Zataria multiflora affects pulmonary function tests, respiratory symptoms, bronchodilator drugs use and hematological parameters in chronic obstructive pulmonary disease patients: A randomized doubled-blind clinical trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Zataria multiflora is employed as an antitussive, anti-spasmodic, analgesic and etc. Agent in traditional medicine. The modern medical studies are also confirmed effects of this plant for treatment of respiratory problems via anti-inflammatory, anti-oxidant and immunomodulatory properties. AIM OF STUDY: We evaluated efficacy of Z. multiflora on tests of pulmonary function, respiratory symptoms, inhaled bronchodilator drugs use, and hematological factors in COPD patients. METHODS: Patients (n = 45) were randomly grouped in the following three groups: placebo group (P), groups received Z. multiflora extract 3 and 6 mg/kg/day (Z3 and Z6). FEV1 and MEF25-75, respiratory symptoms, inhaled bronchodilator drugs use and hematological factors were evaluated before and 1-2 months after treatment. RESULTS: Z. multiflora led to significant enhancement of FEV1 (p < 0.05 to p < 0.01). Respiratory symptoms were also considerably ameliorated following treatment with extracts for 1 and 2 months compared to baseline values (p < 0.05 to p < 0.001). In groups received extract, inhaled bronchodilator drugs use was remarkably declined at the end of study (both, p < 0.05). Reduction of total WBC was observed 1-2 months after treatment in treated groups with extract compared to baseline values (p < 0.05 to p < 0.001). Neutrophils were remarkably declined in Z3 and Z6 groups after 2-monthes compared to 1-month treatment (p < 0.05 to p < 0.01). CONCLUSION: The evidence show therapeutic effect of this herb on COPD patients which could be result from properties that help to decrease inflammation.

The effects of low calorie, high protein diet on body composition, duration and sleep quality on obese adults: A randomized clinical trial.

Background and Aims: The effects of high-protein diets on regulating sleep have received research attention in recent decades. However, no studies have examined the effects of these diets in obese adults. Therefore, this study was conducted to investigate the effects of low-calorie high protein diets on sleep quality in obese adults. Methods: This study is a randomized clinical trial conducted on 60 obese adults (BMI > 29.9 kg/m2) diagnosed with low-quality sleep. All participants were given a diet with a 750-calorie energy deficit. While the control group was given a normal diet, the intervention group received a diet with 30% more protein. Results: The results showed a significant difference between the control group and intervention group with respect to sleep apnea at 30-, 60-, and 90-day follow-up (p < 0.01). Sleep quality, apnea-hypopnea index (AHI), sleep latency (SL), and polysomnography were significantly different between the two groups (p < 0.05), showing an improvement in sleep quality and obstructive sleep apnea in the intervention group (p < 0.05). Conclusion: This study shows that low-calorie high-protein diets can effectively improve apnea, sleep quality, and body composition indices in obese adults.

The effect of a low-calorie, high-protein diet on psychometric variables in obese individuals: a Randomized Clinical Trial.

INTRODUCTION: The last decade has seen the increased prevalence of obesity as a public health challenge, particularly in low- and middle-income countries. At the same time, studies have shown that there is a two-way relationship between low-calorie diets and depression in obese individuals. This study was designed and implemented to investigate the effect of a low-calorie high-protein diet on psychometric variables in obese individuals. MATERIALS AND METHODS: The present study is a Randomized Clinical Trial. Individuals meeting the inclusion criteria were randomly assigned to either the intervention group (low-calorie diet with increased protein percentage) or the control group (standard protein percentage) using block stratification. Psychometric characteristics of the participants were evaluated using the DASS-21 questionnaire. RESULTS: There were no significant differences in enrollment between the two groups with respect to anthropometric variables, body composition, and physical activity (p-value > .05). Similarly, no significant differences were observed between the two groups in terms of psychological variables (depression, anxiety and stress) (p-value > .05). However, the intervention groups had significantly lower depression and anxiety scores 15 days into the intervention (p-value < .05). After 30 and 60 days of intervention, significant differences were observed between the 2 groups in terms of depression, stress, and anxiety (p-value < .05), indicating a relative improvement in psychometric variables in the intervention group (p-value < .05). CONCLUSION: The results of this study showed that low-calorie diets with a high-protein percentage can significantly improve psychometric variables in obese people.Trial registration: Iranian Registry of Clinical Trials identifier: IRCT20221101056371N1..

rAAV TGF-ß and FGF-2 Overexpression via pNaSS-Grafted PCL Films Stimulates the Reparative Activities of Human ACL Fibroblasts.

Lesions in the human anterior cruciate ligament (ACL) are frequent, unsolved clinical issues due to the limited self-healing ability of the ACL and lack of treatments supporting full, durable ACL repair. Gene therapy guided through the use of biomaterials may steadily activate the processes of repair in sites of ACL injury. The goal of the present study was to test the hypothesis that functionalized poly(sodium styrene sulfonate)-grafted poly(ε-caprolactone) (pNaSS-grafted PCL) films can effectively deliver recombinant adeno-associated virus (rAAV) vectors as a means of overexpressing two reparative factors (transforming growth factor beta-TGF-ß and basic fibroblast growth factor-FGF-2) in primary human ACL fibroblasts. Effective, durable rAAV reporter red fluorescent protein and candidate TGF-ß and FGF-2 gene overexpression was achieved in the cells for at least 21 days, especially when pNaSS-grafted PCL films were used versus control conditions, such as ungrafted films and systems lacking vectors or films (between 1.8- and 5.2-fold differences), showing interactive regulation of growth factor production. The expression of TGF-ß and FGF-2 from rAAV via PCL films safely enhanced extracellular matrix depositions of type-I/-III collagen, proteoglycans/decorin, and tenascin-C (between 1.4- and 4.5-fold differences) in the cells over time with increased levels of expression of the specific transcription factors Mohawk and scleraxis (between 1.7- and 3.7-fold differences) and without the activation of the inflammatory mediators IL-1ß and TNF-α, most particularly with pNaSS-grafted PCL films relative to the controls. This work shows the value of combining rAAV gene therapy with functionalized PCL films to enhance ACL repair.

Advanced Gene Therapy Strategies for the Repair of ACL Injuries.

The anterior cruciate ligament (ACL), the principal ligament for stabilization of the knee, is highly predisposed to injury in the human population. As a result of its poor intrinsic healing capacities, surgical intervention is generally necessary to repair ACL lesions, yet the outcomes are never fully satisfactory in terms of long-lasting, complete, and safe repair. Gene therapy, based on the transfer of therapeutic genetic sequences via a gene vector, is a potent tool to durably and adeptly enhance the processes of ACL repair and has been reported for its workability in various experimental models relevant to ACL injuries in vitro, in situ, and in vivo. As critical hurdles to the effective and safe translation of gene therapy for clinical applications still remain, including physiological barriers and host immune responses, biomaterial-guided gene therapy inspired by drug delivery systems has been further developed to protect and improve the classical procedures of gene transfer in the future treatment of ACL injuries in patients, as critically presented here.

Developing novel liquid biopsy by selective capture of viral RNA on magnetic beads to detect COVID-19.

Objectives: Early, specific, and sensitive detection methods of COVID-19 are essential for force stopping its worldwide infection. Although CT images of the lung and/or viral RNA extraction followed by real-time reverse-transcriptase-polymerase chain reaction (rRT-PCR) are widely used; they have some limitations. Here, we developed a highly sensitive magnetic bead-based viral RNA extraction assay followed by rRT-PCR. Materials and Methods: Case group included oropharyngeal/nasopharyngeal and blood samples from 30 patients diagnosed positive by PCR test for COVID-19 and control group included 30 same samples from COVID-19 negative PCR test individuals. RNA was extracted, using viral RNA extraction kit as well as using our hand-made capture bead-based technique. A one-step cDNA synthesis and Real Time PCR was conducted. A two-step comparison of the different viral RNA extraction methods for oropharyngeal/nasopharyngeal and blood samples was performed. Student t-test was applied with a P<0.05 considered statistically significant. Results: In the case group, all 30 mucosal samples extracted either with viral RNA extraction kit or with beads-based assay were COVID-19 positive although in the latter category, Cqs were much lower. Although 43% of plasma samples extracted by bead-based method were found to be positive but no plasma samples extracted with column-based kit were detected positive by Real Time PCR. Conclusion: Bead-based RNA extraction method can reduce RNA loss by its single-tube performance and enhance the test sensitivity. It is also more sensitive to lower viral loads as shown in the detection of blood samples and the lower Cqs of mucosal samples.

COVID-19 cases, hospitalizations and deaths after vaccination: a cohort event monitoring study, Islamic Republic of Iran.

Objective: To investigate the incidence of coronavirus disease 2019 (COVID-19) cases, hospitalizations and deaths in Iranians vaccinated with either AZD1222 Vaxzevria, CovIran® vaccine, SARS-CoV-2 Vaccine (Vero Cell), Inactivated (lnCoV) or Sputnik V. Methods: We enrolled individuals 18 years or older receiving their first COVID-19 vaccine dose between April 2021 and January 2022 in seven Iranian cities. Participants completed weekly follow-up surveys for 17 weeks (25 weeks for AZD1222) to report their COVID-19 status and hospitalization. We used Cox regression models to assess risk factors for contracting COVID-19, hospitalization and death. Findings: Of 89 783 participants enrolled, incidence rates per 1 000 000 person-days were: 528.2 (95% confidence interval, CI: 514.0-542.7) for contracting COVID-19; 55.8 (95% CI: 51.4-60.5) for hospitalization; and 4.1 (95% CI: 3.0-5.5) for death. Compared with SARS-CoV-2 Vaccine (Vero Cell), hazard ratios (HR) for contracting COVID-19 were: 0.70 (95% CI: 0.61-0.80) with AZD1222; 0.73 (95% CI: 0.62-0.86) with Sputnik V; and 0.73 (95% CI: 0.63-0.86) with CovIran®. For hospitalization and death, all vaccines provided similar protection 14 days after the second dose. History of COVID-19 protected against contracting COVID-19 again (HR: 0.76; 95% CI: 0.69-0.84). Diabetes and respiratory, cardiac and renal disease were associated with higher risks of contracting COVID-19 after vaccination. Conclusion: The rates of contracting COVID-19 after vaccination were relatively high. SARS-CoV-2 Vaccine (Vero Cell) provided lower protection against COVID-19 than other vaccines. People with comorbidities had higher risks of contracting COVID-19 and hospitalization and should be prioritized for preventive interventions.

A telemonitoring system to support CPAP therapy in patients with obstructive sleep apnea: a participatory approach in analysis, design, and evaluation.

BACKGROUND: Continues positive airway pressure (CPAP) therapy is a gold standard treatment for moderate to severe cases of OSA (obstructive sleep apnea). The present research aimed to describe the analysis, design, and evaluation of a telemonitoring system to improve CPAP adherence in patients afflicted with OSA. METHODS: The telemonitoring system was developed in five phases. In the exploratory phase, the body of related literature was reviewed. Then a need analysis was conducted through a focus group discussion with sleep medicine specialists and sales company representatives and an interview with patients. The third phase involved data integration. Then the content and system development were done based on the previous phases. Finally, usability and functionality tests were used to evaluate the system. RESULTS: The exploratory phase and the needs analysis were conducted by four sleep medicine specialists, two medical informatics specialists, six key figures of the sales companies, two system developers, and 46 patients in different phases. Based on the results obtained from the data integration phase, the telemonitoring system involved three main parts: a patient's application, a doctor's portal, a selling companies' portal (operator's portal) along with facilitating software for patients to send the CPAP data. Usability and functionality tests were given to 7 and 10 patients, respectively. The total number of usability issues reported by users in the evaluation process was 18, with an average of 2.5 issues per user. The installation problems, disrupted links and improper playing of videos were the main functionalities problems that were solved. CONCLUSION: The telemonitoring system, as a means of communication between patients, doctors, and selling companies, can be used to support patients clinically and technically. It has the potential to improve CPAP adherence in patients with OSA.

Evaluation of Work-Related Symptoms by Job Exposure Matrix in Chronic Pulmonary Diseases - A Cross-sectional Study.

BACKGROUND: Despite the high prevalence of occupational airway disorders, they are usually underestimated by physicians. This study designed to study the prevalence of work-related symptoms (WRS) and their association with occupational exposure in outpatient pulmonary clinics. METHODS: Adults with more than one year of lower respiratory symptoms were included. Retired patients, housewives and those unable to perform spirometry were excluded. Demographic, anthropometric and medical data were documented. The Persian version of National institute for health and safety respiratory questionnaire was used to classify job titles. WRS were defined as 2 (or more) positive questions with improvement of symptoms on days off work. Job exposure matrix (JEM) was used for classifying the type of occupational exposure into one of three categories: high molecular weight (HKW), low molecular weight (LMW) and mixed. RESULTS: A total of 250 patients (69% male) with mean (±SD) age of 40 (±11.6) years, 178 cases of asthma and 59 chronic obstructive pulmonary disease (COPD) cases entered. Occupational exposure was seen in 51.2% of patients (26, 51 and 51 cases with HMW, LMW and mixed, respectively). WRS were lower in those who exercised regularly (24.6% vs. 39.4%) and higher in those with eczema (62.5% vs. 33.6%). Eczema had an odds ratio (OR) of 4.13 (95% CI 1.3 to 12.9, P = 0.01). Exposure to LMW almost tripled the risk of WRS (OR: 2.9, 95% CI: 1.4 to 5.9, P = 0.003) in our patients. CONCLUSION: Pulmonologists are firmly advised to take their patients' occupational and vocational exposures into consideration for treatment plans, especially in those with positive history of eczema and exposure to LMW.

Activity of the yeast vacuolar TRP channel TRPY1 is inhibited by Ca2+-calmodulin binding.

Transient receptor potential (TRP) cation channels, which are conserved across mammals, flies, fish, sea squirts, worms, and fungi, essentially contribute to cellular Ca2+ signaling. The activity of the unique TRP channel in yeast, TRP yeast channel 1 (TRPY1), relies on the vacuolar and cytoplasmic Ca2+ concentration. However, the mechanism(s) of Ca2+-dependent regulation of TRPY1 and possible contribution(s) of Ca2+-binding proteins are yet not well understood. Our results demonstrate a Ca2+-dependent binding of yeast calmodulin (CaM) to TRPY1. TRPY1 activity was increased in the cmd1-6 yeast strain, carrying a non-Ca2+-binding CaM mutant, compared with the parent strain expressing wt CaM (Cmd1). Expression of Cmd1 in cmd1-6 yeast rescued the wt phenotype. In addition, in human embryonic kidney 293 cells, hypertonic shock-induced TRPY1-dependent Ca2+ influx and Ca2+ release were increased by the CaM antagonist ophiobolin A. We found that coexpression of mammalian CaM impeded the activity of TRPY1 by reinforcing effects of endogenous CaM. Finally, inhibition of TRPY1 by Ca2+-CaM required the cytoplasmic amino acid stretch E33-Y92. In summary, our results show that TRPY1 is under inhibitory control of Ca2+-CaM and that mammalian CaM can replace yeast CaM for this inhibition. These findings add TRPY1 to the innumerable cellular proteins, which include a variety of ion channels, that use CaM as a constitutive or dissociable Ca2+-sensing subunit, and contribute to a better understanding of the modulatory mechanisms of Ca2+-CaM.

Olfactory Dysfunction in Patients Infected with 2019 Novel Coronavirus.

INTRODUCTION: The current study aimed at investigating the occurrence and features of olfactory dysfunction in patients with confirmed coronavirus disease 2019 (COVID-19) infection. MATERIALS AND METHODS: Patients with laboratory and clinically confirmed COVID-19 infection were enrolled in this longitudinal study. They were managed in either the inpatient or outpatient setting. The demographic, clinical, and outcome data were retrieved from patients' medical records. Olfactory dysfunction features, including the onset pattern, duration, and recovery time were investigated. The visual analog scale (VAS) was utilized as a self-rating subjective measurement of olfactory function. RESULTS: According to the results, the mean age of the patients (n=502) was obtained at 46.8±18.5 years; moreover, 52.4% and 47.6% of cases were female and male, respectively. It was also revealed that 35.4% and 64.5% of the subjects were outpatients and hospitalized, respectively. Based on the findings, 178 (38.4%) subjects had olfactory dysfunction. The mean values of VAS in hyposmic patients were estimated at 2.5±2.5, 8.3 ±2.1, and 9.4±1.6 at the first evaluation, in 2 weeks, and after 1 month of follow-up (P<0.001). The onset of olfactory dysfunction was more suddenly (58.7%). The majority of cases experienced olfactory dysfunction at the same time as other symptoms 72(51.1%). Based on the results, 0.4% of subjects infected with COVID-19 had olfactory dysfunction as an isolated symptom. The olfactory dysfunction was recovered after 2 weeks in 18 (25.3%) anosmic and 37(46.8%) hyposmic patients. CONCLUSION: Olfactory dysfunction seemed to be an important symptom of COVID-19 infection. The occurrence of this disturbance as a transient self-limited condition was significantly higher among female subjects.

Factors determining the serum 25-hydroxyvitamin D response to vitamin D supplementation: Data mining approach.

Vitamin D supplementation has been shown to prevent vitamin D deficiency, but various factors can affect the response to supplementation. Data mining is a statistical method for pulling out information from large databases. We aimed to evaluate the factors influencing serum 25-hydroxyvitamin D levels in response to supplementation of vitamin D using a random forest (RF) model. Data were extracted from the survey of ultraviolet intake by nutritional approach study. Vitamin D levels were measured at baseline and at the end of study to evaluate the responsiveness. We examined the relationship between 76 potential influencing factors on vitamin D response using RF. We found several features that were highly correlated to the serum vitamin D response to supplementation by RF including anthropometric factors (body mass index [BMI], free fat mass [FFM], fat percentage, waist-to-hip ratio [WHR]), liver function tests (serum gamma-glutamyl transferase [GGT], total bilirubin, total protein), hematological parameters (mean corpuscular volume [MCV], mean corpuscular hemoglobin concentration [MCHC], hematocrit), and measurement of insulin sensitivity (homeostatic model assessment of insulin resistance). BMI, total bilirubin, FFM, and GGT were found to have a positive relationship and homeostatic model assessment for insulin resistance, MCV, MCHC, fat percentage, total protein, and WHR were found to have a negative correlation to vitamin D concentration in response to supplementation. The accuracy of RF in predicting the response was 93% compared to logistic regression, for which the accuracy was 40%, in the evaluation of the correlation of the components of the data set to serum vitamin D.

Design of a Mobile Application and Evaluation of Its Effects on Psychological Parameters of Covid-19 Inpatients: A Protocol for a Randomized Controlled Trial.

Background: Panic of the disease and the associated concerns can lower the quality of life and physical performance. As long as the COVID-19 pandemic is ever on the rise, the psychological pandemic of the disease is on the rise, too. The high prevalence of COVID-19 has further increased physicians' work pressure. Patients' needs are not met adequately by physicians. It seems essential to use aids to monitor patients' needs and serve them properly. Thus, in the present research, suggestions are made on how to evaluate patients' physical and psychological conditions during the treatment via a mobile application. Methods and Analysis: The present research is a randomized, two parallel-group, controlled trial. One-hundred-twelve inpatients diagnosed with the coronavirus will be assigned randomly to the control and intervention groups. In the intervention group, a mobile application will be provided to educate patients, establish two-way interactions between patients and care providers and record patients' symptoms. Those in the control group will receive the usual care. The primary outcome is the change to the depression anxiety stress scales-21 (DASS-21) score from the baseline to 2 weeks after discharge from hospital. It will be measured at the baseline, at the time of discharge, and two weeks later. Ethics and Dissemination: The Ethics committee of Mashhad University of Medical Sciences' approval date was 2020-04-19 with IR.MUMS.REC.1399.118 reference code. Thus far, participants' recruitment has not been completed and is scheduled to end in March 2021. The results will be disseminated in a peer-reviewed journal. Trial Registration: IRCT20170922036314N4 (https://www.irct.ir/trial/47383).

Methylene blue for treatment of hospitalized Covid-19 patients: a randomized, controlled, open-label clinical trial, phase 2

ABSTRACT Background: There is no pharmacological intervention on the treatment of hypoxemia and respiratory distress in COVID-19 patients. Objective: The objective of the study was to study the effect of the reduced form of methylene blue (MB) on the improvement of oxygen saturation (SpO2) and respiratory rate (RR). Methods: In an academic medical center, 80 hospitalized patients with severe COVID-19 were randomly assigned to receive either oral MB along with standard of care (SOC) (MB group, n = 40) or SOC only (SOC group, n=40). The primary outcomes were SpO2 and RR on the 3rd and 5th days. The secondary outcomes were hospital stay and mortality within 28 days. Results: In the MB group, a significant improvement in SpO2 and RR was observed on the 3rd day (for both, p < 0.0001) and also the 5th day (for both, p < 0.0001). In the SOC group, there was no significant improvement in SpO2 (p = 0.24) and RR (p = 0.20) on the 3rd day, although there was a significant improvement of SpO2 (p = 0.002) and RR (p = 0.01) on the 5th day. In the MB group in comparison to the SOC group, the rate ratio of increased SpO2 was 13.5 and 2.1 times on the 3rd and 5th days, respectively. In the MB group compared with the SOC group, the rate ratio of RR improvement was 10.1 and 3.7 times on the 3rd and 5th days, respectively. The hospital stay was significantly shortened in the MB group (p = 0.004), and the mortality was 12.5% and 22.5% in the MB and SOC groups, respectively. Conclusions: The addition of MB to the treatment protocols significantly improved SpO2 and respiratory distress in COVID-19 patients, which resulted in decreased hospital stay and mortality. ClinicalTrials.gov: NCT04370288

Concomitant empyema and peritonitis with Morganella morganii in an immunocompetent patient: A case report.

BACKGROUND: Peritoneal infection following pleural empyema is not a common occurrence. Concomitant pleural empyema and peritonitis have been described in the literature mostly in immunocompromised patients with different pathogenic mechanisms and a wide array of microorganisms. Here we report a case of concomitant pleural empyema and peritonitis with an unusual microorganism in an immunocompetent host. CASE PRESENTATION: The patient is a 42-year-old man with a history of 2 weeks epigastric pain who had been referred for surgical consult after failure of outpatient medical therapy. Physical examination at emergency ward revealed generalized abdominal guarding, tenderness and rebound tenderness. On emergent laparotomy, the peritoneal cavity was full of malodor pus. All abdominal viscera were intact but there was a 2x2 centimeter defect in the top of left hemi-diaphragm. Pus originated from the left thoracic cavity and then drained to the peritoneal cavity. Morganella morganii grew in the culture of aspirated pleural fluid. After abdominal lavage and chest tube drainage and receiving 14 days course of parenteral antibiotics, the patient experienced marked clinical improvement. Punctual history taking revealed a history of pneumonia before the beginning of abdominal symptoms. CONCLUSION: In concomitant empyema and peritonitis in an immunocompetent patient, one should keep in mind the possibility of diaphragmatic defect and infection by unusual organisms like M. m organii.

METHYLENE BLUE FOR TREATMENT OF HOSPITALIZED COVID-19 PATIENTS: A RANDOMIZED, CONTROLLED, OPEN-LABEL CLINICAL TRIAL, PHASE 2.

BACKGROUND: There is no pharmacological intervention on the treatment of hypoxemia and respiratory distress in COVID-19 patients. OBJECTIVE: The objective of the study was to study the effect of the reduced form of methylene blue (MB) on the improvement of oxygen saturation (SpO2) and respiratory rate (RR). METHODS: In an academic medical center, 80 hospitalized patients with severe COVID-19 were randomly assigned to receive either oral MB along with standard of care (SOC) (MB group, n = 40) or SOC only (SOC group, n=40). The primary outcomes were SpO2 and RR on the 3rd and 5th days. The secondary outcomes were hospital stay and mortality within 28 days. RESULTS: In the MB group, a significant improvement in SpO2 and RR was observed on the 3rd day (for both, p < 0.0001) and also the 5th day (for both, p < 0.0001). In the SOC group, there was no significant improvement in SpO2 (p = 0.24) and RR (p = 0.20) on the 3rd day, although there was a significant improvement of SpO2 (p = 0.002) and RR (p = 0.01) on the 5th day. In the MB group in comparison to the SOC group, the rate ratio of increased SpO2 was 13.5 and 2.1 times on the 3rd and 5th days, respectively. In the MB group compared with the SOC group, the rate ratio of RR improvement was 10.1 and 3.7 times on the 3rd and 5th days, respectively. The hospital stay was significantly shortened in the MB group (p = 0.004), and the mortality was 12.5% and 22.5% in the MB and SOC groups, respectively. CONCLUSIONS: The addition of MB to the treatment protocols significantly improved SpO2 and respiratory distress in COVID-19 patients, which resulted in decreased hospital stay and mortality. ClinicalTrials.gov: NCT04370288.

Efficacy and safety of convalescent plasma therapy in severe COVID-19 patients with acute respiratory distress syndrome.

Since SARS-CoV-2 infection is rapidly spreading all around the world, affecting many people and exhausting health care resources, therapeutic options must be quickly investigated in order to develop a safe and effective treatment. The present study was designed to evaluate the safety and efficacy of convalescent plasma (CP) for treating severe cases of COVID-19 who developed acute respiratory distress syndrome (ARDS). Among 64 confirmed cases of severe COVID-19 with ARDS in this study, 32 patients received CP besides first line treatment. Their clinical response and outcome in regard to disease severity and mortality rate were evaluated and compared with the other 32 patients in the control group who were historically matched while randomly chosen from previous patients with the same conditions except for receiving CP therapy. Analysis of the data was performed using SPSS software. Patients with plasma therapy showed improvements in their clinical outcomes including a reduction in disease severity in terms of SOFA and APACHE II scores, the length of ICU stay, need for noninvasive ventilation and intubation and also showed an increase in oxygenation. They also showed reduction in mortality which was statistically significant in less severe cases with mild or moderate ARDS. Early administration of the convalescent plasma could successfully contribute to the treatment of severe COVID-19 patients with mild or moderate ARDS at risk of progressing to critical state.

Oral nano-curcumin formulation efficacy in management of mild to moderate hospitalized coronavirus disease-19 patients: An open label nonrandomized clinical trial.

Curcumin is proposed as a potential treatment option for coronavirus disease-19 (COVID-19) by inhibiting the virus entrance, encapsulation and replication, and modulating various cellular signaling pathways. In this open-label nonrandomized clinical trial, efficacy of nano-curcumin oral formulation has been evaluated in hospitalized patients with mild-moderate COVID-19. Forty-one patients who fulfilled the inclusion criteria were allocated to nano-curcumin (n = 21) group (Sinacurcumin soft gel, contains 40 mg curcuminoids as nanomicelles, two capsules twice a day) or control (n = 20) group, for 2 weeks. Patients' symptoms and laboratory data were assessed at baseline and during follow-up period. Most of symptoms including fever and chills, tachypnea, myalgia, and cough resolved significantly faster in curcumin group. Moreover, SaO2 was significantly higher in treatment group after 2, 4, 7, and 14 days of follow-up and lymphocyte count after 7 and 14 days. Duration of supplemental O2 use and hospitalization was also meaningfully shorter in treatment group. It is also noteworthy to mention that no patient in treatment group experienced deterioration of infection during follow-up period, but it occurred in 40% of control group. Oral curcumin nano-formulation can significantly improve recovery time in hospitalized COVID-19 patients. Further randomized placebo controlled trials with larger sample size are recommended.

Evaluating the effect of an educational intervention on the adherence rate to sleep study: A multi-centered stratified randomized controlled trial.

An appropriate diagnosis and effective treatment of sleep apnea can improve the associated quality of care and reduce morbidities. The study aims to develop and evaluate an educational intervention tailored to patients' needs in order to increase the rate of patients' adherence to physician's prescription for a sleep test. A multi-center, stratified, 2 parallel-arm, randomized controlled trial was conducted. The patients in the intervention group received the educational booklets on sleep apnea and sleep test which was designed based on the extracted factors through an in-depth interview with patients. All participants were contacted after two months to ask whether they completed an assessment for OSA. A total number of 1,650 individuals were screened. Finally, 104 participants were randomized to the control group (n = 50) or intervention group (n = 45) that did not differ significantly in baseline characteristics. The results of the intention to treat analysis indicate that patients in the intervention group were significantly more adherent to attend a sleep assessment for their OSA risk (30%; n = 15/50) than the patients in the control group (11.1%; n = 5/45, P <0.05). Age, history of diabetes, and the educational intervention were effective in performing the sleep test. Time limitations, Condition improvement, and high cost of diagnostic test were the most barriers, respectively. The intervention was successful in improving the adherence rate of patients to prescribed sleep test. However, the adherence rate to sleep study testing is still far from desirable and requires more complex interventions.