scholarly journals Oxygen Persufflation in Liver Transplantation Results of a Randomized Controlled Trial

2019 ◽  
Vol 6 (2) ◽  
pp. 35 ◽  
Author(s):  
Anja Gallinat ◽  
Dieter Paul Hoyer ◽  
Georgios Sotiropoulos ◽  
Jürgen Treckmann ◽  
Tamas Benkoe ◽  
...  
Keyword(s):  
Patient Survival ◽  
Controlled Trial ◽  
Randomized Study ◽  
Serum Levels ◽  
Study Groups ◽  
Liver Preservation ◽  
History Of ◽  
Recipient Age ◽  
Effect Of Oxygen ◽  
Present Trial

Oxygen persufflation has shown experimentally to favorably influence hepatic energy dependent pathways and to improve survival after transplantation. The present trial evaluated oxygen persufflation as adjunct in clinical liver preservation. A total of n = 116 adult patients (age: 54 (23–68) years, M/F: 70/46), were enrolled in this prospective randomized study. Grafts were randomized to either oxygen persufflation for ≥2 h (O2) or mere cold storage (control). Only liver grafts from donors ≥55 years and/or marginal grafts after multiple rejections by other centers were included. Primary endpoint was peak-aspartate aminotransferase (AST) level until post-operative day 3. Standard parameters including graft- and patient survival were analyzed by uni- and multivariate analysis. Both study groups were comparable except for a longer ICU stay (4 versus 3 days) of the donors and a higher recipient age (57 versus 52 years) in the O2-group. Serum levels of TNF alpha were significantly reduced after oxygen persufflation (p < 0.05). Median peak-AST values did not differ between the groups (O2: 580 U/l, control: 699 U/l). Five year graft- and patient survival was similar. Subgroup analysis demonstrated a positive effect of oxygen persufflation concerning the development of early allograft dysfunction (EAD), in donors with a history of cardiopulmonary resuscitation and elevated ALT values, and concerning older or macrosteatotic livers. This study favors pre-implantation O2-persufflation in concrete subcategories of less than optimal liver grafts, for which oxygen persufflation can be considered a safe, cheap and easy applicable reconditioning method.

scholarly journals Comparing the efficacy of intralesional triamcinolone acetonide with verapamil in treatment of keloids: A randomized controlled trial

2019 ◽  
pp. 4-9 ◽  
Author(s):  
Nasrin Saki ◽  
Raya Mokhtari ◽  
Farnoosh Nozari
Keyword(s):  
Controlled Trial ◽  
Randomized Study ◽  
Clinical Problem ◽  
Study Groups ◽  
Sufficient Evidence ◽  
Single Group ◽  
Randomized Controlled ◽  
Alternative Modality ◽  
Single Blind

Background: Keloid management remains a challenging clinical problem despite numerous therapies reported until now. The efficacy of corticosteroids in the treatment of keloids has been well established. The most commonly used corticosteroid is intralesional triamcinolone. Sporadic reports on the use of intralesional verapamil suggest its efficacy. Aim: Since there is not sufficient evidence to support the role of intralesional verapamil as an effective alternative modality, it was decided to undertake a randomized study to determine its efficacy as a treatment for keloids. Methods: A randomized, single-blind, single-group comparison with 15 patients (30 scars) was carried out to compare the effects of intralesional triamcinolone with verapamil injections. Injections were scheduled every 3 weeks accompanied by cryotherapy until complete flattening of the scar or maximum 8 sessions, whichever came earlier. Scar evaluation at each stage was done by serial photographic records as well as by Vancouver scar scale. Statistical analysis was done by Wilcoxon and Mann-Whitney U tests using SPSS version 19. Results: In both study groups there was a reduction in height and pliability at the end of the study. Better improvement in height and pliability was seen with triamcinolone in comparison with verapamil. However, a desired change in vascularity and pigmentation was not seen with either of the drugs. Conclusion: Verapamil is not as effective as triamcinolone in the treatment of keloids.

scholarly journals Investigation of the Effects of Curcumin on Serum Cytokines in Obese Individuals: A Randomized Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Shiva Ganjali ◽  
Amirhossein Sahebkar ◽  
Elahe Mahdipour ◽  
Khadijeh Jamialahmadi ◽  
Sepideh Torabi ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Serum Levels ◽  
Immunomodulatory Effects ◽  
Serum Samples ◽  
Randomized Controlled ◽  
Array Technology ◽  
Significant Difference ◽  
Daily Dose ◽  
Present Trial ◽  
To Receive

Background. Obesity is a disorder often accompanied by a heightened state of systemic inflammation and immunoactivation. The present randomized crossover trial aimed to investigate the efficacy of curcumin, a bioactive polyphenol with established anti-inflammatory and immunomodulatory effects, on the serum levels of a panel of cytokines and mediators in obese individuals.Methods. Thirty obese individuals were randomized to receive curcumin at a daily dose of 1 g or a matched placebo for 4 weeks. Following a 2-week wash-out period, each group was assigned to the alternate treatment regimen for another 4 weeks. Serum samples were collected at the start and end of each study period. Serum levels of IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, VEGF, IFNγ, EGF, MCP-1, and TNFαwere measured using a multiplex Biochip Array Technology based method.Results. Mean serum IL-1β(P=0.042), IL-4 (P=0.008), and VEGF (P=0.01) were found to be significantly reduced by curcumin therapy. In contrast, no significant difference was observed in the concentrations of IL-2, IL-6, IL-8, IL-10, IFNγ, EGF, and MCP-1.Conclusions. The findings of the present trial suggested that curcumin may exert immunomodulatory effects via altering the circulating concentrations of IL-1β, IL-4, and VEGF.

The history of oxygen inhalation as a treatment for cluster headache

Cephalalgia ◽  
2012 ◽  
Vol 32 (12) ◽  
pp. 932-939 ◽  
Author(s):  
Danielle YP Haane ◽  
Thijs HT Dirkx ◽  
Peter J Koehler
Keyword(s):  
Angina Pectoris ◽  
Cluster Headache ◽  
Controlled Trial ◽  
Treatment Method ◽  
Early 20Th Century ◽  
Vascular Headache ◽  
Oxygen Inhalation ◽  
Oxygen Treatment ◽  
History Of ◽  
Effect Of Oxygen

Overview: Oxygen has been a generally accepted treatment method for cluster headache attacks ever since Kudrow (1981) conducted a controlled trial showing that oxygen was equally or even more effective than ergotamine injections. Purpose: The aim of the present study was to provide a historical perspective of oxygen treatment in cluster headache and to find the origin of this treatment. Oxygen for cluster headache was first described by Horton in 1952 and for migraine patients in 1940 by Alvarez. At the time, neither of the authors provided any reason why they chose for this treatment method. The vasoconstrictive effect of oxygen was not described by Horton until 1961. Conclusion: We suggest that these authors originally adhered to the vasoconstrictive theory of vascular headache that was prevalent in the early 20th century until Wolff demonstrated the contrary in the late 1930s. The early literature describes an analogy between angina pectoris and migraine, as both being due to vasoconstriction. As oxygen was described as a treatment for angina pectoris, this may be the reason why oxygen was tried for migraine and cluster headache at a time when they were not recognized as separate entities. Later it turned out to be more effective for cluster headache.

scholarly journals Restrictive Transfusion Strategy after Cardiac Surgery

2021 ◽  
Vol 134 (3) ◽  
pp. 370-380 ◽  
Author(s):  
Norddine Zeroual ◽  
Cinderella Blin ◽  
Marine Saour ◽  
Hélène David ◽  
Safa Aouinti ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Controlled Trial ◽  
Randomized Study ◽  
Study Groups ◽  
University Hospital ◽  
Control Group ◽  
Transfusion Strategy ◽  
Restrictive Transfusion ◽  
Icu Stay ◽  
Restrictive Transfusion Strategy

Background Recent guidelines on transfusion in cardiac surgery suggest that hemoglobin might not be the only criterion to trigger transfusion. Central venous oxygen saturation (Svo2), which is related to the balance between tissue oxygen delivery and consumption, may help the decision process of transfusion. We designed a randomized study to test whether central Svo2–guided transfusion could reduce transfusion incidence after cardiac surgery. Methods This single center, single-blinded, randomized controlled trial was conducted on adult patients after cardiac surgery in the intensive care unit (ICU) of a tertiary university hospital. Patients were screened preoperatively and were assigned randomly to two study groups (control or Svo2) if they developed anemia (hemoglobin less than 9 g/dl), without active bleeding, during their ICU stay. Patients were transfused at each anemia episode during their ICU stay except the Svo2 patients who were transfused only if the pretransfusion central Svo2 was less than or equal to 65%. The primary outcome was the proportion of patients transfused in the ICU. The main secondary endpoints were (1) number of erythrocyte units transfused in the ICU and at study discharge, and (2) the proportion of patients transfused at study discharge. Results Among 484 screened patients, 100 were randomized, with 50 in each group. All control patients were transfused in the ICU with a total of 94 transfused erythrocyte units. In the Svo2 group, 34 (68%) patients were transfused (odds ratio, 0.031 [95% CI, 0 to 0.153]; P &lt; 0.001 vs. controls), with a total of 65 erythrocyte units. At study discharge, eight patients of the Svo2 group remained nontransfused and the cumulative count of erythrocyte units was 96 in the Svo2 group and 126 in the control group. Conclusions A restrictive transfusion strategy adjusted with central Svo2 may allow a significant reduction in the incidence of transfusion. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Farokh Saljughi ◽  
Mitra Savabi-Esfahani ◽  
Shahnaz Kohan ◽  
Soheila Ehsanpour
Keyword(s):  
Pregnant Women ◽  
Maternal Employment ◽  
Controlled Trial ◽  
Role Play ◽  
Intervention Group ◽  
Control Group ◽  
Maternal Behaviour ◽  
Infant Attachment ◽  
Significant Difference ◽  
History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

scholarly journals Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ekaterina Alexeeva ◽  
Gerd Horneff ◽  
Tatyana Dvoryakovskaya ◽  
Rina Denisova ◽  
Irina Nikishina ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Controlled Trial ◽  
Randomized Study ◽  
Primary Objective ◽  
Disease State ◽  
Inactive Disease ◽  
Open Label ◽  
Standard Regimen ◽  
Double Blind ◽  
Early Combination Therapy

Abstract Background Remission is the primary objective of treating juvenile idiopathic arthritis (JIA). It is still debatable whether early intensive treatment is superior in terms of earlier achievement of remission. The aim of this study was to evaluate the effectiveness of early etanercept+methotrexate (ETA+MTX) combination therapy versus step-up MTX monotherapy with ETA added in refractory disease. Methods A multi-centre, double-blind, randomized study in active polyarticular JIA patients treated with either ETA+MTX (n = 35) or placebo+MTX (n = 33) for up to 24 weeks, followed by a 24-week open-label phase. The efficacy endpoints included pedACR30 criteria improvement at week 12, inactive disease at week 24, and remission at week 48. Patients who failed to achieve the endpoints at week 12 or at week 24 escaped to open-label ETA+MTX. Safety was assessed at each visit. Results By intention-to-treat analysis, more patients in the ETA+MTX group reached the pedACR30 response at week 12 (33 (94.3%)) than in the placebo+MTX group (20 (60.6%); p = 0.001). At week 24, comparable percentages of patients reached inactive disease (11 (31.4%) vs 11 (33.3%)). At week 48, 11 (31.4%) and eight (24.2%) patients achieved remission. The median (+/−IQR) times to achieve an inactive disease state in the ETA+MTX and placebo+MTX groups were 24 (14–32) and 32 (24–40) weeks, respectively. Forty-four (74/100 patient-years) adverse events (AEs) were reported, leading to treatment discontinuation in 6 patients. Conclusions Early combination therapy with ETA+MTX proved to be highly effective compared to the standard step-up regimen. Compared to those treated with the standard regimen, more patients treated with a combination of ETA+MTX reached the pedACR30 response and achieved inactive disease and remission more rapidly.

scholarly journals A Combination of Lactoplantibacillus plantarum Strains CECT7527, CECT7528 and CECT7529 Plus Monacolin K Reduces Blood Cholesterol: Results from a Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1206
Author(s):  
Rafael Guerrero-Bonmatty ◽  
Guadalupe Gil-Fernández ◽  
Francisco José Rodríguez-Velasco ◽  
Jordi Espadaler-Mazo
Keyword(s):  
Intervention Group ◽  
Study Groups ◽  
Statin Treatment ◽  
Blood Cholesterol ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Red Yeast Rice ◽  
Monacolin K ◽  
Double Blind ◽  
History Of

Background: Dietary supplements have been proposed to help manage blood cholesterol, including red yeast rice (RYR) extracts, plant sterols and stanols, beta-glucans, and some probiotics. This study was conducted to evaluate the efficacy of RYR (containing 10 mg of monacolin K) combined with 109 CFU of three Lactoplantibacillus plantarum strains (CECT7527, CECT7528, and CECT7529). Methods: A 12-week randomized, double-blinded, placebo-controlled clinical trial was conducted. In total, 39 adult patients were enrolled, having total cholesterol (TC) ≥200 mg/dL, and being statin-naïve or having recently stopped statin treatment because of intolerance. Active product or placebo were taken once daily, and subjects were evaluated at baseline, 6, and 12 weeks. Results: Study groups were comparable at baseline, except for history of recent hypercholesterolemia treatment (81% in active vs. 22% in placebo). Changes in LDL cholesterol and TC became significant compared to placebo (mean difference between groups and standard error of the mean = 23.6 ± 1.5 mg/dL, p = 0.023 and 31.4 ± 1.9 mg/dL, p = 0.011, respectively) upon adjusting for the baseline imbalance in hypercholesterolemia treatment. No adverse effects were noted during the study. Conclusion: This combination of 10 mg of monacolin K and L. plantarum strains was well tolerated and achieved a statistically significant greater reduction in LDL-C and TC in the intervention group compared to the placebo, once adjusting for recent history of hypercholesterolemia treatment.

scholarly journals Comparison of pregnenolone sulfate, pregnanolone and estradiol levels between patients with menstrually-related migraine and controls: an exploratory study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Cecilia Rustichelli ◽  
Elisa Bellei ◽  
Stefania Bergamini ◽  
Emanuela Monari ◽  
Flavia Lo Castro ◽  
...  
Keyword(s):  
Exploratory Study ◽  
Serum Levels ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
Allosteric Modulator ◽  
Positive Allosteric Modulator ◽  
Pregnenolone Sulfate ◽  
Menstrually Related Migraine ◽  
History Of ◽  
Estradiol Levels

Abstract Background Neurosteroids affect the balance between neuroexcitation and neuroinhibition but have been little studied in migraine. We compared the serum levels of pregnenolone sulfate, pregnanolone and estradiol in women with menstrually-related migraine and controls and analysed if a correlation existed between the levels of the three hormones and history of migraine and age. Methods Thirty women (mean age ± SD: 33.5 ± 7.1) with menstrually-related migraine (MM group) and 30 aged- matched controls (mean age ± SD: 30.9 ± 7.9) participated in the exploratory study. Pregnenolone sulfate and pregnanolone serum levels were analysed by liquid chromatography-tandem mass spectrometry, while estradiol levels by enzyme-linked immunosorbent assay. Results Serum levels of pregnenolone sulfate and pregnanolone were significantly lower in the MM group than in controls (pregnenolone sulfate: P = 0.0328; pregnanolone: P = 0.0271, Student’s t-test), while estradiol levels were similar. In MM group, pregnenolone sulfate serum levels were negatively correlated with history of migraine (R2 = 0.1369; P = 0.0482) and age (R2 = 0.2826, P = 0.0025) while pregnenolone sulfate levels were not age-related in the control group (R2 = 0.04436, P = 0.4337, linear regression analysis). Conclusion Low levels of both pregnanolone, a positive allosteric modulator of the GABAA receptor, and pregnenolone sulfate, a positive allosteric modulator of the NMDA receptor, involved in memory and learning, could contribute either to headache pain or the cognitive dysfunctions reported in migraine patients. Overall, our results agree with the hypothesis that migraine is a disorder associated with a loss of neurohormonal integrity, thus supporting the therapeutic potential of restoring low neurosteroid levels in migraine treatment.

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