Holy Family Hospital

Abstract The Indo‐US Cross‐National Dementia Epidemiology Study seeks to compare two rural populations, in the US and India: the Monongahela Valley, a rural community of relatively low socioeconomic status in southwestern Pennsylvania (USA), and Ballabgarh, a rural community near New Delhi in North India. Of Particular interest is the fact that the Ballabgarh elderly population is exclusively Hindi‐speaking, has little or no education and is largely illiterate, rendering its cognitive screening a particular challenge. In this article we report methods and preliminary data on the development of a Hindi cognitive screening instrument suitable for the Ballabgarh elderly population. We use as an example our Hindi adaptation of the Mini‐Mental State Examination (MMSE), a widely used global cognitive screening scale. Systematic, item‐by‐item, empirically based test development has shown that effective modifications can be made to existing tests that require reading and writing; and that culturally sensitive modifications can be made to render the test meaningful and relevant while still tapping the appropriate cognitive domains. Certain cognitive functions, particularly orientation to time, remain difficult to test adequately in this type of population. In Ballabgarh, as in the Monongahela Valley, educated individuals obtain higher test scores. Implications for dementia screening are discussed, including those relevant to the hypothesis that low education predisposes to dementia.

BACKGROUND: Reducing sympathetic output to the heart from the neuraxis can protect against ventricular arrhythmias. The purpose of this study was to assess the value of thoracic epidural anesthesia (TEA) and left cardiac sympathetic denervation (LCSD) in the management of ventricular arrhythmias in patients with structural heart disease. METHODS AND RESULTS: Clinical data of 14 patients (25 to 75 years old, mean+/-SD of 54.2+/-16.6 years; 13 men) who underwent TEA, LCSD, or both to control ventricular tachycardia (VT) refractory to medical therapy and catheter ablation were reviewed. Twelve patients were in VT storm, and 2 experienced recurrent VT despite maximal medical therapy and catheter ablation procedures. The total number of therapies per patient before either procedure ranged from 5 to 202 (median of 24; 25th and 75th percentile, 5 and 56). Eight patients underwent TEA, and 9 underwent LCSD (3 patients had both procedures). No major procedural complications occurred. After initiation of TEA, 6 patients had a large (> or =80%) decrease in VT burden. After LCSD, 3 patients had no further VT, 2 had recurrent VT that either resolved within 24 hours or responded to catheter ablation, and 4 continued to have recurrent VT. Nine of 14 patients survived to hospital discharge (2 TEA alone, 3 TEA/LCSD combined, and 4 LCSD alone), 1 of the TEA alone patients underwent an urgent cardiac transplantation. CONCLUSIONS: Initiation of TEA and LCSD in patients with refractory VT was associated with a subsequent decrease in arrhythmia burden in 6 (75%) of 8 patients (68% confidence interval 51% to 91%) and 5 (56%) of 9 patients (68% confidence interval 34% to 75%), respectively. These data suggest that TEA and LCSD may be effective additions to the management of refractory ventricular arrhythmias in structural heart disease when other treatment modalities have failed or may serve as a bridge to more definitive therapy.

In the digital era, we witness the increasing use of artificial intelligence (AI) to solve problems, while improving productivity and efficiency. Yet, inevitably costs are involved with delegating power to algorithmically based systems, some of whose workings are opaque and unobservable and thus termed the "black box". Central to understanding the "black box" is to acknowledge that the algorithm is not mendaciously undertaking this action; it is simply using the recombination afforded to scaled computable machine learning algorithms. But an algorithm with arbitrary precision can easily reconstruct those characteristics and make life-changing decisions, particularly in financial services (credit scoring, risk assessment, etc.), and it could be difficult to reconstruct, if this was done in a fair manner reflecting the values of society. If we permit AI to make life-changing decisions, what are the opportunity costs, data trade-offs, and implications for social, economic, technical, legal, and environmental systems? We find that over 160 ethical AI principles exist, advocating organisations to act responsibly to avoid causing digital societal harms. This maelstrom of guidance, none of which is compulsory, serves to confuse, as opposed to guide. We need to think carefully about how we implement these algorithms, the delegation of decisions and data usage, in the absence of human oversight and AI governance. The paper seeks to harmonise and align approaches, illustrating the opportunities and threats of AI, while raising awareness of Corporate Digital Responsibility (CDR) as a potential collaborative mechanism to demystify governance complexity and to establish an equitable digital society.

The global burden of antimicrobial resistance is rising and is associated with increased morbidity and mortality in clinical and community setting. Spread of antibiotic resistance to different environmental niches and development of superbugs have further complicated the effective control strategies. International, national and local approaches have been advised for control and prevention of antimicrobial resistance. Rational use of antimicrobials, regulation on over-the-counter availability of antibiotics, improving hand hygiene and improving infection prevention and control are the major recommended approaches. Thorough understanding of resistance mechanism and innovation in new drugs and vaccines is the need. A multidisciplinary, collaborative, regulatory approach is demanded for combating antimicrobial resistance.

Neurobiological mechanisms invoking the release of endogenous opioids and depression of stress hormone release are believed to be the basis of acupuncture analgesia. This study compared plasma beta-endorphin and cortisol levels with self assessment scores of intensity of pain, before and after 10 days of electro-acupuncture treatment in patients suffering from chronic pain as a result of osteoarthritis knees. Forty patients of either sex over 40 years with primary osteoarthritis knee were recruited into a single-blinded, sham-controlled study. For electro-acupuncture group the points were selected according to the Traditional Chinese Medicine Meridian Theory. In the sham group needles were inserted at random points away from true acupoints and no current was passed. Both groups were treated for 10 days with one session every day lasting for 20-25min. Pre- and post-treatment Western Ontario and McMaster Universities (WOMAC) index of osteoarthritis knee and Visual Analogue Scale (VAS) for pain were recorded and blood samples were taken for the measurement of plasma cortisol and beta-endorphin levels. Following electro-acupuncture treatment there was a significant improvement in WOMAC index and VAS (p=0.001), a significant rise in plasma beta-endorphin (p=0.001), and a significant fall in plasma cortisol (p=0.016). In conclusion electro-acupuncture resulted in an improvement in pain, stiffness and disability. Of clinical importance is that an improvement in objective measures of pain and stress/pain associated biomarkers was shown above that of a sham treatment; hence demonstrating acupuncture associated physiological changes beyond that of the placebo effects.

There is a great interest in searching for diagnostic biomarkers in prostate cancer patients. The aim of the pilot study was to evaluate free amino acid profiles in their serum and urine. The presented paper shows the first comprehensive analysis of a wide panel of amino acids in two different physiological fluids obtained from the same groups of prostate cancer patients (n = 49) and healthy men (n = 40). The potential of free amino acids, both proteinogenic and non-proteinogenic, as prostate cancer biomarkers and their utility in classification of study participants have been assessed. Several metabolites, which deserve special attention in the further metabolomic investigations on searching for prostate cancer markers, were indicated. Moreover, free amino acid profiles enabled to classify samples to one of the studied groups with high sensitivity and specificity. The presented research provides a strong evidence that ethanolamine, arginine and branched-chain amino acids metabolic pathways can be a valuable source of markers for prostate cancer. The altered concentrations of the above-mentioned metabolites suggest their role in pathogenesis of prostate cancer and they should be further evaluated as clinically useful markers of prostate cancer.

Maternal expressed emotion (EE) scales were rated for children aged 6-11 with conduct disorders, emotional disorders and a group of non-referred children matched for sex and age (N = 30 in each of the three groups). Maternal warmth distinguished significantly between the three groups (CD < ED < Controls), while criticism distinguished the group of conduct disordered children. Maternal criticism was positively associated with child behaviour ratings even within the non-referred group. These observational ratings of warmth and criticism were found to be much more strongly associated with child behaviour than maternal ratings of their family environment.

BACKGROUND: Brucellosis has unusual clinical manifestations. Ocular involvement caused by brucellosis remains poorly recognized in areas in which brucellosis is endemic. METHODS: A prospective study was performed to evaluate patients attending the Instituto de Medicina Tropical "Alexander von Humboldt" and the Hospital Nacional Cayetano Heredia (Lima, Peru) from January 1980 through December 2005 who received a diagnosis of brucellosis with ocular involvement. Diagnosis was made on the basis of clinical findings as well as agglutinations and/or culture positive for Brucella melitensis. RESULTS: During a period of 26 years, 1551 patients with brucellosis were seen, including 52 patients with ocular brucellosis. We found that 7 (0.7%) of 965 patients with acute brucellosis and 45 (7.9%) of 570 patients with chronic brucellosis had ocular brucellosis (P<.001). In 16 patients with brucellosis, the disease stage was unclassified. The most frequent ocular presentation was uveitis, which was found in 43 (82.7%) of the 52 patients with ocular brucellosis. Posterior uveitis was the most frequent uveal syndrome (21 cases; 45.7%). Patients with panuveitis had the worst visual prognosis: 8 of 9 patients with panuveitis were legally blind, including 5 patients with no light perception. CONCLUSIONS: Brucellosis may involve the eye and can lead to serious complications. In patients with brucellosis, early ophthalmologic evaluation can lead to prompt treatment and might prevent blindness from severe ocular damage.

BACKGROUND: Inconsistent results across association studies including Genome-wide association, have posed a major challenge in complex disease genetics. Of the several factors which contribute to this, phenotypic heterogeneity is a serious limitation encountered in modern medicine. On the other hand, Ayurveda, a holistic Indian traditional system of medicine, enables subgrouping of individuals into three major categories namely Vata, Pitta and Kapha, based on their physical and mental constitution, referred to as Prakriti. We hypothesised that conditioning association studies on prior risk, predictable in Ayurveda, will uncover much more variance and potentially open up more predictive health. OBJECTIVES AND METHODS: Identification of genetic susceptibility markers by combining the prakriti based subgrouping of individuals with genetic analysis tools was attempted in a Rheumatoid arthritis (RA) cohort. Association of 21 markers from commonly implicated inflammatory and oxidative stress pathways was tested using a case-control approach in a total cohort comprising 325 cases and 356 controls and in the three subgroups separately. We also tested few postulates of Ayurveda on the disease characteristics in different prakriti groups using clinico-genetic data. RESULTS: Inflammatory genes like IL1β (C-C-C haplotype, p=0.0005, OR=3.09) and CD40 (rs4810485 allelic, p=0.04, OR=2.27) seem to be the determinants in Vata subgroup whereas oxidative stress pathway genes are observed in Pitta (SOD3 rs699473, p=0.004, OR=1.83; rs2536512 p=0.005; OR=1.88 and PON1 rs662, p=0.04, OR=1.53) and Kapha (SOD3 rs2536512, genotypic, p=0.02, OR=2.39) subgroups. Fixed effect analysis of the associated markers from CD40, SOD3 and TNFα with genotype X prakriti interaction terms suggests heterogeneity of effects within the subgroups. Further, disease characteristics such as severity was most pronounced in Vata group. CONCLUSIONS: This exploratory study suggests discrete causal pathways for RA etiology in prakriti based subgroups, thereby, validating concepts of prakriti and personalized medicine in Ayurveda. Ayurgenomics approach holds promise for biomarker discovery in complex diseases.

The estimate of the global burden of disease predicts that depression will be the second-leading cause of disability worldwide by 2020. Depression is widely prevalent in women in all age groups especially in India where 1.2 billion population lives. In the current scenario of underdiagnosed, untreated cases of females suffering from depression, the hurdles faced by Indian women include inadequate number of mental health professionals, lack of awareness, stigma, disadvantaged position of women, multiple roles, increased levels of stress, and domestic violence. The literature search included an electronic database, published materials, and standard textbooks. The authors have provided a brief overview of different types of depression in females. Epidemiology, etiology, clinical presentation, and management linked to the reproductive cycle of women have been covered. Awareness through public education, early detection, organized national mental health programs, comprehensive management, with judicious utilization of the limited resources would tackle the rising number of cases of female depression, in a cost effective manner, thereby preventing suicide.

The incidence, clinical presentation, etiology, and treatment of sigmoid volvulus in a West African population are described. This retrospective study, based on 146 cases in eight years, shows that the incidence of the disorder of 12 new cases per 100,000 population per year is extremely high in the area described. It also shows that good results can be obtained in the treatment of sigmoid volvulus even in suboptimal conditions in rural hospitals when adhering to sound surgical principles.

Cough is one of the common adverse effects in patients receiving angiotensin-converting enzyme inhibitors (ACEIs). This review presents the current evidence on incidence and mechanisms of cough associated with ACEIs use, and proposes a practical approach for managing the same for optimal cardiovascular (CV) risk reduction. The incidence of dry cough in patients receiving ACEIs vary among individual ACEIs, and is the lowest with perindopril. Cough is thought to originate from multiple mechanisms, bradykinin theory is the most commonly appealed hypothesis. The strategies for optimal management could be temporarily discontinuation of ACEI upon a reported incidence of cough and reintroduction after its remission. However, studies have reported disappearance of cough despite continuing treatment. Another important approach could be adding calcium channel blockers to ACEIs. Switching to alternative drugs such as angiotensin receptor blockers should be suggested in case intolerable symptoms recur and after exclusion of all other possible causes of cough.

OBJECTIVE: Peripheral neutrophilia is one of characteristic laboratory findings in patients with adult Still's disease (ASD). We performed this study to identify the bone marrow findings in patients ASD. METHODS: We examined 12 bone marrow biopsy specimens from patients with ASD. RESULTS: The most frequent finding was granulocyte hyperplasia (12/12, 100%) and hypercellularity was observed in 75.0% (8/12) of patients. Plasmacytosis was present in 8.3% (1/12) of specimens. Histiocytosis and reactive hemophagocytosis were found in 25.0% (4/12) and in 16.7% (2/12) respectively. CONCLUSION: Our results show that bone marrow granulocyte hyperplasia is the main possible mechanism for peripheral neutrophilia and that histiocytic activation is a not infrequent bone marrow findings in patients with ASD.

Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that has resulted in a global pandemic and is caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Zoonotic diseases are infections that are transmitted from animals to humans. COVID-19 caused by SARS-CoV-2 most likely originated in bats and transmitted to humans through a possible intermediate host. Based on published research so far, pangolins are considered the most likely intermediate hosts. Further studies are needed on different wild animal species, including pangolins that are sold at the same wet market or similar wet markets before concluding pangolins as definitive intermediate hosts. SARS-CoV-2 is capable of reverse zoonosis as well. Additional research is needed to understand the pathogenicity of the virus, especially in companion animals, modes of transmission, incubation period, contagious period, and zoonotic potential. Interdisciplinary one health approach handles these mosaic issues of emerging threats by integrating professionals from multiple disciplines like human medicine, veterinary medicine, environmental health, and social sciences. Given that the future outbreak of zoonotic diseases is inevitable, importance must be given for swift identification of the pathogen, source, and transmission methods. Countries should invest in identifying the hot spots for the origin of zoonotic diseases, enhance diagnostic capabilities, and rapid containment measures at local, regional, and national levels. The threat posed by emerging infectious diseases in modern-days also needs combined efforts internationally where a single discipline or nation cannot handle the burden alone.

BACKGROUND AND OBJECTIVES: Although the laparoscopic assisted total gastrectomy (LATG) has been performed in upper gastric cancer, dissection of lymph nodes No. 10 and 11d without resection of the distal pancreas and the spleen has been hard to accomplish, because of the possibilities of injury to splenic vessels and parenchyma of the spleen or pancreas. Herein, we present successful results in laparoscopic pancreas- and spleen-preserving D2 lymph node dissection in advanced upper gastric cancer. METHODS: Between March 2004 and May 2007, 18 clinical T2 patients who underwent LATG with D2 lymph node dissection for upper gastric cancer were enrolled. RESULTS: We used the technique of encircling and pulling the splenic artery with umbilical tape and that helped us complete dissection of lymph nodes No. 10 and 11d without distal pancreatectomy or splenectomy. The mean operative time was 370 min without any perioperative complications or conversion to an open procedure. CONCLUSIONS: Laparoscopic extended lymph node dissection without pancreatectomy or splenectomy can be adapted to the patients with clinical T2 upper gastric cancer. The techniques like taping of the splenic artery can be a useful tip for surgeons who wish to perform laparoscopic complete D2 lymph node dissection in advanced upper gastric cancer.

BACKGROUND: This study reports our experience in the nonsurgical closure of perimembranous ventricular septal defects in children and adolescents with the Amplatzer asymmetric ventricular septal defect occluder and the outcome of an 18-month follow up. METHODS AND RESULTS: Twenty patients (median age:10 years; median weight:32 kg) with perimembranous ventricular septal defect were selected for transcatheter closure with the Amplatzer device. The prosthesis diameter chosen was 1-2 mm larger than the largest measured diameter of the defect on transesophageal echo (TEE). All patients were put on oral aspirin (5 mg/kg/day in children and 150 mg/day in adults) five days prior to and for six months after closure. Follow-up evaluation at 48 hr and 1, 6, 12 and 18 months included clinical examination, electrocardiogram, and a transthoracic echocardiogram. The mean defect diameter on color flow mapping on TEE was 7.1 +/- 2.3 mm. The device diameter ranged from 6-14 mm (median = 8 mm). One patient developed an anaphylactic reaction to contrast. The procedure was successful in 17 out of 19 patients where it was attempted (89.4%). In two patients with associated significant aortic valve prolapse and mild aortic regurgitation the device could not be successfully deployed. A trivial residual shunt observed during postdeployment left ventricular angiogram in 7 of 17 patients (41.2%) completely disappeared at one month follow-up. Three patients had right bundle branch block (2 complete and 1 incomplete) whereas one developed junctional escape rhythm with a right bundle branch block morphology. One patient had clinically silent thromboembolism to the left vertebral artery and another patient had hemolysis which resolved spontaneously within 48 hr. Follow-up at 13.5 +/- 5.3 months (range 1-18 months) revealed no residual shunt. The left ventricular internal dimension in diastole decreased significantly from 45 +/- 6 mm to 40 +/- 6 mm (P < 0.01) at the time of the last follow up. The baseline tricuspid regurgitation (n = 4) and aortic regurgitation (n = 3) remained unchanged during the follow up period. None of the patients developed left ventricular outflow tract obstruction or new aortic or tricuspid regurgitation. There were no other device related complications such as device migration, systemic thromboembolism, infective endocarditis, pericardial effusion or delayed conduction disturbances. CONCLUSIONS: In carefully selected children and young adults, the Amplatzer asymmetric ventricular septal defect occluder is a promising device for transcatheter closure of perimembranous ventricular septal defect with encouraging results on short term follow up.

BACKGROUND: The eradication rate of Helicobacter pylori with standard treatments are decreasing worldwide. AIM: To determine whether adding simvastatin as adjuvant to triple regimen in patients with H. pylori infection will improve the eradication rate. METHODS: We conducted a double-blind, placebo-controlled, randomised clinical trial comparing a 7-day, triple eradication regimen consisting of two antibiotics (clarithromycin 500 mg and amoxicillin 1 g, all twice per day) plus a proton pump inhibitor (omeprazole 20 mg twice daily) supplemented with simvastatin 20 mg (CAO + S) or a comparable placebo (CAO + P). Both the simvastatin and the placebo were taken orally twice daily for 1 week in 113 patients with H. pylori infection. The presence of H. pylori was determined by positive rapid urease test and histology. Eradication was confirmed by ¹³C-urea breath test at least 1 month after treatment. Adverse effects were assessed by questionnaire. RESULTS: A total of 113 patients underwent randomisation. Intention-to-treat analysis (ITT; n = 113) eradication rates were: CAO + S (86%; 95% CI: 78-92%), CAO + P (69%; 95% CI: 64-74%). Per protocol analysis (PP; n = 108) eradication rates were: CAO + S (91%; 95% CI: 84-94%), CAO + P (72%; 95% CI: 65-78%). Eradication rates were higher with CAO + S than CAO + P in PP and ITT (P = 0.03, P = 0.04 respectively). No differences were demonstrated between the two groups concerning compliance or adverse effects. CONCLUSION: In this randomised clinical trial simvastatin as adjuvant to standard therapy improves significantly the H. pylori eradication rate.

CONTEXT: Primary pulmonary neuroendocrine tumors are traditionally classified into 3 major types: typical carcinoid (TC), atypical carcinoid (AC), and large cell neuroendocrine carcinoma (LC) or small cell neuroendocrine carcinoma (SC). Confusion arises frequently regarding the malignant nature of TC and the morphologic differentiation between AC and LC or SC. OBJECTIVE: To provide clinicopathologic evidence to streamline and clarify the histomorphologic criteria for this group of tumors, emphasizing the prognostic implications. PATIENTS: To minimize variability in diagnostic criteria and treatment plans, we analyzed a group of patients whose diagnosis and treatment occurred at a single institution. We reviewed 234 cases of primary pulmonary neuroendocrine tumors and thoroughly studied 50 cases of resected tumors from 1986 to 1995. RESULTS: On the basis of morphologic characteristics and biologic behaviors of the tumors, we agree with many previous investigators that these tumors are all malignant and potentially aggressive. Based on our accumulated data, we have modified Gould criteria and reclassified these tumors into 5 types: (1) well-differentiated neuroendocrine carcinoma (otherwise called TC) (14 cases, with less than 1 mitosis per 10 high-power fields [HPF] with or without minimal necrosis); (2) moderately differentiated neuroendocrine carcinoma (otherwise called low-grade AC) (6 cases, with less than 10 mitoses per 10 HPF and necrosis evident at high magnification); (3) poorly differentiated neuroendocrine carcinoma (otherwise called high-grade AC) (10 cases, with more than 10 mitoses per 10 HPF and necrosis evident at low-power magnification); (4) undifferentiated LC (5 cases, with more than 30 mitoses per 10 HPF and marked necrosis); and (5) undifferentiated SC (15 cases, with more than 30 mitoses per 10 HPF and marked necrosis). The 5-year survival rates were 93%, 83%, 70%, 60%, and 40% for well, moderately, and poorly differentiated, and undifferentiated large cell and small cell neuroendocrine carcinomas, respectively. We found nodal metastasis in 28% of TC in this retrospective review, a figure higher than previously recorded. CONCLUSION: Using a grading system and terms comparable to those used for many years and used for neuroendocrine tumors elsewhere in the body, we found that classification of pulmonary neuroendocrine carcinomas as well, moderately, poorly differentiated, or undifferentiated provides prognostic information and avoids misleading terms and concepts. This facilitates communication between pathologists and clinicians and thereby improves diagnosis and management of the patient.

CT Manifestations of Late Sequelae in Patients with Tuberculous PleuritisJung-Ah Choi1, Ki Taek Hong1, Yu-Whan Oh1, Myung Hee Chung2, Hae Young Seol1 and Eun-Young Kang1Audio Available | Share

OBJECTIVE: The optimal vitamin D intake for nursing women is controversial. Deterioration, at least in bone mass, is reported during lactation. This study evaluated whether vitamin D supplementation during lactation enhances the maternal and infant's vitamin D status, bone mass and body composition. DESIGN AND METHODS: After term delivery, 174 healthy mothers were randomized to receive 1200 IU/d (800 IU/d+400 IU/d from multivitamins) or 400 IU/d (placebo+400 IU/d from multivitamins) of cholecalciferol for 6 months while breastfeeding. All infants received 400 IU/d of cholecalciferol. Serum 25-hydroxyvitamin D [25(OH)D], iPTH, calcium, urinary calcium, and densitometry were performed in mother-offspring pairs after delivery, and at 3 and 6 months later. RESULTS: A total of 137 (79%) (n = 70; 1200 IU/d, n = 67; 400 IU/d) completed the study. 25(OH)D was similar in both groups at baseline (13.7 ng/ml vs. 16.1 ng/ml; P = 0.09) and at 3 months (25.7 ng/ml vs. 24.5 ng/ml; P = 0.09), but appeared higher in the 1200 IU/d group at 6 months of supplementation (25.6 ng/ml vs. 23.1 ng/ml; P = 0.009). The prevalence of 25(OH)D <20 ng/ml was comparable between groups at baseline (71% vs. 64%, P = 0.36) but lower in the 1200 IU/d group after 3 months (9% vs. 25%, P = 0.009) and 6 months (14% vs. 30%, P = 0.03). Maternal and infants' iPTH, calciuria, bone mass and body composition as well as infants' 25(OH)D levels were not significantly different between groups during the study. Significant negative correlations were noted between maternal 25(OH)D and fat mass (R = -0.49, P = 0.00001), android fat mass (R = -0.53, P = 0.00001), and gynoid fat mass (R = -0.43, P = 0.00001) after 6 months of supplementation. CONCLUSIONS: Vitamin D supplementation at a dose of 400 IU/d was not sufficient to maintain 25(OH)D >20 ng/ml in nursing women, while 1200 IU/d appeared more effective, but had no effect on breastfed offspring vitamin D status, or changes in the bone mass and the body composition observed in both during breastfeeding. TRIAL REGISTRATION: ClinicalTrials.gov NCT01506557.