Search

Objectives: To validate the reproducibility and inter/intra‐observer variability of the Pink Esthetic Score/White Esthetic Score (PES/WES) of single tooth‐supported prostheses in the maxillary esthetic zone (13–23). Materials and Methods: Forty‐five patients were randomly assigned to one of the three treatment options (15 patients per group) receiving each one a different crown type: Porcelain fused to metal (PFM), monolithic zirconia, and lithium disilicate. Eight observers from each of four different specialties (Prosthodontists, Orthodontists, Periodontists, and Oral Surgeons) were recruited and assessed twice and four weeks apart (i.e., T1 and T2) 45 photographs of the single tooth‐supported prosthesis using PES/WES and compared them with contralateral teeth. Results: According to the ANOVA and post hoc tests, the zirconia crown type obtained the highest mean score by all observers, with a mean value of 16.70 ± 2.94. The prosthodontists and oral surgeons assigned the lowest mean score to PFM crowns, 13.03 ± 3.47 and 13.80 ± 3.17, respectively. Notably, the prosthodontists awarded the highest scores, specifically 17.50 ± 2.81 for the zirconia crowns. Intraobserver agreement was calculated utilizing the paired t‐test. Pairwise comparisons between observers of different specialties revealed significant intraobserver agreement. Interclass correlation coefficient (ICC) scores were statistically significant among four specialties. No difference was detected concerning the interobserver agreement. Conclusions: The PES/WES index remains consistent across various observers from different specializations, yielding uniform results in the overall esthetic evaluation. Consequently, in light of the presented preliminary positive results, its use might also be considered for the esthetic assessment of single‐tooth‐supported prostheses. Clinical Significance: The PES/WES index may be employed clinically to evaluate single tooth‐supported prostheses as it emerged as a reproducible esthetic scoring system. [ABSTRACT FROM AUTHOR]

The study aimed to investigate the effect of utilization of treatment for insomnia symptoms on the prevalence of major depressive disorder among older adults in India. We used the data from the Longitudinal Ageing Study in India (LASI), 2017–18. The sample included 10,911 older individuals who reported insomnia symptoms. The propensity score matching (PSM) approach was used to compare the depressive disorder among those who received vs. not received treatment. Only 5.7% of older adults reporting insomnia symptoms received treatment. On average, prevalence of depressive disorder among men and women who received treatment for insomnia symptoms was lesser by 0.79 and 0.33 points, respectively, than those who did not receive treatment. In the matched sample, treatment for insomnia symptoms was significantly associated with lesser prevalence of depression for both older men (β= −0.68, p <.001) and older women (β= −0.62, p <.001). The current findings suggest that treatment for insomnia symptoms can reduce the risk of depressive disorder among older adults and the effects are higher among older men than women. [ABSTRACT FROM AUTHOR]

Introduction: Stroke is the sudden loss of neurological function caused by an interruption of the blood flow to the brain. Initially, some 80% of all patients with stroke experience motor impairments of the contralateral limb, i.e hemiparesis. Mirror therapy is relatively new therapeutic intervention that focuses on moving the unimpaired limb. Likewise, another technique called Mental imagery is the cognitive rehearsal of a task in the absence of movement. Aim and Objectives: To compare mirror therapy and mental imagery in improving ankle motor recovery in acute stroke patients. Methodology: 30 stroke patients were selected in the study, and were randomly assigned into two groups. Group A i.e. Mirror Therapy group (n=15) or the Group B i.e. Mental Imagery group (n=15). Both the groups received 30 minutes of their respective therapy that is mirror therapy and mental imagery and in addition to 30 minutes of conventional therapy which included neuro developmental facilitation technique, stretching, gait training that is a total of 1 hour per day for 5 days a week for 4 weeks. Modified Ashworth Scale, 10 Meter Walk test (10MWT), Fugl-Meyer assessment Lower extremity (FMA-LE) scale were administered pre and post intervention to assess the ankle motor function. Results: Only Fugl Meyer Assessment scores on comparison between Group A (Mirror Therapy) and Group B (Mental Imagery) revealed that statistically significant improvement was found in Group B (Mental Imagery) (t-value: 2.140; p-value: .041*). Conclusion: The present study concluded that Mental Imagery proved to be more effective than Mirror Therapy in improving ankle motor recovery in acute stroke patients. [ABSTRACT FROM AUTHOR]

Mastectomy serves as the main surgical treatment for both invasive and in situ breast carcinoma and large phyllodes tumors. It is associated with skin necrosis, seroma, and surgical site infection in up to 30% of patients. In the present trial, we compared the complications in patients undergoing skin flap elevation by one of the 4 techniques: thick skin flap raised by scalpel(group1), thin skin flap raised with scalpel (group 2), thick skin flap raised with diathermy (group 3), and thin skin flap raised with diathermy (group 4). A randomized trial with superiority hypothesis and 2 × 2 factorial design was conducted at All India Institute of Medical Sciences New Delhi. Mastectomy skin flap necrosis (MSN) was recorded as the main outcome of interest. MSN was noted in 2.5% in group1, 10% in group 2, 7.5% in group 3, and 30% in group 4. MSN was observed in 5% cases with thick flap compared to 20% cases with a thin skin flap (p = 0.007). Raising the flap with scalpel was associated with MSN in 6.25% compared to 18.75% in the diathermy group (p = 0.029). We conclude that raising a thick flap with scalpel is associated with lowest risk of skin flap necrosis. Trial Registration: Clinical Trial Registry- India CTRI/2014/09/004978 [ABSTRACT FROM AUTHOR]

Purpose: A locking plate (LP) or non-locking plate (NLP) can be used for distal fibula fracture fixation. However, the advantages of LP over NLP in patients with distal fibula fractures are not clear. In terms of indications, the role of the two plates probably differs; however, to draw comparative conclusions, we conceptualized this systematic review and meta-analysis of studies that directly compared the two plates, wherein both groups' indications and baseline parameters were similar. Methods: An electronic literature search was performed using PubMed/Medline, Embase, Scopus, and Cochrane Library databases for studies comparing the LP versus NLP fixation for the lateral malleolus fracture. A total of 18 studies were included in qualitative and quantitative analysis. A subgroup analysis was performed for patients aged < 55 years and patients aged > 55 years. The statistical analysis was performed by Review Manager Software version 5.4.1. Results: A meta-analysis of 4243 fractures was performed across 18 studies. The rate of fracture union and overall complication rates did not differ between the two fixation groups with an OR of 0.71 (95% CI 0.26, 1.96, p = 0.51 and 1.11 (95% CI 0.84, 1.47, p = 0.47, respectively. There is no difference in the reoperation rate due to minor or major complications between the two groups. There was no difference in functional outcome (MD −0.85, with 95% CI −5.63, 3.93, p = 0.73), but NLP has a shorter surgical duration (MD 3.0, with 95% CI 0.26, 5.75, p = 0.03). A leave-one-out sensitivity analysis performed for overall complications affected the final outcome of the meta-analysis. Conclusion: This meta-analysis demonstrates no clear benefit in selecting LP over NLP for the fixation of lateral malleolus fractures. [ABSTRACT FROM AUTHOR]

Background: Myofascial pain is one of the most common facial region pains, presenting itself with various signs and symptoms like tenderness of masticatory muscles and difficulty in mouth opening. Considering its multifactorial aetiology various treatment modalities are present. Objective: The aim of this study is to compare the effectiveness of transcutaneous electrical nerve stimulation (TENS)and low‐level laser therapy (LLLT) for the patients of temporomandibular disorders (TMDS). Methods: The study was conducted with 20 patients diagnosed with TMDS. Group A received LLLT at 660 nm, 6 J/point, two sessions/week for 4 weeks and group B received TENS at 2–250 Hz, two sessions/week for 4 weeks. Results: Pain Score decreased and mouth opening increased in both groups with time, however, the difference between the two groups was not statistically significant. Right and left lateral excursions showed improvement at different intervals in both groups. However, the LLLT group showed significant improvement. Conclusion: Clinical trial showed improvement in visual analogue scale (VAS), maximum mouth opening (MMO) and lateral excursion in the different time intervals in both the groups with LLLT showed more improvement with lateral excursions movements. [ABSTRACT FROM AUTHOR]

Background: Alcohol dependence is a wide and extending social and physical problem in the world. It affects a person at the individual, family, and society levels. The aim is to study and compare the influence of motivational enhancement therapy (MET) and behavioral couple therapy on the level of motivation in a person with alcohol dependence. Methodology: Pre- and post-test with control group design was used. A total number of 60 subjects were selected using a purposive sampling method. The sample comprised twenty subjects in the behavioral couple therapy treatment as usual (Behavioral couple therapy BCT + TAU) group, twenty subjects in the control (TAU) group, and twenty subjects in the (MET + TAU) group, respectively. The subjects recruited were in the age range of 21-60 years, educated up to primary level and above, with no comorbid psychiatric, neurological disorder, physical problem, multiple substance use coming to outpatient department and inpatient department Department of Psychiatry IMS, BHU, Varanasi, and wife having age above 18 years, married for at least 1 year, educated up to primary level and above. Tools: sociodemographic datasheets, alcohol use disorder identification test, general health questionnaire-12, and stages of change readiness and treatment eagerness scale were utilized. Results: Psychotherapeutic intervention such as MET and behavioral couple therapy plays an effective role in raising motivation to change in alcohol-dependent person to quit alcohol, which is indicated by the significant rise in motivation for the change of alcohol-dependent person's recognition (F = 4.42, P < 0.05) and taking steps (F==3.78, P < 0.05). Conclusion: The present study suggests that combining pharmacological treatment with appropriate psychosocial therapies give fruitful result in the form of a desire to quit alcohol dependence. [ABSTRACT FROM AUTHOR]

Background: Osteoarthritis (OA) is also called Osteoarthrosis or degenerative joint diseases; it represents a vital cause of dejection and defects. With the help of Muscle Energy Technique (MET) claimed to be effective for improvement in flexibility and strength along with cellular nutrition and conservative treatment in knee Joint. Methods: According to the inclusion and exclusion criteria; 60 unilateral participation OA knee patients were randomly placed into two groups, pre and post-test calculation of KOOS scale and knee extension and flexion were done. Group A had MET with conservative treatment along with cellular nutrition. Conclusion: Both Group A and B improves the strength and flexibility of knee joint but in Group A was shown more improvement than Group B. [ABSTRACT FROM AUTHOR]

Background: The Stanford Youth Diabetes Coaching Program (SYDCP) is an evidence-based program led by health care professionals to teach healthy youth who then coach family members with diabetes or other chronic conditions. This purpose of this study is to evaluate a Community Health Worker (CHW)-led implementation of the SYDCP for low-income Latinx students from underserved agricultural communities. Method: CHWs were trained and virtually led 10 training sessions virtually during the COVID-19 for Latinx students who were recruited from high schools in agricultural regions of Washington state. Feasibility measures include recruitment, retention, class attendance, and successful coaching of a family member or friend. Acceptability was measured by responses on the post-training survey. Effectiveness was evaluated by pre-post changes in measures used in prior studies of the SYDCP such as level of activation and diabetes knowledge. Results: Thirty-four students were recruited, 28 completed the training and 23 returned both pre- and post-surveys. Over 80% of students attended 7 or more classes. All met with a family or friend and 74% met with them weekly. Approximately 80% of the students rated the program's usefulness as "very good" or "excellent." Pre-post increases in diabetes knowledge, nutrition-related behaviors, resilience, and activation were significant and similar to those observed in prior published studies of the SYDCP. Conclusions: Findings support the feasibility, acceptability, and effectiveness of a CHW-led implementation of the SYDCP in underserved Latinx communities using a virtual remote model. [ABSTRACT FROM AUTHOR]

This investigation purports to study if gratitude interventions lead to an increase in overall wellbeing among Indian youth during the coronavirus lockdown. Second, to examine if a cumulative effect of two gratitude interventions on wellbeing is greater than a single gratitude intervention. Participants (N = 80) were randomly allocated to the experimental and control groups (n = 40 each). It was found that after administering a single gratitude intervention there was a significant increase in mental health, happiness, and gratitude and a decrease in depression, anxiety, and stress in the experimental group. Moreover, after administering two gratitude interventions together, a greater increase was seen in these variables as compared to the administration of a single gratitude intervention. There was no significant change in the control group in both cases. In summary, online gratitude interventions lead to increase in happiness and mental health and decrease in depression, anxiety, and stress even during crises such as the coronavirus pandemic. Moreover, the cumulative effect of two gratitude interventions is more than a single gratitude intervention. It is suggested that these gratitude interventions should be included in providing mental health care even when clients are not able to meet counselors in physical settings. [ABSTRACT FROM AUTHOR]

Background and Purpose: There is an unmet need for a more effective thrombolytic agent in acute ischemic stroke (AIS) management. Various studies and meta-analysis suggest tenecteplase (TNK) as non-inferior over alteplase (rTPA). The present single-center study compares biosimilar TNK and rTPA in a tertiary care setting. Methods: Data of patients who presented with AIS and underwent intravenous thrombolysis (FVT) were recruited retrospectively from January 2018 to July 2021. Primary efficacy outcome was a modified Rankin score (mRS) at 90 days dichotomized at < = 2. Qualitative and quantitative variables were assessed using Chi-square test and Student's t-test, respectively. Results: A total of 160 patients, 103 in the rTPA and 57 in TNK group, were analyzed. The baseline characteristics were well matched apart from hypertension. Large artery atherosclerosis was the most frequent subtype of stroke among the two groups. Good functional outcome was seen in 47.92% of patients TNK and 64.77% of patients in rTPA group (p = 0.069). No difference was seen in the rates of any ICH (p = 0.29) and mortality at 3 months (p = 0.32) among the two groups. Conclusion: This present study observed no difference in the efficacy and safety between biosimilar TNK and rTPA. Our findings are in concordance with published trials showing equivalence between the two molecules. [ABSTRACT FROM AUTHOR]

Objective: The objective was to evaluate the clinical experience and treatment patterns of generic dapagliflozin usage in different patient profiles in Indian settings. Materials and Methods: A retrospective, multicentric, real-world study included patients with type 2 diabetes mellitus (T2DM) (aged >18 years), inadequately controlled by existing antidiabetic therapy and receiving generic dapagliflozin as an add-on to existing oral antidiabetic drug(s) with or without insulin or switch therapy. Baseline characteristics and treatment-related outcomes were retrieved from the medical records and analyzed. Results: A total of 1935 patients were included, of which 1279 (66.1%) were males. The mean age was 57.4 years, and around half of the patients (51.4%) were aged from 45 to 60 years. Hypertension (55.9%) and dyslipidemia (19.8%) were the common comorbidities. The majority (n = 1122; 60%) of patients received dapagliflozin in combination with one or two antihyperglycemic drugs. More than half of the patients received metformin (56.8%) or sulfonylurea (52.3%) in combination with dapagliflozin. A dose of 10 mg (93.4%) was the most commonly used dose of dapagliflozin. The mean levels of glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose were significantly reduced to 1.1% (1.0-1.1), 30.5 mg/dL (29.2-31.9), and 57.5 mg/dL (55.1-59.9), respectively, after the initiation of dapagliflozin. A total of 1935 patients experienced weight changes during the treatment, of which 90.5% of patients showed weight loss. Hypoglycemic events were reported in 12.5% of patients. Physician global evaluation of efficacy and tolerability showed a majority of patients on a good-to-excellent scale (97.3% and 97.1%). Conclusion: Generic dapagliflozin showed a significant improvement in glycemic parameters and reduced body weight with low hypoglycemic events. The administration of dapagliflozin provided a good-to-excellent efficacy and tolerability profile in patients with T2DM. To the best of our knowledge, this is the first study confirming the efficacy, safety, and usefulness of generic dapagliflozin in patients with T2DM. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to perform an objective and subjective evaluation of the efficacy of positioning stents in radiation-induced xerostomia in patients with tongue carcinoma.Materials and Methods: A total of 30 patients with tongue carcinoma and undergoing conventional radiotherapy were randomly assigned to control (n = 15) and study (n = 15) groups, without and with a positioning stent, respectively. Assessment of salivary output reduction was done before and after radiotherapy, at 3- and 6-month intervals, by measurement of unstimulated and stimulated salivary flow rates (objective evaluation). Xerostomia (subjective evaluation) was noted using six items from the Quality of Life Head and Neck Module (QLQ-H&N35) as proposed by the European Organization for Research and Treatment of Cancer. The significance level was set at .05.Results: Mean unstimulated and stimulated salivary flow rates at 3- and 6-month intervals revealed significantly (P < .05) higher scores for the study group as compared with the control group. The mean quality of life scores in the study group were significantly (P < .05) lower compared with the control group.Conclusion: The use of a positioning stent minimized radiation-induced xerostomia and its symptoms. [ABSTRACT FROM AUTHOR]

Purpose: To compare the short-term outcome of botulinum neurotoxin A (BoNT-A) with or without sodium hyaluronate in the treatment of infantile esotropia (IE).Methods: In this tertiary care hospital-based prospective, interventional, non-randomized study on infants with IE below one year of age, 25 cases were enrolled in the sodium hyaluronate (SH) group to receive 2.5 U BoNT-A injection combined with SH in each medial rectus muscle (MR). Thirty patients were enrolled in the control group to receive 2.5 U BoNT-A injection with normal saline in each MR. The change in mean primary ocular deviation (POD) and complications were assessed at 2 weeks, 1 month, 3 months, and 6 months post injection. Mann-Whitney U test was used for non-parametric unpaired data. Chi-square test and Fisher's exact test were used to test for the strength of the association between the two categorical variables.Results: Satisfactory ocular alignment was achieved in 76% in SH group and 73% in the control group (P value = 0.80). While the change in mean POD was comparable (29.2 prism diopters [PD] vs 29.3 PD; P value = 0.65), the complication rates were significantly lesser in SH (16% vs 33.3%; P value = 0.14).Conclusion: BoNT-A combined with SH is equally effective with lesser complications as compared to botulinum toxin alone in the treatment of IE. [ABSTRACT FROM AUTHOR]

Background: This randomized clinical trial (RCT) aimed to compare the 3-year survival rates of high viscosity glass ionomer restorations (HVGIC) using conventional cavity preparation and atraumatic restorative technique (ART) in primary molars. Materials and Methods: In this RCT, 139 schoolchildren aged 6-9 years with dentinal caries in primary molars were randomly allocated to groups, i.e. the ART group and the conventional group, utilizing a random number generator. Adequate allocation concealment was done. Intervention was delivered using standard procedure and GC Fuji IX ART HVGIC was used as restorations in both the groups. Analysis was carried in 92 participants, and survival rates in both the groups were compared at 12, 24, and 36-month intervals. IBM SPSS software was utilized to analyze the time taken for the procedure and the Kaplan-Meier estimate was used to assess the survival rates. P value of 0.05 was considered statistically significant. Results: The ART took longer to complete (16.48 ± 2.02 min) versus conventional rotary instrumentation (13.15 ± 1.32 min). The conventional method was slightly superior as compared to ART; excellent survival rates (i.e. >90%) were achieved in both groups at the end of 12-month follow-up with no significant differences at the end of 24 and 36 months as evident from Kaplan-Meier estimate (P = 0.255). Conclusion: Three-year follow-up showed that GIC restorations with ART and conventional method carried out using GC Fuji IX ART HVGIC were acceptably successful, substantiating the use of ART for the primary dentition in areas with high caries prevalence and limited access to dental care. [ABSTRACT FROM AUTHOR]

Background: Choledochal cyst is a common congenital anomaly requiring surgical treatment. Nowadays, laparoscopic excision is the preferred approach. We studied a modification in the classical laparoscopic approach to facilitate the dissection of a cyst. Materials and Methods: A prospective comparative study was done on 42 Type I choledochal cyst children. One group was operated by classical laparoscopic technique, while the other group was operated by modification of classical technique by deliberately opening the cyst wall and dividing the cyst into two hemi-cups, followed by dissection and excision. The intraoperative and postoperative parameters were assessed in both the groups. Results: The age, gender ratio, clinical presentation, and cyst diameter were comparable in both the groups. There was a significantly higher success rate (95.7% vs. 73.7%, P = 0.042) and lesser time for cyst excision (96.43 ± 12.15 vs. 120.91 ± 17.38 min P < 0.001) in the modified technique when compared to the classical technique. Further in three patients, it was possible to convert the classical procedure to a modified technique and complete the cyst excision. The postoperative outcomes were similar in both the groups. Conclusion: The modified laparoscopic excision shortens the operative time with higher success rate and comparable short-term morbidity vis-a-vis classical laparoscopic technique. [ABSTRACT FROM AUTHOR]

Background: Plateletpheresis is generally safe but may have adverse reactions. Adverse reactions can negatively influence donor recruitment and retention. Valsalva is a proven method of attenuating pain caused by venipuncture. Aims: The aim was to evaluate the efficacy of the Valsalva maneuver on the attenuation of needle pain and donor anxiety. Settings and Design: This prospective randomized controlled trial was conducted between November 2015 and April 2016 at the Department of Transfusion Medicine. Subjects and Methods: One-hundred and sixty consecutive donors were grouped into control group (C) and Valsalva group (V) each of sample size 80. The Valsalva group performed a Valsalva maneuver and control did nothing before the venipuncture. Anxiety and pain were scored using a 10 cm visual analog scale (VAS). Severity was graded as VAS = 0 defines no pain and anxiety, VAS = 1–3 as mild pain and anxiety, VAS = 4–6 as moderate pain and anxiety, VAS = 7–9 as severe pain and anxiety, whereas VAS = 10 denotes extreme pain and anxiety. Statistical Analysis: Statistical Package for Social Sciences, version 23 was used for analysis. Independent samples t-test/Mann–Whitney U-test was used to compare between treatment and control group, whereas the Wilcoxon signed-rank test was used to test the difference between pre- and postobservations. Results: In the Valsalva group, post-Valsalva anxiety levels were significantly reduced to (1 [0–2]) from their pre-Valsalva values of (2 [0–3]); (P < 0.001). Pain was significantly lower (2[1-2]) in Valsalva group compared to control (4[2–5]); (P < 0.001). Conclusions: Valsalva reduced both severity of venipuncture pain and anxiety. Valsalva can be performed by donors as it is an easy, painless, and nonpharmacological method of pain and anxiety attenuation. [ABSTRACT FROM AUTHOR]

This randomized double-blind placebo-controlled trial evaluated the effects of early postnatal oral vitamin A supplementation (VAS) in 196 inborn very-low birth weight (VLBW) infants requiring respiratory support at 24 h of age. Eligible infants were randomized to receive aqueous syrup of vitamin A (10,000 IU of retinol/dose; n = 98) or placebo (n = 98) on alternate days for 28 days. Primary outcome variable was composite incidence of all-cause mortality and/or oxygen requirement for 28 days. Secondary outcome variables were safety/tolerability of VAS, serum retinol concentration at recruitment and day 28, duration of oxygen requirement and respiratory support and incidences of complications. On intention-to-treat analysis, composite incidence of all-cause mortality and oxygen requirement for 28 days was significantly lower in vitamin A group (relative risk (95% confidence interval), 0.440 (0.229-0.844); p < 0.05, number needed to benefit, 7). Requirement and duration of oxygen supplementation and non-invasive respiratory support, incidences of late-onset sepsis, patent ductus arteriosus, and duration of hospital stay were also significantly lower in vitamin A group. Serum retinol concentration improved significantly after VAS. No major adverse effect was observed.Conclusions: Early postnatal oral VAS was associated with better composite outcome of all-cause mortality and oxygen requirement without any major adverse effects.Clinical Trial Registration: Clinical Trials Registry of India (CTRI/2017/03/008131). What is Known: • Postnatal intramuscular vitamin A supplementation improves the survival, respiratory outcome and other morbidities in very low birth weight neonates without major adverse effects. • Limited studies on oral vitamin A supplementation did not document substantial benefits. What is New: • Early postnatal alternate-day oral vitamin A supplementation at the dose of 10,000 IU/dose for 28 days improves the composite outcome of death and oxygen requirement in very low birth weight neonates with respiratory distress • No major adverse effects were documented. [ABSTRACT FROM AUTHOR]

Introduction: and objective: Tremor is a disabling symptom of PD that usually responds poorly to available standard pharmacological agents. This study aimed to assess the effect of Zonisamide 25 mg on tremor in tremor-dominant PD patients as compared to placebo.Methods: This was a randomized, placebo-controlled, double-blind study. Parkinson's disease patients were allocated either to the intervention group (standard treatment along with Zonisamide 25 mg add-on) or the placebo group (standard treatment along with placebo). Baseline Unified Parkinson's Disease Rating Scale (UPDRS) and Tremor Research Group Essential Tremor Rating Scale (TETRAS) scores, as well as accelerometric tremor analysis were done and follow-up assessments of the same were done after 12 weeks of intervention. Percentage change from baseline in the UPDRS tremor score was the primary outcome whereas percentage change from baseline of total UPDRS score, UPDRS rigidity and bradykinesia scores, TETRAS score, and accelerometric tremor analysis values were the secondary outcomes.Results: There was no significant difference in the percentage change from baseline UPDRS tremor scores between the two groups (placebo: 8.33 [-19.89-23.86] vs drug: 26.14 [-35.58 to -16.07], p-value: 0.164, CI: 0.157-0.171). Best-case analysis for missing values showed a significant improvement in the drug group, compared to the placebo group (p-value: < 0.001, CI: <0.001 - <0.001).Conclusion: Zonisamide at a dose of 25 mg per day did not improve tremor in tremor-dominant PD patients, however, a positive trend was seen as compared to Placebo in the UPDRS tremor score. Larger studies are required to confirm this finding. [ABSTRACT FROM AUTHOR]

Mastalgia is defined as pain in the breast for more than 1 week of menstrual cycle. A number of drugs have been recommended for its treatment. However, there is some debate among the experts about the most beneficial agent. In this study, we compared the effectiveness and cost-effectiveness of centchroman and tamoxifen in the treatment of mastalgia. We recruited 106 ladies with mastalgia in a two-arm parallel design open-labelled randomised controlled trial with a non-inferiority hypothesis comparing 3-month therapy with either centchroman or tamoxifen. The response of therapy was assessed by visual analogue scale (VAS) of 0–10, on 1-, 2-, 3-, and 6-month follow-up. Direct and indirect costs were computed for each patient. Baseline mean VAS score was 6.25 in tamoxifen and 6.49 in centchroman group. Women in both groups enjoyed significant pain relief (pain score became < 3). The number of patients who achieved VAS less than 3 were 51 (96.2%) in centchroman and 49 (92.5%) in tamoxifen group at the end of 3 months of treatment. Centchroman was found to be more effective than tamoxifen (p < 0.001). Cost per unit successful relief of mastalgia in the centchroman group was 393 Nepalese Rupees and that in the tamoxifen group was 311.5 Nepalese Rupees. Centchroman is not inferior to Tamoxifen in relieving mastalgia. Tamoxifen proved more cost-effective than centchroman because of lower cost of tamoxifen in Nepal. [ABSTRACT FROM AUTHOR]

BACKGROUND: Complete lesion after spinal cord injury (SCI) remains irreversible with little hope of neurological recovery. Newer interventions such as re-stimulation of damaged neurons using artificial agents and the use of stem cells for neuronal regeneration have shown promising results. AIM: This study was undertaken for evaluating the neurological status of acute SCI participants after stem cell augmentation and comparing them with other treatment methods. SETTING AND DESIGN: Randomized controlled trial in the northern Indian population. MATERIALS AND METHODS: A total 193 SCI participants of complete paraplegia with unstable T4–L2 injury having thoracolumbar injury severity score ≥4 were enrolled in this study. Participants were randomly allocated for three different treatment modalities, namely, conventional with stem cell augmentation (Group-1), conventional (Group-2), and conservative (Group-3). Neurological recovery after 1 year was evaluated through the ASIA Impairment Scale (AIS)-grading, sensory, and motor scores. STATISTICAL ANALYSIS: T-test for sensory-motor score analysis of each group and analysis of variance for comparison of same variables between the groups. RESULTS: After 1-year significant difference was observed in the AIS-grade, sensory and motor scores in-Group 1 (P < 0.001). In Group-1 versus 2, the mean difference at 1 year for AIS grade, sensory and motor scores were 0.40 (P = 0.010, 95% confidence interval [CI] 0.075–0.727), 8.52 (P = 0.030, 95% CI 0.619–16.419), and 4.55(P = 0.003, 95% CI 1.282–7.815), respectively. In Group-1 versus 3, 1.03, 19.02 and 7.22 (P < 0.001 for each of the parameters) and in Group-2 versus 3, 0.63 (P < 0.001), 10.49 (P = 0.009), and 2.68 (P = 0.019), respectively. CONCLUSIONS: Significant motor neurological recovery and AIS-grade promotion was observed in Group-1 as compared to Group-2 and 3. [ABSTRACT FROM AUTHOR]

Background: In 2013, outpatient use of chloral hydrate (CH) was limited and other alternatives such as oral pentobarbital (PB) were explored to achieve conscious sedation in young children for transthoracic echocardiography (TTE). We aimed to assess efficacy and safety of the two medications. Methods: Clinical information, from a computerized database, about children who received sedation with either CH or PB for TTE at our center (2008–2015) was reviewed, and the two groups were compared for sedation effectiveness and complications. Results: Three thousand eight hundred fifty one pediatric patients (median age 8 months) underwent conscious sedation during TTE (mean doses CH 50 mg/kg, PB 4 mg/kg). Demographic characteristics of the two groups were similar. Sedation failure rate (CH 2.4%, PB 2.9%, P = NS), need for supplemental doses (CH 17.9%, PB 16.2%, P = NS), and overall adverse event rate (PB 1.4%, CH 1.9%; P = NS) were similar in the two groups. There were fewer episodes of respiratory depression with PB (0.3% vs 1.6%, P < 0.05). The rate of paradoxical reactions was higher with PB (1% vs 0.03%, P < 0.05). Increasing age predicted the need for supplemental doses and for sedation failure in both groups. Neonates (7.5% vs 0%) and infants (2% vs 0.6%) given CH were more likely to develop adverse reactions. Conclusion: Chloral hydrate and PB are equally effective. However, CH is associated with an increased incidence of transient desaturation, while PB is associated with an increased incidence of a paradoxical reaction. Increasing age is predictive of the need for supplemental doses and for failure of sedation in both groups. [ABSTRACT FROM AUTHOR]

Aim: To find the aetiological spectrum, clinical features to differentiate organic from functional constipation (FC) and the efficacy of polyethylene glycol (PEG) over lactulose in the treatment of childhood constipation.Methods: From January 2007 to December 2014, 316 consecutive children (up to 18 years) with constipation were included in this study. FC was defined as per Rome III criteria. Standard treatment protocol (disimpaction with PEG followed by laxatives) was followed in FC. Lactulose was used in the first 4 years of study and PEG in the last 4 years. Success of therapy was assessed at 3 months.Results: The median age was 44 (25.00-78.00) months, and 227 (72%) were boys. The majority, 245 (77.5%), had FC, while Hirschsprung disease was the most common organic cause (39.4%). On multivariate analysis, delayed passage of meconium, growth failure, absence of retentive posturing and absent faecal impaction significantly (P < 0.05) determined an organic aetiology. In FC, successful outcome at 3 months was achieved equally with PEG and lactulose (81 vs. 76%, respectively). However, more children in lactulose group had to be switched over to PEG due to lack of efficacy (P = 0.0002).Conclusions: FC is the most common cause of constipation in children. Presence of delayed passage of meconium, growth failure and absence of retentive posturing and absent faecal impaction raise the suspicion of an organic cause. Both lactulose and PEG are equally effective. PEG has an edge over lactulose as the need for switch over was uncommon. [ABSTRACT FROM AUTHOR]

Background: While previous studies have shown higher union rates and a quicker return to work with operative treatment of substantially displaced clavicle fractures, there is disagreement whether operative treatment results in improved clinical outcomes. Patients who undergo operative treatment sometimes require additional surgery for implant removal. Nonoperative treatment may fail so that delayed surgical intervention is ultimately required. The duration for which the clinical benefits of operative treatment remain superior to those of nonoperative treatment has not been well established in the literature. Considering these uncertainties, surgeons are faced with a difficult decision regarding whether operative treatment of a midshaft clavicle fracture will be cost-effective. The purpose of this study was to identify the most cost-effective strategy by considering these uncertain parameters with use of decision-analysis techniques.Methods: An expected-value decision tree was built to estimate the quality-adjusted life years (QALYs) and costs for operative and nonoperative treatment of substantially displaced midshaft clavicle fractures. Values for parameters in the decision model were derived from the literature. Medical costs were obtained from the Medicare database. A Markov model was used to calculate the QALYs for the duration of life expectancy. The decision model was used to analyze the duration for which the clinical results of operative treatment were superior to those of nonoperative treatment during the first 5 years after the operation and during a lifetime. Sensitivity analysis was performed to determine which parameters have the most influence on cost-effectiveness.Results: Operative treatment was more cost-effective than nonoperative treatment in 54% and 68% of the Monte Carlo trials in the 5-year and lifetime analyses, respectively. The cost per QALY with operative management was <$38,000 and <$8,000 in the 5-year and lifetime analyses, respectively. This is below the willingness-to-pay threshold of $50,000 per QALY. For operative treatment to remain cost-effective, its clinical benefits must persist for at least 3 years.Conclusions: Operative treatment is more cost-effective than nonoperative treatment for substantially displaced midshaft clavicle fractures. The clinical benefits derived with operative treatment must persist for at least 3 years for operative treatment to remain cost-effective. This research should not be used to conclude that all clavicle fractures should be treated surgically. It is best that such a decision is made through a patient-surgeon shared decision-making process.Level Of Evidence: Economic and Decision Analysis Level II. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of mobilization with movement and end range mobilization along with conventional therapy for the treatment of frozen shoulder. Study Design: Experimental study design. Subjects: 30 patients between the age group 40 yrs to 60 yrs were selected as per the inclusion and exclusion criterion. Procedure: By random sampling method the 30 subjects were divided into 2 equal groups with 15 patients each.Experimental group A received Hot Pack,Exercises,MWM .Experimental group B received Hot Pack,Exercises,ERM. The study was performed for 4 months.The treatment was given 6 days per week.once in a day for 12 weeks .Evaluation was done before starting the treatment and then after 4 months. Outcomes scores were evaluated using SPADI & ROM . Result: Experimental group A showed improvement in SPADI score 62.9 % and ROM improved by 81.87 degree. The ERM group showed improvement in SPADI scores by 47.9 % and 76.8 degree Conclusion: The study found that both the treatment that is MWM and ERM are effective in the management of frozen shoulder but MWM is found to be slightly more effective. [ABSTRACT FROM AUTHOR]

Background: To study the effect of Lanconone® (1000 mg) on acute pain on exertion as compared to the standard of care, Ibuprofen (400 mg).Method: The study recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Subjects with Pain Visual Analogue Scale of more than 40 mm were included. Uphill walking was provided as the stressor using Naughton's protocol on a treadmill. The subjects walked for 10 minutes continuously followed by a rest period and baseline pain score for index knee joint was recorded. Subjects were administered a single dose of Lanconone® (1000 mg)/Ibuprofen (400 mg). Thereafter the same stressor was provided at 0.5, 1, 2, 3, 4, and 6 hours, subsequently, pain scores were recorded on a visual analogue scale. Double stopwatch method was used to evaluate the onset of pain relief and time taken to meaningful pain relief.Result: Both Lanconone® and Ibuprofen showed the first perceived pain relief at 65.31 ± 35.57 mins as compared to 60.82 ± 32.56 mins respectively. The mean time taken to experience meaningful pain relief in Lanconone® group was 196.59 ± 70.85 mins compared to 167.13 ± 71.41 mins amongst Ibuprofen group. The meaningful pain relief continued for 6 hours.Conclusion: The current study successfully demonstrated rapid pain-relieving potential of Lanconone® which was comparable to Ibuprofen. No adverse event related to the interventions was reported in the study.Trial Registration: Clinical trials.gov NCT02417506 . 21 January 2015. [ABSTRACT FROM AUTHOR]

Abstract: Some treatment planning systems (TPSs), when used for large-field (>14 cm) intensity-modulated radiation therapy (IMRT), create split fields that produce excessive multiple-leaf collimator segments, match-line dose inhomogeneity, and higher treatment times than nonsplit fields. A new method using a fixed-jaw technique (FJT) forces the jaw to stay at a fixed position during optimization and is proposed to reduce problems associated with split fields. Dosimetric comparisons between split-field technique (SFT) and FJT used for IMRT treatment is presented. Five patients with head and neck malignancies and regional target volumes were studied and compared with both techniques. Treatment planning was performed on an Eclipse TPS using beam data generated for Varian 2100C linear accelerator. A standard beam arrangement consisting of nine coplanar fields, equally spaced, was used in both techniques. Institutional dose-volume constraints used in head and neck cancer were kept the same for both techniques. The dosimetric coverage for the target volumes between SFT and FJT for head and neck IMRT plan is identical within ±1% up to 90% dose. Similarly, the organs at risk (OARs) have dose-volume coverage nearly identical for all patients. When the total monitor unit (MU) and segments were analyzed, SFT produces statistically significant higher segments (17.3 ± 6.3%) and higher MU (13.7 ± 4.4%) than the FJT. There is no match line in FJT and hence dose uniformity in the target volume is superior to the SFT. Dosimetrically, SFT and FJT are similar for dose-volume coverage; however, the FJT method provides better logistics, lower MU, shorter treatment time, and better dose uniformity. The number of segments and MU also has been correlated with the whole body radiation dose with long-term complications. Thus, FJT should be the preferred option over SFT for large target volumes. [Copyright &y& Elsevier]

Objective: To evaluate the outcomes of three surgical techniques for the closure of urethrocutaneous fistula (UCF) after hypospadias repair.Materials and Methods: Fifty-one patients (mean age 6.5 years) who underwent UCF closure between June 1998 and February 2008 were divided in to three groups depending on fistula size; group I had <2 mm and (n = 17, 33.4%), group II had 2-4 mm (n = 21, 41.2%) and group III had >4 mm or multiple fistulas (n = 13, 25.4%). Group I patients were treated by excision and simple closure. Patients in group II and III were treated with flip flap technique along with the wrapping of repaired area with scrotal dartos flap and tunneled tunica vaginalis flap (TVF), respectively.Results: Mean surgical time was 45 min (range 30-55), 60 min (range 50-75) and 80 min (range 60-100) in three techniques, respectively. The mean follow-up was 3.5 years (range 6 months-10 years). No patient had recurrence of fistula in group III, while 2 (9.5%) and 4 (25.4%) patients in groups II and I, respectively, had recurrent UCF. No postoperative complications were encountered in the testis or the scrotum. No patient had torsion or deviation of penis.Conclusion: Simple fistula closure carries a higher risk of recurrence even in small sized fistulas. The application of scrotal dartos or TVF for wrapping the repaired area gives excellent results and they are easy to harvest with no harmful effects on the scrotum or testis. [ABSTRACT FROM AUTHOR]

Bisphosphonates are synthetic analogues of pyrophosphate that inhibit bone resorption by their action on osteoclasts. In recent years, bisphosphonates have been used in children for treatment of a growing number of disorders associated primarily with generalized or localized osteoporosis, metabolic bone diseases, heterotopic calcification in soft tissues, and for resistant hypercalcemia. In the present review we discuss the pharmacological aspects of bisphosphonates and related bone pathophysiology, review the pediatric literature on the role of bisphosphonates in childhood diseases and our experience with these drugs. The theoretical concerns of possible adverse effects of these drugs on the growing skeleton have not materialized in the limited pediatric clinical experience. Bisphosphonates provide the pediatrician with an opportunity to treat mineral and bone disorders of childhood which until recently did not have satisfactory therapy, at the same time, being aware of the theoretical concerns on microdamage accumulation in bone, bone quality and teratogenic potential of these drugs. [ABSTRACT FROM AUTHOR]

Background: BCD-022 is a trastuzumab biosimilar which was shown to be equivalent to reference trastuzumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to comparatively assess efficacy and safety of BCD-022 and reference trastuzumab in combination with paclitaxel used as the therapy of metastatic HER2(+) breast cancer. Pharmacokinetics and immunogenicity were also studied.Methods: Patients with no previous treatment for metastatic HER2(+) breast cancer were randomly assigned 1:1 to BCD-022 or reference trastuzumab and were treated with trastuzumab + paclitaxel. Therapy continued for 6 cycles of therapy (every 3 weeks), until progression of the disease or unbearable toxicity. Primary study endpoint was overall response rate. Study goal was to prove equivalent efficacy of BCD-022 and reference trastuzumab. Equivalence margins for 95% CI for difference in overall response rates were set at [- 20%; 20%].Results: In total 225 patients were enrolled into the study, 115 in BCD-022 arm and 110 in reference trastuzumab arm. Overall response rate was 49.6% in BCD-022 arm and 43.6% in reference trastuzumab arm. Limits of 95% CI for difference of overall response rates between arms were [(- 8.05)-19.89%], thus, they lied within predetermined equivalence margins [- 20%; 20%]. Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm). No unexpected adverse reactions were reported throughout the study. No statistically significant differences regarding antibody occurrence rate (either BAb or NAb) was found between BCD-022 (n = 3; 2.65%) and comparator (n = 4; 3.64%). Both drug products are characterized with low occurrence rate and short life of anti-trastuzumab antibodies. Pharmacokinetics assessment after 1st and 6th study drug injection also demonstrated equivalent PK parameters by all outcome measures: AUC0-504, Сmах, Тmax, T1/2. Analysis of Ctrough did not reveal any significant inter-group differences as well.Conclusions: Thus, results of this study have demonstrated therapeutic equivalence of trastuzumab biosimilar BCD-022 and referent trastuzumab drug.Trial Registration: The trial was registered with ClinicalTrials.gov (Study Number NCT01764022 ). The date of registration was January 9, 2013. [ABSTRACT FROM AUTHOR]

Aims: The advantage of biodegradable-polymer drug-eluting stents (BP-DES) versus durable-polymer (DP) DES remains uncertain. We compared neointimal formation and endothelial barrier function of new BP sirolimus-eluting stents (BP-SES, BuMA Supreme®) to other contemporary BP-DES, DP-DES, and bare metal stents (BMS).Methods and Results: Light microscopic assessment in swine coronary arteries showed comparable neointimal formation between BP-SES and DP everolimus-eluting stent (DP-EES). The performance of BP-SES was compared with DP-EES (Xience Xpedition®), BP-EES (Synergy®), and BMS (Multi-Link Vision®) at 45- and 90-days in rabbit ilio-femoral arteries using Evans blue dye (EBD) followed by immunostaining for endothelial barrier proteins (p120/vascular endothelial-cadherin [VE-cad]) to evaluate endothelial barrier function and scanning electron microscopy (SEM) to determine strut tissue coverage. BMS followed by BP-SES and BP-EES exhibited smaller EBD positive areas versus that of DP-EES at 45- and 90-days. p120/VE-cad immunostaining and SEM-determined strut coverage was greater at 45- and 90-days for BMS followed by all DESs. Regardless of stent type, the lack of p120/VE-cad co-localization showed greater leukocyte and platelet aggregation.Conclusion: Three types of DES showed different endothelial healing pattern regardless their equivalent suppression of neointimal formation. [ABSTRACT FROM AUTHOR]

Background: Reduced-dose nivolumab in combination with standard-dose ipilimumab improves objective response and progression-free survival compared with standard-dose ipilimumab alone, but increases toxicity. We assessed the safety and anti-tumour activity of standard-dose pembrolizumab in combination with reduced-dose ipilimumab.Methods: In this open-label, phase 1b trial, we recruited patients from 12 medical centres in Australia, New Zealand, and the USA. Eligible patients were aged at least 18 years, had advanced melanoma, had an Eastern Coooperative Oncology Group performance status of 0 or 1, had measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, had adequate organ function, had resolution of toxic effects of the most recent previous chemotherapy to grade 1 or less, had no active autoimmune disease requiring systemic steroids or immunosuppressive agents, had no active non-infectious pneumonitis, had no uncontrolled thyroid dysfunction or diabetes, had no active brain metastases, and had not received previous immune checkpoint inhibitor therapy. Patients received intravenous pembrolizumab 2 mg/kg plus intravenous ipilimumab 1 mg/kg every 3 weeks for four doses, followed by intravenous pembrolizumab 2 mg/kg every 3 weeks for up to 2 years or disease progression, intolerable toxicity, withdrawal of consent, or investigator decision. The primary endpoint was safety and tolerability. The proportion of patients achieving an objective response assessed per RECIST version 1.1 by independent central review and overall survival were secondary endpoints. We also assessed progression-free survival. The primary endpoint was assessed in all patients who received at least one dose of combination therapy. Activity was assessed in all enrolled patients. This trial is registered with ClinicalTrials.gov, number NCT02089685. Enrolment into this cohort is closed, but patients are still being monitored for safety and anti-tumour activity.Findings: Between Jan 13, 2015, and Sept 17, 2015, we enrolled and treated 153 patients. As of the Oct 17, 2016, cutoff date, median follow-up was 17·0 months (IQR 14·8-18·8). 110 (72%) of 153 patients received all four pembrolizumab plus ipilimumab doses; 64 (42%) remained on pembrolizumab monotherapy. 110 grade 3-4 treatment-related adverse events occurred in 69 (45%) patients. No treatment-related deaths occurred. Treatment-related adverse events led to discontinuation of pembrolizumab and ipilimumab in 22 (14%) patients, including 17 (11%) who discontinued both treatments for the same event and five (3%) who discontinued ipilimumab for one event and later discontinued pembrolizumab for another. 12 (8%) patients discontinued ipilimumab only and 14 (9%) discontinued pembrolizumab only because of treatment-related adverse events. 158 immune-mediated adverse events of any grade occurred in 92 (60%) patients, and 50 immune-mediated adverse events of grade 3-4 occurred in 42 (27%) patients; the most common immune-mediated adverse events were hypothyroidism (25 [16%]) and hyperthyroidism (17 [11%]). 93 (61% [95% CI 53-69]) patients achieved an objective response. Estimated 1 year progression-free survival was 69% (95% CI 60-75), and estimated 1 year overall survival was 89% (95% CI 83-93).Interpretation: Standard-dose pembrolizumab given in combination with four doses of reduced-dose ipilimumab followed by standard-dose pembrolizumab has a manageable toxicity profile and provides robust anti-tumour activity in patients with advanced melanoma. These data suggest that standard-dose pembrolizumab plus reduced-dose ipilimumab might be a tolerable, efficacious treatment option for patients with advanced melanoma. A randomised phase 2 trial of alternative dosing strategies of this combination is underway.Funding: Merck & Co, Inc. [ABSTRACT FROM AUTHOR]

Background: Uveal melanoma is a rare tumour with no established treatments once metastases develop. Although a variety of immune-based therapies have shown efficacy in metastatic cutaneous melanoma, their use in ocular variants has been disappointing. Recently, adoptive T-cell therapy has shown salvage responses in multiple refractory solid tumours. Thus, we sought to determine if adoptive transfer of autologous tumour-infiltrating lymphocytes (TILs) could mediate regression of metastatic uveal melanoma.Methods: In this ongoing single-centre, two-stage, phase 2, single-arm trial, patients (aged ≥16 years) with histologically confirmed metastatic ocular melanoma were enrolled. Key eligibility criteria were an Eastern Cooperative Oncology Group performance status of 0 or 1, progressive metastatic disease, and adequate haematological, renal, and hepatic function. Metastasectomies were done to procure tumour tissue to generate autologous TIL cultures, which then underwent large scale ex-vivo expansion. Patients were treated with lymphodepleting conditioning chemotherapy (intravenous cyclophosphamide [60 mg/kg] daily for 2 days followed by fludarabine [25 mg/m2] daily for 5 days, followed by a single intravenous infusion of autologous TILs and high-dose interleukin-2 [720 000 IU/kg] every 8 h). The primary endpoint was objective tumour response in evaluable patients per protocol using Response to Evaluation Criteria in Solid Tumors, version 1.0. An interim analysis of this trial is reported here. The trial is registered at ClinicalTrials.gov, number NCT01814046.Findings: From the completed first stage and ongoing expansion stage of this trial, a total of 21 consecutive patients with metastatic uveal melanoma were enrolled between June 7, 2013, and Sept 9, 2016, and received TIL therapy. Seven (35%, 95% CI 16-59) of 20 evaluable patients had objective tumour regression. Among the responders, six patients achieved a partial response, two of which are ongoing and have not reached maximum response. One patient achieved complete response of numerous hepatic metastases, currently ongoing at 21 months post therapy. Three of the responders were refractory to previous immune checkpoint blockade. Common grade 3 or worse toxic effects were related to the lymphodepleting chemotherapy regimen and included lymphopenia, neutropenia, and thrombocytopenia (21 [100%] patients for each toxicity); anaemia (14 [67%] patients); and infection (six [29%] patients). There was one treatment-related death secondary to sepsis-induced multiorgan failure.Interpretation: To our knowledge, this is the first report describing adoptive transfer of autologous TILs to mediate objective tumour regression in patients with metastatic uveal melanoma. These initial results challenge the belief that metastatic uveal melanoma is immunotherapy resistant and support the further investigation of immune-based therapies for this cancer. Refinement of this T-cell therapy is crucial to improve the frequency of clinical responses and the general applicability of this treatment modality.Funding: Intramural Research Program of the National Institutes of Health, National Cancer Institute, Center for Cancer Research. [ABSTRACT FROM AUTHOR]

Objective: As part of a strategy to revitalize postpartum family planning services, Government of India revised its policy in 2013 to permit trained nurses and midwives to insert postpartum intrauterine contraceptive devices (PPIUCDs). This study compares two key outcomes of PPIUCD insertions--expulsion and infection--for physicians and nurses/midwives to generate evidence for task sharing.Study Design: We analyzed secondary data from the PPIUCD program in seven states using a case-control study design. We included facilities where both doctors and nurses/midwives performed PPIUCD insertions and where five or more cases of expulsion and/or infection were reported during the study period (January-December 2013). For each case of expulsion and infection, we identified a time-matched control who received a PPIUCD at the same facility and had no complaints. We performed a multiple logistic regression analysis focusing on provider cadre while controlling for potential confounding factors.Results: In 137 facilities, 792 expulsion and 382 infection cases were matched with 1041 controls. Provider type was not significantly associated with either expulsion [odds ratio (OR) 1.84; 95% confidence interval (CI): 0.82-4.12] or infection (OR 0.73; 95% CI: 0.39-1.37). Compared with centralized training, odds of expulsion were higher for onsite (OR 2.32, 95% CI: 1.86-2.89) and on-the-job training (OR 1.23, 95% CI: 1.11-1.36), but odds of infection were lower for onsite (OR 0.45, 95% CI: 0.27-0.75) and on-the-job training (OR 0.31, 95% CI: 0.25-0.37).Conclusion: Trained nurses and midwives who conduct deliveries at public health facilities can perform PPIUCD insertions as safely as physicians.Implications: Institutional deliveries are increasing in India, but most normal vaginal deliveries at public health facilities are attended by nurses and midwives due to a shortage of physicians. Task sharing with nurses and midwives can increase women's access to and the acceptability of quality PPIUCD services. [ABSTRACT FROM AUTHOR]