scholarly journals An alternative to the orthopaedic traction table (fracture table): A prototype of low cost, easy reproduction and good applicability

10.3823/2347 ◽  
2017 ◽  
Vol 10 ◽  
Author(s):  
Diego Ariel de Lima ◽  
Raquel Autran Coelho ◽  
José Alberto Dias Leite ◽  
Lana Lacerda de Lima ◽  
Luiz Lopes Lima
Keyword(s):  
Low Cost ◽  
Good Alternative ◽  
Lower Limbs ◽  
Observer Agreement ◽  
Double Blind Study ◽  
Operating Table ◽  
Double Blind ◽  
Cross Sectional ◽  
Fracture Table

Abstract Background: Orthopaedic traction tables are used as an aid in numerous surgical procedures. The present paper aims to present a prototype of an external device of lower limb traction, which is portable, of simple construction, and can be installed on any operating table, with possible application in surgical and teaching practices. We will compare the quality of radiographic images obtained with the help of this prototype (PT) to those images obtained with the aid of the conventional traction table (CT). Materials and methods: Cross-sectional, observational, and double blind study, approved by the Research Ethics Committee. On two occasions 36 randomly selected radiographs of the lower limbs, 18 of which obtained on the CT and the remaining on the PT, were evaluated by nine physicians. These radiographs were obtained from three volunteer and none of them presented musculoskeletal system disorders previously diagnosed in the study. Examiners rated each picture from 1 to 5, according to the quality of the image obtained. The responses were submitted to statistical analysis by SPSS ®, v23. Comparisons were considered significant when p <0.05, with a 95% confidence interval. Results: The average ratings were similar and all significance tests between the averages were higher than 0.9. The intra-observer agreement was 76.13% for the PT and 82.69% for the CT. The inter-observer agreement was low for both models. Due to its lower weight and smaller size compared to the CT and the material used for prototyping, the production cost of the PT is quite affordable. Conclusions: The PT presented in this paper is a good alternative to CT.   Keywords: Traction table, Fracture table, Orthopaedic surgery, Orthopaedic prototype, Lower limbs.

The Costs and Benefits of Shareholder Democracy: Gadflies and Low-Cost Activism

2020 ◽  
Author(s):  
Nickolay Gantchev ◽  
Mariassunta Giannetti
Keyword(s):  
Low Cost ◽  
Shareholder Value ◽  
Career Concerns ◽  
Costs And Benefits ◽  
Cross Sectional ◽  
Shareholder Proposals ◽  
Active Individual ◽  
Shareholder Democracy ◽  
To Receive

Abstract We show that there is cross-sectional variation in the quality of shareholder proposals. On average, proposals submitted by the most active individual sponsors are less likely to receive majority support, but they occasionally pass if shareholders mistakenly support them and may even be implemented due to directors’ career concerns. While gadfly proposals destroy shareholder value if they pass, shareholder proposals on average are value enhancing in firms with more informed shareholders. We conclude that more informed voting could increase the benefits associated with shareholder proposals.

Final results from ClarIDHy, a global, phase 3, randomized, double-blind study of ivosidenib (IVO) versus placebo (PBO) in patients (pts) with previously treated cholangiocarcinoma (CCA) and an isocitrate dehydrogenase 1 (IDH1) mutation.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4069-4069
Author(s):  
Ghassan K. Abou-Alfa ◽  
Teresa Macarulla ◽  
Milind M. Javle ◽  
Robin Kate Kelley ◽  
Sam Joseph Lubner ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Endpoint ◽  
Failure Time ◽  
Objective Response ◽  
Idh1 Mutation ◽  
High Rate ◽  
Double Blind Study ◽  
Double Blind ◽  
Grade 3

4069 Background: CCA is a rare cancer for which there are limited effective therapies. IDH1 mutations occur in ̃20% of intrahepatic CCAs, resulting in production of the oncometabolite D-2-hydroxyglutarate, which promotes oncogenesis. IVO (AG-120) is a first-in-class, oral, small-molecule inhibitor of mutant IDH1 (mIDH1). ClarIDHy aimed to demonstrate the efficacy of IVO vs PBO in pts with unresectable or metastatic m IDH1 CCA. The primary endpoint was met with significant improvement in progression-free survival (PFS) by independent radiology center (IRC) with IVO vs PBO (hazard ratio [HR] = 0.37, p < 0.0001). Objective response rate (ORR) and stable disease for IVO were 2.4% (3 partial responses) and 50.8% (n = 63) vs 0% and 27.9% (n = 17) for PBO. IVO pts experienced significantly less decline in physical and emotional functioning domains of quality of life at cycle 2 day 1 vs PBO pts (nominal p < 0.05). Methods: Pts with m IDH1 CCA were randomized 2:1 to IVO (500 mg PO QD) or matched PBO and stratified by prior systemic therapies (1 or 2). Key eligibility: unresectable or metastatic m IDH1 CCA based on central testing; ECOG PS 0–1; measurable disease (RECIST v1.1). Crossover from PBO to IVO was permitted at radiographic progression. Primary endpoint: PFS by IRC. Secondary endpoints included overall survival (OS; by intent-to-treat), ORR, PFS (by investigator), safety, and quality of life. The planned crossover-adjusted OS was derived using the rank-preserving structural failure time (RPSFT) model. Results: As of 31 May 2020, ̃780 pts were prescreened for an IDH1 mutation and 187 were randomized to IVO (n = 126) or PBO (n = 61); 13 remain on IVO. Median age 62 y; M/F 68/119; 91% intrahepatic CCA; 93% metastatic disease; 47% had 2 prior therapies. 70% of PBO pts crossed over to IVO. OS data were mature, with 79% OS events in IVO arm and 82% in PBO. Median OS (mOS) was 10.3 months for IVO and 7.5 months for PBO (HR = 0.79; 95% CI 0.56–1.12; one-sided p = 0.093). The RPSFT-adjusted mOS was 5.1 months for PBO (HR = 0.49; 95% CI 0.34–0.70; p < 0.0001). Common all-grade treatment emergent adverse events (TEAEs, ≥ 15%) in the IVO arm: nausea 41%, diarrhea 35%, fatigue 31%, cough 25%, abdominal pain 24%, decreased appetite 24%, ascites 23%, vomiting 23%, anemia 18%, and constipation 15%. Grade ≥ 3 TEAEs were reported in 50% of IVO pts vs 37% of PBO pts, with grade ≥ 3 treatment-related AEs in 7% of IVO pts vs 0% in PBO. 7% of IVO pts experienced an AE leading to treatment discontinuation vs 9% of PBO pts. There were no treatment-related deaths. Conclusions: IVO was well tolerated and resulted in a favorable OS trend vs PBO despite a high rate of crossover. These data – coupled with statistical improvement in PFS, supportive quality of life data, and favorable safety profile – demonstrate the clinical benefit of IVO in advanced m IDH1 CCA. Clinical trial information: NCT02989857.

scholarly journals Analysis of the presence and location of mast cells in periapical cysts and periapical granulomas

2016 ◽  
Vol 64 (4) ◽  
pp. 376-381 ◽  
Author(s):  
Emerson Filipe de Carvalho NOGUEIRA ◽  
Elder Gyress Feitosa FARIAS ◽  
Luciano Barreto SILVA ◽  
Alexandrino Pereira dos SANTOS NETO ◽  
Emanuel Sávio de Souza ANDRADE ◽  
...  
Keyword(s):  
Mast Cells ◽  
Granulation Tissue ◽  
Blue Staining ◽  
Double Blind Study ◽  
Double Blind ◽  
Cross Sectional ◽  
Periapical Granuloma ◽  
Staining Methods ◽  
Periapical Cyst ◽  
Quantitative Descriptive

ABSTRACT Objective: The aim of the present study was to locate mast cells in chronic periapical lesions (granulomas and cysts) by using histochemical techniques and toluidine blue staining. Methods: A quantitative, descriptive, cross-sectional and retrospective research was performed. The sample was obtained from histopathological reports in the archives of the laboratory of surgical pathology of the University of Pernambuco between November 2014 and May 2015. Results: Sixteen cases of granuloma and 21 cases of periapical cysts were selected. The stained slides were analyzed by two examiners at different times, in a double-blind study. Mast cells were found in 13 (61.9%) of the periapical cyst cases, located in the capsule of the lesion. In the periapical granuloma cases, mast cells were found in eight cases (50%), located in the granulation tissue. Conclusion: Mast cells were detected in both cysts and periapical granuloma, located in the capsule and granulation tissue, respectively. Mast cells were more prevalent in periapical cysts than in periapical granuloma.

A 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naïve to potent opioids

2010 ◽  
Vol 1 (3) ◽  
pp. 122-141 ◽  
Author(s):  
Harald Breivik ◽  
Tone Marte Ljosaa ◽  
Kristian Stengaard-Pedersen ◽  
Jan Persson ◽  
Hannu Aro ◽  
...  
Keyword(s):  
Side Effects ◽  
Pain Relief ◽  
Low Dose ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Double Blind Study ◽  
Double Blind ◽  
Skin Reactions ◽  
Local Skin

AbstractObjectivePatients with osteoarthritis (OA) pain often have insufficient pain relief from non-opioid analgesics. The aim of this trial was to study efficacy and tolerability of a low dose 7-day buprenorphine transdermal delivery system, added to a NSAID or coxib regimen, in opioid-naïve patients with moderate to severe OA pain.MethodsA 6 months randomised, double-blind, parallel-group study at 19 centres in Denmark, Finland, Norway, and Sweden, in which OA patients (>40 years) with at least moderate radiographic OA changes and at least moderate pain in a hip and/or knee while on a NSAID or a coxib were randomised to a 7-day buprenorphine patch (n = 100) or an identical placebo patch (n = 99). The initial patch delivered buprenorphine 5 μg/h. This was titrated to 10 or 20 μg/h, as needed. Rescue analgesic was paracetamol 0.5–4 g daily. Statistical analysis of outcome data was mainly with a general linear model, with treatment as factor, the primary joint of osteoarthritis, baseline scores, and season as covariates.ResultsMost patients had OA-radiographic grade II (moderate) or grade III (severe), only 8 in each group had very severe OA (grade IV). The median buprenorphine dose was 10 μg/h. 31 buprenorphine-treated patients and 2 placebo-treated patients withdrew because of side effects. Lack of effect caused 12 placebo-treated and 7 buprenorphine-treated patients to withdraw. The differences in effects between treatments: Daytime pain on movement, recorded every evening on a 0–10 numeric rating scale decreased significantly more (P = 0.029) in the buprenorphine group. Patients’ Global Impression of Change at the end of the double blind period was significantly improved in the buprenorphine group (P = 0.017). The chosen primary effect outcome measure, the Western Ontario and McMaster Universities (WOMAC) OA Index for Pain (P = 0.061), and secondary outcome measures, the WOMAC OA score for functional abilities (P = 0.055), and the WOMAC total score (P = 0.059) indicated more effects from buprenorphine than placebo, but these differences were not statistically significant. In a post-hoc, subgroup analysis with the 16 patients with radiographic grad IV (very severe) excluded, WOMAC OA Index for Pain was significantly (P = 0.039) reduced by buprenorphine, compared with placebo. WOMAC OA score for stiffness and the amount of rescue medication taken did not differ. Sleep disturbance, quality of sleep, and quality of life improved in both groups. Side effects: Typical opioid side effects caused withdrawal at a median of 11 days before completing the 168 days double blind trial in 1/3 of the buprenorphine group. Mostly mild local skin reactions occurred equally often (1/3) in both groups.ConclusionsAlthough the 24 hours WOMAC OsteoArthritis Index of pain was not statistically significantly superior to placebo, day-time movement-related pain and patients’ global impression of improvement at the end of the 6-months double blind treatment period were significantly better in patients treated with buprenorphine compared with placebo. Opioid side effects caused 1/3 of the buprenorphine-patients to withdraw before the end of the 6-months double blind study period.ImplicationsA low dose 7-days buprenorphine patch at 5–20 μg/h is a possible means of pain relief in about 2/3 of elderly osteoarthritis patients, in whom pain is opioid-sensitive, surgery is not possible, NSAIDs and coxibs are not recommended, and paracetamol in tolerable doses is not effective enough. Vigilant focus on and management of opioid side effects are essential.

Daflon 500 mg: Symptoms and Edema

Angiology ◽  
2005 ◽  
Vol 56 (6_suppl) ◽  
pp. S25-S32 ◽  
Author(s):  
Albert-Adrien Ramelet
Keyword(s):  
Quality Of Life ◽  
Controlled Study ◽  
Venous Disease ◽  
Double Blind Study ◽  
Life Questionnaire ◽  
Double Blind ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Significant Difference

Patients suffering from any class of the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification of chronic venous disease (CVD) may be symptomatic (C0s-C6s). Leg heaviness, discomfort, itching, cramps, pain, paresthesia, and edema (C3) are the most frequent manifestations of CVD and a major reason for medical consultation. Daflon 500 mg (micronized purified flavonoid fraction [MPFF]) is an effective treatment for symptoms and edema in CVD as demonstrated in several randomized controlled studies. A 2-month, double-blind study in 40 patients established the superiority of Daflon 500 mg over placebo with regard to symptoms and objective signs. This was confirmed in another double-blind, placebo-controlled trial (2 months’ treatment, 160 patients), and in the Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids (RELIEF) study. The latter included 5,052 patients in 23 countries, using a visual analog scale for evaluating pain, leg heaviness, cramps, and a sensation of swelling. All symptoms showed significant and progressive improvement. The quality-of-life results (scores on the ChronIc Venous Insufficiency quality of life Questionnaire [CIVIQ]) paralleled those of symptoms. The decrease in the ankle and calf circumferences was significantly greater (p<0.001) in the group of patients treated with Daflon 500 mg in two studies, and correlated well with the improvement in the sensation of swelling (p<0.001). This was confirmed with more sophisticated measurement techniques as in the RELIEF study or in a trial assessing edema with an optoelectronic volumeter in 20 patients. A further double-blind, randomized, controlled study established a statistically significant difference in favor of Daflon 500 mg in comparison with diosmin, both on symptoms and edema. The therapeutic efficacy of Daflon 500 mg on CVD symptoms and edema has been demonstrated in double-blind, randomized, controlled studies. Further studies using a new approach may define the most precise and validated methodology for application in future research in phlebology.

scholarly journals Epidural Pethidine or Fentanyl during Caesarean Section: A Double-Blind Comparison

1989 ◽  
Vol 17 (2) ◽  
pp. 157-165 ◽  
Author(s):  
M. J. Paech
Keyword(s):  
Side Effects ◽  
Caesarean Section ◽  
Epidural Fentanyl ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Single Bolus Dose ◽  
Clinical Advantage ◽  
Blind Comparison

The onset, quality and duration of analgesia and side-effects of a single bolus dose of either epidural pethidine 50 mg or fentanyl 100 mcg, administered immediately post-delivery, were compared in a randomised, double-blind study of fifty-five women undergoing epidural caesarean section. The onset of effect was more rapid with fentanyl, a significantly larger number of women achieving complete pain relief fifteen minutes post-administration (P<0.05). The quality of analgesia was good in both groups and the quality and duration of effective analgesia not significantly different. The incidence and severity of side-effects were low, with no significant difference between groups. One patient in the pethidine group experienced early onset respiratory depression; however, she did not require active treatment. Epidural fentanyl 100 mcg appears to offer a small clinical advantage over pethidine 50 mg for intraoperative use during caesarean section.

scholarly journals Microbiological Quality of Drinking Water in Sachets Sold in the City of Yaoundé in Cameroon: Tests of Sensitivity to the Antibiotics of Bacteria Isolated

2020 ◽  
Vol 8 (1) ◽  
pp. 27
Author(s):  
Nguepidjo Gilbert ◽  
Kapso Tchouankep Mireille ◽  
Ngong Ankiambom Innocent ◽  
Tonmeu Douyong Chimène Sandrine ◽  
Enoka Patrice ◽  
...  
Keyword(s):  
Drinking Water ◽  
Low Cost ◽  
Bacterial Species ◽  
Microbiological Quality ◽  
Positive Culture ◽  
Human Beings ◽  
Salmonella Spp ◽  
Cross Sectional ◽  
The City

Water is the basic drink for human beings and drinking water in sachets is very popular because of its relatively low cost and availability. The aim of this study is to determine the bacteriological profile of sachet drinking water sold in the city of Yaounde. It was a descriptive cross-sectional study covering the period from March to June 2019, carried out in the application laboratory of ETMS-Yaounde. A total of 230 samples of drinking water in sachets purchased in different markets in the city of Yaounde were analyzed using Mac Conkey's flooding method. The identification was done on the API 20 E Gallery and the susceptibility test on Mueller Hinton media. The size of the sample was 230 packaged sachet drinking water and 213 of the 230 revealed 92% of positive culture of germs, and only 17 samples gave a negative culture, at a percentage of 8% of isolated germs. The isolated bacterial species and their respective abundances in samples were Enterobacter gergoviae (3%), Klebsiella pneumoniae (5%), Proteus mirabilis (5%), Serratia fonticola (5%), Salmonella choler arizonae cloacae (8%), Salmonella spp. (8%), Enterobacter cloacae (10%), Staphylococcus aureus (10%), Pseudomonas aeruginosa (18%) and Staphylococcus epidermidis (28%). All these tested germs were resistant to Amoxicillin and Erythromycin and 70% of tested germs were sensitive to Gentamycin. Overall, the results revealed poor microbiological quality of these waters. This exposes consumers to health risks, and it is important to inform and sensitize consumers about the risks involved, to educate producers and to control their activities by the health services.

scholarly journals Hydroxychloroquine for prevention of recurrent miscarriage: study protocol for a multicentre randomised placebo-controlled trial BBQ study

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025649 ◽  
Author(s):  
Elisabeth Pasquier ◽  
Luc de Saint-Martin ◽  
Gisèle Marhic ◽  
Celine Chauleur ◽  
Caroline Bohec ◽  
...  
Keyword(s):  
Recurrent Miscarriage ◽  
Low Cost ◽  
Controlled Trial ◽  
Oral Treatment ◽  
Safety Data ◽  
Live Birth Rate ◽  
First Trimester ◽  
Double Blind Study ◽  
Double Blind ◽  
Underlying Mechanisms

IntroductionRecurrent miscarriage (RM), defined by three or more consecutive losses during the first trimester of pregnancy, affects 1%–2% of fertile couples. Standard investigations fail to reveal any apparent cause in ~50% of couples. However, on the basis of animal models and clinical studies, several hypotheses have been put forward concerning underlying mechanisms of RM: altered ovarian reserve, progesterone defect, thrombotic and/or endothelial dysfunction and immunological disturbances. Nonetheless, no study has yet reached conclusive beneficial clinical evidence for a potential treatment in unexplained RM. Hydroxychloroquine (HCQ) is a molecule with extensive safety data during pregnancy. The pharmacological properties of HCQ (eg, antithrombotic, vascular protective, immunomodulatory, improved glucose tolerance, lipidlowering and anti-infectious) could be effective against some mechanisms of unexplained RM. Furthermore, eventhough clinical benefit of HCQ is suggested in prevention of thrombotic and late obstetric events in antiphospholipid (APL) syndrome, there are no data suggesting the benefit of HCQ in RM in the presence of APL antibodies.Methods and analysisTaken all together and given the low cost of HCQ, the aim of this multicentre, randomised, placebo-controlled, double-blind study is to investigate whether HCQ would improve the live birth rate in women with RM, irrespective of maternal thrombophilic status: (1) no known thrombophilia, (2) inherited thrombophilia or (3) APL antibodies. The primary end point is a live and viable birth. After confirming eligibility and obtaining consent, 300 non-pregnant women will be randomised into two parallel groups for a daily oral treatment (HCQ 400 mg or placebo), initiated before conception and stopped at 10 weeks’ gestation. If pregnancy does not occur after 1 year, the treatment will be stopped.Ethics and disseminationAgreement from the French National Public Health and Drug Security Agency (160765A-22) and ethical approval from the Committee for the Protection of Persons of NORD-OUEST I (2016-001330-97) have been obtained.Trial registration numbersNCT0316513; Pre-results.

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