Tag: nevin manimala

Int J Periodontics Restorative Dent. 2023 Jun 20. doi: 10.11607/prd.6013. Online ahead of print.

ABSTRACT

The aim of this retrospective study is to evaluate the performance of implants placed with the All-on-4 technique after a mean time in function of 9 years. Thirty-four patients treated with 156 implants were selected for this study. Eighteen patients underwent teeth extraction on the day of implant placement (group D); 16 were already edentulous (group E). A peri-apical radiograph was taken after a mean of 9 years (range: 5 to 14 years). Success, survival rate, and prevalence of peri-implantitis were calculated. Statistical analysis was used to assess comparisons between groups. After a mean follow-up time of 9 years, the cumulative survival rate was 97.4%, and the success rate was 77.4%. The difference between initial and final radiographs resulted in a mean marginal bone loss (MBL) of 1.3 ± 1.06 mm (range: 0.1 to 5.3 mm). No differences were shown between group D and group E. Fifteen (9.6%) implants in 9 (26.5%) patients were affected by peri-implantitis. This study shows that the All-on-4 technique is a reliable treatment for both edentulous patients and patients that need to undergo dental extractions, with a long follow up. MBL found in this study is similar to MBL around implants used in other rehabilitation types.

PMID:37338922 | DOI:10.11607/prd.6013

Medeni Med J. 2023 Jun 20;38(2):120-127. doi: 10.4274/MMJ.galenos.2023.85688.

ABSTRACT

OBJECTIVE: The preferred therapy for staghorn stones and large kidney stones is percutaneous nephrolithotomy (PCNL). Ultrasound-guided PCNL has definite advantages over fluoroscopy-guided PCNL. Preoperative characteristics are essential to assess better surgical outcomes. The goal of this study was to analyze the correlation of hydronephrosis with surgical outcomes after ultrasound-guided supine PCNL.

METHODS: A retrospective study was conducted at Doris Sylvanus General Hospital. Data of the patients was obtained from hospital records. Hundred and five patients underwent ultrasound-guided PCNL in the supine position from August 2020 to August 2022. Data were analyzed using SPSS 16.0.

RESULTS: The presence of hydronephrosis was 85 (80.95%), which consisted of Grade I 15 (14.30%), Grade II 25 (23.80%), Grade III 28 (26.70%), and Grade IV 17 (16.20%). In our study analysis, complications occurred in 16 patients (15.23%). Grade I complications of the Clavien-Dindo classification was of in 4 cases, 11 cases of grade 2 complications, and 1 patient died. The statistical result was the relationship between grade hydronephrosis and the grade of complication using the modified Clavien-Dindo system. We found a p-value of 0.207 (>0.05), and there is no statistically significant relationship p=0.382 and r=-0.086 was a negative correlation. There is also no statistically significant relationship between hydronephrosis and stone clearance with p=0.310.

CONCLUSIONS: The use of ultrasonographic guidance PCNL has been reported as a safe and effective procedure for the management of large renal stones. In this study, there was no correlation or signification between hydronephrosis and surgical outcome after ultrasound-guided supine PCNL.

PMID:37338913 | DOI:10.4274/MMJ.galenos.2023.85688

JAMA Netw Open. 2023 Jun 1;6(6):e2318919. doi: 10.1001/jamanetworkopen.2023.18919.

ABSTRACT

IMPORTANCE: Understanding the association of civil violence with mental disorders is important for developing effective postconflict recovery policies.

OBJECTIVE: To estimate the association between exposure to civil violence and the subsequent onset and persistence of common mental disorders (in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]) in representative surveys of civilians from countries that have experienced civil violence since World War II.

DESIGN, SETTING, AND PARTICIPANTS: This study used data from cross-sectional World Health Organization World Mental Health (WMH) surveys administered to households between February 5, 2001, and January 5, 2022, in 7 countries that experienced periods of civil violence after World War II (Argentina, Colombia, Lebanon, Nigeria, Northern Ireland, Peru, and South Africa). Data from respondents in other WMH surveys who immigrated from countries with civil violence in Africa and Latin America were also included. Representative samples comprised adults (aged ≥18 years) from eligible countries. Data analysis was performed from February 10 to 13, 2023.

EXPOSURES: Exposure was defined as a self-report of having been a civilian in a war zone or region of terror. Related stressors (being displaced, witnessing atrocities, or being a combatant) were also assessed. Exposures occurred a median of 21 (IQR, 12-30) years before the interview.

MAIN OUTCOMES AND MEASURES: The main outcome was the retrospectively reported lifetime prevalence and 12-month persistence (estimated by calculating 12-month prevalence among lifetime cases) of DSM-IV anxiety, mood, and externalizing (alcohol use, illicit drug use, or intermittent explosive) disorders.

RESULTS: This study included 18 212 respondents from 7 countries. Of these individuals, 2096 reported that they were exposed to civil violence (56.5% were men; median age, 40 [IQR, 30-52] years) and 16 116 were not exposed (45.2% were men; median age, 35 [IQR, 26-48] years). Respondents who reported being exposed to civil violence had a significantly elevated onset risk of anxiety (risk ratio [RR], 1.8 [95% CI, 1.5-2.1]), mood (RR, 1.5 [95% CI, 1.3-1.7]), and externalizing (RR, 1.6 [95% CI, 1.3-1.9]) disorders. Combatants additionally had a significantly elevated onset risk of anxiety disorders (RR, 2.0 [95% CI, 1.3-3.1]) and refugees had an increased onset risk of mood (RR, 1.5 [95% CI, 1.1-2.0]) and externalizing (RR, 1.6 [95% CI, 1.0-2.4]) disorders. Elevated disorder onset risks persisted for more than 2 decades if conflicts persisted but not after either termination of hostilities or emigration. Persistence (ie, 12-month prevalence among respondents with lifetime prevalence of the disorder), in comparison, was generally not associated with exposure.

CONCLUSIONS: In this survey study of exposure to civil violence, exposure was associated with an elevated risk of mental disorders among civilians for many years after initial exposure. These findings suggest that policy makers should recognize these associations when projecting future mental disorder treatment needs in countries experiencing civil violence and among affected migrants.

PMID:37338903 | DOI:10.1001/jamanetworkopen.2023.18919

JAMA Intern Med. 2023 Jun 20. doi: 10.1001/jamainternmed.2023.2215. Online ahead of print.

ABSTRACT

IMPORTANCE: Patients with end-stage kidney disease (ESKD) undergoing long-term hemodialysis often experience a high burden of debilitating symptoms for which effective treatment options are limited.

OBJECTIVE: To compare the effectiveness of a stepped collaborative care intervention vs attention control for reducing fatigue, pain, and depression among patients with ESKD undergoing long-term hemodialysis.

DESIGN, SETTING, AND PARTICIPANTS: Technology Assisted Stepped Collaborative Care (TĀCcare) was a parallel-group, single-blinded, randomized clinical trial of adult (≥18 years) patients undergoing long-term hemodialysis and experiencing clinically significant levels of fatigue, pain, and/or depression for which they were considering treatment. The trial took place in 2 US states (New Mexico and Pennsylvania) from March 1, 2018, to June 31, 2022. Data analyses were performed from July 1, 2022, to April 10, 2023.

INTERVENTIONS: The intervention group received 12 weekly sessions of cognitive behavioral therapy delivered via telehealth in the hemodialysis unit or patient home, and/or pharmacotherapy using a stepped approach in collaboration with dialysis and primary care teams. The attention control group received 6 telehealth sessions of health education.

MAIN OUTCOMES AND MEASURES: The coprimary outcomes were changes in fatigue (measured using the Functional Assessment of Chronic Illness Therapy Fatigue), average pain severity (Brief Pain Inventory), and/or depression (Beck Depression Inventory-II) scores at 3 months. Patients were followed up for 12 months to assess maintenance of intervention effects.

RESULTS: There were 160 participants (mean [SD] age, 58 [14] years; 72 [45%] women and 88 [55%] men; 21 [13%] American Indian, 45 [28%] Black, 28 [18%] Hispanic, and 83 [52%] White individuals) randomized, 83 to the intervention and 77 to the control group. In the intention-to-treat analyses, when compared with controls, patients in the intervention group experienced statistically and clinically significant reductions in fatigue (mean difference [md], 2.81; 95% CI, 0.86 to 4.75; P = .01) and pain severity (md, -0.96; 95% CI, -1.70 to -0.23; P = .02) at 3 months. These effects were sustained at 6 months (md, 3.73; 95% CI, 0.87 to 6.60; P = .03; and BPI, -1.49; 95% CI, -2.58 to -0.40; P = .02). Improvement in depression at 3 months was statistically significant but small (md -1.73; 95% CI, -3.18 to -0.28; P = .02). Adverse events were similar in both groups.

CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that a technology assisted stepped collaborative care intervention delivered during hemodialysis led to modest but clinically meaningful improvements in fatigue and pain at 3 months vs the control group, with effects sustained until 6 months.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03440853.

PMID:37338898 | DOI:10.1001/jamainternmed.2023.2215

JAMA Neurol. 2023 Jun 20. doi: 10.1001/jamaneurol.2023.1660. Online ahead of print.

ABSTRACT

IMPORTANCE: ApTOLL is a TLR4 antagonist with proven preclinical neuroprotective effect and a safe profile in healthy volunteers.

OBJECTIVE: To assess the safety and efficacy of ApTOLL in combination with endovascular treatment (EVT) for patients with ischemic stroke.

DESIGN, SETTING, AND PARTICIPANTS: This phase 1b/2a, double-blind, randomized, placebo-controlled study was conducted at 15 sites in Spain and France from 2020 to 2022. Participants included patients aged 18 to 90 years who had ischemic stroke due to large vessel occlusion and were seen within 6 hours after stroke onset; other criteria were an Alberta Stroke Program Early CT Score of 6 to 10, estimated infarct core volume on baseline computed tomography perfusion of 5 to 70 mL, and the intention to undergo EVT. During the study period, 4174 patients underwent EVT.

INTERVENTIONS: In phase 1b, 0.025, 0.05, 0.1, or 0.2 mg/kg of ApTOLL or placebo; in phase 2a, 0.05 or 0.2 mg/kg of ApTOLL or placebo; and in both phases, treatment with EVT and intravenous thrombolysis if indicated.

MAIN OUTCOMES AND MEASURES: The primary end point was the safety of ApTOLL based on death, symptomatic intracranial hemorrhage (sICH), malignant stroke, and recurrent stroke. Secondary efficacy end points included final infarct volume (via MRI at 72 hours), NIHSS score at 72 hours, and disability at 90 days (modified Rankin Scale [mRS] score).

RESULTS: In phase Ib, 32 patients were allocated evenly to the 4 dose groups. After phase 1b was completed with no safety concerns, 2 doses were selected for phase 2a; these 119 patients were randomized to receive ApTOLL, 0.05 mg/kg (n = 36); ApTOLL, 0.2 mg/kg (n = 36), or placebo (n = 47) in a 1:1:√2 ratio. The pooled population of 139 patients had a mean (SD) age of 70 (12) years, 81 patients (58%) were male, and 58 (42%) were female. The primary end point occurred in 16 of 55 patients (29%) receiving placebo (10 deaths [18.2%], 4 sICH [7.3%], 4 malignant strokes [7.3%], and 2 recurrent strokes [3.6%]); in 15 of 42 patients (36%) receiving ApTOLL, 0.05 mg/kg (11 deaths [26.2%], 3 sICH [7.2%], 2 malignant strokes [4.8%], and 2 recurrent strokes [4.8%]); and in 6 of 42 patients (14%) receiving ApTOLL, 0.2 mg/kg (2 deaths [4.8%], 2 sICH [4.8%], and 3 recurrent strokes [7.1%]). ApTOLL, 0.2 mg/kg, was associated with lower NIHSS score at 72 hours (mean difference log-transformed vs placebo, -45%; 95% CI, -67% to -10%), smaller final infarct volume (mean difference log-transformed vs placebo, -42%; 95% CI, -66% to 1%), and lower degrees of disability at 90 days (common odds ratio for a better outcome vs placebo, 2.44; 95% CI, 1.76 to 5.00).

CONCLUSIONS AND RELEVANCE: In acute ischemic stroke, 0.2 mg/kg of ApTOLL administered within 6 hours of onset in combination with EVT was safe and associated with a potential meaningful clinical effect, reducing mortality and disability at 90 days compared with placebo. These preliminary findings await confirmation from larger pivotal trials.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04734548.

PMID:37338893 | DOI:10.1001/jamaneurol.2023.1660

JAMA. 2023 Jun 20;329(23):2023-2025. doi: 10.1001/jama.2023.8972.

NO ABSTRACT

PMID:37338887 | DOI:10.1001/jama.2023.8972

JAMA. 2023 Jun 20;329(23):2050-2056. doi: 10.1001/jama.2023.8549.

ABSTRACT

IMPORTANCE: Many randomized clinical trials yield statistically nonsignificant results. Such results are difficult to interpret within the dominant statistical framework.

OBJECTIVE: To estimate the strength of evidence in favor of the null hypothesis of no effect vs the prespecified effectiveness hypothesis among nonsignificant primary outcome results of randomized clinical trials by application of the likelihood ratio.

DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional study of statistically nonsignificant results for primary outcomes of randomized clinical trials published in 6 leading general medical journals in 2021.

OUTCOME MEASURES: The likelihood ratio for the null hypothesis of no effect vs the effectiveness hypothesis stated in the trial protocol (alternate hypothesis). The likelihood ratio quantifies the support that the data provide to one hypothesis vs the other.

RESULTS: In 130 articles that reported 169 statistically nonsignificant results for primary outcomes, 15 results (8.9%) favored the alternate hypothesis (likelihood ratio, <1), and 154 (91.1%) favored the null hypothesis of no effect (likelihood ratio, >1). For 117 (69.2%), the likelihood ratio exceeded 10; for 88 (52.1%), it exceeded 100; and for 50 (29.6%), it exceeded 1000. Likelihood ratios were only weakly correlated with P values (Spearman r, 0.16; P = .045).

CONCLUSIONS: A large proportion of statistically nonsignificant primary outcome results of randomized clinical trials provided strong support for the hypothesis of no effect vs the alternate hypothesis of clinical efficacy stated a priori. Reporting the likelihood ratio may improve the interpretation of clinical trials, particularly when observed differences in the primary outcome are statistically nonsignificant.

PMID:37338877 | DOI:10.1001/jama.2023.8549

Medeni Med J. 2023 Jun 20;38(2):111-119. doi: 10.4274/MMJ.galenos.2023.42383.

ABSTRACT

OBJECTIVE: Currently, multiple classification systems exist for the assessment of facial nerve paralysis. This study was designed to choose the most practical system for use in a clinical setting depending on the clinician need. We compared the responsiveness of the 3 facial nerve grading systems, i.e., House-Brackmann, Sydney, and Sunnybrook, as the subjective method and compared the outcomes with the objective method, i.e., the nerve conduction study. The correlation between the subjective and objective assessments was determined.

METHODS: A total of 22 consented participants with facial palsy was assessed with photos and videography recordings where they performed 10 standard facial expressions. The severity of facial paralysis was evaluated with the House-Brackmann, Sydney, and Sunnybrook grading scales subjectively and with the facial nerve conduction study objectively. The assessments were repeated after 3 months.

RESULTS: A Wilcoxon signed-rank test showed that there were statistically significant change in all three gradings after 3-month of assessment. The responsiveness of the nerve conduction study was significant for the nasalis and orbicularis oris muscles. It was not significant for the orbicularis oculi muscle. The nasalis and orbicularis oculi showed statistically significant correlation with the three classification systems except for the orbicularis oculi muscle.

CONCLUSIONS: All three grading systems, House-Brackmann, Sydney, and Sunnybrook, showed statistically significant responsiveness after 3 months of evaluation. The nasalis and orbicularis oculi muscle can be used to predict facial palsy recovery because they showed strong positive and negative correlations with the extent of facial nerve degeneration from the nerve conduction study.

PMID:37338861 | DOI:10.4274/MMJ.galenos.2023.42383

Medeni Med J. 2023 Jun 20;38(2):102-110. doi: 10.4274/MMJ.galenos.2023.48768.

ABSTRACT

OBJECTIVE: Neuroblastoma is one of the common tumors of childhood. The demonstration of new factors such as isocitrate dehydrogenase 1 (IDH1) and isocitrate dehydrogenase 2 (IDH2) mutations will be important in the diagnosis and treatment. IDH1 and IDH2 mutations have been found in many types of cancer, such as malignant gliomas, acute myeloid leukemias, chondrosarcoma, and thyroid carcinoma. This study aimed to investigate the presence of IDH1 or IDH2 mutations in patients with neuroblastoma and to determine whether these mutations were different in terms of age, clinical findings, and response to treatment.

METHODS: Biopsy specimens of 25 patients with pediatric neuroblastoma patients were evaluated for IDH mutations. The clinical and laboratory features of the patients with/without mutation were retrospectively analyzed from a hospital database.

RESULTS: A total of 25 patients for whom genetic analysis could be performed were included in the study (60% male, n=15). The mean age was 32.2±25.9 months (3 days-96 months). IDH1 mutation was detected in 8 (32%) and IDH2 mutations in 5 (20%) patients. These mutations showed no statistically significant relationship with age, tumor localization, laboratory results, stage, and prognosis. However, in the case of IDH mutation, patients were diagnosed at the advanced stage.

CONCLUSIONS: This study demonstrated the relationship between neuroblastoma and IDH mutation for the first time. Because to the fact that the mutation is very heterogeneous, it would be appropriate to conduct a larger series of patients in terms of the impact of the clinical significance of each mutation on the diagnosis and prognosis.

PMID:37338860 | DOI:10.4274/MMJ.galenos.2023.48768

J Dtsch Dermatol Ges. 2023 Jun;21(6):645-647. doi: 10.1111/ddg.15003_g.

NO ABSTRACT

PMID:37338840 | DOI:10.1111/ddg.15003_g