german clinical trial register
Recently Published Documents


TOTAL DOCUMENTS

5
(FIVE YEARS 5)

H-INDEX

1
(FIVE YEARS 1)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ann-Kathrin Lederer ◽  
Alexandra Baginski ◽  
Lena Raab ◽  
Stefanie Joos ◽  
Jan Valentini ◽  
...  

Abstract Background The results of recent surveys indicate that more than 50% of the German population has experience with complementary and alternative medicine (CAM) or uses CAM regularly. This study investigated the CAM usage and CAM-related needs of hospitalized patients at university medical centres in the state of Baden-Württemberg, Germany. Methods A multi-centre, paper-based, pseudonymous survey was carried out by the members of the Academic Centre for Complementary and Integrative Medicine. Patients of all ages, regardless of sex, diagnosis and treatment, who were hospitalized in the Department of Cardiology, Gastroenterology, Oncology, Gynaecology or Surgery at the university medical centres in Freiburg, Heidelberg, Tübingen and Ulm were eligible for inclusion. Results Of the 1275 eligible patients, 67% (n = 854) consented to participate in the survey. Forty-eight percent of the study participants stated that they were currently using CAM. The most frequently used therapies were exercise (63%), herbal medicine (54%) and dietary supplements (53%). Only 16% of the patients discussed CAM usage with their attending physician. Half of the patients (48%) were interested in CAM consultations. More than 80% of the patients desired reliable CAM information and stated that physicians should be better informed about CAM. Conclusions The frequency of CAM usage and the need for CAM counselling among hospitalized patients at university medical centres in Baden-Württemberg are high. To better meet patients’ needs, CAM research and physician education should be intensified. Trial registration German Clinical Trial register (DRKS00015445).


2021 ◽  
Author(s):  
Joachim Risse ◽  
Karsten Szeder ◽  
Ann-Kristin Schubert ◽  
Thomas Wiesmann ◽  
Hanns-Christian Dinges ◽  
...  

Abstract Background:Double lumen tube (DLT) intubation is the most commonly used technique for lung separation. Bronchial blockers (BB) are an alternative, especially for difficult airways. The EZ-bronchial blocker (EZB) is the newest device of the BB family. Methods:A randomised, controlled trial was conducted in 80 patients undergoing elective thoracic surgery using DLT or SLT plus EZB for lung separation (German Clinical Trial Register DRKS00014816). The objective of the study was to compare the clinical performance of EZB with DLT. Primary endpoint was total time to successful lung separation. Secondary endpoints were time subsections, quality of lung collapse, difficulty of intubation, any complications during the procedure, incidence of objective trauma of the oropharynx and supraglottic space and intubation-related subjective symptoms.Results:74 patients were included, DLT group (n = 38), EZB group (n = 36). Median total time for lung separation [IQR] in DLT group was 234 seconds [207 to 294] versus 298 seconds [243 to 369] in EZB group (P=0.007). Quality of lung collapse was equal in both groups, DLT group 89.5% were excellent vs. 83.3 % in the EZB group (P=0.444). Inadequate lung collapse in five patients of the EZB group resulted in unsuccessful repositioning attempts and secondary DLT placement. Endoscopic examinations revealed significantly more carina trauma (P=0.047) and subglottic haemorrhage (P=0.047) in the DLT group. Additionally, postoperative subjective symptoms (sore throat, hoarseness) were more common in the DLT group, as were speech problems.Conclusions:Using the EZB results in prolonged lung separation compared to DLT, prima facie with equal quality of lung collapse for the thoracic surgeon. Five crossover cases demonstrated the superiority of the use of left-sided DLT especially in the indication for EZB for a right open thoracotomy or right video-assisted thoracoscopic surgery (VATS). Using the EZB showed only little evidence for reducing objective airway trauma e.g. less carina trauma as well as subjective complaints.Trial registration:German Clinical Trial Register DRKS00014816, prospectively registered on 07.06.2018https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014816


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Volodymyr Frankovych Vitkovskyy

Abstract Study objective To study the effect of a herbal preparation containing a standardised BNO 1040 extract* (based on lovage root, rosemary leaves and aerial parts of centaury) on the extracorporeal shockwave lithotripsy (ESWL) results in patients with urolithiasis (UL). Methodology 150 patients with UL (aged 18–65 years) treated with ESWL method were divided into 2 equal groups. The main group (n = 75) received standard recommendations and herbal preparation (12 months). The control group (n = 75) received standard recommendations only. The following was evaluated: time and degree of elimination of fragments; the presence of pain and leukocyturia; recurrent stone formation. Results The elimination of fragments was observed up to 14 days in 94.7% of patients in the main group versus 76% of patients in the control group. Renal colic was observed in 6.7% of patients in the main group versus 10.7% of patients in the control group; cases of leukocyturia were observed within 14 days in 10.7% versus 22.7%, respectively. During the year, a recurrent lithiasis was diagnosed in 6.7% of patients in the main group and in 16% of patients in the control group. Conclusion The use of BNO 1040 extract in combination with ESWL: contributes to more rapid and safe elimination of fragments of the calculi and reduces the risk of recurrent stone formation. Trial registration DRKS ID 00021200. Registered retrospectively in German Clinical Trial Register 27.03.2020. https://www.drks.de/


2020 ◽  
Author(s):  
Ann-Kathrin Lederer ◽  
Manuel Hettich ◽  
Roman Huber ◽  
Luciana Hannibal ◽  
Elena Neumann

Abstract Background Vegan diet (VD) is reported to show beneficial health effects including cardiovascular and anti-inflammatory protection, but the underlying mechanisms remain unclear. We hypothesized that adipokines, a special type of cytokine produced by the white adipose tissue with known effects on metabolism and the immune system, may contribute to the observed anti-inflammatory effects of VD. Methods A parallel group interventional trial was designed to evaluate the effect of VD compared to meat-rich diet (MD) on serum levels of two central adipokines, leptin and adiponectin. Fifty-three healthy, omnivore participants (62% female, average age 31 years and BMI 23.1 kg/m2) were randomly assigned to VD or MD for 4 weeks. Results End value comparison between VD group and MD group showed a significantly lower level of adiponectin in the MD group (11.6 vs. 15.5 µg/mL, p = 0.025) indicating a moderate effect size (Cohen’s d = 0.524). Participants’ sex affected adipokine levels requiring a separate analysis of male and female participants. Leptin was increased by MD only in male participants (p = 0.019) whereas adiponectin remained stable. Female participants in VD group showed higher adiponectin levels at the end of trial (compared to VD-baseline, p = 0.023, as well as compared to MD group, p = 0.015). The end concentration of adiponectin depended on diet in female participants (p = 0.010). Conclusion The results of our trial suggest that plasma concentration of leptin and adiponectin do not explain the immunomodulatory potential of VD in healthy participants, but it appears that diet modifies adipokine levels in a sex-specific manner.Trial registration: German Clinical Trial register (DRKS00011963), registered 30 March 2017, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011963.


BMC Nutrition ◽  
2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Josefine Nebl ◽  
Jan Philipp Schuchardt ◽  
Paulina Wasserfurth ◽  
Sven Haufe ◽  
Julian Eigendorf ◽  
...  

Abstract Background The number of people preferring plant-based nutrition is growing continuously in the western world. Vegetarianism and veganism are also becoming increasingly popular among individuals participating in sport. However, whether recreationally active vegetarian and vegan populations can meet their nutritional needs is not clear. Methods The purpose of this cross-sectional study was to compare the nutrient intake of omnivorous (OMN, n = 27), lacto-ovo vegetarian (LOV, n = 25) and vegan (VEG, n = 27) recreational runners (two to five training sessions per week) with intake recommendations of the German, Austrian and Swiss Nutrition Societies (Deutsche, Österreichische und Schweizerische Gesellschaften für Ernährung, D-A-CH) for the general population. Lifestyle factors and supplement intake were examined via questionnaires; dietary habits and nutrient intake were determined based on 3-day dietary records. Results More than half of each group did not reach the recommended energy intake (OMN: 10.4, 8.70–12.1; LOV: 9.67, 8.55–10.8; VEG: 10.2, 9.12–11.3 MJ). Carbohydrate intake was slightly below the recommendations of > 50 EN% in OMN (46.7, 43.6–49.8 EN%), while LOV (49.4, 45.5–53.3 EN%) and VEG (55.2, 51.4–59.0 EN%) consumed adequate amounts (p = 0.003). The recommended protein intake of 0.8 g/kg body weight (D-A-CH) was exceeded in all three groups (OMN: 1.50, 1.27–1.66; LOV: 1.34, 1.09–1.56; VEG: 1.25; 1.07–1.42 g/kg BW; p = 0.047). Only VEG (26.3, 22.7–29.8 EN%) did not achieve the recommended fat intake of 30 EN%. The supply of micronutrients, such as vitamin D and cobalamin, was dependent on supplement intake. Additionally, female OMN and LOV achieved the recommended daily intake of 15 mg iron only after supplementation, while VEG consumed adequate amounts solely via food. Conclusion All three groups were sufficiently supplied with most nutrients despite the exceptions mentioned above. The VEG group even showed advantages in nutrient intake (e.g. carbohydrates, fiber and iron) in comparison to the other groups. However, the demand for energy and several macro- and micronutrients might be higher for athletes. Thus, it is also necessary to analyze the endogenous status of nutrients to evaluate the influence of a vegetarian and vegan diet on the nutrient supply of athletes. Trial registration German Clinical Trial Register (DRKS00012377), registered on April 28, 2017.


Sign in / Sign up

Export Citation Format

Share Document