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NCT ID: NCT02032966 Active, not recruiting - Ankle Fracture Clinical Trials

Surgical Versus Nonsurgical Treatment of Fibular Fractures: A Prospective Randomized Study

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

Isolated surgical repair of the inside portion of the tibia may be enough to stabilize an ankle fracture in which both the tibia and the fibula are broken. This would alleviate the need for another incision, plate, and screws to repair the fibula. The purpose of this study is to help determine if surgically repairing only the tibia fracture will lead to equivalent clinical outcomes when compared with surgical repair of both bones. The hypothesis of this study is that operative stabilization of the medial malleolus fracture only, in otherwise ligamentously stable bimalleolar and/or trimalleolar fractures of the ankle, will lead to equivalent clinical outcomes and functional scores as those treated with operative stabilization of both malleoli and/or all malleoli.

NCT ID: NCT02209415 Active, not recruiting - Pancreatic Cancer Clinical Trials

EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer

EUFURO
Start date: April 2011
Phase: N/A
Study type: Interventional

Follow-up after successful operative treatment of cancer in the esophagus, stomach or pancreas in order to detect recurrent disease is a controversial topic. This is because the methods and the consequence of following these patients is unknown. Therefore the investigators will randomize these patients in to two groups: 1. One group of patients will be offered visits with a specialist surgeon in a outpatient setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is the current standard at our department. 2. The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same intervals as the first group.

NCT ID: NCT02444299 Active, not recruiting - Clinical trials for Avascular Necrosis of the Head of Humerus

Aequalis Resurfacing Head Study

Start date: April 2011
Phase:
Study type: Observational

Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007. The aim of this study is to collect immediate medium and long term data on performance and safety of the implant, retrospectively as well as prospectively, from a consecutive series of patients to assess the patients' outcomes and functional status.

NCT ID: NCT02566473 Active, not recruiting - Osteoarthritis Clinical Trials

FORCE-TJR: Improving Orthopedic Outcomes Through a National TJR Registry

FORCE-TJR
Start date: April 2011
Phase:
Study type: Observational [Patient Registry]

Aim 1. Establish a national registry of diverse patients of orthopedic surgeons representing all regions of the country and varied hospital and surgeon practice settings (e.g., urban/rural, low and high volume) to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and national healthcare policymakers. Collect pre-operative and post-operative patient reported outcomes (PROs) for pain and function. Aim 2: Develop new and transformative comparative effectiveness tools useful to both clinical practice and healthcare policy. Aim 3. Broadly disseminate surveillance reports for adverse events, such as implant revision, hip dislocation, knee manipulation, and identify important variation to inform quality improvement priorities.

NCT ID: NCT02992730 Active, not recruiting - Clinical trials for Breast Cancer Female

Predictors of Adjuvant Endocrine Therapy in Women With Breast Cancer

WHIP
Start date: April 2011
Phase:
Study type: Observational

Breast cancer is the leading cancer diagnosed in women and the second cause of cancer death. Of all racial/ethnic groups in the US, Black women have the highest rate of breast cancer deaths. Two-thirds of Black breast cancer patients have estrogen receptor (ER) positive tumors that can be treated with adjuvant hormonal therapy. If taken for the full five years, this therapy has been shown to reduce mortality by 50%. However, ER positive Black women are more likely to die from their breast cancer as ER positive White women. Preliminary data suggest that non-adherence to adjuvant hormonal therapy could explain some of this disparity. To date, no study has systematically examined psychosocial, healthcare, and biological factors that predict adherence to hormonal therapy in Black women with breast cancer. To begin to fill this knowledge gap, Investigators will conduct a prospective cohort study of 422 ER positive Black breast cancer patients recruited from health maintenance organizations (HMOs). Our primary outcome is adherence to therapy at 36 months post initiation. Specific aims are to: 1) Examine psychosocial factors (e.g. health beliefs, socio-cultural values, etc.) that predict adherence to hormonal therapy; 2) Identify clinical (e.g., side effects), and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy; and 3) Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that predict adherence. Investigators will also explore the role of CYP2D6 genetic variations in adherence to hormonal therapy which is novel and will increase knowledge about this genetic factor in Blacks. The study is focused on the time-period (first 3 years) when women appear to be the most vulnerable to terminating treatment prematurely. A better understanding of predictors of adherence in Black women may help target interventions and ultimately improve potentially avoidable adverse breast cancer outcomes in this underserved group.

NCT ID: NCT01339390 Active, not recruiting - Obesity Clinical Trials

MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in VHA

MOVE OUT
Start date: April 2012
Phase: N/A
Study type: Interventional

Obesity has been linked to several serious medical conditions, including high blood pressure, diabetes, and poor cholesterol levels. For this reason, obesity is likely the most important single contributor to cardiovascular mortality in the United States. Fortunately, intensive weight management programs are an effective treatment for obesity. Such programs help people lose weight and improve their measures of cardiac risk. In response to the growing numbers of obese veterans being treated at VHA facilities, the Department of Veterans Affairs developed the MOVE! Program. Veterans who commit to MOVE! and participate actively do lose weight. Unfortunately, MOVE!, like other weight management programs, requires its participants to attend classes and to exercise, often at locations and times that are inconvenient. The investigators propose to make it easier for eligible patients at the Zablocki VAMC to participate by offering MOVE-style classes and exercise groups at a variety of locations, days, and times. Our program-MOVE OUT-may provide a model for VHA to use nationwide.

NCT ID: NCT01383720 Active, not recruiting - Clinical trials for Calcified Stenotic Native Aortic Valves

REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm

REPRISE I
Start date: April 2012
Phase: Phase 1
Study type: Interventional

This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve stenosis and who are at high risk for surgical intervention.

NCT ID: NCT01435135 Active, not recruiting - HIV Infections Clinical Trials

Study of Late Boost Strategies for HIV-uninfected Participants From Protocol RV 144

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess safety and tolerability of late boost regimens of AIDSVAX B/E alone, ALVAC-HIV alone, or ALVAC-HIV/AIDSVAX B/E combination in HIV-uninfected participants from RV 144.

NCT ID: NCT01478438 Active, not recruiting - Malignant Tumor Clinical Trials

A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers

Start date: April 2012
Phase: N/A
Study type: Interventional

This study will determine the rate of complete tumor ablation of small breast cancers (≤ 20mm) by Novilase Interstitial Laser Therapy (ILT), and determine the sensitivity and specificity of imaging (MRI, mammography and ultrasound) in detecting residual tumor post ILT ablation as correlated to histopathology from the post-ablation excision.

NCT ID: NCT01504451 Active, not recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study

LAAPITUP 2
Start date: April 2012
Phase: Phase 4
Study type: Interventional

This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.