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NCT ID: NCT01813721 Completed - Clinical trials for Chemotherapy-induced Febrile Neutropenia

Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.

Start date: December 2012
Phase: N/A
Study type: Observational

This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.

NCT ID: NCT01813435 Completed - Clinical trials for Coronary Artery Disease (CAD)

GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

Start date: July 1, 2013
Phase: Phase 3
Study type: Interventional

After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications. There are two medication strategies: - Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR - Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely

NCT ID: NCT01813422 Completed - Clinical trials for Hypercholesterolemia

GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound

GLAGOV
Start date: April 18, 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.

NCT ID: NCT01813370 Completed - Prostate Cancer Clinical Trials

A Registry for Patients Treated on the Clinical Trial TAX 3503

Start date: March 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to continue follow-up on patients who were treated on the study called TAX 3505 (MSK IRB #07-101). The sponsor of this study, has decided to end the study early, before all patients have completed all planned follow-up tests. As a result, the investigators do not yet know whether hormonal therapy alone, or in combination with docetaxel, is better at preventing prostate cancer recurrence in patients who had a rising PSA after prostatectomy. This study will continue following patients according to a schedule that is similar to that found in the TAX 3503 (MSK IRB #07-101) study in order to answer that question. This study is known as a registry study. The patients' will not receive any treatment as part of this study. Instead, they will be asked to have a blood test performed once every 12 weeks.

NCT ID: NCT01812967 Completed - Glycemic Control Clinical Trials

Mechanism of Action of Milk and Its Components on Glycemic Control in Healthy Young Men

Start date: n/a
Phase: N/A
Study type: Interventional

The investigators hypothesize that the physiological effects of milk on satiety and glycemic control are mediated by the interaction between its macronutrient components by both insulin-dependent and independent mechanisms.

NCT ID: NCT01812447 Completed - Emphysema Clinical Trials

Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function

EMPROVE
Start date: June 2013
Phase: N/A
Study type: Interventional

EMPROVE is a multicenter, prospective, randomized, controlled study designed to evaluate the safety and long-term effectiveness of the Spiration Valve System in patients with emphysema. Patients appropriate for the EMPROVE study are those who are currently on medical treatment but still symptomatic. EMPROVE also accepts α-1 antitrypsin deficiency patients.

NCT ID: NCT01812148 Completed - Clinical trials for Peritoneal Mesotheliomas

Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)

Start date: January 2012
Phase: N/A
Study type: Observational

Review of the investigators hospital experience in cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) for peritoneal mesotheliomas, using Oxaliplatin as intraperitoneal chemotherapeutic agent.

NCT ID: NCT01811459 Completed - Delirium Clinical Trials

Trial Comparing Haloperidol, Quetiapine and Placebo in the Pharmacological Treatment of Delirium

Haloquet
Start date: February 2013
Phase: Phase 3
Study type: Interventional

Background: Delirium is an important problem in critical care. Its prevalence often reaches 75% in intensive care patients. Its occurrence is associated with numerous complications and deleterious consequences such as death, longer stay, higher cost, and long-term cognitive impairment. Delirium treatment entails correcting its underlying causes and usually initiating a pharmacological intervention with an antipsychotic. Typical antipsychotics, particularly haloperidol, are commonly used to treat delirium although few placebo-controlled trials of pharmacological treatments for delirium have been conducted. Furthermore, appropriate doses for delirium treatment have yet to be established. In critical care, two pilot studies provided the first randomized, placebo-controlled evidence for the pharmacologic treatment of ICU delirium. One found that neither haloperidol nor ziprasidone significantly reduced the incidence or duration of delirium compared with placebo whereas the other one found that quetiapine added to as-needed haloperidol resulted in faster delirium resolution. Objective: The goal of this study is to determine the effectiveness of antipsychotics in regular dosage regimen (quetiapine group and haloperidol group) compared to as-needed haloperidol (placebo group) in the pharmacological treatment of delirium. We will conduct a three-arm randomized controlled trial to achieve this goal. Materials and Methods: During one year, 45 delirious patients from three intensive care units will be recruited and randomized into one of three groups. Randomization will be performed in blocks of 9 by the pharmacy department, using a random numbers table. Patients will be continuously screened for delirium using the Intensive Care Delirium Screening Checklist (ICDSC) as part of routine care. A positive screening score (≥4) will warrant confirmation of delirium diagnosis by the treating physician. Treatment will begin according to randomization group, provided that informed consent has been obtained. Delirium status will be monitored during the episode using the Nursing Delirium Screening Scale (Nu-DESC). When the Nu-DESC monitoring will become negative for delirium (total score below 2), the resolution of the episode will be confirmed by the treating physician. A clinical evaluation by a psychiatrist will be performed within 24-48 hours of each of the two evaluations made by the treating physician (beginning and end of the delirium episode). The treating physician will initiate twice-daily treatment at the first of five levels for each of the three groups: 1) 1 mg of intravenous (IV) haloperidol + oral (PO) placebo, 2) 50 mg of PO quetiapine + IV placebo, or 3) IV + PO placebo. Therapy will be titrated upwards on a daily basis by increments of 1) 1 mg of IV haloperidol or 2) 50 mg of PO quetiapine, or 3) IV + PO placebo every 12 hrs, respectively, if the subject received at least two doses of as-needed haloperidol in the previous 24 hrs. As-needed (PRN) doses of 2 mg of IV haloperidol q 30 minutes will be available to patients from all three groups and administered by nurses until symptoms associated with delirium resolve. In case of unsuccessful as-needed treatment, rescue (STAT) doses of 5 mg of IV haloperidol q 30 minutes will be available to patients from all three groups and will be administered by nurses if agreement is reached with the treating physician that the situation indeed calls for it. The treatment level of patients requiring a STAT dose will immediately be raised to the above level. The treatment will stop when one of the following occurs: (1) the subject is deemed by the treating physicians, based on their clinical judgment, to no longer demonstrate signs of delirium and, therefore, to no longer require scheduled therapy with an antipsychotic agent; (2) 21 days of therapy has elapsed; (3) ICU discharge occurred; or (4) a life-threatening adverse event potentially attributable to the study drug occurred that warranted discontinuation of the study drug. Adverse effects will be closely monitored: extrapyramidal reactions, neuroleptic malignant syndrome, drowsiness, hypotension, QTc prolongation. The treatment level of patients presenting a non life-threatening adverse event will immediately be lowered to the level directly below. The sample size was calculated for a 2-tailed test with an alpha of .05 and a power of .80. The primary statistical analysis will involve Cox proportional time to event analysis comparing the three groups. Secondary analysis will use T-test comparisons for continuous variables and chi square for proportional analysis.

NCT ID: NCT01811095 Completed - Neoplasms Clinical Trials

A Randomized Controlled Trial of a Robotic Simulation Curriculum to Teach Robotic Suturing

Start date: March 2013
Phase: N/A
Study type: Interventional

The aim of this study is to determine if training with a robotic simulator improves ability to perform robotic suturing. We aim to recruit 38 participants (attending surgeons or residents in obstetrics and gynecology, urology, general surgery, or cardiac surgery). Participants will be randomized to training with a virtual reality robotic simulator in addition to clinical work or to usual clinical work alone for a period of 5 weeks. They will be tested at baseline and post-intervention in the task of suturing a inanimate model with the actual surgical robot. After the initial study period, the control group will have the opportunity to cross over and complete the training and then re-testing.

NCT ID: NCT01810419 Completed - Splenomegaly Clinical Trials

Ultrasound Estimation of Spleen Size

Start date: March 2013
Phase: N/A
Study type: Interventional

In internal medicine, assessment of spleen size on physical examination is an extremely important part of the overall evaluation of patients with many illnesses. Examination of the spleen is also one of the core competencies that the investigators expect our students and residents to learn as part of their training. Unfortunately, the sensitivity and specificity of examination of the spleen at the bedside is not very good. The investigators wish to determine if handheld ultrasound can accurately assess spleen size. Doing so would make physical examination of the spleen obsolete and transform training objectives for medical students and residents.