scholarly journals A Randomized, Placebo-controlled, Double-blind Pilot Study of Single-dose Humanized Anti-IL5 Antibody (Reslizumab) for the Reduction of Eosinophilia Following Diethylcarbamazine Treatment of Loa loa Infection

2020 ◽  
Author(s):  
Fanny Legrand ◽  
Jesica Herrick ◽  
Michelle Makiya ◽  
Roshan Ramanathan ◽  
Reagan Thompson ◽  
...  
Keyword(s):  
Single Dose ◽  
Adverse Reactions ◽  
Controlled Trial ◽  
Loa Loa ◽  
Double Blind ◽  
Interleukin 5 ◽  
Diethylcarbamazine Citrate ◽  
Baseline Characteristics ◽  
Eosinophil Activation

Abstract Background Diethylcarbamazine citrate (DEC) treatment of loiasis is complicated by adverse reactions that are correlated with the number of circulating microfilariae (mf). The cause of these reactions is unknown, but they are accompanied by a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia and evidence of eosinophil activation. Methods To explore the role of IL-5 driven eosinophilia in post-DEC reactions, 8 adults with confirmed loiasis and <5000 mf/mL blood were enrolled in a randomized, double-blind, placebo-controlled trial of the humanized anti-IL-5 antibody, reslizumab, (1.0 mg/kg IV) administered 3 to 7 days prior to initiation of DEC treatment (9 mg/kg/day for 21 days). The primary endpoint was the reduction in absolute eosinophil count (AEC) during the first week of DEC treatment. Results Baseline characteristics were comparable between the two groups. Single dose reslizumab lowered the AEC by 77% prior to initiation of DEC therapy (vs. 12% in the placebo group, P < .05). More importantly, AEC remained below baseline in the first week of DEC treatment in all subjects who received reslizumab and in none of the placebo subjects. Mf clearance occurred within 2 days of initiation of DEC in all 7 mf-positive subjects. Mild to moderate adverse events were seen in all 8 subjects and were not significantly different between the groups. Conclusions In summary, although reslizumab was able to blunt peripheral eosinophilia post-DEC treatment in subjects with loiasis and had no effect on microfilarial clearance, the reduction in AEC appeared to have been insufficient to prevent post-treatment AEs.

scholarly journals A double-blind randomized controlled trial of low doses of propranolol, nortriptyline, and the combination of propranolol and nortriptyline for the preventive treatment of migraine

2009 ◽  
Vol 67 (4) ◽  
pp. 973-977 ◽  
Author(s):  
Renan B. Domingues ◽  
André L. Pirajá da Silva ◽  
Simone A. Domingues ◽  
Camila Catherine H. Aquino ◽  
Gustavo W. Kuster
Keyword(s):  
Treatment Period ◽  
Adverse Reactions ◽  
Controlled Trial ◽  
Combined Therapy ◽  
Preventive Treatment ◽  
Double Blind ◽  
Randomized Controlled ◽  
Pre Treatment ◽  
Higher Doses

Few trials have evaluated combination of two or more drugs in the preventive treatment of migraine. In this study three therapeutic regimens were compared: (a) propranolol, at a dose of 40 mg per day, (b) nortriptyline, at a dose of 20 mg per day, and (c) the combination of these two drugs in these dosages. The groups were matched according to age, gender, and frequency of migraine attacks prior to treatment. The period of treatment was two months and the frequency and intensity of headache attacks of the 30 days pre-treatment period were compared with the frequency of headaches in the treatment period. Fourteen patients in groups A and B and sixteen patients in group C have completed the study. Treatment with propranolol, alone or in combination, was shown to be effective. Treatment with nortriptyline alone was not effective. All three therapeutic regimens were safe and side effects were minimal. The frequency of discontinuation of the study was the same in the 3 groups but no patient left the study due to adverse reactions. The combined therapy proved to be as safe as the monotherapy. Further studies evaluating this and other possible combinations of drugs in higher doses and for longer periods, should more clearly elucidate the role of combined therapy in the treatment of migraine.

Abstract P161: Randomized Trial Of Magnesium Glycinate Supplementation And Blood Pressure In Middle-aged Adults

Hypertension ◽  
2020 ◽  
Vol 76 (Suppl_1) ◽  
Author(s):  
Howard D Sesso ◽  
Trisha Copeland ◽  
Jennifer L Coates ◽  
Olubunmi A Solano ◽  
Allison Clar ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Controlled Trial ◽  
Short Term ◽  
Double Blind ◽  
Subgroup Analyses ◽  
History Of ◽  
Baseline Characteristics ◽  
Middle Aged Adults ◽  
Healthy Participants

Introduction: Magnesium (Mg) intake is inversely associated with BP and hypertension risk in observational studies. However, short-term randomized trials on seated BP have been inconsistent, with few studies measuring 24-h ambulatory BP (ABP). In addition, Mg glycinate, a more easily absorbed form of supplemental Mg, has been largely untested in randomized trials and may serve as a first-line approach for BP reduction among those with elevated, untreated, BP. Methods: We conducted a randomized, double-blind, placebo-controlled trial (NCT03688503) testing 480 mg/d of elemental Mg glycinate versus placebo for 12 weeks among 59 otherwise healthy participants aged 30-74 y with elevated seated BP (systolic BP (SBP) 120-149 mmHg and/or diastolic BP (DBP) 80-94 mmHg) and no history of anti-hypertensive medication use. At baseline, 6 weeks, and 12 weeks, we measured seated BP, monitored 24-h ABP, and collected blood samples. Our primary aim tested Mg glycinate on 12-week changes in seated BP and 24-h ABP, and subgroup analyses considered if sex, age, or baseline BP modified the effect of Mg on BP. Results: Baseline characteristics were equally distributed at randomization (mean age, 57.2 y; 58% men) with mean seated BP of 133.4/82.6 mmHg. Compliance was high (Mg, 87%; placebo, 96%). After 12 weeks, there was no significant effect of Mg glycinate versus placebo on seated SBP (-4.5 vs -1.6 mmHg from baseline; p=0.38) and DBP (-1.9 vs -0.9 mmHg from baseline; p=0.64), nor was there any significant effect on overall, daytime, or nighttime 24-h ambulatory SBP and DBP (all p>0.05). In subgroup analyses, the effect of Mg glycinate on seated SBP was suggestively, but non-significantly, stronger among those with baseline seated SBP ≥130 mmHg (-9.3 vs -2.7 mmHg; p=0.12; p, interaction=0.24) and among women (-9.7 vs -3.1 mmHg; p=0.26; p, interaction=0.29). Age, seated DBP, and mean 24-h ambulatory SBP and DBP did not modify the effects of Mg supplementation. Conclusions: A Mg glycinate supplement did not significantly reduce seated or 24-h BP in adults with elevated, untreated BP. Forthcoming analyses will expand on the role of serum and dietary Mg levels. Larger trials are warranted to elucidate possible effects of Mg glycinate on seated SBP among those with elevated BP and among women.

scholarly journals Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aziza Ajlan ◽  
Hassan Aleid ◽  
Tariq Zulfiquar Ali ◽  
Hala Joharji ◽  
Khalid Almeshari ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
De Novo ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Double Blind ◽  
Donor Specific Antibodies

Abstract Background Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not been fully investigated. Aims To compare different induction therapeutic strategies with 2 doses of basiliximab vs. no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol. Methods Prospective, randomized, double blind, non-inferiority, controlled clinical trial Expected outcomes 1. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2. Secondary outcomes: a. Patient and graft survival at 1 year b. eGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs) Trial registration The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.

scholarly journals Can topical epinephrine application to the papilla prevent pancreatitis after endoscopic retrograde cholangiopancreatography? Results from a double blind, multicentre, placebo controlled, randomised clinical trial

2021 ◽  
Vol 8 (1) ◽  
pp. e000562
Author(s):  
Adriana Fabiola Romano-Munive ◽  
J Jesus García-Correa ◽  
Luis F García-Contreras ◽  
José Ramírez-García ◽  
Luis Uscanga ◽  
...  
Keyword(s):  
Endoscopic Retrograde Cholangiopancreatography ◽  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Sterile Water ◽  
Endoscopic Retrograde ◽  
Double Blind ◽  
Registration Number ◽  
Baseline Characteristics ◽  
Randomised Controlled ◽  
Rectal Indomethacin

Background and study aimsPost-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a complication associated with important morbidity, occasional mortality and high costs. Preventive strategies are suboptimal as PEP continues to affect 4% to 9% of patients. Spraying epinephrine on the papilla may decrease oedema and prevent PEP. This study aimed to compare rectal indomethacin plus epinephrine (EI) versus rectal indomethacin plus sterile water (WI) for the prevention of PEP.Patients and methodsThis multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 mL of sterile water or a 1:10 000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure. The trial was stopped half way through after a new publication reported an increased incidence of PEP among patients receiving epinephrine.ResultsOf the 3602 patients deemed eligible, 3054 were excluded after screening. The remaining 548 patients were randomised to EI group (n=275) or WI group (n=273). The EI and WI groups had similar baseline characteristics. Patients in the EI group had a similar incidence of PEP to those in the WI group (3.6% (10/275) vs 5.12% (14/273), p=0.41). Pancreatic duct guidewire insertion was identified as a risk factor for PEP (OR 4.38, 95% CI (1.44 to 13.29), p=0.009).ConclusionSpraying epinephrine on the papilla was no more effective than rectal indomethacin alone for the prevention of PEP.Trial registration numberThis study was registered with ClinicalTrials.gov (NCT02959112).

scholarly journals Eight-day consumption of inulin added to a yogurt breakfast lowers postprandial appetite ratings but not energy intakes in young healthy females: a randomised controlled trial

2015 ◽  
Vol 115 (2) ◽  
pp. 262-270 ◽  
Author(s):  
Sarah Heap ◽  
Jessica Ingram ◽  
Marron Law ◽  
Amy J. Tucker ◽  
Amanda J. Wright
Keyword(s):  
Energy Intake ◽  
Controlled Trial ◽  
Eating Behaviour ◽  
Hormonal Contraceptives ◽  
Double Blind ◽  
Randomised Controlled ◽  
Desire To Eat ◽  
Repeated Consumption ◽  
Healthy Females

AbstractIncreasing feelings of satiety may reduce appetite and energy intake. The role of inulin consumption in impacting satiety is unclear. A randomised double-blind controlled crossover trial aimed to determine the effects of inulin+yogurt on satiety after 1 and 8-d consumption. The preload breakfast included 100 g vanilla yogurt with (yogurt-inulin (YI)) and without (yogurt-control (YC)) 6 g inulin. A total of nineteen healthy females (22·8 (sd 2·7) years) with non-restrained eating behaviour and taking hormonal contraceptives participated in the study. Day 1 and 8 visual analogue scale (VAS) ratings of Hunger, Fullness, Desire to Eat and Prospective Food Consumption (PFC) were collected at fasting and every 30 min for 180 min. Energy intake was calculated from a weighed ad libitum lunch and remainder of day food records. Total AUC was calculated for each VAS. Day 1 (VAS only) and 8 (VAS and energy intakes) data were compared between YI and YC using ANCOVA, and ANOVA was used to compare energy intakes on Day 1. There were no significant differences between Day 1 YI and YC AUC appetite ratings or energy intakes. However, 8-d consumption of YI v. YC was associated with lower Desire to Eat and PFC ratings but similar lunch and total day energy intakes. Therefore, the addition of 6 g inulin to a commercially available yogurt affected feelings of appetite, but not energy intake, after repeated consumption. These results suggest that inulin may be a suitable ingredient to increase dietary fibre consumption, with potential to impact appetite.

scholarly journals The role of zinc supplementation for diarrhoea in children: a critical review

2019 ◽  
Vol 18 (2) ◽  
pp. 190-195
Author(s):  
Wulandari Berliani Putri ◽  
Syaefudin Ali Akhmad ◽  
Sufi Desrini
Keyword(s):  
Developing Countries ◽  
Zinc Supplementation ◽  
Controlled Trial ◽  
Medical Science ◽  
Morbidity And Mortality ◽  
High Morbidity ◽  
Double Blind ◽  
Sanitation And Hygiene ◽  
Study Selection

Background: Nearly 1.7 million children suffer from diarrhoea and around 760,000 die each year. The high prevalence of diarrhoea in the developing countries is closely related to lack of safe drinking water, inadequate sanitation and hygiene, and poor health and nutritional status. These environmental conditions facilitate the spread of infectious disease easily. The great morbidity and mortality of this preventable and treatable disease raise concern on how to save children from this fatal disease by improving management of diarrhoea. Several studies suggest that zinc deficiency contribute towards high morbidity and mortality in diarrhoea. Further, there is an area of uncertainty regarding how significant zinc supplementation will help to reduce the duration and severity of diarrhoea in children compared to the diarrhoea management without zinc? Objective: To critically analyse the current evidences of zinc supplementation in diarrhoea. Data Sources: Keywords searching through MEDLINE Ovid database and additional references from retrieved articles. Study Selection: Limited to randomized controlled trial(RCT) study design and systematic review studies which were conducted from 2006 to 2016. However, there is one prospective cohort study included as it is a follow-up of subjects who participated in the previous double-blind randomized placebo-controlled trial. Data Synthesis: This review involves a summary of 10 articles that have been appraised on their relevance in evaluating the role of zinc in reducing severity and duration of diarrhoea in children. Further, the literature found is synthesised through method used in the studies and the effectiveness of zinc therapy Conclusion: Zinc is relatively safe to be used and it can improve diarrhoea management especially in developing countries. Bangladesh Journal of Medical Science Vol.18(2) 2019 p.190-195

scholarly journals Effect of a single preoperative dose of oral antibiotic to reduce the incidence of surgical site infection following below-knee dermatological flap and graft repair

2019 ◽  
pp. 28-35 ◽  
Author(s):  
Helena Rosengren ◽  
Clare Heal ◽  
Petra Buettner
Keyword(s):  
Surgical Site Infection ◽  
Antibiotic Prophylaxis ◽  
Controlled Trial ◽  
Study Groups ◽  
High Dose ◽  
Antibiotic Administration ◽  
Oral Antibiotic ◽  
Site Infection ◽  
Double Blind

Background: Surgical site infection (SSI) rates for below-knee dermatological surgery are unacceptably high, particularly following complex flap and graft closures. The role of antibiotic prophylaxis for these surgical cases is uncertain. Objective: To determine whether SSI following complex dermatological closures on the leg could be reduced by antibiotic prophylaxis administered as a single oral preoperative dose. Methods: A total of 115 participants were randomized to 2 g of oral cephalexin or placebo 40-60 minutes prior to surgical incision in a prospective, randomized, double-blind, placebo-controlled trial at a primary care skin cancer clinic in North Queensland, Australia. Results: Overall 17/55 (30.9%) controls and 14/55 (25.5%) intervention participants developed infection (P = 0.525). There was no difference between the study groups in adverse symptoms that could be attributed to high-dose antibiotic administration (P = 1).

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