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Outcome Measures and Statistical Analysis
The primary outcome measure was the rate of viral clearance, expressed as a slope coefficient [All analyses were done in a modified intention-to-treat (mITT) population, comprising patients who had ≥3 days follow-up data. A sensitivity analysis showed excellent agreement between all the models (
PMC10640773
RESULTS
RECRUITMENT
The trial began recruitment on 30 September 2021. On 10 June 2022, remdesivir enrollment was stopped as the prespecified success margin had been reached. Of the 439 patients screened by that time, 337 were randomized to either remdesivir (67 patients), no study drug (69 patients), or to other interventions (201 patient...
PMC10640773
Virological Responses
oropharyngeal virus
CORONAVIRUS, VIRUS, SEVERE ACUTE RESPIRATORY SYNDROME
All analytical models of oropharyngeal virus clearance were in excellent agreement. Point estimates and credible intervals (CrIs) were similar, although the nonlinear model gave slightly smaller effect size estimates (Effect of parenteral remdesivir on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral ...
PMC10640773
Adverse Effects
ADVERSE EVENTS
The oropharyngeal swabbing and all treatments were well-tolerated. There were 3 serious adverse events (SAEs) in the control arm and 1 SAE in the remdesivir arm (
PMC10640773
DISCUSSION
COVID-19 illness
DISEASE PROGRESSION, DISEASE, DECAY, TROPICAL DISEASES
This comparative in vivo pharmacodynamic assessment shows that remdesivir accelerates viral clearance in early COVID-19, as would be expected from an effective antiviral drug. Continued uncertainty over the efficacy and value of different COVID-19 treatments has resulted in substantial variation in therapeutic guidelin...
PMC10640773
Supplementary Data
PMC10640773
Supplementary Material
Click here for additional data file.
PMC10640773
Notes
PMC10640773
References
PMC10640773
Background
Water pipe smoking by women threatens their health. Therefore, it is necessary to take measures to reduce this unhealthy behavior. This study aimed to determine the effect of happiness-based education on women’s success of water pipe smoking cessation and happiness.
PMC10629038
Methods
Fordyce happiness
This quasi-experimental study was conducted on female water pipe smokers in Iran, from September to January 2021. The participants (n = 68) were selected using convenience sampling and assigned to the intervention and control groups (34 subjects per group) by blocked randomization. The intervention group received a hap...
PMC10629038
Results
Two months after the intervention, the mean change in the happiness score was significantly higher in the intervention group (2.32 ± 2.31) than that in the control group (-0.29 ± 1.81) (P < 0.001). Furthermore, the mean change in the score of water pipe dependence was significantly different between the intervention (-...
PMC10629038
Conclusion
Fordyce happiness
The results showed that education based on Fordyce happiness program can increase the success of water pipe smoking cessation and happiness in women. Therefore, it is recommended to use similar interventions in women’s health promotion programs.
PMC10629038
Keywords
PMC10629038
Background
Fordyce believes, happiness, depression, deaths, Fordyce
SECONDARY, FORDYCE
Tobacco use kills eight million people worldwide annually. Among these, seven million and about 1.2 million deaths are secondary to direct tobacco use and smoke exposure, respectively [The spread and popularity of WPS in the current societies have been caused by several factors such as the misperception of its harmless...
PMC10629038
Methods
PMC10629038
Study design and participants
cancer, psychological disorders
CANCER, HEART DISEASES, DISEASES
The present quasi-experimental study was conducted in Gerash, southern Iran, from September to January 2021. The sample size was calculated according to a previous study aimed at determining the effect of group education programs on happiness in women [Sample was selected by the convenience method. In this way, all eli...
PMC10629038
Data collection tools
DISEASE
Data collection tools included a general information form, and the Persian versions of Oxford Happiness Inventory (OHI) and Lebanon Water Pipe Dependence Scale-11 (LWDS-11). Data were collected before and two months after the intervention in both groups. A researcher and a trained research assistant collected the data....
PMC10629038
Intervention
Fordyce happiness, Fordyce
EVENTS, FORDYCE
The intervention included a happiness-based education based on the Fordyce happiness program. Fordyce introduced a program consisting of 14 fundamentals. These fundamentals were 14 typical characteristics of happy people that he believed average people can acquire. These fundamentals are: a-being busy and more active; ...
PMC10629038
Data analysis
Data were analyzed using SPSS software version 22. Descriptive tests were used to describe the data. Qualitative variables between the intervention and control groups were compared using the Chi-square test and Fisher’s exact test. Mean differences of water pipe dependence scores (P = 0.002), mean water pipe dependence...
PMC10629038
Results
The mean age of participants was 38.79 ± 11.67 years, with mean ages of 36.41 ± 10.12 and 41.18 ± 12.75 in the intervention and control groups, respectively (P = 0.106). The two groups were not statistically different in terms of demographic variables and water pipe use status (Tables  Comparison of demographic variabl...
PMC10629038
Discussion
Fordyce happiness
This study aimed to determine the effect of happiness-based education on the success of WPS cessation and the happiness of women. The results indicated that the happiness scores of the intervention group improved significantly after the intervention. In addition, their water pipe dependence reduced. Hence, we can concl...
PMC10629038
Strengths and limitations
FORDYCE
The presentation of the intervention using the group formed in the social network is one of the strengths of this study. Moreover, the intervention was implemented by a nurse in collaboration with a psychologist. We showed that with an intervention based on the Fordyce program and using a feasible and convenient method...
PMC10629038
Acknowledgements
This manuscript was extracted from the Master’s thesis of Samira Dehkami and approved by the Vice Chancellor for Research and Technology of Shiraz University of Medical Sciences, Shiraz, Iran. Hereby, we would like to thank Vice Chancellor for Research and Technology of Shiraz University of Medical Sciences for financi...
PMC10629038
Authors’ contributions
ZKh, SD, and KhR made substantial contributions to the conception and design of the study. Data was collected by SD. Data analysis and interpretation were done by ZKh and SD. SD conducted the intervention. ZKh and SD participated in drafting the manuscript. ZKh, SD and KhR revised the manuscript critically for importan...
PMC10629038
Funding
The present study was financially supported by the Vice Chancellor of Research of Shiraz University of Medical Sciences, Shiraz, Iran (Grant No. 22086). The funding body did not play any roles in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.
PMC10629038
Data Availability
Data resources and statistical analysis outputs can be provided by the corresponding author (Zahra Khademian) on reasonable request.
PMC10629038
Declarations
PMC10629038
Ethics approval and consent to participate
For this study, the necessary approvals were obtained from the Ethics Committee of Shiraz University of Medical Sciences (ethics code: IR.SUMS.REC.1399.1034) and the officials of the health centers. All methods were carried out in accordance with Declaration of Helsinki and relevant guidelines and regulations. The obje...
PMC10629038
Consent for publication
Not applicable.
PMC10629038
Competing interests
None of the authors have any competing interests.
PMC10629038
Abbreviations
Lebanon Water Pipe Dependence Scale 11Oxford Happiness InventoryStatistical Package for the Social SciencesWater pipe smoking
PMC10629038
References
PMC10629038
Keywords
post-traumatic stress disorder, PTSD
POSITIVE
The last few decades have seen increasing interest in the use of cannabis for post-traumatic stress disorder (PTSD). Recent attempts to evaluate the clinical efficacy of cannabis for PTSD were inconclusive and generalizability was limited by undesirable features of the study drug. The present clinical trial evaluated t...
PMC10493009
Introduction
PTSD
Cannabis is a flowering plant valued for millennia due to its medicinal and psychoactive properties. Interest in the therapeutic application of cannabinoids has re-emerged after decades of marginalization, with the treatment of mental health conditions among the most prominent applications [Preclinical studies implicat...
PMC10493009
Methods
Administered PTSD
RECRUITMENT
This trial was registered on ClinicalTrials.gov (NCT02517424) and approved by the Clinical Research Ethics Board at the University of British Columbia (H16-01026). Participants provided written informed consent prior to participating. The study was designed as a randomized blinded placebo-controlled cross-over study wi...
PMC10493009
Results
PTSD, DSM-5, Administered PTSD
Comparison of CAPS scores pre and post treatment identified a trend toward reduction in PTSD symptoms (Patient-level change in total PTSD ratings on CAPS-5. Note: CAPS-5, Clinician Administered PTSD Scale for DSM-5; potential range = 0–80
PMC10493009
Acknowledgements
The research team would like to acknowledge the time, effort, and trust of the individuals who participated in the study.
PMC10493009
Authors’ contributions
ZW, IM, and PL designed the study. ZW analyzed the data and was a major contributor in writing this manuscript. MSP assisted with manuscript writing, revision, and formatting. DW, KC, and MSP collected participant data. KO facilitated clinical research activities. All authors read and approved the final manuscript.
PMC10493009
Funding
The study was funded by Tilray through a Clinical Trial Agreement with the University of British Columbia.
PMC10493009
Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC10493009
Declarations
PMC10493009
Ethics approval and consent to participate
This trial was registered on ClinicalTrials.gov (NCT02517424) and approved by the Clinical Research Ethics Board at the University of British Columbia (H16-01026). Participants provided written informed consent prior to participating.
PMC10493009
Consent for publication
Not applicable.
PMC10493009
Competing interests
BLOOM
Philippe Lucas was Vice President, Global Patient Research and Access, for Tilray, the study sponsor, during the course of the clinical trial, and his compensation included stock options for Tilray.Zach Walsh has received research support from Tilray to conduct this study and has also received research support from DOJ...
PMC10493009
References
PMC10493009
1. Introduction
Schizophrenia, schizophrenia, cardiovascular disease, pain
DISEASE, CARDIOVASCULAR DISEASE, DISORDERS, SECONDARY
Background: This study aimed to evaluate the effect of two different types of physical intervention on sedentary behavior and clinical changes in people with schizophrenia. Method: This is a clinical trial including people with schizophrenia in regular outpatient care who realized a 3-month exercise protocol and were s...
PMC9958543
2. Methods
PMC9958543
2.1. Trial Design
schizophrenia
This is a non-randomized clinical trial of two physical interventions (aerobic physical intervention (API) and postural physical intervention (PPI)) over three months in two groups of stable outpatients with diagnosis of schizophrenia. API was applied in patients at a public health facility (Psychosocial Attention Cent...
PMC9958543
2.2. Participants
psychiatric, DSM-5
DISORDERS
Stable outpatients under regular treatment received a psychiatric diagnosis after a three-step procedure consisting of (1) clinical observation with at least 3 evaluations; (2) a family interview; and (3) a review of their medical records performed by a trained psychiatrist. The selected patients met the following incl...
PMC9958543
2.3. Ethics
The study was registered in the Brazilian Research Registry under No. 43408615.7.0000.5327, in the Brazilian Registry of Clinical Trials (ReBEC) under No. RBR-2h2hjy and approved (150066) by the Research Ethics Committee of Hospital de Clínicas de Porto Alegre (HCPA). Patients and their legal guardians provided written...
PMC9958543
2.4. Clinical Assessment
RECRUITMENT
After patient recruitment, previously trained professionals performed a standardized clinical and physical assessment of the study to participants before physical intervention and after 3 months of treatment.
PMC9958543
2.5. Sedentary Lifestyle
Measured by the Simple Physical Activity Questionnaire (SIMPAQ). It is a 5-item clinical tool designed to assess physical activity among populations at high risk of sedentary behavior. The physical activity questionnaire evaluates the last seven days and includes time in bed, sedentary time, time spent walking, type an...
PMC9958543
2.6. Disease Severity
psychiatric
Measured by the Brief Psychiatric Rating Scale (BPRS). It is one of the most widely used instruments to evaluate the presence and severity of various psychiatric symptoms including the Brazilian Unified Health System (SUS) for patient’s monitoring [
PMC9958543
2.7. Physical Performance
THORACIC
Measured by the Six-Minute Walking Test (6MWT). Two trained and certified physical therapists applied 6MWT following the American Thoracic Society Guidelines (2002) [
PMC9958543
2.8. Stretching
BENDING
Measured by the Well’s Bench sit and reach flexibility test. It measures lower limb and hip joint flexibility, with the participant fully extended the legs, with the soles of their feet against the bench, slowly bending and projecting forward as far as possible, and fingers sliding along a scale. The total distance rea...
PMC9958543
2.9. Quality of Life
pain
Measured by the Medical Outcomes Study 36-Item Short Form—SF-36. This instrument is a validated questionnaire method with high sensitivity to detect functional status, among other aspects of quality of life. It includes eight multiple-item subscales of functional capacity, physical limitation, pain, general health, vit...
PMC9958543
2.10. Physical Intervention
PMC9958543
2.10.1. Aerobic Physical Intervention [API]
This 12-week program included a 1 h session of aerobic exercise twice a week. It measures exercises by a digital rate monitor (POLAR FT1
PMC9958543
2.10.2. Physical Intervention
hip abductors
Postural Physical Intervention [PPI]: The 12-week program included twice a week 1 h sessions of postural exercises. Trios or quartets of subjects received an intervention, beginning with a 5 min warm-up with a stationary walk, followed by 15 min of muscle flexibility and joint mobility exercises. After 25 min of global...
PMC9958543
2.11. Statistical Analyses
Statistical analyses used SPSS version 20.0, with categorical variables described by frequencies and percentages, and tested for symmetry by the Kolmogorov Smirnov test. Quantitative variables with symmetrical distribution were expressed by means and standard error or means and standard deviation, and those with asymme...
PMC9958543
3. Results
Out of the 103 patients in the API group that were initially invited to participate, 26 agreed to participate and met the inclusion criteria. Of these, 24 patients (92%) completed the physical exercise intervention. Dropouts consisted of two patients (8%) that did not achieve the minimum attendance. Regarding in PPI gr...
PMC9958543
4. Discussion
schizophrenia, injuries
DISEASE
The major finding of the study was that the aerobic physical intervention program reduced weight, body mass index and blood pressure and increased time exercising, whereas the postural physical intervention showed an improvement in sedentary behavior through SIMPAQ and 6MWT. No effects were seen in flexibility and dise...
PMC9958543
5. Conclusions
schizophrenia
In conclusion, the aim of the present article was to provide a modification of sedentary behavior through aerobic and postural exercise in people with schizophrenia, in addition to observing its effects on physical and mental health. This study showed that both protocols were effective in this population, which are oth...
PMC9958543
Author Contributions
M.F.S. participated in the elaboration of the research project, data collection, intervention, statistical analyses, and writing of the manuscript; V.B.C. collaborated in data collection; and P.B.-d.-A. provided orientation in project elaboration, data acquisition, training in clinical scales, statistical analyses, and...
PMC9958543
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Ethics Committee of Hospital de Clínicas de Porto Alegre (150066 and date approval 07/22/2017).
PMC9958543
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC9958543
Conflicts of Interest
The authors declare that this research was conducted in the absence of any commercial or financial relationships that could be construed as potential conflicts of interest.
PMC9958543
References
SE, schizophrenia
Study Flowchart: Aerobic physical intervention (API) and postural physical intervention (PPI) in people with schizophrenia.Relationship between the distances walked in the 6 min walking test (6MWT) and the upper and lower limit predicted of patients who performed the aerobic physical intervention (API) and 14 cases tha...
PMC9958543
Background
delirium, mouth-breathing
Emergence delirium (ED) is generally occurred after anesthesia associated with increased risks of long-term adverse outcomes. Therefore, this study aimed to evaluate the efficacy of preconditioning with nasal splint and mouth-breathing training on prevention of ED after general anesthesia.
PMC10483790
Methods
REGRESSION
This randomized controlled trial enrolled 200 adult patients undergoing ESS. Patients were randomized to receive either nasal splinting and mouth breathing training (n = 100) or standard care (n = 100) before surgery. The primary outcome was the occurrence of ED within 30 min of extubation, assessed using the Riker Sed...
PMC10483790
Results
Totally 200 patients were randomized and 182 aged from 18 to 82 years with 59.9% of males were included in the final analysis (90 in C-group and 92 in P-group). ED occurred in 16.3% of the intervention group vs. 35.6% of controls (P = 0.004). Male sex, smoking and function endoscopic sinus surgery (FESS) were independe...
PMC10483790
Conclusions
delirium
Preoperative nasal splinting and mouth breathing training significantly reduced the incidence of emergence delirium in patients undergoing endoscopic sinus surgery.
PMC10483790
Trial Registration
ChiCTR1900024925 (
PMC10483790
Keywords
PMC10483790
Background
delirium, motor agitation, agitation, inconsolability, dissociation of consciousness
COMPLICATIONS
Emergence delirium (ED, aka emergence agitation, EA), which referring to a short-term state of dissociation of consciousness during the recovery from general anesthesia, manifested with motor agitation, incoherence, inconsolability, and unresponsiveness, is the most common neuropsychiatric complications after surgery [...
PMC10483790
Methods
PMC10483790
Study design
mouth-breathing
BLIND
This is a randomized, single blind, parallel, controlled study to evaluate the efficacy of nasal splinting and mouth-breathing training in preventing ED in adults after FESS. Adult patients were 1:1 randomly allocated to receive preconditioning treatment or control treatment. The random sequences were generated by comp...
PMC10483790
Patients
nasal malformation, mental illness, neurological diseases, nasal trauma
CHRONIC SINUSITIS, NEUROLOGICAL DISEASE, CARDIOVASCULAR DISEASE
Patients scheduled for FESS at the Shanghai General Hospital, China from September 18th, 2019 to December 16th, 2020 due to chronic sinusitis were screened for eligibility. Inclusion criteria were: age over 18 years old; American Society of Anesthesiologists Classification (ASA) class I–II with no serious cardiovascula...
PMC10483790
Interventions
mouth-breathing, delirium
CAVITY, MUSCLE RELAXATION
Patients in preconditioning group underwent nasal splint preconditioning and mouth breath training in pre-anesthesia room 1 h before surgery. In details, a nasal splint (patent No. 202020982582.9, China) was used to clamp the subnasal cartilage in front of the nasal cavity to block breathing through nose (Fig.   A grap...
PMC10483790
Outcomes
pain, Pain, hyperactive motor behavior
SECONDARY
Outcomes assessed followed the statements of previously published protocol [The main secondary outcome was the severity of ED, which was determined based on the presences of combative behavior, thrashing, and hyperactive motor behavior [Other secondary outcomes included intraoperative monitored parameters, such as dura...
PMC10483790
Sample size
RECRUITMENT
Based on the results from our pilot study, the incidence of ED after FESS was 21.3%. We assumed that the preconditioning would result in reduction of ED occurrence with an odds ratio (OR) of 1/3. At the setting of α = 0.05, an estimated sample size of 164 could provide a 90% of statistical power. Considering a potentia...
PMC10483790
Randomization and blinding
Random number sequence was generated by computer. Single-blind ED assessment was performed by an independent anesthesiologist who was not aware of the grouping information (started observation until after the removal of nasal clip) and a nurse anesthetist (Yuyu Gu) at PACU, with necessary consultation with the intraope...
PMC10483790
Statistical analyses
REGRESSION, SECONDARY
According to the intention-to-treat principle, we used full analysis data set to analyze the primary outcome. The full analysis set (FAS), including all patients underwent randomization and at least once training and with once measurement after surgery, was used for analysis of primary and secondary outcome. Normal dis...
PMC10483790
Results
delirium, SD, nasal obstruction
RECRUITMENT, HBP, DIABETES MELLITUS, REGRESSION, HIGH BLOOD PRESSURE
After screening of 232 patients, 200 met the inclusion and exclusion criteria and finally randomized. Among them, 18 patients were withdrawn (Fig.  Recruitment, randomization, and patient flow diagram of the trial. P-group, group with preconditioning of nasal splint and mouth breathing training; C-group, control groupT...
PMC10483790
Discussion
blindness, throat, postoperative agitation, agitation, mouth-breathing
BLINDNESS
This randomized controlled trial showed that preconditioning with nasal splint and mouth-breathing training preparation significantly decreased the incidence of ED after FESS by more than 50%. The intraoperative sufentanil dosage of the preconditioning group was significantly improved by 20.0 µg. Post-hoc analysis sugg...
PMC10483790
Acknowledgements
Not applicable.
PMC10483790
Author contributions
H.X. contributed to drafting of the manuscript. Z.S. contributed to data curation. Y.G. contributed to supervision. Y.H. contributed to data collection. J.J., X.L. and M.Z. contributed to the operation of the study. Y.Z. contributed to statistical analysis. J.L. contributed to study design and reviewing of the manuscri...
PMC10483790
Funding
This study was supported by Clinical Research Innovation Plan of Shanghai General Hospital [grant number: KD031-ly01to Jinbao Li, CNY 600,000; CTCCR-2021C21 to Hongjiao Xu, CNY 50,000]. The funding only gave financial support.
PMC10483790
Data Availability
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
PMC10483790
Declarations
PMC10483790
Competing interests
The authors declare no competing interests.
PMC10483790
Ethics approval and consent to participate
The study was conducted according to the Declaration of Helsinki and study protocol was approved by the Shanghai General Hospital Institutional Review Board (IRB 2019KY039). Written informed consent to participate was obtained from participants.
PMC10483790
Consent for publication
Not applicable.
PMC10483790
Abbreviations
American Society of Anesthesiologists Classificationemergence deliriumfrequencyFunctional Endoscopic Sinus Surgeryheart rateinterquartile rangeminimum alveolar concentrationnon-invasive blood pressureNumerical Rating Scaleodds ratiopost-anesthesia care unitstandard deviationOxygen saturationtidal volume
PMC10483790
References
PMC10483790
Purpose
hip arthroplasty, femoral cutaneous nerve, THA, postoperative pain
To assess the efficacy of pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve (LFCN) block in controlling postoperative pain and promoting recovery of lower extremity after total hip arthroplasty (THA), and to compare its effectiveness with supra-inguinal fascia iliaca compartment block ...
PMC10390614
Materials and methods
LFCN block
92 patients undergoing THA with general anesthesia were randomly allocated to receive either a PENG with LFCN block (
PMC10390614
Results
The combination of PENG with LFCN blocks resulted in an earlier first postoperative walking time (19.6 ± 9.6 h vs 26.5 ± 8.2 h,
PMC10390614
Conclusions
PENG with LFCN blocks is more effective than S-FICB in shortening the time to first postoperative walk and preservation hip motion after THA, which makes it a suitable addition to enhanced recovery programs following surgery.
PMC10390614