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Is a New Protocol for Acute Lymphoblastic Leukemia Research or Standard Therapy?

Is a New Protocol for Acute Lymphoblastic Leukemia Research or Standard Therapy?

international ALL studies. Pediatric oncologists considered the ALL-10 protocol to be the best available treatment. The ALL-10 protocol also contained a signi fi cant modi fi cation compared with previous ALL protocols. After initial treatment, patients in the ALL-10 protocol were assigned to 1 of 3 different risk groups based on minimal residual disease (MRD) levels. MRD level had been shown to be a strong prognostic factor, 2 but it had not yet been used in the Netherlands to tailor therapy to patients with different MRD levels. The modification in the ALL-10 protocol was that intensity of treatment was based on whether patients were thought to belong to the standard-risk (SR), medium-risk (MR), or high-risk (HR) group. Patients in the SR group would get less intensive treatment than they would have before using ALL-10. Those in MR and HR groups would get more intensive treatment. Because risk stratification with accompanying tailoring of therapy had not been done in previous protocols, the ALL-10 protocol might have been considered experimental.

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Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting

Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting

The diagnosis of cancer is a life-altering experience for anyone. Some cancer patients could have inevitable emo- tions that can interfere with medical care, family, diet, sleep, exercise. The more common diagnosed psychiatric conditions are depression, anxiety, adjustment disorders, delirium. Often, patients have mixed states or combina- tions of symptoms, such as depression and anxiety. Olan- zapine is an atypical antipsychotic drug, some studies have demonstrated the antidepressant efficacy of olanza- pine [16,17]. In this study, whether the use of olanzapine for five days could result in the improvement of QoL because of its antipsychotic effects, which need to further study for no relevant studies to be reported. But we observed olanzapine not only elevated the complete response for CINV, specially for the delayed nausea and vomiting but also improved the emotion, sleep, appetite of the cancer patients compared with the standard therapy regimen of antiemesis. Improvement of the cancer patients QoL during chemotherapy can make the patients more confidence for treatment which can make the patients complete the whole treatment. This will result in the improvement of the clinical efficacy.

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Evaluation of the role of HLA-DR antigens in Japanese type 1 autoimmune hepatitis

Evaluation of the role of HLA-DR antigens in Japanese type 1 autoimmune hepatitis

Of 132 AIH patients, 121 (92 %) were treated by pred- nisolone alone or in combination with an immunomod- ulator (azathioprine, cyclosporine, or tacrolimus). The remaining 11 patients were treated with ursodeoxycholic acid alone because of mild inflammatory activity [17]. Prednisolone alone and in combination with azathio- prine was defined as the “standard therapy.” The initial doses of prednisolone were 0.2–1.0 mg/kg except for 2 patients for whom methylprednisolone pulse therapy (1000 mg/day) was selected. Prednisolone doses were gradually decreased to maintenance doses of 10 mg/day or less. Azathioprine doses were adjusted to 0.5–1 mg/kg and maintained [2]. The other immunomodulators were used for patients who were resistant to the standard ther- apy or could not continue azathioprine use because of ad- verse reaction [2, 18, 19].

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Fibrosis: a key feature of Fabry disease with potential therapeutic implications

Fibrosis: a key feature of Fabry disease with potential therapeutic implications

The assessment of fibrosis has impact on management and on response to therapy. ERT is the standard therapy for Fabry disease. ERT partially cleared microvascular deposits of GL-3 from the heart, kidney and skin of most Fabry patients [46,84-86]. However, deposits in podocytes may persist for years in adults [6,17]. GL-3 clearance from the myocardium and kidney concurs with a decrease of LV mass and an improvement of re- gional myocardial function and stabilizes renal function if started early [6,34,74,87,88]. In contrast, ERT may be less effective in the presence of tissue fibrosis identified either by the presence of glomerulosclerosis in renal bi- opsy, by surrogate markers of kidney fibrosis such as proteinuria >1g/d or an eGFR< 45 ml/min or by evi- dence of replacement fibrosis in LV [5,6,70,71]. Thus even with ERT, the annual progression of LV replace- ment fibrosis is 0.7±0.7% in males and 0.2±0.3% in fe- males [89], emphasizing the need to understand the molecular mechanism and optimize anti-fibrotic therapy. This has two clinical implications: a) Before starting with ERT a baseline staging of the extent of fibrosis should be obtained in all patients for adjusting outcome expecta- tions. Disease stabilization is unlikely in the presence of fibrosis. b) Add-on therapies targeting fibrosis may be beneficial in patients with evidence of fibrosis. These add-on therapies are expected to be used in addition to ERT or to any other treatments aimed at correcting the metabolic defect that are developed, such as chaperones or substrate reducing therapy. Ideally clinical trials should address the safety and efficacy of these ap- proaches in Fabry disease. However, clinical trials of these add-on therapies are unlikely given the low fre- quency of the disease. Until we have clinical trial data, we have to rely on extrapolating concepts that have proven beneficial in other forms of CKD or cardiac fi- brosis. In addition, special attention should be paid to elucidating the mechanisms of generation and actions of suspected pro-fibrotic molecules such as lyso-Gb3 as well as in characterizing their receptors, since limiting their production or preventing their pro-fibrotic action might be beneficial in Fabry disease.

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Single-Agent Thalidomide for Treatment of Malignant Paraganglioma of the Organ of Zuckerkandl

Single-Agent Thalidomide for Treatment of Malignant Paraganglioma of the Organ of Zuckerkandl

Standard treatment for benign pheochromocytomas and paragangliomas is surgical resection. There is, however, no current definitive curative or standard therapy for malignant pheochromocytomas or paragangliomas partly due to the rarity of these tumors. Current therapeutic options include attempts at surgical resection; chemotherapy consisting of cyclophosphamide, vincristine, and dacarbazine (CVD); MIBG-radiotherapy; somatostatin analogues; and new an- tineoplastic therapies including temozolomide and thalid- omide [2–5]. These treatments are aimed primarily at palliation and symptom control as there has been no sta- tistically significant survival benefit with any of these therapies although some patients demonstrate short-lived responses.

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Impact of data from recent clinical trials on strategies for treating patients with type 2 diabetes mellitus

Impact of data from recent clinical trials on strategies for treating patients with type 2 diabetes mellitus

The results from these randomized clinical trials showed improved glycemic control (as measured by HbA 1c ) with a significant difference demonstrated between the intensive antidiabetes therapy and the standard therapy groups. Blood pressure and serum lipid levels improved with appropriate administration of antihypertensive and dyslipidemia treat- ments with the antidiabetes therapies. While weight gain was noted in ACCORD and VADT in the intensive antidiabetes therapy group compared with the standard therapy group, there was weight loss in both treatment groups in ADVANCE, with the greater loss occurring in the standard therapy group ( − 1 kg) versus the intensive therapy group ( − 0.1 kg). Further, ACCORD and ADVANCE were secondary prevention trials for CVD in patients with type 2 diabetes and CVD and/or high risk for CVD, while the VADT study was a primary prevention trial for CVD in veterans with type 2 diabetes.

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Evaluation of Safety and Efficacy of Collagen Peptide as an Add on Therapy to Standard Treatment in Comparison with the Standard Treatment alone in the Management of Patients with Knee Joint Osteoarthritis

Evaluation of Safety and Efficacy of Collagen Peptide as an Add on Therapy to Standard Treatment in Comparison with the Standard Treatment alone in the Management of Patients with Knee Joint Osteoarthritis

This was an open label, comparative, randomized, prospective study. This study included 60 patients with osteoarthritis, who wererandomized into two groups of 30 each. Control group received standard therapy (T.Diclofenac 100mg/day,T.Ranitidine 150mg twice daily and physiotherapy) and Study group received collagen peptide (10g/day) in addition to standard therapy for a period of 12 weeks. They were followed-up once in 2weeks for 12weeks.Pain, stiffness and functional disability were assessed using visual analogue pain scale(VAS) and WOMAC index at baseline and at the end of the study.

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Physiological dose steroid therapy in sepsis [ISRCTN36253388]

Physiological dose steroid therapy in sepsis [ISRCTN36253388]

Patients enrolled in the study were treated with standard therapy used in the treatment of sepsis and septic shock. This therapy could include the following: administration of antibi- otics, fluid replacement, vasoactive drugs, mechanical ventila- tory support, and any other form of supportive therapy deemed necessary by the primary physicians. Soon after the presump- tive diagnosis of severe sepsis, initial laboratory specimens were obtained and within 2 hours the patients were random- ized to treatment with prednisolone or placebo groups. The treatment groups were determined by a computer-generated randomization procedure. The steroid therapy group received prednisolone at a physiological dose. Prednisolone was given intravenously at 06.00 (5 mg) and 18.00 (2.5 mg) for 10 days. The standard therapy group received a placebo infusion con- taining physiological saline solution in an identical manner. Patients and their primary physicians were blinded as to which therapy was administered.

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The influence of probiotic supplementation in the standard therapy were reassessed after 7 day of therapy. The reassessment included vaginal se- cret examination, Sniff test, vaginal pH examination and the examination for the presence of clue cells. The statistical analysis towards all criteria after therapy showed that there was no significant dif- ference in both groups. There was no difference either in the overall recovery of subjects in both groups.

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Clinicopathologic features and treatment efficacy of Chinese patients with BRAF-mutated metastatic colorectal cancer: a retrospective observational study

Clinicopathologic features and treatment efficacy of Chinese patients with BRAF-mutated metastatic colorectal cancer: a retrospective observational study

anti-EGFR antibody panitumumab was 3.2  months and median OS was 7.6 months. Even a doublet cytotoxic reg- imen offered modest clinical activity against this highly aggressive and chemoresistant subset of CRC. To date, no effective strategies have been developed to counteract the aggressiveness of BRAF-mutated tumors. Our data sug- gest that a FOLFOXIR regimen may be effective in such cases. The FOLFOXIRI regimen prolonged PFS and OS, although these outcomes were less favorable than those Fig. 2 Kaplan–Meier estimates of the survival of standard therapy group (treated with cytotoxic doublets with or without bevacizumab regimen) and intensive therapy group (treated with modified FOLFOXIRI [luorouracil, leucovorin, oxaliplatin, and irinotecan] regimen) among mCRC patients with BRAF V600E mutation. mPFS median progression-free survival, mOS median overall survival

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Cost-effectiveness of clostridial collagenase ointment on wound closure in patients with diabetic foot ulcers: economic analysis of results from a multicenter, randomized, open-label trial

Cost-effectiveness of clostridial collagenase ointment on wound closure in patients with diabetic foot ulcers: economic analysis of results from a multicenter, randomized, open-label trial

Patients in the CCO + SSD group had CCO applied once daily, approximately 2 mm thick, to the foot ulcer. The wound was gently covered with an Allevyn® nonadhe- sive dressing (Smith & Nephew, Hull, United Kingdom), which was maintained in place with a secondary bandage (Coban®, 3 M, St. Paul, Minnesota). Patients in the Control group were treated with DFU standard treatments based on the investigators’ clinical preferences. Investigator- selected treatment regimens were allowed in order to emulate ‘real-world’ clinician practice patterns and pre- ferences. These treatments included wet-to-dry dressings (n = 5), hydrogel (n = 1), silver dressing (n = 12), silver sulfadiazine cream (n = 5), or alginate dressing (n = 4), in addition to SSD. Silvercel® (Systagenix Wound Manage- ment, Gargrave, United Kingdom) was the primary silver dressing used by investigators in the clinic and was used as the reference price (in the cost analysis) for silver dress- ings. Hyperbaric or negative pressure therapy was not allowed. At the investigator’s discretion, a hydrogel could be used if deemed necessary to maintain a moist wound environment. Wound area was measured at each study visit using the Applied Research Associated New Zealand Ltd (ARANZ) Silhouette™ digital image capture and wound measurement device (ARANZ Medical, Christchurch, NZ). All patients received SSD commencing with the Week 1 visit. Patients in both groups received SSD of the target ulcer at each of the scheduled study visits (Weeks 2 through 12) if any of the relevant subscales (Edges, Undermining, Necrotic Tissue Type, or Necrotic Tissue Amount) of the Wound Assessment Tool were ≥ 3. If the relevant subscales were all ≤ 2, then SSD was not performed. The Wound Assessment Tool is a modifica- tion of the Bates-Jensen tool [30] and provides a standard- ized, numerical score consisting of 8 subscales in the assessment of the health and overall condition of the wound. Although this was an open-label study, allocation to intervention group was determined using a blinded (or centralized) randomization sequence to prevent potential bias resulting from subjectivity in allocation to treatment (i.e. allocation concealment).

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Sequential therapy versus standard triple therapy in Helicobacter pylori eradication

Sequential therapy versus standard triple therapy in Helicobacter pylori eradication

The diseases include Iron deficiency anemia, Coronary artery disease, Cerebrovascular disease, Hypertension, Raynaud’s phenomena, Migraine headaches, Vomiting of pregnancy, Immune thrombocytopenic purpura, Hyperammonemia, Sudden infant death syndrome, Growth retardation, Anorexia of aging, Rosacea and Chronic urticaria. Diagnoses of H. pylori may be divided into that do (Biopsy based tests) and that do not require sampling of gastric mucosa (non-invasive tests). In biopsy based tests at least three samples (e.g. from the lesser curvature angularis, the greater curve pre-pyloric antrum, and the greater curve body) are taken. The standard hematoxylin and eosin (H&E) stain is excellent to determine histological chronic or chronic active inflammation (gastritis) and demonstrates H. pylori if large number of organisms are present. A special stain (e.g. silver stain) is better at detecting the organism if small numbers of bacteria are present. Attributes of both H&E and a special stain are found in the genta and El-Zimaity ‘triple’ stains, which combine the H&E stain, H. pylori selective stains, and alcian blue to detect intestinal metaplasia (Gents, 1994). The alternative is to use two different stains, a combination of an H&E and a Diff-Quik stain is probably the best alternative (El-Zimaity et al.,1998). Rapid urease test is a rapid test for diagnosis of H. pylori. The basis of the test is the ability of H. pylori to secrete the urease enzyme, which catalyzes the conversion of urea to ammonia and bicarbonate. The test is performed at the time of gastroscopy. A biopsy of mucosa is taken from the antrum of the stomach, and is placed into a medium containing urea and an indicator such as phenol red. The urease produced by H. pylori hydrolyzes urea to ammonia, which raises the pH

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Cost-Effectiveness Of Bevacizumab Concomitant With The Standard Of Therapy For Newly Diagnosed Glioblastoma

Cost-Effectiveness Of Bevacizumab Concomitant With The Standard Of Therapy For Newly Diagnosed Glioblastoma

Glioblastoma Multiforme (GBM), a glioma – cancer of the brain’s glial cells – is the most common and deadly malignant primary central nervous system tumor in developed countries. Two recently completed clinical trials investigating the use of bevacizumab (BEV), a monoclonal antibody, to treat newly diagnosed GBM concomitant with the standard-of-care (SOC) showed mixed survival and quality of life outcomes. In this study, a cost utility study was conducted to investigate if BEV should be used to treat newly diagnosed GBM. A three stage time-dependent Markov model was built using survival estimates from the two clinical trials, costs from Ontario residents diagnosed with GBM between 2003 and 2011, and literature utility values. The expected

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A review of standard pharmacological therapy for adult asthma   Steps 1 to 5

A review of standard pharmacological therapy for adult asthma Steps 1 to 5

A trial in people poorly controlled on moderate-to-high dose ICS plus LABA therapy has suggested that the addition of the long-acting muscarinic antagonist tiotropium (via soft mist inhaler) reduces the risk of a severe exacerbation by 21% compared to placebo. 72 Participants in this trial had persistent airflow limitation, though potentially eligible participants using maintenance oral corticosteroids at more than 5 mg/day were excluded. 72 Tiotropium has recently become approved for maintenance asthma treatment in Europe. In the UK, a therapeutic trial can be considered in people on medium-to-high dose (≥800µg/day of budesonide or equivalent) ICS/LABA with at

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Adverse clinical outcomes associated with double dose clopidogrel compared to the other antiplatelet regimens in patients with coronary artery disease: a systematic review and meta-analysis

Adverse clinical outcomes associated with double dose clopidogrel compared to the other antiplatelet regimens in patients with coronary artery disease: a systematic review and meta-analysis

Background: Recently, several newer antiplatelet treatment strategies have been used in patients with coronary artery disease (CAD). Apart from the dual antiplatelet therapy (DAPT) consisting of aspirin and clopidogrel, double dose clopidogrel (DDC), triple antiplatelet therapy (TAPT) consisting of aspirin, clopidogrel and cilostazol and other newer antiplatelet agents have shown to be effective in different ways. In this analysis, we aimed to systematically compare the adverse clinical outcomes and the bleeding events which were observed when DDC was compared to the other antiplatelet regimens in patients with CAD.

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Steroid-resistant nephrotic syndrome: past and current perspectives

Steroid-resistant nephrotic syndrome: past and current perspectives

Kidney transplantation is the most ideal renal replacement therapy for children with SRNS. Children with SRNS run the risk of recurrence of nephrotic syndrome following transplantation. Recurrence of nephrotic syndrome, if not controlled, can cause delayed graft function, acute rejection, and diminished allograft survival. The majority of informa- tion regarding posttransplant outcomes comes from pediatric patients with FSGS, the most common histopathologic find- ing in patients with SRNS. The risk of recurrence of FSGS posttransplant is ~ 30%. 19 Risk factors for recurrence of

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Negative Pressure Wound Therapy (NPWT) in Breast Surgery

Negative Pressure Wound Therapy (NPWT) in Breast Surgery

was treated for a recurrent primary breast abscess. 12 of the 15 cancer patients underwent mastectomy had subse- quent breast reconstruction procedures. Seven wounds were related to implant or tissue expander placement. Four patients had complicated transverse rectus abdominus myocutaneous (TRAM) flap wounds, and one had a latissimus dorsi flap wound. 15 of 18 patients were treated e ff ectively using NPWT. Two patients required muscle flap coverage. The hospital stay ranged from 3 to 54 days with a mean of 12.1 days. NPWT dressing has been used to promote wound healing after skin grafting, or as a mean to prepare the wound for surgical closure. Seven of the wounds healed by secondary intention, six were successfully treated with subsequent skin grafting, and two were treated with delayed primary closure. Two wounds were both complicated by tissue ischemia and infection requiring operative debridement (Tab. I). The authors concluded that vacuum-assisted closure therapy promotes faster healing and stimulates the formation of healthy granulation tissue. 8

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POTENTIAL BENEFIT OF CURCUMIN ADJUVANT THERAPY TO THE STANDARD H  PYLORI ERADICATION THERAPY IN PATIENTS WITH PEPTIC ULCER DISEASE

POTENTIAL BENEFIT OF CURCUMIN ADJUVANT THERAPY TO THE STANDARD H PYLORI ERADICATION THERAPY IN PATIENTS WITH PEPTIC ULCER DISEASE

In the present study, the healing efficacy of peptic ulcer was increased from (57.89%) with slandered triple therapy alone up to (89.47%) after addition of curcumin adjuvant therapy. The therapeutic potential of curcumin as a monotherapy against H. pylori infection was elegantly studied and reviewed previously by many researchers [5,22,41,42], meanwhile Di Mario et al . stated that administration of 7 days curcumin 30 mg b.i.d, bovine lactoferrin 100 mg b.i.d, N-acetylcysteine 600 mg b.i.d, and pantoprazole 20 mg b.i.d produce only (12%) cure of dyspeptic patients infected with H. pylori , nevertheless, a significant reduction in severity of overall symptoms after 2 months was noticed [43].

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Evolutionary cognitive therapy versus standard cognitive therapy for depression: a protocol for a blinded, randomized, superiority clinical trial

Evolutionary cognitive therapy versus standard cognitive therapy for depression: a protocol for a blinded, randomized, superiority clinical trial

The study has been approved by the ethics commission at Babes-Bolyai University. As with any study on depres- sion, there are ethical concerns that need to be addressed. First, the exclusionary criteria exclude people who pose an imminent danger to themselves or others. These people will be immediately referred to the appropriate services dealing with such cases. Second, if a patient’ s condition worsens during the therapy, the supervising clinical psych- ologist can opt to terminate the treatment ahead of sched- ule and make an appropriate referral. Third, people with mental conditions other than depression are also ex- cluded, and will be referred to the services best suited to dealing with their problems.

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Insights into the pathogenesis of Langerhans cell histiocytosis: the development of targeted therapies

Insights into the pathogenesis of Langerhans cell histiocytosis: the development of targeted therapies

In the LCH-III (2001–2008) study, patients with MS- LCH were divided into two groups (low-risk and risk) depending on the risk of mortality. In the low-risk group, the value of the continuation therapy (6 vs 12 months) was studied with respect to reactivation rate and sequelae. In the risk group, the value of the addition of intermediate-dose methotrexate to the standard combination of PRED and VBL was studied with respect to early response and mortality. A second 6-week course of initial therapy was delivered in patients without optimal response in both groups. The final results of the risk group trial did not prove superiority of the experimental arm with respect to initial response, overall and reactivation-free survival, and toxicity. In the low-risk group, prolongation of the treatment duration resulted in a reduced risk of reactivation (0.50 in the 6-month vs 0.35 in the 12-month arm). 62 Overall, the LCH-III study concluded

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