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Background: Doll therapy (DT) is a non-pharmacological intervention for the treatment of the behavioural and psychological symptoms of dementia (BPSD). We designed a single-blind randomized controlled trial of the 30-day efficacy of DT in reducing the BPSD, professional caregivers' distress and patients' biomarkers of stress, and in improving the exploration and caregiving behaviours. Methods: We randomly assigned 134 women with moderate-to-severe dementia living in nursing homes (NHs) to a DT intervention (DTI, 67) or a sham intervention with a cube (SI, 67). Results: From the first to the 30th session, the DTI group showed a significant decrease in the Neuropsychiatric Inventory-NH (NPI-NH) total score and in the NPI-NH-Distress score compared to the SI group (both p < 0.001). We observed a greater interest in the doll than in the cube, a greater acceptance of a separation from the nurse among DTI participants, and caregiving and exploratory behaviours towards the doll. There were no differences between the groups in the stress biomarkers. Conclusions: Consistent with attachment theory, our findings support the 30-day efficacy of DT, as this non-pharmacological intervention promotes perceptions of security by creating a situation in which patients feel confident and engaged in a caregiving relationship with the doll and reduces the challenging behaviours that are stressful for professional caregivers.

Background: Doll therapy is a non-pharmacological intervention for people with dementia aimed to reduce distressing behaviours. Reliable results on the efficacy of Doll therapy for people with dementia are needed. The concept of attachment theorised by Bowlby has been proposed to explain the Doll therapy process, but it has not been proven to influence the response to doll presentation.Methods/design: This single-blind, randomised controlled trial will involve people with dementia living in nursing homes of the Canton Ticino (Switzerland). Participants will be randomised to one of two interventions: Doll Therapy Intervention or Sham Intervention with a non-anthropomorphic object, using a 1:1 allocation ratio. The two interventions will consist of 30 daily sessions lasting an hour at most, led by a trained nurse for an hour at most. We will enrol 64 participants per group, according to power analysis using an estimated medium effect size (f = 0.25), an alpha level of 0.05, and a power of 0.8. The primary goal is to test the efficacy of the Doll Therapy Intervention versus the Sham Intervention as the net change in the following measures from baseline to 30 days (blinded outcomes): the Neuropsychiatric Inventory-Nursing Home administered by a trained psychologist blinded to group assignment, the professional caregivers' perceived stress scale of the Neuropsychiatric Inventory-Nursing Home, patients' physiological indices of stress (salivary cortisol, blood pressure and heart rate) and interactive behaviours. The secondary goal is to assess the relationship between attachment styles of people with dementia (detected by means of the Adult Attachment Interview to the patients' offspring) and their caregiving behaviours shown during the Doll Therapy Intervention.Discussion: This is the first single-blind, randomised controlled trial on the efficacy of Doll therapy for dementia and an explanatory model of the response of people with dementia to doll presentation.

Objective This retrospective study aimed to compare the sentinel lymph node (SLN) mapping results of methylene blue (MB) and indocyanine green (ICG) in women with early-stage endometrial or cervical cancer. Methods From August 2011 to March 2015, all consecutive patients with stage I endometrial or cervical cancer who underwent SLN mapping with intracervical injection of MB or ICG using a 22-gauge spinal needle were included in the study. Radical or simple hysterectomy with bilateral pelvic and/or aortic lymphadenectomy was performed after SLN mapping. Results Overall, 81 women (64 women with endometrial cancer and 17 women with cervical cancer) underwent surgery, including SLN mapping. Sixty-five patients (80%) underwent minimally invasive surgery. The overall detection rate was 84% (34 of 38) and 100% (43 of 43) for MB and ICG, respectively (P = 0.041). Bilateral SLN detection was higher in the ICG group than in the MB group (88% vs 50; P = 0.002). Eleven patients (13.5%) were found to have positive nodes with at least 1 positive SLN. The sensitivity and negative predictive value of SLN were 100%. Conclusions Real-time florescence mapping with ICG shows better overall detection rate and bilateral mapping than MB alone. In our pilot study, the differences are statistically significant. The higher number of bilateral mapping of ICG may increase the quality of life and recovery of women by reducing the need for complete lymphadenectomy.

The aim of this study is to evaluate the response rate to natural progesterone in non-atypical endometrial hyperplasia and to identify the lowest effective dose. A total of 197 patients of childbearing age with simple or complex hyperplasia were retrospectively identified. The women were treated with a cyclic administration of progesterone at different dosages (100 versus 200 versus 300 mg daily). Endometrial biopsies were performed at 6, 12, 18 months. In comparing progesterone to a regimen of no therapy, a significantly higher remission rate was observed in the progesterone group than in the latter (95 versus 75%, p = 0.05 for simple hyperplasia; 89 versus 35%, p < 0.001 for complex hyperplasia). Out of 60 women with simple hyperplasia, remission was observed in 9/11 (81.8%), 40/41 (97.5%) and 8/8 (100%) patients treated, respectively, with progesterone 100, 200 and 300 mg daily. Out of 72 women with complex hyperplasia, remission was observed in 3/5 (60%), 49/53 (92.4%) and 12/14 (85.7%) patients treated with progesterone 100, 200 and 300 mg daily, respectively. There was no statistically significant difference in the response rate in the two groups, neither with simple nor with complex hyperplasia. In conclusion, progesterone increased the regression rate of both simple and complex hyperplasia.

BackgroundTo assess the long-term oncological outcome and the fertility of young women with early-stage epithelial ovarian cancer (ES/EOC) treated with fertility-sparing surgery (FSS).Patients and methodsAll patients treated with FSS for ES/EOC in two Italian centers were considered for this analysis. Univariate and multivariate analyses were used to test demographic characteristics and clinical features for the association with overall survival (OS), recurrence-free survival (RFS) and fertility.ResultsFrom 1982 to 2010, 240 patients with malignant ES/EOC were treated with FSS in two tertiary centers in Italy. At a median follow-up of 9 years, 27 patients had relapsed (11%) and 11 (5%) had died of progressive disease. Multivariate analysis found only grade 3 negatively affected the prognosis of patients [hazard ratio (HR) for recurrence: 4.2, 95% confidence interval (CI): 1.5-11.7, P = 0.0067; HR for death: 7.6, 95% CI: 2.0-29.3, P = 0.0032]. Grade 3 was also significantly associated with extra-ovarian relapse (P = 0.006). Of the 105 patients (45%) who tried to become pregnant, 84 (80%) were successful.ConclusionsConservative treatment can be proposed to all young patients when tumor is limited to the ovaries, as ovarian recurrences can always be managed successfully. Patients with G3 tumors are more likely to have distant recurrences and should be closely monitored.

During laparotomy for ovarian cancer, three immature oocytes were retrieved from antral follicles. Oocyte were matured, cryopreserved and subsequently used in an IVF cycle in which one embryo was transferred.

Purpose: To assess the activity, efficacy, and tolerability of single-agent paclitaxel and a platinum-containing regimen in previously treated patients with recurrent ovarian cancer. Patients and Methods: Patients who achieved complete remission with platinum-based regimens and whose disease recurred after a progression-free interval of more than 12 months were included in the study. Every 21 days, patients received paclitaxel 175 mg/m(2) intravenously (IV) over 3 hours or cyclophosphomide 500 mg/m(2), doxorubicin 50 mg/m(2), and cisplatin 50 mg/m(2) (CAP) IV. Results: Between June 1992 and May 1995,97 consecutive patients with assessable or measurable disease were randomized to paclitaxel (n = 50) or CAP (n = 47). The median number of cycles on each arm was six. Toxicities included grade 3/4 leukopenia (4% for paclitaxel v 34% for CAP), grade 3/4 neutropenia (13% v 36%), grade 1/2 myalgia (19% v 4%), allergic reactions (15% v 2%), and grade 2/3 nausea and vomiting (17% v 51%). Complete responses were achieved in 17% and 30% of patients receiving paclitaxel and CAP, respectively, and partial responses were achieved in 28% and 25%, respectively (P = .062). At a median follow-up time of 49 months, median progression-free intervals were 9 months for paclitaxel and 15.7 months for CAP (Cox analysis: hazards ratio [HR], 0.60; 95% confidence interval [Cl], 0.37 to 0.97; P = .038); median overall survival times were 25.8 months for paclitaxel and 34.7 months for CAP (Cox analysis: HR, 0.58; 95% Cl, 0.34 to 0.98; P = .043). Conclusion: Rechallenge with either single-agent paclitaxel or platinum-based chemotherapy is effective in this patient population. Preliminary results suggest that single-agent paclitaxel may not be as active as platinum-based chemotherapy in recurrent ovarian cancer. Larger randomized trials are needed. (C) 2002 by American Society of Clinical Oncology.

Background: Hematopoietic toxicity of high-dose carboplatin (HD-CBDCA) chemotherapy can be managed effectively with autologous blood cell support, but no conclusive data are available on its the neuro- and ototoxicity. Patients and methods: We determined the neuro- and ototoxicity of HD-CBDCA in 10 patients affected by advanced ovarian cancer. HD-CBDCA was delivered as 24-hour continous infusion or as 5-day schedules. Each patient underwent an extended clinical and instrumental neurological and otological evaluation before, during and after treatment. Results: After HD-CBDCA only I patient had a clinically-evident peripheral neuropathy, while 3 additional patients had only distal paresthesias. Neurophysiological examination evidenced mild, although diffuse, sensory nerve impairment. Motor nerve impairment war also occasionally observed All the sensory and motor pathological changes had a favorable course during the follow-up period. Ototoxicity was more severe than neurotoxicity and, in one case it was dose-limiting and audiologic impairment tended to remain constant also in the follow-up period. Conclusions: HD-CBDCA treatment can be tolerated by most of the patients, but careful monitoring of neuro- and, especially, ototoxicity should be planned

To report and evaluate a conservative and individualized treatment policy in a homogeneously selected series of patients affected by pure ovarian immature teratoma.