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Introduction
postoperative pain, bleeding, Postoperative pain, hemorrhoids, hypertonus, hemorrhoid, tamponade, pain, trauma
BLEEDING, RECURRENCE, HEMORRHOIDS, HEMORRHOIDS, HEMORRHOID, COMPLICATION, SECONDARY, BACTERIAL INFECTIONS, DISEASES, COMPLICATIONS
Hemorrhoids are common and frequently occurring diseases in the clinical setting, and higher degree hemorrhoids require surgical treatment [For prolapsing hemorrhoids, excisional hemorrhoidectomy continues to be the treatment of choice with the lowest recurrence rate [Despite several advantages in surgical technique an...
PMC10622377
Materials and methods
PMC10622377
Study design
postoperative pain, postoperative bleeding, tamponade
POSTOPERATIVE BLEEDING
The NoTamp study was a German multicenter randomized controlled trial (RCT) designed to compare the effects of perioperative placement of a rectal tamponade on postoperative pain development and occurrence of surgically relevant postoperative bleeding in open hemorrhoidectomy [The trial duration for each randomized pat...
PMC10622377
Cohort participants
postoperative pain, Pain, hemorrhoids, pain, HT, NRS
HEMORRHOIDS, SECONDARY, PATHOLOGY, COMPLICATIONS
The target population for this study included adult patients (18 years or above) suffering from symptomatic grade III or IV hemorrhoids requiring Milligan-Morgan or Parks hemorrhoidectomy [The study protocol did not interfere with standard perioperative measures, and all drugs and treatments administered were recorded ...
PMC10622377
Statistics
Statistical analysis was performed using IBM SPSS Statistics for Windows, Version 28. Armonk, NY: IBM Corp. All categorical variables were presented as counts (with percentages) and were analyzed with chi-squared or Fisher’s exact test. Continuous data were summarized as mean with standard deviation (SD), or median wit...
PMC10622377
Results
PMC10622377
Study cohort
The main data set has been published previously (NoTamp) [
PMC10622377
Primary endpoint: relevant early pain
NRS, pain
Figure Distribution of the maximum postoperative pain levels measured by the NRS within the study cohort in the first 3 days after surgery
PMC10622377
Predictors for early relevant pain
postoperative pain, tamponade, pain
We checked possible predictors in both subgroups with and without relevant postoperative pain until day 3. Univariate analysis revealed that younger age, preoperative pain level, long duration of surgery, and usage of a tamponade were associated with relevant pain after surgery (Table In the multivariate analysis, pude...
PMC10622377
Secondary endpoint: relevant pain after 1 week
postoperative pain, NRS, pain
Secondary endpoint was relevant delayed pain as shown by the NRS > 5 on day 7. For this time point, data of 688 of the 717 in patients (96%) were available. The mean and median (IQR) NRS values at that time were 2.7 and 2 (1–4), respectively. Seventy-four patients (10.8%) complained about relevant pain (NRS 6–10) on da...
PMC10622377
Predictors for relevant delayed pain
pain
Relevant early pain was the strongest predictor for relevant pain after 7 days (OR 3.13, CI95 1.81–5.41, Patient and treatment parameters related to maximum pain level 7 days after surgery. Differences were calculated using the Fisher’s exact test on the binary data, chi-squared test on nominal data, and Mann–Whitney’s...
PMC10622377
Third endpoint: quality of life (QoL)
mean NRS, postoperative pain, Pain, bleeding
ADVERSE EVENT, BLEEDING
Quality of life was assessed preoperatively and with the follow-up on day 7. In the preoperative setting, the indices of 713 of 717 patients were assessed, postoperatively of 690 cases. For this evaluation, we only used pre- and postoperative complete data sets of 686 cases.The mean/median preoperative quality of life ...
PMC10622377
Acknowledgements
DKD, P.
The authors thank the patients and the investigators who participated in this clinical study and every study site that took part: Helios St. Elisabeth Klinik Oberhausen, Helios Klinikum Wuppertal, Helios Klinikum Berlin-Buch, Helios St. Johannes Klinik, Helios Klinik Lengerich, Helios Klinik Hüls, Helios Klinik Jericho...
PMC10622377
Author contribution
CM
CM, LB, and MRL had full access to all study data and take responsibility for the integrity of the data and the accuracy of the analysis. CM and LB were also responsible for the concept and design of this study and drafting of the manuscript. All authors (CM, MRL, R-VF, AK, JB, J-PR, FG, RL, and L) were responsible for...
PMC10622377
Funding
Open Access funding enabled and organized by Projekt DEAL. The Helios Center for Research and Innovation (HCRI), a subsidiary company of the Helios Hospital Group, funded this study. Helios also supported acquisition of study sites and data collection, without having any influence on data analysis, interpretation, or r...
PMC10622377
Data availability
Data will be made available at the website of the NoTamp study. Anonymized raw data are available upon request from the corresponding author or the trial statistician.
PMC10622377
Declarations
PMC10622377
Competing interests
The authors declare no competing interests.
PMC10622377
References
PMC10622377
Background
CRF, fatigue, breast cancer
CRF, BREAST CANCER
Radiotherapy (RT) can lead to cancer-related fatigue (CRF) and decreased health-related quality of life (HRQoL) in breast cancer patients. The purpose of this trial was to examine the feasibility and efficacy of a home-based resistance and aerobic exercise intervention for reducing CRF and improving HRQoL in breast can...
PMC9813229
Methods
breast cancer
BREAST CANCER
Women with breast cancer (
PMC9813229
Results
CRF
CRF
Eighty-nine women completed the study (EX = 43, CON = 46). Over the 12-week intervention, EX completed 1–2 resistance training sessions and accumulated 30–40 min of aerobic exercise weekly. For CRF, EX had a quicker recovery both during and post-RT compared to CON (
PMC9813229
Conclusions
CRF
CRF, BREAST CANCER
Home-based resistance and aerobic exercise during RT is safe, feasible, and effective in accelerating CRF recovery and improving HRQoL. Improvements in CRF and HRQoL for these patients can be achieved with smaller exercise dosages than stated in the generic recommendations for breast cancer.
PMC9813229
Keywords
Open Access funding enabled and organized by CAUL and its Member Institutions
PMC9813229
Introduction
cancer, Breast cancer, CRF
CANCER, BREAST CANCER, CRF
Breast cancer (BCa) is the most common form of cancer among women. In Australia, 1 in 8 women will be diagnosed with BCa by the age of 85 [Exercise could offer a potent stimulus to counteract CRF as it elicits positive adaptations in most of the factors believed to be associated with CRF, HRQoL, and sleep [It has previ...
PMC9813229
Materials and methods
CRF
CRF
This was a two-arm, randomized controlled clinical trial (Fig. Schematic of the research project design. *The serial assessment of CRF and physical activity level at the start of each week
PMC9813229
Participants
One hundred and six (Consort diagram of the study
PMC9813229
Measurements
CRF
SECONDARY, CRF
Assessment of primary and secondary outcome measures took place at: (1) baseline (i.e., week 0, prior to initiating RT and the intervention period); (2) post-RT (i.e., 6 weeks after baseline, after completing RT and mid-way through the intervention period); (3) post-exercise (i.e., 12 weeks after baseline); and (4) fol...
PMC9813229
Primary endpoints
cancer, Chronic Illness, fatigue, Fatigue
CANCER, CHRONIC ILLNESS
Cancer-related fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire. The FACIT-F is a 13-item scale commonly used to assess fatigue in cancer patients [Fatigue was also assessed using the Brief Fatigue Inventory (BFI) at baseline, post-RT, post-exercise, and at...
PMC9813229
Secondary outcome measures
PMC9813229
Quality of life
Cancer
CANCER
HRQoL was assessed using the Functional Assessment of Cancer Therapy for patients with BCa (FACT-B + 4) [
PMC9813229
Sleep duration and quality
cancer, Insomnia
CANCER
Insomnia, poor sleep quality and short sleep durations are the most common problems seen in cancer patients [
PMC9813229
Physical activity
Physical activity was assessed using the Godin Leisure-Time Exercise Questionnaire [
PMC9813229
Radiotherapy completion rates and adverse side effects
Cancer
ADVERSE EVENT, CANCER
Adherence to prescribed RT treatments was recorded using standard clinical measures. Completion rate was reported as the percentage of the planned dose and planned fractions completed during the treatment course. The presence and severity of any adverse side effects was assessed using the National Cancer Institute Comm...
PMC9813229
Adherence to and adverse side effects from the exercise program
fractures
ADVERSE EVENTS, MUSCULOSKELETAL COMPLICATIONS
Adherence to the exercise program was recorded using detailed logbooks. The frequency, duration and intensity of exercise was examined for both aerobic and resistance exercise. The occurrence and severity of any adverse events including musculoskeletal complications (muscle strains, fractures, etc.) were recorded durin...
PMC9813229
Exercise
cancer, CRF
CANCER, CRF
The 12-week home-based exercise intervention was a combination of resistance and aerobic exercise. Each participant completed the pre-exercise questionnaire and medical history, and then had a 1-h consultation with an accredited exercise physiologist. The resulting exercise program was relative to the level of fitness ...
PMC9813229
Statistical analysis
RPE, CRF, diabetes
CARDIOVASCULAR DISEASE, CRF, HYPERTENSION, OSTEOPOROSIS, DIABETES
As this was a pragmatic trial, we aimed to recruit as many patients as possible. To calculate the achieved power, we used the primary endpoint of FACIT-F score at immediately post-RT, as we hypothesized that the effect of exercise on CRF would be the strongest at that time point. Achieved power was calculated using G*P...
PMC9813229
Quality of life
Both groups reported improved HRQoL at 6- and 12-month post-RT (Fig. 
PMC9813229
Sleep duration and quality
There were no changes in sleep duration or total PSQI score for any group at any time point (Fig. 
PMC9813229
Author contributions
GM: formal analysis, investigation, writing—original draft, and final draft approval. PC: conceptualization, methodology, project administration, and final draft approval. CJP-M: conceptualization, methodology, formal analysis, investigation, writing—original draft, project administration, and final draft approval. DAG...
PMC9813229
Funding
Open Access funding enabled and organized by CAUL and its Member Institutions.
PMC9813229
Declarations
PMC9813229
Conflict of interest
The authors declare that they have no conflicts of interest. No funding was received for this work.
PMC9813229
References
PMC9813229
Purpose
Immunocompromised patients have a potentially increased risk for progression to severe COVID-19 and prolonged replication of SARS-CoV-2. This post hoc analysis examined outcomes among immunocompromised participants in the MOVe-OUT trial.
PMC9844162
Methods
hospitalization/death, non-immunocompromised
ADVERSE EVENTS
In phase 3 of MOVe-OUT, non-hospitalized at-risk adults with mild-to-moderate COVID-19 were randomized to receive molnupiravir 800 mg or placebo twice daily for 5 days. Immunocompromised participants were identified based on prior/concomitant medications and/or medical history. All-cause hospitalization/death, adverse ...
PMC9844162
Results
molnupiravir-treated immunocompromised
ADVERSE EVENTS, VIRUS
Fifty-five of 1408 participants were considered immunocompromised. Compared to placebo, fewer molnupiravir-treated immunocompromised participants were hospitalized/died through Day 29 (22.6% [7/31] vs. 8.3% [2/24]), with fewer adverse events (45.2% [14/31] vs. 25.0% [6/24]). A larger mean change from baseline in SARS-C...
PMC9844162
Conclusion
Although the study population was small, these data suggest that molnupiravir treatment for mild-to-moderate COVID-19 in non-hospitalized immunocompromised adults is efficacious and safe and quickly reduces infectious SARS-CoV-2.
PMC9844162
ClinicalTrials.gov Registration Number
NCT04575597.
PMC9844162
Supplementary Information
The online version contains supplementary material available at 10.1007/s15010-022-01959-9.
PMC9844162
Keywords
PMC9844162
Introduction
death, coronavirus disease 2019
CORONAVIRUS DISEASE 2019, ADVERSE EVENTS, DISEASE, MAY, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME
Immunocompromised individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are more likely to progress to severe coronavirus disease 2019 (COVID-19) and have poor outcomes [Molnupiravir is an oral, small-molecule ribonucleoside prodrug of β-D-N4-hydroxycytidine (NHC) which has potent activ...
PMC9844162
Methods
PMC9844162
Design overview, setting, and participants
CANCER, DISEASE
Non-hospitalized adults ≥ 18 years old with laboratory-confirmed mild-to-moderate COVID-19 and at least one risk factor for progression to severe disease were included in the phase 3 component of MOVe-OUT (ClinicalTrials.gov NCT04575597). Participants were randomized within 5 days of onset of COVID-19 signs or symptoms...
PMC9844162
Outcomes
death
ADVERSE EVENT
All-cause hospitalization or death through Day 29 and virologic outcomes with molnupiravir and placebo in immunocompromised and non-immunocompromised participants were assessed in the modified intent-to-treat population (MITT, all randomized participants who received ≥ 1 dose of study drug and were not hospitalized pri...
PMC9844162
SARS-CoV-2 RNA
SARS-CoV-2 RNA titers from nasopharyngeal swabs on Days 1, 3, 5, 10, 15, and 29 were measured using a quantitative RT-PCR assay developed at Q
PMC9844162
SARS-CoV-2 infectivity
Nasopharyngeal specimens collected on Days 1, 3, 5, 10, 15, and 29 with viral RNA > 100,000 copies/mL were serially diluted in duplicate in serum free Eagle Minimum Essential Media and 100 µL of each dilution placed in a 24-well-plate containing > 90% confluent Vero E6 cells. Samples were incubated with cells for 60 mi...
PMC9844162
Next-generation sequencing (NGS)
NGS analysis was performed on nasopharyngeal samples with RNA titers ≥ 600 copies/mL on Days 1 and 5 and on post-treatment nasopharyngeal samples with RNA titers ≥ 100,000 copies/mL on Days 10, 15, and 29. All NGS analyses were performed by Q
PMC9844162
Anti-SARS-CoV-2 nucleocapsid antibody assay
®
The presence of serum antibodies (IgM, IgG, and IgA) to the SARS-CoV-2 nucleocapsid protein were assessed at Days 1, 5, 10, and 29 using the Roche Elecsys® electrochemiluminescence immunoassay performed at a central laboratory (LabCorp, Inc.; Indianapolis, IN, USA).
PMC9844162
Anti-SARS-CoV-2 spike protein neutralizing antibody assay
infection
INFECTION, VIRUS
Assessment for the presence and amount of anti-SARS-CoV-2 spike protein neutralizing antibody activity in serum on Day 1 and on Days 10 and 29 was performed at Monogram Biosciences (South San Francisco, CA, USA) using the SARS-CoV-2 PhenoSense® nAB Assay. Serially diluted (1:40–1:2124 dilutions) serum samples were adde...
PMC9844162
Statistical analysis
death
Descriptive statistics were used to summarize efficacy, safety, and virologic data. For categorical variables, frequency and proportions were calculated using the number of participants with available data as the denominator. Differences in the proportion of participants who experienced hospitalization or death through...
PMC9844162
Role of the sponsor
The trial sponsor, Merck & Co., Inc., Rahway, NJ, USA, was involved in study design, data collection, data analysis, data interpretation, and writing of the report. All authors had access to the study data and final responsibility for the decision to submit for publication.
PMC9844162
Discussion
death, cancer, Nucleocapsid, infection, infectious SARS-CoV-2
ADVERSE EVENTS, INFECTION, VIRUS, CANCER
Immunocompromised participants in phase 3 of the MOVe-OUT trial who received molnupiravir had a lower incidence of all-cause hospitalization or death without any concerning adverse events through Day 29 compared to placebo (8.3% [2/24] versus 22.6% [7/31]). Reductions in viral RNA in both treatment groups were generall...
PMC9844162
Conclusions
Based on the results of this post hoc analysis in participants from phase 3 of MOVe-OUT, the use of molnupiravir appears to be effective and safe for the treatment of mild-to-moderate COVID-19 in non-hospitalized immunocompromised adults at risk for progression to severe COVID-19. There were no notable differences in v...
PMC9844162
Supplementary Information
Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 48 KB)
PMC9844162
Abbreviations
respiratory syndrome
CORONAVIRUS
Confidence intervalCoronavirus disease 2019End-of-therapyHuman immunodeficiency virusLower limit of quantificationLeast squaresLeast squares meanModified intention-to-treatMolnupiravir for oral treatment of COVID-19 in non-hospitalized patientsβ-D-N4-hydroxycytidineNext-generation sequencingPlaque-forming unitsPeople l...
PMC9844162
Acknowledgements
We thank the patients and their families and caregivers for participating in this study, along with all investigators and site personnel. We thank Ying Zhang, PhD for her statistical expertise. Medical writing assistance was provided by Dorothy McCoy, PharmD, BCPS, BCIDP and editorial assistance by Carol Zecca, BS, bot...
PMC9844162
Author contributions
PD
CDA
MGJ, JMS, MLB, HW, HHS, MR, DFF, PD, IK, JF, LFF, S-CC, AW-D, JD, JAG, AP, and CDA contributed to drafting the manuscript and critically revised it for important intellectual content. All authors read and approved the final manuscript.
PMC9844162
Funding
This work was supported by Merck & Co., Inc., Rahway, NJ, USA.
PMC9844162
Availability of data and materials
The data sharing policy, including restrictions, of Merck & Co., Inc., Rahway, NJ, USA is available at
PMC9844162
Declarations
PMC9844162
Conflict of interest
Pierre, HIV, hepatitis
STIS, BROWN
Matthew G. Johnson, Julie M. Strizki, Michelle L. Brown, Hong Wan (at the time of study), Hala H. Shamsuddin, Angela Williams-Diaz, Jiejun Du (at the time of study), Jay A. Grobler, Amanda Paschke, and Carisa De Anda are employees of Merck & Co., Inc., Rahway, NJ, USA. Moti Ramgopal: Consulting fees: Gilead, Merck, Vii...
PMC9844162
References
PMC9844162
1. Introduction
Although studies on sports performance, leadership abilities, group cohesion, and learning motivation have revealed that the sport education model contributes considerably to the development of healthy lifestyles, few studies have explored the development of healthy lifestyles from an educational intervention perspecti...
PMC9915953
2. Methods
PMC9915953
2.1. Research Participants
The research participants consisted of 95 students (47 men, 48 women) from Ming Chuang University. The participants were recruited from two classes and distributed to the experimental group (
PMC9915953
2.2. Experiment Process
Limited by the teaching environment of the classroom system and a fixed class size, this study was unable to conduct randomized equal-group multifactor experiments. For this reason, an unequal-group pretest–posttest design was employed for the experiment. The experiment comprised pretest, intervention, and posttest sta...
PMC9915953
2.3. Research Tool: Healthy Lifestyle Scale
Amended from the scale proposed in Chen et al. [
PMC9915953
2.4. Course Development and the Effectiveness of the Intervention Program
To ensure the effectiveness of the teaching intervention program, the principal investigator recruited one professional badminton instructor and two sport education scholars to convene a sport education model teaching design evaluation group. The group conducted two focus meetings on the intervention program, performed...
PMC9915953
2.5. Statistical Analysis
Statistical analysis was conducted using the SPSS 19.0. The results were analyzed using five methods; (1) participants’ height, weight, and body mass index (BMI) were analyzed using descriptive statistics; (2) homogeneity in sex was tested using a chi-squared test; (3) homogeneity in the participants’ height, weight, a...
PMC9915953
3. Results
PMC9915953
3.1. Homogeneity Testing
REGRESSION
Analysis of the demographic statistics revealed homogeneity between the groups in terms of sex (χThe homogeneity of the within-class regression coefficients for the health promotion (F = 0.567;
PMC9915953
3.2. Healthy Lifestyle Performance
The pretest and posttest scores of the two groups are listed in
PMC9915953
3.3. Covariance Analysis
The covariance analysis (
PMC9915953
4. Discussion
PMC9915953
4.1. Effect of the Sport Education Model on Healthy Lifestyle Performance
This study evaluated the effect of the sport education intervention on healthy lifestyles among students in terms of health promotion, life satisfaction, and interpersonal interaction. The preliminary results indicate that the sport education model has a stronger ability to promote healthy lifestyles than conventional ...
PMC9915953
4.2. Research Limitations
This study had several limitations. First, this study did not use a randomized equal-group multifactor experimental design. As a result, the results may have been affected by sampling bias (e.g., the experience and team participation) and thus cannot be completely generalized to students of other countries, regions, or...
PMC9915953
4.3. Research Suggestions
The results provide a solid foundation for research on exercise and physical education courses. Researchers should follow-up their participants for 1 or 2 months to determine whether the sport education model has a lasting effect in terms of encouraging healthy lifestyles. In addition, studies can use other indicators ...
PMC9915953
5. Conclusions
This study provided preliminary evidence indicating that incorporating the sport education model into physical education courses promotes healthy lifestyles in students and fills the gap in the literature regarding the sport education model. Organized teaching strategies for physical education courses are crucial to he...
PMC9915953
Author Contributions
Conceptualization, C.-C.L., K.-P.K., C.-H.H., Y.-J.L., and C.-C.K.; data curation, C.-C.L., K.-P.K., C.-H.H., Y.-J.L., and C.-C.K.; formal analysis, C.-C.L., K.-P.K., C.-H.H., Y.-J.L., and C.-C.K.; funding acquisition, Y.-J.L.; investigation, C.-C.L., K.-P.K., C.-H.H., Y.-J.L., and C.-C.K.; methodology, C.-C.L., K.-P.K...
PMC9915953
Institutional Review Board Statement
This study was approved by the Institutional Review Board (IRB) of National Taiwan University (serial number: 201812ES018).
PMC9915953
Informed Consent Statement
Informed consent was obtained from all participants involved in the study; and all participants provided their assent to participate.
PMC9915953
Data Availability Statement
Data are available from the corresponding author upon reasonable request.
PMC9915953
Conflicts of Interest
The authors declare no conflict of interest.
PMC9915953
References
REGRESSION, EVENT
Designing learning materials for educational objectives.Arranging sports seasons and trainingAdjusting time based on teaching items and contentLearning about sports experiencesGaining sports knowledgeAdjusting strategy and applicationCognitive objectives:Game planning and managementSports appreciationRecord keepingStra...
PMC9915953
Background
Cancer
CANCER
COVID-19 has impacted both society and medical care. While Germany entered the first lockdown in spring 2020, the PIKKO study (Patient information, communication and competence empowerment in oncology) was still active. The intervention modules, patient navigator (PN), services of the Saarland Cancer Society (SCS), psy...
PMC10183678
Methods
REGRESSION
All patients in the PIKKO intervention group (IG) were invited to complete a questionnaire, n = 503. Furthermore, utilization of the SCS and log files of the ODB were analyzed. For socio-demographic data and contacts with the PN, data from the regular PIKKO surveys were used. In addition to descriptive statistics, chi²...
PMC10183678
Results
REGRESSION, DISEASE
356 patients participated in this supplemental survey. 37.6% reported restrictions. “Restrictions on accompanying persons”, “ban on visits to the wards” and “protective mouth-nose-mask” were reported as the greatest burdens. 39.0% expressed fears that the restrictions would have an impact on the course of their disease...
PMC10183678
Conclusion
Cancer
CANCER
Cancer patients in the IG reported restrictions from the pandemic containment strategies and feared an impact on their recovery. However, whether a burden is perceived as heavy depends more on gender, age, or pre-existing burdens than on whether the lockdown affects PIKKO or not. The utilization of counseling, courses ...
PMC10183678
Trial registration
This study was retrospectively registered in the German Clinical Trial Register under DRKS00016703 (21 Feb 2019, retrospectively registered).
PMC10183678