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.

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.

scholarly journals Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Muhanad AlHareky ◽  
Jehan AlHumaid ◽  
Sumit Bedi ◽  
Maha El Tantawi ◽  
Mazin AlGahtani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
The United States ◽  
Nerve Fibers ◽  
T Test ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Dental Anesthesia ◽  
Gate Control Theory

Background. The ‘‘gate control’’ theory suggests pain can be reduced by simultaneous activation of larger diameter nerve fibers using appropriate coldness, warmth, rubbing, pressure, or vibration. This study investigated the efficacy of a device combining cold and vibration, for needle-related procedural pain in children. Methodology. A total of 51 children aged 5–12 years participated in this randomized controlled clinical trial. Half of the children were in the control group and received maxillary buccal infiltration, by injecting 1.8 ml of 2% lidocaine with 1 : 100,000 adrenaline using topical anesthesia 20% benzocaine gel for 15 seconds, while the other half were in the test group and received the same anesthesia using a commercially available external cold and a vibrating device. A face version of Visual Analogue Scale (VAS) was used as a subjective measure to assess the child’s pain experience. The parents were requested to evaluate the child’s ability to tolerate pain using a behavioral/observational pain scale. Sound, Eyes, and Motor (SEM) scale and Faces, Legs, Activity, Cry, and Consolability (FLACC) scale were used to record the child’s pain as perceived by the external evaluator. T-test or Mann–Whitney U-test was used for scale variables, paired sample T-test or Wilcoxon rank t-test was used for before and after data, and chi-square was used for categorical variable, based on the results of normality test. Results. The results showed a statistically significant reduction in pain after the injection for the test group compared with control using VAS scale (mean = 6.68 (1.09) and 8.42 (0.50); p = 0.001 ) and FLACC scale (mean = 5.92 (1.05) and 8.16 (0.54); p = 0.002 ), but not when using SEM scale (mean 3.22 (0.42) and 4.24 (2.74); p = 0.08 ). Conclusions. Combined external cold and vibrating devices can be an effective alternative in reducing experienced pain and fear in children undergoing infiltration dental anesthesia. This study was registered with clinical trial registry of the United States National Institutes of Health (NIH) at ClinicalTrials.gov (NCT03953001).

scholarly journals HEALING RATE IN DIABETIC FOOT ULCERS TREATED WITH BIOMEMBRANE AND HYDROCOLLOID POWDER: RANDOMIZED CLINICAL TRIAL

2021 ◽  
Author(s):  
Manuela de Mendonça Figueirêdo Coelho ◽  
Luciana Catunda Gomes de Menezes ◽  
Shérida Karanini Paz de Oliveira ◽  
Ana Débora Alcantara Coêlho Bonfim ◽  
Viviane Mamede Vasconcelos Cavalcante ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Healing Rate ◽  
Foot Ulcers ◽  
Calotropis Procera ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Clinical Trial Registry ◽  
Experimental Group

Objective: to evaluate the rate of healing in diabetic foot ulcers treated with a biomembrane of latex proteins from Calotropis procera (BioMem CpLP) when compared to powdered hydrocolloid. Method: randomized controlled clinical trial, registered by the Brazilian Clinical Trial Registry (REBEC), according to protocol RBR-98f3j9, carried out with eight people with diabetic foot, in a diabetic foot clinic, from March to July 2019. In the experimental group (n = 04), biomembrane was applied; in the control group (n = 04), hydrocolloid powder was used. The healing rate was assessed at 30 and 60 days after starting treatment. Results: no statistical differences were found between the healing rates of the control group and the experimental group in the temporal analysis of the initial 30 days (p = 0.726) and in the 60 days following the start of treatment (p = 0.562). Conclusion: BioMem CpLP presented healing rates similar to the conventional product, being an effective and low cost alternative for the treatment of diabetic feet.

scholarly journals Telephone intervention to promote maternal breastfeeding self-efficacy: randomized clinical trial

2021 ◽  
Vol 55 ◽  
Author(s):  
Hilana Dayana Dodou ◽  
Raylla Araújo Bezerra ◽  
Anne Fayma Lopes Chaves ◽  
Camila Teixeira Moreira Vasconcelos ◽  
Lorena Pinheiro Barbosa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Educational Intervention ◽  
Self Efficacy ◽  
Short Form ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Care Hospital ◽  
Telephone Intervention ◽  
Clinical Trial Registry

ABSTRACT Objective: To analyze the effects of an educational intervention via telephone on maternal breastfeeding self-efficacy. Method: Randomized controlled clinical trial including 240 puerperae from a secondary care hospital randomized into two groups: control and intervention. The educational intervention took place at seven, 30, 90, and 150 days postpartum and centered on self-efficacy and motivational interviewing principles. Self-efficacy was measured by the Breastfeeding Self-Efficacy Scale – Short Form. The data followed the abnormal distribution, so non-parametric tests were used. Results: The intervention group obtained higher median breastfeeding self-efficacy scores across the three outcome measures when compared to the control group (p < 0,001). Furthermore, the intervention group showed increased self-efficacy scores at all monitoring moments, which shows that the educational intervention was able to raise and maintain women’s confidence in breastfeeding their child over time. Conclusion: The use of a telephone-based intervention focused on self-efficacy principles and delivered by trained nurses effectively promoted maternal confidence in breastfeeding. Brazilian Clinical Trial Registry: RBR-7m7vc8.

scholarly journals Efficacy and safety of combination treatment of double plasma molecular adsorption system and low volume plasma exchange for patients with hepatitis B virus related acute-on-chronic liver failure: a multicentre randomised controlled clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e047690
Author(s):  
Wenxiong Xu ◽  
Yangmei Li ◽  
Lu Wang ◽  
Hongbo Gao ◽  
Jinjun Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Liver Failure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
The Third ◽  
Efficacy Outcome ◽  
B Virus ◽  
Low Volume ◽  
Randomised Controlled ◽  
Medical University

IntroductionHepatitis B virus (HBV) related acute-on-chronic liver failure (ACLF) is still a common type of liver failure in China. Therefore, we conduct this multicentre, non-blinded, randomised controlled clinical trial to investigate the efficacy and safety of combination treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (PE) for patients with HBV related ACLF.Methods and analysisA total of 200 patients with HBV related ACLF in the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou Eighth People’s Hospital, Nanfang Hospital of Southern Medical University, The Third People’s Hospital of Shenzhen, Xiangya Hospital of Central South University and The First Affiliated Hospital of Anhui Medical University, will be recruited into this trial. Eligible patients will undergo randomisation at a 1:1 ratio to two arms: the control group and the trial group. Patients in control group will receive comprehensive internal medical treatment. Patients in trial group will receive treatment of DPMAS and sequential low volume PE for three times, and comprehensive internal medical treatment. Clinical safety will be assessed by the analysis of adverse events (AEs) and laboratory tests. The primary efficacy outcome will be the incidence of unfavored events including death, liver transplantation and treatment abandonment. The secondary efficacy outcome will be the model for end-stage liver disease score variation. All evaluations will be performed at baseline, and 4, 8, 12, 24, 36, 48 weeks after enrolment. All AEs will be reported as soon as they are noted during the entire study procedure.Ethics and disseminationThis study was approved by Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University (approval no. (2020)02-173-01). The results and conclusions of this clinical trial will be published at academic conferences or in journals.Trial registration numberNCT04597164.

scholarly journals Baidu Jieduan Granule in the Treatment of Coronavirus Disease-2019 (COVID-19): Study Protocol for an Open-Label Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Randomized Controlled ◽  
Epidemic Diseases

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan Granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan Granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan Granule in treatment of severe COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

scholarly journals Efficiency of Corticision in Accelerating Leveling and Alignment of Crowded Lower Anterior Teeth in Young Adult Patients: A Randomised Controlled Clinical Trial

2020 ◽  
Author(s):  
Mohamad Radwan Sirri ◽  
Ahmad S Burhan ◽  
Mohammad Y Hajeer ◽  
Fehmieh R Nawaya ◽  
Abdulaziz Abdulhadi
Keyword(s):  
Clinical Trial ◽  
Treatment Time ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Periodontal Tissues ◽  
Anterior Teeth ◽  
Attached Gingiva ◽  
Randomised Controlled Clinical Trial ◽  
Randomised Controlled ◽  
Leveling And Alignment

Introduction: The evaluation of flapless corticision in conjunction with the conventional treatment in the non-extraction decrowding of lower anterior teeth has not been performed yet in any randomised clinical trial, particularly in terms of treatment time and periodontal indices. Aim: The aim of the study was to compare the duration of leveling and alignment of mild and moderate crowding cases in the lower dental arch between the corticision-assisted fixed orthodontic treatment and the traditional method; and to compare the periodontal indexes between the two groups. Materials and Methods: A parallel-group Randomised Controlled Clinical Trial (RCT) was conducted on 60 patients (mean age 2 1.40±1.63 years). Patients were randomly assigned to either the corticision group or the control group (30 each). Immediately after fixed appliance bonding, three radiographic-guided incisions were performed on the labial surfaces of the alveolar bone between lower anterior teeth by reinforced scalpels and mallets in order to accelerate alignment for patients in the corticision group. Patients in the control group were treated with conventional orthodontics. The outcome measures were the overall time needed for leveling and alignment, periodontal parameters such as Plaque Index (PI), Probing Depth (PD), Gingival Index (GI), and the width of the attached gingiva. Results: The overall treatment time was significantly shorter in the corticision group than the control group. The average leveling and alignment period for the corticision group was 116.46±15.97 days, while it was 159.69±13.76 days in the control group. Comparing the groups, a significant reduction of about 27% was found in the leveling and alignment duration of the corticision group. There were no significant differences in the periodontal parameters (PI, PD, GI, the width of attached gingiva) at the end of leveling and alignment phase in both the groups. Conclusion: Corticision seems to be an effective method to accelerate leveling and alignment in cases of mild and moderate crowding. It did not cause negative effect on the periodontal tissues.

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