Efficacy and Safety of Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone in Patients With Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Phase 1 and Randomized Phase 2 Trial.

Importance: ERBB2 (HER2)-targeted therapy provides benefits in metastatic breast cancer (mBC) and gastric cancer, but additional treatments are needed to maximize efficacy and quality of life.

Objective: To determine maximum tolerated doses (MTDs) of trastuzumab emtansine (T-DM1) plus capecitabine in patients with previously treated ERBB2-positive mBC and locally advanced/metastatic gastric cancer (LA/mGC) (phase 1) and the efficacy and safety of this combination vs T-DM1 alone in patients with mBC (phase 2).

Design, Setting, And Participants: The MTD in phase 1 was assessed using a 3 + 3 design with capecitabine dose modification.

Diagnostic performance of bilateral false profile radiographs in early hip osteoarthritis.

Objectives: 1. To show that the anterior hip joint space is profiled only on the contralateral false profile radiograph. 2.

Efficacy of octreotide long-acting repeatable in neuroendocrine tumors: RADIANT-2 placebo arm post hoc analysis.

Somatostatin analogues (SSA) have demonstrated antiproliferative activity in addition to efficacy for carcinoid symptom control in functional neuroendocrine tumors (NET). A post hoc analysis of the placebo arm of the RAD001 In Advanced Neuroendocrine Tumors-2 (RADIANT-2) study was conducted to assess the efficacy of octreotide long-acting repeatable (LAR) on progression-free survival (PFS) and overall survival (OS) estimated using the Kaplan-Meier method. Out of 213 patients randomized to placebo plus octreotide LAR in RADIANT-2, 196 patients with foregut, midgut, or hindgut NET were considered for present analysis.

Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial.

Background: Many patients with acromegaly do not achieve biochemical control despite receiving high doses of the first-generation somatostatin analogues octreotide or lanreotide. In the PAOLA trial, we aimed to assess the efficacy and safety of two different doses of the somatostatin analogue pasireotide long-acting release compared with active control (octreotide or lanreotide) in patients with inadequately controlled acromegaly.

Methods: In a multicentre, randomised, phase 3 trial, we enrolled eligible patients aged 18 years or older with acromegaly who were inadequately controlled (5-point, 2 h mean growth hormone concentration >2·5 μg/L and insulin-like growth factor 1 [IGF-1] concentration >1·3 times the upper normal limit) and had received 30 mg octreotide long-acting repeatable or 120 mg lanreotide (Somatuline Autogel; Ipsen, UK) as monotherapy for 6 months or longer.

Diagnostic value of clinical tests for degenerative rotator cuff disease in medical practice.

Objectives: To assess the diagnostic value of clinical tests for degenerative rotator cuff disease (DRCD) in medical practice.

Methods: Patients with DRCD were prospectively included. Eleven clinical tests of the rotator cuff have been done.

A direct comparison of intravenous enoxaparin with unfractionated heparin in primary percutaneous coronary intervention (from the ATOLL trial).

Intravenous enoxaparin did not reduce significantly the primary end point (p = 0.06) compared with unfractionated heparin (UFH) in the randomized Acute Myocardial Infarction Treated with primary angioplasty and intravenous enoxaparin Or unfractionated heparin to Lower ischemic and bleeding events at short- and Long-term follow-up (ATOLL) trial. We present the results of the prespecified per-protocol analysis excluding patients who did not receive the treatment allocated by randomization or received both enoxaparin and UFH.

ESM-1 expression in stromal cells is predictive of recurrence after radiofrequency ablation in early hepatocellular carcinoma.

Background & Aims: The prognosis of hepatocellular carcinoma (HCC) treated by radiofrequency ablation (RFA) is mainly linked to tumor recurrence. So far, no tissue biomarker of recurrence has been validated in biopsy samples. We aimed at investigating the prognostic value of tissue biomarkers in HCC biopsy samples of patients treated with RFA.

Safety and efficacy of adjuvant glycoprotein IIb/IIIa inhibitors during primary percutaneous coronary intervention performed from the radial approach for acute ST segment elevation myocardial infarction.

The use of glycoprotein IIb/IIIa receptor inhibitors (GPIs) in high-risk patients with acute coronary syndromes has been associated with reductions in ischemic events but increases in bleeding complications. The role of GPIs in patients who undergo primary percutaneous coronary intervention (PCI) by the transradial approach (TRA) is not well studied. The aim of this post hoc analysis from the randomized prospective Acute Myocardial Infarction Treated With Primary Angioplasty and Intravenous Enoxaparin or Unfractionated Heparin to Lower Ischemic and Bleeding Events at Short- and Long-Term Follow-Up (ATOLL) trial was to assess the safety and efficacy of GPIs in primary PCI performed using the TRA.

Effect of dynamic humeral centring (DHC) treatment on painful active elevation of the arm in subacromial impingement syndrome. Secondary analysis of data from an RCT.

Background: The physiotherapy dynamic humeral centring (DHC) aims to prevent subacromial impingement of rotator cuff tendons during elevation of the arm. The objective of the study was to determine whether DHC acts via an effect on subacromial impingement mechanism by assessing its effect on painful elevation of the arm in subacromial impingement syndrome.

Methods: This is a secondary analysis of results of a randomised controlled trial of the effectiveness of DHC.

Management of lower urinary tract symptoms related to benign prostatic hyperplasia in real-life practice in france: a comprehensive population study.

Background: Male lower urinary tract symptoms (LUTS) are one of the most treated diseases, but little is known about patient trajectories in current clinical practice.

Objective: To describe the dynamic treatment patterns of LUTS presumably due to benign prostatic obstruction (BPO).

Design, Settings, And Participants: All prescriptions of α1-adrenergic receptor blocking agents (α1-blockers), 5α-reductase inhibitors (5-ARIs), and phytotherapy, and all surgeries related to BPO performed in France from 2004 to 2008 were identified using two distinct administrative claim databases maintained by the National Health Insurance system that covers the entire population.

Diffusion-weighted MR imaging of the normal pancreas: reproducibility and variations of apparent diffusion coefficient measurement at 1.5- and 3.0-Tesla.

Purpose: To evaluate reproducibility and variations in apparent diffusion coefficient (ADC) measurement in normal pancreatic parenchyma at 1.5- and 3.0-Tesla and determine if differences may exist between the four pancreatic segments.

Haemoglobin glycation may partly explain the discordance between HbA1c measurement and oral glucose tolerance test to diagnose dysglycaemia in overweight/obese subjects.

Aim: This study assessed whether the poor correlation between HbA1c and oral glucose tolerance test (OGTT) for dysglycaemia diagnosis may be explained by haemoglobin glycation (HbG).

Methods: A total of 1033 consecutive overweight or obese patients with no known diabetes underwent OGTT and measurement of HbA1c to diagnose diabetes and dysglycaemia (American Diabetes Association criteria). For each OGTT result category, low, medium and high HbG was defined according to the mean HbA1c/fructosamine ratio and mean fructosamine.

Prospective short-term evaluation of transurethral needle ablation procedure in an ambulatory setting.

Objective: To assess the results of transurethral needle ablation (TUNA) (Prostiva®, Medtronic, France) performed in an ambulatory setting in men with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH).

Materials And Methods: A multicenter open-label study was conducted. Short-term success was defined by ability to leave the hospital on the evening of the intervention, and absence of rehospitalization due to complications during the first postoperative month.

Helical CT-enteroclysis in the detection of small-bowel tumours: a meta-analysis.

Objective: To perform a meta-analysis to determine sensitivity and specificity estimates of helical CT-enteroclysis in the detection of small-bowel tumours.

Methods: A search for relevant articles published from January 1992 to November 2010 was performed. Study design, patient characteristics and 2 × 2 contingency tables were recorded for eligible studies.

Malignancy and chronic leg ulcers: the value of systematic wound biopsies: a prospective, multicenter, cross-sectional study.

Objective: To determine the frequency of skin cancers associated with chronic leg ulcers (CLUs) presumably of vascular origin and failing to heal (ie, increased wound area or depth) despite 3 months or more of appropriate treatment.

Design: Prospective cross-sectional study.

Setting: Ambulatory or hospitalized patients from 17 dermatology departments.

Effect of long-term propranolol treatment on hepatocellular carcinoma incidence in patients with HCV-associated cirrhosis.

Unlabelled: Propranolol bears antioxidant, anti-inflammatory, and antiangiogenic properties and antitumoral effects and therefore is potentially active in the prevention of hepatocellular carcinoma (HCC). We retrospectively assessed the impact of propranolol treatment on HCC occurrence in a cohort of 291 patients with compensated viral C (HCV) cirrhosis, prospectively followed and screened for HCC detection. Of the 291 patients included in the cohort, 93 patients [50 males: mean age, 59.

Photoselective vaporization of the prostate with GreenLight 120-W laser compared with monopolar transurethral resection of the prostate: a multicenter randomized controlled trial.

Background: Evidence supporting the widespread use of GreenLight High Performance System (HPS) 120-W photoselective vaporization of the prostate (PVP) is lacking.

Objective: To assess the noninferiority of PVP compared with transurethral resection of the prostate (TURP) on urinary symptoms and the superiority of PVP over TURP on length of hospital stay.

Design, Setting, And Participants: A multicenter randomized controlled trial was conducted.

Use of clinical scores to detect dysglycaemia in overweight or obese women.

Aims: To test if the use of either HbA(1c) level or calculated clinical scores including two published scores and a new score (the Bondy score) could help in selecting overweight or obese women who should benefit from oral glucose tolerance test (OGTT) to detect dysglycaemia.

Methods: The French Data from an Epidemiological Study on the Insulin Resistance Syndrome (DESIR) score and the Finnish Diabetes risk score (Findrisk) were calculated, whereas the Bondy score was built in a development sample of 698 women, BMI 37±7 kg/m(2), without known diabetes. External validation was performed in a validation sample of 212 women.

[Results of percutaneous radiofrequency ablation of hepatocellular carcinoma in patients with cirrhosis aged 75 years and over].

Purpose: The objective of this study was to assess the results and tolerance of radiofrequency ablation in patients with cirrhosis and hepatocellular carcinoma (HCC) older than 75 years.

Patients And Methods: Over a period of 9 years from January 2001, 235 patients with cirrhosis and 3 or less HCC≤5 cm of diameter were treated by radiofrequency ablation. Among them, 52 patients older than 75 years were selected for this study.

Tuberculosis in the intensive care unit: A retrospective descriptive cohort study with determination of a predictive fatality score.

Background: Despite effective treatments, tuberculosis-related mortality remains high among patients requiring admission to the intensive care unit (ICU).

Objective: To determine prognostic factors of death in tuberculosis patients admitted to the ICU, and to develop a simple predictive scoring system.

Methods: A 10-year, retrospective study of 53 patients admitted consecutively to the Hôpitaux de Paris, Hôpital Lariboisière (Paris, France) ICU with confirmed tuberculosis, was conducted.

Atorvastatin decreases computed tomography and S100-assessed brain ischemia after subarachnoid aneurysmal hemorrhage: a comparative study.

Objective: Statins, which improve the bioavailability of endogenous nitric oxide and upregulate endothelial nitric oxide synthase, have been used to prevent cerebral vasospasm after aneurysmal subarachnoid hemorrhage. The objective of this study was to determine whether statin therapy diminished vasospasm-induced ischemia as assessed using daily measurements of serum S100B, a biomarker for cerebral ischemia, and computed tomography measurement of ischemic lesion volume.

Design: Single-center study of cases and historical controls.

HCV genotype 3 is associated with a higher hepatocellular carcinoma incidence in patients with ongoing viral C cirrhosis.

Liver steatosis is a main histopathological feature of Hepatitis C (HCV) infection because of genotype 3. Steatosis and/or mechanisms underlying steatogenesis can contribute to hepatocarcinogenesis. The aim of this retrospective study was to assess the impact of infection with HCV genotype 3 on hepatocellular carcinoma (HCC) occurrence in patients with ongoing HCV cirrhosis.

Intravenous enoxaparin or unfractionated heparin in primary percutaneous coronary intervention for ST-elevation myocardial infarction: the international randomised open-label ATOLL trial.

Background: Primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction has traditionally been supported by unfractionated heparin, which has never been directly compared with a new anticoagulant using consistent anticoagulation and similar antiplatelet strategies in both groups. We compared traditional heparin treatment with intravenous enoxaparin in primary PCI.

Methods: In a randomised open-label trial, patients presenting with ST-elevation myocardial infarction were randomly assigned (1:1) to receive an intravenous bolus of 0·5 mg/kg of enoxaparin or unfractionated heparin before primary PCI.

Impact of metformin on the prognosis of cirrhosis induced by viral hepatitis C in diabetic patients.

Context: Insulin resistance plays a role in hepatocarcinogenesis and is decreased by metformin treatment.

Objective: The aim of the study was to assess the influence of metformin treatment on the prognosis of compensated hepatitis C virus (HCV) cirrhosis in patients with type 2 diabetes.

Design And Setting: We studied an observational prospective cohort (1988-2007) at a university hospital referral center.