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This device represents a new option in contraception that has a low failure rate and better bleeding profile and continuation rate than nonhormonal IUDs. Proper patient selection and counseling about amenorrhea are the keys to effective use. [ABSTRACT FROM AUTHOR]

Background: Evidence regarding the analgesic effect of distraction through immersion in virtual reality (VR) for care-induced pain has been documented in several phase 2 trials, but comparison with standard treatments in large, randomized studies is needed., Objective: In this open-label, multicenter, randomized, phase 3 trial, we evaluated the safety and efficacy of a novel VR therapy solution for distraction in the context of bone marrow biopsy., Methods: Bliss is a VR software with 4 imaginary interactive environments in 3 dimensions with binaural sound (head-mounted display). Efficacy regarding pain intensity was evaluated using a visual analog scale (VAS; score from 0 to 10) immediately after the biopsy. Secondary end points were anxiety and tolerance. Modified intention-to-treat analysis was performed., Results: Overall, 126 patients with previously documented untreated or suspected malignant hemopathy between September 6, 2018, and May 18, 2020, were randomly assigned in a 1:1 ratio to receive pain prevention with a mixture of nitrous oxide/oxygen (MEOPA; n=63) or VR (n=63) before and during the bone marrow biopsy. We excluded 8 patients from the final analysis (3 in the MEOPA group and 5 in the VR group). All patients received local anesthesia (lidocaine) before biopsy. Follow-up was limited to 1 month after the biopsy. Participants' median age was 65.5 (range 18-87) years, and 54.2% (64/118) of patients were male. The average pain intensity was 3.5 (SD 2.6, 95% CI -1.6 to 8.6) for the MEOPA group and 3.0 (SD 2.4, 95% CI -1.7 to 7.7) for the VR group, without any significant differences in age, sex, center, and hemopathy (P=.26). Concerning anxiety, 67.5% (79/117; fear of pain questionnaire) of the patients were afraid before the biopsy, and anxiety scores were moderate to very high in 26.3% (30/114; revised Spielberger State-Trait Anxiety Inventory questionnaire) of the patients before the biopsy and 9.0% (10/114) after the biopsy for all patients, without a significant difference between the 2 groups (P=.83). Immersion in VR was well tolerated by the majority (54/57, 95%) of patients in the VR group., Conclusions: The intensity of pain did not significantly differ between both arms. VR was well tolerated, and the satisfaction of patients, nurses, and physicians was very high. VR could be an alternative treatment in case of contraindication or intolerance to MEOPA., Trial Registration: ClinicalTrials.gov NCT03483194; https://clinicaltrials.gov/ct2/show/NCT03483194., (©Katell Le Du, Anne-Lise Septans, Frédéric Maloisel, Hélène Vanquaethem, Anna Schmitt, Marielle Le Goff, Aline Clavert, Marie Zinger, Hugues Bourgeois, Olivier Dupuis, Fabrice Denis, Stéphane Bouchard. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 15.02.2023.)

Purpose: To qualify the quality of patients sexual lives after treatment among women with breast cancer under 35 years old and compare results to the literature., Methods: Sexual quality of life was measured for 84 women aged 20 to 35 years old at diagnosis, with two validated quality of sexual life questionnaires, Brief Index of Sexual Functioning for Women (BISF-W) and Female Sexual Function Index (FSFI), at least six months after breast cancer diagnosis. Two other questionnaires were used to allow us to understand other aspects of their life before cancer and to monitor quality of sexual life during treatment., Results: Forty-three women responded to the questionnaire. The questionnaires demonstrated that more than half of them had problems with their sexuality. The mean total score was 28.08/75 for BISF-W and 25.1 for FSFI (under the cutoff score 26.55). The domain analysis showed an association between the absence of chemotherapy and scores in regard to sexual health. Only 7% had sexual disturbance detected but 49% of the patients wished to have it., Conclusion: Sexual dysfunction in breast cancer survivors is real, has several factors, and cannot be evaluated based only on the organic side effects induced by cancer treatment. Better monitoring and screening seems necessary in order to optimize the quality of sexual life after surviving breast cancer.

Purpose: Totally implantable venous access ports (TIVAP) have been widely used for many years in the management of patients suffering from cancer. The implantation and long-term use of TIVAPs are associated with mechanical, thrombotic, and infectious complications. This is the first exhaustive prospective study of all complications occurring in a whole population on long-term follow-up and therefore allows an objective assessment to be made of the safety of TIVAPs., Methods: We carried out a prospective single-center observational study. All adult patients with cancer who had a TIVAP implanted between January 1 and December 31, 2006 were registered. Early and late complications were recorded until the removal of the device, the patient's death, or until December 31, 2013. Exhaustive data concerning patients and TIVAP was recorded at time of implantation., Results: Four hundred and ninety-three TIVAPs were implanted in 483 adult cancer patients and were followed during a period from 1 to 94 months (median = 18 months) representing a global quantity of 367,359 catheter-days. Eighty-seven complications were recorded (0.237/1000 catheter-days), including 37 infections (0.101/1000 catheter-days), 17 thrombotic events (0.046/1000 catheter-days), and 9 extravasations. Out of the 87 events, 62 (71.3%) occurred during the first year after implantation. Events were therefore extremely rare after 1 year. Thromboembolic and infectious complications were rare and no risk factors for these were found., Conclusions: This study demonstrates excellent tolerability, with only occasional complications. Most of these occurred during the year following implantation. A TIVAP may also be left in place for an extremely long time.

Background: We sought to determine whether the introduction of a new anticoagulation protocol improved the frequency with which target anticoagulation parameters were met in children supported with extracorporeal membrane oxygenation (ECMO). Additionally, we sought to correlate the results of various tests of anticoagulation with the heparin infusion dose (HID) for patients on ECMO and to evaluate the utility of these anticoagulation monitoring tests for the titration of the HID., Methods: A retrospective chart review of 18 patients who received ECMO at an academic tertiary care children's hospital. Nine patients who were managed using a new anticoagulation protocol were matched by age and diagnosis with 9 patients managed with the old protocol. We collected data relating to patient demographics, type of extracorporeal support, disease process, and incidence of bleeding or thrombosis. Anticoagulation parameters collected include the activated clotting time (ACT), activated partial thromboplastin time (aPTT), prothrombin time/international normalized ratio, anti-factor Xa level, and antithrombin 3 level along with the HID at each time point. Patient groups were compared using a Generalized Linear Mixed Model, a mixed model analysis of variance, and correlational studies., Main Results: The percentage of in-range ACT values was not different between the 2 protocols, whereas the percentage of in-range aPTT values was higher in the new anticoagulation protocol (ACT: 37.7% vs 39.5%; aPTT: 25.1% vs 39.8%). After accounting for repeated and variable measures within patients, the probability of obtaining an in-range ACT and aPTT did not differ significantly between the 2 protocols (ACT: P = .3488; aPTT: P = .16). The mean HID did not differ between the 2 groups (35.0 unit/kg/h vs 37.6 unit/kg/h, P = .56). Correlation coefficients demonstrated a significant inverse correlation between the ACT and the HID in both the groups (old: r = -.22, P < .0001; new: r = -.26, P < .0001). We observed a significant positive correlation between the aPTT and the HID in the historical group (r = .25, P < .0001), but no correlation between the aPTT and the HID in the current group (r = -.02, P = .71). The anti-factor Xa level showed a significantly positive correlation with the HID in the current group (r = .62, P < .0001)., Conclusions: A multipronged monitoring regimen slightly increased the amount of time that anticoagulation parameters were within range. Correlations between the HID and the aPTT differed based on anticoagulation protocol, with a positive correlation in the older protocol and no correlation in the new protocol. This may highlight a problem in study design and analysis that requires further examination. Further trials are needed to assess the most useful markers with which anticoagulation protocols for ECMO can be created, adjusted, and evaluated., (© The Author(s) 2015.)

Background: To introduce an updated version of the original Therapeutic Intervention Scoring System (TISS) applicable to critically ill children (TISS-C). This version was designed to assess patient acuity and nursing workload (NW) and to determine a relationship between such assessment and the incidence of adverse events., Methods: Reviewing previous versions of TISS, an updated TISS-C was developed. Items inapplicable to pediatric critical care were eliminated; items current to critical care were added; and items still valid were edited. The point system accounts for the wide range of care provided. Random patients from a predetermined period had TISS-C scores calculated. The TISS-C scores were also calculated on patients with documented adverse events. Baseline scores were compared with scores of patients in whom adverse events had occurred. We determined the pediatric intensive care unit (PICU) NW to be the product of the TISS-C score and the patient-nurse ratio (PNR)., Results: One hundred twenty-five random patients had a mean TISS-C of 14.6 ± 11.8. Patients with any adverse event (98) had a TISS-C of 19.9 ± 11.6 (P < .05). Using our PICU mean PNR of 1.4 (20 patients/14 nurses), the NW for patients with more severe events was 33.6 ± 15.9., Conclusions: Critically ill pediatric patients are more vulnerable to experience adverse events when their derived NW values are high. It is postulated that a critical NW exists, where adverse events are more likely to occur., (© The Author(s) 2014.)

Background: Up to 40% of infants with persistent pulmonary hypertension (PPHN) remains refractory to conventional therapies, and extracorporeal membrane oxygenation (ECMO) is offered as an effective support for this group. However, ECMO is a highly invasive and risky procedure with devastating complications such as intracranial hemorrhage (ICH). In this study, we aimed to determine the risk factors for ICH in infants with PPHN., Methods: A case-control study of patients admitted to the pediatric intensive care unit (PICU) with PPHN requiring ECMO support was conducted. The study was carried out at a 25-bed PICU in large urban tertiary care children's hospital. A total number of 32 subjects were studied. Patients with and without ICH during ECMO were evaluated for activated clotting time (ACT), heparin dosing, platelet count, coagulation profile such as activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR), fibrinogen level, vital signs including heart rate and mean arterial pressure (MAP), transfusion history, gestational age, and severity of pre-ECMO illness as possible risk factors., Results: Low fibrinogen level (115 ± 13 mg/dl) and low platelet counts (37.4 ± 18.3 Thousand/μl) were associated with higher incidence of ICH (p = 0.009 and p = 0.005, respectively). Elevated MAP (69 ± 4.34 mmHg) was also noticed in ICH patients (p = 0.006)., Conclusions: Results demonstrated that low fibrinogen level and low platelet count were associated with ICH in PPHN patients on ECMO. While on ECMO support, maintaining fibrinogen and platelet counts within normal ranges seems crucial to prevent ICH in PPHN patients. This is the first report identifying low fibrinogen level among the risk factors for ICH in infants with PPHN on ECMO support.

Vaginal sildenafil citrate (Viagra, Pfizer, Inc., New York, NY) has been shown to be useful in increasing endometrial thickness and achieving pregnancy in women with varied uterine disorders. However, it failed to demonstrate favorable results in the setting of Asherman's syndrome, a condition characterized by the presence of uterine synechiae. We have successfully applied this treatment in two women noted to have inadequate endometrium after surgical resection of uterine synechiae. Both patients had a history of a postpartum uterine curettage with subsequent secondary infertility. Asherman's syndrome was surgically demonstrated and treated in both patients. Postoperatively, both patients were noted to have a thin endometrium and failed to conceive despite fertility treatment. Subsequently, these women achieved pregnancy in the first treatment cycle with vaginal sildenafil citrate. Using transvaginal ultrasound, endometrial thickness was noted to improve when sildenafil citrate was administered. It is suspected that this medication causes selective vasodilatation, resulting in improved endometrial development.

Background: Treatment of cervical cancer is often effective but at the cost of the woman's fertility. Ovarian transposition with subsequent oocyte retrieval and surrogate pregnancy can enable these patients to become genetic parents. We present the third reported such case., Case: A 22-year-old woman was diagnosed with bulky, stage IB cervical cancer. Following transposition of both ovaries to the upper abdomen, she underwent pelvic irradiation followed by total abdominal hysterectomy. Eleven years later she presented for assisted reproduction. Two oocytes were retrieved following ovarian stimulation and transcutaneous, abdominal oocyte retrieval. One embryo was transferred to the gestational surrogate, resulting in a single intrauterine pregnancy and successful delivery at term., Conclusion: These procedures can preservefertility while successfully treating cervical cancer.

Prolactin (PRL) is a 23-kDa hormone produced by the pituitary and extrapituitary sites. The main target of PRL is the breast, where it affects cellular growth, differentiation, and milk production. Recent evidence suggests that locally produced PRL plays a role in breast tumorigenesis. Our objective was to examine PRL synthesis/release in different tissues of the human breast and determine the effect of ovarian steroids. Breast tissue, obtained from women undergoing mastectomy or breast reduction, was separated into glandular (nonmalignant) and adipose explants and incubated for 10 d. Conditioned media were analyzed for PRL by a bioassay. PRL release from glandular explants decreased by 60% from d 1-3, followed by a 4-fold increase on d 10. PRL release from adipose explants was unchanged from d 1-3 and increased more than 10-fold by d 10. PRL gene expression, determined by RT-PCR, was low on d 0 and markedly increased on d 10 in both types of explants. De novo synthesis of PRL was confirmed by metabolic labeling. Progesterone suppressed PRL release from glandular explants without affecting adipose explants. Estradiol did not alter PRL release from either tissue. In conclusion, the human breast produces and releases bioactive PRL, with a higher release rate by adipose than glandular tissue. The time-dependent rise in PRL release suggests removal from inhibitory control. Progesterone may be one of the factors that suppresses PRL production in the glandular compartment, whereas the factor(s) that regulate adipose PRL are unknown. These data suggest an autocrine/paracrine role for PRL in human glandular and adipose breast tissue.

Prolactin (PRL) has a dual function -- as a circulating hormone and as a cytokine. This understanding is based on PRL production and distinct regulation in extrapituitary sites, its binding to membrane receptors of the cytokine receptor superfamily, and activation of signaling pathways that promote cell growth and survival. There is increasing evidence that PRL plays a role in several types of cancer in reproductive and non-reproductive tissues via local production or accumulation. The expression of both PRL and its receptor in human cancer cell lines of diverse origin lends further support to its action as an autocrine/paracrine growth factor. Establishment of PRL as an active participant in tumorigenesis should inspire the development of novel therapies aimed at reducing tumor growth by suppressing PRL production or by blocking its receptors.

Background: Methotrexate is an effective, safe, low-cost alternative to surgery for treating tubal pregnancies. To our knowledge, there have only been two other reported attempts at treating abdominal pregnancy with methotrexate., Case: Despite two courses of treatment with methotrexate, the pregnancy persisted, and laparoscopy permitted a tissue diagnosis of abdominal pregnancy., Conclusion: Although treatment with methotrexate was not successful in this case, its potential use in abdominal pregnancies merits further investigation.

Purpose: The purpose of this study was to assess the predictive value of a modified form of Kruger's strict criteria for sperm morphology for pregnancy outcomes after intrauterine insemination (IUI) and controlled ovarian hyperstimulation (COH) in the presence of normal sperm concentration and motility., Materials and Methods: A retrospective review of 42 couples undergoing COH/IUI was stratified by favorable or unfavorable sperm morphology. End points were pregnancy or failure of treatment as defined by four or more cycles of COH/ IUI without pregnancy., Results: An unfavorable morphology (< 4%) was highly predictive of failure during COH-IUI (94.45%; 17/18). A normal PIF was a sensitive indicator of those patients who became pregnant (93.8%; 15/16) and had a fair specificity for failure to achieve pregnancy after four cycles of treatment (65.4%; 17/26). Couples with a favorable sperm morphology were 28.3 times as likely to achieve a pregnancy within four cycles of treatment as those with unfavorable sperm morphology [95% confidence limits, 3.2 to 250.5; P < 0.001]., Conclusions: Abnormal strict morphologic assessment is both sensitive and specific for pregnancy outcomes in couples undergoing COH/IUI. Couples with persistently unfavorable sperm morphology should be counseled appropriately and would be better served by more aggressive treatment with in vitro fertilization and embryo transfer.

Alloxan diabetes (sucrose blood concentration greater than or equal to 14 mmol/l) induced lymphocytopenia in noninbred male mice, resulting from the decrease in the number of both T and B lymphocytes differentiated by their reaction to acid phosphatase. At the same time thymic bone marrow lymphopoiesis in mice with diabetes was depressed. Nodular and splenic lymphopoiesis remained virtually unchanged. These disturbances became apparent on the 3rd week after diabetes induction. Alloxan itself has no inhibitory effect on lymphopoiesis.