scholarly journals Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial

2020 ◽  
Author(s):  
Fatemeh Roozbeh ◽  
Majid Saeedi ◽  
Reza Alizadeh-Navaei ◽  
Akbar Hedayatizadeh-Omran ◽  
Shahin Merat ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Significant Difference ◽  
The Difference ◽  
Novel Coronavirus ◽  
Loss Of Appetite

Abstract Introduction Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection. Methods This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1. Results Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P < 0.001. Conclusions In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.

A prospective double-blind randomized controlled trial of the effect of topical bupivacaine on post-operative pain in bilateral nasal surgery with bilateral nasal packs inserted

2005 ◽  
Vol 119 (4) ◽  
pp. 284-288 ◽  
Author(s):  
Malcolm A Buchanan ◽  
Graham R Dunn ◽  
Gillian M MacDougall
Keyword(s):  
Randomized Controlled Trial ◽  
Local Anaesthetic ◽  
Controlled Trial ◽  
Nasal Surgery ◽  
Double Blind ◽  
Control Power ◽  
Randomized Controlled ◽  
Post Operative Pain ◽  
Number Of Patients ◽  
Significant Difference

To ascertain whether local anaesthetic use is of clinical benefit in nasal surgery, a prospective double-blind randomized controlled trial of topical bupivacaine on post-operative pain in patients packed after bilateral nasal surgery was carried out. Each patient received a bupivacaine-soaked and a saline-soaked Merocel pack, thereby acting as their own control. Power analysis ascertained the number of patients required to enter the trial to detect a statistically significant difference in pain. Fifty-seven patients completed the trial. Visual analogue scales determined the level of post-operative pain at different time points in each nostril. Less pain was demonstrated in nostrils containing bupivacaine-soaked packs compared with saline-soaked packs at two hours (p < 0.0001), four hours (p = 0.0183) and six hours (p = 0.0476) post-operatively. Although not statistically significant, less pain was noted on pack removal on the local anaesthetic sides. These results provide clinical-based evidence for the use of bupivacaine as a local anaesthetic in reducing pain following nasal surgery with packing.

scholarly journals A Double-Blind, Randomized, Controlled Trial of Topical Polysporin Triple Compound Versus Topical Mupirocin for the Eradication of Colonization with Methicillin-ResistantStaphylococcus aureusin a Complex Continuing Care Population

2009 ◽  
Vol 20 (3) ◽  
pp. e49-e55 ◽  
Author(s):  
S O’Grady ◽  
Z Hirji ◽  
B Pejcic-Karapetrovic ◽  
S Fung ◽  
H Dedier ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Group Versus ◽  
Polymyxin B ◽  
Controlled Clinical Trial ◽  
Compound Versus ◽  
Double Blind ◽  
Randomized Controlled ◽  
Intranasal Mupirocin ◽  
Medical Wards

BACKGROUND: Intranasal mupirocin or Polysporin Triple (PT) ointment (polymyxin B, bacitracin, gramicidin), in combination with chlorhexidine body washes, have been used for eradicating methicillin-resistantStaphylococcus aureus(MRSA), but no comparative studies have been done.METHODS: A double-blind, randomized, controlled clinical trial to compare the efficacy of mupirocin versus PT ointment in combination with chlorhexidine body washes in eradicating MRSA carriage was conducted. Asymptomatic MRSA carriers, medically stable and at least 18 years of age who were patients on medical wards, received twice daily application of either mupirocin or PT ointment to the anterior nares plus once daily 2% chlorhexidine body washes for seven days. Follow-up swabs from multiple sites using broth enrichment were conducted at 48 h, and one, two, four, eight and 12 weeks.RESULTS: Of 103 patients eligible for analysis (54 mupirocin; 49 PT), no significant differences between the two groups with respect to baseline demographics, risk factors for MRSA or MRSA colonization sites were noted. At 48 h, 35 of 54 (65%) patients in the mupirocin group versus 15 of 49 (31%) in the PT group (P=0.001) were found to be MRSA negative at all sites. Significant differences were observed at one and two weeks but were not maintained at other intervals. In those with complete microbiological follow-up, MRSA eradication at all sites occurred in 12 of 39 (30.8%) mupirocin- and one of 36 (2.8%) PT-treated patients (P=0.001).CONCLUSION: Both agents demonstrated poor efficacy and PT was significantly less efficacious than mupirocin at 12 weeks in eradicating MRSA from all sites.

scholarly journals Efficacy and safety of Levamisole treatment in clinical presentations of non-hospitalized patients with COVID-19: a double-blind, randomized, controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Amirreza Roostaei Firozabad ◽  
Zohreh Akhoundi Meybodi ◽  
Seyed Ruhollah Mousavinasab ◽  
Adeleh Sahebnasagh ◽  
Mohsen Gholinataj Jelodar ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinical Status ◽  
Clinical Importance ◽  
Standard Of Care ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Clinical Benefits ◽  
Study Participants

Abstract Background Levamisole has shown clinical benefits in the management of COVID-19 via its immunomodulatory effect. However, the exact role of Levamisole effect in clinical status of COVID-19 patients is unknown. We aimed to evaluate the efficacy of Levamisole on clinical status of patients with COVID-19 during their course of the disease. Methods This prospective, double-blind, randomized controlled clinical trial was performed in adult patients with mild to moderate COVID-19 (room-air oxygen saturation > 94%) from late April 2020 to mid-August 2020. Patients were randomly assigned to receive a 3-day course of Levamisole or placebo in combination with routine standard of care. Results With 25 patients in each arm, 50 patients with COVID-19 were enrolled in the study. Most of the study participants were men (60%). On days 3 and 14, patients in Levamisole group had significantly better cough status distribution when compared to the placebo group (P-value = 0.034 and 0.005, respectively). Moreover, there was significant differences between the two groups in dyspnea at follow-up intervals of 7 (P-value = 0.015) and 14 (P-value = 0.010) days after receiving the interventions. However, no significant difference in fever status was observed on days 1, 3, 7, and 14 in both groups (P-value > 0.05). Conclusion The results of the current study suggest that Levamisole may improve most of clinical status of patients with COVID-19. The patients receiving Levamisole had significantly better chance of clinical status including cough and dyspnea on day 14 when compared to the placebo. However, the effect-size of this finding has uncertain clinical importance. Trial registration The trial was registered as IRCT20190810044500N7 (19/09/2020).

The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

2021 ◽  
pp. 219256822098547
Author(s):  
R. F. M. R. Kersten ◽  
F. C. Öner ◽  
M. P. Arts ◽  
M. Mitroiu ◽  
K. C. B. Roes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Silicon Nitride ◽  
Interbody Fusion ◽  
Controlled Trial ◽  
Segmental Motion ◽  
Lumbar Interbody Fusion ◽  
Double Blind ◽  
Randomized Controlled ◽  
Disability Questionnaire

Study Design: Randomized controlled trial. Objectives: Lumbar interbody fusion with cages is performed to provide vertebral stability, restore alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used. Silicon nitride (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 cages perform similar to PEEK. Methods: A non-inferiority double-blind multicenter RCT was designed. Patients presenting with chronic low-back pain with or without leg pain were included. Single- or double-level instrumented transforaminal lumbar interbody fusion (TLIF) using an oblique PEEK or Si3N4 cage was performed. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ). The non-inferiority margin for the RMDQ was 2.6 points on a scale of 24. Secondary outcomes included the Oswestry Disability Questionnaire (ODI), Visual Analogue Scales (VAS), SF-36 Physical Function, patient and surgeon Likert scores, radiographic evaluations for subsidence, segmental motion, and fusion. Follow-up was planned at 3, 6, 12, and 24-months. Results: Ninety-two patients were randomized ( i.e. 48 to PEEK and 44 to Si3N4). Both groups showed good clinical improvements on the RMDQ scores of up to 5-8 points during follow-up. No statistically significant differences were observed in clinical and radiographic outcomes. Mean operative time and blood loss were statistically significantly higher for the Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage. Conclusions: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.

Documenting Patients’ and Providers’ Preferences When Proposing a Randomized Controlled Trial: A Qualitative Exploration

2021 ◽  
Author(s):  
Devesh Oberoi ◽  
Cynthia Kwok ◽  
Yong Li ◽  
Cindy Railton ◽  
Susan Horsman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Design ◽  
Controlled Trial ◽  
Primary Care Providers ◽  
Referral Letter ◽  
Care Providers ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Follow Up Care

Abstract Background With advances in cancer diagnosis and treatment, women with early-stage breast cancer (ESBC) are living longer, increasing the number of patients receiving post-treatment follow-up care. Best-practice survivorship models recommend transitioning ESBC patients from oncology-provider (OP) care to community-based care. While developing materials for a randomized controlled trial (RCT) to test the feasibility of a nurse-led Telephone Survivorship Clinic (TSC) for a smooth transition of ESBC survivors to follow-up care, we sought to explore patients’ and OPs’ reactions to our proposed recruitment methods. Methods We used a qualitative study design with content analysis, and a two-pronged approach. We interviewed OPs, seeking feedback on ways to recruit their ESBC patients for the trial, and ESBC patients, seeking input on a questionnaire package assessing outcomes and processes in the trial. Results OPs identified facilitators and barriers and offered suggestions for study design and recruitment process improvement. Facilitators included the novelty and utility of the study and simplicity of methods; barriers included lack of coordination between treating and discharging clinicians, time constraints, language barriers, motivation, and using a paper-based referral letter. OPs suggested using a combination of electronic and paper referral letters and supporting clinicians to help with recruitment. Patient advisors reported satisfaction with the content and length of the assessment package. However, they questioned the relevance of some questions (childhood trauma) while adding questions about trust in physicians and proximity to primary-care providers. Conclusion OPs and patient advisors rated our methods for the proposed trial highly for their simplicity and relevance then suggested changes. These findings document processes that could be effective for cancer-patient recruitment in survivorship clinical trials.

scholarly journals A double-blind randomized controlled trial of topical Curcuma xanthorrhiza Roxb. on mild psoriasis: clinical manifestations, histopathological features, and K6 expressions

2018 ◽  
Vol 27 (3) ◽  
pp. 178-84 ◽  
Author(s):  
Githa Rahmayunita ◽  
Tjut N.A. Jacoeb ◽  
Endi Novianto ◽  
Wresti Indriatmi ◽  
Rahadi Rihatmadja ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinical Manifestations ◽  
Effective Treatment Option ◽  
Psoriasis Area Severity Index ◽  
Double Blind ◽  
Old Patients ◽  
Mean Values ◽  
Significant Difference ◽  
Curcuma Xanthorrhiza ◽  
The Difference

Background: Curcuma xanthorrhiza Roxb. exerts its anti-inflammatory effects by reducing the concentration of IL-6, IL-8, and phosphorylase kinase, which has role in keratinocyte proliferation. Our study aimed to evaluate the efficacy of C. xanthorrhiza in psoriasis.Methods: From 18 to 59 year-old patients with mild psoriasis, 2 similar lesions were selected. The severity assessment was based on the psoriasis area severity index (PASI), Trozak score, and K6 expression. Using a double-blinded randomized method, lesion was treated with 1% C. xanthorrhiza ointment vs placebo for 4 weeks. The results were analyzed by the chi-square test using STATATM V.12 software (Stata Corp.).Results: The study was conducted in 2010 to 2012 with 17 subjects participated. The median of PASI score were reduced significantly in both lesions, either treated with 1% C. xanthorrhiza ointment vs placebo; however when compared between the group, it was not significant (p=0.520). The Trozak score were reduced in lesions treated with 1% C. xanthorrhiza ointment; but it was not significant (p = 0.306). In lesions treated with placebo, the Trozak score was increased significantly. The difference of Trozak score between lesions treated with C. xanthorrhiza and placebo was significant (p=0.024). There was no significant difference of K6 expression in lesions treated with 1% C. xanthorrhiza ointments or placebo as well as on the difference of mean values of K6 expression between the group (p=0.827).Conclusion: Based on the results, 1% C. xanthorrhiza ointment is effective treatment option for mild psoriasis, but longer follow-up period is suggested to confirm this results. C. xanthorrhiza ointment is safe for topical administration as there were no side effects reported in this study.

scholarly journals Mirror therapy for phantom limb and stump pain: a randomized controlled clinical trial in landmine amputees in Cambodia

2018 ◽  
Vol 18 (4) ◽  
pp. 603-610 ◽  
Author(s):  
Ha Sam Ol ◽  
Yang Van Heng ◽  
Lena Danielsson ◽  
Hans Husum
Keyword(s):  
Low Income ◽  
Controlled Trial ◽  
Phantom Limb Pain ◽  
Phantom Limb ◽  
Controlled Clinical Trial ◽  
Mirror Therapy ◽  
Randomized Controlled ◽  
Stump Pain ◽  
The Difference ◽  
Therapy Interventions

Abstract Background and aims The aim of the study was to examine the effect of mirror and tactile therapy on phantom and stump pain in patients with traumatic amputations, with particular reference to amputees in low-income communities. Methods The study was conducted with an open, randomized, semi-crossover case-control design in rural Cambodia. A study sample of 45 landmine victims with trans-tibial amputations was allocated to three treatment arms; mirror therapy, tactile therapy, and combined mirror-and-tactile therapy. Non-responders from the mono-therapy interventions were crossed over to the alternative intervention. The intervention consisted of 5 min of treatment every morning and evening for 4 weeks. Endpoint estimates of phantom limb pain (PLP), stump pain, and physical function were registered 3 months after the treatment. Results All three interventions were associated with more that 50% reduction in visual analogue scale (VAS)-rated PLP and stump pain. Combined mirror-tactile treatment had a significantly better effect on PLP and stump pain than mirror or tactile therapy alone. The difference between the three treatment arms were however slight, and hardly of clinical relevance. After treatment, the reduction of pain remained unchanged for an observation period of 3 months. Conclusions The study documents that a 4-week treatment period with mirror and/or tactile therapy significantly reduces PLP and stump pain after trans-tibial amputations. Implications The article reports for the first time a randomized controlled trial of mirror therapy in a homogenous sample of persons with traumatic amputations. The findings are of special relevance to amputees in low-resource communities.

Citation Advantage of Promoted Articles in a Cross-Publisher Distribution Platform: 36-month Follow-up to a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Paul Kudlow ◽  
Tashauna Brown
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Digital Tool ◽  
Randomized Controlled ◽  
Subject Areas ◽  
The Subject ◽  
The Difference ◽  
Citation Advantage

BACKGROUND There are limited evidence-based strategies that have been shown to increase the rate at which peer-reviewed articles are cited. In a previously reported randomized controlled trial we demonstrated that promotion of article links in an online cross-publisher distribution platform (TrendMD) persistently augments citation rates after 12 months, leading to a statistically significant, 50% increase in citations relative to control. OBJECTIVE To investigate if the citation advantage of promoted articles upholds after 36-months. METHODS Three thousand two hundred articles published in 64 peer-reviewed journals across eight subject areas were block randomized at the subject level to either the TrendMD group (n=1600) or the control group (n=1600) of the study. Articles were promoted in the TrendMD Network for 6 months. We compared the citation rates in both groups after 36 months. RESULTS At 36 months, we found the citation advantage endured; articles randomized to TrendMD showed a 28% increase in mean citations relative to control. The difference in mean citations at 36 months for articles randomized to TrendMD versus control was 10.52, 95% CI [3.79, 17.25] and was statistically significant (p=0.001). CONCLUSIONS To our knowledge, this is the first randomized controlled trial to demonstrate how a post-publication article promotion intervention can be used to persistently augment citations of peer-reviewed articles. TrendMD is an efficient digital tool for knowledge translation and dissemination to targeted audiences to facilitate uptake of research.

P-681 Will the hCG trigger dose used for final oocyte maturation in IVF impact endogenous progesterone during the luteal phase? - A randomized controlled trial

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
L Svenstrup ◽  
J Fedder ◽  
S Möller ◽  
D Pedersen ◽  
K Erb ◽  
...  
Keyword(s):  
Oocyte Maturation ◽  
Luteal Phase ◽  
Controlled Trial ◽  
University Hospital ◽  
Final Oocyte Maturation ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Significant Difference ◽  
Hcg Trigger ◽  
Group 1

Abstract Study question Is there an association between the hCG dose used for ovulation trigger and the endogenous progesterone production during the luteal phase? Summary answer Increased hCG dosing significantly increased the endogenous progesterone level during the luteal phase. What is known already During the luteal phase of an IVF treatment, the endogenous progesterone (P4) production is negatively impacted due to reduced circulating endogenous LH, caused by negative feed-back of elevated steroids; thus, luteal phase support (LPS) with exogenous P4 remains mandatory in IVF. Apart from inducing final oocyte maturation, the gold standard HCG trigger also functions as an early LPS, boosting P4 production by the corpora lutea (CL). P4 plays a pivotal role for embryo implantation and pregnancy, and an optimal P4 level around peri-implantation seems to be essential for the reproductive outcomes of fresh and frozen/thaw embryo transfer cycles. Study design, size, duration A randomized controlled 4-arm study, including a total of 127 IVF patients, enrolled from January 2015 until September 2019 at the Fertility Clinic, Odense University Hospital, Denmark. Participants/materials, setting, methods IVF patients with ≤ 11 follicles ≥ 12 mm were randomized to four groups. Groups 1-3 were triggered with: 5.000 IU, 6.500 IU or 10.000 IU, hCG, respectively, receiving a LPS consisting of 17-α-hydroxy-progesterone (17α OH P4) to distinguish the endogenous P4 from the exogenous supplementation. Group 4 (control) was randomized to a 6.500 IU hCG trigger and standard LPS. A total of eight blood samples were drawn during the early luteal phase. Main results and the role of chance A total of 94 patients completed the study: 21, 22, 25 and 26 patients in each group, respectively. Baseline characteristics were similar, except for the endogenous LH level and cycle lengths. There were no significant differences between groups regarding ovarian stimulation, number of oocytes and embryos. The median number of follicles ≥ 12mm on the day of trigger was 8.5, resulting in 6.6 oocytes being retrieved. Significant differences in P4 levels were seen at OPU+8 (p &lt; 0.001), OPU+10 (p &lt; 0.001) and OPU+14 (p &lt; 0.001), with positive correlations between P4 level and hCG dose. Groups compared individually showed significant difference in P4 between low and high trigger dose at OPU+4 group 1 and 3 (p = 0.037) and OPU+8 group 1 and 3 (p = 0.007) and between all the three groups around implantation at OPU+6 group 1 and 2 (p = 0.011), group 2 and 3 (p = 0.042) and group 1 and 3 (p &lt; 0.001). Higher P4 levels around implantation were related to follicle count and to pregnancy. After logistic regression analyses there were still significant individual differences between the groups. Limitations, reasons for caution Although patients were randomized and strict inclusion and exclusion criteria were used, the RCT was un-blinded, including a relatively small number of patients. Moreover, for dosing purposes urinary hCG as well as recombinant hCG was used and pharmacokinetics differ. Finally, the P4 level could be influenced by circadian fluctuations. Wider implications of the findings This is the first study to explore dose-responses in circulating P4 after hCG trigger in IVF patients. Increasing the hCG trigger dose increased the endogenous P4 around peri-implantation. Personalizing the hCG trigger dose could be a key point to secure the most optimal P4 mid-luteal phase P4 level. Trial registration number Eudract 2013-003304-39

scholarly journals Treament and prevention of anemia with ferrous sulfate plus folic acid in children attending daycare centers in Goiânia, Goiás State, Brazil: a randomized controlled trial

2008 ◽  
Vol 24 (suppl 2) ◽  
pp. s259-s271 ◽  
Author(s):  
Maria Claret Costa Monteiro Hadler ◽  
Dirce Maria Sigulem ◽  
Maria de Fátima Costa Alves ◽  
Vinícius Montenegro Torres
Keyword(s):  
Folic Acid ◽  
Ferrous Sulfate ◽  
Controlled Trial ◽  
Acid Group ◽  
Hemoglobin Level ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Daycare Centers ◽  
Randomized Controlled

The objective of this study was to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid. A double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia, Goiás State, Brazil. The children were assigned to two treatment groups that received a daily dose (5 times a week) of either 4.2mg/kg/day of ferrous sulfate + folic acid (50µg) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo. One of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid (50µg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo. Supplementation lasted approximately three months. Baseline anemia prevalence was 56.1% (95%CI: 48.9-63.1). After treatment, anemia prevalence in the folic acid group (14%) was lower than in the placebo group (34.9%) (p = 0.02). After prophylaxis in the non-anemic children, the incidence of anemia did not differ between the groups, but there was an increase in hemoglobin level in the folic acid group (p = 0.003). Iron plus folic acid was effective for the treatment of anemia and improvement of hemoglobin level in non-anemic children.

Sign in / Sign up

Export Citation Format

Share Document