scholarly journals Radiotherapy for head and neck tumours using an oral fixation and parameter acquisition device and TOMO technology: a randomised controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e052542
Author(s):  
Xiaofang Zhang ◽  
Tianlu Wang ◽  
Xinyan Xiao ◽  
Xia Li ◽  
Chen Yu Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Head And Neck ◽  
Random Number ◽  
Controlled Study ◽  
Control Group ◽  
Scientific Conference ◽  
Head And Neck Tumours ◽  
Acquisition Device ◽  
Oral Fixation ◽  
Randomised Controlled

IntroductionRadiotherapy has become one of the main methods used for the treatment of malignant tumours of the head and neck. Spiral tomographic intensity-modulated radiotherapy has the many advantages of precision radiotherapy, which puts forward high requirements for postural reproducibility and accuracy. We will aim to ensure that the accurate positioning of the tumour will reduce the side effects of radiotherapy caused by positioning errors. We will design and implement this clinical trial using the patent of ‘a radiotherapy oral fixation and parameter acquisition device (patent number: ZL201921877986.5)’.Methods and analysisThis will be a randomised, controlled, prospective study with 120 patients with head and neck tumours. Using the random number table method, a random number sequence will be generated, and the patients will be enrolled in the experimental group (oral fixation device) and the control group (conventional fixation) in a 2:1 ratio. The primary outcome will be the progression-free survival time after the treatment. Secondary outcomes will include the oral mucosal reaction and the quality of life. Follow-ups will be carried out according to the plan. This is V.1.0 of protocol on 1 April 2021. The recruitment process for this clinical trial commenced on 1 May 2021, and will end on 1 October 2022.Ethics and disseminationThe trial received ethical approval from Medical Ethics Committee of Liaoning Provincial Cancer Hospital (number 20210131X). The final results will be presented at a scientific conference and published in a peer-reviewed journal in accordance with the journal’s guidelines.Trial registration numberChiCTR2100045096.

scholarly journals Protocol for Acupuncture Treatment of Lateral Elbow Pain: A Multisite Randomised Controlled Trial in China, Hong Kong, Australia, and Italy

2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Christopher Zaslawski ◽  
Christine Berle ◽  
Marcus Gadau ◽  
Wei Hong Li ◽  
Tie Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hong Kong ◽  
Trial Registration ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Control Group ◽  
Elbow Pain ◽  
Lateral Elbow Pain ◽  
Lateral Elbow ◽  
Randomised Controlled

Background. Lateral elbow pain is one of the most common musculoskeletal pains associated with the upper limb and has an estimated population incidence of 1–3%. Methods/Design. This study protocol is for a multisite randomised controlled study and is designed to evaluate the clinical efficacy of acupuncture in the treatment of chronic (over three months’ duration) lateral elbow pain. Four study sites, in the People’s Republic of China, Hong Kong, Italy, and Australia, will recruit 24 participants each. A total of 96 participants will be randomised to either an acupuncture group or a sham laser control group. The primary outcome measure will be the Disabilities of Arm, Shoulder, and Hand questionnaire with secondary outcome measures of Pain-Free Grip Strength Test, Muscle Tension Test, and a pain visual analogue scale. Discussion. Key features for conducting a multisite international acupuncture randomised clinical trial have been detailed in this protocol. Trial Registration. This trial is registered at Australian and New Zealand Clinical Trial Registry ACTRN12613001138774 on 11 October, 2013.

scholarly journals The control of pain due to dentin hypersensitivity in individuals with molar–incisor hypomineralisation: a protocol for a randomised controlled clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044653
Author(s):  
Ana Paula Taboada Sobral ◽  
Elaine Marcilio Santos ◽  
Ana Cecilia Aranha ◽  
Paulo Vinícius Soares ◽  
Caroline Moraes Moriyama ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tooth Enamel ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Dentin Hypersensitivity ◽  
Molar Incisor Hypomineralisation ◽  
Randomised Controlled Clinical Trial ◽  
Sensitive Teeth ◽  
Randomised Controlled ◽  
Incisor Hypomineralisation

IntroductionDentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: (1) the dentin must be exposed and (2) the dentinal tubules must be open and connected to the pulp. Molar–incisor hypomineralisation (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH. The aim of the proposed randomised, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.Methods and analysisOne hundred and forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with PermaSeal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL, AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, Brazil). In Group 4, sensitive teeth will be treated with both LLL and PermaSeal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated 1 week, 1 month, 3 months and 6 months after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale, to determine the effectiveness of the proposed treatments, as well as differences among the evaluation times for each proposed treatment.Ethics and disseminationThis protocol has been ethically approved by the local medical ethical committee (protocol number: 4.020.261). Results will be submitted to international peer-reviewed journals and presented at international conferences.Trial registration numberNCT04407702.

Effect of adjunctive sodium hyaluronate versus surfactant nasal irrigation on mucociliary clearance in allergic rhinitis: a single-blind, randomised, controlled study

2021 ◽  
pp. 1-4
Author(s):  
E Ocak ◽  
S Mulazimoglu ◽  
D Kocaoz ◽  
E Mirici ◽  
E Dagli ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Mucociliary Clearance ◽  
Isotonic Saline ◽  
Sodium Hyaluronate ◽  
Controlled Study ◽  
Control Group ◽  
Clearance Time ◽  
Nasal Irrigation ◽  
Persistent Allergic Rhinitis ◽  
Randomised Controlled

Abstract Objective To investigate the effects of nasal irrigation with sodium hyaluronate and surfactant solutions on mucociliary clearance time in patients with mild persistent allergic rhinitis. Methods A total of 120 patients diagnosed with mild persistent allergic rhinitis were enrolled in this prospective study. The patients were allocated randomly to the surfactant, sodium hyaluronate or isotonic saline (as a control) nasal irrigation group. The mucociliary clearance times and improvements in mucociliary clearance times were compared. Results Improvements in mean mucociliary clearance time were significantly greater in the surfactant and sodium hyaluronate groups than in the control group (p < 0.01). The mean post-treatment mucociliary clearance time of the surfactant group was significantly lower than that of the control (p < 0.001) and sodium hyaluronate groups (p = 0.03). Conclusion Surfactant and sodium hyaluronate nasal irrigation solutions may both be used as adjunctive treatments for allergic rhinitis. Surfactant nasal irrigation resulted in better mucociliary clearance times.

A Controlled Trial of Home-Based Acute Psychiatric Services

1993 ◽  
Vol 163 (1) ◽  
pp. 49-54 ◽  
Author(s):  
Tom Burns ◽  
Alan Beadsmoore ◽  
Ashok V. Bhat ◽  
Andrew Oliver ◽  
Carola Mathers
Keyword(s):  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Community Based ◽  
Home Based ◽  
Randomised Controlled Study ◽  
One Year ◽  
Randomised Controlled ◽  
Clinical Measures ◽  
Experimental Group

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).

scholarly journals Effects of weekly pain monitoring on back pain outcomes: a non-randomised controlled study

2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Alice Kongsted ◽  
Tue Secher Jensen ◽  
Klaus Doktor ◽  
Lise Hestbæk
Keyword(s):  
Back Pain ◽  
Pain Intensity ◽  
Activity Limitation ◽  
Controlled Study ◽  
Group Differences ◽  
Control Group ◽  
Negative Effects ◽  
Randomised Controlled Study ◽  
Pain Outcomes ◽  
Randomised Controlled

Abstract Background Disease monitoring is an important element of self-management of several chronic diseases. Pain monitoring has become very easily available, but the role in musculoskeletal pain conditions is not clear. Awareness of pain might be helpful for people to understand pain, but focusing on pain may on the contrary negatively affect pain experience and behaviours. The objective of this study was to investigate the potential impact of pain monitoring on low back pain (LBP), specifically to determine if pain intensity, activity limitation and pain control, differed between patients with weekly pain monitoring over 12 months and patients with follow-ups at 2 weeks, 3 months and 12 months. Methods This was a non-randomised controlled study embedded in a cohort study with data collection November 1st 2016 to December 21st 2018. Adults seeking care for LBP were enrolled at the first visit to a chiropractor and followed with surveys after 2 weeks, 3 months and 12 months. Those enrolled first, n = 1,623, furthermore received weekly SMS-questions about pain frequency and pain intensity, whereas those enrolled next was the control group, n = 1,269 followed only by surveys. Outcomes at 12-months were compared, adjusting for group differences on baseline parameters. Results LBP intensity (0–10) was slightly lower at 12-months follow-up in the SMS group than the control group (adjusted beta − 0.40 (95% CI: − 0.62; − 0.19)). No relevant between-group differences were observed for activity limitation (0–100) (1.51 (95% CI: − 0.83; 3.85)) or ability to control pain (0–10) (− 0.08 (95% CI − 0.31; 0.15)). Conclusions Frequent pain monitoring did not demonstrate any negative effects of weekly pain monitoring, and it was perhaps even helpful. The role of self-monitoring as part of self-managing LBP should be explored further including optimal frequencies, formats, and methods for feedback. Trial registration The study was not registered as a clinical trial.

scholarly journals Intravesical dexmedetomidine instillation reduces postoperative catheter-related bladder discomfort in male patients under general anesthesia: a randomized controlled study

2020 ◽  
Author(s):  
Hong Chen ◽  
Bin Wang ◽  
Qin Li ◽  
Juan Zhou ◽  
Rui Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Patient Satisfaction ◽  
General Anesthesia ◽  
Normal Saline ◽  
Rating Scale ◽  
Intravesical Instillation ◽  
Controlled Study ◽  
Control Group ◽  
Post Operation ◽  
Male Patients

Abstract Background: The catheter-related bladder discomfort (CRBD) of male patients is a common clinical problem, albeit lacking effective solutions. The present study aimed to investigate whether intravesical dexmedetomidine instillation alleviates the postoperative urinary discomfort in male patients with catheter under general anesthesia.Methods: This single-blinded, prospective, randomized study included a total of 167 male patients American Society of Anesthesiologists (ASA) physical status I-II scheduled for surgery under general anesthesia were allocated to two groups: 84 in the dexmedetomidine group and 83 in the control group. Dexmedetomidine group patients received intravesical instillation of the drug 0.5 μg/kg and normal saline 20 mL, while the control group received intravesical instillation of 20 mL normal saline. The catheter was clamped for 30 min after intravesical instillation for all patients. CRBD scores and urethra pain numerical rating scale (NRS) scores were measured at admittance to post-anesthesia care unit (PACU) (T0), intravesical instillation (T1), 30 min (T2), 60 min (T3), 2 h (T4) after intravesical instillation, discharged from PACU (T5), and 6 h (T6) and 24 h (T7) after the operation. Patient satisfaction at discharge from PACU and 24 h post-operation were compared between the two groups. Results: CRBD scores and urethra pain NRS scores after 30 min of intravesical dexmedetomidine instillation to 24 h post-operation were significantly lower than the control group (p<0.001), and patient satisfaction was higher at discharge from PACU and 24 h post-operation (p<0.001). No differences were detected in Steward score out of PACU (p=0.213) and from the time of the end of operation to fully awake (p=0.417).Conclusion: Intravesical dexmedetomidine instillation reduces postoperative urinary discomfort and urethra pain and improves satisfaction in male patients under general anesthesia.Clinical Trial Registration: Chinese Clinical Trial Registry (No. ChiCTR1800016429), date of registration 1st June 2018

Efficacy and safety of prophylaxis with once-weekly BAY 79–4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients

2012 ◽  
Vol 108 (11) ◽  
pp. 913-922 ◽  
Author(s):  
Uri Martinowitz ◽  
Jerzy Windyga ◽  
Giovanni Di Minno ◽  
Andrzej Hellmann ◽  
Ingrid Pabinger ◽  
...  
Keyword(s):  
Controlled Study ◽  
Control Group ◽  
Investigational Drug ◽  
Haemophilia A ◽  
Double Blind ◽  
Investigational Treatment ◽  
Joint Health ◽  
Secondary Endpoints ◽  
Recombinant Fviii ◽  
Randomised Controlled

SummaryThe benefits of prophylaxis of haemophilia A patients regarding joint health and quality-of-life are well established. However, adherence to an up to every-other-day infusion regimen is a barrier to widespread adoption of prophylaxis. BAY 79–4980 is an investigational drug consisting of rFVIII-FS (sucrose-formulated recombinant FVIII) reconstituted with liposome solvent. Previous clinical studies showed extended protection from bleeding after a single injection of BAY 79–4980 (13.3 ± 6.2 days) compared with rFVIII-FS (7.2 ± 1.7 days). The effect of once-a-week prophylaxis with BAY 79–4980 (35 IU/kg) compared with three times-per-week rFVIII-FS (25 IU/kg) in previously treated, severe haemophilia A patients was evaluated in a 52-week, double-blind, two-arm, randomised, controlled study. The primary and secondary endpoints were protection from total bleeds and joint bleeds, respectively. Short- and long-term safety and tolerability of BAY 79–4980 including effects on lipid levels were assessed. A total of 139 and 131 subjects were evaluable for safety and efficacy analyses, respectively. A large difference in efficacy between treatment groups was observed with 72.1% (49/68) in the rFVIII-FS control group demonstrating <9 bleeds/year compared with 38.1% (24/63) of BAY 79–4980-treated subjects. A similar difference was seen in annualised joint bleeds, with 43 subjects (63.2%) in the control group demonstrating <5 joint bleeds/year compared with 24 subjects (38.1%) treated with BAY 79–4980. The distribution of bleeds seven days post-prophylactic treatment with BAY 79–4980 showed that 61% of bleeds occurred after day 4 post dosing. There were no safety concerns identified. The investigational treatment arm was prematurely discontinued due to failure to achieve the primary endpoint.

scholarly journals Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024589
Author(s):  
Wen Yao Mak ◽  
Loke Meng Ong ◽  
Bak Leong Goh ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Randomised Controlled ◽  
End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

scholarly journals The Effect of Medium Chain Triglycerides on Time to Nutritional Ketosis and Symptoms of Keto-Induction in Healthy Adults: A Randomised Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Cliff J. d C. Harvey ◽  
Grant M. Schofield ◽  
Micalla Williden ◽  
Joseph A. McQuillan
Keyword(s):  
Clinical Trial ◽  
Healthy Adults ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Medium Chain Triglycerides ◽  
Clinical Trial Registry ◽  
Medium Chain ◽  
Low Carbohydrate ◽  
Randomised Controlled ◽  
Beta Hydroxybutyrate

Medium chain triglycerides (MCTs) are ketogenic and might reduce adverse effects of keto-induction and improve time to ketosis and the tolerability of very low carbohydrate diets. This study investigates whether MCT supplementation improves time to nutritional ketosis (NK), mood, and symptoms of keto-induction. We compared changes in beta-hydroxybutyrate (BOHB), blood glucose, symptoms of keto-induction, and mood disturbance, in 28 healthy adults prescribed a ketogenic diet, randomised to receive either 30 ml of MCT, or sunflower oil as a control, three times per day, for 20 days. The primary outcome measured was the achievement of NK (≥0.5 mmol·L−1 BOHB). Participants also completed a daily Profile of Mood States and keto-induction symptom questionnaire. MCT resulted in higher BOHB at all time points and faster time to NK, a result that failed to reach significance. Symptoms of keto-induction resulted from both diets, with a greater magnitude in the control group, except for abdominal pain, which occurred with greater frequency and severity in the MCT-supplemented diet. There was a possibly beneficial effect on symptoms by MCT, but the effect on mood was unclear. Based on these results, MCTs increase BOHB compared with LCT and reduce symptoms of keto-induction. It is unclear whether MCTs significantly improve mood or time to NK. The trial was registered by the Australia New Zealand Clinical Trial Registry ACTRN12616001099415.

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