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NCT ID: NCT01441791 Completed - Clinical trials for Postoperative Respiratory Complications

PROVHILO:Protective Ventilation During General Anesthesia for Open Abdominal Surgery

PROVHILO
Start date: February 2011
Phase: N/A
Study type: Interventional

The purpose of this international, multicentre, double-blinded randomized controlled trial is to determine if the "open lung approach" providing recruitment maneuvers and PEEP(Positive End Expiratory Pressure) during general anesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery. Participating centres throughout the world will include a total of 900 adult patients undergoing general anesthesia for open abdominal surgery with high or intermediate risk for post-operative pulmonary complications. Patients are randomized and intra-operatively ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication (see below). Secondary endpoints are post-operative extra-pulmonary complications, intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care Unit) (re-) admission, and length of hospital stay.

NCT ID: NCT01441596 Completed - Breast Neoplasms Clinical Trials

Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases

Start date: October 2011
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

NCT ID: NCT01441583 Completed - Heart Failure Clinical Trials

Ingenio Device Algorithm Study

IVORY
Start date: October 2011
Phase: N/A
Study type: Interventional

The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.

NCT ID: NCT01440738 Completed - Healthy Clinical Trials

Effectiveness of a Group Intervention to Promote Health Through a Clinical Trial

Start date: September 2011
Phase: N/A
Study type: Interventional

Objectives Main objective: Assessing the effectiveness of the health workshops, in terms of quality of life. Secondary: To determine the effectiveness of the health workshops in relation to: Increase knowledge of healthy habits (physical activity, diet), incorporate and maintain a balanced diet. Incorporate and maintain regular physical activity; Keep variables related to risk factors (BP, Weight, Cholesterol) within normal limits, reduce cardiovascular risk (RCV). To estimate costs. Methodology Design: randomized controlled trial comparing a group of patients who performed the health workshops with a control group with similar characteristics. Scope of the Study: The study was conducted in 54 health centers of Barcelona city. Subjects of study: general population between 18 and 65 years who consent to. 188 people with speech (have conducted workshops for health) and 188 people without (not made health workshops. Data Analysis: T- test to compare the differences between quantitative variables or equivalent non-parametric if the distribution of the variable does not meet criteria of normality (Kolmogorov-Smirnov).

NCT ID: NCT01440725 Completed - Muscle Injuries Clinical Trials

Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma

PRP-RICE
Start date: October 2009
Phase: Phase 3
Study type: Interventional

This is a multicenter, simple blind, masking of outcomes assessors, parallel, randomised clinical trial in patient with muscle rupture and with hematoma production. The main hypothesis is that infiltration in the area of muscle injury in autologous platelet-rich plasma (PRP)improves muscle regeneration and repair by shortening the time to complete recovery. The main objective is to evaluate the PRP for healing muscular lesions 'tennis leg' type or distal rectus femoral. The secondary objectives are: to evaluate the risk of lesion recurrence; to evaluate the quality of lesion recovery process and evaluate intervention's safety. Experimental treatment will be the administration of PRP autologous (4-8 cc in a unique dose) by muscular infiltration en the empty space generated after the hematoma evacuation. Control treatment will be hematoma evacuation. Both treatment groups will use compressive bandage and they will recommend rest, extremity elevation, local ice and lately physiotherapy. Size sample: 76 patients (38 in each group)

NCT ID: NCT01440712 Completed - Postoperative Ileus Clinical Trials

Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery

Start date: December 2011
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to determine whether the water-soluble contrast (gastrografin) is more effective in the treatment of postoperative ileus than the conventional one.

NCT ID: NCT01440426 Completed - Gingival Recession Clinical Trials

Connective Tissue Graft Versus Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects

Start date: September 2011
Phase: Phase 4
Study type: Interventional

This study deals with coverage of multiple denuded roots. The current standard treatment requires surgical correction and uses soft tissue taken from the roof of the mouth to enhance results. The hypothesis of this trial is that a synthetic collagen matrix (called Mucograft) can be used to replace soft tissue taken from the subject. If the collagen matrix will prove to be equally as effective as the patient own tissue, it will be possible to avoid a more extensive surgery and decrease pain and discomfort.

NCT ID: NCT01440088 Completed - Soft Tissue Sarcoma Clinical Trials

A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

Start date: September 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.

NCT ID: NCT01439880 Completed - Clinical trials for Hypercholesterolemia

Open Label Study of Long Term Evaluation Against LDL-C Trial

OSLER
Start date: October 7, 2011
Phase: Phase 2
Study type: Interventional

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

NCT ID: NCT01439529 Completed - Heart Failure Clinical Trials

ECG Optimization of CRT: Evaluation of Mid-term Response

BEST
Start date: April 2009
Phase: Phase 3
Study type: Interventional

New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated, such as the use of the electrocardiogram. In this prospective, double-blind, study, the investigators will evaluate: Primary endpoint: To compare the clinical response to CRT in patients with the programming optimized by QRS versus the nominal suggested by the device. Secondary endpoints: 1. To compare cardiac remodeling in patients with the programming optimized by QRS versus the nominal suggested by the device. 2. To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS) with respect to the intrinsic rhythm. 3. To evaluate the echocardiographic improvement in left ventricular (LV) filling in both groups. 4. To evaluate the differences in the optimal atrioventricular (AV) delay with atrial sensing or atrial pacing. For that, 180 patients with an indication for CRT will be randomized to nominal programming of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and echocardiographic evaluation will be done at baseline, 6 and 12 months.