scholarly journals Rapid initiation of nasal saline irrigation to reduce morbidity and mortality in COVID+ outpatients: a randomized clinical trial compared to a national dataset

2021 ◽  
Author(s):  
Amy L. Baxter ◽  
Kyle R. Schwartz ◽  
Ryan W. Johnson ◽  
Ann-Marie Kuchinski ◽  
Kevin M. Swartout ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Conflict Of Interest ◽  
Povidone Iodine ◽  
Morbidity And Mortality ◽  
Saline Irrigation ◽  
Nasal Irrigation ◽  
Link Type ◽  
Phone Calls ◽  
Significant Difference

AbstractImportanceSARS-CoV-2 enters the nasopharynx to replicate; mechanical debridement with nasal irrigation soon after diagnosis could reduce morbidity and mortality.ObjectiveTo determine whether initiating nasal irrigation after COVID-19 diagnosis reduces hospitalizations and death, and whether irrigant composition impacts severity.DesignUnblinded randomized clinical trial of two nasal irrigation protocols in outpatients PCR positive for SARS-CoV-2, nested in a prospective case:cohort using laboratory-confirmed cases in the CDC COVID-19 Case Surveillance dataset.SettingSingle-lab community testing facility associated with the emergency department (ED) in Augusta, GA.ParticipantsA consecutive sample of outpatients 55 years and older were contacted from daily COVID-19+ lab reports between September 24 and December 21 of 2020. Patients without supplemental oxygen use or cognitive barriers agreeing to same-day irrigation initiation were remotely consented. Among 826 screened, 321 were unable to be reached, 132 were ineligible, 294 refused participation, and 79 participants were enrolled.InterventionsParticipants were randomly assigned adding 2.5 mL povidone-iodine 10% or 2.5 mL sodium bicarbonate to 240ml of isotonic nasal irrigation twice daily for 14 days.Main Outcomes and MeasuresThe primary outcome was hospitalization or death from COVID-19 within 28 days of enrollment by daily self-report confirmed with phone calls and hospital records, compared to the CDC Surveillance Dataset covering the same time. Secondary outcomes compared symptom resolution by irrigant additive.ResultsSeventy-nine participants were enrolled (mean [SD] age, 64 [8] years; 36 [46%] women; 71% Non-Hispanic White). Analyzed by intention-to-treat, by day 28, COVID-19 symptoms resulted in 1/42 hospitalizations in those irrigating with alkalinization, 0/37 in the povidone-iodine group, (1.27%) and no deaths. Of nearly three million CDC cases, 9.14% were known to be hospitalized, with an additional 1.5% mortality in those without hospitalization data. The total risk of hospitalization or death (10.6%) was 8.4 times that of enrolled patients (SE=2.74; P=.006). 62 completed daily surveys (78%), averaging 1.8 irrigations/day. Eleven had irrigation complaints, and four discontinued. There were no significant differences by additive.ConclusionSARS-CoV-2+ participants initiating nasal irrigation were over 8 times less likely to be hospitalized than the national rate.Trial RegistrationClinicalTrial.gov Identifier: NCT04559035Author ApprovalAll authors have filled out ICMJE and approved submission.Conflict of Interest StatementMaterials were provided by Neilmed Inc. and Rhinosystems Inc. The study was supported by funding from the Bernard and Anne Gray Donor Advised Fund Community Foundation for Greater Atlanta, Neilmed Inc., and Rhinosystems. No authors have conflict of interest.Key PointsQuestionAfter testing positive for COVID-19, will rapidly initiating nasal irrigation with alkaline or povidone-iodine isotonic solution reduce the risk of morbidity and mortality compared to a national dataset?FindingsIn this randomized trial of 79 older adults nested in a case:control with the CDC COVID-19 National Dataset, 1.27% of participants initiating nasal irrigation were hospitalized or died, compared to 10.6%, a significant difference.MeaningIn older outpatients testing positive for SARS-CoV-2 who initiated nasal irrigation rapidly after diagnosis, risk of hospitalization or death was eight times lower than national rates reported by the CDC.

scholarly journals Comparison of effect of auriculotherapy and mefenamic acid on the severity and systemic symptoms of primary dysmenorrhea: a randomized clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Masoomeh Vahedi ◽  
Seyedeh Batool Hasanpoor-Azghady ◽  
Leila Amiri-Farahani ◽  
Imaneh Khaki
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Randomized Clinical Trial ◽  
Mefenamic Acid ◽  
Acid Group ◽  
Primary Dysmenorrhea ◽  
Link Type ◽  
Significant Difference ◽  
Grade 3 ◽  
Systemic Symptoms

Abstract Background Primary dysmenorrhea (PD) is the most common complaint in young women and adolescents. Side effects of non-steroidal anti-inflammatory drugs can limit their use. Therefore, non-pharmacological pain relief methods such as auriculotherapy may play an important role in PD management. This study was conducted to compare the effect of auriculotherapy and mefenamic acid on the severity and systemic symptoms of PD. Methods In a randomized clinical trial, 83 students were randomized into two groups. In the auriculotherapy group, electrical stimulation of the ear was conducted once a week for two menstrual cycles. In each cycle close to menstruation, ear seeds were inserted on pressure points to be pressed in times of pain. In the mefenamic acid group, subjects took mefenamic acid capsules upon seeing the initial symptoms of menstruation until the pain reduces. The primary outcomes were mean pain intensity and systemic symptoms associated with it. Pain intensity was measured through the visual analog scale (VAS) and the verbal multidimensional scoring system (VMS). Systemic symptoms were assessed using VMS, as well as the yes/no question form. Results Mean pain intensity with the VAS was significantly lower in the auriculotherapy group than the mefenamic acid group in the first and second cycles of intervention. There was a significant difference in VMS grade between both groups during the second cycle of intervention. In terms of the systemic symptoms in the second cycle of intervention, no subjects had dysmenorrhea grade 3 (common systemic symptoms) in the auriculotherapy group. Whereas in the mefenamic acid group, 16.7% of the subjects still had dysmenorrhea grade 3. There was no significant difference between the two groups in the frequency of systemic symptoms of PD. There was a significant decrease in the frequency of fatigue and diarrhea in both groups. However, there was a significant reduction in the frequency of nausea, headache, and anger in the auriculotherapy group. Conclusion Mean pain intensity with the VAS was lower with the auriculotherapy. Also, 65.9% of auriculotherapy group subjects were in the dysmenorrhea grades 0 and 1. Therefore, auriculotherapy is recommended because of its fewer complications and more effect on PD. Trial registration ClinicalTrials.gov IRCT20181207041873N1. Registered on February 24, 2019. https://en.irct.ir/user/trial/35967/view

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

Complications and surgical results of stone-directed antegrade pyelography compared to the retrograde pyelographic access method in percutaneous nephrolithotomy using ‘bull’s eye’ technique: A randomized clinical trial

2021 ◽  
pp. 205141582199372
Author(s):  
Dariush Irani ◽  
Abdolreza Haghpanah ◽  
Mohammad Mehdi Hosseini ◽  
Leila Malekmakan ◽  
Mohammad Ali Ashraf ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Percutaneous Nephrolithotomy ◽  
Renal Stones ◽  
Surgical Results ◽  
Retrograde Pyelography ◽  
Antegrade Approach ◽  
Antegrade Pyelography ◽  
Significant Difference ◽  
Bull's Eye

Objectives: This study aimed to evaluate the differences in outcomes and complications in stone-directed antegrade pyelography using the ‘bull’s eye’ technique in patients with renal stones versus the conventional method of percutaneous nephrolithotomy (PCNL). Although conventional PCNL access using retrograde pyelography is useful, it is time-consuming and may cause postoperative discomfort. Herein, we report our experience in the application of this new technique. Methods: Between January 2017 and June 2018, 100 patients participated in this randomized clinical trial. Stone-directed antegrade pyelography using the ‘bull’s eye’ technique under fluoroscopic guidance was used for percutaneous access in the intervention group. The second group, consisting of those who had undergone conventional PCNL using retrograde pyelography and ‘bull’s eye’ technique in the same period, were considered as the controls. Pre- and postoperative laboratory examinations, surgical results and complications were recorded and compared between the two groups. Results: A single calyceal puncture in partial staghorn and staghorn stone patients was sufficient in 72.2% of the antegrade group and in 78.9% of the retrograde group ( p=0.69). The double-puncture technique was necessary for 71.9% of renal pelvis stones in the antegrade group and for 9.4% in the retrograde group ( p<0.001). The antegrade approach reduced the mean operative time and analgesic requirement significantly ( p<0.001). No statistically significant difference, however, was found between the two groups regarding stone migration to the ureter, radiation time and postoperative complications. Conclusions: The stone-directed antegrade approach using the ‘bull’s eye’ technique is a safe and accurate method in PCNL access in patients with radiopaque and semi-opaque renal stones.

scholarly journals A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Christine Elizabeth Jones ◽  
Anna Calvert ◽  
Jo Southern ◽  
Mary Matheson ◽  
Nick Andrews ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Pertussis Toxin ◽  
Geometric Mean ◽  
Control Group ◽  
Primary Immunization ◽  
Link Type ◽  
In Pregnancy ◽  
Pertussis Antigens ◽  
Phase Iv

Abstract Background Pertussis vaccines containing three or five pertussis antigens are recommended in pregnancy in many countries, but no studies have compared the effect on infants’ antigen-specific immunoglobulin G (IgG) concentrations. The aim of this study was to compare anti-pertussis IgG responses following primary immunization in infants of mothers vaccinated with TdaP5-IPV (low dose diphtheria toxoid, tetanus toxoid, acellular pertussis [five antigens] and inactivated polio) or TdaP3-IPV in pregnancy (three pertussis antigens). Methods This multi-centre phase IV randomized clinical trial was conducted in a tertiary referral centre and primary care sites in England. Women were randomized to receive TdaP5-IPV (n = 77) or TdaP3-IPV (n = 77) at 28–32 gestational weeks. A non-randomized control group of 44 women who had not received a pertussis-containing vaccine in pregnancy and their 47 infants were enrolled post-partum. Results Following infant primary immunization, there was no difference in the geometric mean concentrations (GMCs) of anti-pertussis toxin, filamentous haemagglutinin or pertactin IgG between infants born to women vaccinated with TdaP5-IPV (n = 67) or TdaP3-IPV (n = 63). However, the GMC of anti-pertussis toxin IgG was lower in infants born to TdaP5-IPV- and TdaP3-IPV-vaccinated mothers compared to infants born to unvaccinated mothers (n = 45) (geometric mean ratio 0.71 [0.56–0.90] and 0.78 [0.61–0.98], respectively); by 13 months of age, this difference was no longer observed. Conclusion Blunting of anti-pertussis toxin IgG response following primary immunization occurs in infants born to women vaccinated with TdaP5-IPV and TdaP3-IPV, with no difference between maternal vaccines. The blunting effect had resolved by 13 months of age. These results may be helpful for countries considering which pertussis-containing vaccine to recommend for use in pregnancy. Trial registration ClinicalTrials.gov, NCT02145624, registered 23 May 2014

Dance Rhythms Improve Motor Symptoms in Individuals with Parkinson’s Disease: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Jéssica A. Moratelli ◽  
Kettlyn H. Alexandre ◽  
Leonessa Boing ◽  
Alessandra Swarowsky ◽  
Clynton L. Corrêa ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Clinical Trial ◽  
Parkinson's Disease ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Freezing Of Gait ◽  
Motor Symptoms ◽  
Score Change ◽  
Significant Difference ◽  
Binary Group

Background: Evidence-based practices involving dance modalities found in binary (two-beat rhythm) or quaternary (four-beat rhythm) show that dance positively influences the motor aspects of disease.Aim: This randomized clinical trial aimed to analyze the effect of two dance rhythm (binary and quaternary) on the balance, gait, and mobility in individuals with Parkinson’s disease (PD). Methods: Thirty-one individuals with PD were randomized into the binary group (n = 18) and the quaternary group (n = 13). Both groups participated in different dance rhythms lasting 12 weeks, twice a week, for 45 minutes. Results: The binary group showed a significant difference in balance (p = 0.003), freezing of gait (p = 0.007), as well as in the motor aspects of MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), with emphasis on the total values with a score change of 3.23. In the quaternary group, significant differences were found in balance (p = 0.021) with a score change of -2.54 and in the motor aspects of the MDS-UPDRS Part III where the total values stood out with a change of 3.54. Discussion: When comparing the possible effects of binary and quaternary rhythms on the motor symptoms of individuals with PD, it was demonstrated that binary rhythm improved balance, freezing gait, and UPDRSIII. As for the quaternary rhythm, the benefits were in balance and the UPDRSIII. Conclusion: The binary and the quaternary rhythm dance protocols positively influenced the motor symptoms of individuals with PD after 12 weeks of intervention.

scholarly journals Effect of Acupressure on Stress and Anxiety of Patients with Multiple Sclerosis: A Sham-controlled Randomized Clinical Trial

2020 ◽  
Vol 10 (3) ◽  
pp. 270-283
Author(s):  
Mohammad Ali Nahayati ◽  
◽  
Seyed Abolfazl Vaghar Seyyedin ◽  
Hamid Reza Bahrami-Taghanki ◽  
Zahra Rezaee ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Test Scores ◽  
Sham Group ◽  
Applied Pressure ◽  
Intervention Group ◽  
T Test ◽  
Significant Difference ◽  
The Mean

Objective: Stress and anxiety are common in patients with Multiple Sclerosis (MS). These complications exacerbate the symptoms of MS. This study aims to evaluate the effect of acupressure on stress and anxiety of MS patients. Methods: In this randomized clinical trial, participants were 106 MS Patients referred to Multiple Sclerosis Society in Mashhad, Iran. After signing an informed consent form, they completed a demographic form and stress, and the Depression Anxiety Stress Scale - 42 items (DASS-42). Then, they were randomly assigned into intervention and sham groups by tossing a coin. Participants in the intervention group were asked apply a pressure on the Shenmen and Yin Tang acupoints for one month (once per day for 15 minutes), while the sham group applied pressure 2.5 cm below the Shenmen acupoint and 3 cm above the Yin Tang acupoint. Participants in each group were then completed the DASS-42 again one hour after the final session. Data were analyzed using chi-square test, Kolmogorov-Smirnov test, independent t-test, and Paired t-test. Results: In the intervention and sham groups, there was no statistically significant difference between the mean pre-test scores of stress (34.73±5.80 vs. 33.06±6.42) and anxiety (27.09±6.99 vs. 25.31±6.88), and neither between the mean post-test scores of stress (29.20±6.21 vs. 33.73±9.44) and anxiety (22.79±5.68 vs. 25.21±6.72) (P>0.05). However, comparison of DASS-42 scores between groups showed that the mean scores of stress and anxiety in the intervention group were significantly lower than in the sham group (P< 0.05). Conclusion: It seems that acupressure can be used along with other therapeutic and pharmacological interventions to reduce stress and anxiety in patients with MS.

scholarly journals Shear Bond Strength of Brackets Bonded with Self-Etching Primers Compared to Conventional Acid-Etch Technique: A Randomized Clinical Trial

2019 ◽  
Author(s):  
Nasrin Farhadian ◽  
Amirfarhang Miresmaeili ◽  
Vahid Shahidi Zandi
Keyword(s):  
Clinical Trial ◽  
Bond Strength ◽  
Randomized Clinical Trial ◽  
Shear Bond Strength ◽  
Allocation Concealment ◽  
Wilcoxon Test ◽  
Adhesive Remnant Index ◽  
Significant Difference ◽  
Acid Etch ◽  
Registration Number

Objectives: The purpose of this randomized clinical trial (RCT) was to compare the shear bond strength (SBS) of orthodontic brackets bonded to enamel with conventional acid-etch (AE) technique and self-etching primers (SEP). Materials and Methods: Twenty-two patients, requiring extraction of two bicuspids for orthodontic reasons, were recruited. In each individual, following blinding and allocation concealment, one intact premolar received conventional AE, whereas the contralateral premolar received SEP with a split-mouth design. Bonded brackets remained in the oral cavity for two months. Afterward, the teeth were extracted without debonding the brackets. SBS and adhesive remnant index (ARI) were measured using a Universal Instron machine and a stereomicroscope, respectively. Results: The mean SBS of the conventional AE and SEP groups was 9.53 and 9.20 MPa, respectively. Paired t-test showed no statistically significant difference between the two groups (P=0.096). Comparison of ARI between the two groups, using Wilcoxon test, indicated that significantly less adhesive remained on enamel with brackets bonded with SEP compared to brackets bonded with conventional AE (P<0.001) although the SBS was higher in the AE group. Conclusion: The present study indicated that although there is no significant difference in SBS between SEP and conventional AE for bonding orthodontic metal brackets, the amount of residual adhesive on the enamel surface is significantly less with SEP than with conventional AE. (IRCT registration number: IRCT201705099086N3).

scholarly journals O12 OPEN PREPERITONEAL INGUINAL HERNIA REPAIR, TREPP VERSUS TIPP IN A RANDOMIZED CLINICAL TRIAL

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
Willem Bökkerink ◽  
Giel Koning ◽  
Patrick Vriens ◽  
Roland Mollen ◽  
Willem Akkersdijk ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inguinal Hernia ◽  
Hernia Repair ◽  
Learning Curve ◽  
Randomized Clinical Trial ◽  
Inguinal Hernia Repair ◽  
Recurrence Rates ◽  
Significant Difference ◽  
Related Quality

Abstract Aim The preperitoneal mesh position for inguinal hernia repair showed beneficial results regarding Chronic Postoperative Inguinal Pain (CPIP) with low recurrence rates. Two open preperitoneal techniques, the TransREctus Sheath PrePeritoneal (TREPP) and the TransInguinal PrePeritoneal (TIPP) technique, were compared in a randomized clinical trial with the hypothesis of less patients with CPIP after TREPP due to complete avoidance of nerve contact. Materials and Methods Adult patients with a primary unilateral inguinal hernia were randomized to either TREPP or TIPP in four hospitals. Prior to the trial’s start the study protocol was ethically approved and published. Outcomes included CPIP after 1 year (primary outcome) and recurrence rates, adverse events and Health related Quality of Life (secondary outcomes). Follow-up was performed at 2 weeks, 6 months and 1 year. Results Baseline characteristics were comparable in both groups. Pain was less often present after TREPP at 2 weeks and 6 months, but the CPIP at rest at 1 year was comparable 1.9% after TREPP vs 1.4% after TIPP, p = 0.535). The overall recurrence rate was higher in the TREPP group, 8.9% vs 4.6%, p = 0.022). Corrected for a learning curve for TREPP, no significant difference could be assessed (TREPP 5.7% and TIPP 4.8%, p = 0.591). Conclusions both the TREPP and TIPP technique resulted in a low incidence of CPIP after 1 year follow-up. The TREPP method can be considered a solid method for inguinal hernia repair if expertise is present. The learning curve of the TREPP techniques needs further evaluation.

scholarly journals Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

2021 ◽  
Author(s):  
Maj Siercke ◽  
Sanne Pagh Moller ◽  
Lau Caspar Thygesen ◽  
Henrik Sillesen ◽  
Dorthe Overgaard
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Clinical Trial ◽  
Mixed Methods ◽  
Usual Care ◽  
Randomized Clinical Trial ◽  
Intermittent Claudication ◽  
Walking Distance ◽  
Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

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