scholarly journals Predictive Low Glucose Suspend Algorithm in Real Life: A Five-Year Follow-Up Retrospective Analysis

2020 ◽  
pp. 193229682095210
Author(s):  
Claudio Tubili ◽  
Daniela Pollakova ◽  
Maria Rosaria Nardone ◽  
Ugo Di Folco
Keyword(s):  
Clinical Outcomes ◽  
Diabetic Complications ◽  
Statistical Significance ◽  
Real Life ◽  
The Body ◽  
Control Measures ◽  
Low Glucose ◽  
Group 2 ◽  
Group 1

Aim: Sensor-augmented pumps with predictive low glucose suspend function (PLGS-SAP) help patients avoid hypoglycemia and improve quality of life: in this retrospective study, we investigated long-term effects of PLGS-SAP on metabolic outcomes, acute and chronic diabetic complications, in particular cardiovascular events. Materials and Methods: One hundred thirty-nine adults with type 1 diabetes (T1D) treated for more than 10 years with continuous subcutaneous insulin infusion (CSII) were followed for 5 years; 71 (Group 1) started to use PLGS-SAP, and 68 (Group 2) maintained on their non-PLGM insulin pump. Glucose control measures (hemoglobin A1c [HbA1c], acute diabetic complications), clinical outcomes (body mass index [BMI], arterial hypertension, dyslipidemia), chronic diabetes-related complications, and device utilization (continuous glucose monitoring utilization, use of temporary basal rates or special boluses, carbohydrate counting usage) were assessed. Results: The reduction of HbA1c was significant in Group 1 (from 7.5% ± 1.1% to 7.0% ± 1.0%, P = .02), while in Group 2 it did not reach statistical significance (from 7.5% ± 1.1% to 7.4% ± 0.9%, P = .853). BMI increased significantly in Group 2 (from 25.3 ± 2.8 to 25.7 ± 3.4, P < .001), but not in Group 1 (from 25.2 ± 3.5 to 25.2 ± 2.8, P = .887). There were no statistically significant differences in occurrence of acute diabetes complications, other clinical outcomes, prevalence of diabetes-related complications, or device utilization between the groups. Conclusions: In our five-year follow-up experience with T1D CSII users, PLGS-SAP has resulted efficient in improving metabolic control and maintaining the body weight.

Etiology of Cartilage Lesions Does Not Affect Clinical Outcomes of Patellofemoral Autologous Chondrocyte Implantation

Cartilage ◽  
2021 ◽  
pp. 194760352110309
Author(s):  
Alexandre Barbieri Mestriner ◽  
Jakob Ackermann ◽  
Gergo Merkely ◽  
Pedro Henrique Schmidt Alves Ferreira Galvão ◽  
Luiz Felipe Morlin Ambra ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Autologous Chondrocyte Implantation ◽  
Second Generation ◽  
Cartilage Lesion ◽  
Chondrocyte Implantation ◽  
Group 3 ◽  
Group 2 ◽  
Autologous Chondrocyte ◽  
Group 1

Objective To determine the relationship between cartilage lesion etiology and clinical outcomes after second-generation autologous chondrocyte implantation (ACI) in the patellofemoral joint (PFJ) with a minimum of 2 years’ follow-up. Methods A retrospective review of all patients that underwent ACI in the PFJ by a single surgeon was performed. Seventy-two patients with a mean follow-up of 4.2 ± 2.0 years were enrolled in this study and were stratified into 3 groups based on the etiology of PFJ cartilage lesions: patellar dislocation (group 1; n = 23); nontraumatic lesions, including chondromalacia, osteochondritis dissecans, and degenerative defects (group 2; n = 28); and other posttraumatic lesions besides patellar dislocations (group 3; n = 21). Patient’s mean age was 29.6 ± 8.7 years. Patients in group 1 were significantly younger (25.4 ± 7.9 years) than group 2 (31.7 ± 9.6 years; P = 0.025) and group 3 (31.5 ± 6.6 years; P = 0.05). Body mass index averaged 26.2 ± 4.3 kg/m2, with a significant difference between group 1 (24.4 ± 3.2 kg/m2) and group 3 (28.7 ± 4.5 kg/m2; P = 0.005). A clinical comparison was established between groups based on patient-reported outcome measures (PROMs) and failure rates. Results Neither pre- nor postoperative PROMs differed between groups ( P > 0.05). No difference was seen in survivorship between groups (95.7% vs. 82.2% vs. 90.5%, P > 0.05). Conclusion Cartilage lesion etiology did not influence clinical outcome in this retrospective study after second generation ACI in the PFJ. Level of Evidence Level III, retrospective comparative study.

scholarly journals Impact of percutaneous embolization versus subinguinal microsurgical ligation on semen parameters in primary varicocele patients: comparative study

2020 ◽  
Vol 51 (1) ◽  
Author(s):  
Haytham M. Nasser ◽  
Ahmed Hussein ◽  
Gad M. Behairy ◽  
Mostafa Abdo
Keyword(s):  
Sperm Count ◽  
Semen Analysis ◽  
Statistical Significance ◽  
Semen Parameters ◽  
Male Factor ◽  
Percutaneous Embolization ◽  
Significant Difference ◽  
Group 2 ◽  
Group 1

Abstract Background Varicocele is an abnormally dilated pampiniform plexus of the veins within the spermatic cord and is considered the most common correctable cause of male factor infertility. Many approaches are described for treatment either surgical (tradition inguinal, subinguinal, and laparoscopic) or non-surgical percutaneous embolization. During the period from August 2017 to December 2018, we prospectively analyzed the preoperative and post-operative alteration of semen parameters (at 3 and 9 months) of the data collected from 63 patients with clinically evident varicocele referred to our tertiary hospital. Patients were divided into two groups: group 1, thirty-three patients who underwent subinguinal microsurgical ligation, and group 2, thirty patients who underwent percutaneous embolization. Results Sixty-three patients enrolled in this study were divided in two groups: group 1, patients who underwent surgery, and group 2, patients who underwent embolization; the mean age is 24.6 ± 1.27 years in group 1 and 23.7 ± 2 years in group 2; there was no statistically significant difference between the two groups as regards BMI, diabetes, hypertension, and smoking. Bilaterality was present in 15.2% of group 1 patients and 10% in group 2 patients (P value 0.06). Most of the patients were classified as grades 2 and 3 with no statistical significance regarding severity of the disease. Preoperative semen parameters for patients including sperm count, motility, and abnormal forms showed no statistically significant difference between the two groups. Post-intervention semen analysis was done twice during follow-up after 3 months and 9 months from the date of intervention. After 3 months, the semen parameters were improved in both groups in spite of the higher sperm count in group 2 but with no statistical significance. After 9 months follow-up, semen analysis showed persistent increase in sperm mobility in group 1 patients in comparison to group 2 patients. Both groups had better improvement in count of normal form with no statistical significant change. Conclusion Improvement of semen parameters while treating primary varicocele by either subinguinal microsurgery approach or percutaneous embolization shows equivalent outcomes.

scholarly journals Tolerance and Effectiveness of Targeted Therapies in Aged Patients with Metastatic Melanoma

2021 ◽  
Author(s):  
Ondine Becquart ◽  
Bastien Oriano ◽  
Stéphane Dalle ◽  
Laurent Mortier ◽  
Marie Thérèse Leccia ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Elderly People ◽  
Targeted Therapies ◽  
Objective Response ◽  
Real Life ◽  
Standard Regimen ◽  
Aged Patients ◽  
Group 2 ◽  
Group 1

Purpose: Melanoma&rsquo;s incidence is increasing, and elderly people could be significantly impacted since the majority occurs in people over 65 years of age. Combined targeted therapies (TT) are current standard regimen for BRAF mutated metastatic melanoma (MM). Except for subgroups of pivotal trials, little data are available for TT in this population. Materials and Methods: Outcomes were explored in real life patients from MelBase, a French multicentric biobank dedicated to the prospective follow-up of unresectable stage III or IV melanoma. Patients treated by BRAF TT and/or MEK TT combined or not, were included from 2013 to 2017 in 2 groups: group 1 &lt;65-year-old (yo), group 2 &gt;65 yo, analyzed for tolerance and efficacy. Results: 353 patients were included: 231 in group 1, 122 in group 2. Median follow-up was 12 months (M). Median time of treatment was 6.9 M. A total of 80% had at least one Adverse Effect (AE). Most frequent AE (all grades) were mainly skin and subcutaneous, general, and gastrointestinal disorders. A total of 31% of AE were grade 3&ndash;4: 28% in group 1 and 39% in group 2 (p = 0.05). No differences were observed in all AE grades proportion, dose modifications, interruptions, and discontinuations. For each group, median overall survival was 20.3 M (CI 95%: 15.5&ndash;27.9) and 16.3 M (CI: 14.5&ndash;26.9), respectively (p = 0.8). Median progression free survival was 7.8 M (6.4&ndash;9.9) and 7.7 M (CI: 5.8&ndash;11.3) (p = 0.4). Objective response rate was 59% and 50% (p = 0.6). Conclusion: This study on a large multicentric cohort is the first to assess that TT is well tolerated in elderly BRAF-mutated patients such as in patients younger than 65. Efficacy was similar between groups with outcomes reaching those from pivotal studies. There is thus no argument against using TT in elderly people, although an onco-geriatric opinion is welcome for the most vulnerable.

Isokinetic Strength Comparison of Tuberosity Fractures of the Proximal Fifth Metatarsal Treated With Elastic Bandage vs Cast

2020 ◽  
Vol 41 (6) ◽  
pp. 674-682
Author(s):  
Serkan Bayram ◽  
Alper Şükrü Kendirci ◽  
Doğan Kıral ◽  
Türker Şahinkaya ◽  
Mehmet Ekinci ◽  
...  
Keyword(s):  
Muscle Strength ◽  
Clinical Outcomes ◽  
Assistive Devices ◽  
Cast Immobilization ◽  
Functional Scores ◽  
Ankle Muscle ◽  
Group 2 ◽  
Elastic Bandage ◽  
Group 1

Background: The aim of this study was to compare the strength of injured and healthy ankle muscle as well as functional and clinical outcomes between patients with proximal fifth metatarsal tuberosity fractures who received elastic bandage treatment and those who received cast immobilization. Methods: Sixty-five patients who presented to our clinic between February 2018 and April 2019 were randomly divided into 2 groups: 33 received elastic bandages (group 1) and 32 received cast immobilization (group 2). All patients were scheduled for follow-up appointments at our clinic after 2, 4, 8, 12, and 24 weeks. Visual analog scale–foot and ankle (VAS-FA) score, time missed from work, and using assistive devices were recorded as clinical outcomes. Both ankle plantarflexion-dorsiflexion and inversion-eversion muscle strengths (peak torque) were measured using an isokinetic dynamometer for each group and were compared with those of the healthy extremities. Results: The mean missed work was 11.3 days in group 1 and 27.6 days in group 2. Groups 1 and 2 used assistive devices for a mean of 6.7 and 16.2 days, respectively ( P = .001). Group 1 had a significantly higher VAS-FA score at the 2nd, 4th, and 8th week of follow-up compared with group 2, and no significant differences were observed at the time of injury and at the 12th and 24th weeks. The muscle strength deficits in group 1 were present at the 4th week, whereas those in the cast immobilization group were determined at the 4th and 8th weeks in all muscles. During the 12th and 24th week of follow-up, no significantly differences in both extremities were observed between the groups. Conclusion: Elastic bandage treatment was better than cast immobilization in terms of preserving ankle muscle strength, clinical outcomes, and functional scores regardless of the degree of fracture displacement. Moreover, the present study emphasized that cast immobilization offered no advantages in this fracture treatment. Level of Evidence: Level I, prognostic randomized controlled trial.

scholarly journals Tolerance and Effectiveness of Targeted Therapies in Aged Patients with Metastatic Melanoma

Cancers ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 3042
Author(s):  
Ondine Becquart ◽  
Bastien Oriano ◽  
Stéphane Dalle ◽  
Laurent Mortier ◽  
Marie Thérèse Leccia ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Elderly People ◽  
Targeted Therapies ◽  
Objective Response ◽  
Real Life ◽  
Standard Regimen ◽  
Aged Patients ◽  
Group 2 ◽  
Group 1

Purpose: Melanoma’s incidence is increasing, and elderly people could be significantly impacted since the majority occurs in people over 65 years of age. Combined BRAF and MEK targeted therapies (TT) are current standard regimen for BRAF mutated metastatic melanoma (MM). Except for subgroups of pivotal trials, little data are available for TT in this population. Materials and Methods: Outcomes were explored in real life patients from MelBase, a French multicentric biobank dedicated to the prospective follow-up of unresectable stage III or IV melanoma. Patients treated by BRAF TT and/or MEK TT combined or not, were included from 2013 to 2017 in 2 groups: group 1 ≤ 65-year-old (yo), group 2 > 65 yo, analyzed for tolerance and efficacy. Results: 353 patients were included: 231 in group 1, 122 in group 2. Median follow-up was 12 months (M). Median time of treatment was 6.9 M. A total of 80% had at least one Adverse Effect (AE). Most frequent AE (all grades) were mainly skin and subcutaneous, general, and gastrointestinal disorders. A total of 31% of AE were grade 3–4: 28% in group 1 and 39% in group 2 (p = 0.05). No differences were observed in all AE grades proportion, dose modifications, interruptions, and discontinuations. For each group, median overall survival was 20.3 M (CI 95%: 15.5–27.9) and 16.3 M (CI: 14.5–26.9), respectively (p = 0.8). Median progression free survival was 7.8 M (6.4–9.9) and 7.7 M (CI: 5.8–11.3) (p = 0.4). Objective response rate was 59% and 50% (p = 0.6). Conclusion: This study on a large multicentric cohort is the first to assess that TT is well tolerated in elderly BRAF-mutated patients such as in patients younger than 65. Efficacy was similar between groups with outcomes reaching those from pivotal studies. There is thus no argument against using TT in elderly people, although an onco-geriatric opinion is welcome for the most vulnerable.

scholarly journals Comparison of Clinical Characteristics and Outcomes in Patients with STEMI in Croatia and Kosovo

2020 ◽  
Vol 1 (1) ◽  
pp. 24-28
Author(s):  
Koshi Rreze ◽  
◽  
Strozzi Maja ◽  
Milicic Davor ◽  
Elezi Shpend ◽  
...  
Keyword(s):  
Clinical Characteristics ◽  
Interventional Procedure ◽  
Statistical Significance ◽  
Treatment Modalities ◽  
Drug Eluting Stent ◽  
Term Survival ◽  
Significant Difference ◽  
Group 2 ◽  
Group 1

INTRODUCTION The aim of our study was to compare clinical characteristics, risk factors, treatment modalities and medium-term outcomes in STEMI patients in two different countries, Croatia and Kosovo. MATERIAL AND METHODS The study included 77 consecutive patients from two regional hospitals, included in the STEMI network of University Clinical Center Zagreb, Croatia (group 1), and 75 STEMI consecutive patients treated in regional Hospital Gjakova, Kosovo (group 2). Standard laboratory tests were performed in both study groups. Patients were treated by the standard protocol of the country and hospital where they were treated. Immediate clinical outcomes and 6 months follow up results regarding MACE were compared. RESULTS There was no significant difference between groups in basic clinical characteristic except for diabetes mellitus, (x2 = 6.96, P = 0.008, P <0.01) and glycaemia control (U’ = 1530, P = 0.013).No significant difference between two groups in laboratory findings. There was a difference in percent of patients treated with primary PCI, 71 in gr 1 and 55 in group 2, reaching statistical significance (x2 test 8,261, p = 0.0045). In patients treated with PCI, there was no difference in “door to balloon time” (DTB) between groups. There was a remarkable difference in proportion of drug eluting stent (DES) implantation (3.5% in group 1, 29.1% in group 2 (x2 test 13.5, P = 0.0002).The difference partly derives from the relatively large number of balloon interventions in group 2. There was 2 deaths in group 1 in early hospital period, both during interventional procedure, one of the patients was in cardiogenic shock. There was no early mortality in group 2. In 6 month clinical follow up there were 3 deaths in group 2, all in patient with no revascularization, and no death in group 1. CONCLUSION We compared the clinical characteristics, treatment strategies and outcomes, in STEMI patients from two countries. After initial mortality, patients from Croatia had a better mid-term survival after recovery from their AMI compared to patients from Kosovo. Use of revascularization procedures was beneficial, but it was less often performed in Kosovo

The Relationship Between Polyethylene Insert Size and Complications in Total Ankle Replacement

2018 ◽  
Vol 12 (3) ◽  
pp. 253-257
Author(s):  
James M. Cottom ◽  
Steven M. Douthett ◽  
Kelly K. McConnell ◽  
Britton S. Plemmons
Keyword(s):  
Statistical Significance ◽  
Total Ankle Replacement ◽  
Complication Rates ◽  
Polyethylene Insert ◽  
Insert Size ◽  
Ankle Replacement ◽  
Patient Reported ◽  
Group 2 ◽  
Group 1

The purpose of this study was to compare complication rates after total ankle replacement in 2 groups of patients based on polyethylene insert size. The total cohort was divided into 2 groups based on insert size. Group 1 included patients with polyethylene insert size less than 10 mm in thickness. Group 2 included patients with polyethylene insert sizes 10 mm and larger. Available charts were reviewed for patients who underwent primary total ankle arthroplasty by one surgeon. Patient demographics, polyethylene insert size, implant used, concomitant procedures, postoperative complications, and patient-reported outcome scores were recorded. One hundred patients were available for follow-up and were included in this study, which ranged from March 2012 to July 2017. The average follow-up was 31.3 months (range = 10-60 months). Forty-eight females and 52 males were included in this study. There were a total of 63 patients in group 1 and 47 patients in group 2. The total complication rate for patients in group 1 was 11.1% (7/63), and in group 2 it was 16.2% (6/32). There was no statistical significance in complication rates when comparing the 2 groups (P = 0.5427). All patients underwent at least one concomitant procedure at the time of initial ankle replacement. Our findings show that total ankle replacement complication rates are equal when comparing large polyethylene inserts commonly utilized to correct deformities, versus small polyethylene inserts commonly utilized in primary resurfacing. Levels of Evidence: Level IV, Retrospective comparative study

Use of Mineral Trioxide Aggregate with or without a Collagen Sponge as an Apical Plug in Teeth with Immature Apices

2021 ◽  
Vol 45 (3) ◽  
pp. 165-170
Author(s):  
Gün Burak Tek ◽  
Gül Keskin
Keyword(s):  
Retrospective Study ◽  
Clinical Outcomes ◽  
Study Design ◽  
Mineral Trioxide Aggregate ◽  
Collagen Sponge ◽  
Protocol Group ◽  
Significant Difference ◽  
Group 2 ◽  
Group 1

Objective: This retrospective study aimed to evaluate the clinical outcomes of the apical plug performed using MTA with or without collagen sponge in immature anterior maxillary teeth with necrotic pulp. Study design: The study included apical obturation of 20 upper incisor teeth from 18 patients and outcomes of 12-month follow-up. The teeth were divided into 2 groups with 10 cases in each group according to the apexification protocol (Group 1; apical plug with MTA, Group 2; collagen sponge and apical plug with MTA). The artificial apical barrier, approximately 4-mm-thick, was created with MTA in each group. Based on clinical and radiographic criteria, the outcome was assessed using the periapical index (PAI) by 2 calibrated investigators. Results: In this study, 3 of the 6 teeth (50%) in Group 1 and 5 of the 8 teeth (62.5%) in Group 2 healed at the 12-month follow-up. However, there was no statistically significant difference between the groups at the post-treatment follow-up times. Conclusion: The use of collagen as an apical matrix prior to the MTA plug can be suggested due to favorable clinical outcomes.

scholarly journals Surgical Technique and Clinical Outcomes of Osteochondral Autograft Transplantation for Large Osteonecrotic Lesions of the Femoral Condyle With Residual Normal Cartilage: The Eyeglass Technique

2019 ◽  
Vol 7 (10) ◽  
pp. 232596711987244 ◽  
Author(s):  
Hiromitsu Yabumoto ◽  
Yasuaki Nakagawa ◽  
Shogo Mukai
Keyword(s):  
Surgical Technique ◽  
Clinical Outcomes ◽  
Femoral Condyle ◽  
Standard Technique ◽  
Intergroup Difference ◽  
Normal Cartilage ◽  
Osteochondral Autograft ◽  
Group 2 ◽  
Group 1

Background: Osteochondral autograft transplantation (OAT) is usually performed for a defect that is <400 mm2 because of the limitations of autografts. Purpose: To present the surgical technique and clinical outcomes of OAT using the eyeglass technique for large osteonecrotic lesions of the femoral condyle (LOFs) (>400 mm2) with residual normal cartilage. Study Design: Cohort study; Level of evidence, 3. Methods: Cases (group 1) included 15 patients (18 knees) who underwent OAT using the eyeglass technique for LOFs with residual normal cartilage, while controls (group 2) included 11 patients (11 knees) who underwent OAT using the standard technique for small osteonecrotic lesions of the femoral condyle (≤400 mm2). Clinical outcomes were evaluated preoperatively and at the final follow-up (group 1, 56 months; group 2, 48 months) according to the International Knee Documentation Committee (IKDC) objective grade, the IKDC subjective score, and the Japanese Orthopaedic Association (JOA) score. Results: The mean lesion size was 685 mm2 in group 1 and 230 mm2 in group 2. Patients in group 1 had postoperative scores equivalent to those in group 2. The postoperative IKDC subjective scores in group 1 (mean, 86.9) and group 2 (mean, 87.0) showed no significant difference at the final follow-up ( P = .653). For postoperative IKDC objective grades, 83.3% of group 1 and 81.8% of group 2 were graded as “nearly normal” or better, and no significant intergroup difference was found for the IKDC objective grade ( P = .989). Also, no significant intergroup difference was found for the postoperative JOA score (group 1, 93.9; group 2, 81.4; P = .480). Nine second-look arthroscopic procedures were performed in group 1 compared with 4 in group 2, and all patients had plugs that were graded as “nearly normal” or better by the International Cartilage Repair Society classification system. Conclusion: The postoperative results of patients who underwent OAT using the eyeglass technique for large osteonecrotic lesions (>400 mm2) were equivalent to the results of patients who underwent OAT using the standard technique for small osteonecrotic lesions (≤400 mm2).

Intravitreal Aflibercept for the Treatment of Subacute Central Serous Chorioretinopathy

2017 ◽  
Vol 1 (2) ◽  
pp. 101-108 ◽  
Author(s):  
Young Hee Yoon ◽  
Dong Yoon Kim ◽  
Young-Ju Lew ◽  
Kyu-Hyung Park ◽  
Ju Byung Chae ◽  
...  
Keyword(s):  
Central Serous Chorioretinopathy ◽  
Therapeutic Option ◽  
Real Life ◽  
Controlled Clinical Trial ◽  
Eligibility Criteria ◽  
Intravitreal Aflibercept ◽  
Group 2 ◽  
Change In Mean ◽  
Group 1

Purpose: To evaluate the role of intravitreal aflibercept (IVA) for treating persistent central serous chorioretinopathy (CSCR) of more than 6 weeks. Methods: AFlibercept Efficacy in Cscr Treatment (NCT01971190) was a 6-month, phase 2, multicenter, prospective, randomized, controlled clinical trial at 6 clinical sites in Korea. Forty-three patients were randomized into group 1 (29) with 3 monthly IVA administrations or group 2 (14) with sham treatment and followed for 6 months with pro re nata (PRN) IVA. Patients could be retreated with IVA when they met the eligibility criteria for this. The primary end point was a mean change in central subfield thickness (CST) from baseline. Best-corrected visual acuity (BCVA) and CST were checked monthly. Data from a subgroup with long-term follow-up in a real-life practice were also compared. Results: After 3 months of treatment, group 1 had a greater change in mean CST (173.97 vs 80.15 µm; P = .001) and BCVA improvement (10.38 vs 8.62 Early Treatment of Diabetic Retinopathy Study letters; P = .52) than group 2. Among patients whose disease had lasted ≥3 months, BCVA improvement was significantly better in group 1 than in group 2 after 3 months (12.0 vs −2.7 letters; P = .007), and the percentage of eyes requiring PRN IVA was lower in group 1 (50% vs 100%). These differences were attenuated at 6 months but maintained during additional 6-month follow-up. Conclusion: Intravitreal aflibercept may facilitate the anatomical improvement in persistent CSCR and may improve the visual outcomes in relatively chronic cases. The IVA injection may be a therapeutic option for CSCR.

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