: To compare the perinatal outcome and delivery intervals after the induction of labour with the Prostin vaginal tablet versus the Propess vaginal system in pregnant women with term-PROM.
: One ...centre paralleled randomised controlled trial with a computer-generated table to allocate treatments.
: University Medical Centre in Slovenia.
: A total of 205 singleton healthy pregnant women with term-PROM.
: Induction of labour with the Propess vaginal system (intervention group) versus Prostin tablets (control group).
: The rate of failed inductions, complications in labour, time intervals between the PROM, induction, the beginning of the active phase, and delivery.
: A total of 104 patients received Prostin, and 101 patients received Propess. Induction failure rates in the Prostin and the Propess groups were 8/104 (7.7%) and 5/101 (5.0%), respectively (
= 0.80). Delivery abnormalities were uncommon and comparable across the groups. The rates of caesarean sections in the Prostin and Propess groups were 4/96 (4.2%) and 6/96 (6.3%), respectively. The delivery intervals were comparable across the groups.
: In term-PROM pregnancies, the Propess vaginal system is a safe and effective option for inducing labour.
Objective: The purpose of this prospective randomised study was to determine the effect of routine cervical dilatation during elective caesarean section on maternal morbidity.
Methods: Participants ...with indication for elective caesarean section were randomly allocated to two groups. Group A (n = 200) women with intraoperative cervical dilatation; group B (n = 200) women with no intraoperative cervical dilatation.
Results: No demographic differences were observed between groups. There was no significant difference between groups in infectious morbidity (P = 0.87) (relative risk (RR) 1.11, 95% confidence interval (CI) 0.58–2.11), endometritis (P = 0.72) (RR 1.68, 95% CI 0.39–7.14), febrile morbidity (P = 0.66) (RR 1.21, 95% CI 0.51–2.87), wound infection (P = 0.82) (RR 1.11, 95% CI 0.44–2.81), endometritis (P = 0.72) (RR 1.68, 95% CI 0.39–7.14) or urinary tract infection (P = 1.00) (RR 1.00, 95% CI 0.28–3.50), and estimated blood loss (P = 0.2). However, group A had longer operative times compared with the group B (P = 0.01).
Conclusion: Intraoperative digital cervical dilatation during elective caesarean section did not reduce blood loss and postoperative infectious morbidity. The routine digital cervical dilatation during elective caesarean section is not recommended.
Background and purpose:
Around the world, college students physical and mental health is deteriorating. Finding practical ways to enhance college students health is crucial. One of the traditional ...Chinese Qigong exercises is Baduanjin, which is possibly one of the most efficient workout techniques out there. However, it is unknown how Baduanjin practice may affect college students health. The purpose of this study was to evaluate the effect of Qigong Baduanjin on the physical and mental health of female college freshmen.
Materials and methods:
A total of 78 female college students were recruited and randomly divided into Baduanjin group or control group. Participants in the control group were told to keep their original habits of life and exercise. The Baduanjin exercise group received 12 weeks of Baduanjin exercise, 3 days a week and 1 hour a day. After the 12 week randomized controlled trial, the physical and mental health indexes of female students in Baduanjin group and control group were evaluated, including physical shape, physical function, physical fitness and scl-90 self-assessment scale.
Results:
Compared with the control group, at the end of the 12 week intervention, the weight, body mass index, diastolic blood pressure, systolic blood pressure, somatization score, obsessive-compulsive disorder score, interpersonal sensitivity score, depression score, anxiety score and phobic anxiety score of Baduanjin group decreased significantly. Compared with the control group, the vital capacity, vital capacity index, Stand test, Genchi test, Stand on 1 leg with closed eyes, standing bends and squats of the Baduanjin group have been significantly improved.
Conclusion:
Compared with usual activities, Qigong Baduanjin exercise has advantages in improving female college students body shape (weight and body mass index), cardiovascular and respiratory lung function, flexibility, balance ability, muscle endurance and mental health.
Examine whether cognitive behavioral therapy for insomnia (CBT-I) improves sleep in posttraumatic stress disorder (PTSD) as well as nightmares, nonsleep PTSD symptoms, depression symptoms, and ...psychosocial functioning.
RANDOMIZED CONTROLLED TRIAL WITH TWO ARMS: CBT-I and monitor-only waitlist control.
Department of Veterans Affairs (VA) Medical Center.
Forty-five adults (31 females: mean age 37 y (22-59 y) with PTSD meeting research diagnostic criteria for insomnia, randomly assigned to CBT-I (n = 29; 22 females) or monitor-only waitlist control (n = 16; nine females).
Eight-session weekly individual CBT-I delivered by a licensed clinical psychologist or a board-certified psychiatrist.
Measures included continuous monitoring of sleep with diary and actigraphy; prepolysomnography and postpolysomnography and Clinician-Administered PTSD Scale (CAPS); and pre, mid, and post self-report questionnaires, with follow-up of CBT-I participants 6 mo later. CBT-I was superior to the waitlist control condition in all sleep diary outcomes and in polysomnography-measured total sleep time. Compared to waitlist participants, CBT-I participants reported improved subjective sleep (41% full remission versus 0%), disruptive nocturnal behaviors (based on the Pittsburgh Sleep Quality Index-Addendum), and overall work and interpersonal functioning. These effects were maintained at 6-mo follow-up. Both CBT-I and waitlist control participants reported reductions in PTSD symptoms and CAPS-measured nightmares.
Cognitive behavioral therapy for insomnia (CBT-I) improved sleep in individuals with posttraumatic stress disorder, with durable gains at 6 mo. Overall psychosocial functioning improved following CBT-I. The initial evidence regarding CBT-I and nightmares is promising but further research is needed. Results suggest that a comprehensive approach to treatment of posttraumatic stress disorder should include behavioral sleep medicine.
TRIAL NAME: Cognitive Behavioral Treatment Of Insomnia In Posttraumatic Stress Disorder. URL: http://clinicaltrials.gov/ct2/show/NCT00881647.
NCT00881647.
Purpose
To evaluate the efficacy of the Sanyin formula (SYF) plus conventional standard chemotherapy in operable triple-negative breast cancer (TNBC) patients, a randomized controlled trial was ...implemented at 5 hospitals and cancer centers in China between May 23, 2016, and October 31, 2019.
Materials and Methods
Female patients aged 18 to 80 years with operable TNBC after definitive surgery were screened and enrolled. The exclusion criteria included metastatic disease, other tumors, or locally advanced disease. Patients were randomly divided into groups SYF plus conventional standard chemotherapy and placebo plus conventional standard chemotherapy at a ratio of 1:1. The primary endpoint of the investigation was disease-free survival (DFS), and secondary endpoints included overall survival (OS) and toxicity.
Results
A total of 252 operable female TNBC patients were randomized to receive SYF plus conventional standard chemotherapy (N = 127) or a placebo plus conventional standard chemotherapy (N = 125). At a median follow-up of 51 months, 5-year DFS time was longer in those assigned to SYF plus conventional standard chemotherapy compared with placebo plus conventional standard chemotherapy (94.2%vs 85.5%, hazard ratio HR = 0.40; 95%CI, 0.17-0.97;
P
= 0.034). The absolute benefit for 5-year DFS was 8.7% in the SYF plus conventional standard chemotherapy group. No statistically significant difference was observed in OS between the two groups (
P
= 0.23). Patients with negative node status benefited more from SYF plus conventional standard chemotherapy treatment (HR = 0.21,
P
-interaction = 0.013) in accordance with the exploratory subgroup analyses of DFS.
Conclusions
The results of the present study suggest that the traditional Chinese medicine SYF plus conventional chemotherapy regimens is an effective alternative adjuvant chemotherapy strategy for female operable TNBC patients.
Clinical Trial Registration
https://www.chictr.org.cn/searchproj.aspx
, identifier ChiCTR-IPR-16008590.
Background
Research on penile cancer (PeCa) is predominantly conducted in countries with centralized treatment of PeCa-patients. In Germany and Austria (G + A), no state-regulated centralization is ...established, and no information is available on how PeCa-research is organized.
Methods
Current research competence in PeCa was assessed by a 36-item questionnaire sent to all chairholders of urological academic centers in G + A. Based on PubMed records, all scientific PeCa-articles of 2012–2022 from G + A were identified. Current research trends were assessed by dividing the literature search into two periods (P1: 2012–2017, P2: 2018–2022). A bibliometric analysis was supplemented.
Results
Response rate of the questionnaire was 75%, a median of 13 (IQR: 9–26) PeCa-patients/center was observed in 2021. Retrospective case series were conducted by 38.9% of participating clinics, while involvement in randomized-controlled trials was stated in 8.3% and in basic/fundamental research in 19.4%. 77.8% declared an interest in future multicenter projects. 205 PeCa-articles were identified median impact factor: 2.77 (IQR: 0.90–4.37). Compared to P1, P2 showed a significant increase in the median annual publication count (29 (IQR: 13–17) vs. 15 (IQR: 19–29),
p
< 0.001), in multicenter studies (79.1% vs. 63.6%,
p
= 0.018), and in multinational studies (53% vs. 28.9%,
p
< 0.001); the proportion of basic/fundamental research articles significantly declined (16.5% vs. 28.9%,
p
= 0.041). Four of the top-5 institutions publishing PeCa-articles are academic centers. Bibliometric analyses revealed author networks, primary research areas in PeCa, and dominant journals for publications.
Conclusions
Given the lack of centralization in G + A, this analysis highlights the need for research coordination within multicenter PeCa-projects. The decline in basic/fundamental research should be effectively addressed by the allocation of funded research projects.
OBJECTIVES The number of breast cancer survivors throughout the world has increased. Breast cancer survivors need to know how to exercise to improve their clinical outcomes. The purpose of this study ...was to find the effects of an evidence-based combined exercise intervention on the fitness levels of breast cancer survivors.METHODS A total of 38 female breast cancer survivors were randomly assigned to an exercise group (n=19) or a control group who did usual care (n=19). Subjects in the exercise group participated eight weeks of moderate intensity aerobic exercise and bodyweight strength exercise three times per week. Weight, body mass index (BMI), cardiorespiratory fitness, handgrip strength, and flexibility were measured to assess the effects of the exercise intervention.RESULTS Women who completed the exercise intervention had decreased weight and BMI and increased cardiorespiratory fitness, handgrip strength, and flexibility.CONCLUSIONS Breast cancer survivors had improved health outcomes. A combined exercise intervention of moderate intensity three times per week for eight weeks can help breast cancer survivors improve their health. Participating in aerobic exercise and bodyweight strength exercise, which provide dynamic movements and use large muscle groups with no equipment, can help increase physical fitness levels of breast cancer survivors.
•The integrated graduation program improves women’s decision-making in some, but not all, decision-making domains.•Effects are stronger in group receiving economic strengthening combined with family ...coaching offered to all household members including men.•Effects of economic strengthening alone are significant for women in monogamous families, but not in polygynous ones.•Increased access to economic resources does not mediate the effect of intervention on improving women’s decision-making power.•Findings suggest the importance of addressing structural gender inequalities, alongside the efforts to economically empower women.
To promote women’s empowerment, numerous programs provide economic services meant to increase women’s access to economic resources in the household. However, women’s access to economic resources does not always translate into improved bargaining power, and effects of economic strengthening interventions may vary across different decision-making domains. There is little robust evidence, particularly in sub-Saharan Africa, showing the effect of improved access to economic resources on specific domains of decision-making within a family and very little is known about variation in this effect between monogamous and polygynous families. Furthermore, very few assessments explicitly examine specific pathways from participation in economic strengthening interventions to improved decision-making power in the household for women.
Our study aims to address these gaps by examining—in the context of a randomized controlled trial administered in rural Burkina Faso—the effect of an economic strengthening intervention on specific domains of women’s decision-making power and how it relates to monogamous/polygynous family structures and challenges to intra-household gender roles and responsibilities. Furthermore, we examine a specific pathway to better understand whether increased access to economic resources from this intervention translates into improved decision-making power for women.
We use repeated-measures data collected from 360 adult female caregivers in the 3-arm cluster-randomized controlled trial conducted among households living in abject poverty in Burkina Faso. We ran multilevel mixed-effects logistic regression models to examine the effect of the intervention on different domains of women’s involvement into household-level decision-making and variation of this effect by family structure (i.e. polygamous vs. monogamous families). We fit a structural equation model to examine whether access to assets mediates the effect of the intervention on different domains of women’s involvement into household-level decision-making.
We found that economic empowerment intervention increased women’s involvement in making decisions about their children’s well-being, but had no effect on women’s say in making decisions about general household economy. We found most effects to be stronger in the treatment arm that received economic strengthening combined with family coaching offered to the whole household and directly targeting normative beliefs related to child wellbeing and gender norms. We also found no evidence that increased access to assets mediates the effect of intervention on improving women’s decision-making power in different domains.
Our findings suggest that to improve decision-making power for women in their household it is important to address structural gender inequalities and gender norms rooted in patriarchy, alongside the efforts to economically empower women.
The Neurohawk retriever is a new fully radiopaque retriever. A randomized controlled non-inferiority trial was conducted to compare the Neurohawk and the Solitaire FR in terms of safety and efficacy. ...In order to evaluate the efficacy and safety of endovascular treatment in acute ischemic stroke (AIS) caused by intracranial atherosclerotic disease (ICAD) larger vessel occlusion (LVO), a sub-analysis was performed.
Acute ischemic stroke patients aged 18-80 years with LVO in the anterior circulation were randomly assigned to undergo thrombectomy with either the Neurohawk or the Solitaire FR. The primary efficacy endpoint was successful reperfusion (mTICI 2b-3) rate by the allocated retriever. A relevant non-inferiority margin was 12.5%. Safety outcomes were symptomatic intracranial hemorrhage (sICH) and all-cause mortality within 90 days. Secondary endpoints included first-pass effect (FPE), modified FPE, and favorable outcomes at 90 days. In subgroup analysis, the patients were divided into the ICAD group and non-ICAD group according to etiology, and baseline characteristics, angiographic, and clinical outcomes were compared.
A total of 232 patients were involved in this analysis (115 patients in the Neurohawk group and 117 in the Solitaire group). The rates of successful reperfusion with the allocated retriever were 88.70% in the Neurohawk group and 90.60% in the Solitaire group (95%CI of the difference, -9.74% to 5.94%;
= 0.867). There were similar results in FPE and mFPE in both groups. The rate of sICH seemed higher in the Solitaire group (13.16% vs. 7.02%,
= 0.124). All-cause mortality and favorable outcome rates were comparable as well. In subgroup analysis, 58 patients were assigned to the ICAD group and the remaining 174 to the non-ICAD group. The final successful reperfusion and favorable outcome rates showed no statistically significant differences in two groups. Mortality within 90 days was relatively lower in the ICAD group (6.90% vs. 17.24%;
= 0.054).
The Neurohawk retriever is non-inferior to the Solitaire FR in the mechanical thrombectomy of large vessel occlusion-acute ischemic stroke (LVO-AIS). The sub-analysis suggested that endovascular treatment including thrombectomy with the retriever and essential rescue angioplasty is effective and safe in AIS patients with intracranial atherosclerotic disease-larger vessel occlusion (ICAD-LVO).
https://clinicaltrials.gov/ct2/show/NCT04995757, number: NCT04995757.
Abdominal obesity occurs when excessive visceral and subcutaneous fat is built up around the abdomen and stomach, which negatively impacts human health. Moxibustion, arose from Traditional Chinese ...Medicine (TCM), has been widely applied in the treatment of abdominal obesity. Several studies have shown the positive effects of moxibustion in prevention and treatment of endocrine issues and excess body weight. In this context, our study aims to examine the safety and efficacy of the combination of moxibustion and characteristic lifestyle intervention of TCM in the treatment of abdominal obesity.
This study will be a multicenter, randomized, controlled trial conducted from September 2020 to January 2022 that includes 150 participants who have abdominal obesity and meet the eligibility criteria. The participants will be randomly divided into 3 groups in a 2:2:1 allocation ratio. The intervention group will receive moxibustion combined with characteristic lifestyle intervention of TCM; the other group will receive moxibustion combined with lifestyle intervention; the control group will receive lifestyle intervention only. Eight-week moxibustion sessions will be provided to participants assigned to the 2 intervention groups. The characteristic lifestyle intervention of TCM will also last 8 weeks, whereas the lifestyle intervention will last 12 weeks including 8-week treatment period, 4-week follow-up period. The primary outcome is the waist circumference measured by a tape measure. The secondary outcomes include obesity-related indicators, serum biochemical indexs, blood pressure, conversion score of physical symptoms, and measurement of the scale. Adverse events will be recorded during the treatment and follow-up period.
The results are expected to provide clinical evidence for the application of the combination of moxibustion and characteristic lifestyle intervention of TCM in patients with abdominal obesity.
ClinicalTrials.gov, NCT04501198, Registered on 9 June 2020.
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