High-security closed devices are efficient and safe to protect human oocytes from potential risk of viral contamination during vitrification and storage especially in the COVID-19 pandemic

Abstract Purpose The main purpose and research question of the study are to compare the efficacy of high-security closed versus open devices for human oocytes’ vitrification. Methods A prospective randomized study was conducted. A total of 737 patients attending the Infertility and IVF Unit at S.Orsola University Hospital (Italy) between October 2015 and April 2020 were randomly assigned to two groups. A total of 368 patients were assigned to group 1 (High-Security Vitrification™ - HSV) and 369 to group 2 (Cryotop® open system). Oocyte survival, fertilization, cleavage, pregnancy, implantation, and miscarriage rate were compared between the two groups. Results No statistically significant differences were observed on survival rate (70.3% vs. 73.3%), fertilization rate (70.8% vs. 74.9%), cleavage rate (90.6% vs. 90.3%), pregnancy/transfer ratio (32.0% vs. 31.8%), implantation rate (19.7% vs. 19.9%), nor miscarriage rates (22.1% vs. 21.5%) between the two groups. Women’s mean age in group 1 (36.18 ± 3.92) and group 2 (35.88 ± 3.88) was not significantly different (P = .297). A total of 4029 oocytes were vitrified (1980 and 2049 in groups 1 and 2 respectively). A total of 2564 were warmed (1469 and 1095 in groups 1 and 2 respectively). A total of 1386 morphologically eligible oocytes were inseminated by intracytoplasmic sperm injection (792 and 594 respectively, P = .304). Conclusions The present study shows that the replacement of the open vitrification system by a closed one has no impact on in vitro and in vivo survival, development, pregnancy and implantation rate. Furthermore, to ensure safety, especially during the current COVID-19 pandemic, the use of the closed device eliminates the potential samples’ contamination during vitrification and storage.

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Is low antiepileptic drug dose effective in long-term seizure-free patients?

Arquivos de Neuro-Psiquiatria ◽

10.1590/s0004-282x2003000400008 ◽

2003 ◽

Vol 61 (3A) ◽

pp. 566-573 ◽

Cited By ~ 7

Author(s):

Tânia A.M.O. Cardoso ◽

Fernando Cendes ◽

Carlos A.M. Guerreiro

Keyword(s):

Risk Factors ◽

Antiepileptic Drug ◽

Randomized Study ◽

Drug Dose ◽

University Hospital ◽

Seizure Recurrence ◽

Partial Group ◽

Group 2 ◽

Group 1

OBJECTIVE: To investigate the value of leaving seizure-free patients on low-dose medication. METHOD: This was an exploratory prospective randomized study conducted at our University Hospital. We evaluated the frequency of seizure recurrence and its risk factors following complete or partial antiepileptic drug (AED) withdrawal in seizure free patients for at least two years with focal, secondarily generalized and undetermined generalized epilepsies. For this reason, patients were divided into two groups: Group 1 (complete AED withdrawal), and Group 2 (partial AED withdrawal). Partial AED withdrawal was established as a reduction of 50% of the initial dose. Medication was tapered off slowly on both groups. Follow-up period was 24 months. RESULTS: Ninety-four patients were followed up: 45 were assigned to complete (Group 1) AED withdrawal and 49 to partial (Group 2) AED withdrawal. Seizure recurrence frequency after two years follow-up were 34.04% in group 1 and 32.69% in Group 2. Survival analysis showed that the probability of remaining seizure free at 6, 12, 18 and 24 months after randomization did not differ between the two groups (p = 0.8). Group 1: 0.89, 0.80, 0.71 and 0.69; group 2: 0.86, 0.82, 0.75 and 0.71. The analysis of risk factors for seizure recurrence showed that more than 10 seizures prior to seizure control was a significant predictive factor for recurrence after AED withdrawal (hazard ratio = 2.73). CONCLUSION: Leaving seizure free patients on low AED dose did not reduce the risk for seizure recurrence. That is, once the decision of AED withdrawal has been established, it should be complete.

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The Appropriate Time Interval Between Hysteroscopic Polypectomy and the Start of FET : A Retrospective Corchort Study

10.21203/rs.3.rs-110131/v1 ◽

2020 ◽

Author(s):

Zhong-Kai Wang ◽

Hong-Wu Qiao ◽

She-Ling Wu ◽

Wen Zhang ◽

Xiao-Na Yu ◽

...

Keyword(s):

Pregnancy Outcomes ◽

Implantation Rate ◽

Live Birth Rate ◽

Time Interval ◽

Miscarriage Rate ◽

Endometrial Polyps ◽

Group 4 ◽

Academic Center ◽

Group 2 ◽

Group 1

Abstract Objective: To investigate when is the appropriate time interval between hysteroscopic polypectomy and the start of FET cyclesDesign: Retrospective cohort study. Setting: Academic center. Patient(s): All patients diagnosed with endometrial polyps undergoing hysteroscopic polypectomy before FET.Intervention(s): Hysteroscopic polypectomy.MainOutcomeMeasure(s): Patients were divided into four groups based on the time interval between hysteroscopic polypectomy and the start of FET Demographics, baseline FET characteristics, pregnancy outcomes after FET were compared among the groups. A total of 1703 patients met inclusion criteria: 547 patients in group 1 who underwent FET after hysteroscopic polypectomy 1-3menses cycles, 389 patients in group 2 who underwent FET after hysteroscopic polypectomy 4-6 menses cycles, 421 patients in group 3 who underwent FET after hysteroscopic polypectomy 7-12menses cycles, and 373 patients in group 4 who underwent FET after hysteroscopic polypectomy more than 12 menses cycles, whats more the group 1 were divided into 3 groups depend on the time interval between hysteroscopic polypectomy and the start of FET. The FET outcomes were compared.Result(s): There were no differences in the mean number of embryos transferred. The overall pregnancy outcomes were similar for groups 1, 2, 3,and 4: implantation rate (38%, 38.2%, 39.5%and 36.8, respectively), clinical pregnancy rate (51.9%, 48%, 53.2and 50%), spontaneous miscarriage rate (8.4%,8.4%, 12.2and 8.9%), and live birth rate (42.4%. 40.4%, 42.8% and 40.9%). Conclusion(s): IVF outcomes seem to be unrelated to the time interval between the hysteroscopic polyp resection and the initiation of the FET; The abortion rates may be lower if the treatment is started in the first few months post operatively.

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Immediate and long-term results of the first line chemotherapy in patients with metastatic triple negative breast cancer. Final analysis of randomized study

HEALTH OF WOMAN ◽

10.15574/hw.2020.149.75 ◽

2020 ◽

pp. 75-80

Author(s):

S.A. Lyalkin ◽

◽

L.A. Syvak ◽

N.O. Verevkina ◽

◽

...

Keyword(s):

Breast Cancer ◽

Triple Negative Breast Cancer ◽

Triple Negative ◽

Randomized Study ◽

Progression Free Survival ◽

First Line ◽

Free Survival ◽

Group 2 ◽

Line Chemotherapy ◽

Group 1

The objective: was to evaluate the efficacy of the first line chemotherapy in patients with metastatic triple negative breast cancer (TNBC). Materials and methods. Open randomized study was performed including 122 patients with metastatic TNBC. The efficacy and safety of the first line chemotherapy of regimens АТ (n=59) – group 1, patients received doxorubicine 60 мг/м2 and paclitaxel 175 мг/м2 and ТР (n=63) – group 2, patients received paclitaxel 175 мг/м2 and carboplatin AUC 5 were evaluated. Results. The median duration of response was 9.5 months (4.5–13.25 months) in patients received AT regimen and 8.5 months (4.7–12.25 months), in TP regimen; no statistically significant differences were observed, р=0.836. The median progression free survival was 7 months (95% CI 5–26 months) in group 1 and 7.5 months (95% CI 6–35 months) in group 2, p=0.85. Both chemotherapy regimens (AT and TP) had mild or moderate toxicity profiles (grade 1 or 2 in most patients). No significant difference in gastrointestinal toxicity was observed. The incidence of grade 3–4 neutropenia was higher in patients of group 2 (TP regimen): 42.8% versus 27% (р<0.05). Conclusions. Both regimens of chemotherapy (AT and TP) are appropriate to use in the first line setting in patients with metastatic TNBC. Key words: metastatic triple negative breast cancer, chemotherapy, progression free survival, chemotherapy toxicity.

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Outcomes of coaxial microincision cataract surgery versus conventional phacoemulsification surgery

Asian Journal of Ophthalmology ◽

10.35119/asjoo.v16i3.458 ◽

2019 ◽

Vol 16 (3) ◽

pp. 168-178

Author(s):

Anu Malik ◽

Smruti Ranjan Dethi ◽

Yogesh Kumar Gupta ◽

Alka Gupta

Keyword(s):

Cataract Surgery ◽

Randomized Study ◽

Corrected Visual Acuity ◽

Age Related ◽

Significant Difference ◽

Induced Astigmatism ◽

The Mean ◽

Group 2 ◽

Surgically Induced ◽

Group 1

Aim: To compare surgical parameters and visual outcomes of coaxial microincision cataract surgery (MICS) with standard phacoemulsification. Methods: A prospective randomized study was conducted on 60 eyes of 60 patients with age-related uncomplicated cataract who underwent: standard phacoemulsification surgery (30 eyes) i.e., Group 1, or coaxial MICS (30 eyes) i.e., Group 2. Intraoperative parameters were mean effective phacoemulsification power (EPP), effective phacoemulsification time (EPT), and total volume of balanced salt solution (BSS) used. Best-corrected visual acuity (BCVA) and surgically induced astigmatism (SIA) were evaluated pre- and postoperatively. Results: Mean BCVA at 6 weeks was 0.04 ± 0.07 in Group 1 and 0.05 ± 0.08 in Group 2. No significant difference was observed in SIA between the two groups. Mean EPT was 29.80 ± 3.67 seconds in Group 1 and 31.93 ± 4.08 seconds in Group 2. The mean total EPP in Group 1 was 35.77 ± 5.17%, whereas it was 33.70 ± 3.05% in Group 2. There was a significant statistical difference between mean EPP and EPT in the two groups. Mean total BSS volume used in Group 1 was 128.83 ± 19.81 ml, whereas it was 139.33 ± 13.57 ml in Group 2. Conclusion: Although EPT and BSS volume used were significantly higher in coaxial MICS, the postoperative results of the two techniques were comparable.

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Clinical Utilization of Point-of-care Ultrasound After Training: A Prospective Study

10.21203/rs.3.rs-270802/v1 ◽

2021 ◽

Author(s):

Wan-Ching Lien ◽

Chih-Heng Chang ◽

Kah-Meng Chong ◽

Meng-Che Wu ◽

Cheng-Yi Wu ◽

...

Keyword(s):

Image Quality ◽

Positive Impact ◽

University Hospital ◽

Point Of Care Ultrasound ◽

Global Rating ◽

Clinical Trial Registration ◽

Clinical Utilization ◽

Global Ratings ◽

Group 2 ◽

Group 1

Abstract Background: This study aimed to investigate the clinical utilization of PoCUS of the first post-graduate year residents after a PoCUS curriculum. Methods: It was conducted at the emergency department of the National Taiwan University Hospital between July 2015 and October 2017. Every resident had one-month ED training and a curriculum was implemented during the first week. The post-training objective structured clinical examination (OSCE) global ratings were obtained, as well as the sonographic examinations by the residents. The participants were categorized into 4 groups: group 1 performed PoCUS before and after the curriculum; group 2 performed only after the curriculum; group 3 performed only before the curriculum; the last did not perform any examinations. Results: Two hundred and thirty-nine residents participated. The median global rating was 4 (interquartile ranges, 4-5). A significantly increasing number of residents integrated PoCUS into patient care (64 vs. 170, p=0.037) with acceptable image quality after the curriculum. Nearly 30% of residents did not use PoCUS although no differences existed in the OSCE global ratings. Group 1 performed more cases with better image quality and using ≥2 ultrasound applications (8/100 vs. 82/359, p=0.0009) after the curriculum. Group 1 performed more cases with better image quality than group 2 after the curriculum. In groups 3 and 4, “no suitable cases” (25/69), and “choosing other imaging priorities” (43/69) were the main feedbacks for not performing PoCUS. Conclusions: A focused training had a substantial positive impact on the utilization of PoCUS of the residents. The global ratings could not predict whether to integrate PoCUS into clinical practice. Further studies would be needed for the sustained effects of the curriculum and how to encourage these residents in groups 3 and 4 to use PoCUS.Clinical trial registration: NCT03738033.

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COMPARISON OF A NEW VERESS NEEDLE ENTRY METHOD AND CLASSIC VERESS NEEDLE ENTRY METHOD IN GYNECOLOGIC LAPAROSCOPY: A PROSPECTIVE RANDOMIZED STUDY

International Journal of Research -GRANTHAALAYAH ◽

10.29121/granthaalayah.v6.i2.2018.1546 ◽

2018 ◽

Vol 6 (2) ◽

pp. 74-79

Author(s):

Uğurkan Erkayıran ◽

Bülent Köstü ◽

Alev Özer

Keyword(s):

Horizontal Plane ◽

Randomized Study ◽

Veress Needle ◽

Operative Outcomes ◽

Laparoscopic Entry ◽

Gynecologic Laparoscopy ◽

The Mean ◽

Group 2 ◽

Needle Entry ◽

Group 1

Background: To compare cranial 15º angulation of Veres needle to classic Veress needle entry in closed laparoscopic entry in obese patients. Method: Patients with BMI index>30 were divided into two groups. Initial entry into the abdomen in Group 1 (n=29) was performed with the intraumbilical insertion of Veress needle in 90o angle relative to the horizontal plane. In Group 2 (n=31) the Veress needle was placed intraumbilically in a cranial direction, the tip of the needle towards the thoracic cavity, with an angle of 15o to the horizontal plane. Two groups were compared with respect of the operative outcomes. Results: In Group 2, the mean number of Veress needle entries attempt was significantly lower than Group 1 (p=0.01). Time to insertion of the Veress needle was found to be significantly shorter in Group 2 than in Group 1 (p<0.001). While entry failure occurred in 3 patients in Group 1 (10.3%), no failures were monitored in any patients in Group 2 (p= 0.01). Complication rate was significantly lower in Group 2 than in Group 1 (p= 0.03). Conclusion: Placement of Veress needle intraumbilically in a cranial direction at 15°angle to the horizontal plane increases entry success and reduces complications.

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Abstract 20107: Randomized Comparison of Personalized versus Standardized Substrate Modification During Catheter Ablation for Symptomatic Atrial Fibrillation

Circulation ◽

10.1161/circ.132.suppl_3.20107 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Simon Kircher ◽

Arash Arya ◽

David Altmann ◽

Sascha Rolf ◽

Andreas Bollmann ◽

...

Keyword(s):

Atrial Fibrillation ◽

Low Voltage ◽

Randomized Study ◽

Standard Group ◽

Linear Lesions ◽

Substrate Modification ◽

Arrhythmogenic Substrate ◽

Group 2 ◽

Group 1

Introduction: Pulmonary vein (PV) isolation forms the cornerstone of any ablation procedure for atrial fibrillation (AF). There is, however, no uniform strategy how to detect and target left atrial (LA) arrhythmogenic substrate outside the PV antra. Fibrosis that corresponds well to LA low-voltage areas (LVAs) seems to play a key role in AF arrhythmogenesis and might therefore be a suitable target for additional substrate modification (SM). Objective: The purpose of this prospective randomized study was to compare a novel technique for SM based on ablation of potentially arrhythmogenic LA LVAs with a standard approach consisting of empiric LA linear ablation. Methods: Patients (pts) with symptomatic paroxysmal or persistent AF were randomized to standard (group 1) or personalized (group 2) SM. Circumferential PV isolation was the primary step in both groups. In group 1, pre-defined linear lesions were applied at the LA roof and bottom, respectively, and at the mitral isthmus only in pts with persistent AF. In group 2, targets for SM (i.e. LVAs) were identified by detailed bipolar voltage mapping (BVM) during sinus rhythm irrespective of AF type. Peak-to-peak electrogram amplitudes were defined as “normal” (> 0.5 mV), as “low voltages” (0.2 to 0.5 mV), or as “scar” (< 0.2 mV). LVAs were targeted by tissue homogenization and / or strategic linear lesions. The primary endpoint was freedom from any atrial arrhythmia (i.e. AF, atrial flutter, or atrial tachycardia) > 30 seconds off antiarrhythmic drugs on serial 7-d-Holter ECG recordings after a follow-up period of 12 months. Results: In total, 124 ablation-naïve pts (mean age 63 ± 9 years, 62 % male, 49 % with persistent AF) were enrolled in this study. LVAs were present in 18 % of pts with paroxysmal and in 41 % of pts with persistent AF (p<0.05). At the end of the follow-up period, 25 out of 59 pts (42 %) in the conventional group were free from arrhythmia recurrence as compared to 40 out of 59 pts (68 %) in the BVM-guided group (unadjusted log rank p = 0.003). Conclusion: Personalized SM guided by endocardial BVM is associated with a higher success rate compared to a conventional approach applying empirical SM based on AF phenotype.

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353. A Comparison Study of Prevalence and Risk Factors for Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) by Transient Elastography (TE) in HIV-Infected Patients

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.426 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S186-S186

Author(s):

Sunny Choe ◽

Hend Al-Saleh ◽

James Fallon ◽

Herbert Galang ◽

Justin Mathew ◽

...

Keyword(s):

Risk Factors ◽

Transient Elastography ◽

Medical Center ◽

University Hospital ◽

Lower Percentage ◽

Strand Transfer ◽

Nonalcoholic Fatty Liver ◽

Virus Load ◽

Group 2 ◽

Group 1

Abstract Background There are limited data on the prevalence and risk factors of NAFLD and NASH in HIV-infected individuals receiving ART. A large study on this subject was presented at Glasgow 2018, from the University Hospital of Palermo (UHP). Methods We prospectively collected data on epidemiology, comorbidities, CD4, HIV virus load and ART from November 2017 to September 2018 in patients undergoing TE examination with Controlled Attenuation Parameter (CAP) in our HIV clinic at Saint Michael’s Medical Center in Newark, NJ. We used the same parameters to define NAFLD and fibrosis severity that were used for the UHP (CAP >248 dB/m and TE > 7.1 Kpa). We present comparative data between those 2 cohorts. Results We enrolled 624 consecutive HIV-infected individuals (group 1) their baseline epidemiologic characteristics were not significantly different from the UHP cohort (group 2) for age and sex. Prevalence of NAFLD was 51.6% in group 1compared with 42.7% in group 2, and the prevalence of significant fibrosis in those with NAFLD was 31% in group 1, and 23% in group 2. The main differences we found between those 2 cohorts were race: group 1, 68% black and group 2, 87% White, incidence of Diabetes mellitus was 20% in group 1, and 6% in group 2, despite the fact that BMI was not significantly higher in group 1. Other important differences were the mean time on ART, it was 5 years longer for group 1. Finally, there was a trend for a higher incidence of hypertension, a lower percentage of patients with Virus load < 20 c/mL, a lower mean CD4 count, and a higher percentage of integrase strand transfer inhibitors current users in group1. Conclusion NAFLD prevalence is alarming high in patients with HIV disease, it is of utmost importance to understand its natural history, in order to prevent the potentially severe consequences of NASH. Our study suggests that a longer duration on ART might correlate with higher incidence of NAFLD, which would suggest better monitoring of liver health with new ART. Disclosures All authors: No reported disclosures.

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A Prospective Randomized Study: The Usefulness and Efficacy of Negative Pressure Wound Therapy with Lipidocolloid Polyester Mesh Compared to Traditional Negative Pressure Wound Therapy for Treatment of Pressure Ulcers

Pharmaceutics ◽

10.3390/pharmaceutics12090813 ◽

2020 ◽

Vol 12 (9) ◽

pp. 813

Author(s):

Wooyeol Baek ◽

Nara Lee ◽

Eun Jin Han ◽

Tai Suk Roh ◽

Won Jai Lee

Keyword(s):

Wound Healing ◽

Pressure Ulcer ◽

Negative Pressure ◽

Negative Pressure Wound Therapy ◽

Randomized Study ◽

Contact Layer ◽

Control Group ◽

Wound Therapy ◽

Group 2 ◽

Group 1

To improve healing of pressure ulcer wounds, it is important to optimize the conditions of the area surrounding the wound. Negative pressure wound therapy (NPWT) promotes wound healing, however, the removal of NPWT can cause pain or focal bleeding, delaying wound healing or causing infection. In this study, we reviewed the efficacy of the lipidocolloid non-adherent dressing (Urgotul®) as a wound contact layer. A total of 38 patients from the same facility who applied NPWT from April 2016 to October 2019 were included and divided into two groups; NPWT with the lipidocolloid non-adherent dressing (group 1, experimental group, 19 patients) and NPWT only (group 2, control group, 19 patients). The condition of the wound was examined prior to NPWT application, at one week, and again at three weeks after application. No significant differences were found between groups for general characteristics, bacterial culture or photo analysis. However, when comparing groups based on the time of examination, there was a significant reduction of the wound size in group 1 (p = 0.001) but not in group 2 (p = 0.082). Therefore, the current study finds that using the lipidocolloid non-adherent dressing as a wound contact layer in NPWT stimulates healing by shrinking the size of the pressure ulcer wound.

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Comparative evaluation of blood salvage techniques in patients undergoing cardiac surgery with cardiopulmonary bypass

Perfusion ◽

10.1177/0267659117728328 ◽

2017 ◽

Vol 33 (2) ◽

pp. 105-109 ◽

Cited By ~ 3

Author(s):

Serdar Gunaydin ◽

Craig Robertson ◽

Ali Baran Budak ◽

Terence Gourlay

Keyword(s):

Cardiac Surgery ◽

Cardiopulmonary Bypass ◽

Blood Cells ◽

Randomized Study ◽

White Blood Cells ◽

Cell Saver ◽

Blood Salvage ◽

Group 2 ◽

Intraoperative Blood Salvage ◽

Group 1

Background: The primary objective of this study was to test and compare the efficacy of currently available intraoperative blood salvage systems via a demonstration of the level of increase in percentage concentration of red blood cells (RBC), white blood cells 9WBC) and platelets (Plt) in the end product. Methods: In a prospective, randomized study, data of 80 patients undergoing elective cardiac surgery with cardiopulmonary bypass in a 6-month period was collected, of which the volume aspirated from the surgical field was processed by either the HemoSep Novel Collection Bag (Advancis Surgical, Kirkby-in-Ashfield, Notts, UK) (N=40) (Group 1) or a cell- saver (C.A.T.S Plus Autotransfusion System, Fresenius Kabi, Bad Homburg, Germany) (N=40) (Group 2). Results: Hematocrit levels increased from 23.05%±2.7 to 43.02%±12 in Group 1 and from 24.5±2 up to 55.2±9 in Group 2 (p=0.013). The mean number of platelets rose to 225200±47000 from 116400 ±40000 in the HemoSep and decreased from 125200±25000 to 96500±30000 in the cell-saver group (p=0.00001). The leukocyte count was concentrated significantly better in Group 1 (from 10100±4300 to 18120±7000; p=0.001). IL-6 levels (pg/dL) decreased from 223±47 to 83±21 in Group 1 and from 219±40 to 200±40 in Group 2 (p=0.001). Fibrinogen was protected significantly better in the HemoSep group (from 185±35 to 455±45; p=0.004). Conclusions: Intraoperative blood salvage systems functioned properly and the resultant blood product was superior in terms of red blood cell species. The HemoSep group had significantly better platelet and leukocyte concentrations and fibrinogen content.

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