Effect of Umbilical Cord Entanglement and Position on Pregnancy Outcomes

Introduction. To investigate the effect of complex umbilical cord entanglement primarily around the trunk on pregnancy outcomes. Methods. We studied 6307 pregnant women with singleton pregnancies who underwent vaginal delivery of an infant at ≥37 weeks of gestation. Cases were classified into no cord, nuchal cord, and body cord groups and defined as cases without umbilical cord entanglement, one or more loops of the umbilical cord around the neck only, and umbilical cord around the trunk only, respectively. Pregnancy outcomes were compared among these three groups. Results. The no cord, nuchal cord, and body cord group included 4733, 1451, and 123 pregnancies, respectively. Although delivery mode was not significantly different among the three groups, 1-minute Apgar scores <7 and umbilical artery (UA) pH <7.10 were significantly more common in the umbilical cord entanglement groups than in the no cord group. In particular, the frequency of 5-minute Apgar scores <7 was significantly higher (P=0.004), whereas that of UA pH <7.10 tended to be higher (P=0.057) in the body cord group than in the nuchal cord group. Conclusion. Compared to nuchal cord, umbilical cord entanglement around the trunk was associated with a higher risk of low Apgar scores and low UA pH

Impact of the Clinical Trials Act 2018 on clinical trial activity in Japan from 2018 to 2020: a retrospective database study using new and conventional Japanese registries

Objective To clarify the impact of Japan’s Clinical Trials Act (CTA), which was enacted in April 2018, on subsequent clinical trial activity through an analysis of Japanese registry data.Design Retrospective database study.Setting We extracted information on clinical intervention studies registered between 1 April 2018 and 30 September 2020 in the conventional University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) and the new Japan Registry of Clinical Trials (jRCT). We collected and analysed information on registration dates, intervention types, funding, secondary sponsors and use of designated staff in multidisciplinary roles (research planning support, research administration, data management, statistical analysis, monitoring and auditing). The temporal trends in clinical trial activity after CTA enactment were examined.Results A total of 577 CTA-compliant specified clinical trials (ie, studies funded by pharmaceutical companies or studies evaluating the efficacy and safety of off-label drugs or devices in humans) were registered in the jRCT. During the same period, 5068 clinical trials were registered in the UMIN-CTR. The number of specific clinical trials increased immediately after the implementation of the CTA and stabilised in late 2019, whereas the number of clinical trials registered in the UMIN-CTR generally declined over time. Specified clinical trials that received industry funding and public grants were more likely to use designated staff in multidisciplinary roles.Conclusions The implementation of the CTA has not reduced the number of specified clinical trials, but has reduced the total number of intervention trials. The use of designated staff in multidisciplinary roles is associated with funding, secondary sponsors and multicentre studies. It was inferred that funding was needed to establish research infrastructure systems that support high-quality research

Coital Frequency and the Probability of Pregnancy in Couples Trying to Conceive Their First Child: A Prospective Cohort Study in Japan

Background: Low fertility persists but remains unexplained in Japan. We examined whether the probability of pregnancy was influenced by coital frequency, age, reproductive age (assessed by antim&uuml;llerian hormone, AMH), and BMI. Methods: We established a two-year prospective study with a sample of hormonally monitored Japanese women aged 23&ndash;34 years wanting to conceive their first child. For a maximum of 24 weeks participants recorded menstrual bleeding, sexual intercourse, ovulation, and pregnancy. Additional information on pregnancy and infertility treatment was collected one and two years after intake. Results: The natural conception rate and coital frequency were both low in this sample. Among 80 participants, 44% (35) naturally conceived in 24 weeks. After two years, 74% (59) of women had delivered or were currently pregnant, 50% (40) due to natural and 24% (19) due to assisted conception, and 5% (4) were lost to follow-up. By two years, 56% (45) of women had sought fertility treatment. In 18% (58/319) of the observed ovarian cycles across 24 weeks there was no intercourse in a fertile period. Higher coital frequency at intake was associated with increased probability of conception by 24 weeks of follow-up (OR 1.23, 95%CI 1.02, 1.47). Chronological age, reproductive age, and BMI were not associated with the probability of pregnancy at 24 weeks. Conclusions: Our results suggest that first, natural conception rates could potentially increase with more frequent and well timed intercourse, and second that further work is needed to understand why even in a motivated sample of women monitoring their fertile periods, both the conception and coitus rates were low

Modified Pulmonary Index Score Was Sufficiently Reliable to Assess the Severity of Acute Asthma Exacerbations in Children

Background: The Modified Pulmonary Index Score (MPIS) was developed as an indicator of the severity of acute asthma in children. The objective of this study is to evaluate the reliability and validity of the MPIS for children with acute asthma, including those five years or younger in age. Methods: We evaluated the inter-rater reliability and internal consistency of the MPIS by having at least two trained physicians and a nurse—each of whom was blinded to the others’ scores—simultaneously examine inpatients with asthma exacerbation and rate them according to the MPIS. We also evaluated the intraclass correlation coefficient (ICC), kappa, Cronbach’s α and correlations between the MPIS and other indicators associated with asthma severity. Results: A total of 25 children (median age, five years; 13 patients were five years or younger in age) were enrolled in this study. The MPIS showed excellent inter-rater reliability (all ages: ICC = 0.95, 95% CI = 0.94-0.97; five years or younger: ICC = 0.93, 95% CI = 0.89-0.96) and good internal consistency (all ages: Cronbach’s α = 0.87; five years or younger: Cronbach’s α = 0.85). The MPIS showed good correlation with a visual analogue scale assessed by the physicians. Conclusions: The MPIS was a sufficiently reliable assessment tool for children with acute asthma, including those five years or younger in age

Feasibility Study of Virtual Reality–Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention

BackgroundThe clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. ObjectiveWe aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. MethodsThis is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. ResultsParticipant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. ConclusionsThis study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Trial RegistrationJapan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481 International Registered Report Identifier (IRRID)DERR1-10.2196/4969

RT-PCR of peritoneal washings predicts peritoneal pancreatic cancer recurrence.

BACKGROUND:Peritoneal recurrence of pancreatic cancer is a frequent and lethal outcome after R0 resection. A method to predict peritoneal recurrence could be helpful in its prevention. MATERIALS AND METHODS:Peritoneal washings were prospectively obtained from 29 patients in whom R0 resection was performed. Cytological examination (CY) and real-time reverse transcription polymerase chain reaction (RT-PCR) of the peritoneal washing for the detection of cancer-related genes, CEACAM5, KRT7, KRAS, and MUC1, were performed. Clinicopathological characteristics and real-time RT-PCR results of the peritoneal washing were compared between patients whose pancreatic cancer recurred peritoneally (n = 7) and those patients who it did not recur (n = 22). RESULTS:Only one CY-positive (CY+) case was detected, and that patient recurred. MUC1 mRNA expression was significantly higher in the recurrence group (P = 0.015). Cumulative incidence-function analysis demonstrated that peritoneal recurrence rate was significantly higher in MUC1-positive (MUC1+) patients (P = 0.044). MUC1+ patients had significantly decreased disease-free survival (P = 0.009) and disease-specific survival (P = 0.031). MUC1 protein was detected in the primary tumor in 18 of 29 patients. However, no significant difference was observed in the expression of MUC1 protein in peritoneal washings from the primary tumor (P = 0.579). CONCLUSIONS:High expression of MUC1 mRNA in peritoneal washings is a significant risk factor for peritoneal recurrence of pancreatic cancer after R0 resection along with poor disease-specific survival. RT-PCR of MUC1 mRNA in peritoneal washing may be useful for individualization of adjuvant chemotherapy

RT-PCR of peritoneal washings predicts peritoneal pancreatic cancer recurrence.

BACKGROUND:Peritoneal recurrence of pancreatic cancer is a frequent and lethal outcome after R0 resection. A method to predict peritoneal recurrence could be helpful in its prevention. MATERIALS AND METHODS:Peritoneal washings were prospectively obtained from 29 patients in whom R0 resection was performed. Cytological examination (CY) and real-time reverse transcription polymerase chain reaction (RT-PCR) of the peritoneal washing for the detection of cancer-related genes, CEACAM5, KRT7, KRAS, and MUC1, were performed. Clinicopathological characteristics and real-time RT-PCR results of the peritoneal washing were compared between patients whose pancreatic cancer recurred peritoneally (n&nbsp;=&nbsp;7) and those patients who it did not recur (n&nbsp;=&nbsp;22). RESULTS:Only one CY-positive (CY+) case was detected, and that patient recurred. MUC1 mRNA expression was significantly higher in the recurrence group (P&nbsp;=&nbsp;0.015). Cumulative incidence-function analysis demonstrated that peritoneal recurrence rate was significantly higher in MUC1-positive (MUC1+) patients (P&nbsp;=&nbsp;0.044). MUC1+ patients had significantly decreased disease-free survival (P&nbsp;=&nbsp;0.009) and disease-specific survival (P&nbsp;=&nbsp;0.031). MUC1 protein was detected in the primary tumor in 18 of 29 patients. However, no significant difference was observed in the expression of MUC1 protein in peritoneal washings from the primary tumor (P&nbsp;=&nbsp;0.579). CONCLUSIONS:High expression of MUC1 mRNA in peritoneal washings is a significant risk factor for peritoneal recurrence of pancreatic cancer after R0 resection along with poor disease-specific survival. RT-PCR of MUC1 mRNA in peritoneal washing may be useful for individualization of adjuvant chemotherapy