scholarly journals Evaluation of safety and immunogenicity of a group A streptococcus vaccine candidate (MJ8VAX) in a randomized clinical trial

PLoS ONE ◽  
2018 ◽  
Vol 13 (7) ◽  
pp. e0198658 ◽  
Author(s):  
Silvana Sekuloski ◽  
Michael R. Batzloff ◽  
Paul Griffin ◽  
William Parsonage ◽  
Suzanne Elliott ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Vaccine Candidate ◽  
Group A Streptococcus ◽  
Group A

scholarly journals Telemanagement of Home-Isolated COVID-19 Patients Using Oxygen Therapy With Noninvasive Positive Pressure Ventilation and Physical Therapy Techniques: Randomized Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Aya Sedky Adly ◽  
Mahmoud Sedky Adly ◽  
Afnan Sedky Adly
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Physical Therapy ◽  
Randomized Clinical Trial ◽  
Health Care System ◽  
Oxygen Therapy ◽  
Early Stage ◽  
Home Based ◽  
Group A ◽  
Group B

BACKGROUND With the growing stress on hospitals caused by the COVID-19 pandemic, the need for home-based solutions has become a necessity to support these overwhelmed hospitals. OBJECTIVE The goal of this study was to compare two nonpharmacological respiratory treatment methods for home-isolated COVID-19 patients using a newly developed telemanagement health care system. METHODS In this single-blinded randomized clinical trial, 60 patients with stage 1 pneumonia caused by SARS-CoV-2 infection were treated. Group A (n=30) received oxygen therapy with bilevel positive airway pressure (BiPAP) ventilation, and Group B (n=30) received osteopathic manipulative respiratory and physical therapy techniques. Arterial blood gases of PaO<sub>2</sub> and PaCO<sub>2</sub>, pH, vital signs (ie, temperature, respiratory rate, oxygen saturation, heart rate, and blood pressure), and chest computed tomography scans were used for follow-up and for assessment of the course and duration of recovery. RESULTS Analysis of the results showed a significant difference between the two groups (<i>P</i>&lt;.05), with Group A showing shorter recovery periods than Group B (mean 14.9, SD 1.7 days, and mean 23.9, SD 2.3 days, respectively). Significant differences were also observed between baseline and final readings in all of the outcome measures in both groups (<i>P</i>&lt;.05). Regarding posttreatment satisfaction with our proposed telemanagement health care system, positive responses were given by most of the patients in both groups. CONCLUSIONS It was found that home-based oxygen therapy with BiPAP can be a more effective prophylactic treatment approach than osteopathic manipulative respiratory and physical therapy techniques, as it can impede exacerbation of early-stage COVID-19 pneumonia. Telemanagement health care systems are promising methods to help in the pandemic-related shortage of hospital beds, as they showed reasonable effectiveness and reliability in the monitoring and management of patients with early-stage COVID-19 pneumonia. CLINICALTRIAL ClinicalTrials.gov NCT04368923; https://clinicaltrials.gov/ct2/show/NCT04368923

scholarly journals Immunogenicity and Safety of a Chemically Synthesized Divalent Group A Streptococcal Vaccine

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Yongxiang Wu ◽  
Suhua Li ◽  
Yanting Luo ◽  
Yunyue Zhao ◽  
Jiarui Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Amino Acids ◽  
Survival Rate ◽  
Protective Effect ◽  
Health Problem ◽  
Group A Streptococcus ◽  
Peptide Vaccine ◽  
Effective Vaccine ◽  
Histopathological Analysis ◽  
Group A

Background. Group A streptococcus (GAS) infections and poststreptococcal sequelae remain a health problem worldwide, which necessitates searching for an effective vaccine, while no licensed GAS vaccine is available. We have developed a divalent peptide vaccine composed of 84 amino acids to cover the main GAS serotypes (M1 and M12 streptococci) in China, and herein, we aimed to evaluate immunogenicity and safety of this vaccine.Methods. Mice were immunized with the vaccine. ELISA, indirect bactericidal test, and immunofluorescent assay were used to study immunogenicity. GAS challenge assay was used to test the protective effect. Safety was tested by histopathological analysis.Results. Immunized group mice (n=16) developed higher titer antibody after immunization than nonimmunized group mice (n=16) did. This antibody can deposit on the surface of GAS and promote killing of GAS, resulting in 93.1% decrease of M1 GAS and 89.5% of M12 GAS. When challenged with M1 and M12 streptococci, immunized group mice had a higher survival rate (87.5% and 75%) than nonimmunized group mice (37.5% and 25%). No autoimmune reactions were detected on organs of mice.Conclusion. The results suggest that this vaccine shows fair immunogenicity and safety, which will lead our research on GAS vaccine into clinical trial.

scholarly journals Disappointment and adherence among parents of newborns allocated to the control group: a qualitative study of a randomized clinical trial

Trials ◽  
2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Sandra Meinich Petersen ◽  
Vibeke Zoffmann ◽  
Jesper Kjærgaard ◽  
Lone Graff Steensballe ◽  
Gorm Greisen
Keyword(s):  
Clinical Trial ◽  
Qualitative Study ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Group A

scholarly journals Comparison of the effect of Chamomile and Mefenamic Acid on primary dysmenorrhea, associated symptoms and menstrual bleeding – A randomized clinical trial study

2020 ◽  
Author(s):  
Fatemeh Shabani ◽  
Katayon Vakilian ◽  
Fereshteh Narenji ◽  
Mahbubeh Bozorgi ◽  
Soodabeh Bioos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Mefenamic Acid ◽  
Statistical Tests ◽  
Primary Dysmenorrhea ◽  
Verbal Scale ◽  
Associated Symptoms ◽  
Ethics Code ◽  
Group A ◽  
Group B

Abstract Background Dysmenorrhea is one of the most common pelvic pains in women, impairing their quality of life.This study investigated the effects of chamomile sachet and mefenamic acid on primary dysmenorrhea, associated symptoms and bleeding. Methods In this randomized clinical trial, 200 female students with primary dysmenorrhea from Arak universities were randomly assigned to two groups. The group (A) received mefenamic acid (250 mg) and group (B) received chamomile (5000 mg) plus one teaspoonful of honey )as a flavoring( for two days before up to the first three days of menstruation, three times a day in two consecutive cycles. Pain severity, associated symptoms and bleeding were assessed using visual analog scale, Andersch-Milsom Verbal Scale and Higham chart, respectively. Data were analyzed by descriptive and inferential statistical tests by SPSS 21. Results Severe pain during two months after intervention was in 6 (6.3%) of group (B) and 6 (6.3%) in group (A) (p = 0.351, p = 0.332). Mean severity of associated symptoms two months after the treatment was( 4.93 ± 3.54) in group (B) and (5.62 ± 3.54 ) in group (A), indicating further reduction in group (B) but not significant (p = 0.278). Mean of bleeding was (88.71 ± 66.4 vs. 70.54 ± 53. 34) in group (B) and (A) respectively, in two months later. therefore decrease in the two groups but was not significant between groups(p = 0.567). Conclusions It seems chamomile sachet can reduce the severity of pain and bleeding similar to mefenamic acid and even further mitigate the symptoms associated with dysmenorrhea. Trial registration: This study was performed with the proposal approval code of 2611, ethics code of (ARAKMU.REC.1395.164) at Arak University of medical sciences and code of IRCT 2016100825031N5 on 2016.11.08.

scholarly journals LAND BASED EXERCISES VERSUS POOL BASED EXERCISES FOR SWIMMER’S SHOULDER IN COMPETITIVE SWIMMERS: RANDOMIZED CLINICAL TRIAL

2021 ◽  
Vol 10 (4) ◽  
pp. 3296-3299
Author(s):  
Waqar M. Naqvi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Shoulder Pain ◽  
Pain Disability Index ◽  
Pain Disability ◽  
Significant Difference ◽  
Shoulder Strength ◽  
Group A ◽  
Group B ◽  
Competitive Swimmers

To compare the effect of Land based exercises and Pool based exercises for shoulder strength to reduce shoulder pain in competitive swimmers using Shoulder Pain Disability Index (SPADI) score, Hand-Held dynamometer (HHD), Randomized Clinical trial.29 competitive swimmers with age group between 8 to 18 years were evaluated for shoulder pain using Shoulder Pain Disability Index Score [SPADI] and shoulder strength was evaluated using Hand Held Dynamometer [HHD] before and after the study. Then all the subjects were divided into 2 groups, for Group A Pool based exercises were given and for Group B Land based exercises were given. Statistically there is significant difference in values of outcome measures after the study in both groups but there is more significant difference in Group A than Group B. Pool based exercises showed more significant effect on shoulder pain than land based exercises in swimmer’s shoulder.

scholarly journals Telemanagement of Home-Isolated COVID-19 Patients Using Oxygen Therapy With Noninvasive Positive Pressure Ventilation and Physical Therapy Techniques: Randomized Clinical Trial

10.2196/23446 ◽  
2021 ◽  
Vol 23 (4) ◽  
pp. e23446
Author(s):  
Aya Sedky Adly ◽  
Mahmoud Sedky Adly ◽  
Afnan Sedky Adly
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Physical Therapy ◽  
Randomized Clinical Trial ◽  
Health Care System ◽  
Oxygen Therapy ◽  
Early Stage ◽  
Home Based ◽  
Group A ◽  
Group B

Background With the growing stress on hospitals caused by the COVID-19 pandemic, the need for home-based solutions has become a necessity to support these overwhelmed hospitals. Objective The goal of this study was to compare two nonpharmacological respiratory treatment methods for home-isolated COVID-19 patients using a newly developed telemanagement health care system. Methods In this single-blinded randomized clinical trial, 60 patients with stage 1 pneumonia caused by SARS-CoV-2 infection were treated. Group A (n=30) received oxygen therapy with bilevel positive airway pressure (BiPAP) ventilation, and Group B (n=30) received osteopathic manipulative respiratory and physical therapy techniques. Arterial blood gases of PaO2 and PaCO2, pH, vital signs (ie, temperature, respiratory rate, oxygen saturation, heart rate, and blood pressure), and chest computed tomography scans were used for follow-up and for assessment of the course and duration of recovery. Results Analysis of the results showed a significant difference between the two groups (P<.05), with Group A showing shorter recovery periods than Group B (mean 14.9, SD 1.7 days, and mean 23.9, SD 2.3 days, respectively). Significant differences were also observed between baseline and final readings in all of the outcome measures in both groups (P<.05). Regarding posttreatment satisfaction with our proposed telemanagement health care system, positive responses were given by most of the patients in both groups. Conclusions It was found that home-based oxygen therapy with BiPAP can be a more effective prophylactic treatment approach than osteopathic manipulative respiratory and physical therapy techniques, as it can impede exacerbation of early-stage COVID-19 pneumonia. Telemanagement health care systems are promising methods to help in the pandemic-related shortage of hospital beds, as they showed reasonable effectiveness and reliability in the monitoring and management of patients with early-stage COVID-19 pneumonia. Trial Registration ClinicalTrials.gov NCT04368923; https://clinicaltrials.gov/ct2/show/NCT04368923

scholarly journals Efektivitas terapi komplementer propolis telaah terhadap SGHT dan IL-33 sekret hidung penderita rinitis alergi

2019 ◽  
Vol 49 (1) ◽  
pp. 57
Author(s):  
Yunis Sucipta Ibnu ◽  
Dwi Reno Pawarti ◽  
Mansyur Siddiq Wiyadi
Keyword(s):  
Clinical Trial ◽  
Allergic Rhinitis ◽  
Randomized Clinical Trial ◽  
Standard Therapy ◽  
Nasal Secretion ◽  
Tropical Disease ◽  
Double Blind ◽  
Interleukin 33 ◽  
Group A ◽  
Group B

Latar belakang: Rinitis alergi (RA) adalah inflamasi mukosa hidung yang diperantarai oleh IgE. Gejala dapat dinilai dengan Skor Gejala Hidung Total (SGHT). Patofisiologi dan manifestasi klinis RA dipengaruhi oleh berbagai sitokin diantaranya interleukin 33 (IL-33). Efektivitas propolis maupun flavonoid dalam menurunkan SGHT dan kadar IL-33 sekret hidung masih kontroversi. Tujuan: Membuktikan bahwa penambahan propolis pada terapi komplementer RA lebih efektif menurunkan SGHT dan kadar IL-33 sekret hidung. Metode: Penelitian double blind randomized clinical trial (RCT), dilakukan di Unit Rawat Jalan (URJ) Divisi Alergi Imunologi, Departemen Telinga Hidung Tenggorok-Bedah Kepala Leher (THT-KL) RSUD Dr. Soetomo, dan Institute of Tropical Disease, Universitas Airlangga, Surabaya pada bulan September 2018-Januari 2019. Pasien RA yang memenuhi kriteria inklusi diperiksa SGHT dan kadar IL-33 sekret hidung. Terapi diberikan selama 14 hari, evaluasi SGHT dan kadar IL-33 dilakukan hari ke-15. Hasil: Sepuluh sampel mendapat propolis dan terapi standar (kelompok A), sepuluh sampel mendapat terapi standar (kelompok B). Perbandingan SGHT antar kelompok setelah terapi rerata kelompok A=1,6 (SD 1,7), kelompok B=5,2 (SD 1,6). Uji Mann-Whitney satu arah p=0,001 menunjukkan SGHT antar kelompok setelah terapi berbeda signifikan (p<0,005). Rerata kadar IL-33 setelah terapi kelompok A=0,051 (SD 0,005), kelompok B=0,051 (SD 0,013). Uji t nilai p=0,881 menunjukkan kadar IL-33 sekret hidung antar kelompok setelah terapi berbeda tidak signifikan (p>0,005). Kesimpulan: Penambahan propolis sebagai terapi komplementer lebih efektif dalam menurunkan SGHT dibandingkan dengan terapi standar saja, namun tidak efektif dalam menurunkan kadar IL-33 sekret hidung penderita RA. Background: Allergic rhinitis (AR) is a nasal mucosa inflammation mediated by IgE. The symptoms severity is determined by total nasal symptom score (TNSS). The pathophysiology and clinical manifestations of AR are affected by several cytokines, one of which is interleukin 33 (IL-33). Efficacy of propolis or flavonoid in reducing TNSS and IL-33 level in nasal secretion is still a controversy. Purpose: To find out whether propolis addition to standard therapy could be more effective in reducing TNSS and IL-33 level of nasal secretion. Method: Double blind randomized clinical trial (RCT). The study was conducted at Outpatient unit of Department of Allergic and Immunology, Dr. Soetomo General Hospital, Surabaya and Institute of Tropical Disease (ITD) Universitas Airlangga. Allergic rhinitis patients who met inclusion criteria were examined for TNSS and IL-33 nasal secretion level. Therapy was given for 14 days, after which TNSS and IL-33 levels were evaluated on day 15th. Ten samples received propolis and standard therapy (group A), ten samples received standard therapy only (group B). Result: The comparison of TNSS groups after treatment: mean group A=1.6 (SD 1.7), and mean group B=5.2 (SD 1.6). One way Mann-Whitney test showed p=0.001 indicating the TNSS after treatment was significantly different (p<0.005). The comparison of IL-33: mean group A=0.051(SD=0.005) and mean group B=0.051(SD=0.013), t-test p=0.0881 indicating the IL-33 level of nasal secretion after treatment was not significantly different (p>0.005). Conclusion: Propolis as a complementary therapy was more effective reducing TNSS compared to standard therapy only, but it was not effective in reducing IL-33 level of nasal secretion.

scholarly journals Maternal-fetal acute responses to two moderate-intensity exercise types: a randomized clinical trial

10.3823/2558 ◽  
2018 ◽  
Vol 11 ◽  
Author(s):  
Jousilene de Sales Tavares ◽  
Adriana Suely Oliveira Melo ◽  
Suzana Farias Leite ◽  
Alexandre Sergio Silva ◽  
João Guilherme Alves ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Randomized Clinical Trial ◽  
Fetal Heart Rate ◽  
Fetal Heart ◽  
Moderate Intensity ◽  
Maternal Heart Rate ◽  
Group A ◽  
Exercise Type ◽  
Group B

Objective:  This study aims to compare maternal and fetal responses during two physical exercise types. Design:  A randomized clinical trial compared 120 pregnant women, gestational age of 35-37 weeks, 56 exercising on a stationary bicycle (Group A) and 64 on a treadmill (Group B). Methods: Participants were monitored for three 20-minute phases: resting, exercise and recovery.  Fetal heart rate (FHR) and maternal heart rate (MHR) were monitored.  Glucose and lactate levels were evaluated at rest and during exercise. Results:  After the beginning of exercise, maximum lactate (L) levels were reached at 20 minutes and never exceeded 4 mmol/l.  FHR decreased by 22 bpm during exercise in relation to resting values, irrespective of the exercise type (p<0.001).  Comparing the exercise types, the incidence of bradycardia after 10’ was 23.2% in Group A and 35.9% in Group B (p>0.05), increasing at 20’ to 32% and 40.6%, respectively, (p>0.05).  The FHR decrease during exercise was accompanied by a simultaneous increase in its variability (p<0.001), nevertheless a rapid return to resting values was observed shortly after exercise end.  Glucose decreased in both groups irrespective of the exercise type (85 mg/dl at rest; 79 mg/dl during exercise and 81 mg/dl during recovery; p<0.001). There were no hypoglycemia cases. Conclusions: FHR variability increase and the rapid return to resting values after exercise suggests that the FHR fall and the presence of bradycardia during exercise is the fetal physiologic response to blood flow redistribution, with maintenance of fetal well-being. Key-words: Exercise; fetal heart rate; glucose; maternal heart rate; pregnancy Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01383889.

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