A Randomized Controlled Trial to Investigate Safety and Variability of Egg Excretion After Repeated Controlled Human Hookworm Infection

2020 ◽  
Author(s):  
Marie-Astrid Hoogerwerf ◽  
Jan Pieter R Koopman ◽  
Jacqueline J Janse ◽  
Marijke C C Langenberg ◽  
Roos van Schuijlenburg ◽  
...  
Keyword(s):  
Adverse Events ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Egg Load ◽  
Infectious Dose ◽  
Randomized Controlled ◽  
Vaccine Trials ◽  
The Mean ◽  
Bayesian Statistical Modeling ◽  
Hookworm Infections

Abstract Background Controlled human hookworm infections could significantly contribute to the development of a hookworm vaccine. However, current models are hampered by low and unstable egg output, reducing generalizability and increasing sample sizes. This study aims to investigate the safety, tolerability, and egg output of repeated exposure to hookworm larvae. Methods Twenty-four healthy volunteers were randomized, double-blindly, to 1, 2, or 3 doses of 50 Necator americanus L3 larvae at 2-week intervals. Volunteers were monitored weekly and were treated with albendazole at week 20. Results There was no association between larval dose and number or severity of adverse events. Geometric mean egg loads stabilized at 697, 1668, and 1914 eggs per gram feces for the 1 × 50L3, 2 × 50L3, and 3 × 50L3 group, respectively. Bayesian statistical modeling showed that egg count variability relative to the mean was reduced with a second infectious dose; however, the third dose did not increase egg load or decrease variability. We therefore suggest 2 × 50L3 as an improved challenge dose. Model-based simulations indicates increased frequency of stool sampling optimizes the power of hypothetical vaccine trials. Conclusions Repeated infection with hookworm larvae increased egg counts to levels comparable to the field and reduced relative variability in egg output without aggravating adverse events. Clinical Trials Registration NCT03257072.

Efficacy and Safety of Ascending Dosages of Tribendimidine Against Hookworm Infections in Children: A Randomized Controlled Trial

2018 ◽  
Vol 69 (5) ◽  
pp. 845-852
Author(s):  
Jean T Coulibaly ◽  
Noemi Hiroshige ◽  
Yves K N’Gbesso ◽  
Jan Hattendorf ◽  
Jennifer Keiser
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Global Strategy ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Emax Model ◽  
Hookworm Infections

Abstract Background The global strategy to control soil-transmitted helminthiasis is mainly focused on preventive chemotherapy with albendazole and mebendazole. We assessed the efficacy and safety of ascending tribendimidine doses against hookworm infections in African school-aged children, key information for the development of tribendimidine. Methods We performed a single blind, randomized, controlled trial in Côte d’Ivoire between June and August 2017. Eligible participants were randomly assigned to placebo, 100, 200, or 400 mg tribendimidine. Cure rates (CRs, primary outcome) and egg reduction rates (ERRs) were determined 14–21 days after treatment. Clinical symptoms were assessed before treatment and adverse events monitored 3 and 24 hours posttreatment. Results CRs calculated for 130 children dose-dependently increased. The observed CRs were 20.6% (7/34), 21.2% (7/33), 38.7% (12/31), and 53.1% (17/32) for placebo, 100, 200, and 400 mg of tribendimidine, respectively. The Emax model predicted a placebo corrected net effect of 34.3 percentage points (95% confidence interval [CI], 13.3–54.4) for the 400-mg tribendimidine dose. The ERRs (geometric mean) were 30.6% (95% CI, −24.7 to 64.1), 65.4% (95% CI, 24.5–85.9), 82.1% (95% CI, 58.4–92.5) and 92.2% (95% CI, 81.0–97.1) for placebo, 100, 200, and 400 mg tribendimidine, respectively. The Emax model predicted an ERR of 95% at 500 mg. Only mild adverse events and no abnormal biochemical parameters were observed. Conclusion A 400-mg dose of tribendimidine yielded the highest efficacy and was well tolerated. Because children were mostly lightly infected, further investigations with tribendimidine against moderate/heavy hookworm infection are needed. Clinical Trials Registration The trial is registered at www.isrctn.com number ISRCTN81391471.

scholarly journals The effects of a limited infusion rate of fluid in the early resuscitation of sepsis on glycocalyx shedding measured by plasma syndecan-1: a randomized controlled trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Jutamas Saoraya ◽  
Lipda Wongsamita ◽  
Nattachai Srisawat ◽  
Khrongwong Musikatavorn
Keyword(s):  
Adverse Events ◽  
Organ Failure ◽  
Fluid Resuscitation ◽  
Infusion Rate ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Endothelial Glycocalyx ◽  
Open Label ◽  
Randomized Controlled ◽  
Standard Rate

Abstract Background Aggressive fluid administration is recommended in the resuscitation of septic patients. However, the delivery of a rapid fluid bolus might cause harm by inducing degradation of the endothelial glycocalyx. This research aimed to examine the effects of the limited infusion rate of fluid on glycocalyx shedding as measured by syndecan-1 in patients with sepsis-induced hypoperfusion. Methods A prospective, randomized, controlled, open-label trial was conducted between November 2018 and February 2020 in an urban academic emergency department. Patients with sepsis-induced hypoperfusion, defined as hypotension or hyperlactatemia, were randomized to receive either the standard rate (30 ml/kg/h) or limited rate (10 ml/kg/h) of fluid for the first 30 ml/kg fluid resuscitation. Subsequently, the fluid rate was adjusted according to the physician’s discretion but not more than that of the designated fluid rate for the total of 6 h. The primary outcome was differences in change of syndecan-1 levels at 6 h compared to baseline between standard and limited rate groups. Secondary outcomes included adverse events, organ failure, and 90-day mortality. Results We included 96 patients in the intention-to-treat analysis, with 48 assigned to the standard-rate strategy and 48 to the limited-rate strategy. The median fluid volume in 6 h in the limited-rate group was 39 ml/kg (interquartile range [IQR] 35–52 ml/kg) vs. 53 ml/kg (IQR 46–64 ml/kg) in the standard-rate group (p < 0.001). Patients in the limited-rate group were less likely to received vasopressors (17% vs 42%; p = 0.007) and mechanical ventilation (20% vs 41%; p = 0.049) during the first 6 h. There were no significantly different changes in syndecan-1 levels at 6 h between the two groups (geometric mean ratio [GMR] in the limited-rate group, 0.82; 95% confidence interval [CI], 0.66–1.02; p = 0.07). There were no significant differences in adverse events, organ failure outcomes, or mortality between the two groups. Conclusions In sepsis resuscitation, the limited rate of fluid resuscitation compared to the standard rate did not significantly reduce changes in syndecan-1 at 6 h. Trial registration Thai Clinical Trials Registry number: TCTR20181010001. Registered 8 October 2018, http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=4064

scholarly journals Hydroxychloroquine for Early Treatment of Adults With Mild Coronavirus Disease 2019: A Randomized, Controlled Trial

2020 ◽  
Author(s):  
Oriol Mitjà ◽  
Marc Corbacho-Monné ◽  
Maria Ubals ◽  
Cristian Tebé ◽  
Judith Peñafiel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Load ◽  
Adverse Events ◽  
Usual Care ◽  
Symptom Onset ◽  
Early Treatment ◽  
Complete Resolution ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
The Mean

Abstract Background No effective treatments for coronavirus disease 2019 (COVID-19) exist. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be efficacious for outpatients with COVID-19. Methods Multicenter open-label, randomized, controlled trial conducted in Catalonia, Spain, between 17 March and 26 May 2020. Patients recently diagnosed with &lt;5-day of symptom onset were assigned to receive HCQ (800 mg on day 1 followed by 400 mg once daily for 6 days) or usual care. Outcomes were reduction of viral load in nasopharyngeal swabs up to 7 days after treatment start, disease progression up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days. Results A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD, 12.6), mean viral load at baseline was 7.90 log10 copies/mL (SD, 1.82), and median time from symptom onset to randomization was 3 days. No differences were found in the mean reduction of viral load at day 3 (−1.41 vs −1.41 log10 copies/mL in the control and intervention arm, respectively) or at day 7 (−3.37 vs −3.44). Treatment did not reduce risk of hospitalization (7.1% control vs 5.9% intervention) nor shorten the time to complete resolution of symptoms (12 days, control vs 10 days, intervention). No relevant adverse events were reported. Conclusions In patients with mild COVID-19, no benefit was observed with HCQ beyond the usual care.

scholarly journals A randomized, controlled trial of oral versus intravenous fluids for lowering blood glucose in emergency department patients with hyperglycemia

CJEM ◽  
2014 ◽  
Vol 16 (03) ◽  
pp. 214-219 ◽  
Author(s):  
Sanjay Arora ◽  
Marc A. Probst ◽  
Laura Andrews ◽  
Marissa Camilion ◽  
Andrew Grock ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Blood Glucose ◽  
Adverse Events ◽  
Controlled Trial ◽  
Fluid Administration ◽  
Intravenous Fluids ◽  
Glucose Levels ◽  
Randomized Controlled ◽  
Blood Glucose Levels ◽  
The Mean

ABSTRACT Objectives: Blood glucose can be lowered via insulin and/or fluid administration. Insulin, although efficacious, can cause hypoglycemia and hypokalemia. Fluids do not cause hypoglycemia or hypokalemia, but the most effective route of fluid administration has not been well described. This study compared the efficacy and safety of oral versus intravenous fluids for reducing blood glucose in patients with hyperglycemia. Methods: We conducted a prospective, nonblinded, randomized, controlled trial. Inclusion criteria were blood glucose &gt; 13.9 mmol/L, age &gt; 18 years, and ability to tolerate oral fluids. Subjects were excluded for critical illness, contraindication to fluids, and/or hyperglycemia therapy prior to enrolment. Subjects were randomized to receive oral bottled water or intravenous normal saline (maximum 2 L) over 2 hours. The primary outcome of interest was a change in blood glucose at 2 hours across treatment arms. Results: The 48 subjects were randomized. Baseline blood glucose levels and total amount of fluid received were similar between the two groups. The mean decrease in blood glucose at 2 hours was similar for both treatment arms: a mean decrease of 3.4 mmol/L (20.2 mmol/L to 16.8 mmol/L) in the oral fluid group versus a mean decrease of 4.0 mmol/L (19.7 mmol/L to 15.7 mmol/L) in the intravenous fluid group. The mean difference between groups was −0.6 mmol/L (95% confidence interval −2.3–1.2; p = 0.51). No adverse events were observed in either group. Conclusion: In this unblinded randomized trial, oral and intravenous fluids were equally efficacious in lowering blood glucose levels in stable hyperglycemic patients and no adverse events were noted. Physicians should be mindful that, although similar, the reduction in blood glucose was modest in both groups.

The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Ronnie L. Shammas ◽  
Caitlin E. Marks ◽  
Gloria Broadwater ◽  
Elliot Le ◽  
Adam D. Glener ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Lavender Oil ◽  
Entire Cohort ◽  
Randomized Controlled ◽  
Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

Water exchange-assisted vs. carbon dioxide-insufflated single-balloon enteroscopy: randomized controlled trial

Endoscopy ◽  
2021 ◽  
Author(s):  
Shaopeng Liu ◽  
Tao Dong ◽  
Yupeng Shi ◽  
Hui Luo ◽  
Xianmin Xue ◽  
...  
Keyword(s):  
Carbon Dioxide ◽  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Water Exchange ◽  
Controlled Trial ◽  
Control Group ◽  
Balloon Enteroscopy ◽  
Randomized Controlled ◽  
Single Balloon ◽  
Single Balloon Enteroscopy

<b>Background and study aims</b> Single-balloon enteroscopy (SBE) is a valuable but difficult modality for the diagnosis and treatment of small-bowel diseases. The water exchange (WE) method has the advantage of facilitating intubation during colonoscopy. Here, we evaluated the effects of WE on procedure-related variables related to SBE. <b>Patients and methods</b> This randomized controlled trial was conducted in a tertiary-care referral center in China. Patients with attempt at total enteroscopy (ATE) were randomly allocated to undergo WE-assisted (WE group) or carbon dioxide-insufflated enteroscopy (CO<sub>2</sub> group). All patients were planned to undergo both antegrade and retrograde procedures. The primary outcome was the total enteroscopy rate (TER). Secondary outcomes included maximal insertion depth, positive findings, procedural time and adverse events. <b>Results</b> In total, 110 patients were enrolled, with 55 in each group. Baseline characteristics between the two groups were comparable. TER was achieved in 58.2% (32/55) of the WE group and 36.4% (20/55) of the control group (p=0.022). The estimated intubation depth was 521.2±101.4 cm in the WE group and 481.6±95.2 cm in the CO<sub>2</sub> group (p=0.037). The insertion time was prolonged in the WE group compared with CO<sub>2</sub> group (178.9±45.1 min vs. 154.2±27.6 min, p<0.001). Endoscopic findings and adverse events were comparable between the two groups. <b>Conclusions</b> The WE method improved TER and increased intubation depth during SBE. The use of WE did not increase complications of enteroscopy. Clinical trial registation: https://clinicaltrials.gov/， NCT01942863.

scholarly journals The impact of vildagliptin on the daily glucose profile and coronary plaque stability in impaired glucose tolerance patients with coronary artery disease: VOGUE—A multicenter randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hiroyuki Yamamoto ◽  
Akihide Konishi ◽  
Toshiro Shinke ◽  
Hiromasa Otake ◽  
Masaru Kuroda ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Fibrous Cap ◽  
Multicenter Randomized Controlled Trial ◽  
The Mean ◽  
Artery Disease ◽  
Fibrous Cap Thickness ◽  
The Impact

Abstract Background The impact of reduction in glycemic excursion on coronary plaques remains unknown. This study aimed to elucidate whether a dipeptidyl peptidase 4 inhibitor could reduce the glycemic excursion and stabilize the coronary plaques compared with conventional management in coronary artery disease (CAD) patients with impaired glucose tolerance (IGT). Methods This was a multicenter, randomized controlled trial including CAD patients with IGT under lipid-lowering therapy receiving either vildagliptin (50 mg once a day) or no medication (control group) regarding glycemic treatment. The primary endpoint was changes in the minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography at 6 months after intervention. Glycemic variability expressed as the mean amplitude of glycemic excursion (MAGE) measured with a continuous glucose monitoring system was evaluated before and 6 months after intervention. Results A total of 20 participants with 47 lesions were allocated to either the vildagliptin group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions). The adjusted difference of mean changes between the groups was − 18.8 mg/dl (95% confidence interval, − 30.8 to − 6.8) (p = 0.0064) for the MAGE (vildagliptin, − 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), − 22.8° (− 40.6° to − 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, − 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, − 15.1 ± 25.2 μm). Conclusions Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group. These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset. Trial registration Registered in the UMIN clinical trial registry (UMIN000008620), Name of the registry: VOGUE trial, Date of registration: Aug 6, 2012, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010058

scholarly journals Manual Therapy in Cervical and Lumbar Radiculopathy: A Systematic Review of the Literature

2021 ◽  
Vol 18 (11) ◽  
pp. 6176
Author(s):  
Tomasz Kuligowski ◽  
Anna Skrzek ◽  
Błażej Cieślik
Keyword(s):  
Manual Therapy ◽  
Functional Outcomes ◽  
Web Of Science ◽  
Current Knowledge ◽  
Controlled Trial ◽  
Future Research ◽  
Lumbar Radiculopathy ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
The Mean

The aim of this study was to describe and update current knowledge of manual therapy accuracy in treating cervical and lumbar radiculopathy, to identify the limitations in current studies, and to suggest areas for future research. The study was conducted according to PRISMA guidelines for systematic reviews. A comprehensive literature review was conducted using PubMed and Web of Science databases up to April 2020. The following inclusion criteria were used: (1) presence of radiculopathy; (2) treatment defined as manual therapy (i.e., traction, manipulation, mobilization); and (3) publication defined as a Randomized Controlled Trial. The electronic literature search resulted in 473 potentially relevant articles. Finally, 27 articles were accepted: 21 on cervical (CR) and 6 in lumbar radiculopathy (LR). The mean PEDro score for CR was 6.6 (SD 1.3), and for LR 6.7 (SD 1.6). Traction-oriented techniques are the most frequently chosen treatment form for CR and are efficient in reducing pain and improving functional outcomes. In LR, each of the included publications used a different form of manual therapy, which makes it challenging to summarize knowledge in this group. Of included publications, 93% were either of moderate or low quality, which indicates that quality improvement is necessary for this type of research.

The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Asieh Mehdipour ◽  
Parvin Abedi ◽  
Somayeh Ansari ◽  
Maryam Dastoorpoor
Keyword(s):  
Randomized Controlled Trial ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Moderate Depression ◽  
Before And After ◽  
The Mean ◽  
And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

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