhexidine, and vancomycin. We implemented a decision tree comparing the costs and quality-adjusted life-years (QALYs) of these strategies on SSI over a 1-year period for subjects undergoing coronary artery bypass graft surgery from a US health sector perspective. Deterministic and probabilistic sensitivity analyses were conducted to address the uncertainty in the variables. Universal decolonization was the dominant strategy because it resulted in reduced costs at near-equal QALYs compared with TD and ND. Compared with ND, UD decreased costs by $462 and increased QALYs by 0.002 per subject, whereas TD decreased costs by $205 and increased QALYs by 0.001 per subject. For 1,000 subjects, UD prevented 19 SSI and TD prevented 10 SSI compared with ND. Sensitivity analysis showed UD to be the most cost-effective strategy in more than 91% of simulations. For the 220,000 coronary artery bypass graft procedures performed yearly in the United States, UD would save $102 million whereas TD would save $45 million compared with ND. Universal decolonization outperforms other strategies. However, the potential costs savings of $57 million per 220,000 coronary artery bypass graft procedures comparing UD versus TD must be weighed against the potential risk of developing resistance associated with universal decolonization. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Omalizumab facilitates rapid oral desensitization for peanut allergy

PubMed Central

MacGinnitie, Andrew J.; Rachid, Rima; Gragg, Hana; Little, Sara V; Lakin, Paul; Cianferoni, Antonella; Heimall, Jennifer; Makhija, Melanie; Robison, Rachel; Chinthrajah, R. Sharon; Lee, John; Lebovidge, Jennifer; Dominguez, Tina; Rooney, Courtney; Lewis, Megan Ott; Koss, Jennifer; Burke-Roberts, Elizabeth; Chin, Kimberly; Logvinenko, Tanya; Pongracic, Jacqueline A.; Umetsu, Dale T.; Spergel, Jonathan; Nadeau, Kari C.; Schneider, Lynda C.

2017-01-01

Background Peanut oral immunotherapy (OIT) is a promising approach to peanut allergy but reactions are frequent and some patients cannot be desensitized. The anti-IgE medication omalizumab (Xolair) may allow more rapid peanut updosing and decrease reactions. Objective To evaluate if omalizumab facilitated rapid peanut desensitization in highly allergic patients. Methods Thirty-seven subjects were randomized to omalizumab (n=29) or placebo (n=8). After 12 weeks of treatment subjects underwent a rapid one-day desensitization of up to 250 mg of peanut protein, followed by weekly increases up to 2000 mg. Omalizumab was then discontinued and subjects continued on 2000 mg of peanut protein. They underwent an open challenge to 4000 mg peanut protein twelve weeks after stopping study drug. If tolerated, subjects continued on 4000 mg of peanut protein daily. Results The median peanut dose tolerated on the initial desensitization day was 250 mg for omalizumab versus 22.5 mg for placebo treated subject. Subsequently 23 of 29 (79%) subjects randomized to omalizumab tolerated 2000 mg peanut protein 6 weeks after stopping omalizumab versus 1 of 8 (12%) receiving placebo (p<0.01). Twenty-three subjects on omalizumab versus 1 on placebo passed the 4000 mg food challenge. Overall reaction rates were not significantly lower in omalizumab versus placebo treated subjects (OR=0.57 p=0.15), although omalizumab treated subjects were exposed to much higher doses of peanut. Conclusion Omalizumab allows subjects with peanut allergy to be rapidly desensitized over as little as 8 weeks of peanut OIT. In the majority of subjects, this desensitization is sustained after omalizumab is discontinued. Additional studies will help clarify which patients would benefit most from this approach. PMID:27609658

Psychological impact of isotretinoin treatment in patients with moderate and severe acne.

PubMed

Simić, Dubravka; Situm, Mirna; Letica, Edita; Penavić, Jasna Zeljko; Zivković, Maja Vurnek; Tomić, Teo

2009-12-01

Acne patients are subject to different degree of psychosocial distress. The emotional impact of acne vulgaris due to disfigurement caused by the disease is undisputed. Most common reactions to the acne are depression and anxiety. The use of isotretinoin, one of the most effective options in acne treatment, increases depression symptoms. The aim of this study was to investigate the psychological status of the patients with moderate to severe acne and to compare patients treated with isotretinoin with patients treated with vitamin C. A total of 85 patients suffering from acne vulgaris were included in the study. The results of this study do not find a significant correlation between the use of isotretinoin and the psychological effects of the drug.

Prognostic factors in non-surgically treated sciatica: a systematic review.

PubMed

Ashworth, Julie; Konstantinou, Kika; Dunn, Kate M

2011-09-25

When present sciatica is considered an obstacle to recovery in low back pain patients, yet evidence is limited regarding prognostic factors for persistent disability in this patient group. The aim of this study is to describe and summarise the evidence regarding prognostic factors for sciatica in non-surgically treated cohorts. Understanding the prognostic factors in sciatica and their relative importance may allow the identification of patients with particular risk factors who might benefit from early or specific types of treatment in order to optimise outcome. A systematic literature search was conducted using Medline, EMBASE and CINAHL electronic databases. Prospective cohort studies describing subjects with sciatica and measuring pain, disability or recovery outcomes were included. Studies of cohorts comprised entirely of surgically treated patients were excluded and mixed surgically and conservatively treated cohorts were included only if the results were analysed separately by treatment group or if the analysis was adjusted for treatment. Seven adequate or high quality eligible studies were identified. There were conflicting but mainly negative results regarding the influence of baseline pain severity, neurological deficit, nerve root tension signs, duration of symptoms and radiological findings on outcome. A number of factors including age, gender, smoking, previous history of sciatica and heaviness of work do not appear to influence outcome. In contrast to studies of low back pain and purely surgically treated sciatica cohorts, psychological factors were rarely investigated. At present, the heterogeneity of the available studies makes it difficult to draw firm conclusions about sciatica prognosis, and highlights the need for further research for this group of patients. Large scale prospective studies of high methodological quality, using a well-defined, consistent definition of sciatica and investigating psychosocial factors alongside clinical and radiological findings are recommended to identify prognostic factors in this population.

Prognostic factors in non-surgically treated sciatica: A systematic review

PubMed Central

2011-01-01

Background When present sciatica is considered an obstacle to recovery in low back pain patients, yet evidence is limited regarding prognostic factors for persistent disability in this patient group. The aim of this study is to describe and summarise the evidence regarding prognostic factors for sciatica in non-surgically treated cohorts. Understanding the prognostic factors in sciatica and their relative importance may allow the identification of patients with particular risk factors who might benefit from early or specific types of treatment in order to optimise outcome. Methods A systematic literature search was conducted using Medline, EMBASE and CINAHL electronic databases. Prospective cohort studies describing subjects with sciatica and measuring pain, disability or recovery outcomes were included. Studies of cohorts comprised entirely of surgically treated patients were excluded and mixed surgically and conservatively treated cohorts were included only if the results were analysed separately by treatment group or if the analysis was adjusted for treatment. Results Seven adequate or high quality eligible studies were identified. There were conflicting but mainly negative results regarding the influence of baseline pain severity, neurological deficit, nerve root tension signs, duration of symptoms and radiological findings on outcome. A number of factors including age, gender, smoking, previous history of sciatica and heaviness of work do not appear to influence outcome. In contrast to studies of low back pain and purely surgically treated sciatica cohorts, psychological factors were rarely investigated. Conclusions At present, the heterogeneity of the available studies makes it difficult to draw firm conclusions about sciatica prognosis, and highlights the need for further research for this group of patients. Large scale prospective studies of high methodological quality, using a well-defined, consistent definition of sciatica and investigating psychosocial factors alongside clinical and radiological findings are recommended to identify prognostic factors in this population. PMID:21943339

[Overweight and obesity in children treated for congentital heart disease].

PubMed

Perin, Francesca; Carreras Blesa, Carmen; Rodríguez Vázquez Del Rey, Maria Del Mar; Cobo, Inmaculada; Maldonado, José

2018-04-21

The negative impact of overweight and obesity is potentially greater in children affected by a congenital heart disease (CHD). The aim of this study is to calculate the proportion of overweight and obesity in children who underwent an intervention for CHD, and to investigate systolic arterial hypertension as a possible early cardiovascular complication. A retrospective study was conducted on patients aged 6 to 17 years treated for CHD, and healthy control subjects, followed-up in a Paediatric Cardiology Clinic. Body mass index percentiles were calculated according to the criteria of WHO. A review was performed on the anthropometric and clinical data, as well as the systolic blood pressure (SBP). A total of 440 patients were included, of which 220 had CHD. The proportion of combined obesity and overweight (body mass index percentile≥85) was 36.4% (37.3% in healthy subjects and 35.4% in patients with CHD, P=.738). A higher prevalence of obesity (body mass index percentile≥97) was found in CHD patients (22.7%) compared to 15.5% in healthy subjects (P=.015). SBP percentiles were higher in overweight compared to normal-weight patients (P<.001). The prevalence of SBP readings≥the 95th percentile was greater in overweight than in normal weight CHD patients (29.5% versus 7.7%, P<.001) and also in the overweight healthy controls compared to those of normal weight (12.2% versus 0.7%, P<.001). The proportion of obesity is high in treated CHD children and is associated with high SBP levels. The risk of long-term complications needs to be reduced by means of prevention and treatment of obesity in this very vulnerable population. Copyright © 2018. Publicado por Elsevier España, S.L.U.

[Antibiotic prophylaxis with prulifloxacin in women undergoing induced abortion: a randomized controlled trial].

PubMed

Caruso, S; Di Mari, L; Cacciatore, A; Mammana, G; Agnello, C; Cianci, A

2008-02-01

To verify the efficacy of prulifloxacin in prevention of infective morbidity in women undergoing first trimester induced abortion. The aim of the study was to observe the incidence of infection during four weeks following abortion by monitoring the symptoms which require general practitioner prescription or hospitalization. Randomized controlled trial carried on by the Research Group for Sexology, Familiar Planning Service of the Department of Microbiological and Gynecological Science, University of Catania from September 2005 to March 2007. The study included 466 women, ranging in age from 14 to 44 years (mean age 26.7), who were randomized in three groups: group A (153 subjects) treated with 600 mg daily of prulifloxacin for 5 days after abortion; group B (155 subjects) treated with 600 mg daily of prulifloxacin for 3 days after abortion; group C (158 subjects) treated with 600 mg daily of prulifloxacin one day before and 2 days after abortion. Two hundred sixteen were nulliparous (47%), 96 were pluriparous (38.5%). Thirty-two nulliparous (15%) were under eighteen. Among pluriparous, 96 (38.5%) have had previous surgery delivery and 154 (61.5%) spontaneous delivery; moreover, 56 women have had previous surgical interruption during the first-trimester of pregnancy. Surgical abortion was practiced in a range of gestational age between 6th and 11th week of amenorrhea (average week 8.2). The percentage of pelvic inflammatory disease symptoms (pain, fever, leucoxantorrhea ) were about 10.5 in group A, 7.1 in group B and 2.5 in group C. Group C protocol was statistically more effective than group A protocol (P<0.05), but not than group B, even if prevalence of adverse events were less. Antibiotic prophylaxis before surgical abortion and shortening supplies after abortion is more effective than post abortion treatment alone.

Medication for Alzheimer's disease and associated fall hazard: a retrospective cohort study from the Alzheimer's Disease Neuroimaging Initiative.

PubMed

Epstein, Noam U; Guo, Rong; Farlow, Martin R; Singh, Jaswinder P; Fisher, Morris

2014-02-01

Falls are common in the elderly, especially in those with cognitive impairment. The elderly are often treated with several medications, which may have both beneficial and deleterious effects. The use and type of medication in Alzheimer's disease (AD) patients and association with falls is limited. We examined the association between falls and medication use in the Alzheimer's Disease Neuroimaging Initiative (ADNI). Diagnosis, demographics, medication use, apolipoprotein E4 allele status and functional activity level at baseline were gathered for 810 participants enrolled in the ADNI, including healthy controls and subjects with mild cognitive impairment or Alzheimer's. Reports detailing adverse event falls were tabulated. Baseline characteristics were compared between subjects with and without one or more falls. Cox proportional hazards models were conducted to evaluate the association between subject characteristics and hazard of the first fall. Age (p < 0.0001), Functional Activities Questionnaire (p = 0.035), Beers List (p = 0.0477) and medications for treating cognitive symptoms of Alzheimer's (p = 0.0019) were associated with hazard of fall in the univariate model. In the final multivariate model, after adjusting for covariates, Alzheimer's medication use (p = 0.0005) was associated with hazard of fall. Medication was changed by the clinician after an adverse fall event in 9% of the falls. About 7% of the falls were reported as serious adverse events and 6% were reported to be severe. We found a significant association between the use of symptomatic medication treating cognitive symptoms in AD and hazard of fall after adjusting for age and Beers List medication use. Additional pharmacovigilance of the association between falls and Alzheimer's medication use is warranted.

Medication for Alzheimer’s Disease and Associated Fall Hazard: a Retrospective Cohort Study from the Alzheimer’s Disease Neuro-Imaging Initiative

PubMed Central

Epstein, Noam U.; Guo, Rong; Farlow, Martin R.; Singh, Jaswinder P.; Fisher, Morris

2014-01-01

Background Falls are common in the elderly, especially in those with cognitive impairment. The elderly are often treated with several medications which may have both beneficial and deleterious effects. The use and type of medication in Alzheimer’s patients and association with falls is limited. Objective We examined the association between falls and medication use in the Alzheimer’s Disease Neuro-Imaging Initiative (ADNI). Methods Diagnosis, demographics, medication use, apolipoprotein E4 allele status and functional activity level at baseline were gathered for 810 participants enrolled in ADNI including healthy controls and subjects with mild cognitive impairment or Alzheimer’s. Adverse event fall reports were tabulated. Baseline characteristics were compared between subjects with and without one or more falls. Cox proportional hazards models were conducted to evaluate the association between subject characteristics and hazard of first fall. Results Age (p<0.0001), functional activities questionnaire (p=0.035), Beers list (p=0.0477) and medications for treating cognitive symptoms of Alzheimer’s (p=0.0019) were associated with hazard of fall in the univariate model. In the final multivariate model, after adjusting for covariates, Alzheimer’s medication use (p=0.0005) was associated with hazard of fall. Medication was changed after an adverse fall event by the clinician in 9% of the falls. About 7% of the falls were reported as serious adverse events and 6% were reported to be severe. Conclusion We found a significant association between use of symptomatic medication treating cognitive symptoms in Alzheimer’s disease and hazard of fall after adjusting for age and Beers list medication use. Additional pharmaco-vigilance of the association between falls and Alzheimer’s medication use is warranted. PMID:24357133

[Promising conservative treatment using dynamic mobilisation after Achilles tendon rupture].

PubMed

Tengberg, Peter Toft; Barfod, Kristoffer; Krasheninnikoff, Michael; Ebskov, Lars; Troelsen, Anders

2011-10-31

There is no consensus regarding the optimal treatment of acute Achilles tendon ruptures. This review of the literature on the subject shows a significantly higher rate of reruptures (RR) in the conservatively treated group compared to the surgically treated group when the foot is immobilised in the aftertreatment. Recent studies that used early dynamic mobilisation in the conservatively treated group did not show this difference in the RR rate. The latest literature on the subject indicates that non-operative treatment, followed by dynamic aftertreatment, results in the lowest complication rate and a good functional outcome.

The EMPOWER study: randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity.

PubMed

Sarr, Michael G; Billington, Charles J; Brancatisano, Roy; Brancatisano, Anthony; Toouli, James; Kow, Lilian; Nguyen, Ninh T; Blackstone, Robin; Maher, James W; Shikora, Scott; Reeds, Dominic N; Eagon, J Christopher; Wolfe, Bruce M; O'Rourke, Robert W; Fujioka, Ken; Takata, Mark; Swain, James M; Morton, John M; Ikramuddin, Sayeed; Schweitzer, Michael; Chand, Bipan; Rosenthal, Raul

2012-11-01

Intermittent, reversible intraabdominal vagal blockade (VBLOC® Therapy) demonstrated clinically important weight loss in feasibility trials. EMPOWER, a randomized, double-blind, prospective, controlled trial was conducted in USA and Australia. Five hundred three subjects were enrolled at 15 centers. After informed consent, 294 subjects were implanted with the vagal blocking system and randomized to the treated (n = 192) or control (n = 102) group. Main outcome measures were percent excess weight loss (percent EWL) at 12 months and serious adverse events. Subjects controlled duration of therapy using an external power source; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission. Devices in both groups performed regular, low-energy safety checks. Data are mean ± SEM. Study subjects consisted of 90 % females, body mass index of 41 ± 1 kg/m(2), and age of 46 ± 1 years. Device-related complications occurred in 3 % of subjects. There was no mortality. 12-month percent EWL was 17 ± 2 % for the treated and 16 ± 2 % for the control group. Weight loss was related linearly to hours of device use; treated and controls with ≥ 12 h/day use achieved 30 ± 4 and 22 ± 8 % EWL, respectively. VBLOC® therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group.

Emergent HIV-1 Drug Resistance Mutations Were Not Present at Low-Frequency at Baseline in Non-Nucleoside Reverse Transcriptase Inhibitor-Treated Subjects in the STaR Study

PubMed Central

Porter, Danielle P.; Daeumer, Martin; Thielen, Alexander; Chang, Silvia; Martin, Ross; Cohen, Cal; Miller, Michael D.; White, Kirsten L.

2015-01-01

At Week 96 of the Single-Tablet Regimen (STaR) study, more treatment-naïve subjects that received rilpivirine/emtricitabine/tenofovir DF (RPV/FTC/TDF) developed resistance mutations compared to those treated with efavirenz (EFV)/FTC/TDF by population sequencing. Furthermore, more RPV/FTC/TDF-treated subjects with baseline HIV-1 RNA >100,000 copies/mL developed resistance compared to subjects with baseline HIV-1 RNA ≤100,000 copies/mL. Here, deep sequencing was utilized to assess the presence of pre-existing low-frequency variants in subjects with and without resistance development in the STaR study. Deep sequencing (Illumina MiSeq) was performed on baseline and virologic failure samples for all subjects analyzed for resistance by population sequencing during the clinical study (n = 33), as well as baseline samples from control subjects with virologic response (n = 118). Primary NRTI or NNRTI drug resistance mutations present at low frequency (≥2% to 20%) were detected in 6.6% of baseline samples by deep sequencing, all of which occurred in control subjects. Deep sequencing results were generally consistent with population sequencing but detected additional primary NNRTI and NRTI resistance mutations at virologic failure in seven samples. HIV-1 drug resistance mutations emerging while on RPV/FTC/TDF or EFV/FTC/TDF treatment were not present at low frequency at baseline in the STaR study. PMID:26690199

Emergent HIV-1 Drug Resistance Mutations Were Not Present at Low-Frequency at Baseline in Non-Nucleoside Reverse Transcriptase Inhibitor-Treated Subjects in the STaR Study.

PubMed

Porter, Danielle P; Daeumer, Martin; Thielen, Alexander; Chang, Silvia; Martin, Ross; Cohen, Cal; Miller, Michael D; White, Kirsten L

2015-12-07

At Week 96 of the Single-Tablet Regimen (STaR) study, more treatment-naïve subjects that received rilpivirine/emtricitabine/tenofovir DF (RPV/FTC/TDF) developed resistance mutations compared to those treated with efavirenz (EFV)/FTC/TDF by population sequencing. Furthermore, more RPV/FTC/TDF-treated subjects with baseline HIV-1 RNA >100,000 copies/mL developed resistance compared to subjects with baseline HIV-1 RNA ≤100,000 copies/mL. Here, deep sequencing was utilized to assess the presence of pre-existing low-frequency variants in subjects with and without resistance development in the STaR study. Deep sequencing (Illumina MiSeq) was performed on baseline and virologic failure samples for all subjects analyzed for resistance by population sequencing during the clinical study (n = 33), as well as baseline samples from control subjects with virologic response (n = 118). Primary NRTI or NNRTI drug resistance mutations present at low frequency (≥2% to 20%) were detected in 6.6% of baseline samples by deep sequencing, all of which occurred in control subjects. Deep sequencing results were generally consistent with population sequencing but detected additional primary NNRTI and NRTI resistance mutations at virologic failure in seven samples. HIV-1 drug resistance mutations emerging while on RPV/FTC/TDF or EFV/FTC/TDF treatment were not present at low frequency at baseline in the STaR study.

Randomized, Observer-blind, Split-face Compatibility Study with Clindamycin Phosphate 1.2%/Benzoyl Peroxide 3.75% gel and Facial Foundation Makeup

PubMed Central

Pillai, Radhakrishnan

2015-01-01

Background: Cosmetic compatibility in the treatment of acne is an important issue significantly impacting quality of life, but often overlooked, as dermatologists commonly recommended avoidance of cosmetic foundations when treating adult female patients. Fixed combinations of clindamycin/benzoyl peroxide are widely used in the treatment of acne, but little is known about the impact of their concomitant use with facial foundation. Objective: To assess the compatibility of clindamycin phosphate 1. 2%/benzoyl peroxide 3. 75% gel with foundation makeup for up to six hours after application. Methods: Twenty-nine female subjects applied makeup to their face after randomly applying clindamycin phosphate 1. 2%/benzoyl peroxide 3. 75% gel to one side of the face. Investigator and subject self- assessment included facial skin attributes, facial tolerability, and cosmetic compatibility post-application and at Hour 6; as well as cutaneous tolerability. Results: No statistical difference was noted between the treated and untreated side of the face in terms of coverage, blotchiness, appearance, skin tone, or visual smoothness. Tolerability was excellent, with no erythema, edema, dryness, and peeling post-makeup application. For both the treated and untreated side, there was a slight lack of improvement in cosmetic appearance six hours post-makeup application. Conclusion: Clindamycin/benzoyl peroxide 3. 75% gel was shown to have excellent cosmetic compatibility with facial foundation. PMID:26430488

Randomized, Observer-blind, Split-face Compatibility Study with Clindamycin Phosphate 1.2%/Benzoyl Peroxide 3.75% gel and Facial Foundation Makeup.

PubMed

Bhatia, Neal; Pillai, Radhakrishnan

2015-09-01

Cosmetic compatibility in the treatment of acne is an important issue significantly impacting quality of life, but often overlooked, as dermatologists commonly recommended avoidance of cosmetic foundations when treating adult female patients. Fixed combinations of clindamycin/benzoyl peroxide are widely used in the treatment of acne, but little is known about the impact of their concomitant use with facial foundation. To assess the compatibility of clindamycin phosphate 1. 2%/benzoyl peroxide 3. 75% gel with foundation makeup for up to six hours after application. Twenty-nine female subjects applied makeup to their face after randomly applying clindamycin phosphate 1. 2%/benzoyl peroxide 3. 75% gel to one side of the face. Investigator and subject self- assessment included facial skin attributes, facial tolerability, and cosmetic compatibility post-application and at Hour 6; as well as cutaneous tolerability. No statistical difference was noted between the treated and untreated side of the face in terms of coverage, blotchiness, appearance, skin tone, or visual smoothness. Tolerability was excellent, with no erythema, edema, dryness, and peeling post-makeup application. For both the treated and untreated side, there was a slight lack of improvement in cosmetic appearance six hours post-makeup application. Clindamycin/benzoyl peroxide 3. 75% gel was shown to have excellent cosmetic compatibility with facial foundation.

The effect of long-term lithium treatment of bipolar disorder on stem cells circulating in peripheral blood.

PubMed

Ferensztajn-Rochowiak, Ewa; Kucharska-Mazur, Jolanta; Samochowiec, Jerzy; Ratajczak, Mariusz Z; Michalak, Michal; Rybakowski, Janusz K

2017-02-01

To investigate the effect of long-term lithium treatment on very small embryonic-like stem cells (VSELs), haematopoietic stem cells (HSCs), mesenchymal stem cells (MSCs) and endothelial progenitor cells (EPCs) circulating in peripheral blood (PB), in bipolar disorder (BD). The study included 15 BD patients (aged 55 ± 6 years) treated with lithium for 8-40 years (mean 16 years), 15 BD patients (aged 53 ± 7 years) with duration of illness >10 years, who had never received lithium, and 15 healthy controls (aged 50 ± 5 years). The VSELs, HSCs, MSCs and EPCs were measured by flow cytometric analysis. In BD subjects not taking lithium the number of CD34 +  VSELs was significantly higher, and MSCs and EPCs numerically higher, than in control subjects and the number of CD34 +  VSELs correlated with the duration of illness. In lithium-treated patients these values were similar to controls and the number of CD34 +  VSELs correlated negatively with the duration of lithium treatment and serum lithium concentration. Long-term treatment with lithium may suppress the activation of regenerative processes by reducing the number of VSELs circulating in PB. These cells, in BD patients not treated with lithium, may provide a new potential biological marker of the illness and its clinical progress.

GCK-MODY in the US National Monogenic Diabetes Registry: frequently misdiagnosed and unnecessarily treated.

PubMed

Carmody, David; Naylor, Rochelle N; Bell, Charles D; Berry, Shivani; Montgomery, Jazzmyne T; Tadie, Elizabeth C; Hwang, Jessica L; Greeley, Siri Atma W; Philipson, Louis H

2016-10-01

GCK-MODY leads to mildly elevated blood glucose typically not requiring therapy. It has been described in all ethnicities, but mainly in Caucasian Europeans. Here we describe our US cohort of GCK-MODY. We examined the rates of detection of heterozygous mutations in the GCK gene in individuals referred to the US Monogenic Diabetes Registry with a phenotype consistent with GCK-MODY. We also assessed referral patterns, treatment and demography, including ethnicity, of the cohort. Deleterious heterozygous GCK mutations were found in 54.7 % of Registry probands selected for GCK sequencing for this study. Forty-nine percent were previously unnecessarily treated with glucose-lowering agents, causing hypoglycemia and other adverse effects in some of the subjects. The proportion of probands found to have a GCK mutation through research-based testing was similar across each ethnic group. However, together African-American, Latino and Asian subjects represented only 20.5 % of screened probands and 17.2 % of those with GCK-MODY, despite higher overall diabetes prevalence in these groups. Our data show that a high detection rate of GCK-MODY is possible based on clinical phenotype and that prior to genetic diagnosis, a large percentage are inappropriately treated with glucose-lowering therapies. We also find low minority representation in our Registry, which may be due to disparities in diagnostic diabetes genetic testing and is an area needing further investigation.

Identification of phenylbutyrate-generated metabolites in Huntington disease patients using parallel liquid chromatography/electrochemical array/mass spectrometry and off-line tandem mass spectrometry.

PubMed

Ebbel, Erika N; Leymarie, Nancy; Schiavo, Susan; Sharma, Swati; Gevorkian, Sona; Hersch, Steven; Matson, Wayne R; Costello, Catherine E

2010-04-15

Oral sodium phenylbutyrate (SPB) is currently under investigation as a histone deacetylation (HDAC) inhibitor in Huntington disease (HD). Ongoing studies indicate that symptoms related to HD genetic abnormalities decrease with SPB therapy. In a recently reported safety and tolerability study of SPB in HD, we analyzed overall chromatographic patterns from a method that employs gradient liquid chromatography with series electrochemical array, ultraviolet (UV), and fluorescence (LCECA/UV/F) for measuring SPB and its metabolite phenylacetate (PA). We found that plasma and urine from SPB-treated patients yielded individual-specific patterns of approximately 20 metabolites that may provide a means for the selection of subjects for extended trials of SPB. The structural identification of these metabolites is of critical importance because their characterization will facilitate understanding the mechanisms of drug action and possible side effects. We have now developed an iterative process with LCECA, parallel LCECA/LCMS, and high-performance tandem MS for metabolite characterization. Here we report the details of this method and its use for identification of 10 plasma and urinary metabolites in treated subjects, including indole species in urine that are not themselves metabolites of SPB. Thus, this approach contributes to understanding metabolic pathways that differ among HD patients being treated with SPB. Copyright 2010 Elsevier Inc. All rights reserved.

SAFETY AND TOXICITY OF AN ACCELERATED COARSELY FRACTIONATED RADIATION PROTOCOL FOR TREATMENT OF APPENDICULAR OSTEOSARCOMA IN 14 DOGS: 10 GY × 2 FRACTIONS.

PubMed

Pagano, Candace; Boudreaux, Bonnie; Shiomitsu, Keijiro

2016-09-01

Coarsely fractionated radiation is commonly used as a method for pain control in dogs with appendicular osteosarcoma, however there is little published information on optimal protocols. The aim of this retrospective, descriptive study was to report safety and toxicity findings in a sample of dogs with appendicular osteosarcoma that had been treated with a radiation scheme of 10 Gy delivered over two consecutive days for a total of 20 Gy. Dogs were included in the study if they had osteosarcoma that was treated with the aforementioned protocol. Dogs were excluded if treated with the same protocol for any other bone tumor besides osteosarcoma or inadequate follow-up. Thirteen of the 14 patients received adjuvant therapy with pamidronate and a nonsteroidal anti-inflammatory. Nine dogs received adjuvant chemotherapy with carboplatin after radiation was complete. Within a median of 14 days, 92.8% of dogs subjectively had improved pain control. Median duration of response (DOR) was 80 days (range 20-365). The majority of patients developed VRTOG grade one toxicity, primarily alopecia. Five dogs (35.7%) developed pathologic fracture postradiation treatment. Timing of fracture was variable ranging from 24 to 250 days. This radiation protocol was well tolerated, with minimal toxicity, subjectively improved survival time, and had the benefit of being completed in two consecutive days. © 2016 American College of Veterinary Radiology.

Dental implant outcomes may vary in patients with a history of periodontal disease.

PubMed

Stanford, Clark

2010-03-01

This systematic review used a set of defined inclusion criteria and identified 4448 publications. These were sorted and 10 were identified with sufficient strength to be considered in the systematic review. The authors used a series of inclusion criteria to sort though the identified systematic reviews on this topic. Criterion included the following: use of longitudinal studies (up to March 2006) or case series in which all subjects were included, studies addressing only partially edentulous subjects in which a variety of implant systems were used, and reviews that classified and ranked quality of the studies (eg, > 6-month recall, > 10 subjects). All studies were located through a search of MEDLINE and EMBASE. The primary prognostic factor in this study was to identify dental implant outcomes (survival or success as defined by the respective studies) and reports of peri-implantitis in subjects with a previous history of periodontitis. The authors focused on 3 outcome measures: implant survival, implant success, and peri-implantitis. The authors' inclusion criteria were generally all inclusive and did not limit studies based on definitions of these 3 outcomes. The authors state that "overall, the non-periodontitis patients demonstrated better outcomes than treated periodontitis patients," yet they admit that there is a "medium to high level of bias" with a lack of consistent outcome variables. They correctly state that owing to the heterogeneity of study designs (p. 459), they were not able to provide a meta-analysis. Unfortunately, the strength of the associations claimed are difficult to assess because there were no reports of odds ratios or confidence intervals. They also report significant inconsistencies between studies for the key outcome variables. For instance, only 3 of the 9 studies reviewed reported any form of peri-implant bone loss associated with inflammation (peri-implantitis). Bone loss was statistically observed in only 1 study, with a nonsignificant trend of greater bone loss in the subjects who had a history of periodontitis in the other studies reviewed. The authors suggest there is "some evidence" that patients treated for periodontitis may experience more implant loss and complications around implants than patients without periodontitis.

Apparatus and method for treating a cathode material provided on a thin-film substrate

DOEpatents

Hanson, Eric J.; Kooyer, Richard L.

2001-01-01

An apparatus and method for treating a cathode material provided on a surface of a continuous thin-film substrate and a treated thin-film cathode having increased smoothness are disclosed. A web of untreated cathode material is moved between a feed mechanism and a take-up mechanism, and passed through a treatment station. The web of cathode material typically includes areas having surface defects, such as prominences extending from the surface of the cathode material. The surface of the cathode material is treated with an abrasive material to reduce the height of the prominences so as to increase an 85 degree gloss value of the cathode material surface by at least approximately 10. The web of cathode material may be subjected to a subsequent abrasive treatment at the same or other treatment station. Burnishing or lapping film is employed at a treatment station to process the cathode material. An abrasive roller may alternatively be used to process the web of cathode material. The apparatus and method of the present invention may also be employed to treat the surface of a lithium anode foil so as to cleanse and reduce the roughness of the anode foil surface.

Apparatus and method for treating a cathode material provided on a thin-film substrate

DOEpatents

Hanson, Eric J.; Kooyer, Richard L.

2003-01-01

An apparatus and method for treating a cathode material provided on a surface of a continuous thin-film substrate and a treated thin-film cathode having increased smoothness are disclosed. A web of untreated cathode material is moved between a feed mechanism and a take-up mechanism, and passed through a treatment station. The web of cathode material typically includes areas having surface defects, such as prominences extending from the surface of the cathode material. The surface of the cathode material is treated with an abrasive material to reduce the height of the prominences so as to increase an 85 degree gloss value of the cathode material surface by at least approximately 10. The web of cathode material may be subjected to a subsequent abrasive treatment at the same or other treatment station. Burnishing or lapping film is employed at a treatment station to process the cathode material. An abrasive roller may alternatively be used to process the web of cathode material. The apparatus and method of the present invention may also be employed to treat the surface of a lithium anode foil so as to cleanse and reduce the roughness of the anode foil surface.

Evaluating Perceived Naturalness of Facial Expression After Fillers to the Nasolabial Folds and Lower Face With Standardized Video and Photography.

PubMed

Philipp-Dormston, Wolfgang G; Wong, Cindy; Schuster, Bernd; Larsson, Markus K; Podda, Maurizio

2018-06-01

Hyaluronic acid (HA) fillers are commonly used in treating facial wrinkles and folds but have not been studied with standardized methodology to include assessment of standard facial expressions. To assess perceived naturalness of facial expression after treatment with 2 HA fillers manufactured with XpresHAn Technology (also known as Optimal Balance Technology). Treatment was directed to the nasolabial folds (NLFs) and at least 1 additional lower face wrinkle or fold. Maintenance of naturalness, attractiveness, and age at 1 month after optimal treatment were assessed using video recordings and photographs capturing different facial animations. Global aesthetic improvement, subjects' satisfaction, and safety were also evaluated. The treatment was well tolerated. Naturalness of facial expression in motion was determined to be at least maintained in 95% of subjects. Attractiveness was enhanced in 89% of subjects and 79% of subjects were considered to look younger. Most subjects assessed their aesthetic appearance as improved and were satisfied with their treatment. Naturalness and attractiveness can be assessed using video recordings and photographs capturing different facial animations. XpresHAn Technology HA filler treatments create natural-looking results with high subject satisfaction.

The surface properties of carbon fibers and their adhesion to organic polymers

NASA Technical Reports Server (NTRS)

Bascom, W. D.; Drzal, L. T.

1987-01-01

The state of knowledge of the surface properties of carbon fibers is reviewed, with emphasis on fiber/matrix adhesion in carbon fiber reinforced plastics. Subjects treated include carbon fiber structure and chemistry, techniques for the study of the fiber surface, polymer/fiber bond strength and its measurement, variations in polymer properties in the interphase, and the influence of fiber matrix adhesion on composite mechanical properties. Critical issues are summarized and search recommendations are made.

A Simulation Analysis of Work Based Navy Manpower Requirements

DTIC Science & Technology

2012-09-01

Workweek is also the subject of greater discussion in the 2002 CNA study. At the time, the Navy Standard Workweek was 67 hours of...policies, states that the Navy Standard Workweek includes 8 hours of sleep a day (Navy, 2007). To properly model this while also treating...system during these non-scheduled hours . Figure 4 shows an example of a sailor’s schedule as built into Arena. The graph’s x-axis represents the

PRODUCTION OF FLUORINE-CONTAINING HYDROCARBON

DOEpatents

Sarsfield, N.F.

1949-08-01

This patent relates to improvements in the production of fluorine- containing hydrocarbon derivatives. The process for increasing the degree of fluorination of a fluorochlorohydrocarbon comprises subjecting a highly fluorinated fluorochlorohydrocarbon to the action of a dehydrochlorinating agent, and treating the resulting unsaturated body with fluorine, cobalt trifluoride, or silver difluoride. A number of reagents are known as dehydrochlorinaling agents, including, for example, the caustic alkalies, either in an anhydrous condition or dissolved in water or a lower aliphatic alcohol.

Kinetic analysis of volatile formation in milk subjected to pressure-assisted thermal treatments.

PubMed

Vazquez-Landaverde, P A; Qian, M C; Torres, J A

2007-09-01

Volatile formation in milk subjected to pressure-assisted thermal processing (PATP) was investigated from a reaction kinetic analysis point of view to illustrate the advantages of this technology. The concentration of 27 volatiles of different chemical class in milk subjected to pressure, temperature, and time treatments was fitted to zero-, 1st-, and 2nd-order chemical reaction models. Temperature and pressure effects on rate constants were analyzed to obtain activation energy (E(a)) and activation volume (deltaV*) values. Hexanal, heptanal, octanal, nonanal, and decanal followed 1st-order kinetics with rate constants characterized by E(a) values decreasing with pressure reflecting negative deltaV* values. Formation of 2-methylpropanal, 2,3-butanedione, and hydrogen sulfide followed zero-order kinetics with rate constants increasing with temperature but with unclear pressure effects. E(a) values for 2-methylpropanal and 2,3-butanedione increased with pressure, that is, deltaV* > 0, whereas values for hydrogen sulfide remained constant, that is, deltaV* = 0. The concentration of all other volatiles, including methanethiol, remained unchanged in pressure-treated samples, suggesting large negative deltaV* values. The concentration of methyl ketones, including 2-pentanone, 2-hexanone, 2-heptanone, 2-octanone, 2-nonanone, 2-decanone, and 2-undecanone, was independent of pressure and pressure-holding time. PATP promoted the formation of few compounds, had no effect on some, and inhibited the formation of volatiles reported to be factors of the consumer rejection of "cooked" milk flavor. The kinetic behavior observed suggested that new reaction formation mechanisms were not likely involved in volatile formation in PATP milk. The application of the Le Chatelier principle frequently used to explain the high quality of pressure-treated foods, often with no supporting experimental evidence, was not necessary.

The Evaluation of a Pulmonary Display to Detect Adverse Respiratory Events Using High Resolution Human Simulator

PubMed Central

Wachter, S. Blake; Johnson, Ken; Albert, Robert; Syroid, Noah; Drews, Frank; Westenskow, Dwayne

2006-01-01

Objective Authors developed a picture-graphics display for pulmonary function to present typical respiratory data used in perioperative and intensive care environments. The display utilizes color, shape and emergent alerting to highlight abnormal pulmonary physiology. The display serves as an adjunct to traditional operating room displays and monitors. Design To evaluate the prototype, nineteen clinician volunteers each managed four adverse respiratory events and one normal event using a high-resolution patient simulator which included the new displays (intervention subjects) and traditional displays (control subjects). Between-group comparisons included (i) time to diagnosis and treatment for each adverse respiratory event; (ii) the number of unnecessary treatments during the normal scenario; and (iii) self-reported workload estimates while managing study events. Measurements Two expert anesthesiologists reviewed video-taped transcriptions of the volunteers to determine time to treat and time to diagnosis. Time values were then compared between groups using a Mann-Whitney-U Test. Estimated workload for both groups was assessed using the NASA-TLX and compared between groups using an ANOVA. P-values < 0.05 were considered significant. Results Clinician volunteers detected and treated obstructed endotracheal tubes and intrinsic PEEP problems faster with graphical rather than conventional displays (p < 0.05). During the normal scenario simulation, 3 clinicians using the graphical display, and 5 clinicians using the conventional display gave unnecessary treatments. Clinician-volunteers reported significantly lower subjective workloads using the graphical display for the obstructed endotracheal tube scenario (p < 0.001) and the intrinsic PEEP scenario (p < 0.03). Conclusion Authors conclude that the graphical pulmonary display may serve as a useful adjunct to traditional displays in identifying adverse respiratory events. PMID:16929038

The performance of two automatic servo-ventilation devices in the treatment of central sleep apnea.

PubMed

Javaheri, Shahrokh; Goetting, Mark G; Khayat, Rami; Wylie, Paul E; Goodwin, James L; Parthasarathy, Sairam

2011-12-01

This study was conducted to evaluate the therapeutic performance of a new auto Servo Ventilation device (Philips Respironics autoSV Advanced) for the treatment of complex central sleep apnea (CompSA). The features of autoSV Advanced include an automatic expiratory pressure (EPAP) adjustment, an advanced algorithm for distinguishing open versus obstructed airway apnea, a modified auto backup rate which is proportional to subject's baseline breathing rate, and a variable inspiratory support. Our primary aim was to compare the performance of the advanced servo-ventilator (BiPAP autoSV Advanced) with conventional servo-ventilator (BiPAP autoSV) in treating central sleep apnea (CSA). A prospective, multicenter, randomized, controlled trial. Five sleep laboratories in the United States. Thirty-seven participants were included. All subjects had full night polysomnography (PSG) followed by a second night continuous positive airway pressure (CPAP) titration. All had a central apnea index ≥ 5 per hour of sleep on CPAP. Subjects were randomly assigned to 2 full-night PSGs while treated with either the previously marketed autoSV, or the new autoSV Advanced device. The 2 randomized sleep studies were blindly scored centrally. Across the 4 nights (PSG, CPAP, autoSV, and autoSV Advanced), the mean ± 1 SD apnea hypopnea indices were 53 ± 23, 35 ± 20, 10 ± 10, and 6 ± 6, respectively; indices for CSA were 16 ± 19, 19 ± 18, 3 ± 4, and 0.6 ± 1. AutoSV Advanced was more effective than other modes in correcting sleep related breathing disorders. BiPAP autoSV Advanced was more effective than conventional BiPAP autoSV in the treatment of sleep disordered breathing in patients with CSA.

Tachyphylaxis to PACAP-27 after inhibition of NO synthesis: a loss of adenylate cyclase activation

NASA Technical Reports Server (NTRS)

Whalen, E. J.; Johnson, A. K.; Lewis, S. J.

1999-01-01

The vasodilator effects of pituitary adenylate cyclase activating polypeptide (PACAP-27) are subject to tachyphylaxis in rats treated with the nitric oxide synthase inhibitor N(G)-nitro-L-arginine methyl ester (L-NAME). This study examined whether this tachyphylaxis is due to the loss of vasodilator potency of cAMP generated by activation of the G(s) protein-coupled PACAP receptors. Five successive treatments with PACAP-27 (2 nmol/kg iv) produced pronounced vasodilator responses in saline-treated rats that were not subject to tachyphylaxis. The first injection of PACAP-27 (2 nmol/kg iv) in L-NAME (50 micromol/kg iv)-treated rats produced vasodilator responses of similar magnitude to those in saline-treated rats, whereas four subsequent injections produced progressively and markedly smaller responses. The hemodynamic effects of the membrane-permeable cAMP analog 8-(4-chlorophenylthiol)-cAMP (8-CPT-cAMP; 5-15 micromol/kg iv) were similar in L-NAME-treated rats and in L-NAME-treated rats that had received the five injections of PACAP-27. In addition, five injections of 8-CPT-cAMP (10 micromol/kg iv) produced pronounced vasodilator responses in saline- and L-NAME-treated rats that were not subject to the development of tachyphylaxis. These results suggest that a loss of biological potency of cAMP is not responsible for tachyphylaxis to PACAP-27 in L-NAME-treated rats. This tachyphylaxis may be due to the inability of the G(s) protein-coupled PACAP receptor to activate adenylate cyclase.

Method for treating wastewater using microorganisms and vascular aquatic plants

NASA Technical Reports Server (NTRS)

Wolverton, B. C. (Inventor)

1983-01-01

A method for treating wastewater compresses subjecting the wastewater to an anaerobic setting step for at least 6 hours and passing the liquid effluent from the anaerobic settling step through a filter cell in an upflow manner. There the effluent is subjected first to the action of anaerobic and facultative microorganisms, and then to the action of aerobic microorganisms and the roots of at least one vascular aquatic plant.

Hydrocortisone concentration influences time to clinically significant healing of acute inflammation of the ocular surface and adnexa - results from a double-blind randomized controlled trial.

PubMed

Sergiyenko, Nikolay; Sukhina, Ludmila; Bezdetko, Pavel; Kovalenko, Yuriy; Nikitin, Nikolai; Merzbacher, Matthias; Gross, Dorothea; Kohnen, Ralf

2014-05-10

The efficacy of topical ophthalmic corticosteroids depends upon small modifications in preparations, such as drug concentration.The aim of this study was to confirm that hydrocortisone acetate (HC-ac) ophthalmic ointments of 2.5% and 1% are more effective than a 0.5% eye ointment. In this randomized, double-blind, placebo-controlled, parallel-group clinical study, the change of signs and symptoms of acute inflammation of the ocular surface and adnexa was evaluated in 411 subjects. Median time to clinically relevant response as estimated by 50% reduction in clinical signs and symptoms (CSS) total score over the entire trial was similar for subjects treated with HC-ac 2.5% (73.5 h) and for subjects treated with HC-ac 1.0% (67.7 h) and was considerably and significantly longer for subjects treated with HC-ac 0.5% (111.8 h) [p < 0.001 for both dosages]. All trial medications were safe and well tolerated. Hydrocortisone acetate 2.5% and Hydrocortisone acetate 1% eye ointments are efficacious and safe treatments for acute inflammations of the ocular surface or adnexa, and showed significantly better efficacy than a control group treated with Hydrocortisone acetate 0.5% therapy. Current Controlled Trials ISRCTN15464650.

Protocolized fluid therapy in brain-dead donors: the multicenter randomized MOnIToR trial.

PubMed

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-03-01

Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multicenter randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases the number of organs transplanted. We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A "protocol-guided fluid therapy" algorithm targeting the cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor, and our primary analysis was intention to treat. Secondary analyses included: (1) modified intention to treat where only subjects able to receive the intervention were included and (2) 12-month survival in transplant recipients. The study was stopped early. We enrolled 556 donors: 279 protocolized care and 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76 % of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor (95 % CI 3.14-3.63) with protocolized care compared to 3.29 usual care (95 % CI 3.04-3.54; mean difference, 0.1, 95 % CI -0.25 to 0.45; p = 0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95 % CI 3.23-3.8), but not statistically significantly (mean difference, 0.23, 95 % CI -0.15 to 0.61; p = 0.23). Among the 1,430 recipients of organs from study subjects with data available, 56 deaths (7.8 %) occurred in the protocolized care arm and 56 (7.9 %) in the usual care arm in the first year (hazard ratio: 0.97, p = 0.86). In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor.

Prevention of diabetes with pioglitazone in ACT NOW: physiologic correlates.

PubMed

Defronzo, Ralph A; Tripathy, Devjit; Schwenke, Dawn C; Banerji, Maryann; Bray, George A; Buchanan, Thomas A; Clement, Stephen C; Gastaldelli, Amalia; Henry, Robert R; Kitabchi, Abbas E; Mudaliar, Sunder; Ratner, Robert E; Stentz, Frankie B; Musi, Nicolas; Reaven, Peter D

2013-11-01

We examined the metabolic characteristics that attend the development of type 2 diabetes (T2DM) in 441 impaired glucose tolerance (IGT) subjects who participated in the ACT NOW Study and had complete end-of-study metabolic measurements. Subjects were randomized to receive pioglitazone (PGZ; 45 mg/day) or placebo and were observed for a median of 2.4 years. Indices of insulin sensitivity (Matsuda index [MI]), insulin secretion (IS)/insulin resistance (IR; ΔI0-120/ΔG0-120, ΔIS rate [ISR]0-120/ΔG0-120), and β-cell function (ΔI/ΔG × MI and ΔISR/ΔG × MI) were calculated from plasma glucose, insulin, and C-peptide concentrations during oral glucose tolerance tests at baseline and study end. Diabetes developed in 45 placebo-treated vs. 15 PGZ-treated subjects (odds ratio [OR] 0.28 [95% CI 0.15-0.49]; P < 0.0001); 48% of PGZ-treated subjects reverted to normal glucose tolerance (NGT) versus 28% of placebo-treated subjects (P < 0.005). Higher final glucose tolerance status (NGT > IGT > T2DM) was associated with improvements in insulin sensitivity (OR 0.61 [95% CI 0.54-0.80]), IS (OR 0.61 [95% CI 0.50-0.75]), and β-cell function (ln IS/IR index and ln ISR/IR index) (OR 0.26 [95% CI 0.19-0.37]; all P < 0.0001). Of the factors measured, improved β-cell function was most closely associated with final glucose tolerance status.

Clinical tolerance and efficacy of capryloyl salicylic acid peel compared to a glycolic acid peel in subjects with fine lines/wrinkles and hyperpigmented skin.

PubMed

Oresajo, Christian; Yatskayer, Margarita; Hansenne, Isabelle

2008-12-01

Several chemical agents are currently used to perform superficial peels of the face to reduce facial hyperpigmentation and fine lines/wrinkles. Some of the most commonly used agents are alpha hydroxyl acids, such as glycolic acid (GA), or beta hydroxy acid, such as salicylic acid. This study aims to compare the efficacy of GA to that of a novel derivative of salicylic acid, capryloyl salicylic acid (LHA). In a split-face study, 50 female volunteers between the ages of 35 and 60 years with mild to moderate facial hyperpigmentation and fine lines/wrinkles were randomized and LHA or GA peel was applied to one side of the face. Increasing peel concentrations were applied (5-10% LHA or 20-50% GA) based on the tolerance level of the subjects and clinical observations of an expert dermatologist for 12 weeks at biweekly intervals. Of the 44 volunteers who completed the study, at 12 weeks 41% of LHA-treated and 30% of GA-treated subjects demonstrated significant reduction of fine lines/wrinkles compared to baseline. Forty-six percent of LHA-treated subjects and 34% of GA-treated subjects showed significant reduction of hyperpigmentation compared to baseline. LHA treatment was better than GA peels, although there were no statistically significant differences between the two groups. Five percent to 10% of LHA peel is generally safe and as effective as 20-50% GA peel in reducing facial hyperpigmentation and fine lines/wrinkles.

A diet based on high-heat-treated foods promotes risk factors for diabetes mellitus and cardiovascular diseases.

PubMed

Birlouez-Aragon, Inès; Saavedra, Giselle; Tessier, Frédéric J; Galinier, Anne; Ait-Ameur, Lamia; Lacoste, Florence; Niamba, Claude-Narcisse; Alt, Nadja; Somoza, Veronika; Lecerf, Jean-Michel

2010-05-01

The modern Western lifestyle is characterized by the consumption of high-heat-treated foods because of their characteristic taste and flavor. However, it has been shown that treating food at high temperatures can generate potentially harmful compounds that promote inflammation and cardiovascular disease in subjects with diabetes. The aim of this study was to determine whether high-heat-treated foods also pose a risk for healthy subjects. A randomized, crossover, diet-controlled intervention trial with 62 volunteers was designed to compare the potential metabolic effects of 2 diets, one that was based on mild steam cooking and another that was based on high-temperature cooking. These 2 diets differed mainly in their contents of Maillard reaction products (MRPs). MRPs were assessed in the diet and in subjects' feces, blood, and urine samples, with N(epsilon)-carboxymethyllysine as an indicator of MRPs. Biological indicators of glucose and lipid metabolism as well as oxidative stress were analyzed in subjects after 1 mo on each diet. In comparison with the steamed diet, 1 mo of consuming the high-heat-treated diet induced significantly lower insulin sensitivity and plasma concentrations of long-chain n-3 (omega-3) fatty acids and vitamins C and E [-17% (P < 0.002), -13% (P < 0.0001), and -8% (P < 0.01), respectively]. However, concentrations of plasma cholesterol and triglycerides increased [+5% (P < 0.01) and +9% (P < 0.01), respectively]. A diet that is based on high-heat-treated foods increases markers associated with an enhanced risk of type 2 diabetes and cardiovascular diseases in healthy people. Replacing high-heat-treatment techniques by mild cooking techniques may help to positively modulate biomarkers associated with an increased risk of diabetes mellitus and cardiovascular diseases.

The obesity of patients with Laron Syndrome is not associated with excessive nutritional intake.

PubMed

Ginsberg, Shira; Laron, Zvi; Bed, Mira Arbiv; Vaisman, Nachum

2009-03-01

To study the metabolic parameters which may affect the excessive weight of treated and untreated patients with Laron Syndrome. Body composition, daily caloric intake and resting energy expenditure (REE), when possible, were measured for each patient. Caloric intake was calculated based on 7-day food records, REE was measured by indirect calorimetry and body composition was determined by dual energy X-ray absorptiometry (DEXA). Nine untreated adult subjects with Laron Syndrome (6 female subjects, 3 male subjects) aged 28-53 years and 4 girls with Laron Syndrome treated by insulin-like growth factor-I (IGF-I) 120-150 μg/kg/d were included in the study. Patients with Laron Syndrome have an abnormally high body fat (BF) mass (54 ± 10% of body weight) and a relatively low lean body mass (LBM) compared to a healthy normal population. Energy intake varied but in most of the patients was not significantly higher than the measured REE. The REE corrected for LBM was higher than expected, based on our norms for healthy adults. The mean distribution of energy sources in the food was 47% carbohydrates, 17% protein and 36% fat. The severe obesity of patients with Laron Syndrome is not due to hyperphagia or hypometabolism. © 2009 Asian Oceanian Association for the Study of Obesity . Published by Elsevier Ltd. All rights reserved.

Handwriting Movement Kinematics for Quantifying EPS in Patients Treated with Atypical Antipsychotics

PubMed Central

Caligiuri, Michael P.; Teulings, Hans-Leo; Dean, Charles E.; Niculescu, Alexander B.; Lohr, James B.

2009-01-01

Ongoing monitoring of neuroleptic-induced extrapyramidal side effects (EPS) is important to maximize treatment outcome, improve medication adherence and reduce re-hospitalization. Traditional approaches for assessing EPS such as parkinsonism, tardive akathisia, or dyskinesia rely upon clinical ratings. However, these observer-based EPS severity ratings can be unreliable and are subject to examiner bias. In contrast, quantitative instrumental methods are less subject to bias. Most instrumental methods have only limited clinical utility because of their complexity and costs. This paper describes an easy-to-use instrumental approach based on handwriting movements for quantifying EPS. Here, we present findings from psychiatric patients treated with atypical (second generation) antipsychotics. The handwriting task consisted of a sentence written several times within a 2 cm vertical boundary at a comfortable speed using an inkless pen and digitizing tablet. Kinematic variables including movement duration, peak vertical velocity and the number of acceleration peaks, and average normalized jerk (a measure of smoothness) for each up or down stroke and their submovements were analyzed. Results from 59 psychosis patients and 46 healthy comparison subjects revealed significant slowing and dysfluency in patients compared to controls. We observed differences across medications and daily dose. These findings support the ecological validity of handwriting movement analysis as an objective behavioral biomarker for quantifying the effects of antipsychotic medication and dose on the motor system. PMID:20381875

Impact of type 2 diabetes mellitus on recurrent myocardial infarction in China.

PubMed

Li, Wentao; Li, Muwei; Gao, Chuanyu; Wang, Xianpei; Qi, Datun; Liu, Jun; Jin, Qiangsong

2016-11-01

To evaluate the influence of type 2 diabetes mellitus on the long-term outcomes of Chinese patients with previous myocardial infarction, we studied 864 patients with previous myocardial infarction, including 251 with type 2 diabetes mellitus and 613 without type 2 diabetes mellitus, over a median follow-up time of 2.9 years. The type 2 diabetes mellitus patients were subdivided into 95 insulin-treated diabetes mellitus and 156 non-insulin-treated diabetes mellitus subjects. The crude incidences (per 1000 patient-years) in the type 2 diabetes mellitus subjects versus the non-type 2 diabetes mellitus subjects were 43.7 versus 25.1 for recurrent myocardial infarction, 68.7 versus 28.3 for all-cause death and 99.8 versus 49.9 for the composite end point (i.e. recurrent myocardial infarction or all-cause death). Cox regression analysis showed that the adjusted hazard ratios for recurrent myocardial infarction, all-cause death and their combination were 1.67 (95% confidence interval: 1.06-2.74), 1.90 (1.25-2.90) and 1.72 (1.23-2.40), respectively. Significant associations were also observed between insulin treatment and all-cause death. Our findings suggested that type 2 diabetes mellitus is an independent risk factor for recurrent myocardial infarction, all-cause death and the composite end point among previous myocardial infarction patients. © The Author(s) 2016.

Treated prevalence and incidence of dementia among National Health Insurance enrollees in Taiwan, 1996-2003.

PubMed

Chien, I-Chia; Lin, Yu-Chung; Chou, Yiing-Jenq; Lin, Ching-Heng; Bih, Shin-Huey; Lee, Cheng-Hua; Chou, Pesus

2008-06-01

The National Health Insurance database to determine the treated prevalence and incidence of dementia in Taiwan was used in this study. A population-based random sample of 22 118 subjects aged 65 or older was obtained as a dynamic cohort. Those study subjects who had filed at least one service claim from 1996 to 2003 for either outpatient care or inpatient care with a principal diagnosis of dementia were identified. The annual treated prevalence increased from 0.71% to 1.92% from 1996 to 2003. The annual treated incidence rates were around 0.76% to 1.04% per year from 1997 to 2003. The annual treated incidence rates for the 5-year age groups, from 65 to 90 years and older, were 0.44%, 0.65%, 0.98%, 1.46%, 1.81%, and 1.80%, respectively. Both the treated prevalence and incidence rates of dementia in National Health Insurance were lower than those of community studies.

Cancer patients treated with sunitinib or sorafenib have sufficient antibody and cellular immune responses to warrant influenza vaccination.

PubMed

Mulder, Sasja F; Jacobs, Joannes F M; Olde Nordkamp, Michel A M; Galama, Joep M D; Desar, Ingrid M E; Torensma, Ruurd; Teerenstra, Steven; Mulders, Peter F A; Vissers, Kris C P; Punt, Cornelis J A; de Vries, I Jolanda M; van Herpen, Carla M L

2011-07-01

The tyrosine kinase inhibitors sorafenib and sunitinib have efficacy in several types of cancer. Recent studies indicate that these agents affect the immune system. The way it affects the immune response to influenza vaccination is unknown. The aim of this study was to elucidate the specific immune response to seasonal flu vaccination in cancer patients treated with sunitinib or sorafenib. Sunitinib- or sorafenib-treated cancer patients were vaccinated against seasonal influenza with an inactivated vaccine. Healthy controls and patients with metastatic renal cell cancer (mRCC) without systemic treatment (nontreated mRCC controls) were included for comparison. Antibody responses were measured at baseline, day 8, and day 22 by a standard hemagglutination inhibition assay and cellular T-cell responses at baseline and day 8 by proliferation assay and secretion of cytokines. Forty subjects were enrolled: 16 patients treated with sunitinib, 6 patients with sorafenib, 7 nontreated mRCC controls, and 11 healthy controls. All patients treated with sunitinib and sorafenib developed seroprotection rates comparable with controls. Functional T-cell reactivity was observed in all groups, except for patients treated with sorafenib who showed a decreased proliferation rate and IFN-γ/IL-2 production and increased IL-10 compared with healthy controls. We conclude that influenza vaccination should be recommended to cancer patients treated with sunitinib or sorafenib.

Penile vascular indices in surgically treated and conservatively treated penile fracture: does conventional immediate repair matter?

PubMed

Safarinejad, Mohammad Reza; Lashkari, Mohammad Hossein; Babaei, Alireza; Dadkhah, Farid; Kolahi, Ali Asghar

2012-12-01

To investigate the impact of immediate surgical repair and conservative treatment of penile fracture (PF) on penile vascular indices. The study includes 146 surgically treated (group 1), and 56 conservatively treated patients (group 2). All of the participants underwent penile duplex Doppler ultrasonography (PDDU), and Doppler parameters including the peak systolic velocity (PSV), end diastolic velocity (EDV), and resistive index (RI) were measured in both corpora at baseline and after intracavernosal injection of 20 μg prostaglandin E1. Univariable and multivariable Cox regression analysis addressed study variables. An increased number of men in group 2 (25.0%) compared with men in group 1 (19.2%) reported ED, but the difference did not reach statistical significance (P=0.06). In patients with ED the mean PSV did not differ significantly between the group 1 (30.1±4.02 cm/s) and group 2 (30.1±4.02 cm/s) (P=0.32). Also, in patients without ED, the mean PSV for group 1 (82.4±24.1 cm/s) subjects did not differ significantly from the means for the group 2 patients (79.4±27.2 cm/s) (P=0.21). Vascular hemodynamics in fractured corpus cavernosum did not differ significantly between two groups (P=0.08). Current method of surgical treatment does not provide better outcome in terms of erectile function and penile vascular hemodynamics.

Meta-analysis: Smectite in the treatment of acute infectious diarrhoea in children.

PubMed

Szajewska, H; Dziechciarz, P; Mrukowicz, J

2006-01-15

Although not currently recommended, dioctahedral smectite (smectite) is commonly used to treat acute infectious diarrhoea in many countries. To evaluate systematically the effectiveness of smectite in treating acute infectious diarrhoea in children. Using medical subject headings and free-language terms, the following electronic databases were searched for studies relevant to acute infectious diarrhoea and smectite: MEDLINE, EMBASE, CINAHL and The Cochrane Library; additional references were obtained from reviewed articles. Only randomized-controlled trials were included. Nine randomized-controlled trials (1238 participants) met the inclusion criteria. Combined data from six randomized-controlled trials showed that smectite significantly reduced the duration of diarrhoea compared with placebo. The pooled weighted mean difference was (-22.7 h, 95% CI: -24.8 to -20.6) with a fixed model and remained significant in a random effect model (-24.4 h, 95% CI: -29.8 to -19.1). The chance of cure on intervention day 3 was significantly increased in the smectite vs. the control group (RR 1.64, 95% CI: 1.36-1.98; number needed to treat 4, 95% CI: 3-5). Adverse effects were similar in both groups. Smectite may be a useful adjunct to rehydration therapy in treating acute paediatric gastroenteritis. However, the results of this meta-analysis should be interpreted with caution as most of the included studies had important limitations. Cost-effectiveness analyses should be undertaken before routine pharmacological therapy with smectite is recommended.

Targeting Treatments to Improve Cognitive Function in Mood Disorder: Suggestions From Trials Using Erythropoietin.

PubMed

Miskowiak, Kamilla Woznica; Rush, A John; Gerds, Thomas A; Vinberg, Maj; Kessing, Lars V

2016-12-01

There is no established efficacious treatment for cognitive dysfunction in unipolar and bipolar disorder. This may be partially due to lack of consensus regarding the need to screen for cognitive impairment in cognition trials or which screening criteria to use. We have demonstrated in 2 randomized placebo-controlled trials that 8 weeks of erythropoietin (EPO) treatment has beneficial effects on verbal memory across unipolar and bipolar disorder, with 58% of EPO-treated patients displaying a clinically relevant memory improvement as compared to 15% of those treated with placebo. We reassessed the data from our 2 EPO trials conducted between September 2009 and October 2012 to determine whether objective performance-based memory impairment or subjective self-rated cognitive impairment at baseline was related to the effect of EPO on cognitive function as assessed by Rey Auditory Verbal Learning Test (RAVLT) total recall with multiple logistic regression adjusted for diagnosis, age, gender, symptom severity, and education levels. We included 79 patients with an ICD-10 diagnosis of unipolar or bipolar disorder, of whom 39 received EPO and 40 received placebo (saline). For EPO-treated patients with objective memory dysfunction at baseline (n = 16) (defined as RAVLT total recall ≤ 43), the odds of a clinically relevant memory improvement were increased by a factor of 290.6 (95% CI, 2.7-31,316.4; P = .02) compared to patients with no baseline impairment (n = 23). Subjective cognitive complaints (measured with the Cognitive and Physical Functioning Questionnaire) and longer illness duration were associated with small increases in patients' chances of treatment efficacy on memory (53% and 16% increase, respectively; P ≤ .04). Diagnosis, gender, age, baseline depression severity, and number of mood episodes did not significantly change the chances of EPO treatment success (P ≥ .06). In the placebo-treated group, the odds of memory improvement were not significantly different for patients with or without objectively defined memory dysfunction (P ≥ .59) or subjective complaints at baseline (P ≥ .06). Baseline objectively assessed memory impairments and-to a lesser degree-subjective cognitive complaints increased the chances of treatment efficacy on cognition in unipolar and bipolar disorder. ClinicalTrials.gov identifier: NCT00916552. © Copyright 2016 Physicians Postgraduate Press, Inc.

Carotid artery mechanical properties and stresses quantified using in vivo data from normotensive and hypertensive humans.

PubMed

Masson, Ingrid; Beaussier, Hélène; Boutouyrie, Pierre; Laurent, Stéphane; Humphrey, Jay D; Zidi, Mustapha

2011-12-01

The goal of this study was to model the in vivo non-linear mechanical behavior of human common carotid arteries (CCAs) and then to compare wall stresses and associated contributions of micro-constituents in normotensive (NT) and treated hypertensive (HT) subjects. We used an established theoretical model of 3D arterial mechanics that assumes a hyperelastic, anisotropic, active-passive, and residually stressed wall. In vivo data were obtained non-invasively from CCAs in 16 NT (21-64 years old) and 25 treated HT (44-69 years old) subjects. The associated quasi-static boundary value problem was solved semi-analytically over a cardiac cycle while accounting for surrounding perivascular tissue. Best-fit values of model parameters, including those describing contributions by intramural elastin, fibrillar collagen, and vascular smooth muscle, were estimated by a non-linear least-squares method. The model (1) captured temporal changes in intraluminal pressure, (2) estimated wall stress fields that appeared to reflect the presence or absence of age and disease, and (3) suggested changes in mechanical characteristics of wall micro-constituents despite medical treatment of hypertension. For example, age was positively correlated with residual stresses and altered fibrillar collagen in NT subjects, which indirectly validated the modeling, and HT subjects had higher levels of stresses, increased smooth muscle tone, and a stiffer elastin-dominated matrix despite treatment. These results are consistent with prior reports on effects of age and hypertension, but provide increased insight into evolving contributions of cell and matrix mechanics to arterial behavior in vivo.

Proteinuria is associated with neurocognitive impairment in antiretroviral therapy treated HIV-infected individuals.

PubMed

Kalayjian, Robert C; Wu, Kunling; Evans, Scott; Clifford, David B; Pallaki, Muraldihar; Currier, Judith S; Smryzynski, Marlene

2014-09-01

Proteinuria is a marker of vascular dysfunction that predicted increased cardiovascular mortality and is associated with neurocognitive impairment (NCI) in population-based studies. We examined associations between proteinuria and HIV-associated NCI. Multivariable logistic regression was used to examine associations between NCI at the first neurocognitive assessment (baseline) and simultaneous, clinically significant proteinuria [as random spot urine protein-to-creatinine ratios (UP/Cr) ≥200 mg/g] in a prospective multicenter observational cohort study. Generalized estimating equations were used to examine associations between baseline proteinuria and subsequent NCI among subjects without NCI at baseline. NCI was defined as a Z-score, derived from the combination of normalized scores from the Trailmaking A and B and the Wechsler Adult Intelligence Scale-Revised Digit Symbol tests. A total of 1972 subjects were included in this analysis. Baseline proteinuria was associated with increased odds of NCI [odds ratio (OR): 1.41, 95% confidence interval (CI): 1.08 to 1.85; P = 0.01] and with subsequent NCI among subjects without NCI at baseline (OR: 1.39, 95% CI: 1.01 to 1.93; P = 0.046) in multivariable models adjusted for risk factors and potential confounders. Similar associations were evident when these analyses were limited to visits at which time study subjects maintained plasma HIV RNA levels <200 copies per milliliter. The association between proteinuria and NCI observed in this study adds to a growing body of evidence implicating contributions by vascular disease to NCI in antiretroviral treated individuals. Studies examining interventions that improve vascular function are warranted.

Healthcare usage and economic impact of non-treated obesity in Italy: findings from a retrospective administrative and clinical database analysis.

PubMed

Colao, Annamaria; Lucchese, Marcello; D'Adamo, Monica; Savastano, Silvia; Facchiano, Enrico; Veronesi, Chiara; Blini, Valerio; Degli Esposti, Luca; Sbraccia, Paolo

2017-02-24

Investigate the prevalence of obesity in Italy and examine its resource consumption and economic impact on the Italian national healthcare system (NHS). Retrospective, observational and real-life study. Data from three health units from Northern (Bergamo, Lombardy), Central (Grosseto, Tuscany) and Southern (Naples, Campania) Italy. All patients aged ≥18 years with at least one recorded body mass index (BMI) measurement between 1 January 2009 and 31 December 2012 were included. Information retrieved from the databases included primary care data, medical prescriptions, specialist consultations and hospital discharge records from 2009-2013. Costs associated with these data were also calculated. Data are presented for two time periods (1 year after BMI measurement and study end). Primary-to estimate health resources consumption and the associated economic impact on the Italian NHS. Secondary-the prevalence and characteristics of subjects by BMI category. 20 159 adult subjects with at least one documented BMI measurement. Subjects with BMI ≥30 kg/m 2 were defined as obese. The prevalence of obesity was 22.2% (N=4471) and increased with age. At the 1-year observation period, obese subjects who did not receive treatment for their obesity experienced longer durations of hospitalisation (median length: 5 days vs 3 days), used more prescription drugs (75.0% vs 57.7%), required more specialised outpatient healthcare (mean number: 5.3 vs 4.4) and were associated with greater costs, primarily owing to prescription drugs and hospital admissions (mean annual cost per year per patient: €460.6 vs €288.0 for drug prescriptions, €422.7 vs € 279.2 for hospitalisations and €283.2 vs €251.7 for outpatient care), compared with normal weight subjects. Similar findings were observed for the period up to data cut-off (mean follow-up of 2.7 years). Untreated obesity has a significant economic impact on the Italian healthcare system, highlighting the need to raise awareness and proactively treat obese subjects. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Relationship of Caffeine with Adiponectin and Blood Sugar Levels in Subjects with and without Diabetes

PubMed Central

Bhaktha, Geetha; Mayya, Shreemathi; Shantaram, Manjula

2015-01-01

Introduction: Coffee though not usually thought of as healthy food but can be treated as one of the beneficial drink. Many researchers have found strong evidence that coffee reduces the risk of several serious ailments, including diabetes, heart disease, cirrhosis of the liver, etc. The long term beneficial effect of coffee on diabetes is now understood to be more influential and obliging. Materials and Methods: This study comprised 220 healthy subjects of which 143 consumed coffee and 77 did not. These were matched with 90 diabetic subjects. Among the 90 diabetics, 48 consumed coffee and 42 did not consume coffee. Results: The mean adiponectin value was significantly higher in coffee consumed normal and diabetic subjects than the subjects who did not consume coffee. The decrease in fasting blood sugar and HbA1c values were also observed in normal and diabetic subjects who consumed coffee than the other groups who did not consume coffee. Significant difference (p<0.05) in mean FBG, PPBS, HbA1c and adiponectin were observed between coffee consumed and no coffee consumed groups. Conclusion: The long term use of caffeine is more efficient on blood sugar and adiponectin levels, which needed in the prevention of complications in diabetic subjects. PMID:25737971

Cytokine Release Syndrome After Chimeric Antigen Receptor T Cell Therapy for Acute Lymphoblastic Leukemia.

PubMed

Fitzgerald, Julie C; Weiss, Scott L; Maude, Shannon L; Barrett, David M; Lacey, Simon F; Melenhorst, J Joseph; Shaw, Pamela; Berg, Robert A; June, Carl H; Porter, David L; Frey, Noelle V; Grupp, Stephan A; Teachey, David T

2017-02-01

Initial success with chimeric antigen receptor-modified T cell therapy for relapsed/refractory acute lymphoblastic leukemia is leading to expanded use through multicenter trials. Cytokine release syndrome, the most severe toxicity, presents a novel critical illness syndrome with limited data regarding diagnosis, prognosis, and therapy. We sought to characterize the timing, severity, and intensive care management of cytokine release syndrome after chimeric antigen receptor-modified T cell therapy. Retrospective cohort study. Academic children's hospital. Thirty-nine subjects with relapsed/refractory acute lymphoblastic leukemia treated with chimeric antigen receptor-modified T cell therapy on a phase I/IIa clinical trial (ClinicalTrials.gov number NCT01626495). All subjects received chimeric antigen receptor-modified T cell therapy. Thirteen subjects with cardiovascular dysfunction were treated with the interleukin-6 receptor antibody tocilizumab. Eighteen subjects (46%) developed grade 3-4 cytokine release syndrome, with prolonged fever (median, 6.5 d), hyperferritinemia (median peak ferritin, 60,214 ng/mL), and organ dysfunction. Fourteen (36%) developed cardiovascular dysfunction treated with vasoactive infusions a median of 5 days after T cell therapy. Six (15%) developed acute respiratory failure treated with invasive mechanical ventilation a median of 6 days after T cell therapy; five met criteria for acute respiratory distress syndrome. Encephalopathy, hepatic, and renal dysfunction manifested later than cardiovascular and respiratory dysfunction. Subjects had a median of 15 organ dysfunction days (interquartile range, 8-20). Treatment with tocilizumab in 13 subjects resulted in rapid defervescence (median, 4 hr) and clinical improvement. Grade 3-4 cytokine release syndrome occurred in 46% of patients following T cell therapy for relapsed/refractory acute lymphoblastic leukemia. Clinicians should be aware of expanding use of this breakthrough therapy and implications for critical care units in cancer centers.

Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data from the Phase 3 REFINE Trials.

PubMed

Dayan, Steven H; Schlessinger, Joel; Beer, Kenneth; Donofrio, Lisa M; Jones, Derek H; Humphrey, Shannon; Carruthers, Jean; Lizzul, Paul F; Gross, Todd M; Beddingfield, Frederick C; Somogyi, Christine

2018-02-01

ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm2) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin. To evaluate the efficacy and safety of ATX-101 by treatment session. This post-hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse events following each treatment session to further characterize the ATX-101 treatment response and safety profile. In both treatment groups, mean injection volume declined over subsequent treatment sessions, though more markedly in the ATX-101 group. The majority of ATX-101-treated subjects achieved a ≥1-grade improvement in SMF within 2 to 4 treatment sessions based on either clinician or subject assessment. Furthermore, 19.1% of ATX-101-treated subjects (vs 3.9% of placebo-treated subjects) received fewer than 6 treatment sessions owing to subject satisfaction with treatment or lack of sufficient SMF for further treatment. In both treatment groups, the incidence/severity of common injection-site adverse events declined over subsequent treatment sessions. Although up to 6 treatment sessions were permitted in the REFINE trials, most ATX-101-treated subjects achieved an improvement in SMF within 2 to 4 treatment sessions. © 2018 The American Society for Aesthetic Plastic Surgery, Inc.

Correcting Nasojugal Groove with Autologous Cultured Fibroblast Injection: A Pilot Study.

PubMed

Moon, Kyung-Chul; Lee, Hyun-Su; Han, Seung-Kyu; Chung, Ho-Yun

2018-06-01

A new commercial drug that contains autologous cultured fibroblasts has been developed and approved by the United States Food and Drug Administration for improving the appearance of nasolabial folds. However, the treatment requires three sessions every 3-6 weeks. It is known that the skin overlying the nasojugal groove is thinner, and the wrinkle is generally shallower than nasolabial folds. Therefore, we hypothesized that the nasojugal groove could be improved by just one treatment session. Therefore, the purpose of this study was to evaluate the efficacy and safety of autologous cultured fibroblast injection to correct nasojugal grooves. Forty-six subjects with nasojugal grooves were enrolled in this study. They were injected with autologous cultured fibroblasts or placebo in one session. Blinded evaluators and subjects assessed the efficacy using a validated wrinkle assessment scale at 4, 12, and 24 weeks after the injection. Information of adverse events was collected at each visit. Based on the evaluators' assessment at 24 weeks after the injection, 76% of subjects treated with autologous cultured fibroblasts showed improvement whereas 0% of subjects treated with placebo showed improvement (P < 0.0001). Based on self-assessment at 24 weeks after the injection, 72% of subjects treated with autologous cultured fibroblasts and 45% of subjects treated with placebo showed improvement (P = 0.0662). There were no serious adverse events related to autologous cultured fibroblast injection. Autologous cultured fibroblast injection might be effective and safe to correct nasojugal grooves. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Treating multiple body parts for skin laxity and fat deposits using a novel focused radiofrequency device with an ultrasound component: Safety and efficacy study.

PubMed

Chilukuri, Suneel; Denjean, Dominique; Fouque, Linda

2017-12-01

Growing demand for noninvasive skin tightening and reduction in fat results in an increasing pressure for devices with good clinical efficacy, consistency of results, and high patient comfort. The objective was to validate clinical efficacy and versatility of a novel device, which combines radiofrequency (RF) and ultrasound for treating skin laxity and fat deposits. We treated 34 subjects with facial skin laxity and/or abundant body or arm fat deposits. Subjects were divided based on their indications. Ten subjects received treatments to the face, 7 subjects to arms, 8 subjects to thighs, and 9 subjects on abdomen. All patients received 4 treatments on a weekly basis. Photographs of patients were assessed by blinded evaluators to recognize the baseline images from the 3-month follow-up images. Patient comfort and satisfaction were evaluated using a 5-point Likert scale questionnaire. Any adverse events were recorded. Patient images were correctly recognized in >90% of cases in all study groups. Patient questionnaires showed overall satisfaction with the therapy course and results. On a scale of 1 to 5, the patients agreed (4.1) that they are satisfied with the results that the treatment is comfortable (4.1) and that they are satisfied with the treatment time (4.1). No adverse events were reported. Consistent clinical efficacy was confirmed across all the treated areas, together with high patient comfort and satisfaction. We conclude the device is a highly versatile solution that can deliver results across body parts and different indications. © 2017 The Authors Journal of Cosmetic Dermatology Published by Wiley Periodicals, Inc.

[Longitudinal follow-up of contact subjects of cases of tuberculosis in Paris].

PubMed

Fournier, A; Antoun, F; Charlois Ou, C; Muller, G; Ezri, L; Morin, P; Faure, A; Marteau, D; Keshtmand, H; Quelet, S

2015-09-01

To our knowledge, the proportion of active tuberculosis diagnosed after 12-18 months during a screening tuberculosis process in a specialized centre (centre de lutte antituberculeuse [CLAT]) has not been described in France. The majority of other countries do not have any recommendation to screen at this time. We evaluated the number of treated or not treated latent tuberculosis infections (LTI) identified during tuberculosis screening. We identified the causes of ITL non-treatment, the number of active disease cases and the proportion of subjects lost to follow-up after 12-18 months. Among the 1066 contact subjects, 159 (15 %) had a positive QuantiFERON-TB-Gold In-Tube(®) test. A prophylactic treatment with Rifinah(®) was given to 97 (61 %) subjects, 7 (7.3 %) having developed side effects that led to treatment interruption. A high proportion (56 %) of contact subjects were lost of follow-up and the main reason for no prophylactic treatment (20/52, 38 %) was due to these losses. No active disease cases were identified among the 474 (44 %) contact subjects who had a chest X-ray after 12-18 months follow-up by the CLAT. The low level of positive QuantiFERON-TB-Gold In-Tube(®) tests (15 %) could be explained by the high specificity of this test and the strong proportion of occupational contacts, of whom a probably significant number were not exposed to active disease. The absence of active disease at 12-18 months and a majority (56 %) of contact subjects lost from follow-up at this period let us propose not to recall contact subjects at 12-18 months with the exception of those living under the same roof as the index case and/or those having a cumulative contact time of greater than 100 hours during the theoretical infectious period. This proposal remains to be confirmed by other studies, particularly including possible secondary cases diagnosed outside the screening periods by the CLAT. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Neuromedin and FN-38 Peptides for Treating Psychiatric Diseases

USDA-ARS?s Scientific Manuscript database

Methods and compositions for treating psychiatric diseases and disorders are disclosed. The methods provided generally involve the administration of an NMX peptide, an FNX peptide, or an NMX receptor agonist, or analogs or derivatives thereof, to a subject in order to treat psychiatric diseases and ...

Chronic low back pain patients around the world: cross-cultural similarities and differences.

PubMed

Sanders, S H; Brena, S F; Spier, C J; Beltrutti, D; McConnell, H; Quintero, O

1992-12-01

The current study sought to determine whether there were any significant cross-cultural differences in medical-physical findings, or in psychosocial, behavioral, vocational, and avocational functioning, for chronic low back pain patients. Partially double-blind controlled comparison of six different culture groups. Subjects were selected from primarily ambulatory care facilities specializing in treating chronic pain patients. PATIENTS-SUBJECTS: Subjects consisted of 63 chronic low back pain patients and 63 healthy controls. Low back pain patients were randomly selected from six different culture groups (American, Japanese, Mexican, Colombian, Italian, and New Zealander). Ten to 11 were gathered per culture from a pool of patients treated at various pain treatment programs. Likewise, 10 or 11 control group subjects were obtained from each culture from a pool of healthy support staff. The Sickness Impact Profile and the Medical Examination and Diagnostic Information Coding System were used as primary outcome measures. Findings showed that (a) low back pain subjects across all cultures had significantly more medical-physical findings and more impairment on psychosocial, behavioral, vocational, and avocational measures than controls did; (b) Mexican and New Zealander low back pain subjects had significantly fewer physical findings than other low back pain groups did; (c) the American, New Zealander, and Italian low back pain patients reported significantly more impairment in psychosocial, recreational, and/or work areas, with the Americans the most dysfunctional; and (d) findings were not a function of working class, age, sex, pain intensity, pain duration, previous surgeries, or differences in medical-physical findings. It was concluded that there were important cross-cultural differences in chronic low back pain patients' self-perceived level of dysfunction, with the American patients clearly the most dysfunctional. Possible explanations included cross-cultural differences in social expectation; attention; legal-administrative requirements; financial gains; attitudes-expectations about usage, type, and availability of health care; and self-perceived ability and willingness to cope.

Efficacy and safety of an intravenous C1-inhibitor concentrate for long-term prophylaxis in hereditary angioedema

PubMed Central

Craig, Timothy; Shapiro, Ralph; Vegh, Arthur; Baker, James W.; Bernstein, Jonathan A.; Busse, Paula; Magerl, Markus; Martinez-Saguer, Inmaculada; Riedl, Marc A.; Lumry, William; Williams-Herman, Debora; Edelman, Jonathan; Feuersenger, Henrike; Machnig, Thomas

2017-01-01

Background: The plasma-derived, pasteurized, nanofiltered C1-inhibitor concentrate (pnfC1-INH) is approved in the United States as an intravenous (IV) on-demand treatment for hereditary angioedema (HAE) attacks, and, in Europe, as on demand and short-term prophylaxis. Objective: This analysis evaluated Berinert Patient Registry data regarding IV pnfC1-INH used as long-term prophylaxis (LTP). Methods: The international registry (2010–2014) collected prospective and retrospective usage, dosing, and safety data on individuals who used pnfC1-INH for any reason. Results: The registry included data on 47 subjects (80.9% female subjects; mean age, 44.8 years), which reflected 4082 infusions categorized as LTP and a total of 430.2 months of LTP administration. The median absolute dose of pnfC1-INH given for LTP was 1000 IU (range, 500–3000 IU), with a median time interval between infusion and a subsequent pnfC1-INH–treated attack of 72.0 hours (range, 0.0–166.4 hours). Fifteen subjects (31.9%) had no pnfC1-INH–treated HAE attacks within 7 days after pnfC1-INH infusion for LTP; 32 subjects (68.1%) experienced 246 attacks, with rates of 0.06 attacks per infusion and 0.57 attacks per month. A total of 81 adverse events were reported in 16 subjects (34.0%) (0.02 events per infusion; 0.19 events per month); only 3 adverse events were considered related to pnfC1-INH (noncardiac chest pain, postinfusion headache, deep vein thrombosis in a subject with an IV port). Conclusion: In this international registry, IV pnf-C1-INH given as LTP for HAE was safe and efficacious, with a low rate of attacks that required pnfC1-INH treatment, particularly within the first several days after LTP administration. PMID:28381322

Molecular Solutions to Low Vision Resulting from Battlefield Injuries. Addendum

DTIC Science & Technology

2009-05-01

determining how to minimize dry eye after LASIK refractive surgery by developing new tests to predict pre-disposition to refractive surgery induced dry eye...enrolled a total of 132 subjects. Three withdrew without treatment leaving 129 enrolled - 128 have been treated (70 PRK and 58 LASIK ) and 1 is scheduled...granulomatous anterior uveitis OS 2 weeks following uncomplicated LASIK . The subject was treated with Prednisolone Acetate 1.0% ophthalmic suspension

Does chemotherapy improve survival in high-risk stage I and II Merkel cell carcinoma of the skin?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Poulsen, Michael G.; Rischin, Danny; Porter, Ian

2006-01-01

Purpose: The effectiveness of synchronous carboplatin, etoposide, and radiation therapy in improving survival was evaluated by comparison of a matched set of historic control subjects with patients treated in a prospective Phase II study that used synchronous chemotherapy and radiation and adjuvant chemotherapy. Patients and Methods: Patients were included in the analysis if they had disease localized to the primary site and nodes, and they were required to have at least one of the following high-risk features: recurrence after initial therapy, involved nodes, primary size greater than 1 cm, or gross residual disease after surgery. All patients who received chemotherapymore » were treated in a standardized fashion as part of a Phase II study (Trans-Tasman Radiation Oncology Group TROG 96:07) from 1997 to 2001. Radiation was delivered to the primary site and nodes to a dose of 50 Gy in 25 fractions over 5 weeks, and synchronous carboplatin (AUC 4.5) and etoposide, 80 mg/m{sup 2} i.v. on Days 1 to 3, were given in Weeks 1, 4, 7, and 10. The historic group represents a single institution's experience from 1988 to 1996 and was treated with surgery and radiation alone, and patients were included if they fulfilled the eligibility criteria of TROG 96:07. Patients with occult cutaneous disease were not included for the purpose of this analysis. Because of imbalances in the prognostic variables between the two treatment groups, comparisons were made by application of Cox's proportional hazard modeling. Overall survival, disease-specific survival, locoregional control, and distant control were used as endpoints for the study. Results: Of the 102 patients who had high-risk Stage I and II disease, 40 were treated with chemotherapy (TROG 96:07) and 62 were treated without chemotherapy (historic control subjects). When Cox's proportional hazards modeling was applied, the only significant factors for overall survival were recurrent disease, age, and the presence of residual disease. For disease-specific survival, recurrent disease was the only significant factor. Primary site on the lower limb had an adverse effect on locoregional control. For distant control, the only significant factor was residual disease. Conclusions: The multivariate analysis suggests chemotherapy has no effect on survival, but because of the wide confidence limits, a chemotherapy effect cannot be excluded. A study of this size is inadequately powered to detect small improvements in survival, and a larger randomized study remains the only way to truly confirm whether chemotherapy improves the results in high-risk MCC.« less

Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy.

PubMed

Landen, Jaren W; Cohen, Sharon; Billing, Clare B; Cronenberger, Carol; Styren, Scot; Burstein, Aaron H; Sattler, Catherine; Lee, Jae-Hong; Jack, Clifford R; Kantarci, Kejal; Schwartz, Pamela F; Duggan, William T; Zhao, Qinying; Sprenger, Ken; Bednar, Martin M; Binneman, Brendon

2017-09-01

Multiple intravenous doses of ponezumab, an anti-amyloid antibody, were evaluated in subjects with mild-to-moderate Alzheimer's disease (AD). In part A, 77 subjects were randomized to ponezumab 0.1, 0.5, or 1 mg/kg (75 treated) and 26 to placebo (24 treated). In part B, 63 subjects were randomized and treated with ponezumab 3 or 8.5 mg/kg and 32 with placebo. Subjects received 10 infusions over 18 months and were followed for 6 months thereafter. Ponezumab was generally safe and well tolerated. Most common adverse events were fall (16.7% ponezumab, 21.4% placebo), headache (13.8%, 21.4%), and cerebral microhemorrhage (13.8%, 19.6%). Plasma ponezumab increased dose-dependently with limited accumulation. Cerebrospinal fluid penetration was low. Plasma Aβ 1-x and Aβ 1-40 showed robust increases, but cerebrospinal fluid biomarkers showed no dose response. Ponezumab had no effects on cognitive/functional outcomes or brain volume. Multiple-dose ponezumab was generally safe, but not efficacious, in mild-to-moderate AD.

Postprocedural problems in an overdenture population: a longitudinal study.

PubMed

Ettinger, Ronald L; Qian, Fang

2004-05-01

This study reports on endodontic and other post-procedural problems experienced by overdenture patients from 1973 to 1996. There were 395 subjects enrolled in the study; 273 fulfilled the recall criteria. At recall, all subjects were examined by a single examiner, and appropriate maintenance care was performed. The 273 subjects had 666 abutments and 626 endodontically treated teeth; of these, 51 subjects had postprocedural problems in 81 teeth. Thus, 87.1% of the endodontically treated teeth had no postprocedural problems, and 12.9% had postprocedural problems. Of the subpopulation with postprocedural problems, the most common problem was endodontically treated teeth developing periradicular lesions (37.0%) because of recurrent caries causing loss of the restoration sealing the root canal. Twenty of the 30 teeth were successfully retreated. The next most common problem was vertical root fractures (30.9%), followed by vital teeth developing periradicular lesions (19.8%). Most of the failures could have been prevented by better oral hygiene. Vertical root fractures were statistically associated with abutments in the maxilla and opposed by natural teeth; protection of these abutments with thimble crowns could prevent fractures.

MicroSIFT Courseware Evaluations. [Set 11 (223-259), Set 12 (260-293), and a Special Set of 99 LIBRA Reviews of Junior High School Science Software, Including Subject and Title Indexes Covering Sets 1-12 and Special Set L].

ERIC Educational Resources Information Center

Northwest Regional Educational Lab., Portland, OR.

This document consists of 170 microcomputer software package evaluations prepared by the MicroSIFT (Microcomputer Software and Information for Teachers) Clearinghouse at the Northwest Regional Education Laboratory. Set 11 consists of 37 packages. Set 12 consists of 34 packages. A special unnumbered set, entitled LIBRA Reviews, treats 99 packages…

Liver toxicity associated with antiretroviral therapy including efavirenz or ritonavir-boosted protease inhibitors in a cohort of HIV/hepatitis C virus co-infected patients.

PubMed

Neukam, Karin; Mira, José A; Ruiz-Morales, Josefa; Rivero, Antonio; Collado, Antonio; Torres-Cornejo, Almudena; Merino, Dolores; de Los Santos-Gil, Ignacio; Macías, Juan; González-Serrano, Mercedes; Camacho, Angela; Parra-García, Ginés; Pineda, Juan A

2011-11-01

To compare the frequency of grade 3 or 4 transaminase elevations (TEs) in HIV/hepatitis C virus (HCV) co-infected patients who started a three-antiretroviral drug regimen including efavirenz or a ritonavir-boosted protease inhibitor (PI/r) and the influence of pre-existing significant hepatic fibrosis or cirrhosis. All pre-treated or treatment-naive HIV/HCV co-infected patients who started an antiretroviral regimen including two nucleos(t)ide reverse transcriptase inhibitors along with efavirenz or a PI/r in seven Spanish centres from January 2007 to December 2009 were included in this prospective study. Of 262 patients included in this study, 76 (29%) individuals began antiretroviral therapy (ART) including efavirenz and 186 (71%) a PI/r-based combination. The median (interquartile) follow-up was 14.0 (6.2-23.7) months. A total of 20 (7.6%) patients presented grade 3-4 TEs. Four (1.5%) subjects discontinued ART due to this adverse event. Grade 3-4 TEs were observed in 5 (6.6%) subjects receiving efavirenz and 15 (8.1%) treated with PI/r (P = 0.681). Three (6.5%) patients in the efavirenz group with significant fibrosis developed grade 3-4 TEs versus 2 (8.7%) without pre-existing significant fibrosis (P = 0.743). In the PI/r group, the corresponding figures were 10 (8.8%) and 5 (9.3%), respectively (P = 0.931). The frequency of grade 3-4 TEs associated with efavirenz-based ART combinations under clinical practice conditions is low and similar to that found in patients receiving PI/r currently used in HIV/HCV co-infected patients. The baseline fibrosis stage does not have an impact on the development of TEs caused by these antiretroviral drugs in this population.

Comparative gastrointestinal blood loss associated with placebo, aspirin, and nabumetone as assessed by radiochromium (/sup 51/Cr)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lussier, A.; Davis, A.; Lussier, Y.

Nabumetone differs from most other nonsteroidal anti-inflammatory drugs. It is presented to the gut as a nonacidic prodrug, and is metabolized to its active form after absorption. Studies in animals and humans suggest it is less irritating to the gastrointestinal mucosa. This study compared the gastrointestinal microbleeding induced by nabumetone to aspirin (acetylsalicylic acid, ASA), and placebo in a double blind parallel study using chromium /sup 51/Cr labelled red cells to quantitate fecal blood loss (FBL) in healthy volunteers. Thirty subjects were randomized to treatment with nabumetone (2000 mg), ASA (3.6 g) or placebo for 21 days following a 7more » day placebo period. Six subjects served as untreated controls. FBL in nabumetone treated subjects was not significantly different to placebo or untreated subjects. In contrast, ASA-treated subjects exhibited significantly increased FBL than the other 3 groups (P less than .0001).« less

Cleared for takeoff: The effects of hypobaric conditions on traumatic pneumothoraces.

PubMed

Majercik, Sarah; White, Thomas W; Van Boerum, Don H; Granger, Steven; Bledsoe, Joseph; Conner, Karen; Wilson, Emily; Weaver, Lindell K

2014-11-01

Current guidelines suggest that traumatic pneumothorax (tPTX) is a contraindication to commercial airline travel, and patients should wait at least 2 weeks after radiographic resolution of tPTX to fly. This recommendation is not based on prospective, physiologic study. We hypothesized that despite having a radiographic increase in pneumothorax size while at simulated altitude, patients with a recently treated tPTX would not exhibit any adverse physiologic changes and would not report any symptoms of cardiorespiratory compromise. This is a prospective, observational study of 20 patients (10 in Phase 1, 10 in Phase 2) with tPTX that has been treated by chest tube (CT) or high flow oxygen therapy. CT must have been removed within 48 hours of entering the study. Subjects were exposed to 2 hours of hypobaria (554 mm Hg in Phase 1, 471 mm Hg in Phase 2) in a chamber in Salt Lake City, Utah. Vital signs and subjective symptoms were recorded during the "flight." After 2 hours, while still at simulated altitude, a portable chest radiograph (CXR) was obtained. tPTX sizes on preflight, inflight, and postflight CXR were compared. Sixteen subjects (80%) were male. Mean (SD) age and ISS were 49 (5) years and 10.5 (4.6), respectively. Fourteen (70%) had a CT to treat tPTX, which had been removed 19 hours (range, 4-43 hours) before the study. No subject complained of any cardiorespiratory symptoms while at altitude. Radiographic increase in tPTX size at altitude was 5.6 (0.61) mm from preflight CXR. No subject developed a tension tPTX. No subject required procedural intervention during the flight. Four hours after the study, all tPTX had returned to baseline size. Patients with recently treated tPTX have a small increase in the size of tPTX when subjected to simulated altitude. This is clinically well tolerated. Current prohibitions regarding air travel following traumatic tPTX should be reconsidered and further studied. Therapeutic study, level IV.

A double-blind, placebo-controlled clinical trial of the effect of chlorpheniramine on the response of the nasal airway, middle ear and eustachian tube to provocative rhinovirus challenge.

PubMed

Doyle, W J; McBride, T P; Skoner, D P; Maddern, B R; Gwaltney, J M; Uhrin, M

1988-03-01

This paper presents the results of a randomized, double-blind, placebo-controlled study of the efficacy of chlorpheniramine in relieving the symptoms and attenuating the pathophysiologic correlates of a rhinovirus "common cold." Forty healthy, adult, nonatopic subjects were randomly assigned to one of two treatment groups: active drug and placebo. On study Day 0, all subjects were challenged intranasally with rhinovirus type 39 (dose = 100 TCID50). Subjects were cloistered from Day 2 to Day 7, at which time they were treated with either chlorpheniramine or placebo. From 3 days before challenge to study Day 19, subjects had nasal patency assessed by rhinomanometry, eustachian tube function assessed by the 9-step test and sonotubometry, middle ear pressure assessed by tympanometry and nasal clearance assessed by the dyed-saccharin technique. Symptom diaries were maintained throughout the period of follow-up. During cloister, symptoms also were scored by interview, nasal secretions were quantified and nasal washings were performed for viral culture. Results showed that 19 (95%) subjects in the active-treatment group and 18 (90%) subjects in the placebo-treatment group shed virus. Symptomatic colds were observed in 63% of the active-treated and 83% of the placebo-treated subjects. Symptoms increased on Day 1 and peaked at Days 4 to 5. Detrimental changes in other measured functions consistent with those previously reported were observed. During the period of treatment, significant differences in the average symptom scores favoring the active-treatment group were observed for sneezing. Also, weight of expelled secretions was greater and mucociliary clearance rate less on some cloister days for the placebo-treated group. No significant differences between treatment groups in the objective measures of nasal congestion or the response of the middle ear and eustachian tube were documented.

[A case of fibromyalgia treated with medical and autogenic training].

PubMed

Goto, Fumiyuki; Asama, Youji; Nakai, Kimiko

2005-12-01

Fibromyalgia, which is relatively rare, may include symptoms of dizziness, vertigo and tinnitus. Subject was 38 years old woman reporting vertigo and whole body pain. Cochleovestibular function was normal. Pain was gradually intensified during her outpatient clinic and she was admitted. Treatments including intramusclular injection of botulinus toxin and intravenous injection of steroid were applied. Psychological counseling and autogenic training were effective in relieving her pain and vertigo. During her admission, several spells of vertigo occurred but no nystagmus was found. The abnormality in proprioception and neural disintegration may be related to vertigo. Treatment should start as early as possible together with psychological therapy.

A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS.

PubMed

Freedman, M S; Bar-Or, A; Oger, J; Traboulsee, A; Patry, D; Young, C; Olsson, T; Li, D; Hartung, H-P; Krantz, M; Ferenczi, L; Verco, T

2011-10-18

To evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis (SPMS) who express human leukocyte antigen (HLA) haplotype DR2 or DR4 (DR2(+) or DR4(+)). This multicenter randomized 2-year, double-blind, placebo-controlled study included 612 subjects with a diagnosis of SPMS and an Expanded Disability Status Scale (EDSS) score of 3.5-6.5, stratified according to baseline EDSS score (3.5-5.0, or 5.5-6.5) and HLA haplotype (DR2(+) or DR4(+), or DR2(-)/DR4(-)). Upon entry of 100 DR2(-)/DR4(-) subjects, further study enrollment was limited to DR2(+) or DR4(+) subjects. Subjects were randomly assigned to either 500 mg MBP8298 or placebo, given by IV injection once every 6 months for 2 years. The primary outcome measure was time to progression by ≥1.0 EDSS point (or 0.5 point if baseline EDSS was 5.5 or higher), confirmed 6 months later. Secondary outcomes included mean change in EDSS, mean change in Multiple Sclerosis Functional Composite, MRI changes, annualized relapse rate, and quality of life. There were no significant differences between treatment groups in either the primary or secondary endpoints. MBP8298 was well tolerated in all treated subjects with no safety issues identified. In the population studied, treatment with MBP8298 did not provide a clinical benefit compared to placebo. This study provides Class 1 evidence that MBP8298 is not effective in patients with SPMS who are HLA DR2(+) or DR4(+).

Methamphetamine enhances sexual behavior in female rats.

PubMed

Winland, Carissa; Haycox, Charles; Bolton, Jessica L; Jampana, Sumith; Oakley, Benjamin J; Ford, Brittany; Ornelas, Laura; Burbey, Alexandra; Marquette, Amber; Frohardt, Russell J; Guarraci, Fay A

2011-06-01

The present study evaluated the effects of methamphetamine (MA) on sexual behavior in female rats. In Experiment 1, ovariectomized, hormone-primed rats were injected with MA (1.0mg/kg, i.p.) or saline prior to a test for mate choice wherein females could mate with two males simultaneously. Female rats treated with saline returned to their preferred mate faster after receiving intromissions and visited their preferred mate at a higher rate than their non-preferred mate. In contrast, MA-treated female rats spent a similar amount of time with their preferred and non-preferred mate and failed to return to their preferred mate faster than to their non-preferred mate following intromissions. Two weeks later, the females received the same drug treatment but were tested for partner preference wherein females could spend time near a male or female stimulus rat. All subjects spent more time near the male stimulus than the female stimulus. However, the MA-treated rats visited the male stimulus more frequently and spent less time near the female stimulus than the saline-treated rats. Similar to Experiment 1, female rats in Experiment 2 were tested for mate choice and then two weeks later tested for partner preference; however, females received three daily injections of MA (1.0mg/kg, i.p.) or saline. Females treated chronically with MA returned to both males faster following intromissions than females treated with saline, independent of preference (i.e., preferred mate and non-preferred mate). Furthermore, MA-treated rats were more likely to leave either male (i.e., preferred or non-preferred mate) than saline-treated rats after receiving sexual stimulation. Although MA-treated subjects spent more time near the male stimulus than the female stimulus, they spent less time near either when compared to saline-treated subjects. The present results demonstrate that MA affects sexual behavior in female rats partly by increasing locomotion and partly by directly affecting sexual behavior. Copyright © 2011 Elsevier Inc. All rights reserved.

Waist Circumference Is the Best Anthropometric Predictor for Insulin Resistance in Nondiabetic Patients with Schizophrenia Treated with Clozapine But Not Olanzapine

PubMed Central

Henderson, David C.; Fan, Xiaoduo; Sharma, Bikash; Copeland, Paul M.; Borba, Christina P.C.; Freudenreich, Oliver; Cather, Corey; Evins, A. Eden; Goff, Donald C.

2010-01-01

The goal of this study was to evaluate which anthropometric measure (human body measurement) best predicts insulin resistance measured by the insulin sensitivity index (SI) and the homeostasis model of assessment of insulin resistance (HOMA-IR) in nondiabetic patients with schizophrenia patients treated with clozapine or olanzapine. Methods We conducted a cross-sectional study of nondiabetic subjects with schizophrenia being treated with olanzapine or clozapine using a frequently sampled intravenous glucose tolerance test, nutritional assessment, and anthropometric measures to assess the relationship between anthropometric measures and insulin resistance. Results No difference was found between the groups treated with clozapine and olanzapine in age, gender, race, body mass index (BMI), waist circumference (WC), lipid levels, HOMA-IR, or SI. The disposition index (SI × the acute insulin response to glucose), which measures how the body compensates for insulin resistance to maintain a normal glucose level, was significantly lower in the group treated with clozapine than in the group treated with olanzapine (1067 ± 1390 vs. 2521 ± 2805; p = 0.013), suggesting that the subjects treated with clozapine had a reduced compensatory response to IR compared with the subjects treated with olanzapine. In the clozapine group, both higher WC and BMI were significantly associated with elevated HOMA-IR and lower SI; however, WC was a stronger correlate of IR than BMI, as measured by SI (−0.50 vs. −0.40). In the olanzapine group, neither WC nor BMI was significantly associated with any measure of glucose metabolism. Conclusions In this study, WC was the single best anthropometric surrogate for predicting IR in patients treated with clozapine but not olanzapine. The results suggest that WC may be a valuable screening tool for predicting IR in patients with schizophrenia being treated with clozapine who are at relatively higher risk of developing the metabolic syndrome, type 2 diabetes mellitus, and associated cardiovascular disease. PMID:19625881

Construction of a model for predicting creatinine clearance in Japanese patients treated with Cisplatin therapy.

PubMed

Yajima, Airi; Uesawa, Yoshihiro; Ogawa, Chiaki; Yatabe, Megumi; Kondo, Naoki; Saito, Shinichiro; Suzuki, Yoshihiko; Atsuda, Kouichiro; Kagaya, Hajime

2015-05-01

There exist various useful predictive models, such as the Cockcroft-Gault model, for estimating creatinine clearance (CLcr). However, the prediction of renal function is difficult in patients with cancer treated with cisplatin. Therefore, we attempted to construct a new model for predicting CLcr in such patients. Japanese patients with head and neck cancer who had received cisplatin-based chemotherapy were used as subjects. A multiple regression equation was constructed as a model for predicting CLcr values based on background and laboratory data. A model for predicting CLcr, which included body surface area, serum creatinine and albumin, was constructed. The model exhibited good performance prior to cisplatin therapy. In addition, it performed better than previously reported models after cisplatin therapy. The predictive model constructed in the present study displayed excellent potential and was useful for estimating the renal function of patients treated with cisplatin therapy. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

The action of aminoguanidine on the liver of trained diabetic rats

PubMed Central

2013-01-01

Background This study evaluated the effect of aminoguanidine on liver of diabetic rats subject to physical exercises using histological and histochemical techniques. Methods The rats used in this study were divided into five groups: sedentary control, sedentary diabetic, trained diabetic, sedentary diabetic and treated with aminoguanidine, trained diabetic and treated with aminoguanidine. Results The results showed no effect of aminoguanidine on the liver tissue, although there was improvement with exercise training showing cytological, morpho-histological and histochemical alterations in liver cells of animals from groups trained diabetic and/or treated diabetic compared to those individuals in the sedentary control and sedentary diabetic. These changes included: hepatocytes hypertrophy, presence and distribution of polysaccharides in the hepatocytes cytoplasm and, especially, congestion of the liver blood vessels. Conclusion Our results suggest that aminoguanidine is not hepatotoxic, when used at dosage of 1 g/L for the treatment of diabetes complications, and confirmed that the practice of moderate physical exercise assuaged the damage caused by diabetes without the use of insulin. PMID:23837632

Glycolytic and mitochondrial metabolism in pancreatic islets from MSG-treated obese rats subjected to swimming training.

PubMed

Leite, Nayara de Carvalho; Ferreira, Thiago Rentz; Rickli, Sarah; Borck, Patricia Cristine; Mathias, Paulo Cezar de Freitas; Emilio, Henriette Rosa de Oliveira; Grassiolli, Sabrina

2013-01-01

Obese rats obtained by neonatal monosodium glutamate (MSG) administration present insulin hypersecretion. The metabolic mechanism by which glucose catabolism is coupled to insulin secretion in the pancreatic β-cells from MSG-treated rats is understood. The purpose of this study was to evaluate glucose metabolism in pancreatic islets from MSG-treated rats subjected to swimming training. MSG-treated and control (CON) rats swam for 30 minutes (3 times/week) over a period of 10 weeks. Pancreatic islets were isolated and incubated with glucose in the presence of glycolytic or mitochondrial inhibitors. Swimming training attenuated fat pad accumulation, avoiding changes in the plasma levels of lipids, glucose and insulin in MSG-treated rats. Adipocyte and islet hypertrophy observed in MSG-treated rats were attenuated by exercise. Pancreatic islets from MSG-treated obese rats also showed insulin hypersecretion, greater glucose transporter 2 (GLUT2) expression, increased glycolytic flux and reduced mitochondrial complex III activity. Swimming training attenuated islet hypertrophy and normalised GLUT2 expression, contributing to a reduction in the glucose responsiveness of pancreatic islets from MSG-treated rats without altering glycolytic flux. However, physical training increased the activity of mitochondrial complex III in pancreatic islets from MSG-treated rats without a subsequent increase in glucose-induced insulin secretion. Copyright © 2013 S. Karger AG, Basel.

Paliperidone palmitate once-monthly maintains improvement in functioning domains of the Personal and Social Performance scale compared with placebo in subjects with schizoaffective disorder.

PubMed

Fu, Dong-Jing; Turkoz, Ibrahim; Walling, David; Lindenmayer, Jean-Pierre; Schooler, Nina R; Alphs, Larry

2018-02-01

Evaluate the effect of paliperidone palmitate once-monthly (PP1M) injectable on the specific functioning domains of the Personal and Social Performance (PSP) scale in patients with schizoaffective disorder (SCA) participating in a long-term study. This study (NCT01193153) included both in- and outpatient subjects with SCA experiencing an acute exacerbation of psychotic and mood symptoms. Subjects were treated with PP1M either as monotherapy or in combination with antidepressants or mood stabilizers during a 25-week open-label (OL) phase. Stabilized subjects were randomly assigned 1:1 (PP1M or placebo) into a 15-month double-blind (DB) relapse-prevention period. Functioning of the randomized subjects during OL and DB phases was evaluated using the PSP scale (four domains: socially useful activities, personal/social relationships, self-care, and disturbing/aggressive behaviors). Three statistical approaches were utilized to analyze PSP scores to assess robustness and consistency of findings. No adjustments were made for multiplicity. 334 of 667 enrolled subjects were stabilized with PP1M, randomly assigned to PP1M (n=164) or placebo (n=170) in the DB phase, and included in this analysis. Improvements in all PSP domain scores were observed during the OL phase and were maintained during the DB phase with PP1M, but decreased with placebo. Differences compared to placebo were significant in all four PSP domains during the DB phase (P≤0.008). The analysis in this study showed that PP1M improves functioning, as measured by the four PSP domain scores, in symptomatic subjects with SCA. Functioning was maintained compared with placebo. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

The duration of diabetes affects the response to intensive glucose control in type 2 subjects: the VA Diabetes Trial.

PubMed

Duckworth, William C; Abraira, Carlos; Moritz, Thomas E; Davis, Stephen N; Emanuele, Nicholas; Goldman, Steven; Hayward, Rodney; Huang, Grant D; Marks, Jennifer B; Reaven, Peter D; Reda, Domenic J; Warren, Stuart R; Zieve, Franklin J

2011-01-01

The goal of the VA Diabetes Trial (VADT) was to determine the effect of intensive glucose control on macrovascular events in subjects with difficult-to-control diabetes. No significant benefit was found. This report examines predictors of the effect of intensive therapy on the primary outcome in this population. This trial included 1791 subjects. Baseline cardiovascular risk factors were collected by interview and the VA record. The analyses were done by intention to treat. Univariate analysis at baseline of predictors of a primary cardiovascular (CV) event included a prior CV event, age, insulin use at baseline, and duration of diagnosed diabetes (all P < .0001). Multivariable modeling revealed a U-shaped relationship between duration of diabetes and treatment. Modeled estimates for the hazard ratios (HRs) for treatment show that subjects with a short duration (3 years or less) of diagnosed diabetes have a nonsignificant increase in risk (HR > 1.0) after which the HR is below 1.0. From 7 to 15 years' duration at entry, subjects have HRs favoring intensive treatment. Thereafter the HR approaches 1.0 and over-21-years' duration approaches 2.0. Duration over 21 years resulted in a HR of 1.977 (CI 1.77-3.320, P < .01). Baseline c-peptide levels progressively declined up to 15 years and were stable subsequently. In difficult-to-control older subjects with type 2 DM, duration of diabetes altered the response to intensive glucose control. Intensive therapy may reduce CV events in subjects with a duration of 15 years or less and may increase risks in those with longer duration. Published by Elsevier Inc.

[The evaluation of motivation and addiction to nicotine in smokers attempting to quit smoking].

PubMed

Szwed, Angelika

2012-01-01

Smoking cigarettes is a factor which increases the risk of developing many diseases, especially of the circulatory and respiratory systems. Quitting smoking is an essential element of prophylaxis and therapy. The effectiveness of treating the syndrome of nicotine addiction mostly depends on the motivation to give up the habit. The study aimed at evaluating the motivation and the strength of nicotine addiction as well as the factor which motivates smokers for giving up the habit. Sixty-two smokers were included in the study. There were 31 males and 31 females. The mean age of the study subjects was 47.26 ± 14.45. The study was performed using the author-made survey (including for example questions regarding sociodemographic data and motives for quitting smoking), Fagerström Tolerance Questionnaire (for analyzing degree of nicotine addiction) and Schneider Motivation Test (to evaluate the degree of motivation to quit smoking). Thirty-seven subjects out of the total number of 62 were the least addicted to nicotine. They were highly motivated to give up the habit of smoking. The mean value of motivation depended on the level of education of the subjects and was 7.71-8.50 scores. Health concerns were the reasons to make a decision to quit smoking for the majority of the subjects. Health concern is the most common reason for giving up the habit of smoking. The relationship between the motivation to quit smoking and the sex of the subjects was not observed.

Performance of a neuro-fuzzy model in predicting weight changes of chronic schizophrenic patients exposed to antipsychotics.

PubMed

Lan, T H; Loh, E W; Wu, M S; Hu, T M; Chou, P; Lan, T Y; Chiu, H-J

2008-12-01

Artificial intelligence has become a possible solution to resolve the problem of loss of information when complexity of a disease increases. Obesity phenotypes are observable clinical features of drug-naive schizophrenic patients. In addition, atypical antipsychotic medications may cause these unwanted effects. Here we examined the performance of neuro-fuzzy modeling (NFM) in predicting weight changes in chronic schizophrenic patients exposed to antipsychotics. Two hundred and twenty inpatients meeting DSMIV diagnosis of schizophrenia, treated with antipsychotics, either typical or atypical, for more than 2 years, were recruited. All subjects were assessed in the same study period between mid-November 2003 and mid-April 2004. The baseline and first visit's physical data including weight, height and circumference were used in this study. Clinical information (Clinical Global Impression and Life Style Survey) and genotype data of five single nucleotide polymorphisms were also included as predictors. The subjects were randomly assigned into the first group (105 subjects) and second group (115 subjects), and NFM was performed by using the FuzzyTECH 5.54 software package, with a network-type structure constructed in the rule block. A complete learned model trained from merged data of the first and second groups demonstrates that, at a prediction error of 5, 93% subjects with weight gain were identified. Our study suggests that NFM is a feasible prediction tool for obesity in schizophrenic patients exposed to antipsychotics, with further improvements required.

Longitudinal Study of Hypertensive Subjects With Type 2 Diabetes Mellitus: Overall and Cardiovascular Risk.

PubMed

Safar, Michel E; Gnakaméné, Jean-Barthélémy; Bahous, Sola Aoun; Yannoutsos, Alexandra; Thomas, Frédérique

2017-06-01

Despite adequate glycemic and blood pressure control, treated type 2 diabetic hypertensive subjects have a significantly elevated overall/cardiovascular risk. We studied 244 816 normotensive and 99 720 hypertensive subjects (including 7480 type 2 diabetics) attending medical checkups between 1992 and 2011. We sought to identify significant differences in overall/cardiovascular risk between hypertension with and without diabetes mellitus. Mean follow-up was 12.7 years; 14 050 all-cause deaths were reported. From normotensive to hypertensive populations, a significant progression in overall/cardiovascular mortality was observed. Mortality was significantly greater among diabetic than nondiabetic hypertensive subjects (all-cause mortality, 14.05% versus 7.43%; and cardiovascular mortality, 1.28% versus 0.7%). No interaction was observed between hemodynamic measurements and overall/cardiovascular risk, suggesting that blood pressure factors, even during drug therapy, could not explain the differences in mortality rates between diabetic and nondiabetic hypertensive patients. Using cross-sectional regression models, a significant association was observed between higher education levels, lower levels of anxiety and depression, and reduced overall mortality in diabetic hypertensive subjects, while impaired renal function, a history of stroke and myocardial infarction, and increased alcohol and tobacco consumption were significantly associated with increased mortality. Blood pressure and glycemic control alone cannot reverse overall/cardiovascular risk in diabetics with hypertension. Together with cardiovascular measures, overall prevention should include recommendations to reduce alcohol and tobacco consumption and improve stress, education levels, and physical activity. © 2017 American Heart Association, Inc.

Endoscopic spray cryotherapy for esophageal cancer: safety and efficacy

PubMed Central

Greenwald, Bruce D.; Dumot, John A.; Abrams, Julian A.; Lightdale, Charles J.; David, Donald S.; Nishioka, Norman S.; Yachimski, Patrick; Johnston, Mark H.; Shaheen, Nicholas J.; Zfass, Alvin M.; Smith, Jenny O.; Gill, Kanwar Rupinder S.; Burdick, J. Steven; Mallat, Damien; Wolfsen, Herbert C.

2011-01-01

Background Few options exist for patients with localized esophageal cancer ineligible for conventional therapies. Endoscopic spray cryotherapy with low-pressure liquid nitrogen has demonstrated efficacy in this setting in early studies. Objective To assess the safety and efficacy of cryotherapy in esophageal carcinoma. Design Multicenter, retrospective cohort study. Setting Ten academic and community medical centers between 2006 and 2009. Patients Subjects with esophageal carcinoma in whom conventional therapy failed and those who refused or were ineligible for conventional therapy. Interventions Cryotherapy with follow-up biopsies. Treatment was complete when tumor eradication was confirmed by biopsy or when treatment was halted because of tumor progression, patient preference, or comorbid condition. Main Outcome Measurements Complete eradication of luminal cancer and adverse events. Results Seventy-nine subjects (median age 76 years, 81% male, 94% with adenocarcinoma) were treated. Tumor stage included T1-60, T2-16, and T3/4-3. Mean tumor length was 4.0 cm (range 1–15 cm). Previous treatment including endoscopic resection, photodynamic therapy, esophagectomy, chemotherapy, and radiation therapy failed in 53 subjects (67%). Forty-nine completed treatment. Complete response of intraluminal disease was seen in 31 of 49 subjects (61.2%), including 18 of 24 (75%) with mucosal cancer. Mean (standard deviation) length of follow-up after treatment was 10.6 (8.4) months overall and 11.5 (2.8) months for T1 disease. No serious adverse events were reported. Benign stricture developed in 10 (13%), with esophageal narrowing from previous endoscopic resection, radiotherapy, or photodynamic therapy noted in 9 of 10 subjects. Limitations Retrospective study design, short follow-up. Conclusions Spray cryotherapy is safe and well tolerated for esophageal cancer. Short-term results suggest that it is effective in those who could not receive conventional treatment, especially for those with mucosal cancer. PMID:20363410

Endoscopic spray cryotherapy for esophageal cancer: safety and efficacy.

PubMed

Greenwald, Bruce D; Dumot, John A; Abrams, Julian A; Lightdale, Charles J; David, Donald S; Nishioka, Norman S; Yachimski, Patrick; Johnston, Mark H; Shaheen, Nicholas J; Zfass, Alvin M; Smith, Jenny O; Gill, Kanwar Rupinder S; Burdick, J Steven; Mallat, Damien; Wolfsen, Herbert C

2010-04-01

Few options exist for patients with localized esophageal cancer ineligible for conventional therapies. Endoscopic spray cryotherapy with low-pressure liquid nitrogen has demonstrated efficacy in this setting in early studies. To assess the safety and efficacy of cryotherapy in esophageal carcinoma. Multicenter, retrospective cohort study. Ten academic and community medical centers between 2006 and 2009. Subjects with esophageal carcinoma in whom conventional therapy failed and those who refused or were ineligible for conventional therapy. Cryotherapy with follow-up biopsies. Treatment was complete when tumor eradication was confirmed by biopsy or when treatment was halted because of tumor progression, patient preference, or comorbid condition. Complete eradication of luminal cancer and adverse events. Seventy-nine subjects (median age 76 years, 81% male, 94% with adenocarcinoma) were treated. Tumor stage included T1-60, T2-16, and T3/4-3. Mean tumor length was 4.0 cm (range 1-15 cm). Previous treatment including endoscopic resection, photodynamic therapy, esophagectomy, chemotherapy, and radiation therapy failed in 53 subjects (67%). Forty-nine completed treatment. Complete response of intraluminal disease was seen in 31 of 49 subjects (61.2%), including 18 of 24 (75%) with mucosal cancer. Mean (standard deviation) length of follow-up after treatment was 10.6 (8.4) months overall and 11.5 (2.8) months for T1 disease. No serious adverse events were reported. Benign stricture developed in 10 (13%), with esophageal narrowing from previous endoscopic resection, radiotherapy, or photodynamic therapy noted in 9 of 10 subjects. Retrospective study design, short follow-up. Spray cryotherapy is safe and well tolerated for esophageal cancer. Short-term results suggest that it is effective in those who could not receive conventional treatment, especially for those with mucosal cancer. Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Prevention of Diabetes With Pioglitazone in ACT NOW

PubMed Central

DeFronzo, Ralph A.; Tripathy, Devjit; Schwenke, Dawn C.; Banerji, MaryAnn; Bray, George A.; Buchanan, Thomas A.; Clement, Stephen C.; Gastaldelli, Amalia; Henry, Robert R.; Kitabchi, Abbas E.; Mudaliar, Sunder; Ratner, Robert E.; Stentz, Frankie B.; Musi, Nicolas; Reaven, Peter D.

2013-01-01

We examined the metabolic characteristics that attend the development of type 2 diabetes (T2DM) in 441 impaired glucose tolerance (IGT) subjects who participated in the ACT NOW Study and had complete end-of-study metabolic measurements. Subjects were randomized to receive pioglitazone (PGZ; 45 mg/day) or placebo and were observed for a median of 2.4 years. Indices of insulin sensitivity (Matsuda index [MI]), insulin secretion (IS)/insulin resistance (IR; ΔI0–120/ΔG0–120, ΔIS rate [ISR]0–120/ΔG0–120), and β-cell function (ΔI/ΔG × MI and ΔISR/ΔG × MI) were calculated from plasma glucose, insulin, and C-peptide concentrations during oral glucose tolerance tests at baseline and study end. Diabetes developed in 45 placebo-treated vs. 15 PGZ-treated subjects (odds ratio [OR] 0.28 [95% CI 0.15–0.49]; P < 0.0001); 48% of PGZ-treated subjects reverted to normal glucose tolerance (NGT) versus 28% of placebo-treated subjects (P < 0.005). Higher final glucose tolerance status (NGT > IGT > T2DM) was associated with improvements in insulin sensitivity (OR 0.61 [95% CI 0.54–0.80]), IS (OR 0.61 [95% CI 0.50–0.75]), and β-cell function (ln IS/IR index and ln ISR/IR index) (OR 0.26 [95% CI 0.19–0.37]; all P < 0.0001). Of the factors measured, improved β-cell function was most closely associated with final glucose tolerance status. PMID:23863810

Growth charts for non-growth hormone treated Prader-Willi syndrome.

PubMed

Butler, Merlin G; Lee, Jaehoon; Manzardo, Ann M; Gold, June-Anne; Miller, Jennifer L; Kimonis, Virginia; Driscoll, Daniel J

2015-01-01

The goal of this study was to generate and report standardized growth curves for weight, height, head circumference, and BMI for non-growth hormone-treated white male and female US subjects with Prader-Willi syndrome (PWS) between 3 and 18 years of age and develop standardized growth charts. Anthropometric measures (N = 133) were obtained according to standard methods from 120 non-growth hormone-treated white subjects (63 males and 57 females) with PWS between 3 and 18 years of age. Standardized growth curves were developed for the third, 10th, 25th, 50th, 75th, 90th, and 97th percentiles by using the LMS method for weight, height, head circumference, and BMI for PWS subjects along with the normative third, 50th, and 97th percentiles from national and international growth data. The LMS smoothing procedure summarized the distribution of the anthropometric variables at each age using three parameters: power of the Box-Cox transformation λ (L), median μ (M) and coefficient of variation δ (S). Weight, height, head circumference, and BMI standardized growth charts representing 7 percentile ranges were developed from 120 non-growth hormone-treated white male and female US subjects with PWS (age range: 3-18 years) and normative third, 50th, and 97th percentiles from national and international data. We encourage the use of syndrome-specific growth standards to examine and evaluate subjects with PWS when monitoring growth patterns and determining nutritional and obesity status. These variables can be influenced by culture, individual medical care, diet intervention, and physical activity plans. Copyright © 2015 by the American Academy of Pediatrics.

Bioactive Titanate Layers Formed on Titanium and Its Alloys by Simple Chemical and Heat Treatments

PubMed Central

Kokubo, Tadashi; Yamaguchi, Seiji

2015-01-01

To reveal general principles for obtaining bone-bonding bioactive metallic titanium, Ti metal was heat-treated after exposure to a solution with different pH. The material formed an apatite layer at its surface in simulated body fluid when heat-treated after exposure to a strong acid or alkali solution, because it formed a positively charged titanium oxide and negatively charged sodium titanate film on its surface, respectively. Such treated these Ti metals tightly bonded to living bone. Porous Ti metal heat-treated after exposure to an acidic solution exhibited not only osteoconductive, but also osteoinductive behavior. Porous Ti metal exposed to an alkaline solution also exhibits osteoconductivity as well as osteoinductivity, if it was subsequently subjected to acid and heat treatments. These acid and heat treatments were not effective for most Ti-based alloys. However, even those alloys exhibited apatite formation when they were subjected to acid and heat treatment after a NaOH treatment, since the alloying elements were removed from the surface by the latter. The NaOH and heat treatments were also not effective for Ti-Zr-Nb-Ta alloys. These alloys displayed apatite formation when subjected to CaCl2 treatment after NaOH treatment, forming Ca-deficient calcium titanate at their surfaces after subsequent heat and hot water treatments. The bioactive Ti metal subjected to NaOH and heat treatments has been clinically used as an artificial hip joint material in Japan since 2007. A porous Ti metal subjected to NaOH, HCl and heat treatments has successfully undergone clinical trials as a spinal fusion device. PMID:25893014

A TRANSLATIONAL INVESTIGATION TARGETING STRESS-REACTIVITY AND PRE-FRONTAL COGNITIVE CONTROL WITH GUANFACINE FOR SMOKING CESSATION

PubMed Central

McKee, Sherry A.; Potenza, Marc N.; Kober, Hedy; Sofuoglu, Mehmet; Arnsten, Amy F. T.; Picciotto, Marina R.; Weinberger, Andrea H.; Ashare, Rebecca; Sinha, Rajita

2015-01-01

Stress and pre-frontal cognitive dysfunction have key roles in driving smoking, however, there are no therapeutics for smoking cessation which attenuate the effects of stress on smoking and enhance cognition. Central noradrenergic pathways are involved in stress-induced reinstatement to nicotine and in the prefrontal executive control of adaptive behaviors. We used a novel translational approach employing a validated laboratory analogue of stress-precipitated smoking, fMRI, and a proof-of-concept treatment period to evaluate whether the noradrenergic α2a agonist, guanfacine (3mg/day) versus placebo (0mg/day) reduced stress-precipitated smoking in the laboratory, altered cortico-striatal activation during the Stroop cognitive-control task, and reduced smoking following a quit attempt. In nicotine-deprived smokers (n=33), stress versus a neutral condition significantly decreased the latency to smoke, and increased tobacco craving, ad-libitum smoking, and systolic blood pressure in placebo-treated subjects, and these effects were absent or reduced in guanfacine-treated subjects. Following stress, placebo-treated subjects demonstrated decreased cortisol levels whereas guanfacine-treated subjects demonstrated increased levels. Guanfacine, compared to placebo, altered prefrontal activity during a cognitive control task, and reduced cigarette use but did not increase complete abstinence during treatment. These preliminary laboratory, neuroimaging and clinical outcome data were consistent and complementary and support further development of guanfacine for smoking cessation. PMID:25516371

A translational investigation targeting stress-reactivity and prefrontal cognitive control with guanfacine for smoking cessation.

PubMed

McKee, Sherry A; Potenza, Marc N; Kober, Hedy; Sofuoglu, Mehmet; Arnsten, Amy F T; Picciotto, Marina R; Weinberger, Andrea H; Ashare, Rebecca; Sinha, Rajita

2015-03-01

Stress and prefrontal cognitive dysfunction have key roles in driving smoking; however, there are no therapeutics for smoking cessation that attenuate the effects of stress on smoking and enhance cognition. Central noradrenergic pathways are involved in stress-induced reinstatement to nicotine and in the prefrontal executive control of adaptive behaviors. We used a novel translational approach employing a validated laboratory analogue of stress-precipitated smoking, functional magnetic resonance imaging (fMRI), and a proof-of-concept treatment period to evaluate whether the noradrenergic α2a agonist guanfacine (3 mg/day) versus placebo (0 mg/day) reduced stress-precipitated smoking in the laboratory, altered cortico-striatal activation during the Stroop cognitive-control task, and reduced smoking following a quit attempt. In nicotine-deprived smokers (n=33), stress versus a neutral condition significantly decreased the latency to smoke, and increased tobacco craving, ad-libitum smoking, and systolic blood pressure in placebo-treated subjects, and these effects were absent or reduced in guanfacine-treated subjects. Following stress, placebo-treated subjects demonstrated decreased cortisol levels whereas guanfacine-treated subjects demonstrated increased levels. Guanfacine, compared with placebo, altered prefrontal activity during a cognitive-control task, and reduced cigarette use but did not increase complete abstinence during treatment. These preliminary laboratory, neuroimaging, and clinical outcome data were consistent and complementary and support further development of guanfacine for smoking cessation. © The Author(s) 2014.

Isokinetic strength and endurance after percutaneous and open surgical repair of Achilles tendon ruptures.

PubMed

Goren, David; Ayalon, Moshe; Nyska, Meir

2005-04-01

Reports on complete spontaneous Achilles tendon ruptures and associated treatment have become more frequent in the literature in the past two decades, as has the request for treatments that enable the finest possible functional recovery. The best available treatment is a matter of considerable controversy in the literature. The purpose of this study was to compare the isokinetic strength and endurance of the plantarflexor muscle-tendon unit in subjects who sustained rupture of the Achilles tendon and underwent either open surgery or closed percutaneous repair of the Achilles tendon. Twenty patients (18 males, 2 females) with spontaneous ruptures of the Achilles tendon were included in this study. Ten patients were treated by open surgery, and 10 patients were treated percutaneously. All patients had ruptured their Achilles tendon more than 6 months before the study, and all of the ruptures occurred 3.5 years or less before the day of the testing. All patients underwent an oriented physical examination. An isokinetic Biodex dynamometer (Biodex Medical System, Shirley, NY) was used to measure ankle joint angle, and in plantarflexion to calculate the torque at the ankle joint (Newton/meter), and the average work (jouls) for both maximal power and endurance. Each measurement was compared to the normal ankle. Biodex dynamometer evaluations at 90 deg/sec demonstrated a significant difference of maximal voluntary plantarflexor torque, endurance performance and range of motion at the ankle joint between the involved and uninvolved sides in patients treated by either mode of treatment. Yet, no statistically significant differences were revealed for the parameters mentioned above between the subjects that were treated either percutaneously or by an open surgery. In functional terms, the biomechanical outcomes of open surgery and percutaneous repair for acute ruptures of the Achilles tendon are both effective.

Radiofrequency Coblation Versus Intramural Bipolar Cautery for the Treatment of Inferior Turbinate Hypertrophy.

PubMed

Shah, Anil N; Brewster, Douglas; Mitzen, Kelly; Mullin, David

2015-09-01

Compare intramural bipolar electrocautery and radiofrequency coblation in the treatment of inferior turbinate hypertrophy with regards to objective and subjective improvement in nasal obstruction, rate and type of complications, experience during the procedure, and rate of recovery. Prospective, single-blinded study. Single tertiary medical center from 2008 to 2010. Forty-one adult patients with inferior turbinate hypertrophy refractory to medical management were treated with radiofrequency coblation in one nostril and intramural bipolar cautery in the other. Subjective and objective data, including use of a Visual Analog Scale (VAS) for subjective outcomes, acoustic rhinometry, and nasal endoscopy, were then obtained from each patient comparing the 2 techniques. Radiofrequency coblation was significantly less painful than intramural bipolar cautery during the procedure (P = .03) and during the early postoperative period (P < .02) and produced less crusting at 3 weeks (P = .009). Both interventions were similar in subjective and objective improvements in nasal obstruction as measured by acoustic rhinometry and subjective VAS outcomes. Radiofrequency coblation seems to offer an equivalent alternative to bipolar electrocautery for the treatment of inferior turbinate hypertrophy with less discomfort during the procedure and early post-operative period. © The Author(s) 2015.

No One Likes a Snitch.

PubMed

Redman, Barbara; Caplan, Arthur

2015-08-01

Whistleblowers remain essential as complainants in allegations of research misconduct. Frequently internal to the research team, they are poorly protected from acts of retribution, which may deter the reporting of misconduct. In order to perform their important role, whistleblowers must be treated fairly. Draft regulations for whistleblower protection were published for public comment almost a decade ago but never issued (Dahlberg 2013). In the face of the growing challenge of research fraud, we suggest vigorous steps, to include: organizational responsibility to certify the accuracy of research including audit, required whistleblower action in the face of imminent or grave harm to subjects, strengthened legal protections against retaliation including prompt enactment of Federal whistleblower protections and consideration of criminalizing the most egregious cases of research misconduct.

Cardiovascular and heart failure safety profile of vildagliptin: a meta-analysis of 17 000 patients.

PubMed

McInnes, G; Evans, M; Del Prato, S; Stumvoll, M; Schweizer, A; Lukashevich, V; Shao, Q; Kothny, W

2015-11-01

To report the cardiovascular (CV) safety profile and heart failure (HF) risk of vildagliptin from a large pool of studies, including trials in high-risk patients with type 2 diabetes mellitus (T2DM), such as those with congestive HF and/or moderate/severe renal impairment. We conducted a retrospective meta-analysis of prospectively adjudicated CV events. Patient-level data were pooled from 40 double-blind, randomized controlled phase III and IV vildagliptin studies. The primary endpoint was occurrence of major adverse CV events (MACEs; myocardial infarction, stroke and CV death). Assessments of the individual MACE components and HF events (requiring hospitalization or new onset) were secondary endpoints. The risk ratio (RR) of vildagliptin (50 mg once- and twice-daily combined) versus comparators (placebo and all non-vildagliptin treatments) was calculated using the Mantel-Haenszel (M-H) method. Of the 17 446 patients, 9599 received vildagliptin (9251.4 subject-years of exposure) and 7847 received comparators (7317.0 subject-years of exposure). The mean age of the patients was 57 years, body mass index 30.5 kg/m(2) (nearly 50% obese), glycated haemoglobin concentration 8.1% and T2DM duration 5.5 years. A MACE occurred in 83 (0.86%) vildagliptin-treated patients and 85 (1.20%) comparator-treated patients, with an M-H RR of 0.82 [95% confidence interval (CI) 0.61-1.11]. Similar RRs were observed for the individual events. Confirmed HF events were reported in 41 (0.43%) vildagliptin-treated patients and 32 (0.45%) comparator-treated patients, with an M-H RR 1.08 (95% CI 0.68-1.70). This large meta-analysis indicates that vildagliptin is not associated with an increased risk of adjudicated MACEs relative to comparators. Moreover, this analysis did not find a significant increased risk of HF in vildagliptin-treated patients. © 2015 John Wiley & Sons Ltd.

Field Testing of High Current Electrokinetic Nanoparticle Treatment for Corrosion Mitigation in Reinforced Concrete

NASA Technical Reports Server (NTRS)

Cardenas, Henry; Alexander, Joshua; Kupwade-Patil, Kunal; Calle, Luz marina

2010-01-01

Electrokinetic Nanoparticle (EN) treatment was used as a rapid repair measure to mitigate chloride induced corrosion of reinforced concrete in the field. EN treatment uses an electric field to transport positively charged nanoparticles to the reinforcement through the concrete capillary pores. Cylindrical reinforced concrete specimens were batched with 4.5 wt % salt content (based on cement mass). Three distinct electrokinetic treatments were conducted using high current density (up to 5 A/m2) to form a chloride penetration barrier that was established in 5 days, as opposed to the traditional 6-8 weeks, generally required for electrochemical chloride extraction (ECE). These treatments included basic EN treatment, EN with additional calcium treatment, and basic ECE treatment. Field exposures were conducted at the NASA Beachside Corrosion Test Site, Kennedy Space Center, Florida, USA. The specimens were subjected to sea water immersion at the test site as a posttreatment exposure. Following a 30-day post-treatment exposure period, the specimens were subjected to indirect tensile testing to evaluate treatment impact. The EN treated specimens exhibited 60% and 30% increases in tensile strength as compared to the untreated controls and ECE treated specimens respectively. The surfaces of the reinforcement bars of the control specimens were 67% covered by corrosion products. In contrast, the EN treated specimens exhibited corrosion coverage of only 4%. Scanning electron microscopy (SEM) revealed a dense concrete microstructure adjacent to the bars of the treated specimens as compared to the control and ECE specimens. Energy dispersive spectroscopic (EDS) analysis of the polished EN treated specimens showed a reduction in chloride content by a factor of 20 adjacent to the bars. This study demonstrated that EN treatment was successful in forming a chloride penetration barrier rapidly. This work also showed that the chloride barrier was effective when samples were exposed to field conditions at one of the most severely corrosive environments in North America.

Clinical utility of LC3 and p62 immunohistochemistry in diagnosis of drug-induced autophagic vacuolar myopathies: a case-control study.

PubMed

Lee, Han S; Daniels, Brianne H; Salas, Eduardo; Bollen, Andrew W; Debnath, Jayanta; Margeta, Marta

2012-01-01

Some patients treated with chloroquine, hydroxychloroquine, or colchicine develop autophagic vacuolar myopathy, the diagnosis of which currently requires electron microscopy. The goal of the current study was to develop an immunohistochemical diagnostic marker for this pathologic entity. Microtubule-associated protein light chain 3 (LC3) has emerged as a robust marker of autophagosomes. LC3 binds p62/SQSTM1, an adapter protein that is selectively degraded via autophagy. In this study, we evaluated the utility of immunohistochemical stains for LC3 and p62 as diagnostic markers of drug-induced autophagic vacuolar myopathy. The staining was performed on archival muscle biopsy material, with subject assignment to normal control, drug-treated control, and autophagic myopathy groups based on history of drug use and morphologic criteria. In all drug-treated subjects, but not in normal controls, LC3 and p62 showed punctate staining characteristic of autophagosome buildup. In the autophagic myopathy subjects, puncta were coarser and tended to coalesce into linear structures aligned with the longitudinal axis of the fiber, often in the vicinity of vacuoles. The percentage of LC3- and p62-positive fibers was significantly higher in the autophagic myopathy group compared to either the normal control (p<0.001) or the drug-treated control group (p<0.05). With the diagnostic threshold set between 8% and 15% positive fibers (depending on the desired level of sensitivity and specificity), immunohistochemical staining for either LC3 or p62 could be used to identify subjects with autophagic vacuolar myopathy within the drug-treated subject group (p ≤ 0.001). Immunohistochemistry for LC3 and p62 can facilitate tissue-based diagnosis of drug-induced autophagic vacuolar myopathies. By limiting the need for electron microscopy (a time consuming and costly technique with high specificity, but low sensitivity), clinical use of these markers will improve the speed and accuracy of diagnosis, resulting in significantly improved clinical care.

Significance of White-Coat Hypertension in Older Persons With Isolated Systolic Hypertension

PubMed Central

Franklin, Stanley S.; Thijs, Lutgarde; Hansen, Tine W.; Li, Yan; Boggia, José; Kikuya, Masahiro; Björklund-Bodegård, Kristina; Ohkubo, Takayoshi; Jeppesen, Jørgen; Torp-Pedersen, Christian; Dolan, Eamon; Kuznetsova, Tatiana; Stolarz-Skrzypek, Katarzyna; Tikhonoff, Valérie; Malyutina, Sofia; Casiglia, Edoardo; Nikitin, Yuri; Lind, Lars; Sandoya, Edgardo; Kawecka-Jaszcz, Kalina; Imai, Yutaka; Wang, Jiguang; Ibsen, Hans; O’Brien, Eoin; Staessen, Jan A.

2013-01-01

The significance of white-coat hypertension in older persons with isolated systolic hypertension remains poorly understood. We analyzed subjects from the population-based 11-country International Database on Ambulatory Blood Pressure Monitoring in Relation to Cardiovascular Outcomes database who had daytime ambulatory blood pressure (BP; ABP) and conventional BP (CBP) measurements. After excluding persons with diastolic hypertension by CBP (≥90 mm Hg) or by daytime ABP (≥85 mm Hg), a history of cardiovascular disease, and persons <18 years of age, the present analysis totaled 7295 persons, of whom 1593 had isolated systolic hypertension. During a median follow-up of 10.6 years, there was a total of 655 fatal and nonfatal cardiovascular events. The analyses were stratified by treatment status. In untreated subjects, those with white-coat hypertension (CBP ≥140/<90 mm Hg and ABP <135/<85 mm Hg) and subjects with normal BP (CBP <140/<90 mm Hg and ABP <135/<85 mm Hg) were at similar risk (adjusted hazard rate: 1.17 [95% CI: 0.87–1.57]; P=0.29). Furthermore, in treated subjects with isolated systolic hypertension, the cardiovascular risk was similar in elevated conventional and normal daytime systolic BP as compared with those with normal conventional and normal daytime BPs (adjusted hazard rate: 1.10 [95% CI: 0.79–1.53]; P=0.57). However, both treated isolated systolic hypertension subjects with white-coat hypertension (adjusted hazard rate: 2.00; [95% CI: 1.43–2.79]; P<0.0001) and treated subjects with normal BP (adjusted hazard rate: 1.98 [95% CI: 1.49–2.62]; P<0.0001) were at higher risk as compared with untreated normotensive subjects. In conclusion, subjects with sustained hypertension who have their ABP normalized on antihypertensive therapy but with residual white-coat effect by CBP measurement have an entity that we have termed, “treated normalized hypertension.” Therefore, one should be cautious in applying the term “white-coat hypertension” to persons receiving antihypertensive treatment. PMID:22252396

Significance of white-coat hypertension in older persons with isolated systolic hypertension: a meta-analysis using the International Database on Ambulatory Blood Pressure Monitoring in Relation to Cardiovascular Outcomes population.

PubMed

Franklin, Stanley S; Thijs, Lutgarde; Hansen, Tine W; Li, Yan; Boggia, José; Kikuya, Masahiro; Björklund-Bodegård, Kristina; Ohkubo, Takayoshi; Jeppesen, Jørgen; Torp-Pedersen, Christian; Dolan, Eamon; Kuznetsova, Tatiana; Stolarz-Skrzypek, Katarzyna; Tikhonoff, Valérie; Malyutina, Sofia; Casiglia, Edoardo; Nikitin, Yuri; Lind, Lars; Sandoya, Edgardo; Kawecka-Jaszcz, Kalina; Imai, Yutaka; Wang, Jiguang; Ibsen, Hans; O'Brien, Eoin; Staessen, Jan A

2012-03-01

The significance of white-coat hypertension in older persons with isolated systolic hypertension remains poorly understood. We analyzed subjects from the population-based 11-country International Database on Ambulatory Blood Pressure Monitoring in Relation to Cardiovascular Outcomes database who had daytime ambulatory blood pressure (BP; ABP) and conventional BP (CBP) measurements. After excluding persons with diastolic hypertension by CBP (≥90 mm Hg) or by daytime ABP (≥85 mm Hg), a history of cardiovascular disease, and persons <18 years of age, the present analysis totaled 7295 persons, of whom 1593 had isolated systolic hypertension. During a median follow-up of 10.6 years, there was a total of 655 fatal and nonfatal cardiovascular events. The analyses were stratified by treatment status. In untreated subjects, those with white-coat hypertension (CBP ≥140/<90 mm Hg and ABP <135/<85 mm Hg) and subjects with normal BP (CBP <140/<90 mm Hg and ABP <135/<85 mm Hg) were at similar risk (adjusted hazard rate: 1.17 [95% CI: 0.87-1.57]; P=0.29). Furthermore, in treated subjects with isolated systolic hypertension, the cardiovascular risk was similar in elevated conventional and normal daytime systolic BP as compared with those with normal conventional and normal daytime BPs (adjusted hazard rate: 1.10 [95% CI: 0.79-1.53]; P=0.57). However, both treated isolated systolic hypertension subjects with white-coat hypertension (adjusted hazard rate: 2.00; [95% CI: 1.43-2.79]; P<0.0001) and treated subjects with normal BP (adjusted hazard rate: 1.98 [95% CI: 1.49-2.62]; P<0.0001) were at higher risk as compared with untreated normotensive subjects. In conclusion, subjects with sustained hypertension who have their ABP normalized on antihypertensive therapy but with residual white-coat effect by CBP measurement have an entity that we have termed, "treated normalized hypertension." Therefore, one should be cautious in applying the term "white-coat hypertension" to persons receiving antihypertensive treatment.

Long-acting injectable paliperidone palmitate versus oral paliperidone extended release: a comparative analysis from two placebo-controlled relapse prevention studies.

PubMed

Markowitz, Michael; Fu, Dong-Jing; Levitan, Bennett; Gopal, Srihari; Turkoz, Ibrahim; Alphs, Larry

2013-07-11

Increasing availability and use of long-acting injectable antipsychotics have generated a need to compare these formulations with their oral equivalents; however, a paucity of relevant data is available. This post hoc comparison of the long-term efficacy, safety and tolerability of maintenance treatment with paliperidone palmitate (PP) versus oral paliperidone extended release (ER) used data from two similarly designed, randomised, double-blind (DB), placebo-controlled schizophrenia relapse prevention trials. Assessments included measures of time to relapse, symptom changes/functioning and treatment-emergent adverse events (TEAEs). Time to relapse between treatment groups was evaluated using a Cox proportional hazards model. Between-group differences for continuous variables for change scores during the DB phase were assessed using analysis of co-variance models. Categorical variables were evaluated using Chi-square and Fisher's exact tests. No adjustment was made for multiplicity. Approximately 45% of enrolled subjects in both trials were stabilised and randomised to the DB relapse prevention phase. Risk of relapse was higher in subjects treated with paliperidone ER than in those treated with PP [paliperidone ER/PP hazard ratio (HR), 2.52; 95% confidence interval (CI), 1.46-4.35; p < 0.001]. Similarly, risk of relapse after withdrawal of paliperidone ER treatment (placebo group of the paliperidone ER study) was higher than after withdrawal of PP (paliperidone ER placebo/PP placebo HR, 2.25; 95% CI, 1.59-3.18; p < 0.001). Stabilised schizophrenic subjects treated with PP maintained functioning demonstrated by the same proportions of subjects with mild to no difficulties in functioning at DB baseline and end point [Personal and Social Performance (PSP) scale total score >70, both approximately 58.5%; p = 1.000] compared with a 10.9% decrease for paliperidone ER (58.5% vs 47.6%, respectively; p = 0.048). The least squares mean change for Positive and Negative Syndrome Scale (PANSS) total score at DB end point in these previously stabilised subjects was 3.5 points in favour of PP (6.0 vs 2.5; p = 0.025). The rates of TEAEs and AEs of interest appeared similar. This analysis supports maintenance of effect with the injectable compared with the oral formulation of paliperidone in patients with schizophrenia. The safety profile of PP was similar to that of paliperidone ER. Future studies are needed to confirm these findings.

Multicausal systems ask for multicausal approaches: A network perspective on subjective well-being in individuals with autism spectrum disorder.

PubMed

Deserno, Marie K; Borsboom, Denny; Begeer, Sander; Geurts, Hilde M

2017-11-01

Given the heterogeneity of autism spectrum disorder, an important limitation of much autism spectrum disorder research is that outcome measures are statistically modeled as separate dependent variables. Often, their multivariate structure is either ignored or treated as a nuisance. This study aims to lift this limitation by applying network analysis to explicate the multivariate pattern of risk and success factors for subjective well-being in autism spectrum disorder. We estimated a network structure for 27 potential factors in 2341 individuals with autism spectrum disorder to assess the centrality of specific life domains and their importance for well-being. The data included both self- and proxy-reported information. We identified social satisfaction and societal contribution as the strongest direct paths to subjective well-being. The results suggest that an important contribution to well-being lies in resources that allow the individual to engage in social relations, which influence well-being directly. Factors most important in determining the network's structure include self-reported IQ, living situation, level of daily activity, and happiness. Number of family members with autism spectrum disorder and openness about one's diagnosis are least important of all factors for subjective well-being. These types of results can serve as a roadmap for interventions directed at improving the well-being of individuals with autism spectrum disorder.

Long-term Clinical Results after Iloprost Treatment for Bone Marrow Edema and Avascular Necrosis

PubMed Central

Claßen, Tim; Becker, Antonia; Landgraeber, Stefan; Haversath, Marcel; Li, Xinning; Zilkens, Christoph; Krauspe, Rüdiger; Jäger, Marcus

2016-01-01

The treatments of avascular osteonecrosis (AVN) include both conservative and surgical methods which are dependent on the stage and progression of the disease. The vasoactive-prostaglandin-analogue iloprost (PGI2) has been utilized in several areas of medicine and recently has been used for the treatment of AVN. A total of 108 patients with 136 osteonecrosis of different joints, etiology and severity were treated with iloprost. The mean follow-up was 49.71 months: range 15-96 months, and outcome measurements recorded regarding subjective complaints, visual analog scale (pain), function and survival. The outcome scores used include the Harris Hip Score, Knee Society score, Foot and Ankle Survey, visual analogue scale (VAS) and a separate questionnaire. The location and etiology of AVN in our study demonstrated the typical pattern. All of the observed side effects of the therapy were minor and completely reversible. Most of patients (74.8%) showed a significant improvement of subjective complaints and decrease in VAS pain scores after the treatment with iloprost. However, 20% of the treated joints with the stadium Association for Research on Osseous Circulation (ARCO) grade 2, 71% with ARCO 3 and 100% with ARCO 4 underwent subsequent total joint replacement. The medical treatment of bone marrow edema or avascular osteonecrosis by Iloprost provides an safe and effective alternative strategy in the management of AVN presenting in the early stages (ARCO 1 or 2). For more advanced stages (ARCO 3 or 4), surgical intervention should be prioritized. PMID:27114807

Effect of Topical Steroids on Skin Prick Test: A Randomized Controlled Trial.

PubMed

Ebbesen, Anne R; Riis, Lene A; Gradman, Josefine

2018-05-04

Topically applied corticosteroids on the skin can significantly inhibit the wheal response to allergens in skin prick test (SPT). The duration of this effect is unknown. The aim of this study is to investigate the duration of the inhibitory effect of topical corticosteroids on SPT. Twenty-two healthy subjects were included in a single-blinded randomized study. All subjects were skin prick tested using a standard inhalant allergen panel. The subjects were randomized to treat either the left or right forearm with Betnovat ® cream (group III steroid) once a day for 10 days. Subsequently, the subjects were skin prick tested the following 5 days and at day 8 on both forearms. At baseline, the 22 individuals had positive SPT for a total of 72 allergens. Compared with the untreated arm, the mean size of the wheals was significantly reduced on day 1 (12 h after end of treatment) by 0.56 mm (95 % confidence interval (CI) [0.06; 1.06], p = 0.03) for allergens and 0.70 mm [0.32; 1.09] (p = 0.001) for histamine. On day 2 (36 h after end of treatment), the mean difference between treated and untreated arm was 0.47 mm [-0.08; 0.85] (p = 0.02) for allergen-induced wheals and 0.22 mm [-0.21; 0.64] (p = 0.31) for histamine-induced wheal. On day 3, 4, 5, and 8, there was no significant difference. Treatment with topical steroid significantly inhibited the response to SPT for 36 h but for less than 3 days. In addition, we demonstrated that topical applied corticosteroids inhibit the mean wheal size of the positive histamine control for a shorter time than for the allergens. Consequently, positive response to histamine control is not a valid marker for reliable skin prick test in steroid-treated patients. Plain language summary available for this article.

"That Hurts!": Humor and Sadomasochism in "Lolita."

ERIC Educational Resources Information Center

Bick, Ilsa J.

1994-01-01

States that humor is dependent on individual perspective, and that the subject matter of "Lolita" (1962), which concerns child abuse and molestation, is difficult to treat with humor. Argues that despite its subject, "Lolita" continues to be funny. Concludes that viewers know the subject matter is not funny, but while watching,…

Growth hormone favorably affects bone turnover and bone mineral density in patients with short bowel syndrome undergoing intestinal rehabilitation.

PubMed

Tangpricha, Vin; Luo, Menghua; Fernández-Estívariz, Concepción; Gu, Li H; Bazargan, Niloofar; Klapproth, Jan-Michael; Sitaraman, Shanthi V; Galloway, John R; Leader, Lorraine M; Ziegler, Thomas R

2006-01-01

Patients with short bowel syndrome (SBS) have a high prevalence of metabolic bone disease due to nutrient malabsorption and potential effects of parenteral nutrition (PN). Human growth hormone (hGH) has been shown in some studies to have anabolic effects on bone, but hGH effects on bone in patients with SBS are unknown. Adults with PN-dependent SBS underwent a 7-day period of baseline studies while receiving usual oral diet and PN and then began receiving modified diets designed to improve nutrient absorption and daily oral calcium/vitamin D supplements (1500 mg elemental calcium and 600 IU vitamin D, respectively). Subjects were randomized to receive in a double-blind manner either subcutaneous (sc) saline placebo as the control or hGH (0.1 mg/kg/d for 3 weeks, then 0.1 mg/kg 3 days a week for 8 subsequent weeks). Open-label hGH was given from week 13 to week 24 in subjects who required PN after completion of the 12-week double-blind phase. Markers of bone turnover (serum osteocalcin and urinary N-telopeptide [NTX]), vitamin D nutriture (serum calcium, 25-hydroxyvitamin D [25-OH D] and parathyroid hormone [PTH] concentrations), and intestinal calcium absorption were measured at baseline and at weeks 4 and 12. Dual x-ray absorptiometry (DXA) of the hip and spine was performed to determine bone mineral density (BMD) at baseline and weeks 12 and 24. The majority of subjects in each group exhibited evidence of vitamin D deficiency at baseline (25-OH D levels<30 ng/mL; 78% and 79% of control and hGH-treated subjects, respectively). Subjects treated with hGH demonstrated a significant increase from baseline in serum osteocalcin levels at 12 weeks (+62%; p<.05). The levels of NTX were increased over time in the hGH-treated group; however, this did not reach statistical significance. Both NTX and osteocalcin remained unchanged in control subjects. BMD of the spine and total hip was unchanged in subjects treated with placebo or hGH at 24 weeks. However, femoral neck BMD was slightly but significantly decreased in the placebo group at this time point but remained unchanged from baseline in the hGH-treated subjects. hGH therapy significantly increased markers of bone turnover during the initial 3 months of therapy and stabilized femoral neck bone mass over a 6-month period in patients with severe SBS undergoing intestinal rehabilitation.

Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change.

PubMed

Mankoski, Raymond; Stockton, Gwen; Manos, George; Marler, Sabrina; McQuade, Robert; Forbes, Robert A; Marcus, Ronald

2013-10-01

The purpose of this study was to evaluate the impact of prior antipsychotic exposure (PAE) on safety and tolerability outcomes in pediatric subjects receiving aripiprazole treatment. This study was a post-hoc analysis of pooled data from two 8-week, double-blind, randomized, placebo-controlled studies evaluating aripiprazole for the treatment of irritability in pediatric subjects with autistic disorder, aged 6-17 years. Subjects were stratified by PAE; adverse events (AEs), and changes in weight, and metabolic measures were evaluated. For subjects receiving aripiprazole, regardless of PAE, baseline weight, age, gender, and symptom severity were evaluated in a regression model predicting body weight change. Of 316 randomized subjects, 259 (82.0%) were antipsychotic naïve (AN) and 57 (18.0%) had a PAE. Aripiprazole-treated AN subjects were more likely than PAE subjects to report somnolence (11.9% vs. 2.8%), sedation (22.7% vs. 11.1%), or fatigue (17.0% vs. 13.9%). Rates of extrapyramidal disorder and drooling, but not akathisia or tremor, were marginally higher in AN subjects. Overall, 10.8% of aripiprazole-treated AN subjects had at least one AE leading to discontinuation compared with 8.3% of aripiprazole-treated PAE subjects. AN subjects receiving aripiprazole had a larger change in weight from baseline to endpoint compared with those receiving placebo (1.9 vs. 0.7 kg; treatment difference 1.2 kg, 95% CI: 0.5, 1.9) than PAE subjects receiving aripiprazole compared with subjects receiving placebo (0.4 vs. -0.4 kg; treatment difference 0.9 kg, 95% CI: -0.6, 2.4). Regression analysis identified that younger subjects with higher baseline weight z-score were at highest risk for weight gain. There were no significant changes in metabolic measures compared with placebo in either group. Weight gain was more pronounced in AN subjects and more likely to occur in younger subjects with a higher baseline weight z-score. AN subjects were more likely to experience AEs related to somnolence. However, based on discontinuations rates from AEs, overall tolerability was good for both AN and PAE groups. Study of aripiprazole in the treatment of children and adolescents with autistic disorder. Registry: www.clinicaltrials.gov . Identifiers: NCT00332241 and NCT00337571.

Pamidronate Disodium for Palliative Therapy of Feline Bone-Invasive Tumors

PubMed Central

Wypij, Jackie M.; Heller, David A.

2014-01-01

This study sought to quantify in vitro antiproliferative effects of pamidronate in feline cancer cells and assess feasibility of use of pamidronate in cats by assessing short-term toxicity and dosing schedule in cats with bone-invasive cancer. A retrospective pilot study included eight cats with bone invasive cancer treated with intravenous pamidronate. In vitro, pamidronate reduced proliferation in feline cancer cells (P < 0.05). One cat treated with pamidronate in combination with chemotherapy and two cats treated with pamidronate as a single agent after failing prior therapy had subjective clinically stable disease; median progression free interval in these cats from initial pamidronate treatment was 81 days. Three cats developed azotemia while undergoing various treatment modalities including nonsteroidal anti-inflammatory drugs and pamidronate. Median overall survival was 116.5 days for all cats and 170 days for cats with oral squamous cell carcinoma. Median progression free survival was 55 days for all cats and 71 days for cats with oral squamous cell carcinoma. Pamidronate therapy appears feasible for administration in cancer bearing cats with aggressive bone lesions in the dose range of 1-2 mg/kg every 21–28 days for multiple treatments. No acute or short-term toxicity was directly attributable to pamidronate. PMID:25013741

Effect of vitamin D and inhaled corticosteroid treatment on lung function in children.

PubMed

Wu, Ann Chen; Tantisira, Kelan; Li, Lingling; Fuhlbrigge, Anne L; Weiss, Scott T; Litonjua, Augusto

2012-09-15

Low vitamin D levels are associated with asthma and decreased airway responsiveness. Treatment with inhaled corticosteroids improves airway responsiveness and asthma control. To assess the effect of vitamin D levels on prebronchodilator FEV(1), bronchodilator response, and responsiveness to methacholine (PC(20), provocative concentration of methacholine producing a 20% decline in FEV(1)) in patients with asthma treated with inhaled corticosteroids. We measured 25-hydroxyvitamin D levels in the serum of children with persistent asthma at the time of enrollment in the Childhood Asthma Management Program. We divided subjects into the vitamin D sufficiency (>30 ng/ml), insufficiency (20-30 ng/ml), and deficiency (<20 ng/ml) groups. Covariates included age, treatment, sex, body mass index, race, history of emergency department visits, hospitalizations, and season that vitamin D specimen was drawn. Our main outcome measures were change in prebronchodilator FEV(1), bronchodilator response, and PC(20) from enrollment to 8-12 months. Of the 1,024 subjects, 663 (65%) were vitamin D sufficient, 260 (25%) were insufficient, and 101 (10%) were deficient. Vitamin D-deficient subjects were more likely to be older, African American, and have a higher body mass index compared with the vitamin D-sufficient and insufficient subjects. In the inhaled corticosteroid treatment group, prebronchodilator FEV(1) increased from randomization to 12 months by 140 ml in the vitamin D-deficient group and prebronchodilator FEV(1) increased by 330 ml in the vitamin D insufficiency group and by 290 ml in the vitamin D sufficiency group (P = 0.0072), in adjusted models. In children with asthma treated with inhaled corticosteroids, vitamin D deficiency is associated with poorer lung function than in children with vitamin D insufficiency or sufficiency.

Treatment of FBSS Low Back Pain with a Novel Percutaneous DRG Wireless Stimulator: Pilot and Feasibility Study.

PubMed

Weiner, Richard L; Yeung, Anthony; Montes Garcia, Carlos; Tyler Perryman, Laura; Speck, Benjamin

2016-10-01

Test a miniaturized neurostimulator transforaminally placed at the dorsal root ganglion (DRG) and evaluate the device's safety and efficacy in treating failed back surgery syndrome (FBSS) low back pain. Pilot, two-phase study. Eleven subjects with chronic intractable neuropathic trunk and/or lower limbs pain were included. The system consisted of an implantable, miniaturized stimulator, provided by Stimwave Technologies (Freedom-4) and an external transmitter. Only one stimulator per subject was implanted unilaterally and transforaminally at L1 to L5 levels. During Phase 1 of the study, the stimulators were not anchored. In Phase 2, the stimulators were anchored. Subjects were treated during 45 days after which the stimulator was removed. Pain reduction, implant duration, and stimulator migration were registered. Overall pain reduction was 59.9%, with only one device placed at one location, covering only a portion of the painful areas in the majority of the subjects. In Phase 1, the non-anchored stimulators migrated a mean of 8.80 mm and in Phase 2 a mean of 1.83 mm. Stimulator migration did not correlate with changes in pain relief. Mean time-to-implant duration was 10 minutes and no adverse events were reported during implant, follow-up period, or after explant. The pain reduction results indicate that the Freedom-4 spinal cord stimulation (SCS) Wireless System is a viable treatment of low back pain through stimulation of the DRG, and better overall pain reduction may be achieved by implanting multiple devices. With short percutaneous implant times and excellent safety profile, this new system may offer health cost savings. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Effects of valerian on subjective sedation, field sobriety testing and driving simulator performance.

PubMed

Thomas, Kelan; Canedo, Joanne; Perry, Paul J; Doroudgar, Shadi; Lopes, Ingrid; Chuang, Hannah Mae; Bohnert, Kimberly

2016-07-01

The availability of herbal medicines over-the-counter (OTC) has increased the use of natural products for self-treatment. Valerian has been used to effectively treat generalized anxiety disorder and insomnia. Studies suggest that valerenic acid may increase gamma-aminobutyric acid (GABA) modulation in the brain. Benzodiazepines have a similar mechanism of action and have been linked to an increased risk of hospitalizations due to traffic accidents. Despite the risk of somnolence, the safety of driving while under the influence of valerian remains unknown. The purpose of the study was to determine the effects of a one-time valerian 1600mg dose on subjective sedation effects, standardized field sobriety testing (SFST) and driving simulator performance parameters. The study design was a randomized, placebo-controlled, double-blind, cross-over trial. For each session, participants received either a dose of valerian or placebo. The outcome measures included a simple visual reaction test (SVRT), subjective sleepiness scales, SFST performance scores, and driving simulator performance parameters. There were no significant differences in the SVRT or sleepiness scales between placebo and valerian exposures, but the study may have been underpowered. SFST total and individual test failure rates were not significantly different between the two exposures. The driving simulator performance parameters were equivalent between the two exposure conditions. A one-time valerian 1600mg dose, often used to treat insomnia, does not appear to impair driving simulator performance after acute ingestion. Copyright © 2016 Elsevier Ltd. All rights reserved.

Postnatal treatment factors affecting craniofacial morphology of unilateral cleft lip and palate (UCLP) patients in a Japanese population.

PubMed

Alam, M K; Iida, J; Sato, Y; Kajii, Takashi S

2013-12-01

We have evaluated the craniofacial morphology of Japanese patients with unilateral cleft lip and palate (UCLP) and assessed the various postnatal factors that affect it. Lateral cephalograms of 140 subjects (mean (SD) aged 7 (2) years) with UCLP were taken before orthodontic treatment. Surgeons from Hokkaido University Hospital had done the primary operations. The craniofacial morphology was assessed by angular and linear cephalometric measurements. Cheiloplasty, palatoplasty, and preoperative orthopaedic treatment were chosen as postnatal factors. To compare the assessments of the postnatal factors, we made angular and linear cephalometric measurements for each subject and converted them into Z scores in relation to the mean (SD) of the two variables. Subjects treated by the modified Millard cheiloplasty had larger sella-nasion-point A (SNA) and nasion-point A-pogonion (NA-POG) measurements than subjects treated by the modified Millard with a vomer flap cheiloplasty. Two-stage palatoplasty showed consistently better craniofacial morphology than the other palatoplasty. Subjects who had preoperative orthopaedic treatment with a Hotz plate had significantly larger upper incisor/sella-nasion (U1-SN) measurements than who had no preoperative orthopaedic treatment or an active plate. We conclude that in subjects treated by a modified Millard type of cheiloplasty, a two-stage palatoplasty, and a Hotz plate there were fewer adverse effects on craniofacial morphology. Copyright © 2012 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Effect of two-step and one-step surface conditioning of glass ceramic on adhesion strength of orthodontic bracket and effect of thermo-cycling on adhesion strength.

PubMed

Asiry, Moshabab A; AlShahrani, Ibrahim; Alaqeel, Samer M; Durgesh, Bangalore H; Ramakrishnaiah, Ravikumar

2018-08-01

The adhesion strength of orthodontic brackets bonded to dental glass ceramics was evaluated after ceramic surface was treated with two-step and one-step surface conditioning systems, and subjecting to thermo-cycling. A total of forty specimens were fabricated from silica based glass ceramic (lithium disilicate) by duplicating the buccal surface of maxillary first premolar. The specimens were randomly assigned to two experimental groups (n = 20), group one specimens were treated with two-step surface conditioning system (IPS ceramic etching gel™ and Monobond plus™) and group two specimens were treated with one-step surface conditioning system (Monobond etch and prime™). The surface roughness of the specimens after treatment with two-step and one-step surface conditioning system was measured using non-contact surface profilometer. Ten randomly selected specimens from each group were subjected to thermo-cycling and the remaining ten served as baseline. The shear bond strength of the specimens was measured using universal material testing machine. The adhesive remnant index score was calculated, and the results of surface roughness and bond strength were tabulated and subjected to analysis of variance and post hoc tukey's test at a significance level of p < 0.05. The results of the study showed that the specimens treated with two-step conditioning system had higher surface roughness and bond strength than one-step conditioning system. The majority of the specimens treated with both two-step and one-step conditioned specimens showed adhesive failure after subjecting thermo-cycling. Traditional two-step conditioning provides better bond strength. The clinical importance of the study is that, the silane promoted adhesion significantly reduces on exposure to thermo-cycling. Copyright © 2018 Elsevier Ltd. All rights reserved.

A comparison of the effect of convection against diffusion in hemodynamics and cytokines clearance in an experimental model of septic shock.

PubMed

Herrera-Gutiérrez, Manuel E; Seller-Pérez, Gemma; Arias-Verdú, Dolores; Granados, Maria M; Dominguez, Juan M; Navarrete, Rocío; Morgaz, Juán; Gómez-Villamandos, Rafael

2012-10-01

Replacement therapies based on the use of convection have value for the removal of inflammatory mediators. Such therapies have been proposed for the management of septic shock, but diffusion has not proved useful in this scenario, unless high-flow membranes are used. The exact role of diffusion in these cases remains to be clarified because continuous replacement therapies are usually delivered with low-flow membranes and mixed convection-diffusion modalities. However, studies specifically addressing this problem have not been performed. Our aim was to define the efficacy of hemofiltration (convection) and hemodialysis (diffusion) in cytokine clearance and hemodynamic improvement in an experimental model of septic shock. Shock was induced in 15 beagle dogs (weight 10-15 kg) by infusion of 1 mg/kg of ultrapure Escherichia coli lipopolysaccharide diluted in 20 mL saline for 10 minutes. Five animals were followed without interventions (controls), five animals were treated with convection (100 mL kg h) for 6 hours, and five animals were treated with diffusion (100 mL kg h) for 6 hours. All subjects in the control group died during the study, whereas all treated subjects survived. Mean arterial pressure, cardiac output, systolic variability volume, systemic vascular resistances, dPMax, and pulmonary compliance improved in treated subjects. However, the differences in mean arterial pressure and cardiac output were significant only in the convection group and not in the diffusion-treated group.Tumor necrosis factor α rose equally in all groups and decreased only in treated subjects. Interleukin 6 rose in the three groups but decreased only in the convection group and remained unchanged in the control and diffusion groups. Convection and diffusion improved survival and hemodynamic parameters in a septic shock model. Improvement was more pronounced with convection, a difference that may be explained by convective clearance of cytokines.

Prescriptions of Chinese herbal medicine for constipation under the national health insurance in Taiwan.

PubMed

Jong, Maw-Shiou; Hwang, Shinn-Jang; Chen, Yu-Chun; Chen, Tzeng-Ji; Chen, Fun-Jou; Chen, Fang-Pey

2010-07-01

Constipation is a common gastrointestinal problem worldwide. The aim of this study was to determine the frequency of use and prescriptive patterns of Chinese herbal medicine (CHM) in treating constipation by analyzing the claims data of traditional Chinese medicine (TCM) from the National Health Insurance (NHI) in Taiwan. The computerized claims dataset of the TCM office visits and the corresponding prescription files in 2004 compiled by the NHI Research Institute in Taiwan were linked and processed. Visit files with the single diagnostic coding of constipation (ICD-9-CM code 564.0) were extracted to analyze the frequency and pattern of corresponding CHM prescriptions. The association rule was applied to analyze the co-prescription of CHM in treating constipation. There were 152,564 subjects who visited TCM clinics only for constipation in Taiwan during 2004 and received a total of 387,268 CHM prescriptions. Subjects between 20 and 29 years of age comprised the largest number of those treated (25.5%). Female subjects used CHM for constipation more frequently than male subjects (female:male = 3.31:1). There was an average of 4.6 items of single Chinese herbs or formula in a single prescription for constipation. Ma-zi-renwan was the most commonly prescribed herbal formula, while Da-huang (Rheum palmatum) was the most commonly used single Chinese herb. According to the association rule, the most common prescribed pattern of 2-drug combination of CHM for treating constipation was Ban-xia-xie-xin-tang plus Ma-zi-ren-wan, while the 3-drug combination of CHM was Fang-feng-tong-sheng-san, Rheum palmatum and Ma-zi-ren-wan. This study showed the pattern of single Chinese herbs or herbal formulae used in treating constipation in Taiwan. Further clinical trials are needed to evaluate the efficacy and safety of these CHMs in treating constipation. 2010 Elsevier. Published by Elsevier B.V. All rights reserved.

Postnatal width changes in the internal structures of the human mandible: a longitudinal three-dimensional cephalometric study using implants.

PubMed

Baumrind, S; Korn, E L

1992-12-01

This paper presents case-specific quantitative evidence of the systematic lateral displacement of metallic implants in the mandibles of treated and untreated human subjects between the ages of 8.5 and 15.5 years. This evidence appears to be consistent with the inference of small, but systematic increases in distance between the internal structures of the two sides of the osseous mandible during growth. Such a conclusion, however, is inconsistent with traditional beliefs that the internal structures of the mandibular symphysis fuse at the midline during the first post-natal year and remain dimensionally constant thereafter. We recently published evidence of statistically significant transverse displacement of metallic implants in the mandibular body region for 12 of 28 subjects for whom longitudinal data were available. Of the twelve subjects for whom statistically significant changes were observed, widening occurred in eleven cases and narrowing in one. Matching data are now available on concurrent ramus changes for 22 of the same 28 subjects, including 11 of the 12 for whom statistically significant width changes had previously been noted in the body region. In eight of these 11 subjects, statistically significant widening in the ramus region was also observed. No subject had statistically significant widening in the ramus region without also having statistically significant widening in the body region. No subject had statistically significant trans-ramus narrowing.

Effectiveness and tolerability of parenteral testosterone undecanoate: a post-marketing surveillance study.

PubMed

Wolf, Jan; Keipert, Dieter; Motazedi, Heiko; Ernst, Michael; Nettleship, Joanne; Gooren, Louis

2017-12-01

This observational post-marketing study of parenteral testosterone undecanoate (TU) in a non-selected population aimed to: examine the effectiveness of TU as treatment of hypogonadism; record adverse drug reactions (ADR) quantitatively particularly regarding polycythemia, prostate safety and cardiovascular-related metabolic risk factors; and verify whether recommended injection intervals apply to routine clinical practice. Eight hundred and seventy subjects from 259 outpatient units scheduled to visit the clinic six times were included. Effectiveness and tolerability of TU administration were assessed on a 4-point scale. Body weight, waist girth, blood pressure, hemoglobin levels, hematocrit, prostate-specific antigen (PSA), and digital rectal prostate examination were assessed. Over 90% of subjects completed the observational duration of 52.8 ± 9.7 weeks (mean ± SD) and 56% judged effectiveness as very good, 30.8% as good. 63.1% judged tolerability as very good, and 24.4% as good. No adverse effects on indicators of cardiovascular risk were observed. Polycythemia occurred in one subject and a supranormal hematocrit in one subject. Four subjects developed supranormal PSA levels. Prostate carcinoma was found in one subject, one subject had recurrence of a previously surgically treated prostate carcinoma, and the other two showed no indication of malignancy. Parenteral TU is safe, effective, and well-tolerated in clinical practice proving a good therapeutic option for hypogonadism.

Effects of repetitive photodynamic therapy using indocyanine green for acne vulgaris.

PubMed

Seo, Hyun-Min; Min, Hyung-Geun; Kim, Hee-Joong; Shin, Jong-Hun; Nam, Sang-Ho; Han, Kwang-Soo; Ryu, Joung-Ho; Oh, Jeong-Joon; Kim, Ji Young; Lee, Kwang-Joon; Lee, Seung Jae; Kim, Han-Saem; Kim, Jung-In; Song, Min-Kyu; Kim, Won-Serk

2016-10-01

Indocyanine green (ICG) is a photosensitizer recently introduced for the treatment of acne. To evaluate the efficacy and safety of photodynamic therapy (PDT) using ICG in subjects with acne vulgaris and to evaluate whether there was a difference in the efficacy of ICG-PDT between different numbers of treatment. Subjects with acne on the face were included. ICG lotion (0.1%) was applied for 30 minutes, and a long pulse diode laser was used. Three or five treatments per subject were performed over 2 weeks. Acne lesion counts and Leeds revised acne grades were evaluated at baseline and 2 weeks after the last treatment. In total, 47 subjects completed the study. After both three and five ICG-PDT sessions, a significant reduction in acne lesions and significant improvement in Leeds revised acne grades were found in all treated subjects compared to baseline. In the subjects receiving five ICG-PDT sessions, the reduction of papules/pustules was greater than in the subjects receiving three ICG-PDT sessions (P < 0.01, respectively). However, there was no significant change in the count of nodules/cysts, although it is a negative trend (P = 0.066). Adverse effects were minimal. ICG-PDT using long-pulsed diode laser can be a safe and effective tool for acne vulgaris. Moreover, repetitive treatments of five can cause further improvement of inflammatory acne lesions. © 2016 The International Society of Dermatology.

Unilateral deafness after acoustic neuroma surgery: subjective hearing handicap and the effect of the bone-anchored hearing aid.

PubMed

Andersen, Henrik Terkel; Schrøder, Stine Attrup; Bonding, Per

2006-09-01

To evaluate the subjective hearing handicap in patients with unilateral deafness after acoustic neuroma surgery and the effect of the Bone-anchored Hearing Aid (BAHA) on test band. Fifty-nine consecutive patients with unilateral deafness after translabyrintine removal of an acoustic neuroma, treated in Denmark in 2001 and 2002, were included. The patients were asked to complete a questionnaire, which addressed the subjective handicap of unilateral deafness; 90% responded. These patients were invited to test the BAHA on test band, and the subjective and objective effects were recorded. Eighty percent of the patients thought that they had a subjective hearing handicap of some significance. However, only 50% accepted the invitation to test the BAHA. The overall subjective effect was positive, and a significant improvement in speech discrimination in noise with the BAHA was demonstrated. After the test, however, only about 50%, that is, 25% of all patients wished implantation for BAHA treatment. This study shows that unilateral deafness after acoustic neuroma surgery is thought as a handicap in most of the patients and confirms that treatment with the BAHA has positive subjective effects and improves speech discrimination in noise. However, only 25% of the patients wished implantation for BAHA treatment. The implications of these findings are discussed. Data from centers that perform simultaneous acoustic neuroma surgery and implantation for BAHA are necessary for firm conclusions.

Clearance of yellow tattoo ink with a novel 532-nm picosecond laser.

PubMed

Alabdulrazzaq, Hamad; Brauer, Jeremy A; Bae, Yoon-Soo; Geronemus, Roy G

2015-04-01

Although technology and tattoo removal methods continue to evolve, yellow pigment clearance continues to be challenging and usually unsuccessful. We describe a case series of six tattoos containing yellow ink, successfully treated with a frequency-doubled Nd:YAG 532-nm picosecond laser. Case series with six subjects participating for the treatment of multicolored tattoos that contain yellow pigment. Treatments performed with a frequency-doubled Nd:YAG 532-nm picosecond laser at 6-8 week intervals. One subject achieved complete clearance of the treated site after one session, and five subjects required 2-4 treatments to achieve over 75% clearance. Minimal downtime was experienced, and no scarring or textural skin changes were observed in any of the treated sites. This is the first case series that demonstrates effective and consistent reduction of yellow tattoo ink using a frequency doubled Nd:YAG 532-nm laser with a picosecond pulse duration. Treatments were well tolerated and subjects had positive outcomes. This is a small observational case series from an ongoing clinical trial, and studies with a larger sample size and comparative group are needed in the future. © 2015 Wiley Periodicals, Inc.

Biofeedback treatment of constipation: a critical review.

PubMed

Heymen, Steve; Jones, Kenneth R; Scarlett, Yolanda; Whitehead, William E

2003-09-01

This review was designed to 1) critically examine the research design used in investigations of biofeedback for pelvic floor dyssynergia, 2) compare the various biofeedback treatment protocols for pelvic floor dyssynergia-type constipation used in this research, 3) identify factors that influence treatment outcome, and 4) identify goals for future biofeedback research for pelvic floor dyssynergia. A comprehensive review of both the pediatric and adult research from 1970 to 2002 on "biofeedback for constipation" was conducted using a Medline search in all languages. Only prospective studies including five or more subjects that described the treatment protocol were included. In addition, a meta-analysis of these studies was performed to compare the outcome of different biofeedback protocols for treating constipation. Thirty-eight studies were reviewed, and sample size, treatment protocol, outcome rates, number of sessions, and etiology are shown in a table. Ten studies using a parallel treatment design were reviewed in detail, including seven that randomized subjects to treatment groups. A meta-analysis (weighted by subjects) was performed to compare the results of two treatment protocols prevalent in the literature. The mean success rate of studies using pressure biofeedback (78 percent) was superior (P = 0.018) to the mean success rate for studies using electromyography biofeedback (70 percent). However, the mean success rates comparing studies using intra-anal electromyography sensors to studies using perianal electromyography sensors were 69 and 72 percent, respectively, indicating no advantages for one type of electromyography protocol over the other (P = 0.428). In addition to the varied protocols and instrumentation used, there also are inconsistencies in the literature regarding the severity and etiology of symptoms, patient selection criteria, and the definition of a successful outcome. Finally, no anatomic, physiologic, or demographic variables were identified that would assist in predicting successful outcome. Having significant psychological symptoms was identified as a factor that may influence treatment outcome, but this requires further study. Although most studies report positive results using biofeedback to treat constipation, quality research is lacking. Specific recommendations are made for future investigations to 1) improve experimental design, 2) clearly define outcome measures, 3) identify the etiology and severity of symptoms, 4) determine which treatment protocol and which component of treatment is most effective for different types of subjects, 5) systematically explore the role of psychopathology in this population, 6) use an adequate sample size that allows for meaningful analysis, and 7) include long-term follow-up data.

Supervised exercise training counterbalances the adverse effects of insulin therapy in overweight/obese subjects with type 2 diabetes.

PubMed

Balducci, Stefano; Zanuso, Silvano; Cardelli, Patrizia; Salerno, Gerardo; Fallucca, Sara; Nicolucci, Antonio; Pugliese, Giuseppe

2012-01-01

To examine the effect of supervised exercise on traditional and nontraditional cardiovascular risk factors in sedentary, overweight/obese insulin-treated subjects with type 2 diabetes from the Italian Diabetes Exercise Study (IDES). The study randomized 73 insulin-treated patients to twice weekly supervised aerobic and resistance training plus structured exercise counseling (EXE) or to counseling alone (CON) for 12 months. Clinical and laboratory parameters were assessed at baseline and at the end of the study. The volume of physical activity was significantly higher in the EXE versus the CON group. Values for hemoglobin A(1c), BMI, waist circumference, high-sensitivity C-reactive protein, blood pressure, LDL cholesterol, and the coronary heart disease risk score were significantly reduced only in the EXE group. No major adverse events were observed. In insulin-treated subjects with type 2 diabetes, supervised exercise is safe and effective in improving glycemic control and markers of adiposity and inflammation, thus counterbalancing the adverse effects of insulin on these parameters.

Anticancer therapy

DOEpatents

Norenberg, Jeffrey P.

2017-04-04

A subject afflicted with a cancer or precancerous condition is treated by administering an agent that increases expression of somatostatin receptors, and a cytotoxic recognition ligand. In an alternative embodiment, somatostatin analogs, which are radiolabeled are used to treat cancer or precancerous conditions.

Loperamide plus azithromycin more effectively treats travelers' diarrhea in Mexico than azithromycin alone.

PubMed

Ericsson, Charles D; DuPont, Herbert L; Okhuysen, Pablo C; Jiang, Zhi-Dong; DuPont, Margaret W

2007-01-01

Because the combination of loperamide and some antimicrobials has proven to be more efficacious than the antimicrobial agent alone in the treatment of travelers' diarrhea, we set out to prove loperamide plus azithromycin was more efficacious than azithromycin alone. During the summers of 2002 to 2003, 176 US adults recently arrived in Guadalajara, Mexico were enrolled in a prospective, double-blinded, randomized trial of the treatment of acute diarrhea. Subjects received single doses (1,000 or 500 mg) of azithromycin or a single 500 mg dose of azithromycin plus loperamide. Subjects gave a pre- and post-treatment stool sample for analysis and maintained daily diaries of symptoms and passage of stools. The duration of diarrhea was significantly (p=0.0002) shorter following treatment with azithromycin plus loperamide (11 h) than with either dose of azithromycin alone (34 h). In the first 24 hours, the average number of unformed stools passed was 3.4 (azithromycin alone) and 1.2 (combination) for a significant (p<0.0001) difference of 2.2 unformed stools. This difference equated with 20% of azithromycin-treated subjects continuing to pass six or more unformed stools in the first 24 hours post-treatment compared with only 1.7% of combination-treated subjects. For the treatment of travelers' diarrhea in an Escherichia coli predominant region of the world, a single 500 mg dose of azithromycin appeared as effective as a 1,000 mg dose. Loperamide plus 500 mg of azithromycin was safe and more effective than either dose of azithromycin. To realize the substantial clinical benefit that accrues to a subset of subjects, we feel loperamide should routinely be used in combination with an antimicrobial agent to treat travelers' diarrhea.

Tolerance to Chronic Delta-9-Tetrahydrocannabinol (Δ9-THC) in Rhesus Macaques Infected With Simian Immunodeficiency Virus

PubMed Central

Winsauer, Peter J.; Molina, Patricia E.; Amedee, Angela M.; Filipeanu, Catalin M.; McGoey, Robin R.; Troxclair, Dana A.; Walker, Edith M.; Birke, Leslie L.; Stouwe, Curtis Vande; Howard, Jessica M.; Leonard, Stuart T.; Moerschbaecher, Joseph M.; Lewis, Peter B.

2011-01-01

Although Δ9-THC has been approved to treat anorexia and weight loss associated with AIDS, it may also reduce well-being by disrupting complex behavioral processes or enhancing HIV replication. To investigate these possibilities, four groups of male rhesus macaques were trained to respond under an operant acquisition and performance procedure, and administered vehicle or Δ9-THC before and after inoculation with simian immunodeficiency virus(SIVmac251, 100 TCID50/ml, i.v.). Prior to chronic Δ9-THC and SIV inoculation, 0.032– 0.32 mg/kg of Δ9-THC produced dose-dependent rate-decreasing effects and small, sporadic error-increasing effects in the acquisition and performance components in each subject. Following 28 days of chronic Δ9-THC (0.32 mg/kg, i.m.) or vehicle twice daily, delta-9-THC-treated subjects developed tolerance to the rate-decreasing effects, and this tolerance was maintained during the initial 7–12 months irrespective of SIV infection (i.e., +THC/−SIV, +THC/+SIV). Full necropsy was performed on all SIV subjects an average of 329 days post-SIV inoculation, with postmortem histopathology suggestive of a reduced frequency of CNS pathology as well as opportunistic infections in delta-9-THC-treated subjects. Chronic Δ9-THC also significantly reduced CB-1 and CB-2 receptor levels in the hippocampus, attenuated the expression of a proinflammatory cytokine (MCP-1), and did not increase viral load in plasma, cerebrospinal fluid, or brain tissue compared to vehicle-treated subjects with SIV. Together, these data indicate that chronic Δ9-THC produces tolerance to its behaviorally disruptive effects on complex tasks while not adversely affecting viral load or other markers of disease progression during the early stages of infection. PMID:21463073

Metabolic effects of human growth hormone in corticosteroid-treated children

PubMed Central

Morris, Helen G.; Jorgensen, Jacqueline R.; Elrick, Harold; Goldsmith, Richard E.

1968-01-01

The effects of administered human growth hormone (HGH) were evaluated in dwarfed, prepubertal children who were receiving long-term corticosteroid therapy for a chronic disease. During 11 complete metabolic balance studies, the eight corticosteroid-treated children demonstrated impaired response to large doses of HGH with minimal nitrogen and no phosphorus retention. In contrast, two hypopituitary subjects and two asthmatic children not receiving corticosteroid responded to the same preparations of HGH with nitrogen, potassium, and phosphorus retention. Six corticosteroid-treated children were given large doses of HGH (40-120 mg/wk for 4 to 8 months and showed no improvement in their retarded rate of growth, whereas the hypopituitary subjects showed accelerated growth during administration of 10-15 mg of HGH/wk. It is concluded that dwarfism in steroid-treated children results from corticosteroid-induced antagonism of the effects of HGH at the peripheral tissue level. PMID:5637134

Method For Creating Corrosion Resistant Surface On An Aluminum Copper Alloy

DOEpatents

Mansfeld, Florian B.; Wang, You; Lin, Simon H.

1997-06-03

A method for treating the surface of aluminum alloys hang a relatively high copper content is provided which includes the steps of removing substantially all of the copper from the surface, contacting the surface with a first solution containing cerium, electrically charging the surface while contacting the surface in an aqueous molybdate solution, and contacting the surface with a second solution containing cerium. The copper is substantially removed from the surface in the first step either by (i) contacting the surface with an acidic chromate solution or by (ii) contacting the surface with an acidic nitrate solution while subjecting the surface to an electric potential. The corrosion-resistant surface resulting from the invention is excellent, consistent and uniform throughout the surface. Surfaces treated by the invention may often be certified for use in salt-water services.

Efficacy and Safety of Secukinumab in Elderly Subjects with Moderate to Severe Plaque Psoriasis: A Pooled Analysis of Phase III Studies.

PubMed

Körber, Andreas; Papavassilis, Charis; Bhosekar, Vaishali; Reinhardt, Maximilian

2018-02-01

Psoriasis is a chronic inflammatory skin disease, affecting patients of a wide age range, including elderly patients. Elderly patients can respond differently to drug treatments and can be more vulnerable to adverse reactions. There are limited data on biologic therapies for psoriasis in elderly subjects. Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has proven significant efficacy in the treatment of moderate to severe psoriasis. A post-hoc analysis of three phase III trials (ERASURE, FIXTURE and CLEAR) was performed to evaluate the efficacy and safety of secukinumab in elderly subjects. Studies were multicentre, randomized, parallel-group, double-blind, 52-week phase III trials in subjects with moderate to severe plaque psoriasis. For efficacy analyses, 67 elderly subjects (≥ 65 years) treated with secukinumab 300 mg were compared with 841 younger subjects (18-64 years). Psoriasis Area and Severity Index (PASI), Dermatological Life Quality Index (DLQI) and safety were analysed. Elderly subjects had higher baseline frequencies of cardiovascular and metabolic disorders. Secukinumab efficacy in elderly subjects was comparable to that in younger subjects throughout 52 weeks of treatment. PASI 75 response was reached by 81.8% of elderly subjects and 79.4% of younger subjects at Week 52. Similar rates of DLQI 0/1 response were observed. The total rate of adverse events was similar between elderly and younger subjects. Secukinumab at the recommended dose (300 mg) is effective and acceptably safe in subjects aged ≥ 65 years with moderate to severe psoriasis, with quality-of-life benefits, despite an increased prevalence of cardiovascular and metabolic comorbidities in this population.

Sexual dysfunction in subjects treated with inhibitors of 5α-reductase for benign prostatic hyperplasia: a comprehensive review and meta-analysis.

PubMed

Corona, G; Tirabassi, G; Santi, D; Maseroli, E; Gacci, M; Dicuio, M; Sforza, A; Mannucci, E; Maggi, M

2017-07-01

Despite their efficacy in the treatment of benign prostatic hyperplasia, the popularity of inhibitors of 5α-reductase (5ARIs) is limited by their association with adverse sexual side effects. The aim of this study was to review and meta-analyze currently available randomized clinical trials evaluating the rate of sexual side effects in men treated with 5ARIs. An extensive Medline Embase and Cochrane search was performed including the following words: 'finasteride', 'dutasteride', 'benign prostatic hyperplasia'. Only placebo-controlled randomized clinical trials evaluating the effect of 5ARI in subjects with benign prostatic hyperplasia were considered. Of 383 retrieved articles, 17 were included in this study. Randomized clinical trials enrolled 24,463 in the active and 22,270 patients in the placebo arms, respectively, with a mean follow-up of 99 weeks and mean age of 64.0 years. No difference was observed between trials using finasteride or dutasteride as the active arm considering age, trial duration, prostate volume or International Prostatic Symptoms Score at enrollment. Overall, 5ARIs determined an increased risk of hypoactive sexual desire [OR = 1.54 (1.29; 1.82); p < 0.0001] and erectile dysfunction [OR = 1.47 (1.29; 1.68); p < 0.0001]. No difference between finasteride and dutasteride regarding the risk of hypoactive sexual desire and erectile dysfunction was observed. Meta-regression analysis showed that the risk of hypoactive sexual desire and erectile dysfunction was higher in subjects with lower Q max at enrollment and decreased as a function of trial follow-up. Conversely, no effect of age, low urinary tract symptom or prostate volume at enrollment as well as Q max at end-point was observed. In conclusion, present data show that the use of 5ARI significantly increases the risk of erectile dysfunction and hypoactive sexual desire in subjects with benign prostatic hyperplasia. Patients should be adequately informed before 5ARIs are prescribed. © 2017 American Society of Andrology and European Academy of Andrology.

Differential effects of sulindac and indomethacin on blood pressure in treated essential hypertensive subjects.

PubMed

Puddey, I B; Beilin, L J; Vandongen, R; Banks, R; Rouse, I

1985-09-01

Attenuation of the effectiveness of antihypertensive therapy by non-steroidal anti-inflammatory (NSAI) drugs has been attributed to inhibition of systemic or renal vasodilator prostaglandin synthesis, or a combination of both. Indomethacin is a NSAI drug with both renal and extrarenal cyclo-oxygenase inhibition properties. Sulindac is a relatively selective cyclo-oxygenase inhibitor said not to affect urinary prostaglandin excretion. This study examines the relative effect on blood pressure of 4 weeks' treatment, with indomethacin 25 mg three times daily and sulindac 200 mg twice daily, in a randomized placebo controlled trial in 26 hypertensive subjects. In nine patients treated with indomethacin, supine blood pressure rose 11 mmHg systolic and 4 mmHg diastolic by the end of the first week, whereas nine subjects treated with sulindac showed a fall in blood pressure similar to the trend seen in placebo-treated subjects. Indomethacin treatment inhibited renal cyclo-oxygenase with a 78% reduction in urinary prostaglandin E2 excretion and 89% suppression of plasma renin activity. Neither measurement was affected by sulindac. Extrarenal cyclo-oxygenase activity was inhibited by both indomethacin and sulindac with serum thromboxane B2 decreasing by 96% and 69% respectively. The results suggest that the pressor effect of NSAI drugs is predominantly related to renal cyclo-oxygenase inhibition. the lack of effect of sulindac on blood pressure may make it a safer therapeutic option if NSAI drug therapy is necessary in the hypertensive patient.

Clinical trial: oral colon-release parnaparin sodium tablets (CB-01-05 MMX) for active left-sided ulcerative colitis.

PubMed

Celasco, G; Papa, A; Jones, R; Moro, L; Bozzella, R; Surace, M M; Naccari, G C; Gasbarrini, G

2010-02-01

The administration of parnaparin sodium as oral colon-release tablets (CB-01-05 MMX) has been proposed as a novel approach for the treatment of ulcerative colitis (UC). To assess the efficacy and the tolerability of 8 weeks' oral daily administration of 210 mg of parnaparin sodium compared with placebo in subjects treated with stable-doses of oral aminosalicylates. This multicenter, randomized, double-blind proof of concept trial compared the efficacy of CB-01-05 MMX 210 mg tablets to placebo in 141 subjects with mild to moderately active left-sided UC treated with stable-doses of aminosalicylates. The efficacy was assessed by clinical activity index (CAI), endoscopic index (EI) and histological score (HS). A total of 121 subjects (61 in test group and 60 in control group) formed the per protocol (PP) population. After 8 weeks of treatment, clinical remission was achieved in 83.6% of the CB-01-05 MMX group, and in 63.3% in the comparator group (P = 0.011). This effect was also significantly evident in the test group at week 4 (P = 0.028). A significant difference was also detected in rectal bleeding, (disappeared respectively in 75.4% and 55.0%; P = 0.018), and in mucosal friability (recovered respectively in 80.3% and in 56.7%; P = 0.005). CB-01-05 MMX was safe and significantly effective in treating subjects with mild-to-moderate left-sided UC treated with stable-doses of aminosalicylates.

Suicide attempts within 12 months of treatment for substance use disorders.

PubMed

Britton, Peter C; Conner, Kenneth R

2010-02-01

There are limited prospective data on suicide attempts (SA) during the months following treatment for substance use disorders (SUD), a period of high risk. In an analysis of the Drug Abuse Treatment Outcomes Study, a longitudinal naturalistic multisite study of treated SUDs, variables associated with SA in the 12 months following SUD treatment were examined. Participants included 2,966 patients with one or more SUDs. By 12 months, 77 (2.6%) subjects had attempted suicide. Multivariate logistic regression analyses were used to identify variables associated with SA. Variables collected at baseline that were associated with SA included lifetime histories of SA, suicidal ideation (SI), depression, cocaine as primary substance of use, outpatient methadone treatment, and short-term inpatient treatment. Male sex, older age, and minority race or ethnicity were associated with lower likelihood of SA. After controlling for baseline predictors, variables assessed at 12 months associated with SA included SI during follow-up and daily or more use of cocaine. The data contribute to a small but growing literature of prospective studies of SA among treated SUDs, and suggest that SUDs with cocaine use disorders in particular should be a focus of prevention efforts.

[Non-Pharmacological Interventions for Pregnancy-Related Sleep Disturbances].

PubMed

Hung, Hsuan-Man; Chiang, Hsiao-Ching

2017-02-01

Most women experience the worse sleep quality of their life during pregnancy and the early postpartum period. Although pregnancy typically accounts for a relatively short part of a woman's life, the related sleep disturbances may have a significant and negative impact on her long-term health. Approximately 78-80% of pregnant women experience sleep disturbances, including interruptions in deep sleep, decreased total sleep time, poor subjective sleep quality, frequent night waking, and reduced sleep efficacy. Sleep disturbances during pregnancy start during the first trimester and become prevalent during the third trimester. Related factors include physiological and psychosocial changes and an unhealthy lifestyle. As non-pharmacological interventions have the potential to improve sleep quality in 70% to 80% of patients with insomnia, this is the main approached that is currently used to treat pregnancy-related sleep disturbances. Examples of these non-pharmacological interventions include music therapy, aerobic exercise, massage, progressive muscle relaxation, multi-modal interventions, and the use of a maternity support belt. The efficacy and safety of other related non-pharmacological interventions such as auricular acupressure, cognitive therapy, tai chi, and aromatherapy remain uncertain, with more empirical research required. Additionally, non-pharmacological interventions do not effectively treat sleep disturbances in all pregnant women.

Cinnarizine in refractory migraine prophylaxis: efficacy and tolerability. A comparison with sodium valproate.

PubMed

Togha, Mansoureh; Mansoureh, Togha; Rahmat Jirde, Masoud; Nilavari, Kiafar; Ashrafian, Hosein; Razeghi, Soodeh; Kohan, Leila

2008-04-01

This was a double-blind clinical trial designed to assess the efficacy and safety of the cinnarizine (CIN) in patients with migraine who were refractory to propranolol and tricyclic antidepressants in comparison with sodium valproate (SV) to investigate whether CIN could be at least as effective as SV. A total of 125 patients were treated in a treatment period of 12 weeks. All patients had at least one intake of trial medication and 2-week post baseline efficacy observation which all were included in the ITT analysis. Of the 125 subjects treated, 46 discontinued prematurely: 25 from the CIN and 21 from the SV group. The main reasons for premature discontinuation were: lost to follow up (25/46, 63.2%), insufficient response (16/46, 20%), and adverse events (5/46, 12.8%). No statistically significant inter-group differences in the number of discontinuation was observed (p > 0.05). In both groups, number of attacks, intensity, and duration of attacks significantly decreased (p < 0.05). No statistically significant inter-group differences were observed regarding the mean number of attacks, duration, and intensity of migraine attacks for any of the time intervals analysed, except for the mean reduction of third and fourth visits intensity from baseline which were significantly different in two groups (p < 0.05), with the CIN group showing more reduction. Analysis of the number of responders showed that in the CIN group 61.2% subjects were responders, and 63.8% in the SV group. No statistically significant differences between the treatment groups were found for any of the secondary parameters. Overall 26 subjects reported one or more adverse events during the study period: 13 subjects in each group. Five subjects discontinued prematurely due to adverse events; two in the CIN group with significant weight gain, and 3 in the SV group with significant weight gain and severe tremor. These results suggest that CIN is an effective and safe prophylactic agent even in severe migraine headache.

Outcomes in patients with chronic kidney disease not on dialysis receiving extended dosing regimens of darbepoetin alfa: long-term results of the EXTEND observational cohort study

PubMed Central

Galle, Jan-Christoph; Addison, Janet; Suranyi, Michael G.; Claes, Kathleen; Di Giulio, Salvatore; Guerin, Alain; Herlitz, Hans; Kiss, István; Farouk, Mourad; Manamley, Nick; Wirnsberger, Gerhard; Winearls, Christopher

2016-01-01

Background Extended dosing of the erythropoiesis-stimulating agent (ESA) darbepoetin alfa (DA) once biweekly or monthly reduces anaemia treatment burden. This observational study assessed outcomes and dosing patterns in patients with chronic kidney disease not on dialysis (CKD-NoD) commencing extended dosing of DA. Methods Adult CKD-NoD patients starting extended dosing of DA in Europe or Australia in June 2006 or later were followed up until December 2012. Outcomes included haemoglobin (Hb) concentration, ESA dosing, mortality rates and receipt of dialysis and renal transplantation. Subgroup analyses were conducted for selected outcomes. Results Of 6035 enrolled subjects, 5723 (94.8%) met analysis criteria; 1795 (29.7%) received dialysis and 238 (3.9%) underwent renal transplantation. Mean (standard deviation) Hb concentration at commencement of extended dosing was 11.0 (1.5) g/dL. Mean [95% confidence interval (CI)] Hb 12 months after commencement of extended dosing (primary outcome) was 11.6 g/dL (11.5, 11.6) overall and was similar across countries, with no differences between subjects previously treated with an ESA versus ESA-naïve subjects, subjects with versus without prior renal transplant or diabetics versus non-diabetics. Weekly ESA dose gradually decreased following commencement of extended DA dosing and was similar across subgroups. The decrease in weekly DA dose was accompanied by an increase in the proportion of patients receiving iron therapy. Hb concentrations declined following changes in ESA labels and treatment guidelines. The mortality rate (95% CI) was 7.06 (6.68, 7.46) deaths per 100 years of follow-up. Subjects alive at study end had stable Hb concentrations in the preceding year, while those who died had lower and declining Hb concentrations in their last year. Conclusions Long-term, extended dosing of DA maintained Hb concentrations in patients already treated with an ESA and corrected and maintained Hb in ESA-naïve patients. PMID:27190334

Self-reported allergic reactions to peanut on commercial airliners.

PubMed

Sicherer, S H; Furlong, T J; DeSimone, J; Sampson, H A

1999-07-01

Allergic reactions to food occurring on commercial airlines have not been systematically characterized. We sought to describe the clinical characteristics of allergic reactions to peanuts on airplanes. Participants in the National Registry of Peanut and Tree Nut Allergy who indicated an allergic reaction while on a commercial airliner were interviewed by telephone. Sixty-two of 3704 National Registry of Peanut and Tree Nut Allergy participants indicated a reaction on an airplane; 42 of 48 patients or parental surrogates contacted confirmed the reaction began on the airplane (median age of affected subject, 2 years; range, 6 months to 50 years). Of these, 35 reacted to peanuts (4 were uncertain of exposure) and 7 to tree nuts, although 3 of these 7 reacted to substances that may have also contained peanut. Exposures occurred by ingestion (20 subjects), skin contact (8 subjects), and inhalation (14 subjects). Reactions generally occurred within 10 minutes of exposure (32 of 42 subjects), and reaction severity correlated with exposure route (ingestion > inhalation > skin). The causal food was generally served by the airline (37 of 42 subjects). Medications were given in flight to 19 patients (epinephrine to 5) and to an additional 14 at landing/gate return (including epinephrine to 1 and intravenous medication to 2), totaling 79% treated. Flight crews were notified in 33% of reactions. During inhalation reactions as a result of peanut allergy, greater than 25 passengers were estimated to be eating peanuts at the time of the reaction. Initial symptoms generally involved the upper airway, with progression to the skin or further lower respiratory reactions (no gastrointestinal symptoms). Allergic reactions to peanuts and tree nuts caused by accidental ingestion, skin contact, or inhalation occur during commercial flights, but airline personnel are usually not notified. Reactions can be severe, requiring medications, including epinephrine.

Sodium oxybate therapy provides multidimensional improvement in fibromyalgia: results of an international phase 3 trial

PubMed Central

Spaeth, Michael; Bennett, Robert M; Benson, Beverly A; Wang, Y Grace; Lai, Chinglin; Choy, Ernest H

2012-01-01

Background Fibromyalgia is characterised by chronic musculoskeletal pain and multiple symptoms including fatigue, multidimensional function impairment, sleep disturbance and tenderness. Along with pain and fatigue, non-restorative sleep is a core symptom of fibromyalgia. Sodium oxybate (SXB) is thought to reduce non-restorative sleep abnormalities. This study evaluated effects of SXB on fibromyalgia-related pain and other symptoms. Methods 573 patients with fibromyalgia according to 1990 American College of Rheumatology criteria were enrolled at 108 centres in eight countries. Subjects were randomly assigned to placebo, SXB 4.5 g/night or SXB 6 g/night. The primary efficacy endpoint was the proportion of subjects with ≥30% reduction in pain visual analogue scale from baseline to treatment end. Other efficacy assessments included function, sleep quality, effect of sleep on function, fatigue, tenderness, health-related quality of life and subject's impression of change in overall wellbeing. Results Significant improvements in pain, sleep and other symptoms associated with fibromyalgia were seen in SXB treated subjects compared with placebo. The proportion of subjects with ≥30% pain reduction was 42.0% for SXB4.5 g/night (p=0.002) and 51.4% for SXB6 g/night (p<0.001) versus 26.8% for placebo. Quality of sleep (Jenkins sleep scale) improved by 20% for SXB4.5 g/night (p≤0.001) and 25% for SXB6 g/night (p≤0.001) versus 0.5% for placebo. Adverse events with an incidence ≥5% and twice placebo were nausea, dizziness, vomiting, insomnia, anxiety, somnolence, fatigue, muscle spasms and peripheral oedema. Conclusion These results, combined with findings from previous phase 2 and 3 studies, provide supportive evidence that SXB therapy affordsimportant benefits across multiple symptoms in subjects with fibromyalgia. PMID:22294641

Why to Treat Subjects as Fixed Effects

ERIC Educational Resources Information Center

Adelman, James S.; Estes, Zachary

2015-01-01

Adelman, Marquis, Sabatos-DeVito, and Estes (2013) collected word naming latencies from 4 participants who read 2,820 words 50 times each. Their recommendation and practice was that R2 targets set for models should take into account subject idiosyncrasies as replicable patterns, equivalent to a subjects-as-fixed-effects assumption. In light of an…

Diagnosis and Fluoxetine Treatment of Compulsive Behavior Disorder of Adults with Mental Retardation.

ERIC Educational Resources Information Center

Bodfish, James W.; Madison, James T.

1993-01-01

Ten adults with compulsive behavior disorder and six comparison subjects, all with mental retardation, were treated using the medication fluoxetine. Seven of the 10 experimental subjects responded favorably to fluoxetine treatment; none of the comparison subjects responded favorably to the medication. There appeared to be a relation between…

Gait analysis and functional outcome in patients after Lisfranc injury treatment.

PubMed

van Hoeve, S; Stollenwerck, G; Willems, P; Witlox, M A; Meijer, K; Poeze, M

2017-07-18

Lisfranc injuries involve any bony or ligamentous disruption of the tarsometatarsal joint. Outcome results after treatment are mainly evaluated using patient-reported outcome measures (PROM), physical examination and radiographic findings. Less is known about the kinematics during gait. Nineteen patients (19 feet) treated for Lisfranc injury were recruited. Patients with conservative treatment and surgical treatment consisting of open reduction and internal fixation (ORIF) or primary arthrodesis were included. PROM, radiographic findings and gait analysis using the Oxford Foot Model (OFM) were analysed. Results were compared with twenty-one healthy subjects (31 feet). Multivariable logistic regression was used to determine factors influencing outcome. Patients treated for Lisfranc injury had a significantly lower walking speed than healthy subjects (P<0.001). There was a significant difference between the two groups regarding the range of motion (ROM) in the sagittal plane (flexion-extension) in the midfoot during the push-off phase (p<0.001). The ROM in the sagittal plane was significantly correlated with the AOFAS midfoot score (r 2 =0.56, p=0.012), FADI (r 2 =0.47, p=0.043) and the SF-36-physical impairment score (r 2 =0.60, p=0.007) but not with radiographic parameters for quality of reduction. In a multivariable analysis, the best explanatory factors were ROM in the sagittal plane during the push-off phase (β=0.707, p=0.001), stability (β=0.423, p=0.028) and BMI (β=-0.727 p=<0.001). This prediction model explained 87% of patient satisfaction. This study showed that patients treated for Lisfranc injury had significantly lower walking speed and significantly lower flexion/extension in the midfoot than healthy subjects. The ROM in these patients was significantly correlated with PROM, but not with radiographic quality of reduction. Most important satisfaction predictors were BMI, ROM in the sagittal plane during the push-off phase and fracture stability. Copyright © 2017. Published by Elsevier Ltd.

Effect of Laser Therapy on Chronic Osteoarthritis of the Knee in Older Subjects

PubMed Central

Youssef, Enas Fawzey; Muaidi, Qassim Ibrahim; Shanb, Alsayed Abdelhameed

2016-01-01

Introduction: Osteoarthritis (OA) is a common degenerative joint disease particularly in older subjects. It is usually associated with pain, restricted range of motion, muscle weakness, difficulties in daily living activities and impaired quality of life. To determine the effects of adding two different intensities of low-level laser therapy (LLLT) to exercise training program on pain severity, joint stiffness, physical function, isometric muscle strength, range of motion of the knee, and quality of life in older subjects with knee OA. Methods: Patients were randomly assigned into three groups. They received 16 sessions, 2 sessions/week for 8 weeks. Group-I: 18 patients were treated with a laser dose of 6 J/cm2 with a total dose of 48 J. Group-II: 18 patients were treated with a laser dose of 3 J/cm2 with a total dose of 27 J. Group-III: 15 patients were treated with laser without emission as a placebo. All patients received same exercise training program including stretching and strengthening exercises. Patients were evaluated before and after intervention by visual analogue scale (VAS), the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index for quality of life, handheld dynamometer and universal goniometer. Results: T test revealed that there was a significant reduction in VAS and pain intensity, an increase in isometric muscle strength and range of motion of the knee as well as increase in physical functional ability in three treatment groups. Also analysis of variance (ANOVA) proved significant differences among them and the post hoc tests (LSD) test showed the best improvements for patients of the first group. Conclusion: It can be concluded that addition of LLLT to exercise training program is more effective than exercise training alone in the treatment of older patients with chronic knee OA and the rate of improvement may be dose dependent, as with 6 J/cm2 or 3 J/cm2. PMID:27330707

Long-term effect of initiating pramipexole vs levodopa in early Parkinson disease.

PubMed

2009-05-01

To compare the long-term outcomes of subjects initially treated with pramipexole dihydrochloride with those of subjects initially treated with levodopa in the Comparison of the Agonist Pramipexole With Levodopa on Motor Complications of Parkinson's Disease (CALM-PD) trial. Up to 2 years of open extended follow-up of the CALM-PD subjects. Academic movement disorders clinics at 22 sites in the United States and Canada. Patients Patients with early Parkinson disease (N = 301) who required dopaminergic therapy to treat emerging disability were enrolled between October 1996 and August 1997, a subset of whom consented to extended follow-up until August 2003 (n = 222). Intervention Subjects were randomized to receive initial treatment with either pramipexole (n = 151) or levodopa (n = 150). Investigators were permitted to add open-label levodopa or other antiparkinsonian medications to treat ongoing or emerging disability. The primary outcome variable was the time-weighted average of self-reported disability scores in the "on" and "off" states as measured by the Schwab and England Activities of Daily Living Scale at the final visit. Secondary outcomes included the Unified Parkinson's Disease Rating Scale score, the presence and severity of dopaminergic motor complications, quality-of-life scale scores, Geriatric Depression Scale score, Epworth Sleepiness Scale score, and adverse events. After a mean (SD) follow-up of 6.0 (0.2) years, mean (SD) self-reported weighted Schwab and England Activities of Daily Living Scale scores were similar in the initial pramipexole (79.9 [16.2]) and initial levodopa (82.5 [14.6]) groups (P = .19). Dopaminergic motor complications (wearing off, on-off effects, or dyskinesias) were more common in the initial levodopa group (68.4%) than in the initial pramipexole group (50.0%) (P = .002), although disabling dyskinesias were uncommon in both groups. The mean (SD) Epworth Sleepiness Scale score was significantly higher in the initial pramipexole group (11.3 [5.8]) than in the initial levodopa group (8.6 [4.7]) (P < .001). Mean (SD) changes from baseline in the total Unified Parkinson's Disease Rating Scale score did not significantly differ between the initial pramipexole (2.4 [17.4]) and initial levodopa (0.5 [17.1]) groups (P = .11). The policies of initial pramipexole and initial levodopa use followed by open-label levodopa use resulted in similar self-reported disability 6 years after randomization. Persistent differences favoring initial pramipexole were seen in the rates of dopaminergic motor complications, with less severe somnolence favoring initial levodopa. Trial Registration clinicaltrials.gov Identifier: NCT00804479.

The frequency of hematuria in acne vulgaris patients during isotretinoin treatment.

PubMed

Yesilkaya, Burcu; Alli, Nuran; Artuz, R Ferda; Ulu, Ezgi; Kartal, Demet; Cinar, S Levent

2017-03-01

Systemic isotretinoin (13-cis-retinoic acid) is effective in the treatment of acne vulgaris. The most common side effects are mucocutaneous ones. Hematuria seen secondary to isotretinoin treatment is thought to be due to mucosal dryness in the urinary system. This study aims to determine the frequency of hematuria in acne vulgaris patients during isotretinoin treatment. Eighty-eight subjects aged 16-32 years were included in the study group and 52 subjects were in the control group. The subjects were treated for 6 months and were monitored monthly by complete urine analyzes. They were also examined each month in terms of cheilitis, xerosis, epistaxis, rectal bleeding, fatigue, myalgia, weight loss, dry eye, conjunctivitis, headache, dysuria and pollakiuria. In the study group, 15 subjects (17%) had hematuria at least once during the study, and in the control group, four subjects (7.7%) had hematuria. The difference was not statistically significant (p = 0.118). Among the subjects who had hematuria, 11 of them (73.3%) were female and four of them (33.3%) were male in the study group while all the subjects with hematuria in the control group were female. Hematuria and gender did not show a statistically significant correlation. Hematuria was observed in 17% of the study group; this frequency rate was not different from that of the normal population. In subjects having isotretinoin treatment, if all the other reasons or disorders are excluded, one must keep in mind that hematuria may be due to isotretinoin use.

The efficacy in melasma treatment using a 1410 nm fractional photothermolysis laser.

PubMed

Wanitphakdeedecha, R; Keoprasom, N; Eimpunth, S; Manuskiatti, W

2014-03-01

Melasma treatment modalities including topical and procedural therapy have been employed with variable results and high recurrence rate. To quantitatively assess improvement in melasma and side effects after 1410 nm fractional photothermolysis laser treatments and to determine efficacy at 1-, 2- and 3-month follow-up after treatment. Thirty volunteers with melasma were treated with 1410 nm fractional photothermolysis for four passes on full face and additional four passes on melasma area. They were randomly treated on one side of their face with 20 mJ at 5% coverage and the other side of their face with 20 mJ at 20% coverage. All subjects were treated monthly for five times. Melanin index, Visual analogue scale and Melasma Area and Severity Index score were measured at baseline and 1-, 2- and 3-month follow-up after complete treatment protocol. There was statistically significant improvement of Melanin index at 2- and 3-month follow-up visits, but not at 1-month follow-up visit. Visual analogue scale and Melasma Area and Severity Index score improved significantly on both sides at 1-, 2- and 3-month follow-ups. The overall patients' satisfaction was significantly higher on the side treated with 20 mJ, 5% coverage. Adverse reactions included erythema, dryness and post-inflammatory hyperpigmentation on melasma area. Those side effects were significantly more intense on the side treated with 20 mJ, 20% coverage. 1410 nm fractional photothermolysis laser treatment is a safe and temporary effective procedure for melasma; however, long-term follow-up is still needed. Only 5% coverage should be used to minimize risks of adverse effects. © 2013 The Authors Journal of the European Academy of Dermatology and Venereology © 2013 European Academy of Dermatology and Venereology.

Methods for determining the physiological state of a plant

DOEpatents

Kramer, David M.; Sacksteder, Colette

2003-09-23

The present invention provides methods for measuring a photosynthetic parameter. The methods of the invention include the steps of: (a) illuminating a plant leaf until steady-state photosynthesis is achieved; (b) subjecting the illuminated plant leaf to a period of darkness; (c) using a kinetic spectrophotometer or kinetic spectrophotometer/fluorimeter to collect spectral data from the plant leaf treated in accordance with steps (a) and (b); and (d) determining a photosynthetic parameter from the spectral data. In another aspect, the invention provides methods for determining the physiological state of a plant.

Lower pressure synthesis of diamond material

DOEpatents

Lueking, Angela; Gutierrez, Humberto; Narayanan, Deepa; Burgess Clifford, Caroline E.; Jain, Puja

2010-07-13

Methods of synthesizing a diamond material, particularly nanocrystalline diamond, diamond-like carbon and bucky diamond are provided. In particular embodiments, a composition including a carbon source, such as coal, is subjected to addition of energy, such as high energy reactive milling, producing a milling product enriched in hydrogenated tetrahedral amorphous diamond-like carbon compared to the coal. A milling product is treated with heat, acid and/or base to produce nanocrystalline diamond and/or crystalline diamond-like carbon. Energy is added to produced crystalline diamond-like carbon in particular embodiments to produce bucky diamonds.

Systematic review of early cardiometabolic outcomes of the first treated episode of psychosis.

PubMed

Foley, Debra L; Morley, Katherine I

2011-06-01

The increased mortality associated with schizophrenia is largely due to cardiovascular disease. Treatment with antipsychotics is associated with weight gain and changes in other cardiovascular risk factors. Early identification of modifiable cardiovascular risk factors is a clinical imperative but prospective longitudinal studies of the early cardiometabolic adverse effects of antipsychotic drug treatment other than weight gain have not been previously reviewed. To assess the methods and reporting of cardiometabolic outcome studies of the first treated episode of psychosis, review key findings, and suggest directions for future research. PsycINFO, MEDLINE, and Scopus from January 1990 to June 2010. Subjects were experiencing their first treated episode of psychosis. Subjects were antipsychotic naive or had been exposed to antipsychotics for a short known period at the beginning of the study. Cardiometabolic indices were assessed. Studies used a longitudinal design. Sixty-four articles were identified describing 53 independent studies; 25 studies met inclusion criteria and were retained for detailed review. Consolidated Standards of Reporting Trials and Strengthening the Reporting of Observational Studies in Epidemiology checklists were used to assess the methods and reporting of studies. A qualitative review of findings was conducted. Two key hypotheses were identified based on this review: (1) in general, there is no difference in cardiovascular risk assessed by weight or metabolic indices between individuals with an untreated first episode of psychosis and healthy controls and (2) cardiovascular risk increases after first exposure to any antipsychotic drug. A rank order of drugs can be derived but there is no evidence of significant class differences. Recommended directions for future research include assessing the effect on cardiometabolic outcomes of medication adherence and dosage effects, determining the therapeutic window for antipsychotic use in adults and youth, and testing for moderation of outcomes by demographic factors, including sex and age, and clinical and genetic factors.

[Comparative study of two treatment methods for acute periodontal abscess].

PubMed

Jin, Dong-mei; Wang, Wei-qian

2012-10-01

The aim of this short-term study was to compare the clinical efficacy of 2 different methods to treat acute periodontal abscesses. After patient selection, 100 cases of acute periodontal abscess were randomly divided into two groups. The experimental group was treated by supra- and subgingival scaling, while the control group was treated by incision and drainage. A clinical examination was carried out to record the following variables: subjective clinical variables including pain, edema, redness and swelling; objective clinical variables including gingival index(GI), bleeding index(BI), probing depth(PD),suppuration, lymphadenopathy and tooth mobility. The data was analyzed with SPSS 19.0 software package. RESULES: Subjective clinical variables demonstrated statistically significant improvements with both methods from the first day after treatment and lasted for at least 30 days(P<0.05), but the results of experimental group showed much better than the control group 1 day and 7 days after treatment. 30 days after treatment, there was no significant difference between the two groups in pain and swelling improvement(P>0.05), but the experimental group showed more improvement in edema and redness than the control group(P<0.05).On improving objective variables, the experimental group showed significant improvement in GI,BI,PD and suppuration 1 day after treatment(P<0.05).After 7 days, all objective clinical variables in the experimental group improved significantly(P<0.05) in the control group, there were significant improvements in GI,suppuration,lymphadenopathy and tooth mobility(P<0.05) but the four variables of the experimental group showed more improvement than the control group(P<0.05).After 30 days, all objective clinical variables improved significantly in both groups as compared to baseline, but in the experimental group, improvements were more significant regarding to GI,BI,PD,suppuration and tooth mobility(P<0.05). The method of supra- and subgingival scaling was rapid and effective in treatment of acute periodontal abscesses.

Symptom load and general function among patients with erythema migrans: a prospective study with a 1-year follow-up after antibiotic treatment in Norwegian general practice.

PubMed

Eliassen, Knut Eirik; Hjetland, Reidar; Reiso, Harald; Lindbæk, Morten; Tschudi-Madsen, Hedda

2017-03-01

Promptly treated erythema migrans (EM) has good prognosis. However, some patients report persistent symptoms. Do patients with EM have more symptoms than the general population? We describe individual symptoms and general function in EM-patients at time of diagnosis and one year after treatment. Prospective study with 1-year follow up after treatment. Questionnaires included a modified version of the Subjective Health Complaints Inventory, comprising three additional Lyme borreliosis (LB) related symptoms. General function was assessed using a five-point scale modified from the COOP/WONCA charts. Norwegian general practice. A total of 188 patients were included in a randomized controlled trial comparing three antibiotic regimens for EM, of whom 139 had complete data for this study. Individual symptoms, symptom load and general function. Mild symptoms were common, reported by 84.9% at baseline and by 85.6% at follow-up. At baseline, patients reported a mean of 5.4 symptoms, compared with 6.2 after one year. Severely bothersome symptoms and severely impaired general function were rare. Tiredness was the most reported symptom both at baseline and at follow-up. Palsy (other than facial) was the least reported symptom, but the only one with a significant increase. However, this was not associated to the EM. The symptom load was comparable to that reported in the general population. We found an increase in symptom load at follow-up that did not significantly affect general function. Monitoring patients' symptom loads prior to treatment reduce the probability of attributing follow-up symptoms to LB. Key points Erythema migrans has a good prognosis.Patients treated for erythema migrans have a slight increase in symptom load one year after treatment. This increase does not affect general function. The levels of subjective health complaints in patients treated for erythema migrans are comparable to the background population.

The effect of ziprasidone on metabolic syndrome risk factors in subjects with schizophrenia: a 1 year, open-label, prospective study.

PubMed

Chue, Pierre; Mandel, Francine S; Therrien, François

2014-06-01

Metabolic syndrome (MetS) is prevalent in subjects with schizophrenia-related psychotic disorders and contributes to increased rates of premature death due to cardiovascular disease. This study examined the impact of switching from another antipsychotic to ziprasidone on the distribution of the number of risk factors for MetS in subjects with schizophrenia or related psychotic disorders. In this 1 year, open-label, prospective study, all subjects received ziprasidone 40-160 mg/day. Standard exclusion criteria included treatment resistance, physical health disorders, and substance abuse. The primary end point was the percentage of subjects achieving a reduction from baseline of at least one risk factor for MetS at end point (week 52 or premature discontinuation) in the per-protocol population (treated for at least 16 weeks). Secondary end points included the mean change from baseline in number of MetS risk factors, the prevalence of MetS, individual MetS risk factors (waist circumference, blood pressure, fasting triglycerides, high-density lipoprotein cholesterol, and glucose), and 10 year coronary heart disease (Framingham score) risk. www.clinicaltrials.gov: NCT00748566. Of 114 evaluable subjects, 58.77% demonstrated one less MetS risk factor at week 52 (last observation carried forward) compared with baseline. Secondary end points also improved, with reductions in other metabolic parameters (fasting low-density lipoprotein cholesterol, total cholesterol and serum insulin, weight, body mass index and glycosylated hemoglobin [HbA1c]). The 10 year coronary heart disease risk decreased continually over time. The open-label and uncontrolled design is a limitation of the study. Ziprasidone treatment reduced both the rate of MetS and its individual risk factors in subjects with schizophrenia and related psychotic disorders. The results have implications for the selection of first-line treatments in schizophrenia and related psychotic disorders, and provide treatment options for subjects who have developed MetS as a result of other antipsychotics.

Perinatal choline supplementation does not mitigate motor coordination deficits associated with neonatal alcohol exposure in rats.

PubMed

Thomas, Jennifer D; O'Neill, Teresa M; Dominguez, Hector D

2004-01-01

Prenatal alcohol exposure can disrupt brain development, leading to a variety of behavioral alterations including learning deficits, hyperactivity, and motor dysfunction. We have been investigating the possibility that perinatal choline supplementation may effectively reduce the severity of alcohol's adverse effects on behavioral development. We previously reported that perinatal choline supplementation can ameliorate alcohol-induced learning deficits and hyperactivity in rats exposed to alcohol during development. The present study examined whether perinatal choline supplementation could also reduce the severity of motor deficits induced by alcohol exposure during the third trimester equivalent brain growth spurt. Male neonatal rats were assigned to one of three treatment groups. One group was exposed to alcohol (6.6 g/kg/day) from postnatal days (PD) 4 to 9 via an artificial rearing procedure. Artificially and normally reared control groups were included. One half of subjects from each treatment received daily subcutaneous injections of a choline chloride solution from PD 4 to 30, whereas the other half received saline vehicle injections. On PD 35-37, subjects were tested on a parallel bar motor task, which requires both balance and fine motor coordination. Ethanol-exposed subjects exhibited significant motor impairments compared to both control groups whose performance did not differ significantly from one another. Perinatal choline treatment did not affect motor performance in either ethanol or control subjects. These data indicate that the beneficial effects of perinatal choline supplementation in ethanol-treated subjects are task specific and suggest that choline is more effective in mitigating cognitive deficits compared to motor deficits associated with developmental alcohol exposure.

Stereoacuity in children with anisometropic amblyopia.

PubMed

Wallace, David K; Lazar, Elizabeth L; Melia, Michele; Birch, Eileen E; Holmes, Jonathan M; Hopkins, Kristine B; Kraker, Raymond T; Kulp, Marjean T; Pang, Yi; Repka, Michael X; Tamkins, Susanna M; Weise, Katherine K

2011-10-01

To determine factors associated with pretreatment and posttreatment stereoacuity in subjects with moderate anisometropic amblyopia. Data for subjects enrolled in seven studies conducted by the Pediatric Eye Disease Investigator Group were pooled. The sample included 633 subjects aged 3 to <18 years with anisometropic amblyopia, no heterotropia observed by cover test, and baseline amblyopic eye acuity of 20/100 or better. A subset included 248 subjects who were treated with patching or Bangerter filters and had stereoacuity testing at both the baseline and outcome examinations. Multivariate regression models identified factors associated with baseline stereoacuity and with outcome stereoacuity as measured by the Randot Preschool Stereoacuity test. Better baseline stereoacuity was associated with better baseline amblyopic eye acuity (P < 0.001), less anisometropia (P = 0.03), and anisometropia due to astigmatism alone (P < 0.001). Better outcome stereoacuity was associated with better baseline stereoacuity (P < 0.001) and better amblyopic eye acuity at outcome (P < 0.001). Among 48 subjects whose amblyopic eye visual acuity at outcome was 20/25 or better and within one line of the fellow eye, stereoacuity was worse than that of children with normal vision of the same age. In children with anisometropic amblyopia of 20/40 to 20/100 inclusive, better posttreatment stereoacuity is associated with better baseline stereoacuity and better posttreatment amblyopic eye acuity. Even if their visual acuity deficit resolves, many children with anisometropic amblyopia have stereoacuity worse than that of nonamblyopic children of the same age. Copyright © 2011 American Association for Pediatric Ophthalmology and Strabismus. Published by Mosby, Inc. All rights reserved.

A novel non-opioid protocol for medically supervised opioid withdrawal and transition to antagonist treatment.

PubMed

Rudolf, Gregory; Walsh, Jim; Plawman, Abigail; Gianutsos, Paul; Alto, William; Mancl, Lloyd; Rudolf, Vania

2018-01-01

The clinical feasibility of a novel non-opioid and benzodiazepine-free protocol was assessed for the treatment of medically supervised opioid withdrawal and transition to subsequent relapse prevention strategies. A retrospective chart review of DSM-IV diagnosed opioid-dependent patients admitted for inpatient medically supervised withdrawal examined 84 subjects (52 males, 32 females) treated with a 4-day protocol of scheduled tizanidine, hydroxyzine, and gabapentin. Subjects also received ancillary medications as needed, and routine counseling. Primary outcomes were completion of medically supervised withdrawal, and initiation of injectable extended release (ER) naltrexone treatment. Secondary outcomes included the length of hospital stay, Clinical Opiate Withdrawal Scale (COWS) scores, and facilitation to substance use disorder treatment intervention. Ancillary medication use and adverse effects were also assessed. A total of 79 (94%) of subjects completed medically supervised withdrawal. A total of 27 (32%) subjects chose to pursue transition to ER naltrexone, and 24 of the 27 (89%) successfully received the injection prior to hospital discharge. The protocol subjects had a mean length of hospital stay of 3.6 days, and the mean COWS scores was 3.3, 3.4, 2.8, and 2.4 on Day 1, 2, 3, and 4, respectively. Furthermore, 71 (85%) engaged in an inpatient or outpatient substance use disorder (SUD) treatment program following protocol completion. This retrospective chart review suggests the feasibility of a novel protocol for medically supervised opioid withdrawal and transition to relapse prevention strategies, including injectable ER naltrexone. This withdrawal protocol does not utilize opioid agonists or other controlled substances.‬‬‬‬.

Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial.

PubMed

Lee, Michael; Généreux, Philippe; Shlofmitz, Richard; Phillipson, Daniel; Anose, Bynthia M; Martinsen, Brad J; Himmelstein, Stevan I; Chambers, Jeff W

2017-06-01

The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.). ORBIT II was a single-arm trial that enrolled 443 patients at 49U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of <50% without the occurrence of in-hospital MACE.The present analysis reports the final, 3-year follow-up results from ORBIT II. The majority of subjects (88.2%) underwent PCI with drug-eluting stents after orbital atherectomy. There were 360 (81.3%) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%). The 3-year target lesion revascularization rate was 7.8%. In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions. The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%); the 3-year target lesion revascularization rate was 7.8%. Orbital atherectomy of heavily calcified coronary lesions followed by stenting results in a low rate of adverse ischemic events compared with historical controls; it represents a reasonable revascularization strategy for patients with severely calcified coronary lesions. Copyright © 2017 Elsevier Inc. All rights reserved.

Efficacy and Safety of Low-field Synchronized Transcranial Magnetic Stimulation (sTMS) for Treatment of Major Depression.

PubMed

Leuchter, Andrew F; Cook, Ian A; Feifel, David; Goethe, John W; Husain, Mustafa; Carpenter, Linda L; Thase, Michael E; Krystal, Andrew D; Philip, Noah S; Bhati, Mahendra T; Burke, William J; Howland, Robert H; Sheline, Yvette I; Aaronson, Scott T; Iosifescu, Dan V; O'Reardon, John P; Gilmer, William S; Jain, Rakesh; Burgoyne, Karl S; Phillips, Bill; Manberg, Paul J; Massaro, Joseph; Hunter, Aimee M; Lisanby, Sarah H; George, Mark S

2015-01-01

Transcranial Magnetic Stimulation (TMS) customarily uses high-field electromagnets to achieve therapeutic efficacy in Major Depressive Disorder (MDD). Low-field magnetic stimulation also may be useful for treatment of MDD, with fewer treatment-emergent adverse events. To examine efficacy, safety, and tolerability of low-field magnetic stimulation synchronized to an individual's alpha frequency (IAF) (synchronized TMS, or sTMS) for treatment of MDD. Six-week double-blind sham-controlled treatment trial of a novel device that used three rotating neodymium magnets to deliver sTMS treatment. IAF was determined from a single-channel EEG prior to first treatment. Subjects had baseline 17-item Hamilton Depression Rating Scale (HamD17) ≥ 17. 202 subjects comprised the intent-to-treat (ITT) sample, and 120 subjects completed treatment per-protocol (PP). There was no difference in efficacy between active and sham in the ITT sample. Subjects in the PP sample (N = 59), however, had significantly greater mean decrease in HamD17 than sham (N = 60) (-9.00 vs. -6.56, P = 0.033). PP subjects with a history of poor response or intolerance to medication showed greater improvement with sTMS than did treatment-naïve subjects (-8.58 vs. -4.25, P = 0.017). Efficacy in the PP sample reflects exclusion of subjects who received fewer than 80% of scheduled treatments or were inadvertently treated at the incorrect IAF; these subgroups failed to separate from sham. There was no difference in adverse events between sTMS and sham, and no serious adverse events attributable to sTMS. Results suggest that sTMS may be effective, safe, and well tolerated for treating MDD when administered as intended. Copyright © 2015 Elsevier Inc. All rights reserved.

Jet-lag: prevention with Pycnogenol. Preliminary report: evaluation in healthy individuals and in hypertensive patients.

PubMed

Belcaro, G; Cesarone, M R; Steigerwalt, R J; Di Renzo, A; Grossi, M G; Ricci, A; Stuard, S; Ledda, A; Dugall, M; Cornelli, U; Cacchio, M

2008-10-01

This study was conducted with the aim of showing the effects of Pycnogenol on controlling jet-lag symptoms. Oral Pycnogenol, 50 mg tablets 3 times/die, for 7 days starting 2 days prior to the flight was used. The study was divided into two separate parts. In study 1 the most common complaints of patients with jet-lag were evaluated with a rating scale consisting in of a scoring system. In study 2 a brain CT scan was performed after the flight in order to assess minimal brain edema (MBE) in association with typical signs and symptoms, observed in previous published flight studies. Study one included 38 subjects treated with Pycnogenol and 30 controls. The symptomatic jet-lag related total score was significantly lower (indicating a lower level of jet-lag) in the Pycnogenol group. The average duration of any jet lag symptom following the flight was significantly reduced from 39.3 (SD=0.8) hours in controls to an average of 18.2 (SD=3.3) hours in the Pycnogenol group (P<0.05). Study 2 included 34 subjects treated with Pycnogenol and 31 controls. The main observation was the brain CT scan performed within 28 hours after the end of the flight. The difference between the Pycnogenol and the control groups was statistically significant (P<0.05) for all items assessed including the cerebral edema score obtained by CT scan. The short-term memory was significantly altered in the control group and associated to edema and swelling of the lower limbs. The score (and the level of edema) was comparatively higher in a subgroup of hypertensive subjects in the control group. Minor alterations of cardiac function were observed in association with de-stabilisation of blood pressure. Fatigue was also significantly higher in the control group in comparison with the Pycnogenol group. A number of spontaneously reported symptoms was also scored and there was a statistically significant difference (P<0.05) between the Pycnogenol and control groups. In conlusion, Pycnogenol was useful to control jet-lag and minimal brain edema.

Increased platelet reactivity in HIV-1-infected patients receiving abacavir-containing antiretroviral therapy.

PubMed

Satchell, Claudette S; O'Halloran, Jane A; Cotter, Aoife G; Peace, Aaron J; O'Connor, Eileen F; Tedesco, Anthony F; Feeney, Eoin R; Lambert, John S; Sheehan, Gerard J; Kenny, Dermot; Mallon, Patrick W G

2011-10-15

Current or recent use of abacavir for treating human immunodeficiency virus type 1 (HIV-1) infection has been associated with increased rates of myocardial infarction (MI). Given the role of platelet aggregation in thrombus formation in MI and the reversible nature of the abacavir association, we hypothesized that patients treated with abacavir would have increased platelet reactivity. In a prospective study in adult HIV-infected patients, we determined associations between antiretrovirals (ARVs), and in particular the nucleoside reverse transcriptase inhibitor abacavir, and platelet reactivity by measuring time-dependent platelet aggregation in response to agonists: adenosine diphosphate (ADP), thrombin receptor-activating peptide (TRAP), collagen, and epinephrine. Of 120 subjects, 40 were ARV-naive and 80 ARV-treated, 40 of whom were receiving abacavir. No consistent differences in platelet reactivity were observed between the ARV-naive and ARV-treated groups. In contrast, within the ARV-treated group, abacavir-treated subjects had consistently higher percentages of platelet aggregation upon exposure to ADP, collagen, and epinephrine (P = .037, P = .022, and P = .032, respectively) and had platelets that were more sensitive to aggregation upon exposure to TRAP (P = .025). The consistent increases in platelet reactivity observed in response to a range of agonists provides a plausible underlying mechanism to explain the reversible increased rates of MI observed in abacavir-treated patients.

Topical Sandalwood Oil for Common Warts.

PubMed

Haque, Malika; Coury, Daniel L

2018-01-01

The purpose of this study was to evaluate the effectiveness of sandalwood oil for cutaneous viral warts caused by human papillomavirus. Sandalwood oil was applied topically twice daily for 12 weeks to cutaneous warts on any area of the body. Data collected at each visit included measurement of wart size, photograph of the warts, and documentation of treatment compliance and any adverse reactions. Ten subjects were enrolled and received treatment. At the end of the study, 8 of 10 (80%) had complete resolution of all treated warts. The remaining 2 subjects had improvement rated as moderate (25% to >90%). There were no complaints of skin irritation, erythema, itching, peeling of skin or scarring, pain or discomfort, or other adverse events reported. Sandalwood oil appears to be effective in the painless treatment of cutaneous warts caused by human papillomavirus.

Laser light visual cueing for freezing of gait in Parkinson disease: A pilot study with male participants.

PubMed

Bunting-Perry, Lisette; Spindler, Meredith; Robinson, Keith M; Noorigian, Joseph; Cianci, Heather J; Duda, John E

2013-01-01

Freezing of gait (FOG) is a debilitating feature of Parkinson disease (PD). In this pilot study, we sought to assess the efficacy of a rolling walker with a laser beam visual cue to treat FOG in PD patients. We recruited 22 subjects with idiopathic PD who experienced on- and off-medication FOG. Subjects performed three walking tasks both with and without the laser beam while on medications. Outcome measures included time to complete tasks, number of steps, and number of FOG episodes. A crossover design allowed within-group comparisons between the two conditions. No significant differences were observed between the two walking conditions across the three tasks. The laser beam, when applied as a visual cue on a rolling walker, did not diminish FOG in this study.

Clinical assessment of adventitious movements.

PubMed

Brasić, J R; Barnett, J Y; Sheitman, B B; Lafargue, R T; Ahn, S C

1998-12-01

Many procedures with variable validity and reliability have been developed in research settings to evaluate adventitious movements and related phenomena in specific populations, e.g., people with schizophrenia treated with dopamine antagonists, but these only provide global assessments or rate specific movements. A battery for rating individuals with possible movements disorders in a comprehensive way in clinical settings is needed so a protocol to assess briefly and thoroughly potential movement disorders was videotaped for five prepubertal boys with autistic disorder and severe mental retardation in a clinical trial. Utilizing a Movement Assessment Battery, four raters independently scored videotapes of 10-16 movements assessments of each of the five subjects. Experienced raters attained agreement of 59% to 100% on ratings of tardive dyskinesia and 48% to 100% on tics. Hindrances to reliability included poor quality of some tapes, high activity of subjects, and fatigue of raters.

Long-Lasting Permethrin-Impregnated Clothing Protects against Mosquito Bites in Outdoor Workers

PubMed Central

Londono-Renteria, Berlin; Patel, Jaymin C.; Vaughn, Meagan; Funkhauser, Sheana; Ponnusamy, Loganathan; Grippin, Crystal; Jameson, Sam B.; Apperson, Charles; Mores, Christopher N.; Wesson, Dawn M.; Colpitts, Tonya M.; Meshnick, Steven R.

2015-01-01

Outdoor exposure to mosquitoes is a risk factor for many diseases, including malaria and dengue. We have previously shown that long-lasting permethrin-impregnated clothing protects against tick and chigger bites in a double-blind randomized controlled trial in North Carolina outdoor workers. Here, we evaluated whether this clothing is protective against mosquito bites by measuring changes in antibody titers to mosquito salivary gland extracts. On average, there was a 10-fold increase in titer during the spring and summer when mosquito exposure was likely to be the highest. During the first year of the study, the increase in titer in subjects wearing treated uniforms was 2- to 2.5-fold lower than that of control subjects. This finding suggests that long-lasting permethrin-impregnated clothing provided protection against mosquito bites. PMID:26195460

Sensitivity after bilateral prophylactic mastectomy and immediate reconstruction.

PubMed

Gahm, Jessica; Jurell, Göran; Wickman, Marie; Hansson, Per

2007-01-01

The purpose of this retrospective study was to evaluate the cutaneous somatosensory function and patients' subjective experience after bilateral prophylactic mastectomy and immediate reconstruction with implants. Twenty-four patients treated during an eight-year period were included. Somatosensory examination was made at least two years after the latest surgery to study perception thresholds to touch, warmth, cold, and heat pain, using quantitative techniques. Patients also completed a questionnaire about subjective sensitivity. Sixteen women who had had no previous breast surgery were used as a control group. Most patients reported decreased sensitivity in the breasts, which was confirmed by the results from the quantitative somatosensory examination. The results also showed that the ability to experience sexual feelings in the breast is usually lost after this type of operation, and as many as 14 patients reported spontaneous or stimulus-evoked discomfort in the breasts.

Analysis of 2-Week Data from Two Randomized, Controlled Trials Conducted in Subjects with Frequent Heartburn Treated with Esomeprazole 20 mg.

PubMed

Katz, Philip O; Le Moigne, Anne; Pollack, Charles

2017-05-01

These secondary analyses used data from 2 similarly designed studies in subjects experiencing frequent heartburn to evaluate the efficacy of esomeprazole 20 mg once daily for 2 weeks, which reflects the approved over-the-counter dosage and duration. Subjects without endoscopically identified erosive esophagitis who were experiencing heartburn for ≥6 months and ≥4 of 7 days prior to baseline (study 1, N = 368; study 2, N = 349) were randomly assigned to receive double-blind treatment with esomeprazole 40 or 20 mg (administered as esomeprazole magnesium trihydrate 44.5 and 22.3 mg, respectively) or placebo once daily for 4 weeks. Subjects recorded the severity of heartburn in a daily diary, and investigators assessed subjects at each study visit. Two-week assessments were the primary end points of interest in these analyses and included the percentage of subjects with complete heartburn resolution (no episodes during 7 consecutive days), time to sustained complete heartburn resolution (the first of 7 consecutive episode-free days), and heartburn relief (no episodes other than ≤1 mild episode during 7 consecutive days). At week 2, the percentages of subjects who experienced complete heartburn resolution were significantly greater with esomeprazole 40 mg (study 1, 26.1%; study 2, 35.3%) and 20 mg (study 1, 25.2%; study 2, 35.7%) compared with placebo (study 1, 9.0%; study 2, 3.4%) (all, P ≤ 0.001). Beginning on day 1, the percentages of subjects who experienced sustained heartburn resolution was significantly greater in the groups treated with esomeprazole 40 mg (study 1, 19%; study 2, 19%; P < 0.0001) and 20 mg (study 1, 10%; study 2, 15%; P < 0.05) compared with the group that received placebo (study 1, 2%; study 2, 1%). Additionally, at week 2, the percentages of subjects experiencing heartburn relief were significantly greater with esomeprazole 40 mg (study 1, 35.3%; study 2, 40.5%) and 20 mg (study 1, 34.5%; study 2, 46.4%) compared with placebo (study 1, 16.5%; study 2, 8.6%) (all, P ≤ 0.001). The results of this study demonstrate that once-daily treatment with esomeprazole 20 mg for 2 weeks effectively resolved subjects׳ heartburn compared with placebo, beginning on day 1. Studies precede FDA Act 801 clinical trial registration and results submission requirements. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Psychopathological traits of adolescents with functional hypothalamic amenorrhea: a comparison with anorexia nervosa.

PubMed

Bomba, Monica; Corbetta, Fabiola; Bonini, Luisa; Gambera, Alessandro; Tremolizzo, Lucio; Neri, Francesca; Nacinovich, Renata

2014-03-01

Functional hypothalamic amenorrhea (FHA) is a form of anovulation, due to the suppression of hypothalamic-pituitary-ovarian axis, not related to identifiable organic causes. Like adolescents with anorexia nervosa (AN), subjects with FHA show dysfunctional attitudes, low self-esteem, depressive mood, anxiety and inability to cope with daily stress. The aim of the study is to examine similarities and differences between FHA and AN in terms of clinical profiles and psychological variables. 21 adolescents with FHA, 21 adolescents with anorexia nervosa, and 21 healthy adolescents were included in the study. All the teenagers completed a battery of self-administered psychological tests for the detection of behaviors and symptoms attributable to the presence of an eating disorder (EDI-2), depression (CDI), and alexithymia (TAS-20). Different from healthy controls, subjects with FHA and with AN shared common psychopathological aspects, such as maturity issues, social insecurity and introversion, a tendency to depression, excessive concerns with dieting, and fear of gaining weight. Nevertheless, adolescents with AN presented a more profound psychopathological disorder as observed at test comparisons with subjects with FHA. Results show a clinical spectrum that includes AN and FHA and suggest the necessity to treat FHA with a multidisciplinary approach for both organic and psychological aspects.

Comparison of university and private-practice orthodontic treatment outcomes with the American Board of Orthodontics objective grading system.

PubMed

Cook, Devon R; Harris, Edward F; Vaden, James L

2005-06-01

Treatment outcomes and duration of treatment for patients treated in university graduate orthodontic programs and private orthodontic practices were assessed and compared with the ABO objective grading system. The treatment records of 139 randomly selected adolescents who had received comprehensive orthodontic treatment were examined. Seventy-seven subjects had been treated in 3 postgraduate orthodontic clinics, and 62 had been treated in 3 private orthodontic practices. Pretreatment, all subjects had Class II Division 1 malocclusions and ANB angles equal to or greater than 4 degrees . All patients were treated with premolar extractions. Posttreatment dental casts were measured and scored with the ABO objective grading system. No significant differences were found between the groups in the alignment, buccolingual inclination, and overjet components. Patients treated in private practice had significantly lower scores for marginal ridge height and occlusal relationship. Patients treated in the university programs had significantly lower scores for occlusal contact and interproximal contact components. There was no significant difference in the overall score, thus no significant difference in the overall quality of orthodontic treatment outcome between patients treated in university programs and private practices. However, the university group had a significantly larger sample variance for the overall score. There was no significant difference in the duration of the treatment between patients treated in a university setting and in a private practice.

Nonablative 1927 nm fractional resurfacing for the treatment of facial photopigmentation.

PubMed

Brauer, Jeremy A; McDaniel, David H; Bloom, Bradley S; Reddy, Kavitha K; Bernstein, Leonard J; Geronemus, Roy G

2014-11-01

Long-term exposure to sunlight, including ultraviolet A and B, produces signs associated with photoaging and photodamage, including laxity and discoloration of the skin. Initial laser treatment for dyspigmentation included the use of ablative lasers, followed by Q-switched lasers and more recently fractional lasers. We investigated the safety and efficacy of a fractionated 1927nm non-ablative thulium laser for the treatment of photo-induced pigmentation. Prospective multi-center study of subjects with clinically identifiable photopigmentation. The study protocol was approved by BioMed Institutional Review Board (San Diego, CA). Subjects received two treatments with a non-ablative 1927nm fractionated thulium laser (Fraxel Dual 1550/1927 Laser System, Solta, Hayward CA), energy level of 10mJ, coverage of 40% and 4-6 passes. Subject pain, erythema and edema were recorded immediately after treatment. Two dimensional photography was obtained before each treatment and at one and three month follow up visits. Independent blinded physician assessment was performed evaluating overall improvement in appearance as well as pigment specific improvement. Forty men and women, ages 30 to 80 years, Fitzpatrick skin types I-IV, with photo-induced facial pigmentation were enrolled and treated, and 39 completed the three month follow up visit. Mean pain sensation for subjects during laser treatments was reported to be 4.3 on a 10-point scale. Mean scores for erythema, edema, and skin roughness throughout all treatments indicated moderate erythema, mild edema and mild skin roughness. Assessment of overall improvement was graded as moderate to very significant in 82% of subjects at one month and in 69% of subjects at three months after the second treatment. Assessment of lentigines and ephelides demonstrated moderate to very significant improvement in approximately 68% of subjects at the one month and in 51% of subjects at three months after the second treatment. Independent blinded physician assessment of randomized photography also demonstrated a durable response at three month follow up visit. Treatment was well tolerated and no serious adverse events related to treatment were observed or reported. Study limitations included a limited number of male subjects, lack of Fitzpatrick skin types V and VI, and decrease in improvement at 3 months post-treatment. Two treatments with a 1927nm non-ablative fractionated thulium laser produced moderate to marked improvement in overall appearance and pigmentation with high patient satisfaction. The response to treatment was maintained at one and three months follow up.

Efficacy and Safety of Gonadotropin-Releasing Hormone Agonist Treatment to Suppress Puberty in Gender Dysphoric Adolescents.

PubMed

Schagen, Sebastian E E; Cohen-Kettenis, Peggy T; Delemarre-van de Waal, Henriette A; Hannema, Sabine E

2016-07-01

Puberty suppression using gonadotropin-releasing hormone agonists (GnRHas) is recommended by current guidelines as the treatment of choice for gender dysphoric adolescents. Although GnRHas have long been used to treat precocious puberty, there are few data on the efficacy and safety in gender dysphoric adolescents. Therefore, the Endocrine Society guideline recommends frequent monitoring of gonadotropins, sex steroids, and renal and liver function. To evaluate the efficacy and safety of GnRHa treatment to suppress puberty in gender dysphoric adolescents. Forty-nine male-to-female and 67 female-to-male gender dysphoric adolescents treated with triptorelin were included in the analysis. Physical examination, including assessment of Tanner stage, took place every 3 months and blood samples were drawn at 0, 3, and 6 months and then every 6 months. Body composition was evaluated using dual energy x-ray absorptiometry. GnRHa treatment caused a decrease in testicular volume in 43 of 49 male-to-female subjects. In one of four female-to-male subjects who presented at Tanner breast stage 2, breast development completely regressed. Gonadotropins and sex steroid levels were suppressed within 3 months. Treatment did not have to be adjusted because of insufficient suppression in any subject. No sustained abnormalities of liver enzymes or creatinine were encountered. Alkaline phosphatase decreased, probably related to a slower growth velocity, because height SD score decreased in boys and girls. Lean body mass percentage significantly decreased during the first year of treatment in girls and boys, whereas fat percentage significantly increased. Triptorelin effectively suppresses puberty in gender dysphoric adolescents. These data suggest routine monitoring of gonadotropins, sex steroids, creatinine, and liver function is not necessary during treatment with triptorelin. Further studies should evaluate the extent to which changes in height SD score and body composition that occur during GnRHa treatment can be reversed during subsequent cross-sex hormone treatment. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Aromatherapy for the treatment of PONV in children: a pilot RCT.

PubMed

Kiberd, Mathew B; Clarke, Suzanne K; Chorney, Jill; d'Eon, Brandon; Wright, Stuart

2016-11-09

Postoperative nausea and vomiting (PONV) is one of the most common postoperative complications of general anesthesia in pediatrics. Aromatherapy has been shown to be effective in treating PONV in adults. Given the encouraging results of the adult studies, we planned to determine feasibility of doing a large-scale study in the pediatric population. Our group conducted a pilot randomized controlled trial examining the effect of aromatherapy on post-operative nausea and vomiting in patients 4-16 undergoing ambulatory surgery at a single center. Nausea was defined as a score of 4/10 on the Baxter Retching Faces Scale (BARF scale). A clinically significant reduction was defined as a two-point reduction in Nausea. Post operatively children were administered the BARF scale in 15 min internals until discharge home or until nausea score of 4/10 or greater. Children with nausea were randomized to saline placebo group or aromatherapy QueaseEase™ (Soothing Scents, Inc, Enterprise, AL: blend of ginger, lavender, mint and spearmint). Nausea scores were recorded post intervention. A total of 162 subjects were screened for inclusion in the study. Randomization occurred in 41 subjects of which 39 were included in the final analysis. For the primary outcome, 14/18 (78 %) of controls reached primary outcome compared to 19/21 (90 %) in the aromatherapy group (p = 0.39, Eta 0.175). Other outcomes included use of antiemetic in PACU (control 44 %, aromatherapy 52 % P = 0.75, Eta 0.08), emesis (Control 11 %, 9 % aromatherapy, P = 0.87, Eta = 0.03). There was a statistically significant difference in whether subjects continued to use the intervention (control 28 %, aromatherapy 66 %, p-value 0.048, Eta 0.33). Aromatherapy had a small non-significant effect size in treating postoperative nausea and vomiting compared with control. A large-scale randomized control trial would not be feasible at our institution and would be of doubtful utility. ClinicalTrials.gov NCT02663154 .

Persistent Borrelia Infection in Patients with Ongoing Symptoms of Lyme Disease.

PubMed

Middelveen, Marianne J; Sapi, Eva; Burke, Jennie; Filush, Katherine R; Franco, Agustin; Fesler, Melissa C; Stricker, Raphael B

2018-04-14

Lyme disease is a tickborne illness that generates controversy among medical providers and researchers. One of the key topics of debate is the existence of persistent infection with the Lyme spirochete, Borrelia burgdorferi , in patients who have been treated with recommended doses of antibiotics yet remain symptomatic. Persistent spirochetal infection despite antibiotic therapy has recently been demonstrated in non-human primates. We present evidence of persistent Borrelia infection despite antibiotic therapy in patients with ongoing Lyme disease symptoms. In this pilot study, culture of body fluids and tissues was performed in a randomly selected group of 12 patients with persistent Lyme disease symptoms who had been treated or who were being treated with antibiotics. Cultures were also performed on a group of ten control subjects without Lyme disease. The cultures were subjected to corroborative microscopic, histopathological and molecular testing for Borrelia organisms in four independent laboratories in a blinded manner. Motile spirochetes identified histopathologically as Borrelia were detected in culture specimens, and these spirochetes were genetically identified as Borrelia burgdorferi by three distinct polymerase chain reaction (PCR)-based approaches. Spirochetes identified as Borrelia burgdorferi were cultured from the blood of seven subjects, from the genital secretions of ten subjects, and from a skin lesion of one subject. Cultures from control subjects without Lyme disease were negative for Borrelia using these methods. Using multiple corroborative detection methods, we showed that patients with persistent Lyme disease symptoms may have ongoing spirochetal infection despite antibiotic treatment, similar to findings in non-human primates. The optimal treatment for persistent Borrelia infection remains to be determined.

Study of structural changes in the cells of the stimulated seed sprouts

NASA Astrophysics Data System (ADS)

Kovalyshyn, Stepan

2016-10-01

The paper emphasises that one of the easiest and effective methods of pre-treatment of seed is by industrial electrical power frequency. In order to select the most effective treatment regime it is necessary to reveal the mechanism of the impact of electromagnetic fields on biological structures, including plants. In this regard, electron microscopy studies at the cellular level of seedlings of perennial ryegrass seed treated with electric field corona discharge were conducted. It was found that in seedlings of treated seeds the intracellular organisation of the plant varies, resulting in changes during cell division. This is apparently due to a reduction in interphase, including S-phase, resulting in disrupted normal DNA synthesis, chromatin formation and, consequently, the collection of chromosomes. As a result, the cell division is faster, which leads to increased sowing quality of seeds of studied plants. While maintaining the characteristics of the studied cell division of seedling seed which was subjected to electrical stimulation, there is the prospect of a significant increase of seed germination of ryegrass in the future generations.

Application of Moving Bed Biofilm Reactor (MBBR) and Integrated Fixed Activated Sludge (IFAS) for Biological River Water Purification System: A Short Review

NASA Astrophysics Data System (ADS)

Lariyah, M. S.; Mohiyaden, H. A.; Hayder, G.; Hayder, G.; Hussein, A.; Basri, H.; Sabri, A. F.; Noh, MN

2016-03-01

This review paper present the MBBR and IFAS technology for urban river water purification including both conventional methods and new emerging technologies. The aim of this paper is to present the MBBR and IFAS technology as an alternative and successful method for treating different kinds of effluents under different condition. There are still current treatment technologies being researched and the outcomes maybe available in a while. The review also includes many relevant researches carried out at the laboratory and pilot scales. This review covers the important processes on MBBR and IFAS basic treatment process, affecting of carrier type and influent types. However, the research concluded so far are compiled herein and reported for the first time to acquire a better perspective and insight on the subject with a view of meeting the news approach. The research concluded so far are compiled herein and reported for the first time to acquire a better perspective and insight on the subject with a view of meeting the news approach. To this end, the most feasible technology could be the combination of advanced biological process (bioreactor systems) including MBBR and IFAS system.

US Medical Student Performance on the NBME Subject Examination in Internal Medicine: Do Clerkship Sequence and Clerkship Length Matter?

PubMed

Ouyang, Wenli; Cuddy, Monica M; Swanson, David B

2015-09-01

Prior to graduation, US medical students are required to complete clinical clerkship rotations, most commonly in the specialty areas of family medicine, internal medicine, obstetrics and gynecology (ob/gyn), pediatrics, psychiatry, and surgery. Within a school, the sequence in which students complete these clerkships varies. In addition, the length of these rotations varies, both within a school for different clerkships and between schools for the same clerkship. The present study investigated the effects of clerkship sequence and length on performance on the National Board of Medical Examiner's subject examination in internal medicine. The study sample included 16,091 students from 67 US Liaison Committee on Medical Education (LCME)-accredited medical schools who graduated in 2012 or 2013. Student-level measures included first-attempt internal medicine subject examination scores, first-attempt USMLE Step 1 scores, and five dichotomous variables capturing whether or not students completed rotations in family medicine, ob/gyn, pediatrics, psychiatry, and surgery prior to taking the internal medicine rotation. School-level measures included clerkship length and average Step 1 score. Multilevel models with students nested in schools were estimated with internal medicine subject examination scores as the dependent measure. Step 1 scores and the five dichotomous variables were treated as student-level predictors. Internal medicine clerkship length and average Step 1 score were used to predict school-to-school variation in average internal medicine subject examination scores. Completion of rotations in surgery, pediatrics and family medicine prior to taking the internal medicine examination significantly improved scores, with the largest benefit observed for surgery (coefficient = 1.58 points; p value < 0.01); completion of rotations in ob/gyn and psychiatry were unrelated to internal medicine subject examination performance. At the school level, longer internal medicine clerkships were associated with higher scores on the internal medicine examination (coefficient = 0.23 points/week; p value < 0.01). The order in which students complete clinical clerkships and the length of the internal medicine clerkship are associated with their internal medicine subject examination scores. Findings may have implications for curriculum re-design.

Time esophageal pH < 4 overestimates the prevalence of pathologic esophageal reflux in subjects with gastroesophageal reflux disease treated with proton pump inhibitors

PubMed Central

Gerson, Lauren B; Triadafilopoulos, George; Sahbaie, Peyman; Young, Winston; Sloan, Sheldon; Robinson, Malcolm; Miner, Philip B; Gardner, Jerry D

2008-01-01

Background A Stanford University study reported that in asymptomatic GERD patients who were being treated with a proton pump inhibitor (PPI), 50% had pathologic esophageal acid exposure. Aim We considered the possibility that the high prevalence of pathologic esophageal reflux might simply have resulted from calculating acidity as time pH < 4. Methods We calculated integrated acidity and time pH < 4 from the 49 recordings of 24-hour gastric and esophageal pH from the Stanford study as well as from another study of 57 GERD subjects, 26 of whom were treated for 8 days with 20 mg omeprazole or 20 mg rabeprazole in a 2-way crossover fashion. Results The prevalence of pathologic 24-hour esophageal reflux in both studies was significantly higher when measured as time pH < 4 than when measured as integrated acidity. This difference was entirely attributable to a difference between the two measures during the nocturnal period. Nocturnal gastric acid breakthrough was not a useful predictor of pathologic nocturnal esophageal reflux. Conclusion In GERD subjects treated with a PPI, measuring time esophageal pH < 4 will significantly overestimate the prevalence of pathologic esophageal acid exposure over 24 hours and during the nocturnal period. PMID:18498663

Healthy individuals treated with clomipramine: an fMRI study of brain activity during autobiographical recall of emotions.

PubMed

Cerqueira, C T; Sato, J R; de Almeida, J R C; Amaro, E; Leite, C C; Gorenstein, C; Gentil, V; Busatto, G F

2014-07-01

Various functional magnetic resonance imaging studies addressed the effects of antidepressant drugs on brain functioning in healthy subjects; however, none specifically investigated positive mood changes to antidepressant drug. Sixteen subjects with no personal or family history of psychiatric disorders were selected from an ongoing 4-week open trial of small doses of clomipramine. Follow-up interviews documented clear positive treatment effects in six subjects, with reduced irritability and tension in social interactions, improved decision making, higher self-confidence and brighter mood. These subjects were then included in a placebo-controlled confirmatory trial and were scanned immediately after 4 weeks of clomipramine use and again 4 weeks after the last dose of clomipramine. The functional magnetic resonance imaging (fMRI) scans were run during emotion-eliciting stimuli. Repeated-measures analysis of variance of brain activity patterns showed significant interactions between group and treatment status during induced irritability (P<0.005 cluster-based) but not during happiness. Individuals displaying a positive subjective response do clomipramine had higher frontoparietal cortex activity during irritability than during happiness and neutral emotion, and higher temporo-parieto-occipital cortex activity during irritability than during happiness. We conclude that antidepressants not only induce positive mood responses but also act upon autobiographical recall of negative emotions.

Effectiveness and Safety of Large Gel Particle Hyaluronic Acid With Lidocaine for Correction of Midface Volume Deficit or Contour Deficiency.

PubMed

Weiss, Robert A; Moradi, Amir; Bank, David; Few, Julius; Joseph, John; Dover, Jeffrey; Lin, Xiaoming; Nogueira, Alessandra; Mashburn, Jay

2016-06-01

Aging effects, such as facial flatness, increased tissue laxity, and soft tissue descent and deflation, contribute to midface deficiency. To evaluate whether large gel particle hyaluronic acid with lidocaine (LGP-HAL) is more effective in the treatment of midface deficiencies than no treatment. Subjects with mild to substantial loss of midface fullness were randomized 3:1 to LGP-HAL (Restylane Lyft; Galderma Laboratories, L.P., Fort Worth, TX) or no treatment. Treatment success was defined as at least 1-grade improvement in Medicis Midface Volume Scale (MMVS) on each side of the face at 8 weeks as assessed by a blinded evaluator. Secondary efficacy end points included MMVS score, global aesthetic improvement, and subject satisfaction. Significantly greater percent of subjects achieved treatment success in the LGP-HAL group compared to no treatment at all time points through Month 12 (p < .001). One year after initial treatment, 85% of subjects still had a global aesthetic improvement assessed by the treating investigator. Subject satisfaction demonstrated that LGP-HAL improved the aesthetic appearance of the midface. Most reported adverse events (80%) were mild in severity. The LGP-HAL treatment is well tolerated and provides significant improvement up to 12 months for the correction of midface deficiencies.

Population pharmacokinetics of aripiprazole in healthy Korean subjects.

PubMed

Jeon, Ji-Young; Chae, Soo-Wan; Kim, Min-Gul

2016-04-01

Aripiprazole is widely used to treat schizophrenia and bipolar disorder. This study aimed to develop a combined population pharmacokinetic model for aripiprazole in healthy Korean subjects and to identify the significant covariates in the pharmacokinetic variability of aripiprazole. Aripiprazole plasma concentrations and demographic data were collected retrospectively from previous bioequivalence studies that were conducted in Chonbuk National University Hospital. Informed consent was obtained from subjects for cytochrome P450 (CYP) genotyping. The population pharmacokinetic parameters of aripiprazole were estimated using nonlinear mixed-effect modeling with first-order conditional estimation with interaction method. The effects of age, sex, weight, height, and CYP genotype were assessed as covariates. A total of 1,508 samples from 88 subjects in three bioequivalence studies were collected. The two-compartment model was adopted, and the final population model showed that the CYP2D6 genotype polymorphism, height and weight significantly affect aripiprazole disposition. The bootstrap and visual predictive check results were evaluated, showing that the accuracy of the pharmacokinetic model was acceptable. A population pharmacokinetic model of aripiprazole was developed for Korean subjects. CYP2D6 genotype polymorphism, weight, and height were included as significant factors affecting aripiprazole disposition. The population pharmacokinetic parameters of aripiprazole estimated in the present study may be useful for individualizing clinical dosages and for studying the concentration-effect relationship of the drug.

Calcium Hydroxylapatite Dermal Filler for Treatment of Dorsal Hand Volume Loss: Results From a 12-Month, Multicenter, Randomized, Blinded Trial.

PubMed

Goldman, Mitchel P; Moradi, Amir; Gold, Michael H; Friedmann, Daniel P; Alizadeh, Kaveh; Adelglass, Jeffrey M; Katz, Bruce E

2018-01-01

Calcium hydroxylapatite (CaHA) microspheres suspended in a carrier gel is an opaque dermal filler that has been used to provide immediate volume correction in the dorsal hands. To assess the safety and effectiveness of CaHA for the correction of volume loss in the hands up to 12 months. This multicenter, controlled, single-blind study (NCT01832090) included 114 subjects randomized 3:1 to CaHA treatment and untreated control groups. Effectiveness was assessed by blinded investigators using the validated Merz Hand Grading Scale (MHGS). Subject-reported improvement was assessed using the Global Aesthetic Improvement Scale. Effects of treatment on hand function were also assessed. A total of 75% of subjects achieved ≥1-point improvement on the MHGS (p < .0001) at 3 months (primary end point); this response was generally maintained through 12 months. Proportions of subjects reporting improvement ranged from 98% (3 months) to 86% (12 months). There were no clinically significant differences between control and CaHA-treated subjects in any hand function measure. Adverse events were generally expected, minor, short-lived, injection-related, and similar to those observed in previous CaHA clinical studies. Treatment with CaHA results in significant improvement in the appearance of the dorsal hand and is well tolerated.

Jaw Dysfunction Is Associated with Neck Disability and Muscle Tenderness in Subjects with and without Chronic Temporomandibular Disorders

PubMed Central

Silveira, A.; Gadotti, I. C.; Armijo-Olivo, S.; Biasotto-Gonzalez, D. A.; Magee, D.

2015-01-01

Purpose. Tender points in the neck are common in patients with temporomandibular disorders (TMD). However, the correlation among neck disability, jaw dysfunction, and muscle tenderness in subjects with TMD still needs further investigation. This study investigated the correlation among neck disability, jaw dysfunction, and muscle tenderness in subjects with and without chronic TMD. Participants. Forty females between 19 and 49 years old were included in this study. There were 20 healthy controls and 20 subjects who had chronic TMD and neck disability. Methods. Subjects completed the neck disability index and the limitations of daily functions in TMD questionnaires. Tenderness of the masticatory and cervical muscles was measured using an algometer. Results. The correlation between jaw disability and neck disability was significantly high (r = 0.915, P < 0.05). The correlation between level of muscle tenderness in the masticatory and cervical muscles with jaw dysfunction and neck disability showed fair to moderate correlations (r = 0.32–0.65). Conclusion. High levels of muscle tenderness in upper trapezius and temporalis muscles correlated with high levels of jaw and neck dysfunction. Moreover, high levels of neck disability correlated with high levels of jaw disability. These findings emphasize the importance of considering the neck and its structures when evaluating and treating patients with TMD. PMID:25883963

Jaw dysfunction is associated with neck disability and muscle tenderness in subjects with and without chronic temporomandibular disorders.

PubMed

Silveira, A; Gadotti, I C; Armijo-Olivo, S; Biasotto-Gonzalez, D A; Magee, D

2015-01-01

Tender points in the neck are common in patients with temporomandibular disorders (TMD). However, the correlation among neck disability, jaw dysfunction, and muscle tenderness in subjects with TMD still needs further investigation. This study investigated the correlation among neck disability, jaw dysfunction, and muscle tenderness in subjects with and without chronic TMD. Participants. Forty females between 19 and 49 years old were included in this study. There were 20 healthy controls and 20 subjects who had chronic TMD and neck disability. Subjects completed the neck disability index and the limitations of daily functions in TMD questionnaires. Tenderness of the masticatory and cervical muscles was measured using an algometer. The correlation between jaw disability and neck disability was significantly high (r = 0.915, P < 0.05). The correlation between level of muscle tenderness in the masticatory and cervical muscles with jaw dysfunction and neck disability showed fair to moderate correlations (r = 0.32-0.65). High levels of muscle tenderness in upper trapezius and temporalis muscles correlated with high levels of jaw and neck dysfunction. Moreover, high levels of neck disability correlated with high levels of jaw disability. These findings emphasize the importance of considering the neck and its structures when evaluating and treating patients with TMD.

Can Whitening Strips interfere with the Bond Strength of Composite Resins?

PubMed

Firoozmand, Leily Macedo; Reis, Washington Luís Machado dos; Vieira, Mercêdes Aroucha; Nunes, Adriana Gomes; Tavarez, Rudys Rodolfo de Jesus; Tonetto, Mateus Rodrigues; Bramante, Fausto Silva; Bhandi, Shilpa H; Roma, Regina Vieira de Oliveira; Bandeca, Matheus Coelho

2015-04-01

The aim of this study was to investigate in vitro the bond strength of composite resins on enamel previously treated with whitening strips. A total of 48 bovine incisors were allocated to four experimental groups (n = 12 each): G1 (WSC)- treated with 9.5% hydrogen peroxide whitening strips (3D White Whitestrips® Advanced Vivid/CREST); G2 (WSO)-treated with 10% hydrogen peroxide whitening strips (3D WhiteTM/Oral B); G3 (WG)-treated with 7.5% hydrogen peroxide gel with fluorine, calcium and potassium nitrate (White Class®/FGM); and G4 (C)-control not subjected to bleaching treatment. The specimens were subjected to bleaching over 2 weeks following the manufacturers' instructions. Following the elaboration of the composite resin test specimens, the samples were stored in artificial saliva and subsequently subjected to the micro-shear test using the universal testing machine (EMIC®). The bond strength values were analyzed by one-way ANOVA and Tukey's statistical test (5%). Significant differences were observed among the investigated groups (p < 0.05). The G3-WG exhibited greater values compared with the control group and the groups treated with strips, G1-WSC and G2-WSO. Analysis of the bond interface revealed that a large fraction of the failures occurred at the enamel-resin interface. The bond strength decreased following 14 days of treatment with bleaching strips, whereas the whitening gel with 7.5% hydrogen peroxide, calcium and fluorine increased the bond strength.

Consumption of Dairy Yogurt Containing Lactobacillus paracasei ssp. paracasei, Bifidobacterium animalis ssp. lactis and Heat-Treated Lactobacillus plantarum Improves Immune Function Including Natural Killer Cell Activity.

PubMed

Lee, Ayoung; Lee, Young Ju; Yoo, Hye Jin; Kim, Minkyung; Chang, Yeeun; Lee, Dong Seog; Lee, Jong Ho

2017-05-31

The aim of this study was to investigate the impact of consuming dairy yogurt containing Lactobacillus paracasei ssp. paracasei ( L. paracasei ), Bifidobacterium animalis ssp. lactis ( B. lactis ) and heat-treated Lactobacillus plantarum ( L. plantarum ) on immune function. A randomized, open-label, placebo-controlled study was conducted on 200 nondiabetic subjects. Over a twelve-week period, the test group consumed dairy yogurt containing probiotics each day, whereas the placebo group consumed milk. Natural killer (NK) cell activity, interleukin (IL)-12 and immunoglobulin (Ig) G1 levels were significantly increased in the test group at twelve weeks compared to baseline. Additionally, the test group had significantly greater increases in serum NK cell activity and interferon (IFN)-γ and IgG1 than placebo group. Daily consumption of dairy yogurt containing L. paracasei , B. lactis and heat-treated L. plantarum could be an effective option to improve immune function by enhancing NK cell function and IFN-γ concentration (ClinicalTrials.gov: NCT03051425).

Consumption of Dairy Yogurt Containing Lactobacillus paracasei ssp. paracasei, Bifidobacterium animalis ssp. lactis and Heat-Treated Lactobacillus plantarum Improves Immune Function Including Natural Killer Cell Activity

PubMed Central

Lee, Ayoung; Lee, Young Ju; Yoo, Hye Jin; Kim, Minkyung; Chang, Yeeun; Lee, Dong Seog; Lee, Jong Ho

2017-01-01

The aim of this study was to investigate the impact of consuming dairy yogurt containing Lactobacillus paracasei ssp. paracasei (L. paracasei), Bifidobacterium animalis ssp. lactis (B. lactis) and heat-treated Lactobacillus plantarum (L. plantarum) on immune function. A randomized, open-label, placebo-controlled study was conducted on 200 nondiabetic subjects. Over a twelve-week period, the test group consumed dairy yogurt containing probiotics each day, whereas the placebo group consumed milk. Natural killer (NK) cell activity, interleukin (IL)-12 and immunoglobulin (Ig) G1 levels were significantly increased in the test group at twelve weeks compared to baseline. Additionally, the test group had significantly greater increases in serum NK cell activity and interferon (IFN)-γ and IgG1 than placebo group. Daily consumption of dairy yogurt containing L. paracasei, B. lactis and heat-treated L. plantarum could be an effective option to improve immune function by enhancing NK cell function and IFN-γ concentration (ClinicalTrials.gov: NCT03051425). PMID:28561762

Treating Posttraumatic Stress Disorder in Female Victims of Trafficking Using Narrative Exposure Therapy: A Retrospective Audit.

PubMed

Robjant, Katy; Roberts, Jackie; Katona, Cornelius

2017-01-01

Human trafficking is a form of modern slavery that involves the forced movement of people internally within countries, or externally across borders. Victims who are trafficked for sexual exploitation are subject to repeated, multiple trauma, and high rates of mental health problems including posttraumatic stress disorder (PTSD) have been found. Narrative exposure therapy (NET) is an evidence-based treatment for PTSD. In this retrospective audit, we record the results of NET to treat 10 women who had been trafficked for sexual exploitation who were diagnosed with PTSD. All 10 women completed the therapy and experienced a reduction in PTSD severity scores at posttreatment, with improvements that were maintained or further improved at 3-month follow-up. General distress was also significantly reduced following treatment. Although limited by sample size and retrospective design, this audit demonstrates that NET is a feasible treatment for PTSD in this population and warrants further evaluation in a randomized controlled trial. Further adjunctive interventions may also be necessary to treat the additional psychological problems experienced by this population.

[Comparison of band ligation with sclerotherapy for the treatment of bleeding esophageal varices].

PubMed

Ríos, Eddy; Sierralta, Armando; Abarzúa, Marigraciela; Bastías, Joaquín; Barra, María Inés

2012-06-01

Endoscopic band ligation is the treatment of choice for bleeding esophageal varices. However it is not clear if this procedure is associated with less early and late mortality than sclerotherapy. To assess rates of re-bleeding and mortality in cohorts of patients with bleeding esophageal varices treated with endoscopic injection or band ligation. Analysis of medical records and endoscopy reports of two cohorts of patients with bleeding esophageal varices, treated between 1990 and 2010. Of these, 54 patients were treated with sclerotherapy and 90 patients with band ligation. A third cohort of 116 patients that did not require endoscopic treatment, was included. The mean analyzed follow up period was 2.5 years (range 1-16). Collection of data was retrospective for patients treated with sclerotherapy and prospective for patients treated with band ligation. Rates of re-bleeding and medium term mortality were assessed. During the month ensuing the first endoscopic treatment, re-bleeding was recorded in 39 and 72% of patients treated with band ligation and sclerotherapy, respectively (p < 0.01). The relative risk of bleeding after band ligation was 0.53 (95% confidence limits 0.390.73). Death rates until the end of follow up were 20 and 48% among patients with treated with band ligation and sclerotherapy, respectively (p < 0.01), with a relative risk of dying for patients subjected to band ligation of 0.41 (95% confidence limits 0.25-0.68). Band ligation was associated with lower rates of re-bleeding and mortality in these cohorts of patients.

The effectiveness of reducing the daily dose of finasteride in men with benign prostatic hyperplasia

PubMed Central

Sullivan, Michael J; Geller, Jack

2002-01-01

Background Finasteride, a 5 alpha reductase inhibitor, is an established treatment for benign prostatic hyperplasia. The recommended dosage is 5 mg a day, however case reports have show effectiveness with lower doses. The objective of the current study was to determine in men with benign prostatic hyperplasia, previously treated for at least one year with finasteride 5 mg daily, if they will maintain subjective and objective improvements in urinary obstruction when treated with 2.5 mg of finasteride daily for one year. Methods In an open label, prospective study, 40 men with benign prostatic hyperplasia, previously treated for at least one year with 5 mg of finasteride, took 2.5 mg of finasteride daily for one year. Measurements included AUA symptom score, maximum flow rate, voided volume and PSA. Results There were no significant changes in maximum flow rate, voided volume, or AUA symptom score after one year of finasteride 2.5 mg daily therapy. PSA increased significantly, p < .01, after one year of finasteride 2.5 mg daily, 2.0 +1.4 ng/ml, when compared to finasteride 5 mg daily, 1.4+ 1.0 ng/ml. Conclusions The daily dose of finasteride can be reduced to 2.5 mg daily without significant effect on subjective and objective measures of urinary obstruction. Although statistically significant increases in PSA are noted when reducing the daily finasteride dose from 5 mg to 2.5 mg, the clinical significance of a mean .6 ng/ml increase in PSA is questionable. PMID:11818031

The effect of bariatric surgery on direct-acting oral anticoagulant drug levels.

PubMed

Rottenstreich, Amihai; Barkai, Aviv; Arad, Ariela; Raccah, Bruria Hirsh; Kalish, Yosef

2018-03-01

To determine direct-acting oral anticoagulant (DOAC) blood levels in post-bariatric surgery (BS) patients treated with long-term anticoagulation therapy. We identified from medical records patients who underwent BS during 2005-2016 and who were treated with DOACs. We offered testing DOAC blood levels to these patients and to age, sex, body mass index, and serum creatinine-matched individuals treated by DOACs who did not undergo BS. Overall, 36 individuals were enrolled, 18 post-BS patients and 18 control subjects. Of the post-BS patients, 12 underwent laparoscopic sleeve gastrectomy, 4 laparoscopic adjustable gastric banding and 2 laparoscopic Roux-en-Y gastric bypass surgery. Median time lapsed from surgery until study inclusion was 4.9years. Five post-BS patients had peak drug levels below expected levels compared to none of the control subjects (P=0.05). For patients who used apixaban (n=9) and dabigatran (n=2), peak drug levels were within the expected range. In contrast, for the 7 patients who used rivaroxaban, levels were below the expected range in 5, including all four who underwent sleeve gastrectomy and one following adjustable gastric banding. Peak rivaroxaban levels were significantly lower in the post-BS than the control group (P=0.02). This preliminary study suggests that all DOACs, particularly rivaroxaban, be cautiously used following BS, if used at all. Given that vitamin-K antagonists can be easily monitored, they may be a better choice, until more data on DOAC use in this patient population are available. Copyright © 2017 Elsevier Ltd. All rights reserved.

Mycophenolate Mofetil Treatment of Systemic Sclerosis Reduces Myeloid Cell Numbers and Attenuates the Inflammatory Gene Signature in Skin.

PubMed

Hinchcliff, Monique; Toledo, Diana M; Taroni, Jaclyn N; Wood, Tammara A; Franks, Jennifer M; Ball, Michael S; Hoffmann, Aileen; Amin, Sapna M; Tan, Ainah U; Tom, Kevin; Nesbeth, Yolanda; Lee, Jungwha; Ma, Madeleine; Aren, Kathleen; Carns, Mary A; Pioli, Patricia A; Whitfield, Michael L

2018-01-31

Fewer than half of patients with systemic sclerosis demonstrate modified Rodnan skin score improvement during mycophenolate mofetil (MMF) treatment. To understand the molecular basis for this observation, we extended our prior studies and characterized molecular and cellular changes in skin biopsies from subjects with systemic sclerosis treated with MMF. Eleven subjects completed ≥24 months of MMF therapy. Two distinct skin gene expression trajectories were observed across six of these subjects. Three of the six subjects showed attenuation of the inflammatory signature by 24 months, paralleling reductions in CCL2 mRNA expression in skin and reduced numbers of macrophages and myeloid dendritic cells in skin biopsies. MMF cessation at 24 months resulted in an increased inflammatory score, increased CCL2 mRNA and protein levels, modified Rodnan skin score rebound, and increased numbers of skin myeloid cells in these subjects. In contrast, three other subjects remained on MMF >24 months and showed a persistent decrease in inflammatory score, decreasing or stable modified Rodnan skin score, CCL2 mRNA reductions, sera CCL2 protein levels trending downward, reduction in monocyte migration, and no increase in skin myeloid cell numbers. These data summarize molecular changes during MMF therapy that suggest reduction of innate immune cell numbers, possibly by attenuating expression of chemokines, including CCL2. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Adapting to an Uncertain World: Cognitive Capacity and Causal Reasoning with Ambiguous Observations

PubMed Central

Shou, Yiyun; Smithson, Michael

2015-01-01

Ambiguous causal evidence in which the covariance of the cause and effect is partially known is pervasive in real life situations. Little is known about how people reason about causal associations with ambiguous information and the underlying cognitive mechanisms. This paper presents three experiments exploring the cognitive mechanisms of causal reasoning with ambiguous observations. Results revealed that the influence of ambiguous observations manifested by missing information on causal reasoning depended on the availability of cognitive resources, suggesting that processing ambiguous information may involve deliberative cognitive processes. Experiment 1 demonstrated that subjects did not ignore the ambiguous observations in causal reasoning. They also had a general tendency to treat the ambiguous observations as negative evidence against the causal association. Experiment 2 and Experiment 3 included a causal learning task requiring a high cognitive demand in which paired stimuli were presented to subjects sequentially. Both experiments revealed that processing ambiguous or missing observations can depend on the availability of cognitive resources. Experiment 2 suggested that the contribution of working memory capacity to the comprehensiveness of evidence retention was reduced when there were ambiguous or missing observations. Experiment 3 demonstrated that an increase in cognitive demand due to a change in the task format reduced subjects’ tendency to treat ambiguous-missing observations as negative cues. PMID:26468653

A pilot methodology study for the photographic assessment of post-inflammatory hyperpigmentation in patients treated with tretinoin.

PubMed

Rossi, A B; Leyden, J J; Pappert, A S; Ramaswamy, A; Nkengne, A; Ramaswamy, R; Nighland, M

2011-04-01

Post-inflammatory hyperpigmentation (PIH) is a common occurrence in patients with acne vulgaris, particularly in those with skin of colour. A previous study has demonstrated the benefit of tretinoin (retinoic acid) in the treatment of PIH; however, there is currently no standard protocol to evaluate change in PIH following treatment. Based on these findings, we performed a pilot, exploratory, blinded, intraindividual-controlled methodology study that consisted of a photographic assessment protocol with facial mapping.   The study was based on a secondary analysis of a phase 4, community-based trial of 544 acne patients who were treated with tretinoin gel microsphere 0.04% or 0.1%. Only patients with Fitzpatrick types III-V (skin of colour) were included in the study; subjects with Fitzpatrick skin type VI were excluded because the photographic assessment did not allow for proper evaluation. Despite the small number of subjects evaluated (n=25), the results revealed consistent assessment of improvement in PIH between two independent graders (weighted κ=0.84). Further study with a larger population is recommended to validate the accuracy of this method. © 2010 Johnson & Johnson Consumer Companies, Inc. Journal of the European Academy of Dermatology and Venereology © 2010 European Academy of Dermatology and Venereology.

Drug attitude and subjective well-being in antipsychotic treatment monotherapy in real-world settings.

PubMed

Balestrieri, Matteo; Di Sciascio, Guido; Isola, Miriam; Lomonaco, Emanuele; Maso, Elisa; Merli, Roberto; Calò, Salvatore; Bellantuono, Cesario

2009-01-01

To assess using two well-know scales (DAI-30 and SWN) the drug attitude and subjective well-being of patients treated with haloperidol or second-generation antipsychotics (SGA) in four different Italian communities. The sample included 145 patients taking five different antipsychotics (APs) in mono-therapy: haloperidol, clozapine, olanzapine, risperidone, quetiapine. A stepwise multiple regression analysis (SMRA) was used to analyse the contribution of different AP treatments and of other predictors to SWN and DAI-30 scores. Univariate analyses showed no differences in DAI-30 and SWN scores across treatments. The SMRA showed that SWN scores were negatively correlated with the severity of the psychoses (BPRS scores), while the DAI-30 scores were negatively correlated with the severity of the psychoses and positively correlated both with the length of drug treatment and with the use of olanzapine. Our study does not confirm a better drug attitude in patients treated with SGA with respect to haloperidol. The only partial exception is the better performance of olanzapine over haloperidol on DAI-30, which could be due to the lower use of anticholinergic drugs during olanzapine treatment. The differences between the SWN and DAI-30 may give good reason for the use of both instruments during AP treatments.

Prediction of changes in memory performance by plasma homovanillic acid levels in clozapine-treated patients with schizophrenia.

PubMed

Sumiyoshi, Tomiki; Roy, A; Kim, C-H; Jayathilake, K; Lee, M A; Sumiyoshi, C; Meltzer, H Y

2004-12-01

Cognitive dysfunction in schizophrenia has been demonstrated to be dependent, in part, on dopaminergic activity. Clozapine has been found to improve some domains of cognition, including verbal memory, in patients with schizophrenia. This study tested the hypothesis that plasma homovanillic acid (pHVA) levels, a peripheral measure of central dopaminergic activity, would predict the change in memory performance in patients with schizophrenia treated with clozapine. Twenty-seven male patients with schizophrenia received clozapine treatment for 6 weeks. Verbal list learning (VLL)-Delayed Recall (VLL-DR), a test of secondary verbal memory, was administered before and after clozapine treatment. Blood samples to measure pHVA levels were collected at baseline. Baseline pHVA levels were negatively correlated with change in performance on VLL-DR; the lower baseline pHVA level was associated with greater improvement in performance on VLL-DR during treatment with clozapine. Baseline pHVA levels in subjects who showed improvement in verbal memory during clozapine treatment ( n=13) were significantly lower than those in subjects whose memory performance did not improve ( n=14). The results of this study indicate that baseline pHVA levels predict the ability of clozapine to improve memory performance in patients with schizophrenia.

The effects of celery leaf (apium graveolens L.) treatment on blood glucose and insulin levels in elderly pre-diabetics

PubMed Central

Yusni, Yusni; Zufry, Hendra; Meutia, Firdalena; Sucipto, Krishna W.

2018-01-01

Objectives: To analyze the effect of celery leaf extract on blood glucose and plasma insulin levels in elderly pre-diabetics. Methods: This study was conducted between March and November 2014 at the Faculty of Medicine, Syiah Kuala University, Banda Aceh, Indonesia. A quasi-experimental pretest-posttest with a control group was conducted with elderly pre-diabetic volunteers. The subjects included 16 elderly pre-diabetics older than 60 (6 males and 10 females). The subjects were randomly divided into 2 groups: a control group (placebo-treated) and a treatment group (celery-treated). The treatment consisted of celery leaf extract capsules at the dose of 250 mg, 3 times per day (morning, afternoon and evening), 30 minutes before a meal, for 12 days. Data analysis was performed using the t-test (p<0.05). Results: There was a significant decrease in pre-prandial plasma glucose levels (p=0.01) and post-prandial plasma glucose levels (p=0.00), but no significant increase in plasma insulin levels (p=0.15) after celery leaf treatment in elderly pre-diabetics. Conclusion: Celery was effective at reducing blood glucose levels, but there was a lack of association between blood glucose levels and plasma insulin levels in elderly pre-diabetics. PMID:29436564

Clinical Utility of LC3 and p62 Immunohistochemistry in Diagnosis of Drug-Induced Autophagic Vacuolar Myopathies: A Case-Control Study

PubMed Central

Lee, Han S.; Daniels, Brianne H.; Salas, Eduardo; Bollen, Andrew W.; Debnath, Jayanta; Margeta, Marta

2012-01-01

Background Some patients treated with chloroquine, hydroxychloroquine, or colchicine develop autophagic vacuolar myopathy, the diagnosis of which currently requires electron microscopy. The goal of the current study was to develop an immunohistochemical diagnostic marker for this pathologic entity. Methodology Microtubule-associated protein light chain 3 (LC3) has emerged as a robust marker of autophagosomes. LC3 binds p62/SQSTM1, an adapter protein that is selectively degraded via autophagy. In this study, we evaluated the utility of immunohistochemical stains for LC3 and p62 as diagnostic markers of drug-induced autophagic vacuolar myopathy. The staining was performed on archival muscle biopsy material, with subject assignment to normal control, drug-treated control, and autophagic myopathy groups based on history of drug use and morphologic criteria. Principal Findings In all drug-treated subjects, but not in normal controls, LC3 and p62 showed punctate staining characteristic of autophagosome buildup. In the autophagic myopathy subjects, puncta were coarser and tended to coalesce into linear structures aligned with the longitudinal axis of the fiber, often in the vicinity of vacuoles. The percentage of LC3- and p62-positive fibers was significantly higher in the autophagic myopathy group compared to either the normal control (p<0.001) or the drug-treated control group (p<0.05). With the diagnostic threshold set between 8% and 15% positive fibers (depending on the desired level of sensitivity and specificity), immunohistochemical staining for either LC3 or p62 could be used to identify subjects with autophagic vacuolar myopathy within the drug-treated subject group (p≤0.001). Significance Immunohistochemistry for LC3 and p62 can facilitate tissue-based diagnosis of drug-induced autophagic vacuolar myopathies. By limiting the need for electron microscopy (a time consuming and costly technique with high specificity, but low sensitivity), clinical use of these markers will improve the speed and accuracy of diagnosis, resulting in significantly improved clinical care. PMID:22558391

The effects of the topical administration of non-steroidal anti-inflammatory drugs on corneal epithelium and corneal sensitivity in normal subjects.

PubMed

Aragona, P; Tripodi, G; Spinella, R; Laganà, E; Ferreri, G

2000-04-01

To study the changes in the corneal epithelium and corneal sensitivity of healthy subjects after the topical administration of non-steroidal anti-inflammatory drugs (NSAIDs; diclofenac, indomethacin, flurbiprofen and ketorolac) frequently used in ocular therapy. A double-masked parallel clinical study was undertaken on 90 subjects (45 men, 45 women; Caucasian; age 21-46 years, mean +/- SD 27.1 +/- 5 years). The subjects were divided into six groups: group 1 was treated with placebo, group 2 with 0.1% diclofenac, group 3 with 0.1% indomethacin, group 4 with 0.03% flurbiprofen, group 5 with 0.5% ketorolac and group 6 with 0.4% oxybuprocaine. One eye was randomly treated with the study drug and the fellow eye was treated with placebo. The medications were instilled four times, at 5 min intervals. Assessment of the corneal epithelium was carried out by vital fluorescein stain before instillation and 5, 15, 30 and 60 min after instillation of the last drop. Subjective burning sensation was assessed by asking participants to rate burning on a scale from 0 (none) to 3 (severe). After 1 week, assessment of corneal sensitivity was carried out by the Cochet-Bonnet method, repeating the above scheme of instillation and measurement times. None of the study drugs, with the exception of oxybuprocaine, produced evident epithelial damage. All the drugs caused a mean burning sensation greater than the placebo. The diclofenac-treated group showed a statistically significant decrease in corneal sensitivity (p < 0.001) at the measurement carried out 15 min after instillation of the last drop and lasting up to the end of the study, when the corneal anaesthesia was similar to that induced by the topical anaesthetic treatment. No significant changes were demonstrated for the other NSAIDs when compared either with the placebo-treated eyes or with the fellow eyes. Despite a similar mechanism of action and analgesic activity to the other NSAIDs tested, diclofenac was able to induce a reduction in corneal sensitivity. More studies are needed to determine the mechanism of action responsible for this effect.

Pomegranate supplementation improves cognitive and functional recovery following ischemic stroke: A randomized trial.

PubMed

Bellone, John A; Murray, Jeffrey R; Jorge, Paolo; Fogel, Travis G; Kim, Mary; Wallace, Desiree R; Hartman, Richard E

2018-02-13

We tested whether supplementing with pomegranate polyphenols can enhance cognitive/functional recovery after stroke. In this parallel, block-randomized clinical trial, we administered commercially-available pomegranate polyphenol or placebo pills twice per day for one week to adult inpatients in a comprehensive rehabilitation setting starting approximately 2 weeks after stroke. Pills contained 1 g of polyphenols derived from whole pomegranate, equivalent to levels in approximately 8 oz of juice. Placebo pills were similar to the pomegranate pills except that they contained only lactose. Of the 163 patients that were screened, 22 were eligible and 16 were randomized (8 per group). We excluded one subject per group from the neuropsychological analyses since they were lost to follow-up, but we included all subjects in the analysis of functional data since outcome data were available. Clinicians and subjects were blinded to group assignment. Neuropsychological testing (primary outcome: Repeatable Battery for the Assessment of Neuropsychological Status) and functional independence scores were used to determine changes in cognitive and functional ability. Pomegranate-treated subjects demonstrated more neuropsychological and functional improvement and spent less time in the hospital than placebo controls. Pomegranate polyphenols enhanced cognitive and functional recovery after stroke, justifying pursuing larger clinical trials.

Comparing diagnostic tests on benefit-risk.

PubMed

Pennello, Gene; Pantoja-Galicia, Norberto; Evans, Scott

2016-01-01

Comparing diagnostic tests on accuracy alone can be inconclusive. For example, a test may have better sensitivity than another test yet worse specificity. Comparing tests on benefit risk may be more conclusive because clinical consequences of diagnostic error are considered. For benefit-risk evaluation, we propose diagnostic yield, the expected distribution of subjects with true positive, false positive, true negative, and false negative test results in a hypothetical population. We construct a table of diagnostic yield that includes the number of false positive subjects experiencing adverse consequences from unnecessary work-up. We then develop a decision theory for evaluating tests. The theory provides additional interpretation to quantities in the diagnostic yield table. It also indicates that the expected utility of a test relative to a perfect test is a weighted accuracy measure, the average of sensitivity and specificity weighted for prevalence and relative importance of false positive and false negative testing errors, also interpretable as the cost-benefit ratio of treating non-diseased and diseased subjects. We propose plots of diagnostic yield, weighted accuracy, and relative net benefit of tests as functions of prevalence or cost-benefit ratio. Concepts are illustrated with hypothetical screening tests for colorectal cancer with test positive subjects being referred to colonoscopy.

Antidepressant use in Alzheimer's disease patients: results of the REAL.FR cohort.

PubMed

Arbus, Christophe; Gardette, Virginie; Bui, Eric; Cantet, Christelle; Andrieu, Sandrine; Nourhashémi, Fati; Schmitt, Laurent; Vellas, Bruno

2010-02-01

Psychotropic medication is widely prescribed in clinical practice for the management of behavioral and psychological symptoms of dementia (BPSD) in Alzheimer's disease (AD). However, there have been few pharmaco-epidemiological studies or studies conducted in a natural setting on the real use of antidepressants in AD. The aim of this survey was to assess the prevalence of antidepressant use in AD and to identify the clinical factors associated with antidepressant prescription. REAL.FR is a four-year, prospective, multi-center study. Baseline data including demographic characteristics, clinical variables and drug intake were obtained. Depressive symptoms were determined using the Neuropsychiatric Inventory (NPI). A total of 686 AD patients were included. Antidepressant treatment was prescribed for 34.8% of patients. Clinically significant depressive symptoms (NPI >or= 4) were observed in 20.5% of the total population. Although depressed subjects were significantly more likely to be treated with antidepressants than non-depressed subjects (p<0.0001), only 60% of depressed subjects overall were prescribed an antidepressant. In multivariate analysis, clinically significant depressive symptoms were associated with antidepressant prescription although this result was only observed in subjects without a previous history of depression. The available data on antidepressant efficacy in BPSD other than depression (in particular, agitation, aggression and, occasionally, psychotic symptoms) do not influence prescription choices. Depressive symptoms may be taken more seriously in the absence of a previous history of depression, leading to increased antidepressant prescription rates in individuals presenting with depression for the first time.

Relationship between resilience, social support as well as anxiety/depression of lung cancer patients: A cross-sectional observation study.

PubMed

Hu, Tingjie; Xiao, Jian; Peng, Juan; Kuang, Xiao; He, Bixiu

2018-01-01

The mood of patients with lung carcinoma would be greatly influenced by the diagnosing and treating processes. This study was aimed to explore the effects of resilience between social assistance and anxiety/depression of patients with lung cancer, which may assist in clinical intervention. A cross-sectional pilot study was conducted on lung cancer patients at Xiangya Hospital of Central South University, China. A total of 289 patients aged 25-81 years were included in this study. Correlational analyses revealed that anxiety/depression was negatively associated with psychological resilience and each dimension of social assistance, including subjective support, objective support along with the supports utilization (P < 0.01). Furthermore, psychological resilience was positively related to subjective support (P < 0.01), support utilization (P < 0.01) along with objective support (P < 0.05). Mediational analyses showed that, on the one hand, resilience could partially mediate the relation between anxiety and subjective support and totally mediate the relationship between support utilization and anxiety. On the other hand, resilience could totally mediate the relation between depression and subjective support and partially mediate the relation between support utilization and depression. However, resilience did not play an intermediary role between anxiety/depression and objective support. Lower psychological anxiety and depression would be experienced by lung cancer patients with higher resilience and social support. The level of anxiety and depression would be indirectly affected by social support through the mediation of resilience.

Rifaximin for small intestinal bacterial overgrowth in patients without irritable bowel syndrome.

PubMed

Boltin, Doron; Perets, Tsachi Tsadok; Shporn, Einav; Aizic, Shoshana; Levy, Sigal; Niv, Yaron; Dickman, Ram

2014-10-17

Rifaximin is a minimally absorbed antibiotic with high luminal activity, used to treat various gastrointestinal diseases. Although rifaximin has been proposed as first line treatment for small intestinal bacterial overgrowth (SIBO), few data are available regarding its efficacy in non-IBS subjects. We aimed to assess the ability of rifaximin to normalize lactulose-H2 breath tests in non-IBS subjects with symptoms suggestive of SIBO. Consecutive non-IBS patients presenting with bloating and flatulence were prospectively recruited and submitted to lactulose-H2 breath testing (LBT). Patients who had a positive result were offered rifaximin 1200 mg daily for 10 days. Breath testing was repeated two weeks after treatment completion in all patients in order to assess for response. A total of 19 patients with a positive result received rifaximin and repeated the breath test (7 (36.8%) males, age 56.5 ± 17.6 years). The mean peak hydrogen excretion was 13.7 ± 2.8 and 10.3 ± 7.3 ppm at baseline and following rifaximin treatment, respectively (t = 1.98, p = 0.06). LBT normalized in 8/19 (42.1%) subjects. No patients reported symptom resolution. No adverse events were reported. Strengths include the study's prospective design. Limitations include the small sample size and open label design. Rifaximin was not effective in normalizing LBT in our cohort of non-IBS subjects with symptoms suggestive of SIBO.

Immune Response Following Photodynamic Therapy For Bladder Cancer

NASA Astrophysics Data System (ADS)

Raymond K.

1989-06-01

This study was undertaken to determine if photodynamic therapy (PDT) produces an immunologic response in patients treated for bladder cancer. Gamma interferon, interleukin 1-beta, interleukin 2 and tumor necrosis factor-alpha were assayed in the urine of four patients treated with photodynamic therapy for bladder cancer, in seven patients undergoing transurethral procedures, and in five healthy control subjects. Quantifiable concentrations of all cytokines, except gamma interferon, were measured in urine samples from the PDT patients treated with the highest light energies, while no urinary cytokines were found in the PDT patient who received the lowest light energy or in the control subjects. These findings suggest that a local immunologic response may occur following PDT for bladder cancer. Such an immunologic response activated by PDT may be an additional mechanism involved in bladder tumor destruction.

Intrinsic sensory deprivation induced by neonatal capsaicin treatment induces changes in rat brain and behaviour of possible relevance to schizophrenia

PubMed Central

Newson, Penny; Lynch-Frame, Ann; Roach, Rebecca; Bennett, Sarah; Carr, Vaughan; Chahl, Loris A

2005-01-01

Schizophrenia is considered to be a neurodevelopmental disorder with origins in the prenatal or neonatal period. Brains from subjects with schizophrenia have enlarged ventricles, reduced cortical thickness (CT) and increased neuronal density in the prefrontal cortex compared with those from normal subjects. Subjects with schizophrenia have reduced pain sensitivity and niacin skin flare responses, suggesting that capsaicin-sensitive primary afferent neurons might be abnormal in schizophrenia. This study tested the hypothesis that intrinsic somatosensory deprivation, induced by neonatal capsaicin treatment, causes changes in the brains of rats similar to those found in schizophrenia. Wistar rats were treated with capsaicin, 50 mg kg−1 subcutaneously, or vehicle (control) at 24–36 h of life. At 5–7 weeks behavioural observations were made, and brains removed, fixed and sectioned. The mean body weight of capsaicin-treated rats was not significantly different from control, but the mean brain weight of male, but not female, rats, was significantly lower than control. Capsaicin-treated rats were hyperactive compared with controls. The hyperactivity was abolished by haloperidol. Coronal brain sections of capsaicin-treated rats had smaller cross-sectional areas, reduced CT, larger ventricles and aqueduct, smaller hippocampal area and reduced corpus callosum thickness, than brain sections from control rats. Neuronal density was increased in several cortical areas and the caudate putamen, but not in the visual cortex. It is concluded that neonatal capsaicin treatment of rats produces brain changes that are similar to those found in brains of subjects with schizophrenia. PMID:16041396

Prevalence and Annual Incidence of Thyroid Disease in Korea from 2006 to 2015: A Nationwide Population-Based Cohort Study.

PubMed

Kwon, Hyemi; Jung, Jin Hyung; Han, Kyung Do; Park, Yong Gyu; Cho, Jung Hwan; Lee, Da Young; Han, Ji Min; Park, Se Eun; Rhee, Eun Jung; Lee, Won Young

2018-06-01

The incidence of thyroid nodules has increased worldwide in recent years. Thyroid dysfunction is a potential risk factor for hypercholesterolemia, cardiovascular disease, osteoporosis, arrhythmia, and neuropsychiatric disease. This study investigated the prevalence and annual incidence of thyroid nodules, hypothyroidism, and hyperthyroidism in Koreans. In this nationwide population-based cohort study, 51,834,660 subjects were included using the National Health Information database from 2006 to 2015, after the exclusion of subjects with thyroid cancer. The prevalence in Korea in 2015 of thyroid nodules, hypothyroidism in patients taking thyroid hormone, and hyperthyroidism in patients undergoing treatment was 15.82/1,000 population, 15.94/1,000 population, and 2.76/1,000 population, respectively. All these diseases were more prevalent among women than among men. The number of incident cases of these three thyroid diseases steadily increased from 2006 to 2012, and then decreased through 2015. The incidence of thyroid nodules, hypothyroidism treated with thyroid hormone, and treated hyperthyroidism was 6.79/1,000 population, 1.76/1,000 population, and 0.55/1,000 population, respectively, in Korea in 2015. The use of methimazole continuously increased, from 33% of total antithyroid drug prescriptions in 2006 to 74.4% in 2015, and it became the most frequently prescribed antithyroid drug in Korea. In contrast, the use of propylthiouracil continuously decreased. This was the first nationwide study of the prevalence and annual incidence of thyroid nodules, hypothyroidism, and hyperthyroidism to take into account recent changes and to include the current status of patients receiving treatment. Copyright © 2018 Korean Endocrine Society.

The predictive consequences of parameterization

NASA Astrophysics Data System (ADS)

White, J.; Hughes, J. D.; Doherty, J. E.

2013-12-01

In numerical groundwater modeling, parameterization is the process of selecting the aspects of a computer model that will be allowed to vary during history matching. This selection process is dependent on professional judgment and is, therefore, inherently subjective. Ideally, a robust parameterization should be commensurate with the spatial and temporal resolution of the model and should include all uncertain aspects of the model. Limited computing resources typically require reducing the number of adjustable parameters so that only a subset of the uncertain model aspects are treated as estimable parameters; the remaining aspects are treated as fixed parameters during history matching. We use linear subspace theory to develop expressions for the predictive error incurred by fixing parameters. The predictive error is comprised of two terms. The first term arises directly from the sensitivity of a prediction to fixed parameters. The second term arises from prediction-sensitive adjustable parameters that are forced to compensate for fixed parameters during history matching. The compensation is accompanied by inappropriate adjustment of otherwise uninformed, null-space parameter components. Unwarranted adjustment of null-space components away from prior maximum likelihood values may produce bias if a prediction is sensitive to those components. The potential for subjective parameterization choices to corrupt predictions is examined using a synthetic model. Several strategies are evaluated, including use of piecewise constant zones, use of pilot points with Tikhonov regularization and use of the Karhunen-Loeve transformation. The best choice of parameterization (as defined by minimum error variance) is strongly dependent on the types of predictions to be made by the model.

The effect of methylphenidate on prefrontal cognitive functioning, inattention, and hyperactivity in velocardiofacial syndrome.

PubMed

Green, Tamar; Weinberger, Ronnie; Diamond, Adele; Berant, Michael; Hirschfeld, Leora; Frisch, Amos; Zarchi, Omer; Weizman, Abraham; Gothelf, Doron

2011-12-01

Methylphenidate (MPH) is commonly used to treat attention-deficit/hyperactivity disorder (ADHD) in all children, including those with velocardiofacial syndrome (VCFS). Yet concerns have been raised regarding its safety and efficacy in VCFS. The goal of this study was to examine the safety and efficacy of MPH in children with VCFS. Thirty-four children and adolescents with VCFS and ADHD participated in a randomized, controlled trial with a 2:1 ratio of MPH versus placebo. All subjects underwent a cardiological evaluation before and after MPH administration. The primary outcome measure was prefrontal cognitive performance following a single dose of MPH or placebo. A follow-up assessment was conducted after a 6-month treatment with MPH. Compared with placebo, single MPH administration was associated with a more robust improvement in prefrontal cognitive performance, including achievements in the Hearts and Flowers executive function task and the visual continuous performance task. After 6 months of treatment, a 40% reduction in severity of ADHD symptoms was reported by parents on the Revised Conners Rating Scale. All subjects treated with MPH reported at least one side effect, but it did not necessitate discontinuation of treatment. MPH induced an increase in heart rate and blood pressure that was usually minor, but was clinically significant in two cases. No differences in response to MPH were observed between catechol-O-methyltransferase Met versus Val carriers. The use of MPH in children with VCFS appears to be effective and relatively safe. A comprehensive cardiovascular evaluation for children with VCFS before and during stimulant treatment is recommended.

No evidence of depression, anxiety, and sexual dysfunction following penile fracture.

PubMed

Penbegul, N; Bez, Y; Atar, M; Bozkurt, Y; Sancaktutar, A A; Soylemez, H; Ozen, S

2012-01-01

There is a gap in the literature about psychological status of patients following penile fracture surgery. We aimed to assess the long-term psychological status of penile fracture patients who have been treated by immediate surgical repair. A total of 32 patients with penile fracture have been treated surgically at our center. These 32 patients and 30 healthy control subjects were included in the study. All participants have completed the Hospital Anxiety and Depression Scale (HADS), Glombok-Rust Inventory of Satisfaction Scale (GRISS), and the premature ejaculation diagnostic tool (PEDT). The mean age of patients was 30.4 years and the mean body mass index was 27.3 kg m(-2). Sexual intercourse was the most common cause of the fracture. Immediate surgical repair was performed in all cases using a circumferential subcoronal incision and none of the patients had urethral injury intraoperatively. All tears were unilateral with a mean size of 1.5 cm. Only two patients had superficial dorsal vein rupture. At the day of assessment, the mean time elapsed after penile trauma was 15.9±6.3 months (range: 6-23). Only three patients had complications due to penile fracture including minimal penile curvature, penile nodule, and penile pain during intercourse. The mean scores obtained from PEDT, HADS, and GRISS did not show any statistically significant difference between groups. Anxiety, depression, premature ejaculation, and sexual dyssatisfaction levels were similar in both penile fracture patients who underwent immediate surgical repair and healthy control subjects. Immediate surgical repair of corporal ruptures have not shown any harmful psychogenic sequelae on patients with penile fracture.

The short-term treatment effects on the microbiota at the dorsum of the tongue in intra-oral halitosis patients--a randomized clinical trial.

PubMed

Ademovski, Seida Erovic; Persson, G Rutger; Winkel, Edwin; Tangerman, Albert; Lingström, Peter; Renvert, Stefan

2013-03-01

This study aims to assess the effects of rinsing with zinc- and chlorhexidine-containing mouth rinse with or without adjunct tongue scraping on volatile sulfur compounds (VSCs) in breath air, and the microbiota at the dorsum of the tongue. A randomized single-masked controlled clinical trial with a cross-over study design over 14 days including 21 subjects was performed. Bacterial samples from the dorsum of the tongue were assayed by checkerboard DNA-DNA hybridization. No halitosis (identified by VSC assessments) at day 14 was identified in 12/21 subjects with active rinse alone, in 10/21 with adjunct use of tongue scraper, in 1/21 for negative control rinse alone, and in 3/21 in the control and tongue scraping sequence. At day 14, significantly lower counts were identified only in the active rinse sequence (p < 0.001) for 15/78 species including, Fusobacterium sp., Porphyromonas gingivalis, Pseudomonas aeruginosa, Staphylococcus aureus, and Tannerella forsythia. A decrease in bacteria from baseline to day 14 was found in successfully treated subjects for 9/74 species including: P. gingivalis, Prevotella melaninogenica, S. aureus, and Treponema denticola. Baseline VSC scores were correlated with several bacterial species. The use of a tongue scraper combined with active rinse did not change the levels of VSC compared to rinsing alone. VSC scores were not associated with bacterial counts in samples taken from the dorsum of the tongue. The active rinse alone containing zinc and chlorhexidine had effects on intra-oral halitosis and reduced bacterial counts of species associated with malodor. Tongue scraping provided no beneficial effects on the microbiota studied. Periodontally healthy subjects with intra-oral halitosis benefit from daily rinsing with zinc- and chlorhexidine-containing mouth rinse.

Nuclear Receptors and AMPK: Can Exercise Mimetics Cure Diabetes?

PubMed Central

Wall, Christopher E.; Yu, Ruth T.; Atkins, Anne R.; Downes, Michael; Evans, Ronald M.

2016-01-01

Endurance exercise can lead to systemic improvements in insulin sensitivity and metabolic homeostasis, and is an effective approach to combat metabolic diseases. Pharmacological compounds that recapitulate the beneficial effects of exercise, also known as “exercise mimetics,” have the potential to improve disease symptoms of metabolic syndrome. These drugs, which can increase energy expenditure, suppress hepatic gluconeogenesis, and induce insulin sensitization, have accordingly been highly scrutinized for their utility in treating metabolic diseases including diabetes. Nevertheless, the identity of an efficacious exercise mimetic still remains elusive. In this article, we will highlight several nuclear receptors and cofactors that are putative molecular targets for exercise mimetics, and review recent studies that provide advancements in our mechanistic understanding of how exercise mimetics exert their beneficial effects. We will also discuss evidence from clinical trials utilizing these compounds in human subjects to evaluate their efficacy in treating diabetes. PMID:27106806

Eight years later: outcomes of CBT-treated versus untreated anxious children.

PubMed

Adler Nevo, Gili W; Avery, David; Fiksenbaum, Lisa; Kiss, Alex; Mendlowitz, Sandra; Monga, Suneeta; Manassis, Katharina

2014-09-01

Anxiety disorders are the most common psychiatric disorders of childhood, generate significant distress, are considered precursors to diverse psychiatric disorders, and lead to poor social and employment outcomes in adulthood. Although childhood anxiety has a significant impact on a child's developmental trajectory, only a handful of studies examined the long-term impact of treatment and none included a control group. The aim of this study was to conduct a long-term follow-up (LTFU) of anxious children who were treated with Cognitive-Behavioral Therapy (CBT) compared to a matched group of children who were not. Subjects comprised 120 children: a treatment group which included the first 60 consecutive consenting children who were diagnosed with an anxiety disorder and treated with CBT between the years 1997 and 2003 and a control group, 60 matched children who were assessed but not treated with CBT. An "ex-post-facto" design was used to compare the two groups. Children showed lower rates of anxiety diagnosis (about 50% for both groups) and significantly improved functioning at LTFU (time effect P < 0.0001; no group difference). Anxiety levels were significantly lower in the nontreatment group at LTFU as compared to initial assessment (P = 0.02), but not in the treatment group, and a significant between-group difference was found (P = 0.01) according to child. An inverse relationship was found between self-efficacy/self-esteem and anxiety outcome ([P = 0.0008] and [P = 0.04], respectively). This study supports the assumption that childhood anxiety disorders may improve without treatment and highlights self-efficacy/self-esteem as potential factors in recovery.

Survey on diabetic patients treated with insulin during the fasting month of Ramadan

PubMed Central

Abid, Mohamed; Hsairi, Mohamed; Elleuch, Mouna; Ben Aissa, Emna

2018-01-01

Aim To estimate the proportion of diabetic patients on insulin, who interrupt fasting during Ramadan, and describe the reported reasons of this interruption. Design This is a national observational survey of diabetic patients treated with insulin and fasting during the month of Ramadan 2013, proposed to all endocrinologists willing to participate. Consecutive patients were included until the required sample size, estimated at 498 patients, was obtained. Conducted among patients recruited by endocrinologists during the month following Ramadan 2013. Results Five hundred twenty-six (526) patients were included, of which 51 (9.7%) had type 1 diabetes. The mean age was 36.8 ± 11.6 and 58.3 ± 10.0 years for type 1 and type 2 diabetes, respectively. The proportions of male subjects were 62.8% and 57.5% for type 1 and type 2 diabetes, respectively. The mean duration of diabetes was 11.0 ± 8.8 and 14.4 ± 7.9 years for type 1 and type 2 diabetes, respectively. During Ramadan, more than 55% (54.9% and 55.8% for type 1 and type 2 diabetes, respectively) of patients were treated with insulin analog and over a third with mixed insulin. In this study population, 71.5% reported having fasted without interruption during the month of Ramadan. The average number of non-fasted days was 3.0 ± 6.7, mainly due to hypoglycemic episodes. Conclusion According to this observational survey conducted in Tunisia, most patients with diabetes treated with insulin (insulin in more than half of the cases) were able to fast without interruption during Ramadan. PMID:29416371

Evaluation of crystalline changes and resistance to demineralization of the surface of human dental enamel treated with Er:YAG laser and fluoride using x-ray diffraction analysis and Vickers microhardness

NASA Astrophysics Data System (ADS)

Behroozibakhsh, Marjan; Shahabi, Sima; Ghavami-Lahiji, Mehrsima; Sadeghian, Safura; Sadat Faal Nazari, Neda

2018-06-01

This study aimed to investigate the changes in crystalline structure and resistance to demineralization of human dental surface enamel treated with erbium-doped yttrium aluminium garnet laser (Er:YAG) laser and fluoride. The enamel surfaces were divided into four groups according to the treatment process including, (L): irradiated with Er:YAG; (F): treated with acidulated phosphate fluoride gel (LF): Pre-irradiated surfaces with Er:YAG subjected to acidulated phosphate fluoride gel and (FL): laser irradiation was performed on the fluoridated enamel surface. Before and after the treatment procedure, the samples were evaluated using X-ray diffraction, scanning electron microscope (SEM) and the Vickers microhardness test. The surface microhardness values also were measured after a pH-cycling regime and acid challenge. The a-axis of all lased groups was contracted after treatment procedure. Measurement of the area under the peaks showed the highest crysallinity in the FL group. The hardness values of all laser treated samples significantly reduced after treatment procedure compared to the F group (p  ⩽  0.001). The morphological observations showed remarkable changes on the lased enamel surfaces including cracks, craters and exposed prisms. These findings suggest, irradiation of the Er:YAG laser accompanying with fluoride application can induce some beneficial crystalline changes regarding the acid-resistance properties of enamel, however, the craters and cracks produced by laser irradiation can promote enamel demineralization and consequently the positive effects of the Er:YAG laser will be eliminated.

Thyroid function tests in patients taking thyroid medication in Germany: Results from the population-based Study of Health in Pomerania (SHIP).

PubMed

Hannemann, Anke; Friedrich, Nele; Haring, Robin; Krebs, Alexander; Völzke, Henry; Alte, Dietrich; Nauck, Matthias; Kohlmann, Thomas; Schober, Hans-Christof; Hoffmann, Wolfgang; Wallaschofski, Henri

2010-08-16

Studies from iodine-sufficient areas have shown that a high proportion of patients taking medication for thyroid diseases have thyroid stimulating hormone (TSH) levels outside the reference range. Next to patient compliance, inadequate dosing adjustment resulting in under- and over-treatment of thyroid disease is a major cause of poor therapy outcomes. Using thyroid function tests, we aim to measure the proportions of subjects, who are under- or over-treated with thyroid medication in a previously iodine-deficient area. Data from 266 subjects participating in the population-based Study of Health in Pomerania (SHIP) were analysed. All subjects were taking thyroid medication. Serum TSH levels were measured using immunochemiluminescent procedures. TSH levels of < 0.27 or > 2.15 mIU/L in subjects younger than 50 years and < 0.19 or > 2.09 mIU/L in subjects 50 years and older, were defined as decreased or elevated, according to the established reference range for the specific study area. Our analysis revealed that 56 of 190 (29.5%) subjects treated with thyroxine had TSH levels outside the reference range (10.0% elevated, 19.5% decreased). Of the 31 subjects taking antithyroid drugs, 12 (38.7%) had TSH levels outside the reference range (9.7% elevated, 29.0% decreased). These proportions were lower in the 45 subjects receiving iodine supplementation (2.2% elevated, 8.9% decreased). Among the 3,974 SHIP participants not taking thyroid medication, TSH levels outside the reference range (2.8% elevated, 5.9% decreased) were less frequent. In concordance with previous studies in iodine-sufficient areas, our results indicate that a considerable number of patients taking thyroid medication are either under- or over-treated. Improved monitoring of these patients' TSH levels, compared to the local reference range, is recommended.

Flight microangiopathy on long-haul flights: prevention of edema and microcirculation alterations with Venoruton.

PubMed

Cesarone, M R; Belcaro, G; Geroulakos, G; Griffin, M; Ricci, A; Brandolini, R; Pellegrini, L; Dugall, M; Ippolito, E; Candiani, C; Simeone, E; Errichi, B M; Di Renzo, A

2003-04-01

The aim of this study was the evaluation of the effects of Venoruton (HR) on the prevention and control of flight microangiopathy and edema in subjects with varicose veins flying for more than 7 hours. A group of 80 patients with varicose veins, edema, and initial skin alterations due to chronic venous hypertension were included. Measurements of skin laser Doppler (LDF) resting flux (RF), PO2 and rate of ankle swelling (RAS), were made before and after the flights (within 2 hours before the flights and within 2 hours after the flights). The length of the flights was between 7 and 9 hours; all seats were in coach class. The two groups (treatment and control) were comparable for age and sex distribution. The variation (decrease) in PO2 was significant in both groups. In subjects treated with HR the decrease in PO2 was smaller (p < 0.05). The decrease in LDF-RF was significant in both groups with a higher flux at the end of the flight in the treated subjects (p < 0.05). The venoarteriolar response was decreased at the end of the flights. The decrease was less evident in the treatment group (p < 0.05). The increase in RAS was significant in the control group while it was limited in the HR group. In conclusion, HR is useful for reducing the increased capillary filtration and in controlling edema in patients with chronic venous disease in long-haul flights. HR is effective to control flight microangiopathy associated with edema.

Clinical Pharmacokinetics and Pharmacodynamics of Febuxostat.

PubMed

Kamel, Bishoy; Graham, Garry G; Williams, Kenneth M; Pile, Kevin D; Day, Richard O

2017-05-01

Febuxostat is a xanthine oxidoreductase inhibitor that has been developed to treat chronic gout. In healthy subjects, the pharmacokinetic parameters of febuxostat after multiple oral dose administration include an oral availability of about 85 %, an apparent oral clearance (CL/F) of 10.5 ± 3.4 L/h and an apparent volume of distribution at steady state (V ss /F) of 48 ± 23 L. The time course of plasma concentrations follows a two-compartment model. The initial half-life (t ½ ) is approximately 2 h and the terminal t ½ determined at daily doses of 40 mg or more is 9.4 ± 4.9 h. Febuxostat is administered once daily. The maximum (peak) plasma concentrations are approximately 100-fold greater than the trough concentrations. Consequently, there is no significant accumulation of the drug during multiple dose administration. There are few data on the pharmacokinetics of febuxostat in patients with gout. While the pharmacokinetic parameters are not affected by mild to moderate hepatic impairment, there is no consensus on whether renal impairment has any effect on the pharmacokinetics of febuxostat. Febuxostat is extensively metabolised by oxidation (approximately 35 %) and acyl glucuronidation (up to 40 %); febuxostat acyl glucuronides are cleared by the kidney. In healthy subjects treated with multiple doses of febuxostat 10-240 mg, the concentrations of serum urate are reduced by a maximum of about 80 %. The percentage reduction in the concentrations of serum urate is slightly less in gouty patients than in healthy subjects.

Telomerase reverse transcriptase (TERT) expression and role of vincristine sulfate in mouse model of malignancy related peritoneal ascites: an experimental metastatic condition.

PubMed

Chaklader, M; Das, P; Pereira, J A; Chatterjee, S; Basak, P; Law, A; Banerjee, T; Chauhan, S; Law, S

2011-06-01

To evaluate the efficacy of intraperitoneal vincristine administration into ascitic sarcoma-180 bearing mice as a model of human malignant ascites regarding various peritoneal/retroperitoneal sarcomatosis, and to evaluate the flowcytometric telomerase reverse transcriptase expression for the diagnostic and prognostic purposes. Present study included disease induction by intraperitoneal homologous ascitic sarcoma-180 transplantation followed by in vivo intraperitoneal drug administration to study mitotic index, flowcytometric cell cycle and telomerase reverse transcriptase expression pattern, erythrosin-B dye exclusion study for malignant cell viability assessment. Besides, in vitro malignant ascite culture in presence and absence of vincristine sulfate and survival study were also taken into consideration. Intraperitoneal vincristine administration (concentration 0.5 mg/kg body weight) significantly diminished the mitotic index in diseased subjects in comparison to untreated control subjects. Treated group of animals showed increased life span and median survival time. Cell viability assessment during the course of drug administration also revealed gradual depression on cell viability over time. Flowcytometric cell cycle analysis showed a good prognostic feature of chemotherapeutic administration schedule by representing high G2/M phase blocked cells along with reduced telomerase reverse transcriptase positive cells in treated animals. We conclude that long term administration of vincristine sulfate in small doses could be a good pharmacological intervention in case of malignant peritoneal ascites due to sarcomatosis as it indirectly reduced the level of telomerase reverse transcriptase expression in malignant cells by directly regulating cell cycle and simultaneously increased the life expectancy of the diseased subjects.

Therapy with gastric acidity inhibitors increases the risk of acute gastroenteritis and community-acquired pneumonia in children.

PubMed

Canani, Roberto Berni; Cirillo, Pia; Roggero, Paola; Romano, Claudio; Malamisura, Basilio; Terrin, Gianluca; Passariello, Annalisa; Manguso, Francesco; Morelli, Lorenzo; Guarino, Alfredo

2006-05-01

Gastric acidity (GA) inhibitors, including histamine-2 receptor antagonists (H2 blockers) and proton pump inhibitors (PPIs), are the mainstay of gastroesophageal reflux disease (GERD) treatment. A prolonged GA inhibitor-induced hypochlorhydria has been suggested as a risk factor for severe gastrointestinal infections. In addition, a number of papers and a meta-analysis have shown an increased risk of pneumonia in H2-blocker-treated intensive care patients. More recently, an increased risk of community-acquired pneumonia associated with GA inhibitor treatment has been reported in a large cohort of adult patients. These findings are particularly relevant to pediatricians today because so many children receive some sort of GA-blocking agent to treat GERD. To test the hypothesis that GA suppression could be associated with an increased risk of acute gastroenteritis and pneumonia in children treated with GA inhibitors, we conducted a multicenter, prospective study. The study was performed by expert pediatric gastroenterologists from 4 pediatric gastroenterology centers. Children (aged 4-36 months) consecutively referred for common GERD-related symptoms (for example, regurgitation and vomiting, feeding problems, effortless vomiting, choking), from December 2003 to March 2004, were considered eligible for the study. Exclusion criteria were a history of GA inhibitors therapy in the previous 4 months, Helicobacter pylori infection, diabetes, chronic lung or heart diseases, cystic fibrosis, immunodeficiency, food allergy, congenital motility gastrointestinal disorders, neuromuscular diseases, or malnutrition. Control subjects were recruited from healthy children visiting the centers for routine examinations. The diagnosis of GERD was confirmed in all patients by standard criteria. GA inhibitors (10 mg/kg ranitidine per day in 50 children or 1 mg/kg omeprazole per day in 50 children) were prescribed by the physicians for 2 months. All enrolled children were evaluated during a 4-month follow-up. The end point was the number of patients presenting with acute gastroenteritis or community-acquired pneumonia during a 4-month follow-up study period. We obtained data in 186 subjects: 95 healthy controls and 91 GA-inhibitor users (47 on ranitidine and 44 on omeprazole). The 2 groups were comparable for age, gender, weight, length, and incidence of acute gastroenteritis and pneumonia in the 4 months before enrollment. Rate of subjects presenting with acute gastroenteritis and community-acquired pneumonia was significantly increased in patients treated with GA inhibitors compared with healthy controls during the 4-month follow-up period. In the GA inhibitor-treated group, the rate of subjects presenting with acute gastroenteritis and community-acquired pneumonia was increased when comparing the 4 months before and after enrollment. No differences were observed between H2 blocker and PPI users in acute gastroenteritis and pneumonia incidence in the previous 4 months and during the follow-up period. On the contrary, in healthy controls, the incidence of acute gastroenteritis and pneumonia remained stable. This is the first prospective study performed in pediatric patients showing that the use of GA inhibitors was associated with an increased risk of acute gastroenteritis and community-acquired pneumonia in GERD-affected children. It could be interesting to underline that we observed an increased incidence of intestinal and respiratory infection in otherwise healthy children taking GA inhibitors for GERD treatment. On the contrary, the majority of the previous data showed that the patients most at risk for pneumonia were those with significant comorbid illnesses such as diabetes or immunodeficiency, and this points to the importance of GA suppression as a major risk factor for infections. In addition, this effect seems to be sustained even after the end of therapy. The results of our study are attributable to many factors, including direct inhibitory effect of GA inhibitors on leukocyte functions and qualitative and quantitative gastrointestinal microflora modification. Additional studies are necessary to investigate the mechanisms of the increased risk of infections in children treated with GA inhibitors, and prophylactic measures could be considered in preventing them.

SA17. Response to Treatment With Valbenazine (NBI-98854) in Subjects With Tardive Dyskinesia

PubMed Central

Kane, John; Josiassen, Richard; Burke, Joshua; Jimenez, Roland; Siegert, Scott; Liang, Grace

2017-01-01

Abstract Background: Tardive dyskinesia (TD) is a persistent and potentially disabling movement disorder resulting from exposure to dopamine receptor-blocking agents (DRBAs), such as antipsychotics. Valbenazine is a novel and highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor that is being evaluated for the treatment of TD and other movement disorders. Clinical studies include a Phase 3 trial of valbenazine in adults who had TD and underlying schizophrenia/schizoaffective disorder or mood disorder (KINECT 3; NCT02274558). The primary end point of this trial was met as demonstrated by a significant difference between valbenazine 80 mg/day and placebo for the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score (Items 1–7) change from baseline. Additional analyses of AIMS data from this trial were conducted to assess treatment response in subjects with TD. Methods: In this 6-week, double-blind, placebo-controlled trial, subjects were randomized 1:1:1 to once-daily treatment with valbenazine 80 mg, valbenazine 40 mg, or placebo. Treatment response was defined as ≥50% reduction in the AIMS total score. AIMS responders were analyzed by study visit (Weeks 2, 4, and 6) in the intent-to-treat (ITT) population and in subgroups categorized by underlying psychiatric diagnosis (schizophrenia/schizoaffective disorder or mood disorder). Numbers needed to treat (NNTs) were calculated for AIMS responders (valbenazine vs placebo) at Week 6. Significance testing was not conducted in the subgroups. Results: At Week 6 in the ITT population (N = 225), AIMS responder rates were significantly higher with valbenazine than with placebo: 80 mg, 40.0% (P < .0001; NNT = 4); 40 mg, 23.8% (P = .0200; NNT=7); placebo, 8.7%. Treatment with valbenazine 80 mg versus placebo also resulted in significantly higher responder rates at Week 2 (23.4% vs 5.3%, P = .0016) and Week 4 (28.8% vs 9.7%, P = 0.0039). Subjects treated with valbenazine 40 mg also had higher response rates at Week 2 (14.3% vs 5.3%) and Week 4 (15.6% vs 9.7%) relative to placebo-treated subjects, but the differences were not statistically significant. In subjects with schizophrenia/schizoaffective disorder (n = 148) or mood disorder (n = 77), AIMS responder rates were higher with valbenazine than placebo at all study visits. The highest responder rates were found at Week 6 and similar in the schizophrenia subgroup (80 mg, 40.9%, NNT = 4; 40 mg, 26.2%, NNT = 6; placebo, 9.3%) and mood subgroup (80 mg, 38.5%, NNT = 4; 40 mg, 19.0%, NNT=9; placebo, 7.7%). Conclusion: These study results, based on a rigorous definition of treatment response, indicate that substantial TD improvements occurred more frequently with valbenazine than placebo in adults diagnosed with schizophrenia/schizoaffective disorder or mood disorder. A significant difference between the 80-mg dose and placebo for the AIMS response was observed as early as 2 weeks of treatment.

Prospective Clinical Study of 551 Cases of Liposuction and Abdominoplasty Performed Individually and in Combination

PubMed Central

2013-01-01

Background: Despite the popularity of these procedures, there are limited published prospective studies evaluating liposuction and abdominoplasty. Lipoabdominoplasty is a subject of recent attention. Several investigators have recommended alternative techniques that preserve the Scarpa fascia in an effort to reduce complications, particularly the risk of seromas. Methods: Over a 5-year period, 551 consecutive patients were treated with ultrasonic liposuction alone (n = 384), liposuction/abdominoplasty (n = 150), or abdominoplasty alone (n = 17). In lipoabdominoplasties, the abdomen and flanks were first treated with liposuction. A traditional flap dissection was used for all abdominoplasties. Scalpel dissection was used rather than electrodissection. A supine “jackknife” position was used in surgery to provide maximum hip flexion, allowing a secure deep fascial repair. Results: The complication rate after liposuction was 4.2% vs 50% for patients treated with an abdominoplasty. Approximately half of the abdominoplasty complications were minor scar deformities, including widened umbilical scars (17.3%) that were revised. The seroma rate after abdominoplasties was 5.4%; there were no seromas after liposuction alone. Conclusions: Lipoabdominoplasty may be performed safely, so that patients may benefit from both modalities. The seroma rate is reduced by avoiding electrodissection, making Scarpa fascia preservation a moot point. A deep fascial repair keeps the abdominoplasty scar within the bikini line. Deep venous thrombosis and other complications may be minimized with precautions that do not include anticoagulation. PMID:25289226

A prospective, randomised, within-subject study of ALA-PDT for actinic keratoses using different irradiation regimes.

PubMed

Zaar, O; Sjöholm Hylén, A; Gillstedt, M; Paoli, J

2018-05-12

Photodynamic therapy (PDT) can be used to treat large fields of actinic keratoses (AKs) with high clearance rates. A notable downside is the amount of pain that accompany the treatment. This study aimed to optimise the illumination protocol during conventional PDT in order to reduce pain without compromising treatment effectiveness. In this prospective, randomised study with a split-face design, patients with, symmetrically distributed AKs were included. All patients were treated using a ALA 78 mg/g gel. One side was illuminated with the Aktilite ® CL-128 lamp and the other side with the RhodoLED ® lamp in which the light intensity gradually increased to a maximum of 60%. Both sides received a total light dose of 37 J/cm 2 . Pain during the treatment was measured using a visual analogue scale. The clinical effectiveness of the two treated sides was assessed after 12 weeks. 29 patients with 399 AKs were included. Illumination with the gradually increasing light intensity resulted in a decrease of the median VAS score by 1.1 points. Clearance rates were similar between the two lamps. Minimising the light intensity during the illumination phase of PDT reduces pain, while still preserving a high clearance rate of AKs. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Endoscopic balloon dilatation as an effective treatment for lower and upper benign gastrointestinal system anastomotic stenosis.

PubMed

Akarsu, Cevher; Unsal, Mustafa Gokhan; Dural, Ahmet Cem; Kones, Osman; Kocatas, Ali; Karabulut, Mehmet; Kankaya, Burak; Ates, Mustafa; Alis, Halil

2015-04-01

Endoscopic balloon dilatation (EBD) is currently accepted as an effective, safe, and first-line treatment of postoperative benign gastrointestinal anastomosis stenosis (BGAS); however, a limited number of publications on the subject exist in the literature. The aim of the study was to retrospectively evaluate the efficiency of endoscopic dilatation in patients with postoperative intestinal anastomotic stenoses at a single surgical center. Patients with postoperative BGAS treated by EBD at our institution from February 2008 to 2012 were included. The dilatations were all performed using through-the-scope balloons. The balloon was introduced into the stricture using a guidewire under radiologic guidance. Each dilatation session consisted of 2 to 3 two-minute multistep inflations of the balloon until adequate dilatation was achieved. Of the 48 patients included in the study, 44 patients (91.7%) fully recovered and 4 (8.3%) did not respond to treatment. The mean follow-up period was 24 months (range, 3 to 57 mo). Four patients who did not respond to the procedure were treated surgically. Two patients (4.1%) with intestinal perforation during EBD were treated conservatively with a stent. EBD has a low rate of complications and a high success rate, is well tolerated, and avoids further surgical procedures for BGAS. Therefore, EBD should be the first choice of treatment for postoperative anastomotic stenoses.

Long-Term Major Clinical Outcomes in Patients With Long Chain Fatty Acid Oxidation Disorders Before and After Transition to Triheptanoin Treatment—A Retrospective Chart Review

PubMed Central

Vockley, Jerry; Marsden, Deborah; McCracken, Elizabeth; DeWard, Stephanie; Barone, Amanda; Hsu, Kristen; Kakkis, Emil

2015-01-01

Background Long chain fatty acid oxidation disorders (LC-FAOD) are caused by defects in the metabolic pathway that converts stored long-chain fatty acids into energy, leading to a deficiency in mitochondrial energy production during times of physiologic stress and fasting. Severe and potentially life threatening clinical manifestations include rhabdomyolysis, hypoglycemia, hypotonia/weakness, cardiomyopathy and sudden death. We present the largest cohort of patients to date treated with triheptanoin, a specialized medium odd chain (C7) triglyceride, as a novel energy source for the treatment of LC-FAOD. Methods This was a retrospective, comprehensive medical record review study of data from 20 of a total 24 patients with LC-FAOD who were treated for up to 12.5 years with triheptanoin, as part of a compassionate use protocol. Clinical outcomes including hospitalization event rates, number of hospitalization days/year, and abnormal laboratory values were determined for the total period of the study before and after triheptanoin treatment, as well as for specified periods before and after initiation of triheptanoin treatment. Other events of interest were documented including rhabdomyolysis, hypoglycemia, and cardiomyopathy. Results LC-FAOD in these 20 subjects was associated with 320 hospitalizations from birth to the end date of study. The mean hospitalization days/year decreased significantly by 67% during the period after triheptanoin initiation (n=15; 5.76 vs 17.55 vs; P=0.0242) and a trend toward a 35% lower hospitalization event rate was observed in the period after triheptanoin initiation compared with the before-treatment period (n=16 subjects >6 months of age; 1.26 vs 1.94; P=0.1126). The hypoglycemia event rate per year in 9 subjects with hypoglycemia problems declined significantly by 96% (0.04 vs 0.92; P=0.0091) and related hospitalization days/year were also significantly reduced (n=9; 0.18 vs 8.42; P=0.0257). The rhabdomyolysis hospital event rate in 11 affected subjects was similar before and after treatment but the number of hospitalization days/year trended lower in the period after triheptanoin initiation (n=9; 2.36 vs 5.94; P=0.1224) and peak CK levels trended toward a 68% decrease from 85,855 to 27,597 units in 7 subjects with reported peak CK values before and after treatment (P=0.1279). Triheptanoin was generally well tolerated. Gastrointestinal symptoms were the most commonly reported side effects. Conclusions This retrospective study represents the largest analysis reported to date of treatment of LC-FAOD with triheptanoin. The data suggest that triheptanoin improves the course of disease by decreasing the incidence and duration of major clinical manifestations and should be the focus of prospective investigations. Significant heterogeneity in the routine clinical care provided to subjects during the periods studied and the natural variation of clinical course of LC-FAODs with time emphasize the need additioanl study of the use of triheptanoin. PMID:26116311

The windowed sound therapy: a new empirical approach for an effectiv personalized treatment of tinnitus.

PubMed

Lugli, Marco; Romani, Romano; Ponzi, Stefano; Bacciu, Salvatore; Parmigiani, Stefano

2009-01-01

We auditorily stimulated patients affected by subjective tinnitus with broadband noise containing a notch around their tinnitus frequency. We assessed the long-term effects on tinnitus perception in patients listening to notched noise stimuli (referred to as windowed sound therapy [WST]) by measuring the variation of subjects' tinnitus loudness over a period of 2-12 months. We tested the effectiveness of WST using non-notched broadband noise and noise of water as control sound therapies. We found a significant long-term reduction of tinnitus loudness in subjects treated with notched noise but not in those treated with control stimulations. These results point to the importance of the personalized sound treatment of tinnitus sufferers for the development of an effective tinnitus sound therapy.

22 CFR 229.445 - Marital or parental status.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., or marital status that treats students differently on the basis of sex. (b) Pregnancy and related...'s pregnancy, childbirth, false pregnancy, termination of pregnancy, or recovery therefrom, unless... offered to non-pregnant students. (4) Subject to § 229.235(d), a recipient shall treat pregnancy...

22 CFR 146.445 - Marital or parental status.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., or marital status that treats students differently on the basis of sex. (b) Pregnancy and related...'s pregnancy, childbirth, false pregnancy, termination of pregnancy, or recovery therefrom, unless... offered to non-pregnant students. (4) Subject to § 146.235(d), a recipient shall treat pregnancy...

22 CFR 229.445 - Marital or parental status.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., or marital status that treats students differently on the basis of sex. (b) Pregnancy and related...'s pregnancy, childbirth, false pregnancy, termination of pregnancy, or recovery therefrom, unless... offered to non-pregnant students. (4) Subject to § 229.235(d), a recipient shall treat pregnancy...

22 CFR 146.445 - Marital or parental status.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., or marital status that treats students differently on the basis of sex. (b) Pregnancy and related...'s pregnancy, childbirth, false pregnancy, termination of pregnancy, or recovery therefrom, unless... offered to non-pregnant students. (4) Subject to § 146.235(d), a recipient shall treat pregnancy...

22 CFR 146.445 - Marital or parental status.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., or marital status that treats students differently on the basis of sex. (b) Pregnancy and related...'s pregnancy, childbirth, false pregnancy, termination of pregnancy, or recovery therefrom, unless... offered to non-pregnant students. (4) Subject to § 146.235(d), a recipient shall treat pregnancy...

22 CFR 229.445 - Marital or parental status.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., or marital status that treats students differently on the basis of sex. (b) Pregnancy and related...'s pregnancy, childbirth, false pregnancy, termination of pregnancy, or recovery therefrom, unless... offered to non-pregnant students. (4) Subject to § 229.235(d), a recipient shall treat pregnancy...

22 CFR 146.445 - Marital or parental status.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., or marital status that treats students differently on the basis of sex. (b) Pregnancy and related...'s pregnancy, childbirth, false pregnancy, termination of pregnancy, or recovery therefrom, unless... offered to non-pregnant students. (4) Subject to § 146.235(d), a recipient shall treat pregnancy...

22 CFR 229.445 - Marital or parental status.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., or marital status that treats students differently on the basis of sex. (b) Pregnancy and related...'s pregnancy, childbirth, false pregnancy, termination of pregnancy, or recovery therefrom, unless... offered to non-pregnant students. (4) Subject to § 229.235(d), a recipient shall treat pregnancy...

22 CFR 146.445 - Marital or parental status.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., or marital status that treats students differently on the basis of sex. (b) Pregnancy and related...'s pregnancy, childbirth, false pregnancy, termination of pregnancy, or recovery therefrom, unless... offered to non-pregnant students. (4) Subject to § 146.235(d), a recipient shall treat pregnancy...

22 CFR 229.445 - Marital or parental status.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., or marital status that treats students differently on the basis of sex. (b) Pregnancy and related...'s pregnancy, childbirth, false pregnancy, termination of pregnancy, or recovery therefrom, unless... offered to non-pregnant students. (4) Subject to § 229.235(d), a recipient shall treat pregnancy...

Dynamic upper airway changes during sleep in patients with obstructive sleep apnea syndrome.

PubMed

Chuang, Li-Pang; Chen, Ning-Hung; Li, Hsueh-Yu; Lin, Shih-Wei; Chou, Yu-Ting; Wang, Chao-Jan; Liao, Yu-Fang; Tsai, Ying-Huang

2009-12-01

The narrowing pattern of the upper airway in obstructive sleep apnea patients may be different in sleep as compared with awake. Three different types of obstruction were observed in these subjects during drug-induced sleep. The different obstruction pattern during drug-induced sleep suggests that different strategies should be selected in upper airway management. To identify the sites of narrowing and evaluate dynamic upper airway movement in patients with obstructive sleep apnea syndrome (OSAS) while awake and asleep. This study included 10 patients treated for OSAS between August 2003 and June 2004. Overnight polysomnography was performed on all patients. Parameters including gender, age, neck circumference, and body mass index were recorded. Ultra-fast MRI during awake and drug-induced sleep was arranged to evaluate the dynamic motion of the upper airway. The narrowing pattern of the upper airway during awake differed from the narrowing pattern during drug-induced sleep in 3 of 10 subjects. Three different types, palatal obstruction, combined upper and lower pharyngeal obstruction, and circumferential obstruction of the upper airway, were observed in these patients during drug-induced sleep.

Objective assessment of isotretinoin-associated cheilitis: Isotretinoin Cheilitis Grading Scale.

PubMed

Ornelas, Jennifer; Rosamilia, Lorraine; Larsen, Larissa; Foolad, Negar; Wang, Quinlu; Li, Chin-Shang; Sivamani, Raja K

2016-01-01

Isotretinoin remains an effective treatment for severe acne. Despite its effectiveness, it includes many side effects, of which cheilitis is the most common. To develop an objective grading scale for assessment of isotretinoin-associated cheilitis. Cross-sectional clinical grading study. UC Davis Dermatology clinic. Subjects were older than 18 years old and actively treated with oral isotretinoin. Oral Isotretinoin. We developed an Isotretinoin Cheilitis Grading Scale (ICGS) incorporating the following four characteristics: erythema, scale/crust, fissures and inflammation of the commissures. Three board-certified dermatologists independently graded photographs of the subjects. The Kendall's coefficient of concordance (KCC) for the ICGS was 0.88 (p < 0.0001). The Kendall's coefficient was ≥0.72 (p < 0.0001) for each of the four characteristics included in the grading scale. An image-based measurement for lip roughness statistically significantly correlated with the lip scale/crusting assessment (r = 0.52, p < 0.05). The ICGS is reproducible and relatively simple to use. It can be incorporated as an objective tool to aid in the assessment of isotretinoin associated cheilitis.

Cognitive Training for Improving Executive Function in Chemotherapy-Treated Breast Cancer Survivors

PubMed Central

Kesler, Shelli; Hosseini, S. M. Hadi; Heckler, Charles; Janelsins, Michelle; Palesh, Oxana; Mustian, Karen; Morrow, Gary

2013-01-01

Difficulties with thinking and problem solving are very common among breast cancer survivors. We tested a computerized cognitive training program for 41 breast cancer survivors. The training program was associated with significant improvements in thinking and problem-solving skills. Our findings demonstrate potential for our online, home-based cognitive training program to improve cognitive difficulties among breast cancer survivors. Background A majority of breast cancer (BC) survivors, particularly those treated with chemotherapy, experience long-term cognitive deficits that significantly reduce quality of life. Among the cognitive domains most commonly affected include executive functions (EF), such as working memory, cognitive flexibility, multitasking, planning, and attention. Previous studies in other populations have shown that cognitive training, a behavioral method for treating cognitive deficits, can result in significant improvements in a number of cognitive skills, including EF. Materials and Methods In this study, we conducted a randomized controlled trial to investigate the feasibility and preliminary effectiveness of a novel, online EF training program in long-term BC survivors. A total of 41 BC survivors (21 active, 20 wait list) completed the 48 session training program over 12 weeks. The participants were, on average, 6 years after therapy. Results Cognitive training led to significant improvements in cognitive flexibility, verbal fluency and processing speed, with marginally significant downstream improvements in verbal memory as assessed via standardized measures. Self-ratings of EF skills, including planning, organizing, and task monitoring, also were improved in the active group compared with the wait list group. Conclusions Our findings suggest that EF skills may be improved even in long-term survivors by using a computerized, home-based intervention program. These improvements may potentially include subjective EF skills, which suggest a transfer of the training program to real-world behaviors. PMID:23647804

Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects

PubMed Central

Tay, Lee; Leon, Francisco; Vratsanos, George; Raymond, Ralph; Corbo, Michael

2007-01-01

The effect of abatacept, a selective T-cell co-stimulation modulator, on vaccination has not been previously investigated. In this open-label, single-dose, randomized, parallel-group, controlled study, the effect of a single 750 mg infusion of abatacept on the antibody response to the intramuscular tetanus toxoid vaccine (primarily a memory response to a T-cell-dependent peptide antigen) and the intramuscular 23-valent pneumococcal vaccine (a less T-cell-dependent response to a polysaccharide antigen) was measured in 80 normal healthy volunteers. Subjects were uniformly randomized to receive one of four treatments: Group A (control group), subjects received vaccines on day 1 only; Group B, subjects received vaccines 2 weeks before abatacept; Group C, subjects received vaccines 2 weeks after abatacept; and Group D, subjects received vaccines 8 weeks after abatacept. Anti-tetanus and anti-pneumococcal (Danish serotypes 2, 6B, 8, 9V, 14, 19F and 23F) antibody titers were measured 14 and 28 days after vaccination. While there were no statistically significant differences between the dosing groups, geometric mean titers following tetanus or pneumococcal vaccination were generally lower in subjects who were vaccinated 2 weeks after receiving abatacept, compared with control subjects. A positive response (defined as a twofold increase in antibody titer from baseline) to tetanus vaccination at 28 days was seen, however, in ≥ 60% of subjects across all treatment groups versus 75% of control subjects. Similarly, over 70% of abatacept-treated subjects versus all control subjects (100%) responded to at least three pneumococcal serotypes, and approximately 25–30% of abatacept-treated subjects versus 45% of control subjects responded to at least six serotypes. PMID:17425783

[Health care for adolescents with gender dysphoria].

PubMed

Fernández, María; Guerra, Patricia; Martín, Eloya; Martínez, Noelia; Álvarez-Diz, Jose Antonio

2018-02-28

Dysphoria gender treatment in adolescents is recent. Studies of adolescents treated with analogs are reduced. To ensure the quality of care and safety of the child, follow-up studies are necessary. The aim of the present research was to describe the characteristics of the process of medical and psychological attention in adolescents with the DG in the Gender Identity Treatment Unit of Asturias in the period 2007-2015. The sample included 20 minors attended in the Gender Identity Treatment Unit of Asturias in the period 2007-2015. The clinical history was made to collect the variables. It was made descriptive analysis. 10% of adolescents abandoned in the process of psychological counseling, 80% began to be valued by endocrinology and 10% continued exclusively in psychological consultations. Of the medical treated adolescents, 13.3% were treated with analogues and 86.7% received cross-hormonal treatment (THC) directly. The most prevalent secondary effects were dermatological problems (40%), followed by mastodynia without galactorrhea (26.7%) and hot flashes (20%). 20% performed gender confirmation surgeries. The profile of the adolescent treated in the unit of Asturias is a subject that begins hormonal treatment after psychological accompaniment and endocrinological evaluation. The minor has adverse effects after treatment. Once the hormonal treatment has been established, they do not abandon the process.

Some design issues of strata-matched non-randomized studies with survival outcomes.

PubMed

Mazumdar, Madhu; Tu, Donsheng; Zhou, Xi Kathy

2006-12-15

Non-randomized studies for the evaluation of a medical intervention are useful for quantitative hypothesis generation before the initiation of a randomized trial and also when randomized clinical trials are difficult to conduct. A strata-matched non-randomized design is often utilized where subjects treated by a test intervention are matched to a fixed number of subjects treated by a standard intervention within covariate based strata. In this paper, we consider the issue of sample size calculation for this design. Based on the asymptotic formula for the power of a stratified log-rank test, we derive a formula to calculate the minimum number of subjects in the test intervention group that is required to detect a given relative risk between the test and standard interventions. When this minimum number of subjects in the test intervention group is available, an equation is also derived to find the multiple that determines the number of subjects in the standard intervention group within each stratum. The methodology developed is applied to two illustrative examples in gastric cancer and sarcoma.

Anhedonia in depressed patients on treatment with selective serotonin reuptake inhibitor anti-depressant--A two-centered study in Malaysia.

PubMed

Yee, Anne; Chin, Soo Cheng; Hashim, Aili Hanim bt; Harbajan Singh, Manveen Kaur A P; Loh, Huai Seng; Sulaiman, Ahmad Hatim; Ng, Chong Guan

2015-01-01

Anhedonia is the reduced ability to experience pleasure. It is a core symptom of depression and is particularly difficult to treat. This study aims to compare the level of anhedonia between depressed patients on anti-depressants and healthy subjects. A total of 111 depressed patients on selective serotonin reuptake inhibitor (SSRI) and 82 healthy subjects were recruited from the outpatient psychiatric services at two major general hospitals in a cross-sectional study. Subjects were assessed using the Mini International Neuropsychiatric Interview 5.0.0 or MINI, Beck's Depression Index (BDI), and Snaith-Hamilton Pleasure Scale (SHAPS). Relevant personal and sociodemographic information were also collected. There was a significant association between educational level and SHAPS-M scores (P < 0.01) among the participants. Most items in the SHAPS scores were significantly different (P < 0.01) in the depressed subjects treated with anti-depressant compared with the healthy subjects, after adjusting the confounding factors, BDI score, and educational level. Anhedonia often persists in depressed patients despite on SSRI anti-depressant treatment.

Placebo-controlled, double-blind trial of intravenous ribavirin for the treatment of hantavirus cardiopulmonary syndrome in North America.

PubMed

Mertz, Gregory J; Miedzinski, Lil; Goade, Diane; Pavia, Andrew T; Hjelle, Brian; Hansbarger, Christine O; Levy, Howard; Koster, Frederick T; Baum, Kenneth; Lindemulder, Adeline; Wang, Wenquan; Riser, Laura; Fernandez, Humberto; Whitley, Richard J

2004-11-01

BACKGROUND. Ribavirin is active in vitro against hantaviruses, but the findings of an open trial of the use of intravenous ribavirin for the treatment of hantavirus cardiopulmonary syndrome (HCPS) were inconclusive. Subjects with suspected HCPS in the prodrome or cardiopulmonary phase but without shock were eligible for randomization to receive either intravenous ribavirin (33 mg/kg [