66,005 results match your criteria loss trial

Changes in white adipose tissue gene expression in a randomized control trial of dieting obese men with lowered serum testosterone alone or in combination with testosterone treatment.

Endocrine 2021 Apr 17. Epub 2021 Apr 17.

Department of Medicine Austin Health, University of Melbourne, Heidelberg, Victoria, Australia.

Purpose: The aim of this study was to determine early weight loss-associated changes in subcutaneous abdominal white adipose tissue (WAT) gene expression in obese men with lowered serum testosterone by RNA next-generation sequencing.

Methods: Fourteen men, mean age (IQR) 51.6 years (43. Read More

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The development and initial validation of the Breast Cancer Recurrence instrument (BreastCaRe)-a patient-reported outcome measure for detecting symptoms of recurrence after breast cancer.

Qual Life Res 2021 Apr 16. Epub 2021 Apr 16.

Psychological Aspects of Cancer, Danish Cancer Society Research Center, Strandboulevarden 49, 2100, Copenhagen, Denmark.

Purpose: Patient-reported outomes (PRO) may facilitate prompt treatment. We describe the development and psychometric properties of the first instrument to monitor for symptoms of breast cancer (BC) recurrence.

Methods: This study is nested in the MyHealth randomized trial of nurse-led follow-up based on electronically-collected PROs. Read More

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Selective AKT kinase inhibitor capivasertib in combination with fulvestrant in PTEN-mutant ER-positive metastatic breast cancer.

NPJ Breast Cancer 2021 Apr 16;7(1):44. Epub 2021 Apr 16.

Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Five to ten percent of ER+ metastatic breast cancer (MBC) tumors harbor somatic PTEN mutations. Loss of function of this tumor-suppressor gene defines a highly aggressive, treatment-refractory disease for which new therapies are urgently needed. This Phase I multipart expansion study assessed oral capivasertib with fulvestrant in patients with PTEN-mutant ER+ MBC. Read More

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Impact of endothelial shear stress on absorption process of resorbable magnesium scaffold: A BIOSOLVE-II substudy.

Cardiovasc Revasc Med 2021 Apr 9. Epub 2021 Apr 9.

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC, USA. Electronic address:

Background/purpose: Local hemodynamic forces such as endothelial shear stress (ESS) may have an influence on appropriate neointimal healing, vessel remodeling, and struts absorption process following second-generation drug-eluting resorbable magnesium scaffold (RMS, Magmaris, Biotronik AG, Buelach, Switzerland) placement. The aim of this study was to investigate the impact of ESS assessed by optical coherence tomography (OCT)-based computational fluid dynamic (CFD) simulations on absorption process and coronary lumen dimension after Magmaris implantation.

Methods And Results: A total of 22 patients who were enrolled in the BIOSOLVE-II trial and underwent serial OCT assessment immediately after Magmaris implantation and at 6- and 12-month follow-up were included. Read More

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Informal caregivers during the COVID-19 pandemic perceive additional burden: findings from an ad-hoc survey in Germany.

BMC Health Serv Res 2021 Apr 16;21(1):353. Epub 2021 Apr 16.

Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität Berlin, and Institute of Medical Sociology and Rehabilitation Sciences, Virchowweg 22, 10117, Berlin, Germany.

Background: While the relation between care involvement of informal caregivers and caregiver burden is well-known, the additional psychosocial burden related to care involvement during the COVID-19 pandemic has not yet been investigated.

Methods: A total of 1000 informal caregivers, recruited offline, participated in a cross-sectional online survey from April 21 to May 2, 2020. Questionnaires were used to assess COVID-19-specific changes in the care situation, negative feelings in the care situation, problems with implementation of COVID-19 measures, concerns/excessive demands, loss of support, change in informal caregivers' own involvement in care and problems with provision, comprehension & practicability of COVID-19 information, and to relate these issues to five indicators of care involvement (i. Read More

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No association of genetic variants in TLR4, TNF-α, IL10, IFN-γ, and IL37 in cytomegalovirus-positive renal allograft recipients with active CMV infection-Subanalysis of the prospective randomised VIPP study.

PLoS One 2021 16;16(4):e0246118. Epub 2021 Apr 16.

Department of Nephrology, University Clinic Frankfurt, Goethe University Frankfurt, Frankfurt, Germany.

Background: Cytomegalovirus (CMV) infection is amongst the most important factors complicating solid organ transplantation. In a large prospective randomized clinical trial, valganciclovir prophylaxis reduced the occurrence of CMV infection and disease compared with preemptive therapy in CMV-positive renal allograft recipients (VIPP study; NCT00372229). Here, we present a subanalysis of the VIPP study, investigating single nucleotide polymorphisms (SNPs) in immune-response-related genes and their association with active CMV infection, CMV disease, graft loss or death, rejection, infections, and leukopenia. Read More

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Age-related hearing loss, depression and auditory amplification: a randomized clinical trial.

Eur Arch Otorhinolaryngol 2021 Apr 16. Epub 2021 Apr 16.

University Clinic of Otorhinolaryngology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.

Purpose: Our study investigates the effectiveness of aural rehabilitation to decrease depressive symptoms in older adults, and the relationship between hearing loss and depression.

Methods: A randomized controlled study was conducted at a hearing rehabilitation center with people over 65 years old. Participants were randomly allocated to the intervention group who received hearing aids, or to the control group. Read More

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A large observational data study supporting the PROsPeR score classification in poor ovarian responders according to live birth outcome.

Hum Reprod 2021 Apr 16. Epub 2021 Apr 16.

Global Medical Affairs Fertility, R&D Biopharma, Merck Healthcare KGaA, Darmstadt, Germany.

Study Question: Can the Poor Responder Outcome Prediction (PROsPeR) score identify live birth outcomes in subpopulations of patients with poor ovarian response (POR) defined according to the ESHRE Bologna criteria (female age, anti-Müllerian hormone (AMH), number of oocytes retrieved during the previous cycle (PNO) after treatment with originator recombinant human follitropin alfa?

Summary Answer: The PROsPeR score discriminated the probability of live birth in patients with POR using observational data with fair discrimination (AUC ≅ 70%) and calibration, and the AUC losing less than 5% precision compared with a model developed using the observational data.

What Is Known Already: Although scoring systems for the likelihood of live birth after ART have been developed, their accuracy may be insufficient, as they have generally been developed in the general population with infertility and were not validated for patients with POR. The PROsPeR score was developed using data from the follitropin alfa (GONAL-f; Merck KGaA, Darmstadt, Germany) arm of the Efficacy and Safety of Pergoveris in Assisted Reproductive Technology (ESPART) randomized controlled trial (RCT) and classifies women with POR as mild, moderate or severe, based upon three variables: female age, serum AMH level and number of oocytes retrieved during the previous cycle (PNO). Read More

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Maternal age at birth and daughter's fecundability.

Hum Reprod 2021 Apr 16. Epub 2021 Apr 16.

Department of Epidemiology, Boston University School of Public Health, Boston, MA, USA.

Study Question: Do daughters of older mothers have lower fecundability?

Summary Answer: In this cohort study of North American pregnancy planners, there was virtually no association between maternal age ≥35 years and daughters' fecundability.

What Is Known Already: Despite suggestive evidence that daughters of older mothers may have lower fertility, only three retrospective studies have examined the association between maternal age and daughter's fecundability.

Study Design, Size, Duration: Prospective cohort study of 6689 pregnancy planners enrolled between March 2016 and January 2020. Read More

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Evaluation of root-knot nematode resistance assays for sugarcane accession lines in Australia.

J Nematol 2021 1;53. Epub 2021 Mar 1.

Sugar Research Australia, 90 Old Cove Road, Woodford, Qld, 5414, Australia.

Root-knot nematode () is an important pathogen of sugarcane and can cause significant yield loss in sandy soil. Resistance to root-knot nematode is not common in commercial cultivars of sugarcane. In order to find new sources of resistance for root-knot nematodes, Sugar Research Australia (SRA) has screened new sets of accession lines derived from introgression breeding between wild relatives of sugarcane and commercial parents, and sugarcane accession lines from advanced stages of the core selection programs. Read More

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Is splenic hilar lymph node dissection necessary for proximal gastric cancer surgery?

Ann Gastroenterol Surg 2021 Mar 8;5(2):173-182. Epub 2020 Dec 8.

Gastric Surgery Division National Cancer Center Hospital East Kashiwa Japan.

Advanced proximal gastric cancer sometimes metastasizes to the splenic hilar lymph nodes (No. 10 LN). Total gastrectomy combined with splenectomy is performed for complete removal of the No. Read More

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Sex-related differences in cognitive trajectories in older individuals with type 2 diabetes and overweight or obesity.

Alzheimers Dement (N Y) 2021 9;7(1):e12160. Epub 2021 Apr 9.

Departments of Medicine and Epidemiology Columbia University Irving Medical Center New York New York USA.

Introduction: It is unknown whether rates of cognitive decline differ between older women and men with type 2 diabetes (T2D) and overweight or obesity.

Methods: Two to four cognitive assessments were obtained across up to 10 years from 2799 adults (mean age 68 years; 62% women) with T2D who had been enrolled in a clinical trial of weight loss intervention. Sex-related differences in means and rates of decline of cognitive scores were assessed. Read More

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The STEP 1 trial for weight loss: a step change in treating obesity?

Amanda I Adler

Nat Med 2021 Apr;27(4):589-590

Oxford Centre for Diabetes Endocrinology and Metabolism, University of Oxford, Oxford, UK.

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Effects of the SGLT2 Inhibitor Dapagliflozin on Energy Metabolism in Patients With Type 2 Diabetes: A Randomized, Double-Blind Crossover Trial.

Diabetes Care 2021 Apr 15. Epub 2021 Apr 15.

Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands

Objective: SGTL2 inhibitors increase urinary glucose excretion and have beneficial effects on cardiovascular and renal outcomes. The underlying mechanism may involve caloric restriction-like metabolic effects due to urinary glucose loss. We investigated the effects of dapagliflozin on 24-h energy metabolism and insulin sensitivity in patients with type 2 diabetes. Read More

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Randomized Trial of Interleukin-6 Receptor Inhibition in Patients With Acute ST-Segment Elevation Myocardial Infarction.

J Am Coll Cardiol 2021 Apr;77(15):1845-1855

Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; K. G. Jebsen Cardiac Research Centre and Centre for Heart Failure Research, University of Oslo, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

Background: Prompt myocardial revascularization with percutaneous coronary intervention (PCI) reduces infarct size and improves outcomes in patients with ST-segment elevation myocardial infarction (STEMI). However, as much as 50% of the loss of viable myocardium may be attributed to the reperfusion injury and the associated inflammatory response.

Objectives: This study sought to evaluate the effect of the interleukin-6 receptor inhibitor tocilizumab on myocardial salvage in acute STEMI. Read More

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Effect of citalopram on hippocampal volume in first-episode schizophrenia: Structural MRI results from the DECIFER trial.

Psychiatry Res Neuroimaging 2021 Apr 7;312:111286. Epub 2021 Apr 7.

Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America; Nathan Kline Institute for Psychiatric Research, 140 Old Orangeburg Road, Orangeburg, NY 10962, United States of America. Electronic address:

Hippocampal volume loss is prominent in first episode schizophrenia (FES) and has been associated with poor clinical outcomes and with BDNF genotype; antidepressants are believed to reverse hippocampal volume loss via release of BDNF. In a 12-month, placebo-controlled add-on trial of the antidepressant, citalopram, during the maintenance phase of FES, negative symptoms were improved with citalopram. We now report results of structural brain imaging at baseline and 6 months in 63 FES patients (34 in citalopram group) from the trial to assess whether protection against hippocampal volume loss contributed to improved negative symptoms with citalopram. Read More

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Vaccination COVID-19 chez les donneurs de sang indiens: évaluer l'impact sur la période de report.

Transfus Clin Biol 2021 Apr 12. Epub 2021 Apr 12.

Department of Immunohematology and Blood Transfusion, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Swami Ram Nagar, Jolly Grant Dehradun, 248016, Uttarakhand, India. Electronic address:

The only efficacious way to provide people with herd immunity against the novel corona virus [nCoV] is to administer an appropriate vaccine and help check the current pandemic. With the genetic sequence data of the nCoV already available since January 10, 2020, leading pharmaceutical companies, world over, in turn, have started working on the clinical trials to produce vaccines against this nCoV. In fact, many vaccines under the Phase III trial have claimed to demonstrate their efficacy as high as 95% against nCoV. Read More

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Robust Face Alignment via Deep Progressive Reinitialization and Adaptive Error-driven Learning.

IEEE Trans Pattern Anal Mach Intell 2021 Apr 15;PP. Epub 2021 Apr 15.

Regression-based face alignment involves learning a series of mapping functions to predict the true landmark from an initial estimation of the alignment. Most existing approaches focus on learning efficacious mapping functions from some feature representations to improve performance. The issues related to the initial alignment estimation and the final learning objective, however, receive less attention. Read More

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Assessment of Cumulative Incidence and Severity of Primary Open-Angle Glaucoma Among Participants in the Ocular Hypertension Treatment Study After 20 Years of Follow-up.

JAMA Ophthalmol 2021 Apr 15. Epub 2021 Apr 15.

Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.

Importance: Ocular hypertension is an important risk factor for the development of primary open-angle glaucoma (POAG). Data from long-term follow-up can be used to inform the management of patients with ocular hypertension.

Objective: To determine the cumulative incidence and severity of POAG after 20 years of follow-up among participants in the Ocular Hypertension Treatment Study. Read More

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A semiparametric modeling approach for analyzing clinical biomarkers restricted to limits of detection.

Pharm Stat 2021 Apr 14. Epub 2021 Apr 14.

Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina, USA.

Before biomarkers can be used in clinical trials or patients' management, the laboratory assays that measure their levels have to go through development and analytical validation. One of the most critical performance metrics for validation of any assay is related to the minimum amount of values that can be detected and any value below this limit is referred to as below the limit of detection (LOD). Most of the existing approaches that model such biomarkers, restricted by LOD, are parametric in nature. Read More

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Efficacy and Safety of the Association of Nimodipine and Choline Alphoscerate in the Treatment of Cognitive Impairment in Patients with Cerebral Small Vessel Disease. The CONIVaD Trial.

Drugs Aging 2021 Apr 15. Epub 2021 Apr 15.

Department of Biomedical and Clinical Sciences, 'L. Sacco' Hospital, University of Milan, Via Giovanni Battista Grassi 74, 20157, Milan, Italy.

Background: No approved treatment is available for patients with vascular cognitive impairment (VCI) due to cerebral small vessel disease (SVD).

Objective: The CONIVaD (Choline Alphoscerate and Nimodipine in Vascular Dementia) study aimed to investigate the feasibility, efficacy, and safety of a combined treatment with choline alphoscerate and nimodipine in patients with SVD and mild-to-moderate cognitive impairment.

Methods: Within this pilot, single-center (university hospital), double-blinded, randomized clinical trial, patients were randomized to two arms: 1-year treatment with nimodipine 30 mg three times a day (TID) plus choline alphoscerate 600 mg twice a day (BID) (arm 1) or nimodipine 30 mg TID plus placebo BID (arm 2). Read More

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Is the stepping-down approach a better option than multiple daily injections in obese patients with poorly controlled Type 2 diabetes on advanced insulin therapy?

Endocrinol Diabetes Metab 2021 Apr 20;4(2):e00204. Epub 2020 Dec 20.

Department of Internal Medicine University of California San Francisco, Fresno Medical Education Program Fresno CA USA.

Aim: To determine whether de-escalating from advanced insulin therapy (AIT) to the combined use of metformin, an SGLT2 inhibitor, a GLP1 receptor agonist and basal insulin is the better option than multiple daily insulin injections (MDI) in obese patients with poorly controlled T2DM.

Methods: This was a 16-week, prospective, randomized, controlled trial. Twenty-two obese patients with T2DM on AIT were randomized to intervention (step-down) or control (MDI) group. Read More

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Comparison between volunteer- and expert-led versions of a community-based weight-loss intervention.

Prev Med Rep 2021 Jun 29;22:101370. Epub 2021 Mar 29.

Faculty of Health and Sport Sciences, University of Tsukuba, Japan.

This study compared the effect of volunteer- and expert-led versions of a community-based weight-loss intervention in a non-randomized comparative trial conducted in Ibaraki, Japan from 2016 to 2017. Participants were 145 Japanese adults with overweightness or obesity, aged 20-69 years, with 77 in a volunteer-led group and 68 in an expert-led group. Both groups received the same program content and intervention period. Read More

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Evaluation of the efficacy of lycopene gel compared with minocycline hydrochloride microspheres as an adjunct to nonsurgical periodontal treatment: A randomised clinical trial.

J Dent Sci 2021 Mar 30;16(2):691-699. Epub 2020 Sep 30.

College of Dentistry, University of Sulaimani, Sulaymaniyah, Iraq.

Background/purpose: The prescription of antibiotics as an adjunct to mechanical periodontal therapy in patients with severe periodontitis is recommended; however, the side effects of antibiotics are a major concern. The aim of this study was to evaluate the efficacy of lycopene (Lyc) antioxidant gel versus minocycline hydrochloride microspheres (ARISTIN) as an adjunct to the nonsurgical treatment of periodontitis.

Materials And Methods: Three identical periodontal pockets/patient received root surface debridement followed by the random application of either ARISTIN, Lyc, or placebo gel (control, Ctrl). Read More

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Tranexamic acid use to decrease blood loss in primary shoulder and elbow replacement: A systematic review and meta-analysis.

J Orthop 2021 Mar-Apr;24:239-247. Epub 2021 Mar 18.

Musculoskeletal Research Unit, University of Bristol, Level 1 Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.

Purpose: Tranexamic acid (TXA) is an inexpensive antifibrinolytic agent that significantly reduces peri-operative blood loss and transfusion requirements after total hip and knee replacement. This meta-analysis demonstrates the effects of TXA on blood loss in total shoulder replacement (TSR) and total elbow replacement (TER).

Methods: We systematically searched MEDLINE, EMBASE and CENTRAL from inception to September 03, 2020 for randomised controlled trial (RCTs) and observational studies. Read More

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Metformin for early comorbid glucose dysregulation and schizophrenia spectrum disorders: a pilot double-blind randomized clinical trial.

Transl Psychiatry 2021 Apr 14;11(1):219. Epub 2021 Apr 14.

Centre for Addiction and Mental Health, Toronto, ON, Canada.

Patients with schizophrenia have exceedingly high rates of metabolic comorbidity including type 2 diabetes and lose 15-20 years of life due to cardiovascular diseases, with early accrual of cardiometabolic disease. In this study, thirty overweight or obese (Body Mass Index (BMI) > 25) participants under 40 years old with schizophrenia spectrum disorders and early comorbid prediabetes or type 2 diabetes receiving antipsychotic medications were randomized, in a double-blind fashion, to metformin 1500 mg/day or placebo (2:1 ratio; n = 21 metformin and n = 9 placebo) for 4 months. The primary outcome measures were improvements in glucose homeostasis (HbA1c, fasting glucose) and insulin resistance (Matsuda index-derived from oral glucose tolerance tests and homeostatic model of insulin resistance (HOMA-IR)). Read More

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Almond Bioaccessibility in a Randomized Crossover Trial: Is a Calorie a Calorie?

Mayo Clin Proc 2021 Mar 30. Epub 2021 Mar 30.

Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Ontario, Canada; Toronto 3D (Diet, Digestive Tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Ontario, Canada; Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, Ontario, Canada; Division of Endocrinology & Metabolism, St. Michael's Hospital, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada. Electronic address:

Objective: To investigate the energy and macronutrient bioaccessibility of almonds in individuals with hyperlipidemia.

Methods: In a previously reported randomized crossover trial, men and postmenopausal women with hyperlipidemia incorporated 3 isoenergetic supplements into a National Cholesterol Education Program Step 2 diet for 1 month each between September 20, 2000, and June 27, 2001. Supplements provided consisted of full-dose almonds (73±5 g/d), half-dose almonds (38±3 g/d) plus half-dose muffins, and full-dose muffins (control). Read More

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Repetitive deep TMS for the reduction of body weight: Bimodal effect on the functional brain connectivity in "diabesity".

Nutr Metab Cardiovasc Dis 2021 Feb 25. Epub 2021 Feb 25.

Department of Biomedical Sciences for Health, Università Degli Studi di Milano, Milan, Italy; Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Sesto San Giovanni, MI, Italy. Electronic address:

Background And Aims: Deep repetitive Transcranial Magnetic Stimulation (deep rTMS) over the bilateral insula and prefrontal cortex (PFC) can promote weight-loss in obesity, preventing cardiometabolic complications as Type 2 Diabetes (T2D). To investigate the changes in the functional brain integration after dTMS, we conducted a resting-state functional connectivity (rsFC) study in obesity.

Methods And Results: This preliminary study was designed as a randomized, double-blind, sham-controlled study: 9 participants were treated with high-frequency stimulation (realTMS group), 8 were sham-treated (shamTMS group). Read More

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February 2021