scholarly journals An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial

2011 ◽  
Vol 107 (11) ◽  
pp. 1616-1622 ◽  
Author(s):  
Jean-Christophe Rozé ◽  
Sébastien Barbarot ◽  
Marie-José Butel ◽  
Nathalie Kapel ◽  
Anne-Judith Waligora-Dupriet ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Infant Formula ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Secretory Iga ◽  
Control Group ◽  
Double Blind ◽  
Randomised Controlled ◽  
Similar Growth ◽  
Experimental Group

The aim of the present study was to evaluate the safety, tolerance and preventive effect on atopic dermatitis of an experimental α-lactalbumin-enriched and symbiotic-supplemented infant formula. A total of ninety-seven non-breastfed term neonates were enrolled into a double-blind, multicentre, randomised controlled trial in which they received experimental (n 48) or standard formula (n 49) for 6 months. The primary outcome was weight at 6 months of age. Secondary outcomes were gastrointestinal tolerance and manifestation of atopic dermatitis. Faecal secretory IgA (SIgA) concentration and microbiota composition of forty-three infants were analysed at 1 and 6 months. Growth was similar in both groups. At 1 month, compared to those in the control group, infants in the experimental group exhibited less crying or agitation, and more quiet behaviour (P = 0·03). At 6 months, atopic dermatitis was less frequently observed in the experimental group (P < 0·05). Decrease of faecal SIgA concentration between 1 and 6 months was mainly observed in the control group. This decrease was significantly associated with atopic dermatitis (P < 0·014) and negatively correlated to the level of colonisation by bifidobacteria (P < 0·005). In conclusion, compared to the control formula, the experimental formula guaranteed a similar growth, was better tolerated at 1 month and had a protective effect against the development of atopic dermatitis.

Megavitamin and Dietary Treatment in Schizophrenia: A Randomised, Controlled Trial

1999 ◽  
Vol 33 (1) ◽  
pp. 84-88 ◽  
Author(s):  
Kevin Vaughan ◽  
Nathaniel McConaghy
Keyword(s):  
Positive Relationship ◽  
Controlled Trial ◽  
Serum Vitamin ◽  
Dietary Treatment ◽  
Serum Levels ◽  
Control Group ◽  
Double Blind ◽  
Randomised Controlled ◽  
Experimental Group

Objective: The aim of this study was to assess the efficacy of adjunctive megavitamin and dietary treatment in schizophrenia. Method: Arandom allocation double-blind, controlled comparison of dietary supplement and megavitamin treatment, and an alternative procedure was given for 5 months to 19 outpatients with a diagnosis of schizophrenia. In addition to usual follow-up, the experimental group received amounts of megavitamins based on their individual serum vitamin levels plus dietary restriction based on Radioallergosorbent (RAST) tests. The control group received 25 mg vitamin C and were prescribed substances considered allergenic from the RAST test. Results: Five months of treatment showed marked differences in serum levels of vitamins but no consistent self-reported symptomatic or behavioural differences between groups. Conclusions: This study does not provide evidence supporting a positive relationship between regulation of levels of serum vitamins and clinical outcome in schizophrenia over 5 months.

scholarly journals The CARESSES Randomised Controlled Trial: Exploring the Health-Related Impact of Culturally Competent Artificial Intelligence Embedded Into Socially Assistive Robots and Tested in Older Adult Care Homes

2021 ◽  
Author(s):  
Chris Papadopoulos ◽  
Nina Castro ◽  
Abiha Nigath ◽  
Rosemary Davidson ◽  
Nicholas Faulkes ◽  
...  
Keyword(s):  
Older Adult ◽  
Controlled Trial ◽  
Control Group ◽  
Culturally Competent ◽  
Adult Care ◽  
Assistive Robots ◽  
Sf 36 ◽  
Randomised Controlled ◽  
Experimental Group ◽  
Group 1

AbstractThis trial represents the final stage of the CARESSES project which aimed to develop and evaluate a culturally competent artificial intelligent system embedded into social robots to support older adult wellbeing. A parallel group, single-blind randomised controlled trial was conducted across older adult care homes in England and Japan. Participants randomly allocated to the Experimental Group or Control Group 1 received a Pepper robot for up 18 h across 2 weeks. Two versions of the CARESSES artificial intelligence were tested: a fully culturally competent system (Experimental Group) and a more limited version (Control Group 1). Control Group 2 (Care As Usual) participants did not receive a robot. Quantitative outcomes of interest reported in the current paper were health-related quality of life (SF-36), loneliness (ULS-8), and perceptions of robotic cultural competence (CCATool-Robotics). Thirty-three residents completed all procedures. The difference in SF-36 Emotional Wellbeing scores between Experimental Group and Care As Usual participants over time was significant (F[1] = 6.614, sig = .019, ηp2 = .258), as was the comparison between Any Robot used and Care As Usual (F[1] = 5.128, sig = .031, ηp2 = .146). There were no significant changes in SF-36 physical health subscales. ULS-8 loneliness scores slightly improved among Experimental and Control Group 1 participants compared to Care As Usual participants, but this was not significant. This study brings new evidence which cautiously supports the value of culturally competent socially assistive robots in improving the psychological wellbeing of older adults residing in care settings.

scholarly journals Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA)

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037842
Author(s):  
Wei Chen ◽  
Naya Huang ◽  
Haiping Mao ◽  
Xiao Yang ◽  
Qian Zhou ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Cardiovascular Outcomes ◽  
Control Group ◽  
Type I ◽  
Dialysis Patients ◽  
Double Blind ◽  
Randomised Controlled

IntroductionThe prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.Methods and analysesThis prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.Trial registration numberNCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.Protocol versionThe protocol version number and date are YLT-1604-V2.0 and 15 December 2016.

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).

Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial

Gut ◽  
2020 ◽  
pp. gutjnl-2020-322026
Author(s):  
Vincent Huberty ◽  
Ivo Boskoski ◽  
Vincenzo Bove ◽  
Pauline Van Ouytsel ◽  
Guido Costamagna ◽  
...  
Keyword(s):  
Weight Loss ◽  
Lifestyle Modification ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Body Weight Loss ◽  
Total Body Weight ◽  
Control Group ◽  
Short Term ◽  
Randomised Controlled

ObjectiveEndoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium).DesignEligible patients (body mass index 30–40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG.ResultsOf the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%.ConclusionsThis study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment.Trial registration numberNCT03255005.

scholarly journals Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

2020 ◽  
Vol 7 (1) ◽  
pp. e000376
Author(s):  
Sivakami Janahiraman ◽  
Chan Yen Tay ◽  
Jie Min Lee ◽  
Wen Ling Lim ◽  
Chun Hoe Khiew ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Educational Programme ◽  
Control Group ◽  
Randomised Controlled ◽  
The Impact ◽  
Experimental Group

ObjectivePreprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.DesignAn accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).ResultsA total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).ConclusionAn intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.

scholarly journals Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1530 ◽  
Author(s):  
Alfonso Rodriguez-Herrera ◽  
Kelly Mulder ◽  
Hetty Bouritius ◽  
Rocio Rubio ◽  
Antonio Muñoz ◽  
...  
Keyword(s):  
Infant Formula ◽  
Reference Group ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Daily Weight Gain ◽  
Control Group ◽  
Double Blind ◽  
Control Infant ◽  
Breastfed Infants ◽  
Experimental Versus

This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%; p < 0.02). Both study formulae are well-tolerated, support an adequate infant growth and are safe for use in healthy term infants. Compared to the control formula, the partly fermented formula with prebiotics induces stool consistencies closer to breastfed infants.

scholarly journals The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Joscha Reinhard ◽  
Swati Peiffer ◽  
Nicole Sänger ◽  
Eva Herrmann ◽  
Juping Yuan ◽  
...  
Keyword(s):  
Medical Care ◽  
Success Rate ◽  
Controlled Trial ◽  
Randomised Trial ◽  
External Cephalic Version ◽  
Control Group ◽  
Amniotic Fluid Index ◽  
Double Blind ◽  
Standard Medical Care ◽  
Clinical Hypnosis

Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group.Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 370/7(259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone ().Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (), successful ECV, whereas 38 women, who received NLP, had a 44.7% () successful ECV (). The control group had similar patient characteristics compared to the intervention groups (). In the control group () 27.3% () had a statistically significant lower successful ECV procedure than NLP () and hypnosis and NLP ().Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

scholarly journals Effectiveness of mental simulations on the early mobilization of patients after cesarean section: a randomized controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna Prokopowicz ◽  
Katarzyna Byrka
Keyword(s):  
Process Simulation ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Early Mobilization ◽  
Mental Simulation ◽  
Controlled Study ◽  
Control Group ◽  
Simulation Group ◽  
Randomised Controlled ◽  
Experimental Group

AbstractWe aimed to investigate whether psychological intervention (single mental simulation) among women after cesarean surgery (CC) can affect their willingness to verticalize, actual verticalization, and the duration of the first mobilization. In this prospective randomised, controlled study, 150 women after CC were divided into 3 groups: experimental group with process-simulation with elements of relaxation, experimental group with outcome-simulation with elements of relaxation and control group with elements of relaxation only. After a 5-h stay in the post-operative room, women listened to a recording with a stimulation. Pain and anxiety of verticalization were measured before and after listening to the recording and after verticalization. Almost 12% more patients verticalized in the process-simulation group than in the control group. Percentages of mobilized patients were: 39.4% the process-simulation group; 32.8% in the outcome-simulation group; 27.7% controls (p = 0.073). Mobilization was 5 min longer in the process-simulation group then in control (p < 0.01). Anxiety after the simulation was a significant covariate of the willingness to verticalize, actual verticalization and time spent in mobilization. We conclude that a single mental simulation can effectively motivate patients for their first verticalization after CC. Perceived anxiety before verticalization may affect the effectiveness of interventions, so we recommend to check it at the postoperative care.ClinicalTrials.gov Identifier: NCT04829266.

scholarly journals Chinese Herbal Medicine Combined with Entecavir to Reduce the Off-therapy Recurrence Risk in HBeAg-positive Chronic Hepatitis B Patients: a Multicenter, Double-blind, Randomized Controlled Trial in China

2020 ◽  
Author(s):  
Xiaoke Li ◽  
Ludan Zhang ◽  
Yong'an Ye ◽  
Hongbo Du ◽  
Mei Qiu ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Controlled Trial ◽  
Recurrence Risk ◽  
Control Group ◽  
Consolidation Therapy ◽  
Double Blind ◽  
Positive Chronic Hepatitis ◽  
Experimental Group

Abstract Background Nucleos(t)ide analogues (NAs) are the first-line option against chronic hepatitis B (CHB). NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of virological relapse after discontinuation. The combined therapy of NAs plus traditional Chinese medicine (TCM) is widely accepted and has been recognized as a prospective alternative approach in China. Based on preliminary works, this study was designed to observe the therapeutic effect of TCM plus entecavir (ETV) against HBeAg-positive chronic hepatitis B with respect to reducing the recurrence risk after NA withdrawal.Methods/design The study is a nationwide, multicenter, double-blind, randomized, placebo-controlled trial with a duration of 120 weeks. A total of 18 hospitals and 490 eligible Chinese HBeAg-positive CHB patients will be enrolled and randomly allocated into the experimental group and control group in a 1:1 ratio. Patients in the experimental group will be prescribed TCM formulae (Tiaogan-BuXu-Jiedu granules) plus ETV 0.5 mg per day for consolidation therapy for 96 weeks. Patients in the control group will be prescribed TCM granule placebo plus ETV 0.5 mg per day for the same course. After consolidation therapy, all patients will discontinue their trial drugs and be closely monitored over the next 24 weeks. Once clinical recurrence (CR) occurs, ETV treatment will be restarted. The primary outcome is the cumulative rate of CR at the end of this trial.Conclusion This study is the first of its kind to observe therapeutic effects with respect to reducing recurrence after NA withdrawals after unified integrative consolidation therapy in the CHB population.Trial registration Chinese Clinical Trial Registry No. ChiCTR1900021232, 2019/02/02, http://www.chictr.org.cn/showproj.aspx?proj=35297

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