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https://www.readbyqxmd.com/read/28206871/swallowing-therapy-and-progressive-resistance-training-in-head-and-neck-cancer-patients-undergoing-radiotherapy-treatment-randomized-control-trial-protocol-and-preliminary-data
#1
Sara F Hajdú, Irene Wessel, Christoffer Johansen, Claus A Kristensen, Zahra T Kadkhoda, Christina C Plaschke, Susanne O Dalton
BACKGROUND: Head and neck cancer (HNC) patients are often challenged by treatment induced dysphagia and trismus. Traditionally, rehabilitation is initiated when loss of function has already occurred. There is increasing evidence that it is of benefit to patients to initiate an early rehabilitation process before and during treatment. HNC patients have a unique set of functional challenges such as pre- and post-treatment dysphagia, pain and weight loss. The aim of the trial is to investigate the effects of swallowing and mouth-opening exercises combined with progressive resistance training (PRT) during radiotherapy...
February 2017: Acta Oncologica
https://www.readbyqxmd.com/read/28173775/evaluation-and-implementation-of-highly-challenging-balance-training-in-clinical-practice-for-people-with-parkinson-s-disease-protocol-for-the-hibalance-effectiveness-implementation-trial
#2
Breiffni Leavy, Lydia Kwak, Maria Hagströmer, Erika Franzén
BACKGROUND: If people with progressive neurological diseases are to avail of evidence-based rehabilitation, programs found effective in randomized controlled trials (RCT's) must firstly be adapted and tested in clinical effectiveness studies as a means of strengthening their evidence base. This paper describes the protocol for an effectiveness-implementation trial that will assess the clinical effectiveness of a highly challenging balance training program (the HiBalance program) for people with mild-moderate Parkinson's disease (PD) while simultaneously collecting data concerning the way in which the program is implemented...
February 7, 2017: BMC Neurology
https://www.readbyqxmd.com/read/28166816/the-achru-cpp-versus-usual-care-for-older-adults-with-type-2-diabetes-and-multiple-chronic-conditions-and-their-family-caregivers-study-protocol-for-a-randomized-controlled-trial
#3
Maureen Markle-Reid, Jenny Ploeg, Kimberly D Fraser, Kathryn Ann Fisher, Noori Akhtar-Danesh, Amy Bartholomew, Amiram Gafni, Andrea Gruneir, Sandra P Hirst, Sharon Kaasalainen, Caralyn Kelly Stradiotto, John Miklavcic, Carlos Rojas-Fernandez, Cheryl A Sadowski, Lehana Thabane, Jean A C Triscott, Ross Upshur
BACKGROUND: Many community-based self-management programs have been developed for older adults with type-2 diabetes mellitus (T2DM), bolstered by evidence from randomized controlled trials (RCTs) that T2DM can be prevented and managed through lifestyle modifications. However, the evidence for their effectiveness is contradictory and weakened by reliance on single-group designs and/or small samples. Additionally, older adults with multiple chronic conditions (MCC) are often excluded because of recruiting and retention challenges...
February 6, 2017: Trials
https://www.readbyqxmd.com/read/28164801/beyond-intent-to-treat-itt-a-complier-average-causal-effect-cace-estimation-primer
#4
James L Peugh, Daniel Strotman, Meghan McGrady, Joseph Rausch, Susmita Kashikar-Zuck
Randomized control trials (RCTs) have long been the gold standard for allowing causal inferences to be made regarding the efficacy of a treatment under investigation, but traditional RCT data analysis perspectives do not take into account a common reality: imperfect participant compliance to treatment. Recent advances in both maximum likelihood parameter estimation and mixture modeling methodology have enabled treatment effects to be estimated, in the presence of less than ideal levels of participant compliance, via a Complier Average Causal Effect (CACE) structural equation mixture model...
February 2017: Journal of School Psychology
https://www.readbyqxmd.com/read/28159703/cognitive-behavioral-therapy-for-insomnia-in-stable-heart-failure-protocol-for-a-randomized-controlled-trial
#5
Nancy S Redeker, Andrea K Knies, Christopher Hollenbeak, H Klar Yaggi, John Cline, Laura Andrews, Daniel Jacoby, Anna Sullivan, Meghan O'Connell, Joanne Iennaco, Lisa Finoia, Sangchoon Jeon
BACKGROUND: Chronic insomnia is associated with disabling symptoms and decrements in functional performance. It may contribute to the development of heart failure (HF) and incident mortality. In our previous work, cognitive-behavioral therapy for insomnia (CBT-I), compared to HF self-management education, provided as an attention control condition, was feasible, acceptable, and had large effects on insomnia and fatigue among HF patients. OBJECTIVES: The purpose of this randomized controlled trial (RCT) is to evaluate the sustained effects of group CBT-I compared with HF self-management education (attention control) on insomnia severity, sleep characteristics, daytime symptoms, symptom clusters, functional performance, and health care utilization among patients with stable HF...
January 31, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28158982/study-protocol-thyroid-hormone-replacement-for-untreated-older-adults-with-subclinical-hypothyroidism-a-randomised-placebo-controlled-trial-trust
#6
David J Stott, Jacobijn Gussekloo, Patricia M Kearney, Nicolas Rodondi, Rudi G J Westendorp, Simon Mooijaart, Sharon Kean, Terence J Quinn, Naveed Sattar, Kirsty Hendry, Robert Du Puy, Wendy P J Den Elzen, Rosalinde K E Poortvliet, Jan W A Smit, J Wouter Jukema, Olaf M Dekkers, Manuel Blum, Tinh-Hai Collet, Vera McCarthy, Caroline Hurley, Stephen Byrne, John Browne, Torquil Watt, Douglas Bauer, Ian Ford
BACKGROUND: Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH. METHODS: Participants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4...
February 3, 2017: BMC Endocrine Disorders
https://www.readbyqxmd.com/read/28156601/what-s-in-the-special-sauce-of-protocol-driven-outpatient-palliative-care-consultations
#7
Marie Bakitas, J Nicholas Dionne-Odom, Jennifer Frost, Margaret Plunkett, Lisa A Lisa A Stephens, Peggy Bishop
: 139 Background: Initial outpatient palliative care consultations (OPCC) in clinics are usually requested for uncontrolled symptoms. The purpose of this substudy was to determine the nature of recommendations made in early PC (EPC) protocol-driven OPCC. METHODS: Using a standardized tool, we conducted a content analysis on the assessment and plan components of protocol-driven OPCCs. OPCCs were conducted as a component of the ENABLE [Educate, Nurture, Advise, Before Life Ends] RCT (10/2010-9/2013) consisting of an OPCC and 6 structured weekly telephone coaching sessions and monthly follow up either at study entry (early) or 12 weeks later (delayed)...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28156492/food-as-medicine-a-randomized-controlled-trial-rct-of-home-delivered-medically-tailored-meals-hdmtm-on-quality-of-life-qol-in-metastatic-lung-and-non-colorectal-gi-cancer-patients
#8
Raymond Mailhot Vega, Lisa Zullig, Alissa Wassung, Dorella Walters, Noah Berland, Kevin Lee Du, Jiyoung Ahn, Cynthia G Leichman, Deirdre Jill Cohen, Ping Gu, Abraham Chachoua, Lawrence P Leichman, Karen Pearl, Peter B Schiff
: 155 Background: Malnutrition incidence in cancer approaches 85%, disproportionately burdening those with lung, GI, and advanced stage cancers. Malnourished patients have impaired chemotherapy response, shorter survival, longer hospital stays, and decreased QoL. Home delivered meals are nutritional interventions that improve patient well-being, nutrition, and lower healthcare costs in the elderly but have not been studied as an intervention in cancer patients. HDMTM are nutritionist prescribed home delivered meals tailored to patient's symptoms, co-morbidities, and health needs...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28152984/rationale-for-and-design-of-the-posta-study-evaluation-of-neurocognitive-outcomes-after-immediate-adenotonsillectomy-compared-to-watchful-waiting-in-preschool-children
#9
Karen A Waters, Jasneek Chawla, Margaret-Anne Harris, Carolyn Dakin, Helen Heussler, Robert Black, Alan Cheng, Hannah Burns, John D Kennedy, Kurt Lushington
BACKGROUND: IQ deficits are linked to even mild obstructive sleep apnoea (OSA) in children. Although OSA is commonly first diagnosed in the pre-school age group, a randomised trial is still needed to assess IQ outcomes after adenotonsillectomy in the pre-school age-group. This randomised control trial (RCT) will primarily determine whether adenotonsillectomy improves IQ compared to no adenotonsillectomy after 12 months, in preschool (3-5 year-old) children with mild to moderate OSA. METHODS: This protocol is for an ongoing multi-centred RCT with a recruitment target of 210 subjects (105 in each arm)...
February 2, 2017: BMC Pediatrics
https://www.readbyqxmd.com/read/28152167/implementation-of-observational-pain-management-protocol-for-residents-with-dementia-a-cluster-rct
#10
Justina Y W Liu, Claudia K Y Lai
OBJECTIVES: To investigate whether the implementation of the Observational Pain Management Protocol (Protocol) can improve pain management for nursing home residents with dementia. DESIGN: A two-group, single-blinded, cluster-randomized controlled trial. SETTING: Seventeen nursing homes. PARTICIPANTS: Hundred and twenty eight recruited residents with advanced dementia and pain-related diagnoses were allocated to either the control or the experimental conditions based on the randomized group allocated to their home...
February 2, 2017: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/28148280/optimizing-adalimumab-treatment-in-psoriasis-with-concomitant-methotrexate-optimap-study-protocol-for-a-pragmatic-single-blinded-investigator-initiated-randomized-controlled-trial
#11
Celine Busard, Stef Menting, Sun-Jine van Bezooijen, Juul van den Reek, Barbara Hutten, Errol Prens, Elke de Jong, Martijn van Doorn, Phyllis Spuls
BACKGROUND: The introduction of anti-tumor necrosis factor medications has revolutionized the treatment of psoriasis with achievement of treatment goals (Psoriasis Area and Severity Index score 75, remission) that are not usually met with conventional systemics. Nevertheless, some patients continue to experience persistent disease activity or treatment failure over time. Strategies to optimize treatment outcomes include the use of concomitant methotrexate, which has demonstrated beneficial effects on pharmacokinetics and treatment efficacy in psoriasis and other inflammatory diseases...
February 2, 2017: Trials
https://www.readbyqxmd.com/read/28141913/systemic-corticosteroid-regimens-for-prevention-of-bronchopulmonary-dysplasia-in-preterm-infants
#12
REVIEW
Wes Onland, Anne Pmc De Jaegere, Martin Offringa, Anton van Kaam
BACKGROUND: Cochrane systematic reviews show that systemic postnatal corticosteroids reduce the risk of bronchopulmonary dysplasia (BPD) in preterm infants. However, corticosteroids have also been associated with an increased risk of neurodevelopmental impairment. It is unknown whether these beneficial and adverse effects are modulated by differences in corticosteroid treatment regimens. OBJECTIVES: To assess the effects of different corticosteroid treatment regimens on mortality, pulmonary morbidity, and neurodevelopmental outcome in very low birth weight (VLBW) infants...
January 31, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28130435/cumulative-live-birth-rates-after-one-art-cycle-including-all-subsequent-frozen-thaw-cycles-in-1050-women-secondary-outcome-of-an-rct-comparing-gnrh-antagonist-and-gnrh-agonist-protocols
#13
M Toftager, J Bogstad, K Løssl, L Prætorius, A Zedeler, T Bryndorf, L Nilas, A Pinborg
STUDY QUESTION: Are cumulative live birth rates (CLBRs) similar in GnRH-antagonist and GnRH-agonist protocols for the first ART cycle including all subsequent frozen-thaw cycles from the same oocyte retrieval? SUMMARY ANSWER: The chances of at least one live birth following utilization of all fresh and frozen embryos after the first ART cycle are similar in GnRH-antagonist and GnRH-agonist protocols. WHAT IS KNOWN ALREADY: Reproductive outcomes of ART treatment are traditionally reported as pregnancies per cycle or per embryo transfer...
January 26, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28129779/targeting-functional-fitness-hearing-and-health-related-quality-of-life-in-older-adults-with-hearing-loss-walk-talk-n-listen-study-protocol-for-a-pilot-randomized-controlled-trial
#14
Justin Lambert, Rouzbeh Ghadry-Tavi, Kate Knuff, Marc Jutras, Jodi Siever, Paul Mick, Carolyn Roque, Gareth Jones, Jonathan Little, Harry Miller, Colin Van Bergen, Donna Kurtz, Mary Ann Murphy, Charlotte Ann Jones
BACKGROUND: Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. METHODS: This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL...
January 28, 2017: Trials
https://www.readbyqxmd.com/read/28129746/study-protocol-of-the-tired-study-a-randomised-controlled-trial-comparing-either-graded-exercise-therapy-for-severe-fatigue-or-cognitive-behaviour-therapy-with-usual-care-in-patients-with-incurable-cancer
#15
Hanneke Poort, Constans A H H V M Verhagen, Marlies E W J Peters, Martine M Goedendorp, A Rogier T Donders, Maria T E Hopman, Maria W G Nijhuis-van der Sanden, Thea Berends, Gijs Bleijenberg, Hans Knoop
BACKGROUND: Fatigue is a common and debilitating symptom for patients with incurable cancer receiving systemic treatment with palliative intent. There is evidence that non-pharmacological interventions such as graded exercise therapy (GET) or cognitive behaviour therapy (CBT) reduce cancer-related fatigue in disease-free cancer patients and in patients receiving treatment with curative intent. These interventions may also result in a reduction of fatigue in patients receiving treatment with palliative intent, by improving physical fitness (GET) or changing fatigue-related cognitions and behaviour (CBT)...
January 28, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28128977/a-tailored-intervention-for-pap-adherence-the-scip-pa-trial
#16
Amy M Sawyer, Tonya S King, Terri E Weaver, Douglas A Sawyer, Miranda Varrasse, Jamie Franks, Alexa Watach, Ann M Kolanowski, Kathy C Richards
OBJECTIVE/BACKGROUND: Positive airway pressure (PAP) is highly efficacious treatment but nonadherence is prevalent with little improvement over the last 15 years. Tailored interventions show promise for promoting adherence to other treatments. The study objective was to examine feasibility and acceptability of a tailored intervention to promote PAP adherence. PARTICIPANTS: The convenience sample met inclusion criteria: newly diagnosed OSA; treatment-naïve; ≥ 18 years...
January 27, 2017: Behavioral Sleep Medicine
https://www.readbyqxmd.com/read/28126015/cognitive-remediation-therapy-plus-behavioural-weight-loss-compared-to-behavioural-weight-loss-alone-for-obesity-study-protocol-for-a-randomised-controlled-trial
#17
Evelyn Smith, Charlotte Whittingham
BACKGROUND: Current research indicates that obese individuals have cognitive deficits in executive function, leading to difficulties with planning, impulse control and decision-making. High levels of inflammation have been proposed to contribute to executive function deficits in individuals with obesity. METHODS/DESIGN: One hundred and seventy-six obese participants will be randomly assigned to one of two groups: (1) behavioural weight loss alone (BWL) group = 8 sessions of individual BWL sessions plus 12 group BWL sessions or (2) Cognitive Remediation Therapy for Obesity (CRT-O) plus BWL group (CRT-O + BWL) = 8 sessions of individual CRT-O plus 12 group BWL sessions...
January 26, 2017: Trials
https://www.readbyqxmd.com/read/28122696/neurofeedback-as-a-treatment-for-impulsivity-in-a-forensic-psychiatric-population-with-substance-use-disorder-study-protocol-of-a-randomized-controlled-trial-combined-with-an-n-of-1-clinical-trial
#18
Sandra Fielenbach, Franc Cl Donkers, Marinus Spreen, Stefan Bogaerts
BACKGROUND: Impulsivity and substance use disorder (SUD) are strongly interconnected, with persons scoring high on impulsivity being more vulnerable to develop substance abuse, facing more challenges for successful treatment, and being more prone to engage in criminal behavior. Studies have shown that impulsivity and craving for substances are strongly correlated. Neurofeedback is an effective treatment to reduce impulsive behavior. This study intends to determine to what extent a neurofeedback-intervention that is aimed at reducing impulsivity can also reduce levels of craving in forensic patients with SUD and comorbid Axis I and/or II diagnoses...
January 25, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28122157/fidelity-scorecard-evaluation-of-a-caregiver-delivered-symptom-management-intervention
#19
Dawn Frambes, Rebecca Lehto, Alla Sikorskii, Irena Tesnjak, Barbara Given, Gwen Wyatt
AIM: To evaluate and quantify intervention fidelity of a symptom management protocol through implementation of a scorecard, using an exemplar study of caregiver-delivered reflexology for breast cancer patients. BACKGROUND: Studies on caregiver-delivered symptom management interventions seldom include adequate information on protocol fidelity, contributing to potentially suboptimal provision of the therapeutic intervention, hindering reproducibility and generalizability of the results...
January 25, 2017: Journal of Advanced Nursing
https://www.readbyqxmd.com/read/28116777/pharmacological-treatment-for-antipsychotic-related-constipation
#20
REVIEW
Susanna Every-Palmer, Giles Newton-Howes, Mike J Clarke
BACKGROUND: Antipsychotic-related constipation is a common and serious adverse effect, especially for people taking clozapine. Clozapine has been shown to impede gastrointestinal motility, leading to constipation, and has been reported in up to 60% of patients receiving clozapine. In rare cases, complications can be fatal. Appropriate laxatives should be prescribed to treat constipation in people taking antipsychotics, but there is a lack of guidance on the comparative effectiveness and harms of different agents in this population...
January 24, 2017: Cochrane Database of Systematic Reviews
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