Publications by authors named "Mohamed El Idrissi"

28 Publications

  • Page 1 of 1

How Can a Multidisciplinary Approach Improve Prognosis of Soft-Tissue Sarcomas of Extremities?

Int J Surg Oncol 2021 24;2021:8871557. Epub 2021 Mar 24.

Department of Pathology, Hassan II University Hospital, Fez, Morocco.

Soft-tissue sarcomas are malignant tumors that require good management within specialized centers. Our study aims to assess the benefit of handling these kinds of tumors using the Multidisciplinary Meeting (MDM) approach. The current paper details this approach through a prospective study that has lasted for 42 months in the HASSAN II University Hospital Center, Fez, Morocco. During this research work, 116 cases were selected with an average age of 53 years. In 95.7% of the cases, it was found that the lower limb was the most frequent tumor type (78.4%). Also, ninety-two (92) patients (79.3%) have had a prior biopsy. Ninety-nine (99) patients (85.3%) have received a magnetic resonance imaging scan (MRI) before surgery. Sixty-three (63) patients were operated on, including R0 resection used for 37 patients, R1 used for 21 patients, and R2 used for five patients. As a result, liposarcomas were the most frequent type (30.1%), followed by synovial sarcomas (14.6%), leiomyosarcomas (9.5%), ewing sarcoma (8.6), and undifferentiated pleomorphic sarcomas (7.7%). In addition, neoadjuvant chemotherapy was used for 36 patients. The other 22 patients received adjuvant chemotherapy and/or radiotherapy. The overall survival rate was 60.56 months, which proves a significant improvement, thanks to the multidisciplinary meeting approach. . The conducted investigation has shown that using MDM for managing soft-tissue sarcomas of extremities improves the patients' survival rate. Moreover, results have proven MDM might allow optimal treatment regarding less local recurrence and metastasis.
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http://dx.doi.org/10.1155/2021/8871557DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012127PMC
March 2021

[Emergency coverage of post-traumatic losses of cutaneous substances of the anterior face of the knee using proximally based sural fasciocutaneous flap: about 4 cases of articular wounds].

Pan Afr Med J 2020 1;36:58. Epub 2020 Jun 1.

Service de Chirurgie Ostéo-articulaire B4, CHU Hassan II, Fès, Maroc.

Our study reports 4 cases of male patients with wounds on the anterior face of the knee loosing cutaneous substance after motorcycle accident. The patients had undergone surgery involving the debridement and the application of four proximally based sural fasciocutaneous flaps since 2012. The average age of patients ranged from 28 to 42 years. The highest loss of cutaneous substance measured 14 x 10 cm. The average pedicle length was 14 cm. The post-operative suites were uneventful with a satisfactory wound healing. From a functional point of view the knee and the ankle were completely mobile. This study shows the effectiveness and reliability of proximally based sural fasciocutaneous flap in the coverage of post-traumatic losses of cutaneous substances of the anterior face of the knee, and allows for limit the indications for heads of the gastrocnemius muscle flaps.
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http://dx.doi.org/10.11604/pamj.2020.36.58.7321DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7371442PMC
December 2020

Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis.

Lancet Infect Dis 2019 09 6;19(9):988-1000. Epub 2019 Aug 6.

CureVac, Tübingen, Germany.

Background: The adjuvanted recombinant zoster vaccine (Shingrix) can prevent herpes zoster in older adults and autologous haemopoietic stem cell transplant recipients. We evaluated the safety and immunogenicity of this vaccine in adults with haematological malignancies receiving immunosuppressive cancer treatments.

Methods: In this phase 3, randomised, observer-blind, placebo-controlled study, done at 77 centres worldwide, we randomly assigned (1:1) patients with haematological malignancies aged 18 years and older to receive two doses of the adjuvanted recombinant zoster vaccine or placebo 1-2 months apart during or after immunosuppressive cancer treatments, and stratified participants according to their underlying diseases. The co-primary objectives of the study were the evaluation of safety and reactogenicity of the adjuvanted recombinant zoster vaccine compared with placebo from the first vaccination up to 30 days after last vaccination in all participants; evaluation of the proportion of participants with a vaccine response in terms of anti-glycoprotein E humoral immune response to the adjuvanted recombinant zoster vaccine at month 2 in all participants, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia; and evaluation of the anti-glycoprotein E humoral immune responses to the vaccine compared with placebo at month 2 in all participants, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia. We assessed immunogenicity in the per-protocol cohort for immunogenicity and safety in the total vaccinated cohort. The study is registered with ClinicalTrials.gov, number NCT01767467, and with the EU Clinical Trials Register, number 2012-003438-18.

Findings: Between March 1, 2013, and Sept 10, 2015, we randomly assigned 286 participants to adjuvanted recombinant zoster vaccine and 283 to placebo. 283 in the vaccine group and 279 in the placebo group were vaccinated. At month 2, 119 (80·4%, 95% CI 73·1-86·5) of 148 participants had a humoral vaccine response to adjuvanted recombinant zoster vaccine, compared with one (0·8%, 0·0-4·2) of 130 participants in the placebo group, and the adjusted geometric mean anti-glycoprotein E antibody concentration was 23 132·9 mIU/mL (95% CI 16 642·8-32 153·9) in the vaccine group and 777·6 mIU/mL (702·8-860·3) in the placebo group (adjusted geometric mean ratio 29·75, 21·09-41·96; p<0·0001) in all patients, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia. Humoral and cell-mediated immune responses persisted above baseline until month 13 in all strata and, as expected, vaccine was more reactogenic than placebo (within 7 days after vaccination pain was reported by 221 [79·5%] of 278 vaccine group participants and 45 [16·4%] of 274 placebo group participants; fatigue was reported by 162 [58·3%] of 278 vaccine group participants and 102 [37·2%] of 274 placebo group participants). Incidences of unsolicited or serious adverse events, potential immune-mediated diseases, disease-related events, and fatal serious adverse events were similar between the groups.

Interpretation: The immunocompromised adult population with haematological malignancies is at high risk for herpes zoster. The adjuvanted recombinant zoster vaccine, which is currently licensed in certain countries for adults aged 50 years and older, is likely to benefit this population.

Funding: GlaxoSmithKline Biologicals SA.
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http://dx.doi.org/10.1016/S1473-3099(19)30163-XDOI Listing
September 2019

Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT).

Biol Blood Marrow Transplant 2019 12 5;25(12):2474-2481. Epub 2019 Aug 5.

Royal Melbourne Hospital, Melbourne, Victoria, Australia.

Herpes zoster (HZ) can have a substantial impact on quality of life (QoL). The vaccine efficacy (VE) of a recombinant zoster vaccine (RZV) was 68.2% (95% confidence interval [CI], 55.6% to 77.5%) in a phase 3 study in adult autologous hematopoietic stem cell transplant (HSCT) recipients (NCT01610414). Herein, we report the impact of RZV on patients' QoL. Autologous HSCT recipients were randomized 1:1 to receive 2 doses of RZV or placebo, given 1 to 2 months apart. QoL was measured by the Short Form Survey-36 and Euro-QoL-5 Dimension at baseline, 1 month, and 1 year postdose 2 and during suspected HZ episodes with the Zoster Brief Pain Inventory (ZBPI). The RZV impact on ZBPI burden of illness and burden of interference scores was estimated. The 2 scores were calculated from the area under the curve (days 0 to 182) of the ZBPI worst pain and ZBPI activities of daily living scores, respectively, assuming a score of 0 for patients not having a confirmed HZ episode. The ZBPI maximum worst pain score was significantly lower in the RZV than placebo group (mean: 5.8 versus 7.1, P = .011). Consequently, the VE estimates for HZ burden of illness (82.5%; 95% CI, 73.6 to 91.4) and burden of interference (82.8%; 95% CI, 73.3 to 92.3) were higher than the HZ VE estimate (ie, 68.2%). RZV showed significantly better QoL scores than placebo 1 week following rash onset among patients with confirmed HZ. In addition to reducing the risk of HZ and its complications, RZV significantly reduced the impact of HZ on patients' QoL in those who developed breakthrough disease.
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http://dx.doi.org/10.1016/j.bbmt.2019.07.036DOI Listing
December 2019

Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial.

JAMA 2019 07;322(2):123-133

Duke University Medical Center, Durham, North Carolina.

Importance: Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster.

Objective: To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients.

Design, Setting, And Participants: Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT.

Interventions: Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n = 922) or placebo (n = 924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter.

Main Outcomes And Measures: The primary end point was occurrence of confirmed herpes zoster cases.

Results: Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P < .001), equivalent to 68.2% vaccine efficacy. Of 8 secondary end points, 3 showed significant reductions in incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR, 0.1; 95% CI, 0.00-0.78; P = .02) and of other prespecified herpes zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22; 95% CI, 0.04-0.81; P = .02) and in duration of severe worst herpes zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days; hazard ratio, 0.62; 95% CI, 0.42-0.89; P = .01). Five secondary objectives were descriptive. Injection site reactions were recorded in 86% of vaccine and 10% of placebo recipients, of which pain was the most common, occurring in 84% of vaccine recipients (grade 3: 11%). Unsolicited and serious adverse events, potentially immune-mediated diseases, and underlying disease relapses were similar between groups at all time points.

Conclusions And Relevance: Among adults who had undergone autologous HSCT, a 2-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months.

Trial Registration: ClinicalTrials.gov Identifier: NCT01610414.
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http://dx.doi.org/10.1001/jama.2019.9053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6618796PMC
July 2019

Hydrophobicity-responsive engineered mesoporous silica nanoparticles: application in the delivery of essential nutrients to bacteria combating oil spills.

Chem Commun (Camb) 2019 Jul 11;55(52):7478-7481. Epub 2019 Jun 11.

University of Applied Sciences and Arts Northwestern Switzerland, School of Life Sciences, Institute of Chemistry and Bioanalytics, Hofackerstrasse 30, CH-4132 Muttenz, Switzerland.

Facile chemical modification of mesoporous silica particles allows the production of gated reservoir systems capable of hydrophobicity-triggered release. Applied to the delivery of nutrients specifically to an oil phase, the systems developed have been shown to reliably assist the bacterial degradation of hydrocarbons. The gated system developed, made of C hydrocarbon chains, is demonstrated to be in a closed collapsed state in an aqueous environment, yet opens up through solvation by lipophilic alkanes and releases its content on contact with the oil phase.
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http://dx.doi.org/10.1039/c9cc02801cDOI Listing
July 2019

Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials.

Vaccine 2019 04 29;37(18):2482-2493. Epub 2019 Mar 29.

GSK, Wavre, Belgium. Electronic address:

Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.

Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period.

Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.

Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV.
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http://dx.doi.org/10.1016/j.vaccine.2019.03.043DOI Listing
April 2019

Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial.

Clin Infect Dis 2020 01;70(2):181-190

GSK, Wavre, Belgium.

Background: The incidence of herpes zoster is up to 9 times higher in immunosuppressed solid organ transplant recipients than in the general population. We investigated the immunogenicity and safety of an adjuvanted recombinant zoster vaccine (RZV) in renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy.

Methods: In this phase 3, randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled and received 2 doses of RZV or placebo 1-2 months (M) apart 4-18M posttransplant. Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates were assessed at 1M post-dose 1, and 1M and 12M post-dose 2. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Solicited general symptoms and unsolicited AEs were also collected 7 days before first vaccination. Serious AEs (including biopsy-proven allograft rejections) and potential immune-mediated diseases (pIMDs) were recorded up to 12M post-dose 2.

Results: Two hundred sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 and April 2017. gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across postvaccination time points and persisted above prevaccination baseline 12M post-dose 2. Local AEs were reported more frequently by RZV than placebo recipients. Overall occurrences of renal function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were similar between groups.

Conclusions: RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose.

Clinical Trials Registration: NCT02058589.
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http://dx.doi.org/10.1093/cid/ciz177DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6938982PMC
January 2020

Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial.

Cancer 2019 04 1;125(8):1301-1312. Epub 2019 Feb 1.

GSK, Wavre, Belgium.

Background: The adjuvanted recombinant zoster vaccine (RZV) has demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age and 68% efficacy in autologous hematopoietic stem cell transplant recipients ≥18 years of age. We report the immunogenicity and safety of RZV administered to patients with solid tumors (STs) before or at the start of a chemotherapy cycle.

Method: In this phase 2/3 observer-blind, multicenter study (NCT01798056), patients with STs who were ≥18 years of age were randomized (1:1) to receive 2 doses of RZV or placebo 1-2 months apart and stratified (4:1) according to the timing of the first dose with respect to the start of a chemotherapy cycle (first vaccination 8-30 days before the start or at the start [±1 day] of a chemotherapy cycle). Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T cell frequencies, and vaccine response rates (VRRs) were assessed 1 month after dose 1 and 1 and 12 months after dose 2. Reactogenicity and safety were assessed in the total vaccinated cohort through 12 months after dose 2.

Results: There were 232 participants in the total vaccinated cohort, 185 participants in the according-to-protocol cohort for humoral immunogenicity, and 58 participants in the according-to-protocol cohort for cell-mediated immunogenicity. Postvaccination anti-gE antibody concentrations, gE-specific CD4 T cell frequencies and VRRs were higher in RZV recipients than in placebo recipients. Solicited adverse events (AEs) were more frequent among RZV recipients than placebo recipients. Incidence of unsolicited AEs, serious AEs, fatalities, and potential immune-mediated diseases were similar between RZV and placebo recipients.

Conclusion: RZV was immunogenic in patients with STs receiving immunosuppressive chemotherapies. Humoral and cell-mediated immune responses persisted 1 year after vaccination. No safety concerns were identified.
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http://dx.doi.org/10.1002/cncr.31909DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6766894PMC
April 2019

The Impact of Reactogenicity After the First Dose of Recombinant Zoster Vaccine on the Physical Functioning and Quality of Life of Older Adults: An Open-Label, Phase III Trial.

J Gerontol A Biol Sci Med Sci 2019 07;74(8):1217-1224

GSK, Wavre, Belgium.

Background: Herpes zoster and its related complications are associated with significant medical burden, which negatively affects quality of life and daily functioning of the patients. The recently licensed recombinant zoster vaccine (RZV) offers high efficacy but is associated with local and systemic reactions. This study assessed the impact of RZV on the quality of life and daily functioning of participants and implications for caregivers.

Methods: Four hundred and one adults aged 50 years or older received single RZV doses at 0 and 2 months in this open-label, single-arm, multicenter study (NCT02979639). Change in mean SF-36 Physical Functioning score following first-dose administration, quality of life, reactogenicity, safety, productivity loss, and health care resource utilization was assessed. The current analysis was performed post-vaccine dose-1; safety follow-up will continue until 1 year post-dose-2.

Results: The most common solicited local symptoms were injection-site pain (77.5%), redness (23.0%), and swelling (13.3%); the most frequent solicited systemic reactions were fatigue (33.5%), headache (28.3%), and myalgia (26.8%). Grade 3 reactogenicity occurred in 9.5% of participants and was associated with a transient clinically important decrease in SF-36 Physical Functioning score (affecting activities such as walking, carrying groceries, climbing stairs) on Days 1 and 2 post-first vaccination. No clinically meaningful reductions in mean SF-36 Physical Functioning scale scores from pre- to post-RZV dose-1 were observed (mean +1.9 points, primary end point), and no overall quality-adjusted-life-year loss was recorded post-dose-1. Five participants reported lost workdays; caregiver workload was not increased.

Conclusions: Overall, the physical functioning and quality of life of older adults were not affected by a first RZV dose. The observed reactogenicity was consistent with previous studies.
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http://dx.doi.org/10.1093/gerona/gly218DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6625580PMC
July 2019

[Hip arthroscopy in patients with femoroacetabular impingement: about 2 cases].

Pan Afr Med J 2018 17;30:36. Epub 2018 May 17.

Service de Chirurgie Ostéo-articulaire B4, CHU Hassan II, Université Sidi Mohammed Ben Abdellah, 3000 Fès, Maroc.

Femoroacetabular impingement (FAI) can causes hip pain in young subjects and in athletes. His diagnosis is based on clinical and radiological examinations. Surgical treatment is based on conventional surgery or on arthroscopy. Arthroscopy proves to be a reliable technique in the treatment of FAI. It is effective on the pain and improves performances of athletes in order to enable them to resume their activities within a very short space of time. We here report our experience within our Department in treating 2 patients with FAI with arthroscopy. Modified Harris score significantly improved at the last follow-up (24 and 18 months).
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http://dx.doi.org/10.11604/pamj.2018.30.36.14008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6110557PMC
September 2018

[Infection and detachment of total hip prosthesis due to listeria monocytogenes].

Pan Afr Med J 2018 9;30:18. Epub 2018 May 9.

Service de Chirurgie Orthopédique et Traumatologie, Centre Hospitalier René Dubos, 95300 Pontoise, France.

Joint prostheses are increasingly used in our current practice. Infection is one of the most dreaded complications; it is most often due to germs of the skin flora. Listeria monocytogenes rarely causes this infection. We here report the case of a patient with hip prosthesis infected by this germ. Favorable outcome was obtained by antibiotic therapy and single-stage prosthesis replacement.
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http://dx.doi.org/10.11604/pamj.2018.30.18.14016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6110569PMC
September 2018

Nanosensors based on polymer vesicles and planar membranes: a short review.

J Nanobiotechnology 2018 Aug 30;16(1):63. Epub 2018 Aug 30.

Department of Chemistry, University of Basel, Mattenstrasse 24a, 4002, Basel, Switzerland.

This review aims to summarize the advance in the field of nanosensors based on two particular materials: polymer vesicles (polymersomes) and polymer planar membranes. These two types of polymer-based structural arrangements have been shown to be efficient in the production of sensors as their features allow to adapt to different environment but also to increase the sensitivity and the selectivity of the sensing device. Polymersomes and planar polymer membranes offer a platform of choice for a wide range of chemical functionalization and characteristic structural organization which allows a convenient usage in numerous sensing applications. These materials appear as great candidates for such nanosensors considering the broad variety of polymers. They also enable the confection of robust nanosized architectures providing interesting properties for numerous applications in many domains ranging from pollution to drug monitoring. This report gives an overview of these different sensing strategies whether the nanosensors aim to detect chemicals, biological or physical signals.
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http://dx.doi.org/10.1186/s12951-018-0393-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6116380PMC
August 2018

Ulnar nerve entrapment complicating radial head excision.

Int J Surg Case Rep 2017 14;41:511-515. Epub 2017 Nov 14.

Department of Osteoarticular Surgery B4, Hassan II University Hospital, Fès, Morocco.

Introduction: Several mechanisms are involved in ischemia or mechanical compression of ulnar nerve at the elbow.

Presentation Of Case: We hereby present the case of a road accident victim, who received a radial head excision for an isolated fracture of the radial head and complicated by onset of cubital tunnel syndrome. This outcome could be the consequence of an iatrogenic valgus of the elbow due to excision of the radial head. Hitherto the surgical treatment of choice it is gradually been abandoned due to development of radial head implant arthroplasty. However, this management option is still being performed in some rural centers with low resources.

Discussion: The radial head plays an important role in the stability of the elbow and his iatrogenic deformity can be complicated by cubital tunnel syndrome.

Conclusion: An ulnar nerve release was performed with favorable outcome.
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http://dx.doi.org/10.1016/j.ijscr.2017.11.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5723363PMC
November 2017

Using Polarized Spectroscopy to Investigate Order in Thin-Films of Ionic Self-Assembled Materials Based on Azo-Dyes.

Nanomaterials (Basel) 2018 Feb 15;8(2). Epub 2018 Feb 15.

Nano-Science Center & Department of Chemistry, University of Copenhagen, Universitetsparken 5, 2100 København Ø, Denmark.

Three series of ionic self-assembled materials based on anionic azo-dyes and cationic benzalkonium surfactants were synthesized and thin films were prepared by spin-casting. These thin films appear isotropic when investigated with polarized optical microscopy, although they are highly anisotropic. Here, three series of homologous materials were studied to rationalize this observation. Investigating thin films of ordered molecular materials relies to a large extent on advanced experimental methods and large research infrastructure. A statement that in particular is true for thin films with nanoscopic order, where X-ray reflectometry, X-ray and neutron scattering, electron microscopy and atom force microscopy (AFM) has to be used to elucidate film morphology and the underlying molecular structure. Here, the thin films were investigated using AFM, optical microscopy and polarized absorption spectroscopy. It was shown that by using numerical method for treating the polarized absorption spectroscopy data, the molecular structure can be elucidated. Further, it was shown that polarized optical spectroscopy is a general tool that allows determination of the molecular order in thin films. Finally, it was found that full control of thermal history and rigorous control of the ionic self-assembly conditions are required to reproducibly make these materials of high nanoscopic order. Similarly, the conditions for spin-casting are shown to be determining for the overall thin film morphology, while molecular order is maintained.
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http://dx.doi.org/10.3390/nano8020109DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5853740PMC
February 2018

[Total hip arthroplasty for the treatment of congenital hip dislocations in adults: about 15 cases].

Pan Afr Med J 2016 29;25:201. Epub 2016 Nov 29.

Service de Chirurgie Osteo-Articulaire B4, CHU Hassan II, Fès, Maroc.

Total hip arthroplasty for the treatment of congenital dislocation represents a challenge for the orthopedic surgeon. It is now well established that the treatment of congenital hip dislocation in adults is a real "functional miracle". The evolution of surgical techniques and materials has expanded the indications for prosthetic replacement including the most complex cases and thus going against Charnley and Feagin who wrote in 1973 that there was no place for total hip arthroplasty in inveterate dislocations. We conducted a retrospective study of a series of THP 15 for the treatment of congenital hip dislocation in adults;sociodemographic, clinical, paraclinical and therapeutic data were collected from the medical records of 15 patients and also via a written questionnaire which was completed during their last follow-up visit. The average age of our patients was 28 years; female sex ratio was 2F/1H. Severe dysplasia stage VI according to Crowe's classification was present in 4 cases, type III in 9 cases and type II only in 2 cases. All patients underwent cemented total hip arthroplasty, a reinforcement ring was used in 9 cases and a bone graft in 2 cases. At last follow-up visit PMA functional scores were excellent and very good in 74% of cases. Surgical treatment of congenital hip dislocations in adults must meet strict health standards as congenital hip dislocations often occurs in young female population that is more demanding as to the aesthetic and functional outcomes. Several surgical techniques have tried to solve the problems related to this disease, acetabular and femoral hypoplasia, leg length inequality. Total hip arthroplasty for the treatment of congenital dislocations in adults remains a challenge for the orthopaedic surgeon. This is a difficult surgical procedure which requires technical skills and careful pre-design programming to reduce the occurrence of adverse events especially in the particular case of young female population.
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http://dx.doi.org/10.11604/pamj.2016.25.201.10534DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5326186PMC
March 2017

Template-free hierarchical self-assembly of a pyrene derivative into supramolecular nanorods.

Chem Commun (Camb) 2017 Feb;53(12):1973-1976

School of Life Sciences, University of Applied Sciences and Arts Northwestern Switzerland, Gründenstrasse 40, Muttenz CH-4132, Switzerland.

The accurate molecular design of organic building blocks is of great importance for the creation of large supramolecular entities with precise dimensional organisation. Herein we report on the design of a new pyrene derivative that yields, through a hierarchical self-assembly process and in the absence of template, stable and well defined nanorods. X-ray diffraction studies allowed elucidation of the three dimensional packing of this pyrene derivative within the self-assembled nanorods.
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http://dx.doi.org/10.1039/c6cc09731fDOI Listing
February 2017

Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study.

J Infect Dis 2015 Apr 3;211(8):1279-87. Epub 2014 Nov 3.

GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.

Background: Human immunodeficiency virus (HIV)-infected individuals are at increased risk of herpes zoster (HZ), even in the antiretroviral therapy (ART) era. Because concerns exist about the use of live-attenuated vaccines in immunocompromised individuals, a subunit vaccine may be an appropriate alternative.

Methods: This phase 1/2, randomized, placebo-controlled study evaluated the immunogenicity and safety of an investigational HZ subunit vaccine (HZ/su). Three cohorts of HIV-infected adults aged ≥18 years were enrolled: 94 ART recipients with a CD4(+) T-cell count of ≥200 cells/mm(3), 14 ART recipients with a CD4(+) T-cell count of 50-199 cells/mm(3), and 15 ART-naive adults with a CD4(+) T-cell count of ≥500 cells/mm(3). Subjects received 3 doses of HZ/su (50 µg varicella-zoster virus glycoprotein E [gE] combined with AS01B adjuvant) or 3 doses of saline at months 0, 2, and 6.

Results: One month after dose 3, serum anti-gE antibody concentrations and frequencies of gE-specific CD4(+) T cells were higher following HZ/su vaccination than after receipt of saline (P < .0001). Median cell-mediated immune responses peaked after dose 2. Humoral and cell-mediated immune responses persisted until the end of the study (month 18). No vaccination-related serious adverse events were reported. No sustained impact on HIV load or CD4(+) T-cell count was noted following vaccinations.

Conclusions: HZ/su was immunogenic and had a clinically acceptable safety profile in HIV-infected adults.

Clinical Trials Registration: NCT01165203.
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http://dx.doi.org/10.1093/infdis/jiu606DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4371767PMC
April 2015

A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients.

Blood 2014 Nov 18;124(19):2921-9. Epub 2014 Sep 18.

GlaxoSmithKline Vaccines, King of Prussia, PA.

Recombinant herpes zoster (HZ) vaccines may be an alternative to the live-attenuated HZ vaccine for immunocompromised individuals. This was a phase 1/2, randomized, observer-blind, placebo-controlled study in adults with multiple myeloma, non-Hodgkin lymphoma (B- or T-cell), Hodgkin lymphoma, or acute myeloid leukemia who had undergone autologous hematopoietic stem-cell transplant 50 to 70 days earlier. Subjects (N = 121) were randomized 1:1:1:1 to receive (at months 0, 1, 3) three doses of 50 μg varicella-zoster virus glycoprotein E (gE) adjuvanted with AS01B, 3 doses of gE adjuvanted with AS01E, 1 dose of saline followed by 2 doses of gE/AS01B, or 3 doses of saline. One month after the last dose (6 months after transplant), frequencies of CD4(+) T cells expressing ≥2 activation markers after induction with gE and anti-gE antibody concentrations were higher with all gE/AS01 regimens than with saline. Both responses persisted up to 1 year in subjects vaccinated with gE/AS01. Immune responses were higher in the gE/AS01B 3-dose group than in the gE/AS01B 2-dose group but not higher than in the gE/AS01E 3-dose group. One serious adverse event (pneumonia) was considered vaccine related. Both formulations and both schedules were immunogenic and well tolerated in this population. This study was registered at www.clinicaltrials.gov as #NCT00920218.
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http://dx.doi.org/10.1182/blood-2014-04-573048DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4327150PMC
November 2014

Superior antigen-specific CD4+ T-cell response with AS03-adjuvantation of a trivalent influenza vaccine in a randomised trial of adults aged 65 and older.

BMC Infect Dis 2014 Jul 30;14:425. Epub 2014 Jul 30.

Department of Molecular Virology and Microbiology, Baylor College of medicine, Houston, Texas, USA.

Background: The effectiveness of trivalent influenza vaccines may be reduced in older versus younger adults because of age-related immunosenescence. The use of an adjuvant in such a vaccine is one strategy that may combat immunosenescence, potentially by bolstering T-cell mediated responses.

Methods: This observer-blind study, conducted in the United States (US) and Spain during the 2008-2009 influenza season, evaluated the effect of Adjuvant System AS03 on specific T-cell responses to a seasonal trivalent influenza vaccine (TIV) in ≥65 year-old adults.Medically-stable adults aged ≥65 years were randomly allocated to receive a single dose of AS03-adjuvanted TIV (TIV/AS03) or TIV. Healthy adults aged 18-40 years received only TIV. Blood samples were collected on Day 0, Day 21, Day 42 and Day 180. Influenza-specific CD4+ T cells, defined by the induction of the immune markers CD40L, IL-2, IFN-γ, or TNF-α, were measured in ex vivo cultures of antigen-stimulated peripheral blood mononuclear cells.

Results: A total of 192 adults were vaccinated: sixty nine and seventy three ≥65 year olds received TIV/AS03 and TIV, respectively; and fifty 18 - 40 year olds received TIV. In the ≥65 year-old group on Day 21, the frequency of CD4+ T cells specific to the three vaccine strains was superior in the TIV/AS03 recipients to the frequency in TIV (p < 0.001). On Days 42 and 180, the adjusted-geometric mean specific CD4+ T-cell frequencies were also higher in the TIV/AS03 recipients than in the TIV recipients (p < 0.001). Furthermore, the adjusted-geometric mean specific CD4+ T-cell frequencies were higher in the ≥65 year-old recipients of TIV/AS03 than in the18 - 40 year old recipients of TIV on Days 21 (p = 0.006) and 42 (p = 0.011).

Conclusion: This positive effect of AS03 Adjuvant System on the CD4+ T-cell response to influenza vaccine strains in older adults could confer benefit in protection against clinical influenza disease in this population.

Trial Registration: (Clinicaltrials.gov.). NCT00765076.
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http://dx.doi.org/10.1186/1471-2334-14-425DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4138369PMC
July 2014

A randomized controlled study to evaluate the immunogenicity of a trivalent inactivated seasonal influenza vaccine at two dosages in children 6 to 35 months of age.

Hum Vaccin Immunother 2013 Sep 19;9(9):1978-88. Epub 2013 Jun 19.

Universidad Nacional Autonoma de Mexico; Mexico City, Mexico.

The trivalent inactivated influenza vaccine Fluarix™ is licensed in the US for adults and children from 3 years old. This randomized observer-blind study (NCT00764790) evaluated Fluarix™ at two doses; 0.25 ml (Flu-25) and 0.5 ml (Flu-50) in children aged 6-35 months. The primary objective was to demonstrate immunogenic non-inferiority vs. a control vaccine (Fluzone®; 0.25 ml). Children received Flu-25 (n = 1107), Flu-50 (n = 1106) or control vaccine (n = 1104) at Day 0 and for un-primed children, also on Day 28. Serum hemagglutination-inhibition titers were determined pre-vaccination and at Day 28 (primed) or Day 56 (un-primed). Non-inferiority was assessed by post-vaccination geometric mean titer (GMT) ratio, (upper 95% confidence interval [CI] ≤ 1.5) and difference in seroconversion rate (upper 95% CI ≤ 10%). Reactogenicity/safety was monitored. The immune response to Flu-50 met all regulatory criteria. Indicated by adjusted GMT ratios [with 95% CI], the criteria for non-inferiority of Flu-50 vs. control vaccine were reached for the B/Florida strain (1.13 [1.01-1.25]) but not for the A/Brisbane/H1N1 (1.74 [1.54-1.98]) or A/Uruguay/H3N2 (1.72 [1.57-1.89]) strains. In children aged 18-35 months similar immune responses were observed for Flu-50 and the control vaccine. Flu-50 induced a higher response than Flu-25 for all strains. Temperature (≥ 37.5°C) was reported in 6.2%, 6.4%, and 6.6% of the Flu-25, Flu-50, and control group, respectively. Reactogenicity/safety endpoints were within the same range for all vaccines. In children aged 6-35 months, immune responses with Flu-50 fulfilled regulatory criteria but did not meet the pre-defined criteria for non-inferiority vs. control. This appeared to be due to differences in immunogenicity in children aged<18 months.
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http://dx.doi.org/10.4161/hv.25363DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3906365PMC
September 2013

AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial.

Lancet Infect Dis 2013 Jun 19;13(6):485-96. Epub 2013 Mar 19.

Health Sciences North and Advanced Medical Research Institute of Canada, Sudbury, ON, Canada.

Background: We aimed to compare AS03-adjuvanted inactivated trivalent influenza vaccine (TIV) with non-adjuvanted TIV for seasonal influenza prevention in elderly people.

Methods: We did a randomised trial in 15 countries worldwide during the 2008-09 (year 1) and 2009-10 (year 2) influenza seasons. Eligible participants aged at least 65 years who were not in hospital or bedridden and were without acute illness were randomly assigned (1:1) to receive either AS03-adjuvanted TIV or non-adjuvanted TIV. Randomisation was done in an internet-based system, with a blocking scheme and stratification by age (65-74 years and 75 years or older). Participants were scheduled to receive one vaccine in each year, and remained in the same group in years 1 and 2. Unmasked personnel prepared and gave the vaccines, but participants and individuals assessing any study endpoint were masked. The coprimary objectives were to assess the relative efficacy of the vaccines and lot-to-lot consistency of the AS03-adjuvanted TIV (to be reported elsewhere). For the first objective, the primary endpoint was relative efficacy of the vaccines for prevention of influenza A (excluding A H1N1 pdm09) or B, or both, that was confirmed by PCR analysis in year 1 (lower limit of two-sided 95% CI had to be greater than zero to establish superiority). From Nov 15, to April 30, in both years, participants were monitored by telephone or site contact and home visits every week or 2 weeks to identify cases of influenza-like illness. After onset of suspected cases, we obtained nasal and throat swabs to identify influenza RNA with real-time PCR. Efficacy analyses were done per protocol. This trial is registered with ClinicalTrials.gov, number NCT00753272.

Findings: We enrolled 43 802 participants, of whom 21 893 were assigned to and received the AS03-adjuvanted TIV and 21 802 the non-adjuvanted TIV in year 1. In the year 1 efficacy cohort, fewer participants given AS03-adjuvanted than non-adjuvanted TIV were infected with influenza A or B, or both (274 [1·27%, 95% CI 1·12-1·43] of 21 573 vs 310 [1·44%, 1·29-1·61] of 21 482; relative efficacy 12·11%, 95% CI -3·40 to 25·29; superiority not established). Fewer participants in the year 1 efficacy cohort given AS03-adjuvanted TIV than non-adjuvanted TIV were infected with influenza A (224 [1·04%, 95% CI 0·91-1·18] vs 270 [1·26, 1·11-1·41]; relative efficacy 17·53%, 95% CI 1·55-30·92) and influenza A H3N2 (170 [0·79, 0·67-0·92] vs 205 [0·95, 0·83-1·09]; post-hoc analysis relative efficacy 22·0%, 95% CI 5·68-35·49).

Interpretation: AS03-adjuvanted TIV has a higher efficacy for prevention of some subtypes of influenza than does a non-adjuvanted TIV. Future influenza vaccine studies in elderly people should be based on subtype or lineage-specific endpoints.

Funding: GlaxoSmithKline Biologicals SA.
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http://dx.doi.org/10.1016/S1473-3099(13)70046-XDOI Listing
June 2013

Use of real-time polymerase chain reaction (rtPCR) as a diagnostic tool for influenza infection in a vaccine efficacy trial.

J Clin Virol 2012 Jan 11;53(1):22-8. Epub 2011 Nov 11.

Vaccine Research Center, University of Tampere, Biokatu 10, Tampere, Finland.

Background: Conventional techniques for diagnosing influenza based on viral cell culture or disease serology have limitations, and molecular assays, such as real-time polymerase chain reaction (rtPCR) are increasingly used.

Objectives: To evaluate the use of rtPCR as a diagnostic tool for the determination of influenza virus infection.

Study Design: This prospective, double-blind, placebo-controlled, randomised efficacy study was conducted in persons aged 18-64 years. Cases of influenza-like-illness (ILI), defined as at least one systemic symptom [fever ≥37.8°C and/or myalgia] and at least one respiratory symptom [cough and/or sore throat] were identified by active and passive surveillance. For each case of suspected ILI, nasal and throat swabs were collected and analysed by viral culture and rtPCR.

Results: 227 ILI cases were positive by rtPCR while 64% (145/227) were positive by both rtPCR and culture. For both assays, the maximum percentage of swabs that tested positive was on Day 0, thereafter positive samples by rtPCR remained constant until Day 5 but decreased progressively by culture. All rtPCR positive cases with a viral load of below 4.5log(10) copies/sample were negative by culture. There were however culture negative cases with high viral loads. Vaccine efficacy for influenza was estimated as 54.7% by rtPCR (culture positive or negative) and 61.6% by culture irrespective of match to vaccine strain. Clinical severity was not significantly different between culture positive cases and culture negative but rtPCR positive cases.

Conclusions: rtPCR is a sensitive and specific diagnostic tool for influenza vaccine efficacy studies.
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http://dx.doi.org/10.1016/j.jcv.2011.10.013DOI Listing
January 2012