Top 10 Biorxiv Papers Today in Clinical Trials


2.002 Mikeys
#1. Human extinction learning is accelerated by an angiotensin antagonist via ventromedial prefrontal cortex and its connections with basolateral amygdala
Feng Zhou, Yayuan Geng, Jialin Li, Pan Feng, Congcong Liu, Weihua Zhao, Tingyong Feng, Adam Guastella, Keith Kendrick, Benjamin Becker
Recent translational research suggests a role of the renin-angiotensin (RA) system in threat extinction and underlying neuroplasticity; however, whether and how pharmacological modulation of the RA system influences physiological and neural manifestations of threat during extinction learning in humans is unclear. Here we report that pre-extinction administration of losartan, an angiotensin II type 1 receptor antagonist, accelerated attenuation of physiological threat expression. During early extinction, losartan enhanced threat-signal specific ventromedial prefrontal cortex (vmPFC) activation and its coupling with the basolateral amygdala. Multivoxel pattern analysis revealed that losartan reduced whole brain, particularly vmPFC, threat expression and voxel-wise mediation analyses further confirmed that losartan-accelerated extinction crucially involved vmPFC processing. Overall the results provide initial evidence for a critical role of the RA system in extinction learning in humans and suggest that adjunct losartan...
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bn_becker: https://t.co/cwdQwjWxHe Fear extinction can be accelerated via targeting the renin angiotensin system with losartan. Effects mediated by the amygdala prefrontal circuit. New work from my PhD student Zhou Feng - a huge step towards clinical translation. Well done!
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Authors: 10
Total Words: 11338
Unqiue Words: 2954

1.996 Mikeys
#2. Use of a pandemic H1N1 strain with updated haemagglutinin and neuraminidase results in increased nasopharyngeal shedding and improved immunogenicity to Russian-backbone live attenuated influenza vaccine among children aged 2 – 4 years old: an open label, prospective, observational, phase 4 study in The Gambia.
Benjamin B Lindsey, Ya Jankey Jagne, Edwin P Armitage, Anika Singanayagam, Hadijatou J Sallah, Sainabou Drammeh, Elina Senghore, Nuredin I Mohammed, David Jeffries, Katja Hoschler, John S Tregoning, Adam Meijer, Ed Clarke, Tao Dong, Wendy Barclay, Beate Kampmann, Thushan I de Silva
Background: Poor efficacy and effectiveness of the pandemic H1N1 (pH1N1) component in intranasal live attenuated influenza vaccine (LAIV) has been demonstrated in several studies. The reasons for this are unclear, but may be due to impaired replicative fitness of pH1N1 A/California/07/2009-like (Cal09) LAIV strains. Methods: In an open-label, prospective, observational, phase 4 study, we evaluated the impact of updating the pH1N1 component in the Russian-backbone trivalent LAIV from Cal09 in 2016-17 (n=118) to an A/Michigan/45/2015-like strain (A/17/New York/15/5364, NY15) in 2017-18 (n=126), on shedding and immunogenicity in Gambian children aged 2-4 years old. The study was nested within a larger randomised controlled trial investigating LAIV-microbiome interactions (ClinicalTrials.gov [NCT02972957][1]). Findings: Cal09 showed impaired nasopharyngeal shedding compared to H3N2 and influenza B, along with sub-optimal serum antibody and T-cell responses. Following the switch to NY15, a significant increase in pH1N1 shedding was...
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Sample Sizes : [118, 126]
Authors: 17
Total Words: 8406
Unqiue Words: 2557

0.0 Mikeys
#3. Effects and Feasibility of Hyperthermic Baths for Patients with Depressive Disorder: A Randomized Controlled Clinical Pilot Trial
Johannes Naumann, Catharina Sadaghiani, Iris Kruza, Luisa Denkel, Gunver Kienle, Roman Huber
Background: Evaluation of efficacy, safety and feasibility of hyperthermic baths (HTB; head-out-of-water-immersion in 40°C), twice a week, compared to a physical exercise program (PEP; moderate intensity aerobic exercises) in moderate to severe depression. Method: Single-site, open-label randomized controlled 8-week parallel-group pilot study at an university outpatient clinic as part of usual depression care. Medically stable outpatients with depressive disorder (ICD-10: F32/F33) as determined by the 17-item Hamilton Depression Rating Scale (HAM-D) score ≥18 and a score ≥2 on item 1 (Depressed Mood) were randomly assigned to receive either two sessions of HTB or PEP per week (40-45 min) provided by two trained doctoral students. An independent biometric center used computer-generated tables to allocate treatments. Primary outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). Linear regression analyses, adjusted for baseline values, were performed to estimate intervention effects on...
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biorxivpreprint: Effects and Feasibility of Hyperthermic Baths for Patients with Depressive Disorder: A Randomized Controlled Clinical Pilot Trial https://t.co/5N01aTBmUA #bioRxiv
CCriadoPerez: (study here for those interested: https://t.co/2q1VDCyVFc)
painphysio: Depression may be helped by hot baths, finds pilot study >> https://t.co/IiNTnXiNen >> soak for up to 30 mins + hot water bottle and blankets for a further 20 mins. Easy to do at home. Possible that effects are due to a change in circadian rhythm... https://t.co/WxPxtsWoiM
inductivestep: @newscientist Here's the original https://t.co/hTiMjov2uP https://t.co/YY7PPQT3xZ
inductivestep: @MailOnline Here is a link to the original unpublished, non-peer reviewed article: https://t.co/hTiMjov2uP https://t.co/ZzTj3IQ3mC
PavelProsselkov: "...HTB (HyperThermic Baths) seems to be a fast-acting, safe and easy accessible method leading to clinically relevant improvement in depressive disorder" PP: and HoTB (the HypoThermic) would be even more effective )https://t.co/V0Qrs56Cmy
enfermeria: Baño de agua caliente podría ayudar a combatir la #Depresion leve o moderada By @SergioParra_ https://t.co/faWgIeGrPq Aunque etiología no es segura, podría estar relacionado ✂️ritmo circadiano. Tb Tª del cuerpo implicada. 📥@CCriadoPerez https://t.co/SvHwuOFaHZ Nuevas vías 👍👏👏 https://t.co/1lcknRv2ND
Umasi1981: biorxivにClinicalTrialsなんてあったのか Effects and Feasibility of Hyperthermic Baths for Patients with Depressive Disorder: A Randomized Controlled Clinical Pilot Trial https://t.co/jPbvqdwKD4
cyberjennifer: " A small study has found that afternoon baths just twice a week produce a moderate but persistent lift to mood. The size of the benefit was similar to that seen with physical exercise" https://t.co/yEtcuifyrx https://t.co/qMekZvJKpj #exerciseisoverrated
panspartner: Effects and Feasibility of Hyperthermic Baths for Patients with Depressive Disorder: A Randomized Controlled Clinical Pilot Trial https://t.co/gnDCAUXvpQ
dadababako1966: Effects and Feasibility of Hyperthermic Baths for Patients with Depressive Disorder https://t.co/o6cdlRH5bF https://t.co/RFXBgc5qBK
inductivestep: RT @inductivestep: @MailOnline Here is a link to the original unpublished, non-peer reviewed article: https://t.co/hTiMjov2uP https://t.co…
XYisnotXX: RT @CCriadoPerez: (study here for those interested: https://t.co/2q1VDCyVFc)
AikateriniVK: RT @inductivestep: @MailOnline Here is a link to the original unpublished, non-peer reviewed article: https://t.co/hTiMjov2uP https://t.co…
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Authors: 6
Total Words: 6922
Unqiue Words: 2580

0.0 Mikeys
#4. Glenohumeral Injection Using Anatomic Landmark Versus Sonographic Needle Guidance
Timothy S Moore, Cole F Paffett, Wilmer L Sibbitt, William A Hayward, James I Gibb, Selma D Kettwich, Roderick A Fields, N. Suzanne Emil, Monthida Fangtham, Arthur D Bankhurst
Objective: We hypothesized ultrasound (US) guidance improves outcomes of corticosteroid injection of the painful shoulder. Methods: 30 patients with symptomatic shoulders due to osteoarthritis were randomized to glenohumeral injection with 3 milliliters of 1% lidocaine and 60 mg of triamcinolone acetonide using the anterior approach with 1) conventional anatomic landmark palpation-guidance or 2) US-guidance. Injection pain (visual analogue pain scale (VAS)), pain at outcome (2 weeks and 6 months), therapeutic duration, time-to-next-injection, and costs were determined. Results: Injection pain was less with US (VAS: 0.3 (0.6) cm) vs. landmark-guidance (VAS: 1.4 (2.4) cm, 95% CI of difference: 0.5<1.1<1.7, p=0.05). Pain scores were similar at 2 weeks: US: 2.2 (2.4) cm; Landmark: 1.8 (2.7) cm, 95% CI of difference: -2.2<-0.4<1.4, p=0.66 and 6 months: US: 5.8 (2.8) cm; Landmark: 6.4 (2.9) cm, 95% CI of difference: -0.4<0.6< 1.1, p =0.71. Therapeutic duration (US: 3.9 (1.5) months; Landmark: 3.0 (1.2) months, 95% CI of difference: -1.4...
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Authors: 10
Total Words: 7112
Unqiue Words: 2155

0.0 Mikeys
#5. Improvement in Patient-Reported Sleep in Type 2 Diabetes and Prediabetes Participants Receiving a Continuous Care Intervention with Nutritional Ketosis
Morgan Siegmann, Shaminie Athinarayanan, Sarah Hallberg, Amy McKenzie, Nasir Bhanpuri, Wayne Campbell, James McCarter, Stephen Phinney, Jeff Volek, Christa Van Dort
Objective: Sleep disruption is frequently associated with type 2 diabetes (T2D) and hyperglycemia. We recently reported the effectiveness of a continuous care intervention (CCI) emphasizing nutritional ketosis for improving HbA1c, body weight and cardiovascular risk factors in T2D patients. The present study assessed the effect of this CCI approach on sleep quality using a subjective patient-reported sleep questionnaire. Methods: A non-randomized, controlled longitudinal study; 262 T2D and 116 prediabetes patients enrolled in the CCI and 87 separately recruited T2D patients continued usual care (UC) treatment. Patients completed the Pittsburgh Sleep Quality Index (PSQI) questionnaire. A PSQI score of >5 (scale 0 to 21) was used to identify poor sleepers. Results: Global sleep quality improved in the CCI T2D (p<0.001) and prediabetes (p<0.001) patients after one year of intervention. Subjective sleep quality (component 1), sleep disturbance (component 5) and daytime dysfunction (component 7), also showed improvements in the CCI T2D...
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Authors: 10
Total Words: 8822
Unqiue Words: 2794

0.0 Mikeys
#6. Derivation of a simple postoperative delirium incidence and severity prediction model
Heidi Lindroth, Lisa Bratzke, Sara Twadell, Paul Rowley, Janie Kildow, Mara Danner, Lily Turner, Brandon Hernandez, Wesley Chang, Roger Brown, Robert D. Sanders
Background: Delirium is an important postoperative complication, yet a simple and effective delirium prediction model remains elusive. We hypothesized that the combination of the National Surgical Quality Improvement Program (NSQIP) risk calculator for serious complications (NSQIP-SC) or risk of death (NSQIP-D), and cognitive tests of executive function (Trail Making Test A and B [TMTA, TMTB]), could provide a parsimonious model to predict postoperative delirium incidence or severity. Methods: Data were collected from 100 adults (>65yo) undergoing major non-cardiac surgery. In addition to NSQIP-SC, NSQIP-D, TMTA and TMTB, we collected participant age, sex, ASA score, tobacco use, type of surgery, depression, Framingham risk score, and preoperative blood pressure. Delirium was diagnosed with the Confusion Assessment Method (CAM), and the Delirium Rating Scale-R-98 (DRS) was used to assess symptom severity. LASSO and Best Subsets logistic and linear regression were employed in line with TRIPOD guidelines. Results: Three participants...
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Authors: 11
Total Words: 6767
Unqiue Words: 2552

0.0 Mikeys
#7. Clinical data specification and coding for cross-analyses with omics data in autoimmune disease trials
Roberta Lorenzon, Iannis Drakos, Claire Ribet, Sophie Harris, Maeva Cordoba, Olivia Tran, Eric Dasque, Patrice Cacoub, Agnes Hartemann, Bahram Bodaghi, David Saadoun, Francis Berenbaum, Gilles Grateau, Pierre Ronco, Olivier Benveniste, Kuberaka Mariampillai, Jeremie Sellam, Philippe Seksik, Michelle Rosenzwajg, Adrien Six, Claude Bernard, Caroline Aheng, Eric Vicaut, David Klatzmann, Encarnita Mariotti-Ferrandiz
Objectives: Autoimmune and inflammatory diseases (AIDs) form a continuum of autoimmune and inflammatory diseases, yet AIDs' nosology is based on syndromic classification. The TRANSIMMUNOM trial ([NCT02466217][1]) was designed to re-evaluate AIDs nosology through clinic-biological and multi-omics investigations of patients with one of 19 selected AIDs. To allow cross-analyses of clinic-biological data together with omics data, we needed to integrate clinical data in a harmonized database. Materials and Methods: We assembled a clinical expert consortium (CEC) to select relevant clinic-biological features to be collected for all patients and a cohort management team comprising biologists, clinicians and computer scientists to design an electronic case report form (eCRF). The eCRF design and implementation has been done on OpenClinica, an open-source CFR-part 11 compliant electronic data capture system. Results: The CEC selected 865 clinical and biological parameters. The CMT selected coded the items using CDISC standards into 5835...
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Authors: 25
Total Words: 6183
Unqiue Words: 2532

0.0 Mikeys
#8. Exploratory analyses suggest less cognitive decline on nilvadipine treatment in very mild Alzheimer's disease subjects.
Laila Abdullah, Fiona Crawford, Heather Langlois, Suzanne Hendrix, Sean Kennelly, Brian Lawlor, Michael Mullan
Background: This study explores whether the baseline severity of Alzheimer's disease (AD) subjects in the NILVAD trial modified the effects of nilvadipine, a dihydropyridine calcium channel blocker shown to target multiple aspects of AD pathology in preclinical studies. Methods: Exploratory analyses were performed on the modified intention-to-treat (mITT) dataset (n = 497) to examine the response to nilvadipine in very mild, mild and moderate AD subjects. The main outcome measures included total scores and subscales of the Alzheimer's Disease Assessment Scale Cognitive 12 (ADAS-Cog 12) and the Clinical Dementia Rating Scale sum of boxes (CDR-sb). All statistical analyses were adjusted for the confounding effects of the apolipoprotein E (APOE) ε4 allele and education and effect modification by gender in order to examine the interactive effects of nilvadipine and AD severity over the 78-week study period. Results: Compared to their respective placebo controls, nilvadipine-treated very mild AD subjects showed lower decline whereas...
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Authors: 7
Total Words: 7271
Unqiue Words: 2146

0.0 Mikeys
#9. Attentional Bias Modification is associated with fMRI Response towards Negative Stimuli in Residual Depression: A Randomized Controlled Trial
Eva Hilland, Nils Inge Landro, Catherine Harmer, Michael Browning, Luigi Angelo Maglanoc, Rune Jonassen
Background Modification of attentional biases (ABM) may lead to more adaptive emotion perception and emotion regulation. Understanding the neural basis of these effects may lead to greater precision for future treatment development. Task-related fMRI following ABM training has so far not been investigated in depression. The main aim of the RCT was to explore differences in brain activity after ABM training in response to emotional stimuli. Methods A total of 134 previously depressed individuals were randomized into 14 days of ABM- or a placebo training followed by an fMRI emotion regulation task. Depression symptoms and subjective ratings of perceived negativity during fMRI was examined between the training groups. Brain activation was explored within predefined areas (SVC) and across the whole brain. Activation in areas associated with changes in attentional biases (AB) and degree of depression was explored. Results The ABM group showed reduced activation within the amygdala and within the anterior cingulate cortex (ACC) when...
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Authors: 6
Total Words: 7224
Unqiue Words: 2522

0.0 Mikeys
#10. Effects of Attentional Bias Modification on Residual Symptoms in depression. A Randomized Controlled Trial.
Rune Jonassen, Catherine J Harmer, Eva Hilland, Luigi A Maglanoc, Brage Kraft, Michael Browning, Tore C Stiles, Vegard O Haaland, Torkil Berge, Nils Inge Landro
Background: Following treatment, many depressed patients have significant residual symptoms. However, large randomised controlled trials (RCT) in this population are lacking. When Attention bias modification training (ABM) leads to more positive emotional biases, associated changes in clinical symptoms have been reported. A broader and more transparent picture of the true advantage of ABM based on larger and more stringent clinical trials have been requested. Aims: To evaluate the early effect of two weeks ABM training on blinded clinician-rated and self-reported residual symptoms, and whether changes towards more positive attentional biases (AB) would be associated with symptom reduction. Method: A total of 321 patients with a history of depression were included in a preregistered randomized controlled double-blinded trial. Patients were randomised to an emotional ABM paradigm over fourteen days or a closely matched control condition. Symptoms based on the Hamilton Rating Scale for Depression (HRSD) and Beck Depression Inventory...
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Authors: 10
Total Words: 5797
Unqiue Words: 1978

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