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Background: Obesity is a global problem leading to reduced life expectancy, cardiovascular diseases, diabetes and many types of cancer. Even people willing to accept treatment only achieve a mean weight loss of about 5 kg using commercial weight loss programs. Surgical interventions, e.g. sleeve gastrectomy or gastric bypass are effective but accompanied by risk of serious complications and side effects. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). To date, a randomized comparison between these devices has not been undertaken or shown to be superior to a sham procedure.
Methods: We designed a multi-center, randomized, patient and assessor-blinded, controlled trial comparing weight loss in endoscopically implanted IB vs. DJBL vs. a sham procedure. A total of 150 patients with a BMI > 35 kg/m2 or > 30 with obesity-related comorbidities and indication for proton pump inhibitors are randomized to receive either IB, DJBL or a sham gastroscopy (2:2:1 ratio). All participants undergo regular dietary consultation. The IB will be removed after 6 months, whereas the DJBL will be explanted after 12 months. All patients will receive gastroscopies at implantation and explantation of the devices or sedation without gastroscopy to maintain blinding. Main exclusion criteria are malignant diseases, peptic ulcer or previous bariatric intervention. Weight loss 12 months after explantation of the devices, changes in comorbidities, quality of life, complication rates and safety will be evaluated.
Discussion: This trial could help to identify the most effective and safest endoscopic device, thus determining the new standard procedure for endoscopic bariatric treatment.
Trial registration: 16th January 2017. DRKS00011036. Funded by the German Research Foundation (DFG).
Die Bewertung des Kastenwesens bei Mahatma Gandhi als Element des nationalen Unabhängigkeitskampfes
(1998)
Da die Kasten die gesellschaftliche Realität Indiens in vielen Bereichen noch immer bestimmen und sie aufgrund der Demokratisierung Indiens nach der Unabhängigkeit als einheitliche Wählergruppe auch verstärkt politischen Einfluß ausüben, hält die Diskussion über dieses gesellschaftliche Phänomen unvermin-dert an. Die dabei zu Tage tretenden Kontroversen betreffen nicht nur die wis-senschaftliche Theoriebildung bezüglich der Entstehung, Entwicklung und Funktionsweise des Kastenwesens, sondern prägen auch die Diskussion über zukunftsorientierte Gesellschaftsentwürfe. Solche Entwürfe haben entweder die völlige Zerschlagung aller Kastenstrukturen zum Ziel oder fordern zumindest deren umfassende Reform. So macht vor allem die Dalit-Bewegung das Kas-tenwesen für die eigene Unterdrückung und Diskriminierung in der Gesellschaft verantwortlich und zielt auf die Herauslösung der Dalits aus der bestehenden Gesellschaft ab, ohne jedoch explizit einen alternativen Gesellschaftsentwurf zu entwickeln.[1] Die Hindutva-Bewegung dagegen hat den Blick auf einen mo-dernen (Hindu-) Nationalstaat gerichtet, in dem ein die Gesellschaft zergliedern-des Kastenwesen ebenfalls keinen Platz hat, auch wenn dieser Bewegung von ihren Gegnern regelmäßig das Gegenteil unterstellt wird.[2] Swami Vivekanan-da sah den Weg zu einer Überwindung des Kastenwesens in der Brahmanisie-rung der gesamten Gesellschaft, die er religiös begründete, indem er das Ende des Kali-Yuga verkündete.[3] Die Hare-Krishna-Bewegung fordert eine Abwen-dung von einem erblich determinierten Kastenwesen hin zu einem System, in dem die Einordnung gemäß den Fähigkeiten und Leistungen des Individuums erfolgt. Ein solches System soll sich an vedischen Traditionen orientieren und an das viergliedrige Ständewesens des im Rigveda beschriebenen ‘Varnashrama’ angelehnt sein.[4] Der Gesellschaftsentwurf Mahatma Gandhis und vor allem die darin vertretene Sichtweise des Kastenwesens werden in der gegenwärtigen Diskussion ebenfalls immer wieder aufgegriffen, wobei je nach eigener ideologischer Ausrichtung sehr unterschiedliche Interpretationen gegeben werden. So wird Gandhi gelegentlich unterstellt, das Kastenwesen bedingungslos verteidigt zu haben, wäh-rend er anderen als scharfer Kritiker des Systems gilt. Dieses breite Spektrum an Einschätzungen erstaunt jedoch keineswegs, da Gandhis Aussagen zum Kas-tenwesen von großer Zurückhaltung geprägt sind und damit nur durch die ver-gleichende Analyse verschiedener Aussagen verständlich werden. Diese Analyse soll hier geleistet werden, wobei auch der historische Kontext miteinbezogen werden muß, durch den Gandhis Gedankengang erst seine Plausibilität gewinnt. ...
Castes still determine the social reality of India in many fields and affect politics more and more by functioning as vote banks which are decisive in elections. Thus it is small wonder that there is an ongoing discussion about this social phe-nomenon. The controversies in the course of this discussion not only relate to academic theories concerning the origin, the evolution and the mode of opera-tion of the caste system but also determine the discussion about reform models for the Indian society. Such models either strive for the complete abolition of the caste system or at least call for a comprehensive reform of it. Especially the Dalit movement blames the caste system for the oppression and discrimination of the Dalits in society and tries to withdraw them from this system.[1] Yet the Dalit movement does not develop any alternative social draft. The Hindutva movement makes a strong effort to establish a modern (Hindu) nation which is only possible by overcoming the caste system that totally divides the society. Thus Hindutva is against the caste system though the antagonists of this move-ment usually maintain the contrary.[2] Swami Vivekananda holds that the only way to overcome the caste system is the Brahmanization of the whole society. For this he gives a religious explanation as he announces the end of the Kali-Yuga.[3] The Hare Krishna movement wants to turn away from a hereditary caste system towards a system where every individual is classified according to his skills and performance. Such a system should be based on Vedic traditions and especially on the fourfold varna system which is described in the ancient Rigveda.[4] Gandhi’s social draft and above all its attitude towards the caste system are often part of the current discussion but the interpretations differ according to the inter-preter’s ideological direction. Thus some charge Gandhi with having defended the caste system unconditionally, while others consider him a sharp critic of the system. This large spectrum is hardly surprising, since Gandhi’s comments are very reserved and can only become understandable by a comparative analysis of different statements on the caste system made by him during his political career. This article intends to provide such an analysis without neglecting the historical context which is vital to make Gandhi’s ideas clear. ...
Das Christentum in Kerala
(2000)
Nach der letzten indischen Volkszählung aus dem Jahre 1991 bekannten sich in Indien knapp 20 Mio. Menschen zum christlichen Glauben, was einem Bevölkerungsanteil von 2,34% entsprach. [1] Unter der Annahme, dass sich der Anteil der Christen an der Gesamtbevölkerung nicht signifikant verändert hat, liegt unter Berücksichtigung des allgemeinen Bevölkerungswachstums die Zahl der indischen Christen gegenwärtig bei etwa 23 Mio. Hinsichtlich der Verteilung der Christen gibt es erhebliche regionale Unterschiede. Über die Hälfte leben in den vier südlichen Unionsstaaten Kerala, Tamil Nadu, Karnataka und Andhra Pradesh, eine weitere Konzentration liegt im Nordosten Indiens (Assam, Nagaland, Meghalaya, Mizoram und Manipur) vor, wo noch einmal gut 20% der Christen leben. In den anderen Landesteilen sind sie dagegen sehr viel weniger zahlreich vertreten. ...
Observation of enhanced subthreshold K+ production in central collisions between heavy nuclei
(1994)
In the very heavy collision system 197Au+197Au the K+ production process was studied as a function of impact parameter at 1 GeV/nucleon, a beam energy well below the free N-N threshold. The K+ multiplicity increases more than linearly with the number of participant nucleons and the K+/ pi + ratio rises significantly when going from peripheral to central collisions. The measured K+ double differential cross section is enhanced by a factor of 6 compared to microscopic transport calculations if secondary processes (Delta N-->K Lambda N and Delta Delta -->K Lambda N) are ignored.
Background: Although anterior cruciate ligament (ACL) tear-prevention programs may be effective in the (secondary) prevention of a subsequent ACL injury, little is known, yet, on their effectiveness and feasibility. This study assesses the effects and implementation capacity of a secondary preventive motor-control training (the Stop-X program) after ACL reconstruction.
Methods and design: A multicenter, single-blind, randomized controlled, prospective, superiority, two-arm design is adopted. Subsequent patients (18–35 years) with primary arthroscopic unilateral ACL reconstruction with autologous hamstring graft are enrolled. Postoperative guideline rehabilitation plus Classic follow-up treatment and guideline rehabilitation plus the Stop-X intervention will be compared. The onset of the Stop-X program as part of the postoperative follow-up treatment is individualized and function based. The participants must be released for the training components. The endpoint is the unrestricted return to sport (RTS) decision. Before (where applicable) reconstruction and after the clearance for the intervention (aimed at 4–8 months post surgery) until the unrestricted RTS decision (but at least until 12 months post surgery), all outcomes will be assessed once a month. Each participant is consequently measured at least five times to a maximum of 12 times. Twelve, 18 and 24 months after the surgery, follow-up-measurements and recurrence monitoring will follow. The primary outcome assessement (normalized knee-separation distance at the Drop Jump Screening Test (DJST)) is followed by the functional secondary outcomes assessements. The latter consist of quality assessments during simple (combined) balance side, balance front and single-leg hops for distance. All hop/jump tests are self-administered and filmed from the frontal view (3-m distance). All videos are transferred using safe big content transfer and subsequently (and blinded) expertly video-rated. Secondary outcomes are questionnaires on patient-reported knee function, kinesiophobia, RTS after ACL injury and training/therapy volume (frequency – intensity – type and time). All questionnaires are completed online using the participants’ pseudonym only.
Group allocation is executed randomly. The training intervention (Stop-X arm) consists of self-administered home-based exercises. The exercises are step-wise graduated and follow wound healing and functional restoration criteria. The training frequency for both arms is scheduled to be three times per week, each time for a 30 min duration. The program follows current (secondary) prevention guidelines.
Repeated measurements gain-score analyses using analyses of (co-)variance are performed for all outcomes.
Trial registration: German Clinical Trials Register, identification number DRKS00015313. Registered on 1 October 2018.
The National Institutes of Health Stroke Scale (NIHSS) score is the most frequently used score worldwide for assessing the clinical severity of a stroke. Prior research suggested an association between acute symptomatic seizures after stroke and poorer outcome. We determined the frequency of acute seizures after ischemic stroke in a large population-based registry in a central European region between 2004 and 2016 and identified risk factors for acute seizures in univariate and multivariate analyses. Additionally, we determined the influence of seizures on morbidity and mortality in a matched case–control design. Our analysis of 135,117 cases demonstrated a seizure frequency of 1.3%. Seizure risk was 0.6% with an NIHSS score at admission <3 points and increased up to 7.0% with >31 score points. Seizure risk was significantly higher in the presence of acute non-neurological infections (odds ratio: 3.4; 95% confidence interval: 2.8–4.1). A lower premorbid functional level also significantly increased seizure risk (OR: 1.7; 95%CI: 1.4–2.0). Mortality in patients with acute symptomatic seizures was almost doubled when compared to controls matched for age, gender, and stroke severity. Acute symptomatic seizures increase morbidity and mortality in ischemic stroke. Their odds increase with a higher NIHSS score at admission.
Ferric carboxymaltose (FCM) has been shown to achieve rapid replenishment of iron stores and correction of anaemia in various populations with iron deficiency. A decrease in serum phosphate (PO43−) levels, which in most cases is asymptomatic, has been reported with IV iron preparations. Hypophosphataemia (HP) is a known adverse drug reaction with FCM. This post hoc pooled analysis investigates the frequency, duration, risk factors, and clinical signs of HP as reported in interventional clinical trials with FCM. Pooled data from subjects enrolled across 45 clinical trials in different therapy areas were included. A three-step adjudication process was utilised to identify adverse events of HP. Stratified analyses by therapy group and stepwise logistic regression analysis were used to identify predictors of HP. This pooled analysis confirms that FCM is associated with increased rates of serum PO43− lowering, but mean serum PO43− values were seen to recover at Week 4 and further recover at Week 8. Among all subjects receiving FCM therapy (n = 6879), 41.4% (n = 2847) reached a PO43− nadir value <2.5 mg/dL at any point on study and 0.7% (n = 49) reached a nadir <1 mg/dL. Although gastroenterology and women’s health subjects were identified to be at higher risk, occurrence of severe HP (<1 mg/dL [0.3 mmol/L]) following FCM administration was not observed to be common among subjects in these studies. Furthermore, there was no correlation between laboratory serum PO43− values and the occurrence of reported adverse events related to low PO43− levels.
Background and Aims: The IL-12/23 inhibitor ustekinumab (UST) opened up new treatment options for patients with Crohn’s disease (CD). Due to the recent approval, real-world German data on long-term efficacy and safety are lacking. This study aimed to assess the clinical course of CD patients under UST therapy and to identify potential predictive markers.
Methods: Patients with CD receiving UST treatment in three hospitals and two outpatient centers were included and retrospectively analyzed. Rates for short- and long-term remission and response were analyzed with the help of clinical (Harvey–Bradshaw Index (HBI)) and biochemical (C-reactive protein (CRP), Fecal calprotectin (fCal)) parameters for disease activity.
Results: Data from 180 patients were evaluated. One-hundred-and-six patients had a follow-up of at least eight weeks and were included. 96.2% of the patients were pre-exposed to anti- TNFα agents and 34.4% to both anti-TNFα and anti-integrin antibodies. The median follow-up was 49.1 weeks (95% CI 42.03-56.25). At week 8, 51 patients (54.8%) showed response to UST, and 24 (24.7%) were in remission. At week 48, 48 (51.6%) responded to UST, and 25 patients (26.9%) were in remission. Steroid-free response and remission at week eight was achieved by 30.1% and 19.3% of patients, respectively. At week 48, 37.6% showed steroid-free response to UST, and 20.4% of the initial patient population was in steroid-free remission.
Conclusion: Our study confirms short- and long-term UST effectiveness and tolerability in a cohort of multi-treatment-exposed patients.
Iron deficiency, with or without anemia, is the most frequent hematological manifestation in individuals with cancer, and is especially common in patients with colorectal cancer. Iron is a vital micronutrient that plays an essential role in many biological functions, in the context of which it has been found to be intimately linked to cancer biology. To date, however, whereas a large number of studies have comprehensively investigated and reviewed the effects of excess iron on cancer initiation and progression, potential interrelations of iron deficiency with cancer have been largely neglected and are not well-defined. Emerging evidence indicates that reduced iron intake and low systemic iron levels are associated with the pathogenesis of colorectal cancer, suggesting that optimal iron intake must be carefully balanced to avoid both iron deficiency and iron excess. Since iron is vital in the maintenance of immunological functions, insufficient iron availability may enhance oncogenicity by impairing immunosurveillance for neoplastic changes and potentially altering the tumor immune microenvironment. Data from clinical studies support these concepts, showing that iron deficiency is associated with inferior outcomes and reduced response to therapy in patients with colorectal cancer. Here, we elucidate cancer-related effects of iron deficiency, examine preclinical and clinical evidence of its role in tumorigenesis, cancer progression and treatment response. and highlight the importance of adequate iron supplementation to limit these outcomes.
