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Die Nukleinsäure-Amplifikations Testung (NAT) von Blutprodukten wurde Mitte der 90er Jahre von europäischen Plasma verarbeitenden Firmen und großen deutschen Blutspendediensten entwickelt. Primäres Ziel war eine verbesserte Sicherheit von Blutprodukten, indem das so genannte diagnostische Fenster nach einer Virusinfektion bis zum ersten Nachweis von Antikörpern so weit wie möglich geschlossen werden sollte. Bei einer qualitätsgerechten PCR kommen bereits der Probenentnahme, dem Probentransport sowie der Probenlagerung große Bedeutung zu, da vermieden werden muß, daß es durch ungeeignete Antikoagulanzien oder Entnahmetechniken zu einem Sensitivitätsverlust kommt oder daß Kontaminationen falsch positive Ergebnisse hervorrufen. Wird ein Pooling von Proben durchgeführt, ergibt sich ein Verdünnungsfaktor, weshalb darauf zu achten ist, dass gegebenenfalls nachfolgende Anreicherungsschritte für Viren, wie z.B. eine Zentrifugation, implementiert werden. Der Gesamtprozeß von Pooling und Virusanreicherung ist ebenso wie die Probenvorbereitung durch geeignete Maßnahmen zu validieren und durch Qualitätssicherungsmaßnahmen zu flankieren. Die in der Extraktion der viralen Nukleinsäuren verwendeten Reagenzien sollten im Laboralltag möglichst einfach zu handhaben sein, keine Gefährdung des Laborpersonals darstellen und die Virus-Nukleinsäure gleichzeitig mit höchster Effizienz freisetzen und in sehr hoher Reinheit für die anschließende Amplifikation bereitstellen. Qualitätssicherungmaßnahmen sollen hier sowohl die geforderte Effizienz des Prozesses sichern als auch verhindern, daß es in dieser kritischen Phase zu Kontaminationen kommt. Zur Amplifikation stehen verschiedene Methoden zur Verfügung, wobei die PCR, insbesondere bei inhouse-Systemen, die weiteste Verbreitung gefunden hat. Der Prozeß der Amplifikation sollte möglichst im geschlossenen System erfolgen, wie dies z.B. in Real-time PCR-Systemen die Regel ist, ohne daß das Reaktionsgefäß während oder nach dem Amplifikationsprozeß geöffnet werden muß. Dies gewährleistet eine hohe Sicherheit vor Kontaminationen durch freigesetzte Amplifikate. Im Blutspendewesen ist es von höchster Bedeutung, daß negative Ergebnisse tatsächlich negative Blutspenden anzeigen. Interne Kontrollen, die eine korrekte Funktionsweise jeder individuellen PCR signalisieren, sollten deshalb in jeder Reaktion mitgeführt werden. Neben internen Kontrollen sind externe Negativ- und Positiv-Kontrollen mitzuführen, um falsch positive Reaktionen nachzuweisen bzw. auch die vor der PCR liegenden Prozesse wie Virusanreicherung und Extraktion zu überwachen. Alle Prozesse sind nach den von den Behörden festgelegten Kriterien durchgängig zu validieren, und es ist routinemäßig an externen Qualitätskontrollmaßnahmen (Ringversuchen) teilzunehmen.
Background
For rheumatoid arthritis (RA), the treat-to-target concept suggests attaining remission or at least low disease activity (LDA) after 12 weeks.
Objectives
This German, prospective, multicenter, non-interventional study aimed to determine the proportion of patients with RA who achieved their treat-to-target aim after 12 and 24 weeks of etanercept (ETN) treatment in a real-life setting, as opposed to patients achieving their therapeutic target at a later timepoint (week 36 or 52).
Methods
A total of 824 adults with a confirmed diagnosis of RA without prior ETN treatment were included. Remission and LDA were defined as DAS28 < 2.6 and DAS28 ≤ 3.2, respectively.
Results
The proportion of patients achieving remission was 24% at week 12 and 31% at week 24. The proportion of patients achieving LDA was 39% at week 12 and 45% at week 24. The proportion of patients achieving remission or LDA further increased beyond week 24 up to week 52. Improvement in pain and reduction in concomitant glucocorticoid treatment were observed. Improvements in patient-reported outcomes were also seen in patients who did not reach remission or LDA. No new safety signals were detected.
Conclusions
A considerable proportion of patients with RA attained the target of remission or LDA after 12 weeks of ETN treatment. Even beyond that timepoint, the proportion of patients achieving treatment targets continued to increase up to week 52.
Trial Registration
ClinicalTrials.gov Identifier: NCT02486302.
Plain Language Summary
Physicians measure response to treatment of rheumatoid arthritis using a disease activity score (DAS28). People with a DAS28 of less than 2.6 have very few to no symptoms (also called remission). People with a DAS28 of 3.2 or less, called low disease activity, may experience mild symptoms. When people do not respond to treatment after 12 weeks, it is usually recommended to prescribe a different treatment. Researchers do not know how many people who do not respond after 12 weeks would respond if treatment were continued. A total of 824 German people with rheumatoid arthritis who received a drug called etanercept for up to 52 weeks took part in this study. Researchers wanted to know how many people had remission or low disease activity after 12 weeks and 24 weeks of treatment.
After 12 weeks, 24 in 100 people had remission; this increased to 31 in 100 people after 24 weeks. Thirty-nine in 100 people had low disease activity after 12 weeks; this increased to 45 in 100 people after 24 weeks. The number of people with remission or low disease activity increased with longer treatment (up to 52 weeks). People needed less additional treatment with a type of drug called glucocorticoids. The people in this study experienced side effects that were similar to those reported by people who took etanercept in previous studies.
The researchers concluded that a considerable proportion of people responded to treatment with etanercept after 12 weeks. This proportion increased when treatment was continued for longer than 12 weeks.
Porous tantalum trabecular metal biomaterial has a similar structure to trabecular bone, and was recently added to titanium dental implants as a surface enhancement. The purpose of this prospective pilot study was to describe 5-year survival results and crestal bone level changes around immediately-provisionalized Trabecular Metal Dental Implants. Eligible patients were adults in need of ≥1 implants in the posterior jaw. A non-occluding single acrylic provisional crown was in place for up to 14 days before final restoration. Clinical evaluations with radiographs were conducted at each follow-up visit (1 month, 3 months, 6 months, and 1 to 5 years). The primary endpoint was implant survival, characterized using the Kaplan-Meier method. The secondary endpoint was changes in crestal bone level, evaluated using a paired t-test to compare mean crestal bone levels between the baseline, 6-month, and annual follow-up values. In total, 30 patients (37 implants) were treated. Mean patient age was 45.5 years, and 63% were female. There was one implant failure; cumulative survival at 5 years was 97.2%. After the initial bone loss of 0.40 mm in the first 6 months, there were no statistically significant changes in crestal bone level over time up to 5 years of follow-up.
Objective: Liver stiffness measurement (LSM) is a tool used to screen for significant fibrosis and portal hypertension. The aim of this retrospective multicentre study was to develop an easy tool using LSM for clinical outcomes in advanced chronic liver disease (ACLD) patients.
Design: This international multicentre cohort study included a derivation ACLD patient cohort with valid two-dimensional shear wave elastography (2D-SWE) results. Clinical and laboratory parameters at baseline and during follow-up were recorded. LSM by transient elastography (TE) was also recorded if available. The primary outcome was overall mortality. The secondary outcome was the development of first/further decompensation.
Results: After screening 2148 patients (16 centres), 1827 patients (55 years, 62.4% men) were included in the 2D-SWE cohort, with median liver SWE (L-SWE) 11.8 kPa and a model for end stage liver disease (MELD) score of 8. Combination of MELD score and L-SWE predict independently of mortality (AUC 0.8). L-SWE cut-off at ≥20 kPa combined with MELD ≥10 could stratify the risk of mortality and first/further decompensation in ACLD patients. The 2-year mortality and decompensation rates were 36.9% and 61.8%, respectively, in the 305 (18.3%) high-risk patients (with L-SWE ≥20 kPa and MELD ≥10), while in the 944 (56.6%) low-risk patients, these were 1.1% and 3.5%, respectively. Importantly, this M10LS20 algorithm was validated by TE-based LSM and in an additional cohort of 119 patients with valid point shear SWE-LSM.
Conclusion: The M10LS20 algorithm allows risk stratification of patients with ACLD. Patients with L-SWE ≥20 kPa and MELD ≥10 should be followed closely and receive intensified care, while patients with low risk may be managed at longer intervals.
Rationale: Studies have suggested mental health improvements following the use of the psychotropic plant concoction ayahuasca in non-clinical and clinical samples.
Objectives: The present observational study assessed depressive symptomatology in 20 clinically depressed patients (symptom score > 13 on the Beck’s Depression Inventory) before attendance of an ayahuasca ceremony and 1 month and 1 year after. Secondary measures included ratings of altered states of consciousness and ego dissolution during the ayahuasca ceremony as well as global measures of mindfulness, satisfaction with life, depression, anxiety, and stress.
Results: Twenty participants completed baseline and 1-day follow-up, 19 completed measures at 1-month follow-up, and 17 completed measures at 1-year follow-up. BDI scores reduced from baseline (M = 22.7) to all post-ceremony measures (Ms 11.45, 12.89, and 8.88, for 1-day, 1-month, and 1-year follow-up, respectively). After 1 day, 12/20 participants were in remission (BDI < 13). Remission rates after 1 month and 1 year were 13/19 and 12/17, respectively. Three participants remained mildly depressed (BDI 14–19) at the 1-month and 1-year follow-up. Two participants did not respond and remained at a moderate/severe level of depression at 1-year follow-up. Reductions on the secondary mental health measures and increases in mindfulness and satisfaction with life were found up to 1 year post-ceremony. Improvements in clinical depression and mental health correlated with levels of experienced ego dissolution and oceanic boundlessness during the ceremony up to 1 month after the ceremony. Engagement in additional mental health treatments or use of another psychedelic during study participation may have contributed to improved mental health ratings at 1-year follow-up.
Conclusion: Ayahuasca produces long-term mental health improvements in clinically depressed patients, which highlights its therapeutic potential.
Rapidity-odd directed flow measurements at midrapidity are presented for Λ, Λ¯, K±, K0s and ϕ at sNN−−−−√= 7.7, 11.5, 14.5, 19.6, 27, 39, 62.4 and 200 GeV in Au+Au collisions recorded by the STAR detector at the Relativistic Heavy Ion Collider. These measurements greatly expand the scope of data available to constrain models with differing prescriptions for the equation of state of quantum chromodynamics. Results show good sensitivity for testing a picture where flow is assumed to be imposed before hadron formation and the observed particles are assumed to form via coalescence of constituent quarks. The pattern of departure from a coalescence-inspired sum-rule can be a valuable new tool for probing the collision dynamics.
Surface temperature is a fundamental parameter of Earth’s climate. Its evolution through time is commonly reconstructed using the oxygen isotope and the clumped isotope compositions of carbonate archives. However, reaction kinetics involved in the precipitation of carbonates can introduce inaccuracies in the derived temperatures. Here, we show that dual clumped isotope analyses, i.e., simultaneous ∆47 and ∆48 measurements on the single carbonate phase, can identify the origin and quantify the extent of these kinetic biases. Our results verify theoretical predictions and evidence that the isotopic disequilibrium commonly observed in speleothems and scleractinian coral skeletons is inherited from the dissolved inorganic carbon pool of their parent solutions. Further, we show that dual clumped isotope thermometry can achieve reliable palaeotemperature reconstructions, devoid of kinetic bias. Analysis of a belemnite rostrum implies that it precipitated near isotopic equilibrium and confirms the warmer-than-present temperatures during the Early Cretaceous at southern high latitudes.
We report the triton (t) production in Au+Au collisions at sNN−−−√ = 7.7 -- 200 GeV measured at mid-rapidity (|y|< 0.5) by the STAR experiment from the first phase of the beam energy scan at the Relativistic Heavy Ion Collider (RHIC). The nuclear compound yield ratio (Nt×Np/N2d), which is predicted to be sensitive to the local density fluctuation of neutrons, monotonically decreases with increasing charged-particle multiplicity (dNch/dη) and exhibits a scaling behavior. The multiplicity dependence of the yield ratios are compared with calculations from coalescence and thermal models. Relative to the coalescence baseline, enhancements of the yield ratios are observed in the 0%-10% most central collisions at 19.6 and 27 GeV with a significance of 2.3σ and 3.4σ, respectively, with a combined significance of 4.1σ. The measured significance of these enhancements decreases with smaller pT acceptance. The enhancements are not observed in peripheral collisions and model calculations without critical fluctuation. Important implications on the QCD phase structure and the production mechanism of light nuclei in heavy-ion collisions are discussed.
The STAR collaboration presents jet substructure measurements related to both the momentum fraction and the opening angle within jets in \pp and \AuAu collisions at \sqrtsn =200 GeV. The substructure observables include SoftDrop groomed momentum fraction (\zg), groomed jet radius (\rg), and subjet momentum fraction (\zsj) and opening angle (\tsj). The latter observable is introduced for the first time. Fully corrected subjet measurements are presented for \pp collisions and are compared to leading order Monte Carlo models. The subjet \tsj~distributions reflect the jets leading opening angle and are utilized as a proxy for the resolution scale of the medium in \AuAu collisions. We compare data from \AuAu collisions to those from \pp which are embedded in minimum-bias \AuAu events in order to include the effects of detector smearing and the heavy-ion collision underlying event. The subjet observables are shown to be more robust to the background than \zg~and \rg.
We observe no significant modifications of the subjet observables within the two highest-energy, back-to-back jets, resulting in a distribution of opening angles and the splittings that are vacuum-like. We also report measurements of the differential di-jet momentum imbalance (AJ) for jets of varying \tsj. We find no qualitative differences in energy loss signatures for varying angular scales in the range 0.1< \tsj <0.3, leading to the possible interpretation that energy loss in this population of high momentum di-jet pairs, is due to soft medium-induced gluon radiation from a single color-charge as it traverses the medium.
Oxytocin, welches primär als Hormon bekannt ist, beeinflusst als Neuromodulator viele kognitive Prozesse, die an sozialem Verhalten, wie Sprache, beteiligt sind. Einerseits verändert es akustische Merkmale von gesprochener Sprache, andererseits erleichtert es auf perzeptueller Ebene die Emotionserkennung in der Sprachwahrnehmung und Körpersprache. Bislang war nicht bekannt, wie Oxytocin Hirnaktivität während des Sprechens verändert. Wir hypothetisierten, dass dieser Neuromodulator ähnlich wie Dopamin kortiko-basale Schaltkreise bahnen könnte.
Wir führten eine doppelt-verblindete Verhaltens- und funktionelle Kernspintomographiestudie durch, in der 52 gesunde Probanden an zwei getrennten Untersuchungsterminen entweder intranasales Oxytocin oder ein Placebo erhielten. Die Teilnehmer lasen Sätze außerhalb des Kernspintomographen und im Scanner leise oder laut mit entweder neutraler oder fröhlicher Intonation vor.
Die Verabreichung von Oxytocin erhöhte den zweiten Formanten der produzierten Vokale. Höhere Frequenzen dieses akustischen Parameters wurden zuvor mit einer positiven Valenz gesprochener Sprache in Verbindung gebracht; jedoch konnten unabhängige Beurteiler*innen die akustischen Unterschiede in unserem experimentellen Setting nicht konsistent unterscheiden.
Als neuronales Korrelat verstärkte Oxytocin die präparatorische subkortikale Gehirnaktivität im ventralen Pallidum und Striatum. Auch kortikal erhöhte Oxytocin präparatorische Gehirnaktivität in Regionen des dorsalen wie auch des ventralen Sprachverarbeitungsstroms, in sensomotorischen Kortizes und limbischen sowie exekutiven Regionen. In einigen dieser Regionen modulierte der genetische Oxytocin- Rezeptor-Polymorphismus rs53576 die durch die Oxytocin-Verabreichung verursachte Gehirnaktivität. Ähnlich wie Dopamin modulierte Oxytocin außerdem kortiko-basale Schaltkreise, die an der Generierung von fröhlicher Prosodie beteiligt sind. Während der Vorbereitung von Sprache erhöhte der Neuromodulator die funktionelle Konnektivität zwischen dem ventralem Pallidum und dem dorsolateralen präfrontalen Kortex mit einem spiegelbildlichen Profil während des eigentlichen Sprechens, einen Effekt den wir als „gating“ (Bahnung) interpretierten.
Unsere Ergebnisse legen nahe, dass mehrere neuronale Prozesse, die der Sprachproduktion zugrundeliegen, durch Oxytocin moduliert werden. Das Muster ähnelt hierbei dem anderer Neuromodulatoren wie Dopamin. Die vorliegende Arbeit charakterisiert somit erstmals Oxytocineffekte auf die mit Sprachproduktion assoziierte Hirnaktivität und funktionelle Konnektivität.
The STAR collaboration presents jet substructure measurements related to both the momentum fraction and the opening angle within jets in p+p and Au+Au collisions at sNN−−−√=200 GeV. The substructure observables include SoftDrop groomed momentum fraction (zg), groomed jet radius (Rg), and subjet momentum fraction ((zSJ)) and opening angle ((θSJ)). The latter observable is introduced for the first time. Fully corrected subjet measurements are presented for p+p collisions and are compared to leading order Monte Carlo models. The subjet θSJ distributions reflect the jets leading opening angle and are utilized as a proxy for the resolution scale of the medium in Au+Au collisions. We compare data from Au+Au collisions to those from p+p which are embedded in minimum-bias Au+Au events in order to include the effects of detector smearing and the heavy-ion collision underlying event. The subjet observables are shown to be more robust to the background than zg and (Rg).
We observe no significant modifications of the subjet observables within the two highest-energy, back-to-back jets, resulting in a distribution of opening angles and the splittings that are vacuum-like. We also report measurements of the differential di-jet momentum imbalance (AJ) for jets of varying θg. We find no qualitative differences in energy loss signatures for varying angular scales in the range 0.1<θSJ<0.3, leading to the possible interpretation that energy loss in this population of high momentum di-jet pairs, is due to soft medium-induced gluon radiation from a single color-charge as it traverses the medium.
We study the beam-energy and system-size dependence of \phi meson production (using the hadronic decay mode \phi -- K+K-) by comparing the new results from Cu+Cu collisions and previously reported Au+Au collisions at \sqrt{s_NN} = 62.4 and 200 GeV measured in the STAR experiment at RHIC. Data presented are from mid-rapidity (|y|<0.5) for 0.4 < pT < 5 GeV/c. At a given beam energy, the transverse momentum distributions for \phi mesons are observed to be similar in yield and shape for Cu+Cu and Au+Au colliding systems with similar average numbers of participating nucleons. The \phi meson yields in nucleus-nucleus collisions, normalised by the average number of participating nucleons, are found to be enhanced relative to those from p+p collisions with a different trend compared to strange baryons. The enhancement for \phi mesons is observed to be higher at \sqrt{s_NN} = 200 GeV compared to 62.4 GeV. These observations for the produced \phi(s\bar{s}) mesons clearly suggest that, at these collision energies, the source of enhancement of strange hadrons is related to the formation of a dense partonic medium in high energy nucleus-nucleus collisions and cannot be alone due to canonical suppression of their production in smaller systems.
STAR's measurements of directed flow (v1) around midrapidity for π±, K±, K0S, p and p¯ in Au + Au collisions at $\sqrtsNN = 200$ GeV are presented. A negative v1(y) slope is observed for most of produced particles (π±, K±, K0S and p¯). In 5-30% central collisions a sizable difference is present between the v1(y) slope of protons and antiprotons, with the former being consistent with zero within errors. The v1 excitation function is presented. Comparisons to model calculations (RQMD, UrQMD, AMPT, QGSM with parton recombination, and a hydrodynamics model with a tilted source) are made. For those models which have calculations of v1 for both pions and protons, none of them can describe v1(y) for pions and protons simultaneously. The hydrodynamics model with a tilted source as currently implemented cannot explain the centrality dependence of the difference between the v1(y) slopes of protons and antiprotons.
STAR's measurements of directed flow (v1) around midrapidity for π±, K±, K0S, p and p¯ in Au + Au collisions at $\sqrtsNN = 200$ GeV are presented. A negative v1(y) slope is observed for most of produced particles (π±, K±, K0S and p¯). The proton v1(y) slope is found to be much closer to zero compared to antiprotons. A sizable difference is seen between v1 of protons and antiprotons in 5-30% central collisions. The v1 excitation function is presented. Comparisons to model calculations (RQMD, UrQMD, AMPT, QGSM with parton recombination, and a hydrodynamics model with a tilted source) are made. Anti-flow alone cannot explain the centrality dependence of the difference between the v1(y) slopes of protons and antiprotons.
We report measurements of the longitudinal double-spin asymmetry, ALL, for inclusive jet and dijet production in polarized proton-proton collisions at midrapidity and center-of-mass energy s√ = 510 GeV, using the high luminosity data sample collected by the STAR experiment in 2013. These measurements complement and improve the precision of previous STAR measurements at the same center-of-mass energy that probe the polarized gluon distribution function at partonic momentum fraction 0.015 ≲x≲ 0.25. The dijet asymmetries are separated into four jet-pair topologies, which provide further constraints on the x dependence of the polarized gluon distribution function. These measurements are in agreement with previous STAR measurements and with predictions from current next-to-leading order global analyses. They provide more precise data at low dijet invariant mass that will better constraint the shape of the polarized gluon distribution function of the proton.
We report measurements of the longitudinal double-spin asymmetry, ALL, for inclusive jet and dijet production in polarized proton-proton collisions at midrapidity and center-of-mass energy s√ = 510 GeV, using the high luminosity data sample collected by the STAR experiment in 2013. These measurements complement and improve the precision of previous STAR measurements at the same center-of-mass energy that probe the polarized gluon distribution function at partonic momentum fraction 0.015 ≲x≲ 0.25. The dijet asymmetries are separated into four jet-pair topologies, which provide further constraints on the x dependence of the polarized gluon distribution function. These measurements are in agreement with previous STAR measurements and with predictions from current next-to-leading order global analyses. They provide more precise data at low dijet invariant mass that will better constraint the shape of the polarized gluon distribution function of the proton.