An open-label, randomized study of the impact on insulin sensitivity, lipid profile and vascular inflammation by treatment with lopinavir/ritonavir or raltegravir in HIV-negative male volunteers

2016 ◽  
Vol 22 (2) ◽  
pp. 145-151 ◽  
Author(s):  
Paul Randell ◽  
Akil Jackson ◽  
Ana Milinkovic ◽  
Marta Boffito ◽  
Graeme Moyle
Keyword(s):  
Insulin Sensitivity ◽  
Lipid Profile ◽  
Vascular Inflammation ◽  
Randomized Study ◽  
Open Label ◽  
Male Volunteers ◽  
The Impact ◽  
Hiv Negative

scholarly journals The Effect of Smartphone-Based Cognitive Training on the Functional/Cognitive Markers of Schizophrenia: A One-Year Randomized Study

2020 ◽  
Vol 9 (11) ◽  
pp. 3681
Author(s):  
Marek Krzystanek ◽  
Krzysztof Krysta ◽  
Mariusz Borkowski ◽  
Katarzyna Skałacka ◽  
Jacek Przybyło ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Cognitive Training ◽  
Cognitive Rehabilitation ◽  
Reference Group ◽  
Paranoid Schizophrenia ◽  
Randomized Study ◽  
Functional Markers ◽  
Open Label ◽  
Antipsychotic Therapy ◽  
The Impact

Background: Cognitive impairment is associated with long-term disability that results in the deterioration of both the social and professional status of individuals with schizophrenia. The impact of antipsychotic therapy on cognitive function is insufficient. Cognitive training is therefore proposed as a tool for cognitive rehabilitation in schizophrenia. In this study we investigated the effect of self-administered cognitive training using a smartphone-based application on the cognitive function of paranoid schizophrenia patients focusing on response time, correct answer rate, incorrect answer rate, and fatigability to check, if these functions can be functional markers of successful cognitive-smartphone rehabilitation. Methods: 1-year multicenter, open-label randomized study was conducted on 290 patients in a state of symptomatic remission. 191 patients were equipped with the full version of the application and conducted cognitive training twice a week. Reference group (n = 99) was provided with a version of the application having only limited functionality, testing the cognitive performance of patients every 6 months. Results: Statistically significant improvement was observed in both the rate of correct answers (by 4.8%, p = 0.0001), and cognitive fatigability (by 2.9%, p = 0.0001) in the study group, along with a slight improvement in the rate of incorrect answers (by 0.9%, p = 0.15). In contrast, the reference group, who performed cognitive training every 6 months, demonstrated no significant changes in any cognitive activities. Conclusions: Cognitive trainings facilitated by a smartphone-based application, performed regularly for a longer period of time are feasible and may have the potential to improve the cognitive functioning of individuals with schizophrenia. Correct answers and cognitive fatigability have potential to be functional markers of successful smartphone-based psychiatric rehabilitations in schizophrenia patients.

Direct-acting antivirals inducing HCV-RNA sustained suppression improve Xerophthalmia in HCV-infected patients

2021 ◽  
Vol 16 ◽  
Author(s):  
Benedetto Caroleo ◽  
Lidia Colangelo ◽  
Maria Donato ◽  
Marco Balestrieri ◽  
Mauro Soda ◽  
...  
Keyword(s):  
Randomized Study ◽  
Hcv Infection ◽  
Laboratory Evaluation ◽  
Hcv Rna ◽  
Direct Acting Antivirals ◽  
Open Label ◽  
Dry Eyes ◽  
Group 2 ◽  
Direct Acting ◽  
The Impact

Background: Hepatitis C virus (HCV) infection represents a global problem, and it is related to both hepatic and extra-hepatic manifestations (e.g., xerophthalmia). New direct-acting antivirals (DAAs), IFN-free treatments, are commonly used to manage HCV infection. However, the impact of new DAAs on dry eyes (xerophthalmia) is lacking. In this study, we evaluated its incidence in HCV patients and the effect of DAAs on this manifestation. Methods: We performed an observational open-label non-randomized study in HCV patients from 01 April 2018 to 01 June 2020. Results : Patients who satisfied the inclusion criteria underwent clinical and laboratory evaluation, Schirmer's test, and Break-up time test. Enrolled patients were divided in two groups: Group 1: HCV patients with xerophthalmia: 24 patients (16 male and 8 female), HCV-RNA 2,685,813 ± 1,145,698; Group 2: HCV patients without xerophthalmia: 35 patients (19 male and 16 female), HCV-RNA 2,614,757 ± 2,820,433. The follow-ups (3 and 6 months after the enrollment) documented an improvement in both eyes’ manifestations and HCV-infection (HCV-RNA undetected). Conclusion: In conclusion, in this study, we reported that xerophthalmia could appear in HCV patients, and DAAs treatment reduces this manifestation without the development of adverse drug reactions.

scholarly journals Impact of IGF(CA)19 gene polymorphism on the metabolic response to GH therapy in adult GH-deficient patients

2014 ◽  
Vol 170 (2) ◽  
pp. 273-281 ◽  
Author(s):  
C Giavoli ◽  
E Profka ◽  
E Sala ◽  
M Filopanti ◽  
A M Barbieri ◽  
...  
Keyword(s):  
Insulin Sensitivity ◽  
Lipid Profile ◽  
Metabolic Response ◽  
Gene Promoter ◽  
Model Assessment ◽  
Fat Percentage ◽  
Glucose Levels ◽  
Design And Methods ◽  
The Impact

ObjectiveA polymorphism in the promoter region of theIGF1gene has been linked to serum IGF1 levels, risk of diabetes, and cardiovascular diseases with conflicting results. The aim of this study was to investigate the impact of this polymorphism on the short-term (1 year,n=98) and long-term (5 years,n=50) metabolic response to recombinant human GH (rhGH) in GH-deficient (GHD) adults.Design and methodsProspective study on GHD adults. Different genotypes were studied by microsatellite method. According to the most frequent 192 bp allele (19 cytosine–adenosine-repeats), subjects were divided into homozygous (19/19), heterozygous (19/X), and noncarriers (X/X).ResultsBasal characteristics of patients as well as their response to rhGH in terms of decrease in body fat percentage and increase in IGF1 levels were not different in the three genotype-groups. Conversely, after 1-year rhGH, a significant worsening of insulin sensitivity (i.e. increase in fasting glucose levels and homeostasis model assessment of insulin resistance) and a significant improvement in lipid profile (i.e. reduction in total cholesterol and LDL-cholesterol) were recorded only in homozygous subjects. In the long-term, insulin sensitivity was restored in all the patients, while a significant improvement in lipid profile was observed in homozygous and heterozygous subjects, but not in noncarrier subjects. No difference in rhGH dose among groups was recorded throughout the study.ConclusionsIn GHD adults, the presence of the WT allele in the IGF1 gene promoter may enhance sensitivity to either negative or positive metabolic changes induced by rhGH.

Isonatric Dialysis Biofeedback in Hemodiafiltration with Online Regeneration of Ultrafiltrate in Hypertensive Hemodialysis Patients: A Randomized Controlled Study

2015 ◽  
Vol 41 (1-3) ◽  
pp. 87-93 ◽  
Author(s):  
Louise Chevalier ◽  
Christian Tielemans ◽  
Frederic Debelle ◽  
Dominique Vandervelde ◽  
Christine Fumeron ◽  
...  
Keyword(s):  
Arterial Hypertension ◽  
Randomized Study ◽  
Dry Weight ◽  
Hemodialysis Patients ◽  
Controlled Study ◽  
Hypertension Control ◽  
Open Label ◽  
Randomized Controlled ◽  
Short Summary ◽  
The Impact

Dialysis biofeedback in hemodiafiltration with online regeneration of ultrafiltrate (HFR) could help to improve arterial hypertension. We evaluated the impact of isonatric HFR (HFR-iso) on hypertension control compared to conventional HFR. Forty-seven hemodialysis patients were included and randomized (ratio 2/1) HFR-iso versus HFR during 24 dialysis sessions. In the HFR-iso group (32 patients, 768 dialysis sessions), the predialytic systolic blood pressure (BP) decreased from S1 to S24 of 9 ± 20 mm Hg and increased of 5 ± 24 mm Hg in the HFR group (15 patients, 360 dialysis sessions), variation that differed between the 2 groups (ΔS1-S24, p = 0.035; interaction group*time, p = 0.012). The diastolic BP (HFR-iso -3 ± 14 mm Hg vs. HFR 5 ± 13 mm Hg; p = 0.088), the DDD of antihypertensive treatment and the dry weight did not vary significantly during the study. Number of sessions complicated by symptomatic hypotension was similar in the 2 groups. HFR-iso improved BP control without increasing dialysis hypotension episodes. Short Summary: In this multicenter, open-label, controlled, randomized study, we evaluated the impact of dialysis biofeedback in HFR on arterial hypertension compared to conventional HFR. We observed that HFR-iso improved arterial BP control without increasing dialysis hypotension episodes.

scholarly journals Effect of alirocumab on coronary plaque in patients with coronary artery disease assessed by optical coherence tomography

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Fei Gao ◽  
Zhi Jian Wang ◽  
Xiao Teng Ma ◽  
Hua Shen ◽  
Li Xia Yang ◽  
...  
Keyword(s):  
Optical Coherence Tomography ◽  
Standard Care ◽  
Ldl Cholesterol ◽  
Randomized Study ◽  
Coronary Plaque ◽  
Optical Coherence ◽  
Pcsk9 Inhibitors ◽  
Open Label ◽  
Cholesterol Levels ◽  
The Impact

Abstract Background Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors have been demonstrated to produce significantly greater reduction in LDL cholesterol levels and cardiovascular events than standard statin therapy. However, evidence on the impact of PCSK9 inhibitors on coronary plaque composition and morphology is limited. Methods In this open-label randomized study, eligible patients with intermediate coronary lesions and elevated LDL cholesterol values were randomized to either alirocumab 75 mg Q2W plus statin (atorvastatin 20 mg/day or rosuvastatin 10 mg/day) therapy or standard care. Optical coherence tomography (OCT) assessments for target lesions were obtained at baseline and at 36 weeks of follow-up. Results LDL cholesterol levels were significantly decreased in both the alirocumab and standard care arms, whereas the absolute reduction in LDL cholesterol was significantly greater in patients treated with alirocumab (1.72 ± 0.51 vs. 0.96 ± 0.59, P < 0.0001). Compared with standard care, the addition of alirocumab to statins was associated with significantly greater increases in minimum fibrous cap thickness (18.0 [10.8–29.2] μm vs 13.2 [7.4–18.6] μm; P = 0.029), greater increases in minimum lumen area (0.20[0.10–0.33] mm2 vs 0.13 [0.12–0.24] mm2; P = 0.006) and a greater diminution in maximum lipid arc (15.1̊ [7.8–24.5] vs. 8.4̊ [2.0–10.5]; P = 0.008). Conclusions The addition of alirocumab to statins can not only provide additional LDL cholesterol lowering effects but also have a potential role in promoting a more stable plaque phenotype. Trial registration ClinicalTrials.gov Identifier: NCT04851769. Registered 2 Mar 2019.

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