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NCT ID: NCT01573351 Completed - Hepatitis C Virus Clinical Trials

Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

Hallmark QUAD
Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.

NCT ID: NCT01573234 Completed - Wounds and Injuries Clinical Trials

Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions

Start date: April 2012
Phase: Phase 3
Study type: Interventional

Evaluation of clinical efficacy of My Skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with cut injuries and abrasions with particular regard to: Wound healing (complete reepithelialization) and patient's pain. In the context of the study will be collected secondary outcomes related to type of lesion and its clinical evolution through the analysis of the items in the scale of the Pressure Sore Status Tool(PSST).

NCT ID: NCT01573091 Completed - Heart Failure Clinical Trials

Cardiac Resynchronization Therapy Modular Registry

CRT-MORE
Start date: December 2011
Phase: N/A
Study type: Observational

The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.

NCT ID: NCT01572727 Completed - Breast Cancer Clinical Trials

A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation

BELLE-4
Start date: August 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

NCT ID: NCT01572584 Completed - Pneumothorax Clinical Trials

Lung Ultrasound in the Evaluation of Pneumothorax Size

LUS-PNXsize
Start date: December 2011
Phase: N/A
Study type: Observational

Background - Assessment of the percentage of lung collapse is crucial in the therapeutic decision-making of pneumothorax. - The methods normally used to this purpose are radiological. Computerized tomography scan (CT) is highly accurate because it allows the exact evaluation of the volume of the air layer. However, in clinical practice assessment of the volume of pneumothorax mainly relies on the measurement of the inter-pleural distance at conventional chest radiography (CXR). This latter method is inaccurate. - Lung ultrasound is a new method highly accurate in the first diagnosis of pneumothorax, with a sensitivity superior to CXR and similar to CT in case of traumatic pneumothorax. - The scientific community is actually debating about the usefulness of lung ultrasound in the quantification of pneumothorax []. Lung ultrasound can assess the superficial extension of the pneumothorax, but cannot evaluate its volume. Aim - Main purpose of the study is to compare measurement of the superficial extension of pneumothorax on the chest wall obtained by lung ultrasound, to the evaluation of the air volume performed by CT in patients with pneumothorax. - The main hypothesis of the study is that the cut-off between small (<11% of lung collapse) and large (>11% of lung collapse) pneumothorax can be identified by a lung ultrasound evaluation of the superficial extension of pneumothorax. - Second purpose of the study is to compare the accuracies of lung ultrasound and CXR in predicting the volume of pneumothorax assessed by CT. - Secondary hypothesis is that lung ultrasound demonstrates greater accuracy in the prediction of volume of pneumothorax and percentage of lung collapse. Methods - Patients with a diagnosis of pneumothorax confirmed at CT are prospectively enrolled and submitted to lung ultrasound within 20 min from the CT study. - Different locations of the sonographic "lung point" on the chest wall (i.e. the point on the chest wall where the sonographic pattern of the normally aerated lung alternates with the pathologic sonographic pattern of pneumothorax) are compared with different volumes of pneumothorax measured by CT.

NCT ID: NCT01572571 Completed - Hypotension Clinical Trials

Ultrasound in Undifferentiated Hypotension

US-UHP
Start date: December 2011
Phase: N/A
Study type: Observational

Background - Symptomatic undifferentiated hypotension represents a negative prognostic factor and the strongest predictor of in-hospital mortality. - Misdiagnosis may lead to delayed or incorrect treatment of some life-threatening conditions. Aim - The aim of the study is to evaluate the feasibility and accuracy of a new bedside ultrasound method that consists in the focused imaging of the thorax, abdomen and leg veins, in emergency. Methods - Hypotensive (<100 mm/Hg) patients presenting to our emergency department, complaining of at least one of the neurologic, respiratory and cutaneous signs and symptoms of inadequate tissue perfusion, are prospectively studied by ultrasound-focused assessment of the heart, lungs, inferior vena cava, peritoneum, aorta and leg deep veins. - On the basis of physical examination and ultrasound results, the operator declares the diagnostic hypothesis without influencing the attending physician and the following diagnostic procedure (which includes ultrasound, when needed). - The diagnostic hypothesis is compared with the final diagnosis, obtained after the hospital route and discussed by a panel of three blinded experts (one radiologist, one cardiologist and one emergency physician). - The statistical agreement is calculated by the k of Cohen with p-value, confidence intervals and raw agreement (Ra).

NCT ID: NCT01572038 Completed - Breast Neoplasms Clinical Trials

A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer

PERUSE
Start date: June 1, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

NCT ID: NCT01571284 Completed - Clinical trials for Colorectal Cancer Metastatic

Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen

Start date: May 30, 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants Secondary Objective: To document the Health-Related Quality of Life of aflibercept in this participants population

NCT ID: NCT01571141 Completed - HPV Infection Clinical Trials

Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection

Start date: n/a
Phase: Phase 4
Study type: Interventional

Human papillomavirus (HPV) infection is a worldwide problem strictly linked to the development of cervical cancer. Persistence of the infection is one of the main factors responsible for the invasive progression and women diagnosed with intraepithelial squamous lesions are referred for further assessment and surgical treatments which are prone to complications. Despite this, there are several reports on the spontaneous regression of the infection. In this study the investigators will evaluate the effectiveness of a long term polyhexamethylene biguanide (PHMB)-based local treatment in improve the viral clearance reducing the time exposure to the infection and avoiding the complications associated with the invasive treatments currently available. Women diagnosed with HPV infection were randomly assigned to receive six months of treatment with a PHMB-based gynaecological solution (Monogin®) or to remain untreated for the same period of time. The administration of Monogin® has been performed every three days for fifteen days and then every fifteen days for the subsequent six months.

NCT ID: NCT01570686 Completed - Hypertension Clinical Trials

8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension

Start date: April 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.