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1.
World J Urol ; 42(1): 423, 2024 Jul 21.
Article in English | MEDLINE | ID: mdl-39033475

ABSTRACT

BACKGROUND AND PURPOSE: The present study aims to investigate the effects of external neuromuscular electrical stimulation (NMES) on urinary symptoms, pelvic floor muscle strength (PFMS), quality of life (QoL), sexual function, perception of subjective improvement (PSI), and satisfaction in urgency urinary incontinence (UUI). MATERIALS AND METHODS: The randomized sham-controlled study design was employed in this study. Women aged 18-65 years, who were diagnosed with UUI, were randomly allocated into the NMES (external NMES + lifestyle advice, n = 15) and sham groups (sham NMES + lifestyle advice, n = 15). Both groups performed the application for 30 min, three days a week for eight weeks. Urinary symptoms were evaluated by using the International Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) and a 3-day bladder diary. PFMS was assessed using the Modified Oxford Scale (MOS), QoL using the King's Health Questionnaire (KHQ), and sexual function using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). The PSI and satisfaction were questioned. RESULTS: There was a higher level of decrease in the ICIQ-SF score, the mean number of voids/night and UI, all scores related to the KHQ (excluding interpersonal relationships), and a higher level of increase in maximum voiding volume, MOS scores, PISQ-12-emotional, PISQ-12-physical, and PISQ-12-total scores in the NMES group when compared to the sham group (p < 0.05). PSI and satisfaction were at higher levels in the NMES group than in the sham group (p < 0.05). CONCLUSIONS: External NMES was an effective and complementary method in reducing urinary symptoms and improving PFMS, QoL, sexual function, PSI, and satisfaction level in women with UUI. CLINICAL TRIAL REGISTRATION: NCT04727983.


Subject(s)
Electric Stimulation Therapy , Quality of Life , Urinary Incontinence, Urge , Humans , Female , Middle Aged , Adult , Urinary Incontinence, Urge/therapy , Electric Stimulation Therapy/methods , Young Adult , Aged , Pelvic Floor , Muscle Strength/physiology , Adolescent , Treatment Outcome , Patient Satisfaction
2.
Cancer ; 129(17): 2685-2693, 2023 09 01.
Article in English | MEDLINE | ID: mdl-37129197

ABSTRACT

BACKGROUND: In lung cancer, overexpression of nuclear export proteins can result in inactivation of critical tumor suppressor proteins and cell-cycle regulators. Selective suppression of nuclear export proteins has immunomodulatory activities. Here, clinical safety and early efficacy data are presented on the combination of pembrolizumab and an oral selective nuclear export inhibitor, selinexor, for the treatment of metastatic non-small cell lung cancer (mNSCLC). METHODS: The primary objective of this prospective investigator-initiated study was to determine the safety and tolerability of selinexor in combination with pembrolizumab in patients with mNSCLC. Secondary objectives included determination of objective tumor response rate, disease control rate, and progression-free survival duration. RESULTS: A total of 17 patients were included in the final analysis. Fifteen (88%) received more than two lines of prior systemic therapy and 10 (59%) had prior exposure to anti-PD-1/programmed death-ligand 1 (PD-L1) therapy. The median age was 67.5 years. Ten patients had grade ≥3 adverse events related to selinexor treatment. Responses to treatment occurred in patients who did and did not undergo previous anti-PD-1/PD-L1 therapy and in patients with activating driver mutations. The median overall survival and progression-free survival were 11.4 months (95% CI, 3.4-19.8 months) and 3.0 months (95% CI, 1.7-5.7 months), respectively. The overall response rate was 18% and the 6-month disease control rate was 24%. CONCLUSIONS: Selinexor in combination with pembrolizumab demonstrated promising antitumor activity in patients with mNSCLC, including those who had previously received anti-PD-1/PD-L1 therapy. The therapy-related toxic effects were consistent with the prior safety data for both drugs, and no overlapping toxic effects were observed. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02419495. PLAIN LANGUAGE SUMMARY: New strategies to prevent or reverse resistance to immune checkpoint inhibitors are under investigation. Selective inhibitors of nuclear export proteins, such as selinexor, can induce restoration of tumor-suppressing pathways and induce potent immunomodulatory activities. This article contains the clinical safety and early efficacy data on the combination of pembrolizumab and selinexor in treatment of metastatic non-small cell lung cancer.


Subject(s)
Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Humans , Aged , Carcinoma, Non-Small-Cell Lung/drug therapy , Lung Neoplasms/pathology , B7-H1 Antigen , Prospective Studies
3.
Cancer ; 129(14): 2201-2213, 2023 07 15.
Article in English | MEDLINE | ID: mdl-37016732

ABSTRACT

BACKGROUND: Selinexor (KPT-330) is a potent inhibitor of exportin 1 (XPO1), in turn inhibiting tumor growth. Selinexor enhances the antitumor efficacy of eribulin in triple-negative breast cancer (TNBC) in vitro and in vivo. Given the unmet medical need in TNBC and sarcoma, the authors explored the safety and efficacy of this combination. METHODS: The authors conducted a phase 1b trial of combined selinexor and eribulin using a 3 + 3 dose-escalation design in patients who had advanced solid tumors and in those who had TNBC in a dose-expansion cohort. RESULTS: Patients with TNBC (N = 19), sarcoma (N = 9), and other cancers (N = 3) were enrolled in the dose-escalation cohort (N = 10) and in the dose-expansion cohort (N = 21). The median number lines of prior therapy received was four (range, from one to seven prior lines). The most common treatment-related adverse events for selinexor were nausea (77%), leukopenia (77%), anemia (68%), neutropenia (68%), and fatigue (48%). One dose-limiting toxicity occurred at the first dose level with prolonged grade 3 neutropenia. The recommended phase 2 dose was 80 mg of selinexor orally once per week and 1 mg/m2 eribulin on days 1 and 8 intravenously every 3 weeks. The objective response rate (ORR) was 10% in three patients. In the dose-escalation cohort, the ORR was 10%, whereas six patients with had stable disease. In the TNBC dose-expansion cohort (n = 18), ORR was 11%, and there were two confirmed partial responses with durations of 10.8 and 19.1 months (ongoing). CONCLUSIONS: Selinexor and eribulin had an acceptable toxicity profile and modest overall efficacy with durable responses in select patients. PLAIN LANGUAGE SUMMARY: Effective therapies for advanced, triple-negative breast cancer and sarcoma represent an unmet need. Exportin 1 is associated with the transport of cancer-related proteins. Preclinical studies have demonstrated tumor growth inhibition and enhanced tumor sensitivity in patients who receive selinexor combined with eribulin. In this phase 1b study, the authors evaluated the safety profile and clinical activity of the combination of selinexor, a potent oral inhibitor of exportin 1, and eribulin in patients with advanced cancers enriched for triple-negative breast cancer or sarcoma. The combination was well tolerated; most adverse events were mild or moderate, reversible, and managed with dose modifications or growth factor support. The combination of selinexor and eribulin produced an antitumor response, particularly in some patients with triple-negative breast cancer. This work lays the foundation for prospective investigations of the role of selinexor and eribulin in the treatment of triple-negative breast cancer.


Subject(s)
Neutropenia , Sarcoma , Soft Tissue Neoplasms , Triple Negative Breast Neoplasms , Humans , Triple Negative Breast Neoplasms/drug therapy , Triple Negative Breast Neoplasms/pathology , Prospective Studies , Sarcoma/drug therapy , Soft Tissue Neoplasms/drug therapy , Antineoplastic Combined Chemotherapy Protocols/adverse effects
4.
Oncologist ; 28(8): 714-721, 2023 08 03.
Article in English | MEDLINE | ID: mdl-36952233

ABSTRACT

BACKGROUND: Despite the clinical benefit of immune checkpoint inhibitors (ICIs), patients with a viral hepatitis have been excluded from clinical trials because of safety concerns. The purpose of this study was to determine the incidence rate of adverse events (AEs) in patients with viral hepatitis who received ICIs for cancer treatment. MATERIALS AND METHODS: We conducted a retrospective study in patients with cancer and concurrent hepatitis B or C, who had undergone treatment with ICI at MD Anderson Cancer Center from January 1, 2010 to December 31, 2019. RESULTS: Of the 1076 patients screened, we identified 33 with concurrent hepatitis. All 10 patients with HBV underwent concomitant antiviral therapy during ICI treatment. Sixteen of the 23 patients with HCV received it before the initiation of ICI. The median follow-up time was 33 months (95% CI, 23-45) and the median duration of ICI therapy was 3 months (IQR, 1.9-6.6). Of the 33 patients, 12 (39%) experienced irAEs (immune-related adverse events) of any grade, with 2 (6%) having grade 3 or higher. None of the patients developed hepatitis toxicities. CONCLUSION: ICIs may be a therapeutic option with an acceptable safety profile in patients with cancer and advanced liver disease.


Subject(s)
Hepatitis, Viral, Human , Neoplasms , Humans , Immune Checkpoint Inhibitors/adverse effects , Retrospective Studies , Neoplasms/drug therapy , Antiviral Agents
5.
Gynecol Oncol ; 168: 76-82, 2023 01.
Article in English | MEDLINE | ID: mdl-36423446

ABSTRACT

OBJECTIVE: Selinexor is a first-in-class, oral selective inhibitor of nuclear export (SINE) compound which blocks Exportin-1 (XPO1). Our objective was to determine maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of selinexor and weekly paclitaxel. METHODS: This was an open label, single-center, multi-arm phase 1b study utilizing a "3 + 3" design and a "basket-type" expansion in recurrent solid tumors. Selinexor (60 mg or 80 mg twice weekly orally) and weekly paclitaxel (80 mg IV 2 week on, 1 week off) were one of 13 parallel arms. Efficacy was evaluated using RECIST version 1.1. RESULTS: All 35 patients treated were evaluable for toxicity and 31 (88%) were evaluable for response. Patient diagnoses included platinum-resistant/refractory ovarian (n = 28), breast (n = 4), prostate (n = 2), and cervical (n = 1) cancer. Patients had a median of four prior therapies (range 1-10), and 47% had a prior taxane in the recurrent setting. There were no DLTs and 60 mg was chosen as the RP2D due to long-term tolerability. Ninety-seven percent of patients had at least one treatment-emergent adverse event (TEAE), and the most common grade ≥ 3 TEAE were neutropenia (46%), anemia (31%), and nausea (21%). Among 24 evaluable patients with ovarian cancer, response rate was 17%, CBR was 58%, and median PFS was 6.8 months (95% CI 3.7, not reached (NR)). CONCLUSIONS: Oral selinexor in combination with weekly paclitaxel demonstrated promising clinical activity with manageable toxicity. This combination should be considered for further exploration in a randomized study, especially in ovarian malignancies.


Subject(s)
Neoplasms, Second Primary , Ovarian Neoplasms , Male , Humans , Female , Paclitaxel , Neoplasm Recurrence, Local/drug therapy , Neoplasm Recurrence, Local/etiology , Ovarian Neoplasms/etiology , Hydrazines , Antineoplastic Combined Chemotherapy Protocols/adverse effects
6.
Oncologist ; 26(7): 558-e1098, 2021 07.
Article in English | MEDLINE | ID: mdl-33491277

ABSTRACT

LESSONS LEARNED: Advanced germ cell tumors are aggressive and associated with poor prognosis. Pembrolizumab was overall well tolerated in 12 heavily pretreated patients. Three patients had radiographic stable disease that lasted for 10.9 months, 5.5 months, and 4.5 months, respectively. Published data of immunotherapeutic agents in patients with advanced germ cell tumors are confirmed. The limited antitumor activity of immunotherapy in germ cell tumors is, at least partially, attributed to tumor biology (low tumor mutational burden; low PD-1 expression) and other poor-risk features. Tumor profiling to understand the mechanisms of resistance to pembrolizumab and innovative clinical trials that may include immunotherapy are warranted. BACKGROUND: Advanced germ cell tumors are associated with poor prognosis. We investigated the role of pembrolizumab in patients with advanced germ cell tumors. METHODS: We analyzed a prespecified cohort of an open-label, phase II clinical trial in which patients with advanced germ cell tumors were treated with pembrolizumab (200 mg) intravenously every 21 days. The endpoints of the study were the non-progression rate (NPR) at 27 weeks, safety, and tolerability. An NPR >20% was considered successful and worthy of further pursuit. RESULTS: From August 2016 to February 2018, 12 patients (10 men, 2 women) were treated (median age, 35 years [range, 22-63 years]; median number of prior systemic therapies, 3.5 [range, 2-7]; median number of metastatic sites, 3 [range, 2-8]). Overall, pembrolizumab was well tolerated. One patient experienced both grade 1 immune-related skin rash and grade 3 immune-related pneumonitis. No patient died from toxicity. Three patients had radiographic stable disease that lasted for 10.9 months, 5.5 months, and 4.5 months, respectively. No objective response was noted. The median progression-free survival was 2.4 months (95% confidence interval [CI], 1.5-4.5 months), and the median overall survival was 10.6 months (95% CI, 4.6-27.1 months). The 27-week NPR was 9.0% (95% CI, 0.23-41.2%). CONCLUSION: Overall, pembrolizumab was safe and had limited antitumor activity in these patients. In the advanced, metastatic setting, tumor profiling to understand the mechanisms of resistance to immunotherapy and innovative clinical trials to identify efficacious combination regimens rather than off-label use of pembrolizumab are warranted.


Subject(s)
Antineoplastic Agents, Immunological , Neoplasms, Germ Cell and Embryonal , Adult , Antibodies, Monoclonal, Humanized/adverse effects , Antineoplastic Agents, Immunological/adverse effects , Female , Humans , Male , Middle Aged , Neoplasms, Germ Cell and Embryonal/drug therapy , Progression-Free Survival , Young Adult
7.
J Obstet Gynaecol Res ; 47(8): 2666-2676, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34062619

ABSTRACT

AIM: We aimed to evaluate the mental health and sleep quality of pregnant women in different trimesters during coronavirus disease 2019 (COVID-19) pandemic and investigate the effect of quarantine and new lifestyle changes that come into our lives with pandemic with on this subject. METHODS: It was conducted on pregnant women (n = 149) who attended routine pregnancy prenatal visit during their pregnancy weeks. The data were collected using sociodemographic and clinical data form, Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality, Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI) to evaluate maternal depression and anxiety. RESULTS: A significant correlation was observed between the week of gestation and depression, anxiety, and defective sleep scores (p < 0.001). A moderate positive correlation was found between the week of gestation and depression (r: 0.628). A high level of positive correlation was found between the week of gestation and defective sleep quality and anxiety scores (r: 0.858, r: 0.754). A statistically significant increase in depression, anxiety, and defective sleep quality was found in the group staying in home quarantine (p = 0.002). CONCLUSION: This study showed that the COVID-19 pandemic can cause depression, anxiety, and serious sleep disorders in pregnant women. The depression and anxiety scores of pregnant women in home quarantine were also found to be higher than the group not in quarantine. As the week of gestation progresses, mental health symptoms worsen and sleep quality deteriorates.


Subject(s)
COVID-19 , Pandemics , Anxiety/epidemiology , Cross-Sectional Studies , Depression/epidemiology , Female , Humans , Pregnancy , SARS-CoV-2 , Sleep
8.
J Obstet Gynaecol ; 41(3): 421-427, 2021 Apr.
Article in English | MEDLINE | ID: mdl-32662316

ABSTRACT

The effects of HPV vaccination on embryo yield and pregnancy outcomes in IVF cycles with fresh embryo transfer (ET) were investigated. First, embryo yielding rates (EYR) in 2795 cycles with and without HPV vaccination were compared by retrospective cohort study design. EYR of HPV vaccinated and non-vaccinated patients were not significantly different (OR, 1.66; 95% CI, 0.76-3.63). Second, ET outcomes were compared for 155 HPV vaccine + cycles and 465 HPV vaccine - cycles after matching for ages and cycle attempt number. The differences in the number of retrieved oocytes (10.2 ± 6.1, 11.2 ± 6.7; p = .161), mature (MII) oocytes (8.7 ± 5.7, 9.8 ± 6.3; p = .088), two pronuclear zygotes (2PN) (5.4 ± 4.1, 6.1 ± 4.6; p = .110) and fertilisation rates (0.62 ± 0.23, 0.62 ± 0.23; p = .539) were insignificant between the two groups. Moreover, positive (OR, 0.74; 95% CI, 0.47-1.16), clinical (0.60; 0.36-1.01) and the ongoing pregnancy (0.55; 0.30-1.01) rates were lower in the HPV vaccinated group but the difference was not statistically significant.IMPACT STATEMENTWhat is already known on this subject? There are recent case studies that report premature ovarian insufficiency (POI) following a post-vaccination autoimmune response against the HPV vaccine. These studies suggest that the possible trigger for the immune reaction might be the immunogen content of the vaccine. However, the number of clinical studies investigating the effects of the HPV vaccine on reproductive function and in vitro fertilisation outcomes is limited.What do the results of this study add? In contrast to the case reports suggesting impaired reproductive and ovarian functions in HPV vaccinated patients, this study finds that in IVF patients HPV vaccinated and non-vaccinated women have similar EYR, MII, 2PN, oocyte counts, fertilisation rates, positive, clinical and ongoing pregnancy rates.What are the implications of these findings for clinical practice and/or further research? The results suggest the HPV vaccine does not have a negative impact on embryo yielding rates oocyte counts and fertilisation rates, positive, clinical and ongoing pregnancy rates in IVF treatments. Hence, they can be safely used for primary prevention against cervical cancer.


Subject(s)
Embryo Transfer/statistics & numerical data , Fertilization in Vitro/statistics & numerical data , Oocyte Retrieval/statistics & numerical data , Papillomaviridae/immunology , Papillomavirus Vaccines/adverse effects , Adult , Female , Fertilization in Vitro/methods , Humans , Odds Ratio , Oocytes/immunology , Oocytes/virology , Papillomavirus Infections/prevention & control , Pregnancy , Pregnancy Rate , Retrospective Studies
9.
J Obstet Gynaecol Res ; 46(10): 2050-2058, 2020 Oct.
Article in English | MEDLINE | ID: mdl-32748523

ABSTRACT

AIM: To investigate the protective effect of octreotide and lanreotide on ovarian damage in experimental ovarian ischemia-reperfusion injury. METHODS: Fifty-six rats were separated into seven groups; group 1: sham group, group 2: surgical control group with 3-h torsion and detorsion, group 3: 0.02 mg/kg s.c. octreotide 30 min before 3-h torsion, group 4; octreotide just after detorsion for 7 days, group 5: octreotide 30 min before torsion and just after detorsion for 7 days, group 6: single time 20 mg/kg s.c. lanreotide before torsion, group 7: single time lanreotide just after detorsion. RESULTS: All histopathological scores except congestion were significantly lower in group 1 than other groups. In addition, hemorrhage (group 2 vs 4: P < 0.05), degeneration (group 2 vs 4: P < 0.05, group 2 vs 5: P < 0.01 and group 2 vs 6: P < 0.05) and total damage score (group 2 vs 4: P < 0.05, group 2 vs 5: P < 0.05, group 2 vs 6: P < 0.05 and group 2 vs 7: P < 0.05) were significantly lower than other groups. Moreover, ovarian tissue total oxidant status and oxidative stress index levels were significantly decreased in groups 5 (both P < 0.05) and 7 (both P < 0.05) when compared to group 2. Furthermore, tissue levels of peroxynitrite were significantly higher in group 2 than groups 1, 3 and 5 (all P < 0.05). CONCLUSIONS: Octreotide and lanreotide have a protective role against ischemia-reperfusion damage in rat torsion detorsion model by improving histopathological and biochemical findings including tissue levels of total oxidant status, oxidative stress index and peroxynitrite.


Subject(s)
Ovarian Diseases , Reperfusion Injury , Animals , Female , Humans , Octreotide/pharmacology , Octreotide/therapeutic use , Oxidative Stress , Peptides, Cyclic , Rats , Reperfusion Injury/drug therapy , Reperfusion Injury/prevention & control , Somatostatin/analogs & derivatives
10.
Turk J Med Sci ; 50(6): 1513-1522, 2020 10 22.
Article in English | MEDLINE | ID: mdl-32927928

ABSTRACT

Background/aim: To evaluate the protective effect of melatonin on ovarian ischemia reperfusion injury in a rat model. Materials and methods: Forty-eight rats were separated equally into 6 groups. Group 1: sham; Group 2: surgical control with 3-h bilateral ovarian torsion and detorsion; Group 3: intraperitoneal 5% ethanol (1 mL) just after detorsion (as melatonin was dissolved in ethanol); Group 4: 10 mg/kg intraperitoneal melatonin 30 min before 3-h torsion; Group 5:10 mg/kg intraperitoneal melatonin just after detorsion; Group 6:10 mg/kg intraperitoneal melatonin 30 min before torsion and just after detorsion. Both ovaries and blood samples were obtained 7 days after detorsion for histopathological and biochemical analysis. Results: In Group 1, serum levels of total oxidant status (TOS) (µmol H2O2 equivalent/g wet tissue)were significantly lower than in Group2 (P = 0.0023), while tissue TOS levels were lower than in Group 3 (P = 0.0030). Similarly, serum and tissue levels of peroxynitrite in Group 6were significantly lower than those ofGroup 2 (P = 0.0023 and P = 0.040, respectively). Moreover, serum oxidative stress index (OSI) (arbitrary unit) levels were significantly increased in Group 2 when compared to groups 1 and 6 (P = 0.0023 and P= 0.0016, respectively) and in Group 3 with respect to groups 1, 4, 5, and 6 (P = 0.0023, P = 0.0026, P = 0.0008, and P = 0.0011, respectively). Furthermore, there was a significant decrease in histopathological scores including follicular degeneration, vascular congestion, hemorrhage, and inflammation in the melatonin and sham groups in comparison with control groups. Additionally, primordial follicle count was significantly higher in Group 6 than in Group 2 (P = 0.0002). Conclusion: Melatonin attenuates ischemia reperfusion damage in a rat torsion/detorsion model by improving histopathological and biochemical findings including OSI and peroxynitrite.


Subject(s)
Melatonin/pharmacology , Ovary/metabolism , Oxidative Stress/drug effects , Peroxynitrous Acid/metabolism , Reperfusion Injury/metabolism , Animals , Female , Ovarian Torsion/metabolism , Ovarian Torsion/pathology , Ovary/pathology , Rats , Rats, Wistar , Reperfusion Injury/pathology
11.
Acta Odontol Scand ; 77(8): 574-583, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31174442

ABSTRACT

Objective: The purpose of this study was to identify the 100 top-cited articles in endodontics and analyse their bibliometric characteristics. Material and methods: The Web of Science database was reviewed to identify the relevant articles. Results: One hundred and three articles were included because the last four articles had the same number of citations. The top-cited article received 2115 citations. The articles were published in 28 different journals, with the most popular publication being the Journal of Endodontics (n = 36). The most prolific country was the United States (n = 41), followed by Sweden (n = 17) and Switzerland (n = 8). The most prolific author and institution were M. Torabinejad (n = 12) and Umeå University (n = 9), respectively. The majority of articles were of a basic science nature (n = 55), while endodontic microbiology (n = 24) was the most frequent subspecialty. The most common study design used in clinical articles was non-randomized experimental study (n = 5). Half of the clinical articles (n = 11) had a level III evidence score. Conclusions: The present citation analysis provides insights into the historical progress and current trends in endodontics.


Subject(s)
Bibliometrics , Endodontics , Dental Care , Humans , Research Design , Sweden , United States
12.
J Obstet Gynaecol ; 39(2): 157-163, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30280612

ABSTRACT

This study investigates the predictive power of serum progesterone/estradiol (P/E2) level for estimating the live birth rate in patients who had a serum progesterone (P) rate ≥ 1.5 ng/mL on the human chorionic gonadotropin (hCG) administration day and who received the gonadotropin-releasing hormone (GnRH) antagonist protocol and intracytoplasmic sperm injection (ICSI). This retrospective cohort study included 176 cycles. The P/E2 ratio was lower in patients with a live birth (0.73 ± 0.54) than those without a live birth (1.05 ± 1.38), but the difference was not statistically significant (p = .158). According to the receiver operating characteristic curve analysis of the hCG day P/E2 ratio, the area under the curve was 0.579 (95% confidence interval: 0.478 - 0.680, p = .158) for predicting live birth. In conclusion, this study suggests that a P/E2 ratio is not a significant predictor of a live birth rate in the patients with an hCG-day serum progesterone level of ≥1.5 ng/mL undergoing GnRH antagonist ICSI cycles with a fresh embryo transfer. Impact statement What is already known on this subject? As the progesterone (P) levels in the late follicular phase correlate with the estradiol (E2) levels and the increase in mature follicles, earlier studies have proposed the trigger-day progesterone/estradiol (P/E2) ratio as a potential new marker for a premature luteinisation and live birth success. Most of these studies were conducted on long agonist cycles, and found that arbitrarily defined P/E2 ratio of >1 to be associated with poor pregnancy outcomes. What do the results of this study add? This study retrospectively examines the gonadotropin-releasing hormone (GnRH) antagonist cycles with a trigger-day serum P value of ≥1.5 ng/mL undergoing the intracytoplasmic sperm injection (ICSI) treatment. The receiver operating characteristic (ROC) curve analysis did not identify a statistically significant threshold value for the trigger-day P/E2 ratio that was beneficial in predicting a live birth. The P/E2 ratio was also lower in the cycles with a live birth than those without a live birth, although the difference was not statistically significant. What are the implications of these findings for clinical practice and/or further research? The trigger-day P/E2 ratio does not seem to be an efficient prognostic factor for a live birth in the GnRH antagonist ICSI cycles with a trigger-day serum progesterone level of ≥1.5 ng/mL. Further studies are needed to clarify the association of the trigger-day P/E2 ratio and the pregnancy outcomes in GnRH antagonist ICSI cycles.


Subject(s)
Embryo Transfer/statistics & numerical data , Estradiol/blood , Gonadotropin-Releasing Hormone/antagonists & inhibitors , Progesterone/blood , Sperm Injections, Intracytoplasmic/statistics & numerical data , Adult , Birth Rate , Female , Humans , Pregnancy , Retrospective Studies
13.
Gynecol Endocrinol ; 34(1): 25-27, 2018 Jan.
Article in English | MEDLINE | ID: mdl-29073793

ABSTRACT

Mankind has been expressing the breeding topic for thousands of years. Reproduction is the primary instinct of human beings and it is a social, cultural, medical issue. Demographic infertility is one of them, which is defined infertility as the inability to become pregnant with a live birth, within five years of regular sexual contact based upon a consistent union status in marriage maintaining a desire for a child with the lack of contraceptive use and non-lactating. A first mentions about infertility and surrogacy is discovered on a 4000-year-old clay tablet of marriage contract belonging to the Assyrian period exhibited at Istanbul Archeology Museum in Turkey. In conclusion, there are many different ways to solve infertility problems like surrogacy as mentioned even 4000 years ago in this Assyrian clay tablet of marriage contract as the first time in the literature. Medical treatments in relation to human infertility will continue to be the focus of social and cultural debates. Hence, more legislation and regulation will come in many countries to control the unauthorized exploitation of the patient.


Subject(s)
Infertility/history , Surrogate Mothers , Archaeology , Female , History, Ancient , Humans , Male , Marriage/history , Marriage/legislation & jurisprudence , Paleography , Turkey , Writing
14.
J Digit Imaging ; 31(2): 210-223, 2018 04.
Article in English | MEDLINE | ID: mdl-28685320

ABSTRACT

We investigated the association between the textural features obtained from 18F-FDG images, metabolic parameters (SUVmax, SUVmean, MTV, TLG), and tumor histopathological characteristics (stage and Ki-67 proliferation index) in non-small cell lung cancer (NSCLC). The FDG-PET images of 67 patients with NSCLC were evaluated. MATLAB technical computing language was employed in the extraction of 137 features by using first order statistics (FOS), gray-level co-occurrence matrix (GLCM), gray-level run length matrix (GLRLM), and Laws' texture filters. Textural features and metabolic parameters were statistically analyzed in terms of good discrimination power between tumor stages, and selected features/parameters were used in the automatic classification by k-nearest neighbors (k-NN) and support vector machines (SVM). We showed that one textural feature (gray-level nonuniformity, GLN) obtained using GLRLM approach and nine textural features using Laws' approach were successful in discriminating all tumor stages, unlike metabolic parameters. There were significant correlations between Ki-67 index and some of the textural features computed using Laws' method (r = 0.6, p = 0.013). In terms of automatic classification of tumor stage, the accuracy was approximately 84% with k-NN classifier (k = 3) and SVM, using selected five features. Texture analysis of FDG-PET images has a potential to be an objective tool to assess tumor histopathological characteristics. The textural features obtained using Laws' approach could be useful in the discrimination of tumor stage.


Subject(s)
Carcinoma, Non-Small-Cell Lung/diagnostic imaging , Carcinoma, Non-Small-Cell Lung/pathology , Image Interpretation, Computer-Assisted/methods , Lung Neoplasms/diagnostic imaging , Lung Neoplasms/pathology , Positron-Emission Tomography/methods , Female , Fluorodeoxyglucose F18 , Humans , Lung/diagnostic imaging , Lung/pathology , Male , Middle Aged , Radiopharmaceuticals , Retrospective Studies
15.
Minim Invasive Ther Allied Technol ; 27(3): 177-185, 2018 Jun.
Article in English | MEDLINE | ID: mdl-28639836

ABSTRACT

BACKGROUND: Hysterectomy, the most common major gynecological operation worldwide, consists of removal of the uterus and can be performed abdominally, vaginally, or laparoscopically. A uterine manipulator is a key device used for uterine manipulation and cannulation in hysterectomies. The challenges of conventional manipulators are to move the uterus in two distinct planes and to identify cervical landmarks during circular cut and coagulation. MATERIAL AND METHODS: In this study, a structural synthesis of the two degrees of freedom parallel manipulator was performed considering the constraints noted by surgeons. Computer-aided design and assembly of the manipulator, the cervicovaginal cap with LEDs, and the external parts were performed before rapid prototyping. The final design of the uterine manipulator was then manufactured from stainless steel and tested on an artificial uterus model using a test chamber. RESULTS: This article presents the design, production and testing processes of an innovative manipulator with a motion capability up to 80° workspace both in the sagittal and coronal planes and an illumination system, easily detectable by the laparoscope, was successfully implemented on the manipulator's cervical cap in order to overcome the drawbacks of conventional uterine manipulators. CONCLUSIONS: Despite all the current studies and uterine manipulators on the market, no research has incorporated all the features mentioned above.


Subject(s)
Equipment Design , Hysterectomy/instrumentation , Uterus/surgery , Computer-Aided Design , Female , Humans , Laparoscopy/instrumentation , Lighting/instrumentation , Models, Anatomic , Vagina/surgery
16.
Gynecol Endocrinol ; 33(9): 716-720, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28454508

ABSTRACT

The aim of this cross-sectional study is to compare endometrial flushing fluid levels of αVß3 integrin, glycodelin and PGF2α during the midluteal phase of the menstrual cycle of women with polycystic ovary syndrome (PCOS, n = 20), myoma uteri (n = 20) and endometrioma (n = 19) with the healthy controls (n = 20). After collecting samples at the midluteal phase of ovulatory volunteers and storing them at -80 °C, αVß3 integrin, glycodelin and PGF2α levels were analyzed using ELISA. The mean ages of the groups were 28.90 ± 5.45, 37.25 ± 2.73, 32.84 ± 6.62 and 32.15 ± 5.18 in PCOS, myoma uteri, endometrioma and control groups, respectively. The αVß3 integrin level (ng/ml) was statistically significantly higher in endometrioma group (9.70 ± 1.72, p < 0.05) as compared to myoma uteri and control groups. Similarly, glycodelin level (ng/ml) was significantly higher in endometrioma group (341.04 ± 93.32) than PCOS (p < 0.01), myoma uteri (p < 0.001) and healthy subjects (p < 0.001). Moreover, PGF2α level (350.04 ± 464.50 ng/ml) was significantly higher in PCOS group relative to myoma uteri (p < 0.001), endometrioma (p < 0.05) and control (p < 0.05) groups. In conclusion, αVß3 integrin level was significantly higher in endometrioma subjects than those with myoma uteri and control groups; glycodelin level was significantly higher in endometrioma group than other three groups, and lastly, PCOS patients had significantly higher PGF2α levels than those patients with myoma uteri, endometrioma and controls.


Subject(s)
Dinoprost/metabolism , Endometriosis/metabolism , Endometrium/metabolism , Glycodelin/metabolism , Integrin alphaVbeta3/metabolism , Leiomyoma/metabolism , Polycystic Ovary Syndrome/metabolism , Uterine Neoplasms/metabolism , Adult , Body Fluids/metabolism , Cross-Sectional Studies , Female , Humans , Young Adult
17.
Gynecol Endocrinol ; 33(9): 728-732, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28447505

ABSTRACT

In this retrospective multicenter cohort study, women with congenital hypogonadotrophic hypogonadism (CHH) (n = 57) who underwent intra-cytoplasmic sperm injection in-between 2010-2014 were compared to age-matched controls with tubal factor infertility (n = 114) to assess ovarian stimulation cycle and pregnancy outcomes. Live birth rates (LBRs) per started cycle were 31.6 and 24.6% in CHH and controls groups, respectively (p = 0.36). Comparable success rates were also confirmed with the logistic regression analysis (OR: 1.44, 95% CI: 0.78-2.67, p = 0.24). Of the 57 women with CHH, 19 were stimulated with the gonadotropin-releasing hormone (GnRH) antagonist protocol, 13 with the long-GnRH-agonist protocol. Pituitary suppression (PS) was not employed in the remaining 25 cases. Compared to women with PS, women without PS had significantly higher embryo implantation rates (21.6 versus 52.6%, p = 0.03). Although there was a trend favoring no PS, LBRs (25.0 versus 40.0%, p = 0.26) per cycle were short of statistical significance. LBRs per cycle (57.1 versus 31.2%, p = 0.11) and miscarriage rates (11.1 versus 16.7%, p = 0.75) were similar between CHH women who were given estrogen + progesterone and progesterone alone to support the luteal phase. In conclusion, the optimal stimulation protocol appears to be exogenous gonadotropin stimulation alone, without PS, and progesterone-only luteal phase support in CHH patients.


Subject(s)
Birth Rate , Hypogonadism/therapy , Infertility, Female/therapy , Live Birth , Sperm Injections, Intracytoplasmic , Adult , Cohort Studies , Embryo Transfer , Female , Fertility Agents, Female/therapeutic use , Gonadotropin-Releasing Hormone/analogs & derivatives , Gonadotropin-Releasing Hormone/therapeutic use , Humans , Hypogonadism/congenital , Infertility, Female/congenital , Ovulation Induction/methods , Pregnancy , Treatment Outcome , Young Adult
18.
Pak J Med Sci ; 33(4): 909-914, 2017.
Article in English | MEDLINE | ID: mdl-29067064

ABSTRACT

BACKGROUND & OBJECTIVE: Violence against women is a widespread problem and has serious implications on women's health. Infertility, in many ways, is a very stressful condition that affect social and marital life of a couple; moreover, compared to fertile women, infertile women are twice as vulnerable against violence. Our objective was to determine the prevalence of violence and define the effect of infertility on violence on women receiving infertility treatment. METHODS: Descriptive and cross-sectional study was carried out 301 infertile women between November 2015 and August 2016 in a state hospital, Izmir. Data were collected as "Sociodemographic Characteristics Form" and "Infertile Women's Exposure to Violence Determination Scale". RESULTS: The mean age of women was 31.77±5.46 years; the average duration of marriage was 6.93±4.53 years. About 32.5% of women stated that they have suffered from violence throughout their lives and 4.7% of women were still suffering from violence, while 5.0% of women were subjected to violence after infertility was diagnosed. CONCLUSION: It is an encouraging finding that infertile women have a low exposure to violence. However, despite a low violence rate, there is an increase in violence toward women who have been diagnosed with infertility.

19.
Scand J Gastroenterol ; 51(8): 903-7, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27124324

ABSTRACT

OBJECTIVE: Research data demonstrating nutritional habits of functional dyspepsia (FD) patients are very limited. This is the first study to evaluate nutritional habits in FD subgroups according to Rome III criteria. Our aim was to evaluate nutritional habits of FD patients and determine the food items that may provoke a dyspepsia symptom. METHODS: A total of 168 adults with FD and 135 healthy control subjects participated in the study. FD subjects were divided into epigastric pain syndrome (EP-FD), postprandial distress syndrome (PS-FD), mixed (MX-FD) subgroups according to Rome Criteria III. Subjects completed a questionnaire that included a short-form food frequency questionnaire. Furthermore, subjects were asked to list the food items that were causing a dyspepsia symptom. RESULTS: Functional dyspepsia subjects had a slightly higher BMI (26.1 ± 4.97 kg/m(2)) than control subjects (24.6 ± 4.08 kg/m(2)). The most common symptom triggering foods among all the FD groups were fried and fatty foods (27.1%), hot spices (26.4%), and carbonated drinks (21.8%). In FD subgroups, carbonated drinks were more likely to cause a symptom in PS-FD group (37.3%) than MX-FD (25.7%) and EP-FD (22.1%) groups. There was no difference in frequency of main meals and snacks among any of the groups. CONCLUSION: Fatty and spicy foods and carbonated drinks were the most common symptom triggering food items in FD group. In subgroups, carbonated drinks and legumes were more likely to cause a symptom in PS-FD. Removing these food items during the course of treatment might help alleviate the symptoms.


Subject(s)
Diet , Dyspepsia/etiology , Adolescent , Adult , Aged , Dyspepsia/classification , Female , Humans , Male , Middle Aged , Surveys and Questionnaires , Young Adult
20.
BMC Oral Health ; 16(1): 111, 2016 Oct 11.
Article in English | MEDLINE | ID: mdl-27724900

ABSTRACT

BACKGROUND: Due to the detrimental effect of blood contamination on the physico-chemical properties of mineral trioxide aggregate (MTA), obtaining an effective hemostasis in the surgical crypt during apical surgery is of paramount importance. The purpose of this in vivo study was to analyze the effect of Ankaferd Blood Stopper® (ABS) contamination on the biocompatibility of MTA. METHODS: Forty of 56 Wistar-Albino rats were divided randomly and equally into two groups (MTA and MTA-ABS) according to whether or not a hemostatic agent was used. The remaining 16 rats were designated as the control group. Rats in the experimental groups received freshly mixed MTA-Angelus in polyethylene tubes, which were inserted into monocortical bore holes created in their tibias. In the MTA-ABS group only, 0.5 mL of ABS solution was administered topically on the defect sites followed by implantation of MTA tubes. Inflammation, foreign-body reaction (FBR), necrosis, fibrosis, and new bone formation (NBF) were studied 7, 30, 60, and 90 days after implantation. RESULTS: On day7, statistically significant differences were found in tissue reactions with regard to NBF and necrosis (p = 0.044 and p = 0.024, respectively), the latter being observed in 40 % of the samples only in the MTA-ABS group. Slight inflammation in all groups was confined to day-7 only. Mild necrosis was present in the MTA-ABS group only on day-7. Severity of the foreign body reaction and fibrosis was limited. New bone formation increased gradually over time in all groups, reaching a maximum on day-90. CONCLUSIONS: MTA and ABS-contaminated MTA are equally biocompatible. ABS does not impair the properties of MTA.


Subject(s)
Aluminum Compounds , Calcium Compounds , Hemostatics , Oxides , Plant Extracts , Silicates , Animals , Bismuth , Drug Combinations , Rats , Rats, Wistar
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