Decision tree algorithm in locally advanced rectal cancer: an example of over-interpretation and misuse of a machine learning approach.

Purpose: To analyse the classification performances of a decision tree method applied to predictor variables in survival outcome in patients with locally advanced rectal cancer (LARC). The aim was to offer a critical analysis to better apply tree-based approach in clinical practice and improve its interpretation.

Materials And Methods: Data concerning patients with histological proven LARC between 2007 and 2014 were reviewed.

Impact of clinical complete response on treatment outcomes in patients with locally advanced HPV-negative oropharyngeal squamous cell carcinoma.

Objective: To evaluate treatment outcomes after definitive chemoradiotherapy (CRT) for human papilloma virus (HPV)-negative oropharyngeal squamous cell carcinoma (OPSCC).

Materials And Methods: We analyzed data concerning HPV-negative OPSCC patients treated with curative intent. All patients received concomitant high-dose cisplatin-based chemotherapy.

Treating lupus patients with antimalarials: analysis of safety profile in a single-center cohort.

This longitudinal retrospective study aims at describing the safety profile and the reasons for discontinuation of antimalarials in patients with systemic lupus erythematosus (SLE) and discoid lupus erythematosus (DLE), focusing on ocular toxicity. We analyzed the clinical data of 845 SLE and DLE patients; 59% of them were taking antimalarials: 1.4% chloroquine (CQ), 88.

Perspectives on Some Controversies in Cardiovascular Disease Risk Assessment in the Pharmaceutical Development of Glucose-Lowering Medications.

The U.S. Food and Drug Administration (FDA) issued guidance on requirements to assess cardiovascular disease (CVD) risk with drugs being developed for approval for clinical use.

Safety and adverse effects associated with raloxifene: multiple outcomes of raloxifene evaluation.

Objective: To examine the effect of raloxifene on major adverse events that occur with postmenopausal estrogen therapy or tamoxifen.

Methods: The Multiple Outcomes of Raloxifene Evaluation, a multicenter, randomized, double-blind trial, enrolled 7,705 postmenopausal women with osteoporosis. Women were randomly assigned to raloxifene 60 mg/d or 120 mg/d or placebo.

Baseline characteristics of participants in the Raloxifene Use for The Heart (RUTH) trial.

The Raloxifene Use for The Heart (RUTH) trial is a randomized, placebo-controlled, double-blind trial designed to determine whether raloxifene 60 mg/day compared with placebo lowers the risk of coronary events (coronary death, nonfatal myocardial infarction [MI], or hospitalized acute coronary syndromes other than MI) and reduces the risk of invasive breast cancer in women at risk for a major coronary event. Raloxifene is a selective estrogen receptor modulator that improves cardiovascular risk factors, reduces the risk of vertebral fracture, and is associated with a reduced incidence of invasive breast cancer in postmenopausal women with osteoporosis. Between June 1998 and August 2000, 10,101 women were enrolled at 187 sites in 26 countries.

Design and methods of the Raloxifene Use for The Heart (RUTH) study.

Raloxifene is a selective estrogen receptor modulator that lowers total and low-density lipoprotein (LDL) cholesterol, reduces the risk of vertebral fracture, and is associated with a reduced incidence of invasive breast cancer in postmenopausal women with osteoporosis. The Raloxifene Use for The Heart (RUTH) trial is designed to determine whether raloxifene 60 mg/day compared with placebo: (1) lowers the risk of the coronary events (coronary death, nonfatal myocardial infarction [MI], or hospitalized acute coronary syndromes other than MI); and (2) reduces the risk of invasive breast cancer in women at risk for a major coronary event. RUTH is a double-blind, placebo-controlled, randomized clinical trial of 10,101 postmenopausal women aged > or =55 years from 26 countries.

Hormone and nonhormone therapy for the maintenance of postmenopausal health: the need for randomized controlled trials of estrogen and raloxifene.

Multiple health benefits have been postulated for the long-term use of hormone therapy in postmenopausal women, most notably for prevention of osteoporotic fractures and coronary heart disease, as well as several risks, including cancer of the breast and uterus and venous thromboembolism. Cardiovascular disease is the most common cause of death among postmenopausal women. If real, the reduction in risk of coronary heart disease by hormone use suggested by observational studies would likely outweigh the risks.

New method for quantitatively determining aortic regurgitant volume using Doppler color flow imaging: experimental validation study.

We have developed a method to provide the two-dimensional distribution of blood flow velocity and the blood flow volume rate in the ascending aorta from the cross-sectional Doppler color flow image. Regional blood flow velocities were determined by converting color intensities of the cross-sectional Doppler color flow image into the corresponding flow velocities with the correction with the spatial ultrasound beam incident angle. The spatial ultrasound beam incident angle was estimated from the geometric characteristics of the color flow image contour.

Hyperventilation-echocardiography test for the diagnosis of myocardial ischaemia at rest.

The purpose of this study was to assess the feasibility, safety, specificity and sensitivity of the hyperventilation test performed under echocardiographic monitoring for the provocation of vasospastic ischaemia. Hyperventilation (approximately 30 cycles.min-1 for 5 min) was performed in 104 hospitalized patients, referred for pain typical of angina at rest, under 2-D echocardiographic and 12-lead electrocardiographic monitoring.

Efficacy of isosorbide-5-mononitrate versus nifedipine in preventing spontaneous and ergonovine-induced myocardial ischaemia. A double-blind, placebo-controlled study.

This study was designed to assess the efficacy of oral nifedipine as compared to oral isosorbide-5-mononitrate in the prevention of spontaneous and induced vasospastic myocardial ischaemia. Twenty-one patients admitted to the Coronary Care Unit as a result of angina at rest underwent both Holter monitoring and an echo-ergonovine test during placebo and following either isosorbide-5-mononitrate or nifedipine according to a double-blind randomized trial. Both drugs caused a statistically significant reduction in spontaneous (87% and 95%, respectively) and induced ischaemic attacks (66% and 75%, respectively).

Monitoring of cardiac output during exercise in coronary patients: a Doppler study.

The monitoring of aortic blood flow velocities by transcutaneous continuous-wave Doppler was performed in 45 patients to determine, non-invasively, the haemodynamic response to exercise in subsets of coronary patients during a multistage supine exercise tests. Group I consisted of 14 patients with ischaemia on effort (IE); group II, 12 patients with both IE and prior myocardial infarction (MI); group III, 19 patients with MI and no IE; there were also 12 normals. Peak flow velocity (PV) indices of cardiac output (CO), of peripheral resistance (PR) and of stroke work (SW) were measured every min.

Inhibition of platelet function during in vivo infusion of isosorbide mononitrates: relationship between plasma drug concentration and hemodynamic effects.

Isosorbide monitrates (IS-2-MN and IS-5-MN), hepatic metabolites of isosorbide dinitrate, inhibit platelet function in vitro very differently, with IS-2-MN being much more potent than IS-5-MN. To assess their antiplatelet properties in vivo and to compare time and dosage requirements, we infused both IS-2-MN and IS-5-MN for 30 minutes, on 2 separate days, into nine patients with stable coronary artery disease, at rates of 4 mg/hr (n = 4) and 8 mg/hr (n = 5). Two additional patients received IS-5-MN at 16 mg/hr.

Multiparametric approach to diagnosis of non-Q-wave acute myocardial infarction.

The present study investigated whether the lack of enzyme increase is reason enough to exclude necrosis in patients with ischemic heart disease who develop electrocardiographic sustained ST-T changes in the absence of Q waves. In 15 consecutive patients with angina who developed sustained ST-T changes during hospitalization, the presence of myocardial necrosis was investigated by a prospective multiparametric approach. Serum enzymes and myoglobin, pyrophosphate uptake, 2-dimensional echocardiography, perfusion scintigraphy, left ventriculography and coronary angiography were evaluated.

Oral isosorbide 5-mononitrate can protect from myocardial ischemia induced by ergonovine test and by isometric effort. Preliminary results from an echocardiographic acute study in anginal patients.

Isosorbide 5-mononitrate (IS 5-MN) has favourable pharmacodynamic properties, such as the specific half-life (close to 5 h) and the bioavailability (100% after oral ingestion). The efficacy of IS 5-MN (20 mg t.i.

Echocardiographic documentation of myocardial ischemia in presence of angina pectoris without ST-T changes.

A frequent clinical problem is to document the elusive entity of electrocardiographically silent myocardial ischemia. Since echocardiography offers a practical tool to detect reversible mechanical changes due to ischemia, 32 patients with angina on effort, and coronary artery disease, and 15 patients with angina at rest were studied. In all 47 patients electrocardiographic changes during effort or rest pain were inconclusive.

Echocardiography in the study of myocardial ischemia in man: the clinical model of Prinzmetal's angina.

Standard echocardiography was employed to study the clinical model of myocardial ischemia with ST-segment elevation, well known as Prinzmetal's angina. Ultrasonic monitoring was performed during the appearance of ST-segment elevation, from onset of pain, during an ergonovine maleate test, hemodynamic monitoring, radioisotopic studies and, occasionally, during routine examinations, when spontaneous episodes occurred. Reliability of findings was supported by two important conditions: each patient acted as his own control, since recording was carried out from basal state to basal state, throughout ischemia, or from ischemia to basal state; behaviour of ischemic walls was compared with that of non-ischemic ones.

Dipyridamole-echocardiography test in angina at rest: noninvasive assessment of coronary stenosis underlying spasm.

In a previous study performed in patients with effort angina pectoris, we showed that the dipyridamole-echocardiography test (DET) is feasible and useful for the detection of coronary artery disease. The positivity of the test (consisting of two-dimensional echocardiography [2 DE] combined with dipyridamole infusion [0.14 mg/kg/min for 4 minutes]) is linked to the appearance of regional asynergy.

The therapeutic role of isosorbide-5-mononitrate+ in stable and unstable angina pectoris.

Various studies on the pharmacodynamic and clinical properties of isosorbide-5-mononitrate (IS-5-MN) indicate that this drug is effective in the treatment of stable angina pectoris. Acute and chronic studies, in fact, show an improved performance and an amelioration of the clinical status in patients under treatment. On the other hand, acute studies on vasospastic and mixed angina, two common clinical manifestations of coronary artery disease, have demonstrated the capability of IS-5-MN in preventing episodes of transient myocardial ischemia.

Echocardiographic versus hemodynamic monitoring during attacks of variant angina pectoris.

Six attacks of variant angina (2 spontaneous, 4 induced by ergonovine) were studied in 6 patients by combined echocardiographic and hemodynamic monitoring. A decrease of percent systolic thickening of the ischemic wall, which occurred as early as the decrease in peak dP/dt of contraction, was detected before the onset of ST-segment elevation ("pre-electrocardiographic phase"). At this stage, no significant change in left ventricular (LV) end-diastolic pressure or end-diastolic diameter was observed.

Transient myocardial ischemia with minimal electrocardiographic changes: an echocardiographic study in patients with Prinzmetal's angina.

Kn patients with Prinzmetal's angina, episodes of transient T wave abnormalities (T abn) are often documented in addition to the typical episodes of ST segment elevation (ST). As the interpretation of these minor ECG changes is still uncertain, we investigated if transient T abn are associated with reversible ventricular asynergies, similar to episodes with ST. For this purpose an ECG lead and a two-dimensional echocardiographic projection, which showed clear-cut changes during previous episodes of ST, were simultaneously monitored in five patients with Prinzmetal's angina for a total of 13 hours and 20 minutes.