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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]

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]

Objective: To assess the efficacy and safety of fixed-dose combinations (FDC) of triple-drug dapagliflozin, sitagliptin, and metformin (DSM) compared with FDC of two-drug sitagliptin and metformin (SM), in Indian adult patients with type 2 diabetes (T2D). Methods: A multicentric, randomized, double-blind, active-controlled, Phase 3 study (CTRI/2021/10/037461) was conducted on 274 Indian adult patients with T2D. Patients were randomized (1:1) to receive either an FDC of triple-drug (n = 137) dapagliflozin propanediol 10 mg, sitagliptin phosphate 100 mg, and metformin hydrochloride 1000 mg extended-release (DSM) or FDC of two-drug (n = 137) sitagliptin phosphate 100 mg and metformin hydrochloride 1000 mg sustained-release (SM), for 16 weeks. The primary endpoint was a change in HbA1c, while the secondary endpoints were changes in fasting plasma glucose (FPG), postprandial glucose (PPG), body weight, and safety. Results: Both DSM and SM FDCs reduced HbA1c significantly (-1.45% and -1.00%, respectively, both p < 0.0001), however, HbA1c lowering was superior with DSM (∆ -0.45%; p = 0.0005) compared to SM, at week 16. Similarly, both DSM and SM FDCs reduced FPG and PPG significantly, however, FPG (∆ -12.4 mg/dl; p = 0.003) and PPG reduction (∆ -18.45 mg/dl; p = 0.01) were significantly superior to DSM compared to SM, respectively. No significant reduction in body weight was observed between the two arms. Both FDCs were well tolerated. Conclusion: FDC of DSM was superior to SM in reducing HbA1c, FPG, and PPG in Indian adults with T2D. Both triple and dual FDCs had optimal safety profiles. [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: Psoriasis is an inflammatory systemic disease with a chronic relapsing course. Methotrexate, a dihydrofolate reductase inhibitor, and Apremilast, an oral phosphodiesterase type 4 inhibitor, are currently the mainstay drugs in the treatment of psoriasis. Aims and Objectives: To compare the efficacy of Methotrexate with a combination of Methotrexate and Apremilast in treating chronic plaque psoriasis. Materials and Methods: The present study was a prospective comparative study conducted among 40 patients, aged above 18 years, with clinically diagnosed psoriasis attending Dermatology OPD of a tertiary care hospital in North India. The study utilised a pre-structured proforma to record a detailed demographic profile and clinical examination related to chronic plaque psoriasis. The patients were divided into two groups of 20 each. Group A was treated with oral Methotrexate, while Group B was treated with oral Apremilast and Methotrexate, and they were evaluated every 4 weeks for 12 weeks. Necessary investigations were done wherever indicated. Results: The male-to-female ratio was 1.35, and the majority (55.0%) of patients belonged to the age group of 31-50 years. 27.5% of patients had comorbidities like diabetes, hypertension, etc., The mean PASI score of group A at the first, second and third follow-ups was higher than that of group B. The reduction in mean PASI score was statistically significant in group B at successive follow-ups, with a percentage improvement of 89.4% at the end of 12 weeks. Conclusions: When comparing monotherapy with methotrexate and multidrug therapy with Methotrexate and Apremilast, multidrug therapy had better efficacy. [ABSTRACT FROM AUTHOR]

Cyclical mastalgia of moderate to severe degree requires systemic drug therapy. Tamoxifen is the drug of choice worldwide. A novel molecule, centchroman/Ormeloxifene, developed in India, was found to be equally effective in previous studies. However, its optimal dose regimen is uncertain. We conducted three-arm randomized controlled trial to compare the effectiveness in relieving breast pain. Group 1 received tamoxifen 10 mg daily, and groups 2 and 3 received centchroman 30 mg twice and 30 mg thrice a week, respectively, for 3 months with a follow-up of 3 more months. Breast pain score, nodularity score, sonographic evaluation of the breasts and ovaries, quality of life scores, and adverse events were recorded. The number of patients enrolled was 32, 31, and 30 in group 1, group 2, and group 3, respectively. All three groups had significant improvement in breast pain scores [group 1 (5 → 2), group 2 (5 → 2), group 3 (6 → 2), p < 0.001)], nodularity scores [group1 (1 → 0), group 2 (1 → 0), group 3 (1 → 0), p < 0.001)] and in the quality of life scores over time. However, no significant differences were observed in-between the groups. Transient ovarian cyst formation and menstrual irregularities were more common with a higher dose of centchroman. Centchroman in the dosages of 30 mg twice or thrice a week is as effective as a daily dose of tamoxifen 10 mg in relieving pain, nodularity, and improving quality of life scores. The dose of centchroman 30 mg twice a week for 12 weeks has the least adverse effects and should be accepted as the optimal dosage regimen. There is a need of further study with a greater number of participants and longer follow-up. Trial registration number: CTRI/2018/02/012043 (Registered on: 21/02/2018). [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]

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]

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]

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: The need to study prognosis after incidence of acute ischemic stroke (AIS) has fueled researchers to identify predictors apart from neurological, functional, or disability measures. The purpose of this study was to test and validate a newly developed clinico-biomarker assessment module in AIS and also to investigate the role of serum vascular endothelial growth factor (VEGF) after AIS.Materials and Methods: A randomized controlled study with sample size of 250 patients suffering from AIS within 2 weeks of the index event were conducted and followed up for a period of three months. Age, gender, stroke subtype, previous stroke history, dysarthria, stroke localization, wakeup strokes, and Glasgow Coma Scale (GCS) were dichotomized as present or absent using the National Institute of Health Stroke Scale (NIHSS) which consists of four subcategories. The additional serum VEGF was scored between 1 and 4 (0-200 = 1, 200-300 = 2, 300-400 = 3, and 400-500 = 4). All these were summed under a clinical biomarker (CB) module with highest score of 30.Results: The mean VEGF in 125 patients was 378.4 + 98.9 pg/ml, indicating a moderately high increase with a score of 3 on CB module. Multiple regression analysis revealed that the CB model was fit to predict prognosis and severity [R2 = 0.86, F (23.4, 6);P = 0.001], with NIHSS subscore, prestroke status, and VEGF being very strong predictors. When only the clinical module was tested on all 250 patients, it was found that the NIHSS subscore, time to stroke onset and prestroke functional status were the most common [R2 = 0.79; F (45,9);P = 0.005].Conclusion: This study demonstrates that VEGF is highly upregulated in AIS with severe disability as compared to healthy controls. This biomarker is a strong predictor of severity and functionality when combined with clinical variables three months post the ishemic event. [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]

Background: Although curcumin's effect on head and neck cancer has been studied in vitro and in vivo, to the authors' knowledge its efficacy is limited by poor systemic absorption from oral administration. APG-157 is a botanical drug containing multiple polyphenols, including curcumin, developed under the US Food and Drug Administration's Botanical Drug Development, that delivers the active components to oromucosal tissues near the tumor target.Methods: A double-blind, randomized, placebo-controlled, phase 1 clinical trial was conducted with APG-157 in 13 normal subjects and 12 patients with oral cancer. Two doses, 100 mg or 200 mg, were delivered transorally every hour for 3 hours. Blood and saliva were collected before and 1 hour, 2 hours, 3 hours, and 24 hours after treatment. Electrocardiograms and blood tests did not demonstrate any toxicity.Results: Treatment with APG-157 resulted in circulating concentrations of curcumin and analogs peaking at 3 hours with reduced IL-1β, IL-6, and IL-8 concentrations in the salivary supernatant fluid of patients with cancer. Salivary microbial flora analysis showed a reduction in Bacteroidetes species in cancer subjects. RNA and immunofluorescence analyses of tumor tissues of a subject demonstrated increased expression of genes associated with differentiation and T-cell recruitment to the tumor microenvironment.Conclusions: The results of the current study suggested that APG-157 could serve as a therapeutic drug in combination with immunotherapy.Lay Summary: Curcumin has been shown to suppress tumor cells because of its antioxidant and anti-inflammatory properties. However, its effectiveness has been limited by poor absorption when delivered orally. Subjects with oral cancer were given oral APG-157, a botanical drug containing multiple polyphenols, including curcumin. Curcumin was found in the blood and in tumor tissues. Inflammatory markers and Bacteroides species were found to be decreased in the saliva, and immune T cells were increased in the tumor tissue. APG-157 is absorbed well, reduces inflammation, and attracts T cells to the tumor, suggesting its potential use in combination with immunotherapy drugs. [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]

Objective: To compare the efficacy and safety of intramyometrial vasopressin plus rectal misoprostol with intramyometrial vasopressin alone to reduce blood loss during laparoscopic myomectomy.Study Design: A randomized, single-blind, controlled trial was conducted at All India Institute of Medical Sciences, New Delhi, India. Sixty women with symptomatic leiomyoma scheduled for laparoscopic myomectomy were recruited for the study. Thirty women received intramyometrial vasopressin plus rectal misoprostol (30 min before procedure) (Group I) and 30 women received intramyometrial vasopressin alone (Group II) during laparoscopic myomectomy. The primary outcome measure was intra-operative blood loss during surgery. Secondary outcome measures included decrease in postoperative haemoglobin, ease of enucleation of myomas, duration of surgery, need for additional haemostatic measures or blood transfusion, intra- and postoperative morbidity, and duration of hospital stay.Results: The baseline demographic features and characteristics of leiomyomas were comparable in both groups. The mean (±standard deviation) blood loss in Group I was 139 ± 96.7 ml, which was significantly less than that for Group II (206 ± 101.2 ml) (p = 0.008). The mean postoperative haemoglobin was 11.6 ± 1.3 g/dl in Group I and 10.0 ± 1.2 g/dl in Group II (p = 0.001). Although blood loss was not clinically significant in either group, the decrease in haemoglobin was significantly higher in Group II. The mean score for ease of enucleation (surgeon-rated measure) was significantly lower in Group I (2.6 ± 1.1) compared with Group II (3.4 ± 1.1) (p = 0.029). Intra- and postoperative vital signs, duration of surgery, need for blood transfusion and postoperative morbidity were comparable in both groups.Conclusions: The addition of rectal misoprostol to intramyometrial vasopressin led to a significant reduction in blood loss and decreased the postoperative drop in haemoglobin. The combination also improved the ease of enucleation of myomas. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the present study was to clinically evaluate and compare the efficacy and retention of various types of intracanal posts in the restoration of grossly decayed deciduous anterior teeth. The various posts used were polyethylene post, glass post, and composite post.Materials and Methods: A total number of 16 patients with 45 grossly decayed primary anterior teeth were selected. After biomechanical preparation and obturation, patients were randomly divided on the basis of posts to be used into three groups (Group I: Polyethylene post; Group II: Glass post, and Group III: Composite post). Then, space was created in the obturated canal and posts were placed, followed by core build up.Results: After an interval of 12 months, 86.67% of the teeth exhibited complete retention of the post restored with polyethylene post (P > 0.005) and 93.3% of the teeth exhibited complete retention of the post that were restored with glass post (P > 0.005) whereas only 60% of the teeth exhibited complete retention of the post that were restored with composite post (P< 0.005). Only 20% of the teeth exhibited marginal discoloration in both Groups I and III and 13.33% in Group II and this was nonsignificant.Conclusion: Both glass post and polyethylene post proved to be effective. Glass post showed the maximum retention and marginal adaptation followed by polyethylene post. Thus, it appears to be of potential interest for use especially in clinical pediatric dentistry. [ABSTRACT FROM AUTHOR]

Alcohol use, physical activity, diet, and cigarette smoking are modifiable cardiovascular risk factors that have a substantial impact on the risk of myocardial infarction, stroke, and cardiovascular death. We hypothesized that these behaviors may alter concentrations of cardiac troponin, a marker of myocyte injury, and B-type natriuretic peptide, a marker of myocyte stress. Both markers have shown strong association with adverse cardiovascular outcomes. In 519 women with no evidence of cardiovascular disease, we measured circulating concentrations of cardiac troponin T, using a high-sensitivity assay (hsTnT), and the N-terminal fragment of B-type natriuretic peptide (NT-proBNP). We used logistic regression to determine if these behaviors were associated with hsTnT ≥ 3 ng/l or with NT-proBNP in the highest quartile (≥ 127.3 ng/l). The median (Q1 to Q3) NT-proBNP of the cohort was 68.8 ng/l (40.3 to 127.3 ng/l), and 30.8% (160 of 519) of the cohort had circulating hsTnT ≥ 3 ng/l. In adjusted models, women who drank 1 to 6 drinks/week had lower odds of having a hsTnT ≥ 3 ng/l (odds ratio 0.58, 95% confidence interval 0.34 to 0.96) and lower odds of having an elevated NT-proBNP (odds ratio 0.55, 95% confidence interval 0.32 to 0.96). We were subsequently able to validate the results for B-type natriuretic peptide in a large independent cohort. In conclusion, our results suggest that regular alcohol consumption is associated with lower concentrations of hsTnT and NT-proBNP, 2 cardiovascular biomarkers associated with cardiovascular risk, and raise the hypothesis that the beneficial effects of alcohol consumption may be mediated by direct effects on the myocardium. [ABSTRACT FROM AUTHOR]

Background and Objectives: Patients on mechanical ventilation in intensive care unit (ICU) are often uncomfortable because of anxiety, pain, and endotracheal intubation; therefore, require sedation. Alpha-2 agonists are known to produce sedation. We compared clonidine and dexmedetomidine as sole agents for sedation. Study Design: Prospective, randomized, controlled open-label study. Materials and Methods: A total of 70 patients requiring a minimum of 12 h of mechanical ventilation with concomitant sedation, were randomly allocated into two groups. Group C (n = 35) received intravenous (IV) clonidine (1 μg/kg/h titrated up to 2 μg/kg/h to attain target sedation), and Group D (n = 35) received IV dexmedetomidine for sedation (loading 0.7 μg/kg and maintenance 0.2 μg/kg/h titrated up to 0.7 μg/kg/h to achieve target sedation). A Ramsay Sedation Score of 3-4 was considered as target sedation. Additional sedation with diazepam was given when required to achieve target sedation. The quality of sedation, hemodynamic changes and adverse effects were noted and compared between the two groups. Results: Target sedation was achieved in 86% observations in Group D and 62% in Group C (P = 0.04). Additional sedation was needed by more patients in Group C compared with Group D (14 and 8 in Groups C and D, respectively, P = 0.034), mainly due to concomitant hypotension on increasing the dose of clonidine. Hypotension was the most common side-effect in Group C, occurring in 11/35 patients of Group C and 3/35 patients of Group D (P = 0.02). Rebound hypertension was seen in four patients receiving clonidine, but none in receiving dexmedetomidine. Conclusion: Both clonidine and dexmedetomidine produced effective sedation; however, the hemodynamic stability provided by dexmedetomidine gives it an edge over clonidine for short-term sedation of ICU patients. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and complications of uterine artery embolization (UAE) versus laparoscopic occlusion of uterine vessels (LOUV) in the management of symptomatic fibroids.Methods: A pilot randomized clinical trial in which 20 patients with symptomatic fibroids were randomly allocated into two groups. Ten women underwent UAE, and 10 women underwent LOUV. Symptomatic improvement in menorrhagia and reduction in the volumes of the uterus and the fibroid were assessed at 3 and 6 months.Results: The patients were comparable with regard to age and parity. At 6 months, there was no significant difference in the mean reduction in menstrual blood loss, uterine volume, and volume of the dominant fibroid between the two groups (P=0.436, P=0.796, P=1.00, respectively). However, higher pain scores were recorded on day 1 in the UAE group compared with the LOUV group (P=0.0002).Conclusions: The effects of UAE and LOUV in the management of symptomatic fibroids are comparable. The main advantage of LOUV is less postoperative pain compared with UAE. [ABSTRACT FROM AUTHOR]

After a report of reduced seroconversion to measles in infants, aged 6 mo, given vitamin A with their measles vaccination, serious concerns were raised regarding the safety of the WHO's recommendation that infants be supplemented with vitamin A at the time of measles immunization. To determine the impact of coadministered vitamin A on the antibody response to measles vaccine given to infants aged 9 mo, the more common age for immunization in developing countries, we conducted a randomized, double-blind, placebo-controlled trial in an urban slum community in Delhi. Infants (618) were randomly allocated to receive 30 mg vitamin A or a placebo with the measles immunization. Antibodies to measles were measured by ELISA in serum samples obtained at before (baseline) and 12 wk after immunization. Overall, the seroconversion rates did not differ between vitamin A (89.5%) and placebo (87.6%) groups. There were no significant differences in the geometric mean titers in the two groups (ratio of geometric means, 1.19; 95% confidence interval, 0.97-1.46). Among malnourished infants, the geometric mean titer was significantly greater in the vitamin A group compared to the placebo group (ratio of geometric means, 1.57; 95% confidence interval, 1. 18-2.0), but seroconversion rates did not differ. There were no differences in seroconversion rates and geometric mean titers in the two study groups among the well-nourished children. These results indicate that 30 mg vitamin A does not reduce the immune response to the coadministered vaccine and, therefore, can be continued to be given safely in public health programs. [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]

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: Less than one-third of smokers hospitalized with an acute coronary syndrome (ACS) remain abstinent following discharge. We assessed whether varenicline, begun in-hospital, is efficacious for smoking cessation following ACS.Methods and Results: We conducted a multi-center, double-blind, randomized, placebo-controlled trial in which smokers hospitalized with an ACS were randomized to varenicline or placebo for 12 weeks. All patients received low-intensity counseling. The primary end point was point-prevalence smoking abstinence assessed at 24 weeks by 7-day recall and biochemical validation using expired carbon monoxide. A total of 302 patients were randomized (mean age 55±9 years; 75% male; 56% ST-segment elevation myocardial infarction; 38% non-ST-segment elevation myocardial infarction; 6% unstable angina). Patients smoked a mean of 21±11 cigarettes/d at the time of hospitalization and had been smoking for a mean of 36±12 years. At 24 weeks, patients randomized to varenicline had significantly higher rates of smoking abstinence and reduction than patients randomized to placebo. Point-prevalence abstinence rates were 47.3% in the varenicline group and 32.5% in the placebo group (P=0.012; number needed to treat=6.8). Continuous abstinence rates were 35.8% and 25.8%, respectively (P=0.081; number needed to treat=10.0), and rates of reduction ≥50% in daily cigarette consumption were 67.4% and 55.6%, respectively (P=0.05; number needed to treat=8.5). Adverse event rates within 30 days of study drug discontinuation were similar between groups (serious adverse events: varenicline 11.9%, placebo 11.3%; major adverse cardiovascular events: varenicline 4.0%, placebo 4.6%).Conclusions: Varenicline, initiated in-hospital following ACS, is efficacious for smoking cessation. Future studies are needed to establish safety in these patients.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00794573. [ABSTRACT FROM AUTHOR]

Purpose: Recent evidence has shown that buccal infiltration with articaine alone can be used to anesthetize dental tissues for various dental procedures. The purpose of this study was to evaluate the efficacy of articaine compared to lidocaine for extraction of primary maxillary molars and assess whether palatal anesthesia could be achieved with buccal infiltration injection but without the need for palatal infiltration.Methods: One hundred and two children requiring primary maxillary molar extraction were randomly selected to receive buccal infiltration using either articaine or lidocaine. During extraction, The Wong Baker Facial Pain Scale (FPS) was employed for subjective evaluation and Modified Behavior Pain Scale (MBPS) values, heart rate, and blood pressure were recorded for objective evaluation. Effectiveness of anesthesia was checked using subjective symptoms and probing.Results: Palatal anesthesia with buccal infiltration could not be obtained in any of the groups. Statistically significantly higher MBPS pain scale values were seen with lidocaine as compared to articaine. FPS, heart rate, and blood pressure values presented no statistically significant difference in the two groups.Conclusions: Although buccal infiltration with articaine failed to provide adequate palatal anesthesia, it can still be considered a good alternative to lidocaine for local anesthesia in children. [ABSTRACT FROM AUTHOR]