Top 10 Biorxiv Papers Today in Clinical Trials


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#1. Short-term aerobic training does not improve memory functioning in relapsing remitting multiple sclerosis - a randomized controlled trial
Lisa Baquet, Helge Hasselmann, Stefan Patra, Jan Patrick Stellmann, Eik Vettorazzi, Andreas K Engel, Sina Rosenkranz, Jana Poettgen, Stefan M Gold, Karl Heinz Schulz, Christoph Heesen
Background: Only few aerobic exercise intervention trials specifically targeting cognitive functioning have been performed in MS. Objective and methods: This randomized controlled trial aimed to determine the effects of aerobic exercise on cognition in relapsing-remitting MS. The primary outcome was verbal memory (Verbal learning and memory test, VLMT). Patients were randomized to an intervention group (IG) program or a waitlist control group (CG). Patients in the IG exercised according to an individually tailored training schedule (with 2-3 sessions per week for 12 weeks). The primary analysis was carried out using the intention-to-treat (ITT) sample with ANCOVA adjusting for baseline scores. Results: 77 RRMS patients were screened and 68 participants randomized (CG n=34; IG n=34). The sample comprised 68% females, had a mean age of 39 years, a mean disease duration of 6.3 years, and a mean EDSS of 1.8. No significant effects were detected in the ITT analysis for the primary endpoint VLMT or any other cognitive measures....
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biorxivpreprint: Short-term aerobic training does not improve memory functioning in relapsing remitting multiple sclerosis - a randomized controlled trial https://t.co/LiGVBakmdJ #bioRxiv
PavelProsselkov: The effects of aerobic exercise on cognition in relapsing-remitting MS: "...no significant treatment effects were observed for quality of life, fatigue, or depressive symptoms" https://t.co/w4PWuP1FAy
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Sample Sizes : [34, 34, 20, 60, 30, 11, 5, 4, 34, 34, 23, 11, 77, 68, 34, 31, 3, 1, 9, 3, 2, 4, 34, 4, 1, 1, 29, 29, 23, 34, 34, 34, 34, 34, 34, 34, 34, 34]
Authors: 11
Total Words: 6390
Unqiue Words: 2458

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#2. 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

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#3. 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

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#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

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#5. 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

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#6. 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 &gt;&gt; https://t.co/IiNTnXiNen &gt;&gt; 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

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#7. 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

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#8. Cost-effectiveness of telephone-based weight loss support for patients with knee osteoarthritis: Results of an economic evaluation alongside a pragmatic randomised controlled trial
Kate M O'Brien, Johanna M van Dongen, Amanda Williams, Steven J Kamper, John Wiggers, Rebecca K Hodder, Elizabeth Campbell, Emma K Robson, Robin Haskins, Chris Rissel, Christopher M Williams
Background: The prevalence of knee osteoarthritis is increasing worldwide. Obesity is an important modifiable risk factor for both the incidence and progression of knee osteoarthritis. Consequently, international guidelines recommend patients with knee osteoarthritis who are overweight receive support to lose weight. However, few overweight patients with knee osteoarthritis receive care to support weight loss. Telephone-based interventions are one potential solution to provide scalable care to the many patients with knee osteoarthritis. The objective of this study is to evaluate whether referral to a telephone-based weight management and healthy lifestyle service for patients with knee osteoarthritis, who are overweight or obese, is cost-effective from a societal perspective compared to usual care. Methods: A cost-effectiveness analysis was undertaken alongside a pragmatic randomised controlled trial. We randomised 120 patients with knee osteoarthritis to an intervention or usual care control group in a 1:1 ratio. Participants in...
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Authors: 11
Total Words: 7577
Unqiue Words: 2439

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#9. 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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#10. Dosage Matters: A Randomized Controlled Trial of Rehabilitation Dose in the Chronic Phase after Stroke
Carolee Winstein, Bokkyu Kim, Sujin Kim, Clarisa Martinez, Nicolas Schweighofer
Background and Purpose: For stroke rehabilitation, task-specific training in animal models and human rehabilitation trials is considered important to trigger inherent neuroplasticity, promote motor learning, and functional recovery. Little is known, however, about what constitutes an effective dosage of therapy. Methods: This is a parallel group, four arm, single blind, phase I, randomized control trial of four dosages of upper extremity therapy delivered in an outpatient setting during the chronic phase after stroke. Participants were randomized into groups that varied in total dosage of therapy (i.e., 0, 15, 30, or 60 hours). Seven hundred and four participants were assessed for eligibility, 50 were eligible to enroll, 45 were randomized, 44 participated and 41 completed the study. Planned primary analyses used linear mixed effects regression to model baseline to post-intervention changes in the Motor Activity Log-Quality of Movement rating (MALQ) and the Wolf Motor Function Test (WMFT) time score as a function of therapy...
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keith_lohse: Important paper on dose-effects in #stroke rehabilitation. I'm sure I'll have a lot of questions for the authors at @ASNRehab in San Diego 😉😀 https://t.co/fRpdrFxQAi
anniemccluskey2: Thx Keith - paper to add to my list ...@stroke_ed https://t.co/ri8WRDfcBE https://t.co/ju8tDS9DyX
davidedesousa: @anniemccluskey2 @SimoneDorsch @kscriv2013 @stroke_ed https://t.co/YZhDoDeqRf on my reading list for thesis. Please share any others you happen to find Simone.
pt_neuro: Dosage Matters: A Randomized Controlled Trial of Rehabilitation Dose in the Chronic Phase after Stroke https://t.co/jGOplW4Q2H
Physiohomecare1: RT @pt_neuro: Dosage Matters: A Randomized Controlled Trial of Rehabilitation Dose in the Chronic Phase after Stroke https://t.co/jGOplW4Q2H
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Authors: 5
Total Words: 6093
Unqiue Words: 2072

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