Browsing by Subject "randomized controlled trial"

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  • Kuhle, J.; Hardmeier, M.; Disanto, G.; Gugleta, K.; Ecsedi, M.; Lienert, C.; Amato, M. P.; Baum, K.; Buttmann, M.; Bayas, A.; Brassat, D.; Brochet, B.; Confavreux, C.; Edan, G.; Färkkilä, Markus; Fredrikson, S.; Frontoni, M.; D'Hooghe, M.; Hutchinson, M.; De Keyser, J.; Kieseier, B. C.; Kuempfel, T.; Rio, J.; Polman, C.; Roullet, E.; Stolz, C.; Vass, K.; Wandinger, K. P.; Kappos, L.; European Long Term Follow Up Study (2016)
    Objectives: To explore long-term effects of treatment and prognostic relevance of variables assessed at baseline and during the European secondary progressive multiple sclerosis (SPMS) trial of interferon beta 1b (IFNB-1b). Methods: We assessed 362 patients (60% female; median age 41 years; Expanded Disability Status Scale (EDSS): 5.5; 51% randomized to IFNB-1b) for their EDSS and treatment history after 10 years. Non-parametric analysis of covariance (ANCOVA) and multivariate linear regression models were applied. Results: Median EDSS was 6.0 at the end of the randomized controlled trial (RCT), in the IFNB-1b and placebo groups, and 7.0 in long-term follow-up patients (those receiving IFNB-1b in the RCT were 6.5 and those receiving placebo in the RCT were 7.0; p = 0.086). 24 patients (6.6%) were deceased. The EDSS at baseline and the EDSS change during the RCT were the most important predictors of the EDSS 10 years later (partial R-2: 0.47). The ability to predict changes in EDSS 10 years after the RCT was limited (R-2: 0.12). Magnetic resonance imaging (MRI) measures remained in the predictive models, but explained <5% of the variability. Conclusions: The results from this analysis did not provide convincing evidence to support a favorable long-term outcome in those patients allocated IFNB-1b during the RCT, in our SPMS cohort. The progressive stage of the disease remains largely unpredictable by clinical and conventional MRI measures, so better prognostic markers are needed.
  • Matthews, David R.; Paldanius, Päivi M.; Stumvoll, Michael; Han, Jackie; Bader, Giovanni; Chiang, YannTong; Proot, Pieter; Del Prato, Stefano (2019)
    Aims To ensure the integrity of the planned analyses and maximize the clinical utility of the VERIFY study results by describing the detailed concepts behind its statistical analysis plan (SAP) before completion of data collection and study database lock. The SAP will be adhered to for the final primary data analysis of the VERIFY trial. Materials and Methods Vildagliptin efficacy in combination with metformin for early treatment of T2DM (VERIFY) is an ongoing, multicentre, randomized controlled trial aiming to demonstrate the clinical benefits of glycaemic durability and glucose control achieved with an early combination therapy in newly-diagnosed type 2 diabetes (T2DM) patients. Results The SAP was initially designed at the study protocol conception phase and later modified, as reported here, in collaboration between the steering committee members, statisticians, and the VERIFY study leadership team. All authors were blinded to treatment allocation. An independent statistician has additionally retrieved and presented unblinded data to the independent data safety monitoring committee. An overview of the trial design with a focus on describing the fine-tuning of the analysis plan for the primary efficacy endpoint, risk of initial treatment failure, and secondary, exploratory and pre-specified subgroup analyses is provided here. Conclusion According to optimal trial practice, the details of the statistical analysis and data-handling plan prior to locking the database are reported here. The SAP accords with high-quality standards of internal validity to minimize analysis bias and will enhance the utility of the reported results for improved outcomes in the management of T2DM.
  • Sippola, Suvi; Grönroos, Juha; Sallinen, Ville; Rautio, Tero; Nordström, Pia; Rantanen, Tuomo; Hurme, Saija; Leppäniemi, Ari; Meriläinen, Sanna; Laukkarinen, Johanna; Savolainen, Heini; Virtanen, Johanna; Salminen, Paulina (2018)
    Introduction Recent studies show that antibiotic therapy is safe and feasible for CT-confirmed uncomplicated acute appendicitis. Spontaneous resolution of acute appendicitis has already been observed over a hundred years ago. In CT-confirmed uncomplicated acute diverticulitis (left-sided appendicitis), studies have shown no benefit from antibiotics compared with symptomatic treatment, but this shift from antibiotics to symptomatic treatment has not yet been widely implemented in clinical practice. Recently, symptomatic treatment of uncomplicated acute appendicitis has been demonstrated in a Korean open-label study. However, a double-blinded placebo-controlled study to illustrate the role of antibiotics and spontaneous resolution of uncomplicated acute appendicitis is still lacking. Methods and analysis The APPAC III (APPendicitis ACuta III) trial is a multicentre, double-blind, placebo-controlled, superiority randomised study comparing antibiotic therapy with placebo in the treatment CT scan-confirmed uncomplicated acute appendicitis aiming to evaluate the role of antibiotics in the resolution of uncomplicated acute appendicitis. Adult patients (18-60 years) with CT scan-confirmed uncomplicated acute appendicitis (the absence of appendicolith, abscess, perforation and tumour) will be enrolled in five Finnish university hospitals. Primary endpoint is success of the randomised treatment, defined as resolution of acute appendicitis resulting in discharge from the hospital without surgical intervention within 10 days after initiating randomised treatment (treatment efficacy). Secondary endpoints include postintervention complications, recurrent symptoms after treatment up to 1year, late recurrence of acute appendicitis after 1year, duration of hospital stay, sick leave, treatment costs and quality of life. A decrease of 15 percentage points in success rate is considered clinically important difference. The superiority of antibiotic treatment compared with placebo will be analysed using Fisher's one-sided test and CI will be calculated for proportion difference. Ethics and dissemination This protocol has been approved by the Ethics Committee of Turku University Hospital and the Finnish Medicines Agency (FIMEA). The findings will be disseminated in peer-reviewed academic journals. Trial registration number NCT03234296; Pre-results.
  • Broch, Kaspar; Gude, Einar; Karason, Kristjan; Dellgren, GÖran; Radegran, Goran; Gjesdal, Grunde; Gustafsson, Finn; Eiskjaer, Hans; Lommi, Jyri; Pentikäinen, Markku; Lemström, Karl B.; Andreassen, Arne K.; Gullestad, Lars (2020)
    Background Cardiac allograft vasculopathy (CAV) is characterized by diffuse thickening of the arterial intima. Statins reduce the incidence of CAV, but despite the use of statins, CAV remains one of the leading causes of long-term death after heart transplant. Inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9) substantially reduce cholesterol levels but have not been tested in heart transplant recipients. Methods The Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients (EVOLVD) trial ( Identifier: NCT03734211) is a randomized, double-blind trial designed to test the effect of the PCSK9 inhibitor evolocumab on coronary intima thickness in heart transplant recipients. Adults who have received a cardiac transplant within the past 4-8 weeks are eligible. Exclusion criteria include an estimated glomerular filtration rate <20 mL/min/1.73 m(2), renal replacement therapy, or contraindications to coronary angiography with intravascular ultrasound. 130 patients will be randomized (1:1) to 12-month treatment with evolocumab or matching placebo. The primary endpoint is the coronary artery intima thickness as measured by intravascular ultrasound. Conclusion The EVOLVD trial is a randomized clinical trial designed to show whether treatment with the PCSK9 inhibitor evolocumab can ameliorate CAV over the first year after heart transplant.
  • Cowley, Benjamin; Holmstrom, Edua; Juurmaa, Kristiina; Kovarskis, Levas; Krause, Christina M. (2016)
    Background: We report a randomized controlled clinical trial of neurofeedback therapy intervention for ADHD/ADD in adults. We focus on internal mechanics of neurofeedback learning, to elucidate the primary role of cortical self-regulation in neurofeedback. We report initial results; more extensive analysis will follow. Methods: Trial has two phases: intervention and follow-up. The intervention consisted of neurofeedback treatment, including intake and outtake measurements, using a waiting-list control group. Treatment involved 40 h-long sessions 2-5 times per week. Training involved either theta/beta or sensorimotor-rhythm regimes, adapted by adding a novel "inverse-training" condition to promote self-regulation. Follow-up (ongoing) will consist of self-report and executive function tests. Setting: Intake and outtake measurements were conducted at University of Helsinki. Treatment was administered at partner clinic Mental Capital Care, Helsinki. Randomization: We randomly allocated half the sample then adaptively allocated the remainder to minimize baseline differences in prognostic variables. Blinding: Waiting-list control design meant trial was not blinded. Participants: Fifty-four adult Finnish participants (mean age 36 years; 29 females) were recruited after screening by psychiatric review. Forty-four had ADHD diagnoses, 10 had ADD. Measurements: Symptoms were assessed by computerized attention test (T.O.V.A.) and self-report scales, at intake and outtake. Performance during neurofeedback trials was recorded. Results: Participants were recruited and completed intake measurements during summer 2012, before assignment to treatment and control, September 2012. Outtake measurements ran April August 2013. After dropouts, 23 treatment and 21 waiting-list participants remained for analysis. Initial analysis showed that, compared to waiting-list control, neurofeedback promoted improvement of self-reported ADHD symptoms, but did not show transfer of learning to T.O.V.A. Comprehensive analysis will be reported elsewhere.
  • Hjorth-Hansen, Henrik; Stenke, Leif; Soderlund, Stina; Dreimane, Arta; Ehrencrona, Hans; Gedde-Dahl, Tobias; Gjertsen, Bjorn Tore; Hoglund, Martin; Koskenvesa, Perttu; Lotfi, Kourosh; Majeed, Waleed; Markevarn, Berit; Ohm, Lotta; Olsson-Stromberg, Ulla; Remes, Kari; Suominen, Merja; Simonsson, Bengt; Porkka, Kimmo; Mustjoki, Satu; Richter, Johan; NCMLSG (2015)
  • the TRIGR Invest; Virtanen, Suvi M.; Cuthbertson, David; Nucci, Anita M.; Hyytinen, Mila; Salonen, Marja; Savilahti, Erkki; Knip, Mikael (2021)
    The international Trial to Reduce IDDM in the Genetically at Risk (TRIGR) tested the hypothesis whether extensively hydrolyzed casein-based versus regular cow's milk-based infant formula reduces the risk of type 1 diabetes. We describe dietary compliance in the trial in terms of study formula intake, feeding of nonrecommended foods, and serum cow's milk antibody concentration reflecting intake of cow's milk protein among 2,159 eligible newborn infants with a biological first-degree relative affected by type 1 diabetes and with HLA-conferred susceptibility to type 1 diabetes. The participating infants were introduced to the study formula feeding at the median age of 15 days with a median duration of study formula use of 63 days. During the intervention, 80% of the infants received study formula. Of these, 57% received study formula for at least 2 months. On average, 45.5 l of study formula were used per infant. Only 13% of the population had received a nonrecommended food by the age of 6 months. The dietary compliance was similar in the intervention and control arm. The reported cow's milk consumption by the families matched very well with measured serum casein IgA and IgG antibody concentration. To conclude, good compliance was observed in this randomized infant feeding trial. Compliance varied between the regions and those infants who were breastfed for a longer period of time had a shorter exposure to the study formula. High dietary compliance in infant feeding trial is necessary to allow accurate interpretation of study results.
  • ALBINO Study Group; Maiwald, C.A.; Annink, K.V.; Rüdiger, M.; Benders, M.J.N.L.; Van Bel, F.; Allegaert, K.; Naulaers, G.; Bassler, D.; Klebermaß-Schrehof, K.; Vento, M.; Guimarães, H.; Stiris, T.; Cattarossi, L.; Metsäranta, M.; Vanhatalo, S.; Mazela, J.; Metsvaht, T.; Jacobs, Y. (2019)
    Background: Perinatal asphyxia and resulting hypoxic-ischemic encephalopathy is a major cause of death and long-term disability in term born neonates. Up to 20,000 infants each year are affected by HIE in Europe and even more in regions with lower level of perinatal care. The only established therapy to improve outcome in these infants is therapeutic hypothermia. Allopurinol is a xanthine oxidase inhibitor that reduces the production of oxygen radicals as superoxide, which contributes to secondary energy failure and apoptosis in neurons and glial cells after reperfusion of hypoxic brain tissue and may further improve outcome if administered in addition to therapeutic hypothermia. Methods: This study on the effects of ALlopurinol in addition to hypothermia treatment for hypoxic-ischemic Brain Injury on Neurocognitive Outcome (ALBINO), is a European double-blinded randomized placebo-controlled parallel group multicenter trial (Phase III) to evaluate the effect of postnatal allopurinol administered in addition to standard of care (including therapeutic hypothermia if indicated) on the incidence of death and severe neurodevelopmental impairment at 24 months of age in newborns with perinatal hypoxic-ischemic insult and signs of potentially evolving encephalopathy. Allopurinol or placebo will be given in addition to therapeutic hypothermia (where indicated) to infants with a gestational age ≥ 36 weeks and a birth weight ≥ 2500 g, with severe perinatal asphyxia and potentially evolving encephalopathy. The primary endpoint of this study will be death or severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years. Effects on brain injury by magnetic resonance imaging and cerebral ultrasound, electric brain activity, concentrations of peroxidation products and S100B, will also be studied along with effects on heart function and pharmacokinetics of allopurinol after iv-infusion. Discussion: This trial will provide data to assess the efficacy and safety of early postnatal allopurinol in term infants with evolving hypoxic-ischemic encephalopathy. If proven efficacious and safe, allopurinol could become part of a neuroprotective pharmacological treatment strategy in addition to therapeutic hypothermia in children with perinatal asphyxia. Trial registration: NCT03162653, www.ClinicalTrials.gov, May 22, 2017. © 2019 The Author(s).
  • Sandborg, Johanna; Söderström, Emmie; Henriksson, Pontus; Bendtsen, Marcus; Henström, Maria; Leppänen, Marja H.; Maddison, Ralph; Migueles, Jairo H.; Blomberg, Marie; Löf, Marie (2021)
    Background: Excessive gestational weight gain (GWG) during pregnancy is a major public health concern associated with negative health outcomes for both mother and child. Scalable interventions are needed, and digital interventions have the potential to reach many women and promote healthy GWG. Most previous studies of digital interventions have been small pilot studies or have not included women from all BMI categories. We therefore examined the effectiveness of a smartphone app in a large sample (n=305) covering all BMI categories. Objective: To investigate the effectiveness of a 6-month intervention (the HealthyMoms app) on GWG, body fatness, dietary habits, moderate-to-vigorous physical activity (MVPA), glycemia, and insulin resistance in comparison to standard maternity care. Methods: A 2-arm parallel randomized controlled trial was conducted. Women in early pregnancy at maternity clinics in Östergötland, Sweden, were recruited. Eligible women who provided written informed consent completed baseline measures, before being randomized in a 1:1 ratio to either an intervention (n=152) or control group (n=153). The control group received standard maternity care while the intervention group received the HealthyMoms smartphone app for 6 months (which includes multiple features, eg, information; push notifications; self-monitoring; and feedback features for GWG, diet, and physical activity) in addition to standard care. Outcome measures were assessed at Linköping University Hospital at baseline (mean 13.9 [SD 0.7] gestational weeks) and follow-up (mean 36.4 [SD 0.4] gestational weeks). The primary outcome was GWG and secondary outcomes were body fatness (Bod Pod), dietary habits (Swedish Healthy Eating Index) using the web-based 3-day dietary record Riksmaten FLEX, MVPA using the ActiGraph wGT3x-BT accelerometer, glycemia, and insulin resistance. Results: Overall, we found no statistically significant effect on GWG (P=.62); however, the data indicate that the effect of the intervention differed by pre-pregnancy BMI, as women with overweight and obesity before pregnancy gained less weight in the intervention group as compared with the control group in the imputed analyses (-1.33 kg; 95% CI -2.92 to 0.26; P=.10) and completers-only analyses (-1.67 kg; 95% CI -3.26 to -0.09; P=.031]). Bayesian analyses showed that there was a 99% probability of any intervention effect on GWG among women with overweight and obesity, and an 81% probability that this effect was over 1 kg. The intervention group had higher scores for the Swedish Healthy Eating Index at follow-up than the control group (0.27; 95% CI 0.05-0.50; P=.017). We observed no statistically significant differences in body fatness, MVPA, glycemia, and insulin resistance between the intervention and control group at follow up (P≥.21). Conclusions: Although we found no overall effect on GWG, our results demonstrate the potential of a smartphone app (HealthyMoms) to promote healthy dietary behaviors as well as to decrease weight gain during pregnancy in women with overweight and obesity.
  • Markkula, N.; Lehti, V.; Adhikari, P.; Pena, S.; Heliste, J.; Mikkonen, E.; Rautanen, M.; Salama, E.; Guragain, B. (2019)
    Background. An essential strategy to increase coverage of psychosocial treatments globally is task shifting to non-medical counsellors, but evidence on its effectiveness is still scarce. This study evaluates the effectiveness of lay psychosocial counselling among persons with psychological distress in a primary health care setting in rural Nepal. Methods. A parallel randomized controlled trial in Dang, rural Nepal (NCT03544450). Persons aged 16 and older attending primary care and with a General Health Questionnaire (GHQ-12) score of 6 or more were randomized (1:1) to receive either non-medical psychosocial counselling (PSY) or enhanced usual care (EUC). PSY was provided by lay persons with a 6-month training and consisted of 5-weekly counselling sessions of 35-60 min with a culturally adapted solution-focused approach. EUC was provided by trained primary health workers. Participants were followed up at 1 (T1) and 6 months (T2). The primary outcome, response to treatment, was the reduction of minimum 50% in the Beck Depression Inventory (BDI) score. Results. A total of 141 participants, predominantly socially disadvantaged women, were randomized to receive PSY and 146 to EUC. In the PSY, 123 participants and 134 in the EUC were analysed. In PSY, 101 participants (81.4%) had a response compared with 57 participants (42.5%) in EUC [percentage difference 39.4% (95% CI 28.4-50.4)]. The difference in BDI scores at T2 between PSY and EUC was -7.43 (95% CI -9.71 to -5.14). Conclusions. Non-medical (lay) psychosocial counselling appears effective in reducing depressive symptoms, and its inclusion in mental health care should be considered in low-resource settings.
  • Munukka, Matti; Waller, Benjamin; Häkkinen, Arja; Nieminen, Miika T.; Lammentausta, Eveliina; Kujala, Urho M.; Paloneva, Juha; Kautiainen, Hannu; Kiviranta, Ilkka; Heinonen, Ari (2020)
    Objective To conduct a secondary analysis to study the effects, those 4 months of aquatic resistance training have on self-assessed symptoms and quality of life in post-menopausal women with mild knee osteoarthritis (OA), after the intervention and after a 12-month follow-up period. Methods A total of 87 post-menopausal volunteer women, aged 60-68 years, with mild knee OA were recruited in a randomized, controlled, 4-month aquatic training trial (RCT) and randomly assigned to an intervention (n = 43) and a control (n = 44) group. The intervention group participated in 48 supervised aquatic resistance training sessions over 4 months while the control group maintained their usual level of physical activity. Additionally, 77 participants completed the 12-month post-intervention follow-up period. Self-assessed symptoms were estimated using the OA-specific Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Health-related Quality of life (HRQoL) using the generic Short-form Health Survey (SF-36). Results After 4 months of aquatic resistance training, there was a significant decrease in the stiffness dimension of WOMAC -8.5 mm (95% CI = -14.9 to -2.0, P = .006) in the training group compared to the controls. After the cessation of the training, this benefit was no longer observed during the 12-month follow-up. No between-group differences were observed in any of the SF-36 dimensions. Conclusions The results of this study show that participation in an intensive aquatic resistance training program did not have any short- or long-term impact on pain and physical function or quality of life in women with mild knee OA. However, a small short-term decrease in knee stiffness was observed.
  • Ray, Carola; Figuereido, Rejane; Vepsäläinen, Henna; Lehto, Reetta; Pajulahti, Riikka; Skaffari, Essi; Sainio, Taina; Hiltunen, Pauliina; Lehto, Elviira; Korkalo, Liisa; Sääksjärvi, Katri; Sajaniemi, Nina; Erkkola, Maijaliisa; Roos, Eva (2020)
    The study examines the effects of a preschool-based family-involving multicomponent intervention on children's energy balance-related behaviors (EBRBs) such as food consumption, screen time and physical activity (PA), and self-regulation (SR) skills, and whether the intervention effects differed among children with low or high parental educational level (PEL) backgrounds. The Increased Health and Wellbeing in Preschools (DAGIS) intervention was conducted as a clustered randomized controlled trial, clustered at preschool level, over five months in 2017-2018. Altogether, 802 children aged 3-6 years in age participated. Parents reported children's consumption of sugary everyday foods and beverages, sugary treats, fruits, and vegetables by a food frequency questionnaire, and screen time by a 7-day diary. Physical activity was assessed by a hip-worn accelerometer. Cognitive and emotional SR was reported in a questionnaire by parents. General linear mixed models with and without repeated measures were used as statistical methods. At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children's EBRBs between the intervention and the control groups when stratified by PEL. The improvement in cognitive SR skills among low PEL intervention children differed from low PEL control children, the significance being borderline. The DAGIS multicomponent intervention did not significantly affect children's EBRBs or SR. Further sub-analyses and a comprehensive process evaluation may shed light on the non-significant findings.
  • Paavola, Mika; Malmivaara, Antti; Taimela, Simo; Kanto, Kari; Järvinen, Teppo L. N. (2017)
    Introduction: Arthroscopic subacromial decompression (ASD) is the most commonly performed surgical intervention for shoulder pain, yet evidence on its efficacy is limited. The rationale for the surgery rests on the tenet that symptom relief is achieved through decompression of the rotator cuff tendon passage. The primary objective of this superiority trial is to compare the efficacy of ASD versus diagnostic arthroscopy (DA) in patients with shoulder impingement syndrome (SIS), where DA differs only by the lack of subacromial decompression. A third group of supervised progressive exercise therapy (ET) will allow for pragmatic assessment of the relative benefits of surgical versus non-operative treatment strategies. Methods and Analysis: Finnish Subacromial Impingement Arthroscopy Controlled Trial is an ongoing multicentre, three-group randomised controlled study. We performed two-fold concealed allocation, first by randomising patients to surgical (ASD or DA) or conservative (ET) treatment in 2:1 ratio and then those allocated to surgery further to ASD or DA in 1:1 ratio. Our two primary outcomes are pain at rest and at arm activity, assessed using visual analogue scale (VAS). We will quantify the treatment effect as the difference between the groups in the change in the VAS scales with the associated 95% CI at 24 months. Our secondary outcomes are functional assessment (Constant score and Simple shoulder test), quality of life (15D and SF-36), patient satisfaction, proportions of responders and non-responders, reoperations/treatment conversions, all at 2 years post-randomisation, as well as adverse effects and complications. We recruited a total of 210 patients from three tertiary referral centres. We will conduct the primary analysis on the intention-to-treat basis. Ethics and Dissemination: The study was approved by the Institutional Review Board of the Pirkanmaa Hospital District and duly registered at ClinicalTrials.gov. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations. © 2017 Article author(s).
  • Vink, P.; Torrell, J.M.R.; Fructuoso, A.S.; Kim, Sung-Joo; Kim, Sang-Il; Zaltzman, J.; Ortiz, F.; Plana, J.M.C.; Rodriguez, A.M.F.; Rodrigo, H.R.; Marti, M.C.; Perez, R.; Roncero, F.M.G.; Kumar, D.; Chiang, Y.-J.; Doucette, K.; Pipeleers, L.; Morales, M.L.A.; Rodriguez-Ferrero, M.L.; Secchi, Antonio; McNeil, S.A.; Campora, L.; Di Paolo, E.; El Idrissi, M.; López-Fauqued, M.; Salaun, B.; Heineman, T.C.; Oostvogels, L. (2020)
    Background. The incidence of herpes zoster is up to 9 times higher in immunosuppressed solid organ transplant recipients than in the general population. We investigated the immunogenicity and safety of an adjuvanted recombinant zoster vaccine (RZV) in renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy. Methods. In this phase 3, randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled and received 2 doses of RZV or placebo 1-2 months (M) apart 4-18M posttransplant. Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates were assessed at 1M post-dose 1, and 1M and 12M post-dose 2. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Solicited general symptoms and unsolicited AEs were also collected 7 days before first vaccination. Serious AEs (including biopsy-proven allograft rejections) and potential immune-mediated diseases (pIMDs) were recorded up to 12M post-dose 2. Results. Two hundred sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 and April 2017. gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across postvaccination time points and persisted above prevaccination baseline 12M post-dose 2. Local AEs were reported more frequently by RZV than placebo recipients. Overall occurrences of renal function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were similar between groups. Conclusions. RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose. © The Author(s) 2019.
  • Hackenberg, T.; Mentula, P.; Leppaniemi, A.; Sallinen, V. (2017)
    Background and Aims: The laparoscopic approach has been increasingly used to treat adhesive small-bowel obstruction. The aim of this study was to compare the outcomes of a laparoscopic versus an open approach for adhesive small-bowel obstruction. Material and Methods: Data were retrospectively collected on patients who had surgery for adhesive small-bowel obstruction at a single academic center between January 2010 and December 2012. Patients with a contraindication for the laparoscopic approach were excluded. A propensity score was used to match patients in the laparoscopic and open surgery groups based on their preoperative parameters. Results: A total of 25 patients underwent laparoscopic adhesiolysis and 67 patients open adhesiolysis. The open adhesiolysis group had more suspected bowel strangulations and more previous abdominal surgeries than the laparoscopic adhesiolysis group. Severe complication rate (Clavien-Dindo 3 or higher) was 0% in the laparoscopic adhesiolysis group versus 14% in the open adhesiolysis group (p = 0.052). Twenty-five propensity score-matched patients from the open adhesiolysis group were similar to laparoscopic adhesiolysis group patients with regard to their preoperative parameters. Length of hospital stay was shorter in the laparoscopic adhesiolysis group compared to the propensity score-matched open adhesiolysis group (6.0 vs 10.0 days, p = 0.037), but no differences were found in severe complications between the laparoscopic adhesiolysis and propensity score-matched open adhesiolysis groups (0% vs 4%, p = 0.31). Conclusion: Patients selected to be operated by the open approach had higher preoperative morbidity than the ones selected for the laparoscopic approach. After matching for this disparity, the laparoscopic approach was associated with a shorter length of hospital stay without differences in complications. The laparoscopic approach may be a preferable approach in selected patients.
  • Grau-Sanchez, Jennifer; Ramos-Escobar, Neus; Sierpowska, Joanna; Rueda, Nohora; Susana, Redón; Rifà, Xavi; Veciana de las Heras, Misericordia; Pedro, Jordi; Särkämö, Teppo Tapio; Duarte, Esther; Rodríguez-Fornells, Antoni (2018)
    The effect of music-supported therapy (MST) as a tool to restore hemiparesis of the upper extremity after a stroke has not been appropriately contrasted with conventional therapy. The aim of this trial was to test the effectiveness of adding MST to a standard rehabilitation program in subacute stroke patients. A randomized controlled trial was conducted in which patients were randomized to MST or conventional therapy in addition to the rehabilitation program. The intensity and duration of the interventions were equated in both groups. Before and after 4 weeks of treatment, motor and cognitive functions, mood, and quality of life (QoL) of participants were evaluated. A follow-up at 3 months was conducted to examine the retention of motor gains. Both groups significantly improved their motor function, and no differences between groups were found. The only difference between groups was observed in the language domain for QoL. Importantly, an association was encountered between the capacity to experience pleasure from music activities and the motor improvement in the MST group. MST as an add-on treatment showed no superiority to conventional therapies for motor recovery. Importantly, patient's intrinsic motivation to engage in musical activities was associated with better motor improvement.
  • Räty, Silja; Borrmann, Carolin; Granata, Giuseppe; Cardenas-Morales, Lizbeth; Schoenfeld, Ariel; Sailer, Michael; Silvennoinen, Katri; Holopainen, Juha; De Rossi, Francesca; Antal, Andrea; Rossini, Paolo M.; Tatlisumak, Turgut; Sabel, Bernhard A. (2021)
    Background: Occipital strokes often cause permanent homonymous hemianopia leading to significant disability. In previous studies, non-invasive electrical brain stimulation (NIBS) has improved vision after optic nerve damage and in combination with training after stroke. Objective: We explored different NIBS modalities for rehabilitation of hemianopia after chronic stroke. Methods: In a randomized, double-blinded, sham-controlled, three-armed trial, altogether 56 patients with homonymous hemianopia were recruited. The three experiments were: i) repetitive transorbital alternating current stimulation (rtACS, n=8) vs. rtACS with prior cathodal transcranial direct current stimulation over the intact visual cortex (tDCS/rtACS, n=8) vs. sham (n = 8); ii) rtACS (n = 9) vs. sham (n = 9); and iii) tDCS of the visual cortex (n = 7) vs. sham (n = 7). Visual functions were evaluated before and after the intervention, and after eight weeks follow-up. The primary outcome was change in visual field assessed by high-resolution and standard perimetries. The individual modalities were compared within each experimental arm. Results: Primary outcomes in Experiments 1 and 2 were negative. Only significant between-group change was observed in Experiment 3, where tDCS increased visual field of the contralesional eye compared to sham. tDCS/rtACS improved dynamic vision, reading, and visual field of the contralesional eye, but was not superior to other groups. rtACS alone increased foveal sensitivity, but was otherwise ineffective. All trial-related procedures were tolerated well. Conclusions: This exploratory trial showed safety but no main effect of NIBS on vision restoration after stroke. However, tDCS and combined tDCS/rtACS induced improvements in visually guided performance that need to be confirmed in larger-sample trials.
  • Ngandu, Tiia; Lehtisalo, Jenni; Levalahti, Esko; Laatikainen, Tiina; Lindstrom, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hanninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia (2014)