bluuebunny/crossref_metadata_2025_split huggingface dataset:
A Prospective Observational Study on Effect of Short-Term Periodic Steroid Premedication on Bone Metabolism in Gastrointestinal Cancer (ESPRESSO-01)
Authors: Nakamura Michio , Ishiguro Atsushi , Muranaka Tetsuhito , Fukushima Hiraku , Yuki Satoshi , Ono Kota , Murai Taichi , Matsuda Chika , Oba Ayane , Itaya Kazufumi , Sone Takayuki , Yagisawa Masataka , Koike Yuta , Endo Ayana , Tsukuda Yoko , Ono Yuji , Kudo Takahiko , Nagasaka Atsushi , Nishikawa Shuji , Komatsu Yoshito 
Published: March 2017

Abstract

Background
A multicenter prospective observational study evaluated the effect of gastrointestinal cancer chemotherapy with short-term periodic steroid premedication on bone metabolism.

Patients and Methods
Seventy-four patients undergoing chemotherapy for gastrointestinal cancer were studied. The primary endpoints were changes in bone mineral densities (BMDs) and metabolic bone turnover 16 weeks after initiation of chemotherapy. BMDs, measured by dual-energy x-ray absorptiometry, and serum cross-linked N-telopeptides of type I collagen (sNTX), and bone alkaline phosphatase (sBAP) were assessed for evaluation of bone resorption and formation, respectively.

Results
In 74.3% (55/74) of the patients, BMDs were significantly reduced at 16 weeks relative to baseline. The percent changes of BMD were −1.89% (95% confidence interval [CI], −2.67% to −1.11%: p &lt; .0001) in the lumbar spine, −2.24% (95% CI, −3.59% to −0.89%: p = .002) in the total hip, and −2.05% (95% CI, −3.11% to −0.99%: p &lt; .0001) in the femoral neck. Although there was no significant difference in sNTX levels during 16 weeks (p = .136), there was a significant increase in sBAP levels (p = .010). Decreased BMD was significantly linked to number of chemotherapy cycles (p = .02). There were no significant correlations between changes in BMDs and the primary site of malignancy, chemotherapy regimens, total cumulative steroid dose, steroid dose intensity, and additive steroid usage.

Conclusion
Gastrointestinal cancer chemotherapy with periodic glucocorticoid premedication was associated with reduced BMD and increased sBAP levels, which were linked to number of chemotherapy cycles but independent of primary site, chemotherapy regimen, duration, and additive steroid usage.
Cardiac Safety of Dual Anti-HER2 Therapy in the Neoadjuvant Setting for Treatment of HER2-Positive Breast Cancer
Authors: Yu Anthony F. , Singh Jasmeet C. , Wang Rui , Liu Jennifer E. , Eaton Anne , Oeffinger Kevin C. , Steingart Richard M. , Hudis Clifford A. , Dang Chau T. 
Published: March 2017

Abstract

Background
Trastuzumab and pertuzumab are approved for the neoadjuvant treatment of human epidermal growth receptor 2 (HER2)-positive breast cancer, but cardiac safety data is limited. We report the cardiac safety of dose-dense doxorubicin and cyclophosphamide (AC) followed by paclitaxel, trastuzumab, and pertuzumab (THP) in the neoadjuvant setting followed by adjuvant trastuzumab-based therapy.

Methods
Fifty-seven patients treated with neoadjuvant dose-dense AC-THP followed by adjuvant trastuzumab-based therapy between September 1, 2013, and March 1, 2015, were identified. The primary outcome was cardiac event rate, defined by heart failure (New York Heart Association [NYHA] class III/IV) or cardiac death. Patients underwent left ventricular ejection fraction (LVEF) monitoring at baseline, after AC, and serially during 1 year of anti-HER2 therapy.

Results
The median age was 46 years (range 26–68). Two (3.5%) patients developed NYHA class III/IV heart failure 5 and 9 months after initiation of trastuzumab-based therapy, leading to permanent discontinuation of anti-HER2 treatment. Seven (12.3%) patients developed a significant LVEF decline (without NYHA class III/IV symptoms). The median LVEF was 65% (range 55%–75%) at baseline and 64% (range 53%–72%) after AC, and decreased to 60% (range 35%–70%), 60% (range 23%–73%), 61% (range 25%–73%), and 58% (range 28%–66%) after 3, 6, 9, and 12 months (± 6 weeks) of trastuzumab-based therapy.

Conclusion
The incidence of NYHA class III/IV heart failure after neoadjuvant AC-THP (followed by adjuvant trastuzumab-based therapy) is comparable to rates reported in trials of sequential doxorubicin and trastuzumab. Our findings do not suggest an increased risk of cardiotoxicity from trastuzumab plus pertuzumab following a doxorubicin-based regimen.
A Phase Ib Study of Sorafenib (BAY 43-9006) in Patients with Kaposi Sarcoma
Authors: Uldrick Thomas S. , Gonçalves Priscila H. , Wyvill Kathleen M. , Peer Cody J. , Bernstein Wendy , Aleman Karen , Polizzotto Mark N. , Venzon David , Steinberg Seth M. , Marshall Vickie , Whitby Denise , Little Richard F. , Wright John J. , Rudek Michelle A. , Figg William D. , Yarchoan Robert 
Published: March 2017

Abstract

Lessons Learned
Oral targeted agents are desirable for treatment of Kaposi sarcoma (KS); however, in patients with HIV, drug–drug interactions must be considered. In this study to treat KS, sorafenib was poorly tolerated at doses less than those approved by the U.S. Food and Drug Administration for hepatocellular carcinoma and other cancers, and showed only modest activity. Sorafenib's metabolism occurs via the CYP3A4 pathway, which is inhibited by ritonavir, a commonly used antiretroviral agent used by most patients in this study. Strong CYP3A4 inhibition by ritonavir may contribute to the observed sorafenib toxicity. Alternate antiretroviral agents without predicted interactions are preferred for co-administration in patients with HIV and cancers for which sorafenib is indicated.

Background
We conducted a phase Ib study of sorafenib, a vascular epithelial growth factor receptor (VEGFR), c-kit, and platelet derived growth factor receptor (PDGFR)-targeted treatment in Kaposi sarcoma (KS). We evaluated drug–drug interactions between sorafenib and ritonavir, an HIV medication with strong CYP3A4 inhibitory activity.

Methods
Two cohorts were enrolled: HIV-related KS on ritonavir (Cohort R) and HIV-related or classical KS not receiving ritonavir (Cohort NR). Sorafenib dose level 1 in cohort R (R1) was 200 mg daily and 200 mg every 12 hours in cohort NR (NR1). Steady-state pharmacokinetics were evaluated at cycle 1, day 8. KS responses and correlative factors were assessed.

Results
Ten patients (nine HIV+) were enrolled: R1 (eight), NR1 (two). Median CD4+ count (HIV+) was 500 cells/µL. Dose-limiting toxicities (DLTs) were grade 3 elevated lipase (R1), grade 4 thrombocytopenia (R1), and grade 3 hand-foot syndrome (NR1). Two of seven evaluable patients had a partial response (PR; 29%; 95% CI 4%–71%). Steady-state area under the curve of the dosing interval (AUCTAU) of sorafenib was not significantly affected by ritonavir; however, a trend for decreased AUCTAU of the CYP3A4 metabolite sorafenib-N-oxide (3.8-fold decrease; p = .08) suggests other metabolites may be increased.

Conclusion
Sorafenib was poorly tolerated, and anti-KS activity was modest. Strong CYP3A4 inhibitors may contribute to sorafenib toxicity, and ritonavir has previously been shown to be a CYP3A4 inhibitor. Alternate antiretroviral agents without predicted interactions should be used when possible for concurrent administration with sorafenib.
A study to assess awareness amongst pregnant women about the effects of drugs on the fetus and self-medication
Authors: Banzal Neeta , Saxena Kirti , Dalal Malti , Srivastava S. K. 
Published: March 2017

Background: The present study was conducted with an objective to assess the awareness of drug use in pregnancy, to assess the knowledge of pregnant women on effect of drugs on foetus and to assess the self-medication among pregnant women.Methods: This was a prospective, observational, cross-sectional study conducted on randomly selected 200 pregnant women attending a tertiary care hospital in Surat, Gujarat, India. Data was collected by means of a pre-designed semi-structured questionnaire composed of 26 questions on self-medication during pregnancy and knowledge about that. The data was collected by interview technique in which each participant was asked questions in the language of her understanding in a separate room.Results: The average age of the participants was 23.7±3.68 years. About 91% were not aware about the effect of medication on the health of foetus and did not even enquire about it. At the time of survey, 74% pregnant women were on some kind of medication. More than 80% were not aware about the duration of medication. About 51% were taking medication on regular basis. The proportion of self-medication among pregnant women was 8.5% (includes 5.5% by themselves and 3% by advice of chemists).Conclusions: There is a lack of awareness amongst the pregnant women regarding the effect of the drugs on the health of foetus. More than half of the women take medication on regular basis. However, low proportion of self-medication during pregnancy suggests that during pregnancy women preferred to take advise of physician for medication rather than taking self-medication.
Monitoring of adverse drug reactions to antidepressant drugs in a teaching hospital
Authors: Munoli Swetha , Patil Soumya B. 
Published: March 2017

Background: Adverse drug reactions (ADRs) are considered among the leading causes of morbidity and mortality. Adverse drug reactions are important determinants of non-adherence to antidepressant treatment, but their assessment is complicated by overlap with depressive symptoms and lack of reliable self-report measures The present study was therefore undertaken to monitor the ADRs of the antidepressant in the psychiatric outpatient unit of Raichur Institute of Medical Sciences, Raichur, Karnataka, IndiaMethods: Study was conducted from December 2012 to November 2013, the patients on antidepressant drugs from psychiatry out- patient department (OPD) of Raichur Institute of Medical Sciences were considered for analysis. The patients were diagnosed by consultant psychiatrist. Data was collected in standard questionnaire format. All patients diagnosed with psychiatric disorder as per ICD 10 criteria and receiving treatment with antidepressant were included. Assessment of causality and severity of recorded adverse events was done using WHO assessment scale and modified Siegel and Hartwig Scale respectively.Results: In our study 74 adverse drug reactions(ADRs) were seen among 52 cases, total 263 cases were screened.CNS and Anticholinergic side effects were most common adverse drug reactions noted. Tricyclic antidepressants (TCA) and Selective serotonin reuptake inhibitors (SSRIs) were the drugs causing maximum ADRs. Assessment of causality and severity of recorded adverse events showed possible to probable and mild to moderate severity respectively.Conclusions: CNS and Anticholinergic side effects were most common adverse drug reactions noted. Tricyclic antidepressants (TCA) were most commonly prescribed drugs followed by Selective serotonin reuptake inhibitors (SSRIs). Tricyclic antidepressants (TCA) and Selective serotonin reuptake inhibitors (SSRIs) accounted for most of ADRs (87.8%). Assessment of causality of recorded adverse events showed no certain cause and assessment of severity of recorded adverse events showed no severe cases.
Isoniazid induced acute generalised exanthematous pustulosis
Authors: Ahire Niteen S. , Dudhagaonkar Sujata , Harle Krishna , Rakhunde Sharad 
Published: March 2017

Tuberculosis (TB) poses major health problem in developing countries including India. According to WHO in 2010 survey, there were about 9.4 million active pulmonary TB Patients worldwide, out of that 2.3 million case were found in India. Isoniazid is known to be the least toxic among the first line antitubercular drugs. Hypersensitivity reactions due to Isoniazid may present in the form of fever and skin rash. We hereby report a case of acute generalised exanthematous pustulosis due to isoniazid in a patient on anti-tubercular treatment. We also established the causality, severity, and preventability of the suspected adverse drug reactions (ADRs).
Recent trends in management of haemorrhoids
Authors: Ali S. Asif , Shoeb Mohammad Fazelul Rahman 
Published: March 2017

Background: Haemorrhoids are common clinical conditions. Their treatment is one of the most challenging situations in the field of general surgery. In this study, we compared and evaluated the results and postoperative complications of Lords dilatation procedure and haemorrhoidectomy.Methods: The study evaluates comparative results of Lords dilatation procedure and haemorrhoidectomy. This study was conducted over a period of 1 year from January 1984 to December 1984. It includes 40 patients with haemorrhoids who attended surgical OPD of Krishnarajendra Hospital, Mysore. These 40 patients were selected randomly and divided into two groups of 20 patients each (Lords dilatation group and haemorrhoidectomy group). All parameters including clinical, physical and baseline investigations for all patients were recorded and finally analysed.Results: The age of the patients ranged from 20-70 years. Male preponderance was observed (7:1). The commonest symptoms were mass per rectum (90% and 85%) and bleeding P/R (85%), pain during defecation (85% and 70%) in Lords dilatation and haemorrhoidectomy groups respectively. Protoscopic examination revealed the presence of grade II haemorrhoids in most of the patients in both the groups, 45% and 65% respectively. Postoperative complications including pain, sphincter incontinence, bleeding and urinary retention is high in haemorrhoidectomy group as compared to Lords dilatation group. Recurrence of haemorrhoids (5%) and fecal incontinence (5%) was observed in Lords dilatation group after 6 months of treatment.Conclusions: Haemorrhoidectomy for treatment of hemorrhoids offers the best immediate and long term results compared to Lords dilatation.
Hyperbilirubinemia as a predictor of the severity of acute appendicitis - an observational study
Authors: Cheekuri Sadhan Kumar , Mohanty Alok , Ganesh T. , Kannan R. , Smile Robinson 
Published: March 2017

Background: Appendicitis is the most common acute abdominal condition requiring emergency surgery, with a lifetime risk of 6%. Appendectomy continues to be one of the commonest procedures in general surgery, accounts for approximately 1% of all surgical operation. Despite the increased use of ultrasonography, computed tomography scanning and laparoscopy, the rate of misdiagnosis of appendicitis has remained constant (15.3%). The aim of this study was to whether Serum Bilirubin can be considered as a new laboratory marker to aid in the diagnosis of acute appendicitis and if so, does it have the predictive capacity to warn us about complicated appendicitis.Methods: This was prospective observational study done in Mahatma Gandhi Medical College and Research Institute, Pondicherry between November 2014 and August 2016. About 110 patients of acute appendicitis who had undergone appendicectomy were studied. Data was collected and analyzed critically.Results: Males 66 (60%) outnumbered females 44 (40%) and overall mean age was 26.61±12.37 years. Of the 110 patients, 9% were normal appendix, 59.09% were confirmed as acute appendicitis while 31.81% were diagnosed with complicated appendicitis on biopsy. The Sensitivity and Specificity of serum bilirubin as a marker in predicting Acute appendicitis and complicated appendicitis was 47.6% and 90.9% respectively. Similarly, the Positive predicative value and Negative predicative value for the same was 88.5% and 61.5% respectively with odds ratio 12.4 with significant p value <0.0001.Conclusions: Serum bilirubin is easily available test and cheap and can be estimated from the sample of blood drawn for routine blood investigations. Patients with clinical signs and symptoms of appendicitis and with hyperbilirubinemia should be identified as having a higher probability of complicated appendicitis. Hence, serum bilirubin levels have a predictive potential for the diagnosis of severity of acute appendicitis and need for early appendicectomy. If total serum bilirubin is added to already existing laboratory tests, then the diagnosis of complicated appendicitis in clinically suspected cases can be made with fair degree of accuracy, the need for CECT and MRI can be reduced and unnecessary delay in appendicectomy can be avoided.
A study of surgical profile of patients undergoing appendectomy
Authors: Dhruv Kamlesh , Meshram Sunita , Agrawal Sujan Narayan 
Published: March 2017

Background: The most common cause of acute abdomen in surgical is appendicitis. Among the surgeries of abdomen performed all over the world, appendectomy is the most common operation performed. Many studies have shown variations of age, gender in acute appendicitis as well as the seasonal variations in the occurrence of acute appendicitis, although the cause is not found yet. Objective was to study the surgical profile of patients undergoing appendectomy.Methods: A total of 302 patients who have undergone appendectomy were included in the present study which was hospital based cross sectional study. The study was carried out for two years at Osmania General Hospital, Hyderabad, India. Permission from Institutional Ethics Committee permission was obtained. From each and every patient included in the study, initially Informed individual consent was taken.Results: The incidence of appendicitis is much more in females i.e. 60% compared to only 40% in males. Appendicitis was most common in younger age groups of below 30 years of age. As the age increased the incidence of appendicitis decreased. From 83.2% at 30 or less than 30 of age it drastically dropped down to 15.9% in the age group of 30-49 years and in the age group of 50 and above, the incidence of appendicitis came down to less than one percentage. Only three cases were recorded above the age of 50 years.Conclusions: Present study revealed more rates in females. The disease was more common in younger age groups. The most common presenting symptom was abdominal pain. Presence of abdominal mass was absent in the present study.
Sutureless versus conventional thyroidectomy
Authors: Mohamed Wael Barakaat Ahmed , Ahmed Ahmed Eisa 
Published: March 2017

Background: The thyroid gland is a highly-vascularized organ, prompt and effective hemostasis is a crucial part of the procedure. Nowadays with the major advent of energy devices such as ultrasonic coagulation (Harmonic Scalpel, Ethicon) and bipolar energy (LigaSure, Valleylab) for cutting and hemostasis introducing new methods of vessel ligation and division without increasing the risk of postoperative complications. The aim of this study was to compare the outcome of the use of the Harmonic® FOCUS and conventional suture ligation technique in a prospective comparative study of open total thyroidectomy.Methods: This was prospective comparative study at Sohag University Hospital, Sohag, Egypt. Patients were divided into two groups, the first group included patients who had the Harmonic® FOCUS thyroidectomy group or Sutureless thyroidectomy (S group), and the second group included patients who received Conventional thyroidectomy group (C group).Results: Between September 2014 and September 2016, 69 patients, with thyroid disease were enrolled in this study. 34 patients (49.3%) had a Sutureless total thyroidectomy and 35 patients (50.7%) had a conventional total thyroidectomy, the mean age for Sutureless thyroidectomy was39.85±8.47 years and for conventional group was 43.17±9.69 years. the operative time, intraoperative blood loss, postoperative, drainage volume, transient hypocalcaemia, overall postoperative complications and hospital stay were significantly lower in Sutureless thyroidectomy group. no significant difference between both group as regard recurrent laryngeal nerve function.Conclusions: Sutureless thyroidectomy is the procedure of choice for treatment of thyroid diseases as it had shorter operative time, reduction of overall complications rate and good function results.
Possible mechanisms of development of carcinoma of breast in patients with early-onset cataract
Authors: Singh Kaushal Deep , Faridi Shahbaz Habib , Lodhi Mehershree 
Published: March 2017

Background: A nation-wide population based retrospective cohort study from Taiwan in 2014 suggested a propensity of developing breast cancer in young females with early-onset cataract. One such patient presented to us who was a young non-obese female with a large lump in the right breast with skin nodules and bilateral painless progressive diminution of vision. Patient was diagnosed as locally advanced carcinoma of right breast with axillary metastasis (stage IIIB) and bilateral early-onset nuclear cataract. Mechanism of this possible association has never been described.Methods: A comprehensive online English literature search was done using various electronic search databases. Different search terms related to pathogenesis of carcinoma breast and cataract, and their possible association, were used. An advanced search was further conducted by combining all the search fields in abstracts, keywords, and titles.Results: We summarized the data from the searched articles and found that there are certain biochemical pathways and genetic associations that link cancer to cataract. We identified four specific links between carcinoma breast and cataract (in some cases even early-onset cataract). The four mechanisms which explained this possible association included metabolic syndrome, action of reactive oxygen species, genetic polymorphisms and environmental factors.Conclusions: The evidence linking early-onset cataract with cancer is relatively new so possible mechanisms of development of breast cancer in patients with early-onset cataract needs to be elucidated. These plausible connections can further help to take up large scale molecular, biochemical, epidemiological and clinical studies to investigate this association in terms of cause-effect relationship. The impact this association can have, on understanding cataract and cancer pathogenesis; and its potential in reducing cancer incidence in patients with EOC, can be profound.