Sovateltide (ILR-1620) Improves Motor Function and Reduces Hyperalgesia in a Rat Model of Spinal Cord Injury.

BACKGROUND: Spinal cord injury (SCI) presents a major global health challenge, with rising incidence rates and substantial disability. Although progress has been made in understanding SCI's pathophysiology and early management, there is still a lack of effective treatments to mitigate long-term consequences. This study investigates the potential of sovateltide, a selective endothelin B receptor agonist, in improving clinical outcomes in an acute SCI rat model. METHODS: Thirty male Sprague-Dawley rats underwent sham surgery (group A) or SCI and treated with vehicle (group B) or sovateltide (group C). Clinical tests, including Basso, Beattie, and Bresnahan scoring, inclined plane, and allodynia testing with von Frey hair, were performed at various time points. Statistical analyses assessed treatment effects. RESULTS: Sovateltide administration significantly improved motor function, reducing neurological deficits and enhancing locomotor recovery compared with vehicle-treated rats, starting from day 7 post injury. Additionally, the allodynic threshold improved, suggesting antinociceptive properties. Notably, the sovateltide group demonstrated sustained recovery, and even reached preinjury performance levels, whereas the vehicle group plateaued. CONCLUSIONS: This study suggests that sovateltide may offer neuroprotective effects, enhancing neurogenesis and angiogenesis. Furthermore, it may possess anti-inflammatory and antinociceptive properties. Future clinical trials are needed to validate these findings, but sovateltide shows promise as a potential therapeutic strategy to improve functional outcomes in SCI. Sovateltide, an endothelin B receptor agonist, exhibits neuroprotective properties, enhancing motor recovery and ameliorating hyperalgesia in a rat SCI model. These findings could pave the way for innovative pharmacological interventions for SCI in clinical settings.

Sexual Function of Male Survivors of Hematological Malignancy Treated by Autologous Hematopoietic Stem Cell Transplantation: A Multicenter Controlled Observational Study.

A multicenter, observational, cross-sectional study was conducted to assess the sexual function of male survivors of hematological malignancy treated by autologous hematopoietic stem cell transplantation (AHSCT) and to compare it with that of healthy male controls. By convenience sampling, 71 sexually active male survivors of hematological malignancy who underwent AHSCT were recruited, as well as 74 healthy men. A questionnaire with demographic and clinical data and the International Index of Erectile Function (IIEF) were completed. Survivors had a median age of 47 years, a median time since transplant of 3 years, and 46.5% had Hodgkin lymphoma. Based on the IIEF, they had a high level of sexual function, with best functioning domain "erection" and worst "overall satisfaction". Healthy men had statistically significantly higher scores in all domains of the IIEF, except for "orgasm" (p = 0.205). There was a statistically significant association between sexual function and age (p < 0.0005), years since transplantation (p = 0.006), functional status (p < 0.0005), having children (p < 0.0005), relationship status (p = 0.001), education (p < 0.0005), diagnosis (p < 0.0005) and disease relapse (p = 0.017). Multivariate analysis showed that only age was a strong prognostic factor of sexual function (p < 0.0005). After age was excluded from the model, because of the strong effect it had on the dependent variable, functional status (p = 0.015), education (p = 0.002) and diagnosis (p = 0.001) had a statistically significant association with sexual function. These findings indicate the importance of sexual function for survivors' well-being and the need for implementation of integrated care plans for survivors of hematological malignancy.

Fibroblast Growth Factor 23 (FGF23) and Klotho Protein in Beta-Thalassemia.

Derangements in phosphate and calcium homeostasis are common in patients with beta-thalassemia. Fibroblast growth factor 23 (FGF23) is among the main hormones regulating phosphate levels, while several studies underline an interplay between iron (Fe) and FGF23. Herein, we investigated, for the first time, the serum intact molecule (iFGF23) and the carboxyl-terminal fragment (C-FGF23) and Klotho levels simultaneously in patients with beta-thalassemia major receiving iron chelation regimens in comparison to healthy control subjects. We also correlated them with the body iron burden. The observational case-control study included 81 subjects (40 thalassemic patients and 41 healthy controls). Serum iFGF23, C-FGF23 and Κlotho were measured by ELISA. Parathormone, 25-hydroxycholecalciferol, calcium, and phosphorus were measured in blood and/or urine. The degree of hemosiderosis was evaluated by assessing the serum ferritin levels and performing T2* MRI measurements. Serum C-FGF23 levels were significantly lower in patients compared to control subjects (p=0.04), while iFGF23 and Klotho levels did not differ. Serum C-FGF23 levels were negatively correlated with ferritin (r=-0,421, p=0.018), whereas there were no significant correlations of each of the three factors with the iron chelation therapy. Decreased serum C-FGF23 levels were found in ßTh patients which may be attributed to inhibition of proteolytic cleavage of iFGF23. Further studies in a greater number of patients will shed more light on the disturbances of the iFGF23, Klotho and C-FGF23 in thalassemia and their possible role in bone disease of such patients.

Depression as mediator and or moderator on the relationship between hopelessness and patients' desire for hastened death.

PURPOSE: Previous findings have shown that depression in advanced stages of cancer is associated with hopelessness and frequently with wishes for hastened death. The current study tries to investigate the relationship between hopelessness and desire for hastened death and if depression may be a moderator and/or mediator role in patients with advanced cancer. METHOD: The participants were 102 patients with advanced cancer which they completed the Beck Hopelessness Scale (BHS), the Greek Schedule of Attitudes towards Hastened Death (G-SAHD), and the Greek Beck Depression Inventory (BDI). RESULTS: Depression was highly correlated with hopelessness and desire for hastened death. Mediation analyses revealed that hopelessness influenced desire for hastened death as well as indirectly by its effect on depression. Similarly, depression was found as moderator in the relationship between hopelessness with desire for hastened death. CONCLUSIONS: Hopelessness and desire for hastened death in patients with advanced cancer should be diagnosed and treated by taking into consideration the optimum care of depression as a priority in palliative care.

Psychometric Properties of the Multidimensional Scale of Perceived Social Support in Greek Nurses.

BACKGROUND: Psychosocial well-being in the workplace may increase retention of oncology nurses, while a lack of social support has been a predictor of occupational stress in nurses. PURPOSE: To further explore this phenomenon by examining the psychometric properties of the Multidimensional Scale of Perceived Social Support in Greek nurses working in oncology and mental health settings. METHODS: A cross-sectional design was used. The sample consisted of 150 nurses (70 oncology nurses and 80 mental health nurses) from the area of greater Athens who joined the study. The scale was translated to Greek using the "forward-backward" procedure. The Multidimensional Scale of Perceived Social Support's internal consistency reliability (Cronbach's α), stability (intraclass correlation coefficient), factor structure (factor analysis), and convergent validity (correlation with Ways of Coping Questionnaire) were examined. RESULTS: A three-factor (significant others, family, and friends) model was confirmed. The subscales representing the three factors demonstrated excellent internal consistency reliability (Cronbach's αs > .90) and stability intraclass correlation coefficient (>.90). CONCLUSIONS: The measure is reliable and valid, and it can be used to assess nurses' social support; the results of such an assessment could be helpful when selecting strategies for assisting nurses.

Factors Affecting Opioid Treatment in Cancer Patients.

PURPOSE: Pain is prevalent in cancer patients, appearing to be moderate to severe in more than one third of them. Despite the fact that fentanyl is widely used with effective analgesic results, some patients do not correspond to treatment, resulting in opioid change. METHODS: This is a cohort study, performed in Greek patients with cancer. Its scope was to identify potential reasons responsible for opioid change, due to transdermal-fentanyl intolerance, resulting from inadequate analgesia (pain relief<33% in 1week) and/or unacceptable adverse-events (grade≥3 at Common Terminology Criteria-v4.0). The final sample included 289 participants. To investigate responsible reasons for transdermal-fentanyl intolerance we studied its relation with patients' history, haematology, biochemistry, body-mass-index, demographic and disease related characteristics. The Eastern Cooperative Oncology Group performance status scale, the Mini Mental State Examination questionnaire, the M.D.Anderson Symptom Inventory and the Greek Brief Pain Inventory were also used to measure performance status and quality-of-life for the same reason. RESULTS: Almost one third of the patients had to change to an alternative opioid oral-morphine in order to achieve adequate analgesia or/and avoid adverse-events. The most common adverse-events observed were nausea/vomiting and sleepiness. Statistical analysis demonstrated that younger age (OR=0.976) and obesity (OR=0.29 against underweight, OR=0.39 against normal, OR=0.48 against pre-obese) had a higher possibility to contribute to modification of the analgesic treatment. Furthermore, a higher impact of symptoms in patient's life (OR=1.184) and chemotherapy (OR=2.109) could also contribute to the need of change of the opioid analgesic medication. CONCLUSION: This study found significant variables for transdermal-fentanyl intolerance. This knowledge may help person-center care in moderate to severe cancer pain. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.

Advanced Cancer Patients' Perceptions of Dignity: The Impact of Psychologically Distressing Symptoms and Preparatory Grief.

PURPOSE: The present study assesses the relationship between patient dignity in advanced cancer and the following variables: psychological distress, preparatory grief, and sociodemographic and clinical characteristics. METHODS: The sample consisted of 120 patients with advanced cancer. The self-administered questionnaires were as follows: the Preparatory Grief in Advanced Cancer Patients (PGAC), the Patient Dignity Inventory-Greek (PDI-Gr), the Greek Schedule for Attitudes toward Hastened Death (G-SAHD), and the Greek version of the Hospital Anxiety and Depression Scale (G-HADS). RESULTS: Moderate to strong statistically significant correlations were found between the 4 subscales of PDI-Gr (psychological distress, body image and role identity, self-esteem, and social support) with G-HADS, G-SAHD, and PGAC ( P < .005), while physical distress and dependency was moderately correlated with depression. Multifactorial analyses showed that preparatory grief, depression, and age influenced psychological distress, while preparatory grief, depression, and performance status influenced body image and role identity. CONCLUSIONS: Preparatory grief, psychological distress, and physical symptoms had significant associations with perceptions of dignity among patients with advanced cancer. Clinicians should assess and attend to dignity-distressing factors in the care of patients with advanced cancer.

Experimental Hemorrhagic Shock Protocol in Swine Models: The Effects of 21-Aminosteroid on the Small Intestine.

BACKGROUND: The protective potential of lazaroids has been reported in previous studies on ischemia/reperfusion and induced hemorrhagic shock protocols. OBJECTIVES: The present study is the first experimental protocol on the effects of the antioxidant factor U-74389G on the small intestine of swine models in a hemorrhagic shock protocol and resuscitation with 3 different types of fluids. METHODS: The study included 49 Landrace breed swine that were divided into groups of 7 each. Hemorrhage was provoked 45 minutes after starting the surgical protocol (0 minutes), followed by resuscitation starting 30 minutes after haemorrhage ceased by using 3 different fluids. Three groups (Group A, resuscitation using blood; Group B, resuscitation with Ringer's lactate solution; and Group C, resuscitation with hypertonic saline solution) underwent resuscitation with fluid alone, and another 3 groups (named A', B,' and C') were administered lazaroid U-74389G in addition to fluid. Control Group S underwent all the surgical procedures without hemorrhagic shock. Vital signs, complete blood count, and biochemical markers were analyzed, and tissue samples of the small intestine were collected from all animals. Further, malondialdehyde, tumor necrosis factor-α, and levels of inflammation in the tissue sample were measured. RESULTS: In Group S-A-A' and Group S-C-C', the analysis did not show statistically significant differences in the percentage changes of histopathology, malondialdehyde, and tumor necrosis factor-α through time. In Group S-B-B', the malondialdehyde levels in the small intestine were reduced in both the B and B' groups, without lazaroid (Group B) (P = 0.038) and lazaroid (Group B') (P = 0.011), compared with Group S (control), but the group without lazaroid (Group B) had greater reduction in malondialdehyde levels than the group treated with lazaroid (Group B'). With regard to the biochemistry results, 24% reduction was observed for alkaline phosphatase (P = 0.022) in Group A' treated with lazaroid compared with that in the untreated group. Lastly, for the complete blood count parameters, a 14% reduction in white blood cells was observed in Group B', which was treated with lazaroid in all phases (P = 0.015) (absolute value = 6.23) compared with Group B (absolute value = 13.74). CONCLUSIONS: Despite few initial findings of this study suggesting that administration of lazaroid U-74389G may have some potential in attenuation of the effects of hemorrhagic shock in the small intestine of swine models, no differences remained after correction for multiple comparisons was made. Therefore, further research is required to investigate this result thoroughly.

Attachment orientations of Greek cancer patients in palliative care. A validation study of the Experiences in Close Relationships scale (ECR-M16).

PURPOSE: Health-care professionals may serve as attachment figures, nevertheless little research has been made in the palliative context. The psychometric properties of the brief ECR-M16 in Greek cancer patients were explored. METHODS: The ECR-M16 was translated into Greek (G-ECR-M16), and was administered to 100 patients before starting palliative care and 7 days later to test its stability. Patients (N=35) also completed the EORTC QLQ-C30 scales. RESULTS: Cronbach's alphas for the discomfort for closeness, anxiety and avoidance scales were 0.871, 0.762, and 0.761, respectively. Test-retest reliability was very satisfactory (p< 0.0005). Factor analysis yielded three factors (58.75% of the variance). Known-groups validity showed that discomfort with closeness had a statistically significant correlation with advanced disease stage (p=0.022). CONCLUSIONS: The G-ECR-M16 is a valid research tool for the attachment patterns' impact in Greek cancer patients.

Reliability and Validity of the Greek Version of Patient Generated-Subjective Global Assessment in Cancer Patients.

The authors sought to determine the reliability and validity of psychometric properties of the Greek Patient-Generated Subjective Global Assessment (PG-SGA) in cancer patients attending a palliative care unit. The scale was translated into Greek. The study took place in an outpatient palliative care unit and 238 cancer patients completed the nutrition assessment. For treatment effect, the index was administered to 164 patients, whereas for the test of the instrument's robustness to 100 patients. Both assessments took place 15 days after the baseline assessment. Ninety-three patients were well-nourished, 104 were moderately malnourished, and 41 were severely malnourished. Reliability was assessed by the internal consistency and test-retest of the instrument. Validity was assessed with construct validity using the PG-SGA items, treatment effect, and criterion validity. Weight loss, physical examination, activities and function, and symptoms were predictors to the classification. Mean values in male patients classified as severely malnourished had the lowest values in all objective parameters except serum albumin, whereas severely malnourished female patients had the lowest values in all objective parameters except serum albumin and arm muscle circumference (AMC). Values of serum transferrin, AMC, and body mass index were significantly lower in patients classified as severely malnourished. The Greek PG-SGA is a psychometrically sound assessment in Greek cancer patients.

The influence of sense of control and cognitive functioning in older cancer patients' depression.

OBJECTIVE: This study aimed to evaluate the associations between depression, sense of control, and cognitive functioning, as well as the predictive power of sense of control and cognitive functioning in older cancer patients' depression. METHODS: Eighty-six cancer patients were referred to a palliative care unit. They completed the 15-item Geriatric Depression Scale, the Cancer Locus of Control, and the Mini Mental State Examination questionnaires. RESULTS: Higher perceived control over the 'course of illness' was associated with higher levels of depressive symptoms (p < 0.0005), whereas lower perceived control over the 'cause of illness' was associated with higher depressive symptoms. The same results were found for 'cause of illness' between non-depressed and depressed patients (p = 0.001). Multivariate analysis revealed that whereas an external orientation in 'course of illness' increased the likelihood of depression (p = 0.002), an external orientation in 'cause of illness' decreased the likelihood of depression (p = 0.05). CONCLUSIONS: Older cancer patients' sense of control orientation over the course of illness and the cause of illness predicted the levels of depressive symptomatology.

Effect of parathyroidectomy versus risedronate on volumetric bone mineral density and bone geometry at the tibia in postmenopausal women with primary hyperparathyroidism.

The objective of the study was to evaluate the effect of parathyroidectomy (PTX) versus 35 mg once-weekly (ow) risedronate administration on volumetric bone mineral density (vBMD) and bone geometry at the tibia in postmenopausal women with primary hyperparathyroidism (PHPT). Our open-label prospective observational study included 32 postmenopausal women with PHPT as the study group: 16 underwent PTX and 16 were treated with 35 mg ow risedronate for 2 years. We assessed areal BMD (aBMD) by DXA, and vBMD and bone mineral content (BMC) (cortical and trabecular area) by peripheral quantitative computed tomography (pQCT) at the tibia at baseline and at 2 years. Risedronate did not result in any significant change on vBMD and structural pQCT indices. PTX resulted in significant increase in trabecular (trab) BMC (6.44 %) and vBMD (4.64 %), with percent increase being significantly higher than risedronate (p < 0.05). At cortical sites, there was no significant change following PTX. However, the percent change in cortical (cort) vBMD was higher following PTX versus risedronate (0.39 % vs. -0.26 %, p < 0.05). In conclusion, in postmenopausal women with PHPT, PTX is superior to ow risedronate, in terms of improvement of trabecular mineralization and vBMD at the tibia, whereas the effect at cortical sites is less pronounced.

Enhancement of bone regeneration with the combination of platelet-rich fibrin and synthetic graft.

INTRODUCTION: Platelet-rich fibrin (PRF) is a relatively new developed platelet concentrate with several benefits over platelet-rich plasma. The aim of this study was to compare healing properties of PRF and its combination with a ceramic synthetic material (graft) composed of hydroxyapatite and b-tricalcium phosphate in an animal model. METHODS: A bone deficit was surgically created in each femoral condyle of 15 New Zealand white rabbits. In each animal, 1 limb had (a) PRF only and the other (b) PRF plus synthetic graft material randomly implanted. Experimental animals were killed 3 months postoperatively. Histological and radiological examinations were made by means of computed tomography and peripheral quantitative computed tomography. RESULTS: Mean density of the healed bone was statistically significantly greater when synthetic material was used (P < 0.0005). Moreover, combination of PRF with the synthetic material resulted in more cortical and subcortical bone formation (P = 0.038 and P = 0.037, respectively). CONCLUSIONS: The addition of the ceramic material significantly increased the formation of new bone, providing a better substrate for bone regeneration.

Activities of daily living in Greek cancer patients treated in a palliative care unit.

GOALS OF WORK: To assess the psychometric properties of the Activities of Daily Living (ADL) scale on a Greek sample of advanced cancer patients. PATIENTS AND METHODS: The scale was translated with the forward-backward procedure to Greek. The ADL scale was administered to 136 advanced cancer patients. It was administered twice, with a 3-day interval, to 40 (of the 136) eligible patients with advanced cancer to assess the scale's stability. For the assessment of treatment effect, the index was administered to 90 (of the 136) patients 15 days later. Together with the ADL scale, the patients also completed the Instrumental Activities of Daily Living (IADL) scale. Confirmatory factor analysis was carried out using the AMOS 7.0 analysis. The reliability was assessed by the internal consistency (Cronbach's alpha co-efficients), and test/retest (Spearman's r value) of the instrument. Validity was assessed with construct validity using the IADL scale, treatment-effect, known groups, and convergent validity. MAIN RESULTS: The homogeneity of the scale proved to be satisfactory (cronbach alpha = 0.88). Overall test-retest reliability was satisfactory. Construct validity has shown satisfactory correlations with IADL p < 0.0005. Convergent validity and treatment effect were satisfactory at p < 0.0005 and p < 0.05, respectively. Known groups validity detected differences according to patient's performance status (p < 0.0005). CONCLUSIONS: The results suggest that the Greek version of ADL administered in cancer patients treated in a palliative care unit is a reliable and valid clinical instrument.

Can the Day of the Week and the Time of Birth Predict the Mode of Delivery According to Robson Classification?

Worldwide, the cesarean section rate has steadily increased from 6.7% in 1990 to 21.1% in 2018 and is expected to rise even more. The World Health Organization propose the adoption of the Robson classification system as a global standard for monitoring, evaluating, and comparing delivery rates. The purpose of the current study is to use the Robson classification system to investigate how, independently of medical factors, the day of the week and time of delivery may be related to the mode of birth. In the sample analysis, we included the records of 8572 women giving birth in one private health facility in Greece. Over 60% of deliveries during the study period were performed by cesarean section, 30.6% by vaginal delivery, and 8.5% of deliveries were performed by operative vaginal delivery. The results of this study indicate that the lowest birth rates are observed on Monday, Saturday, and Sunday. Nulliparous women with no previous cesarean delivery, with a singleton in cephalic presentation ≥37 weeks with spontaneous labor (group 1) are 73% more likely to deliver by cesarean section between 08:00 A.M. and 03:59 P.M. compared to those who give birth between 12:00 A.M. and 07:59 A.M. Also, multiparous women with a single cephalic term pregnancy and one previous cesarean section (group 5.1) are 16.7 times more likely to deliver by cesarean section in the morning compared to overnight deliveries. These results point out two non-clinical variables that influences the CS rate. The Robson classification system was a useful tool for the above comparisons.

Implementation of the Robson Classification in Greece: A Retrospective Cross-Sectional Study.

Cesarean sections have become the most commonly performed operations around the world. The World Health Organization recommended the use of the Robson classification system as a universal standard to establish a joint control system in healthcare facilities. The aim of this study was to implement the Robson classification for the first time in Greece to identify trends in cesarean births and examine the groups of women who are the main contributors to the increasing rates. Moreover, the indicators for cesarean sections will be evaluated as per the Robson classification. In the sample analysis, we included the records of 8572 women giving birth in one private health facility in Greece. A total of 8572 women gave birth during the study period, of which 5224 (60.9%) were cesarean section births and 3348 (39.1%) were vaginal births. In our study, according to the Robson classification, the largest contributors to the overall CS rate were as follows: (a) nulliparous women with a single cephalic term pregnancy, who were either labor induced or delivered by cesarean section before labor-Group 2 (34.6%); (b) multiparous women with a single cephalic term pregnancy and at least one previous cesarean section-Group 5 (30.7%); (c) women with a single cephalic preterm pregnancy-Group 10 (11.7%); (d) women with multiple pregnancies-Group 8 (7.0%). Our study is expected to assist policymakers in Greece in planning further interventions for each subgroup of women in order to reduce the overall CS rate and unnecessary CSs.

Sexual Function in Women Survivors of Hematologic Malignancy after Autologous Hematopoietic Stem Cell Transplantation.

A multicenter, cross-sectional study was conducted to assess the sexual function of women survivors of hematologic malignancy after autologous hematopoietic stem cell transplantation (AHSCT), and to compare it with that of healthy women controls. Fifty-six sexually active women survivors of hematologic malignancy who underwent AHSCT were recruited through convenience sampling, as well as 60 healthy women. Demographic and clinical data questionnaires and the Female Sexual Function Index (FSFI) were completed. Survivors had a median age of 44 years and a median time since transplant of 3 years, while 48.2% had Hodgkin Lymphoma. Survivors reported an average level of sexual dysfunction, with a total score mean ± SD = 22.51 ± 8.95. The best sexual functioning domain was "pain" and the most affected was "orgasm". There was a statistically significant association between survivors' sexual function and age (p < 0.0005) in both the unifactorial and the multifactorial analysis. In addition, there was a statistically significant association between survivors' sexual function and functional status (p < 0.0005), menopausal status (p < 0.0005), the presence of children (p = 0.002), education (p < 0.0005), and diagnosis (p < 0.0005). Healthy women had statistically significantly higher scores in all FSFI subscales (p < 0.0005). Women survivors of hematologic malignancy, treated by AHSCT, had impaired sexual function, implying the need to implement regular sexual health assessment in survivorship care.

The Effect of Ceratonia siliqua Supplement on Bone Mineral Density in Ovariectomy-induced Osteoporosis in Rats.

AIM: This study aimed to investigate the effect of Ceratonia siliqua on bone mineral density (BMD) as a non-pharmaceutical alternative treatment for postmenopausal osteoporosis. MATERIALS AND METHODS: Thirty mature female Wistar rats were randomly separated into three groups of 10: Control, ovariectomized (OVX), and ovariectomized-plus-C. siliqua (OVX+CS). Total and proximal BMD were measured by dual-energy X-ray absorptiometry (DEXA) in all groups before ovariectomy, and at 3 and 6 months postoperatively. At the end of the study, the femurs were subjected to a three-point bending test. RESULTS: DEXA revealed no statistically significant difference in absolute values or percentage changes for total tibial BMD between OVX+CS and OVX groups throughout the study. In the proximal tibia, both absolute values and BMD percentage changes from baseline were higher in the OVX+CS group compared to the OVX group after 3 and 6 months of C. siliqua administration. Three-point bending test revealed a significantly higher thickness index in the OVX+CS group compared to the OVX group and a higher cross-sectional area index compared to the control group. CONCLUSION: Long-term administration of C. siliqua may be considered a non-pharmaceutical alternative treatment for postmenopausal osteoporosis. Further research is required to properly investigate the effects, and suitable treatment dose and schedule.

A test of the psychometric properties of the cancer locus of control scale in Greek patients with advanced cancer.

OBJECTIVE: The study aimed to assess the psychometric properties of the Cancer Locus of Control (CLOC) scale on a Greek sample of advanced cancer patients. METHODS: The scale was translated with the forward-backward procedure to Greek. The CLOC scale was administered to 140 advanced cancer patients. It was administered twice, with a 3-day interval, to 100 (of the 140) eligible patients with advanced cancer. Together with the CLOC scale, the patients also completed the Greek Mental Adjustment to Cancer (G-MAC) scale. Confirmatory factor analysis was carried out using the AMOS 7.0 analysis. The reliability was assessed by the internal consistency (Cronbach's α coefficients), test-retest (Spearman's r value) of the instrument, and inter-item correlations. Construct validity was assessed using the G-MAC scale, interscale correlations, item-scale correlations, and scales-total correlations. RESULTS: The homogeneity of the subscales proved to be satisfactory (α coefficient ranged from 0.713 to 0.786). Overall test-retest reliability was satisfactory at p < 0.0005. Construct validity has shown moderate correlations with G-MAC p < 0.0005. Interscale and inter-item correlations were satisfactory at p < 0.05. CONCLUSIONS: The results suggest that the Greek version of CLOC administered in cancer patients treated in a palliative care unit is a reliable and valid clinical instrument.

Study protocol of a randomised controlled trial for the effectiveness of a functional partial body weight support treadmill training (FPBWSTT) on motor and functional skills of children with ataxia.

INTRODUCTION: A great heterogeneity characterises the paediatric population with ataxia, which has been studied poorly. The lack of postural control and coordination, in addition with features of the 'ataxic' gait are linked with functional limitations. Studies on physiotherapy interventions for children with ataxia are highly needed for identifying optimal training strategies for improving motor and functional related skills. METHODS AND ANALYSIS: A stratified randomised control clinical trial of a 4-week functional partial body weight support treadmill training, (5 days/week 45 min/day) and 2-month follow-up period will be applied in children with ataxia, aged 8-18 years old with Gross Motor Function Classification System II-IV. Participants will be allocated to experimental group (intervention and usual care) or control group (usual care), using stratified randomisation process into two strata (progressive and non-progressive ataxia). Participants will be assessed at baseline, by the end of the 4-week period and by the end of a 2-month period as a follow-up measurement. Motor and functional skills will be assessed using the Gross Motor Function Measure-D and E, the Pediatric Balance Scale, the 10-meter walk test, the 6-minute walk test, the Scale for Assessment and Rating Ataxia, the timed up and go test and children's spatiotemporal gait features will be assessed through GaitSens software recording over a 2 min low treadmill gait speed, while three-dimensional gait analysis will be performed for kinetic and kinematic analysis of the lower limbs in all three levels of movement. Two-way mixed Analysis of Variance (ANOVA) with factors 'intervention' (between group) and 'time' (within group) will be used for the analysis of all parameters. Analysis of Covariance (ANCOVA) will be used in case of imbalance of baseline measurements. Statistical significance will be set at p<0.05 using the statistical package SPSS V.21.00. ETHICS AND DISSEMINATION: University of West Attica (study's protocol: 14η/26-04-2021) and 'ATTIKON' General University Hospital of Athens (study's protocol: Γ ΠΑΙΔ, ΕΒΔ 149/20-3-2020). Trial results of the main trial will be submitted for publication in a peer-reviewed journal and/or international conference. TRAIL REGISTRATION NUMBER: ISRCTN54463720.