Clinical Trials Logo

Filter by:
NCT ID: NCT02051088 Active, not recruiting - Clinical trials for Peripheral Arterial Disease

Swedish Drug-elution Trial in Peripheral Arterial Disease

SWEDEPAD
Start date: November 2014
Phase: N/A
Study type: Interventional

Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation). In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies. In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.

NCT ID: NCT02041845 Active, not recruiting - Clinical trials for Small Cell Lung Carcinoma

Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer

THORA
Start date: July 8, 2014
Phase: N/A
Study type: Interventional

The majority of patients with limited disease small cell lung cancer (SCLC) experience recurrent disease despite receiving concurrent chemoradiotherapy. New agents and dose-escalation of chemotherapy have not provided a survival benefit. Local failure accounts for high proportion of recurrences. Improved thoracic radiotherapy (TRT) might increase local control and thus reduce the recurrence rate and prolong survival. Positron emission tomography (PET CT) is better for staging of SCLC than computer tomography (CT) and bone scan. More precise localization of tumors leads to more accurate definition of target volumes for TRT and reduce the radiation dose to normal tissue. A large proportion of patients relapse and die within one and two year after therapy. Few patients survive longer than three years. Thus, two-year survival is considered a clinically highly relevant measure of efficacy. The aim of this study is to compare two schedules of TRT with respect to local control, progression free survival, overall survival, toxicity and health-related quality of life. In addition patients who have the best outcomes and tolerate chemoradiotherapy will be characterized (e.g. clinical characteristics, blood biomarkers, body composition).

NCT ID: NCT02032823 Active, not recruiting - Breast Cancer Clinical Trials

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

OlympiA
Start date: April 22, 2014
Phase: Phase 3
Study type: Interventional

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

NCT ID: NCT02024126 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Exercise Therapy in Patients With Knee Osteoarthritis

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

Osteoarthritis (OA) is one of the most common form of chronic diseases in the adult population, and approximately 800 000 people in Sweden (population of 9 million people) suffer from this disease, which causes joint pain, stiffness, swelling, loss of function and sick leave. There is increasing evidence that exercise therapy is effective for patients with knee OA. However, there is little knowledge on long-term effects and what type of exercises dosage is most effective. In this present clinical trial, which is a Nordic collaborative project with researchers from different research groups in Sweden and Norway, we intend to investigate short and long-term effects comparing high dosage exercise therapy (each treatment lasting 80 to 90 min) vs. a relatively low dosage exercise program (25 to 30 min) in patients diagnosed with knee OA. Patients in both intervention groups receive three treatments a week for 12 weeks making a total of 36 treatments. Primary outcome is pain-ratings and function (The Knee Injury and Osteoarthritis Outcome Score (KOOS)). Secondary outcome concerns various health-ratings and objective functional tests. Regarding predictors for outcome, we plan also to investigate different psychosocial variables as well as patient's beliefs regarding exercise. Feasibility of how high-dose exercise therapy actually works in primary care health care settings is also planned to be reported. Patients are being assessed by blinded assessor at inclusion, at end of intervention (3 mo), and at six and 12 mo after end of treatment. We plan to include a total of 200 subjects from primary health care settings, two in Norway and two in Sweden, with radiographic-verified knee OA with knee pain and decreased function. The patients have to be within the 45 to 85 age group. Patients are excluded if they have been scheduled for knee surgery or have some other form of illness/disease that limits the exercise tolerance (e.g. heart disease or systemic/metabolic diseases or chronic obstructive airways disease). A major goal is to grade exercises so that they are performed pain-free or close to pain-free in both intervention groups. The principle of deloading is used to meet this goal using a high number of repetitions in sets as pain modulation. The results from this study will give new information about the effectiveness of graded exercise therapy in patients with knee OA, and new knowledge if outcome can be related to the exercise dosage performed.

NCT ID: NCT02018744 Active, not recruiting - Clinical trials for Safety and Performance of the Nellix Endovascular Sealing System

Nellix® Registry Study: EVAS-Global

EVAS-FORWARD 1
Start date: October 2013
Phase:
Study type: Observational [Patient Registry]

This registry has been designed as a multicenter, single arm, open label, post-market registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed up to discharge discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment). This registry of the Nellix System, which has received the market authorization of the European Union (Conformité Européenne, CE-certification) in a "real world" patient population treated in a multicenter setting will provide an assessment of the generalizability of the approach and System. Up to 300 patients diagnosed with abdominal aortic aneurysm (AAA) who are considered candidates for Endovascular Repair, in up to 30 international centers will be enrolled in the study.

NCT ID: NCT02003924 Active, not recruiting - Prostate Cancer Clinical Trials

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

PROSPER
Start date: October 31, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

NCT ID: NCT01997970 Active, not recruiting - Obesity Clinical Trials

NEAT - Prevention and Treatment of Overweight and Obesity.

InphactUm
Start date: February 2014
Phase: N/A
Study type: Interventional

This study will investigate the effect on Non-exercise Activity Thermogenesis (NEAT) when implementing active workstation at offices compared to conventional office work. The primary hypothesis is that this implementation will lead to a significant increase in time spent walking per day.

NCT ID: NCT01985074 Active, not recruiting - Clinical trials for The Focus is to Investigate Effect of a Case Management Interventions in Frequent Visitors to Emergency Departments

A Case Management Study Targeted to Reduce Health Care Utilization for Frequent Emergency Department Visitors

Start date: July 2010
Phase: N/A
Study type: Interventional

The aim of the study is to determine whether a nurse-managed telephone-based case-management intervention can reduce healthcare utilization and improve self-assessed health status in frequent emergency department users.

NCT ID: NCT01983241 Active, not recruiting - Clinical trials for Pulmonary Emphysema in Alpha-1 PI Deficiency

Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

SPARTA
Start date: November 2013
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.

NCT ID: NCT01980381 Active, not recruiting - Depression Clinical Trials

Treatment of Depression and/or Anxiety - the Tree Theme Method® (TTM) as an Intervention

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

Depression and anxiety are among our most common diseases and the prevalence is increasing. When suffering from depression or anxiety, the individual's ability to cope with everyday life occupations is decreased, as well as the ability to relate to others. The Tree Theme Method® (TTM) is a treatment method. The purpose is to enhance the ability to develop strategies for occupations in everyday life and relationships with others. The method involves using creative activities to create a life story focusing on everyday occupations and to create an imagination of future possibilities/goals. The TTM is a short-term therapy with five sessions. The treatment also implies that the patient is asked to identify various homework tasks to perform between the sessions. The aim of the project is to investigate the effects of the TTM compared to a control group for people with depression and anxiety diagnosis. The intention is to examine the effect on outcome measures regarding psychological symptoms, everyday occupations and health. The study has been approved by the Regional Ethical Review Board. The project is a randomized multicenter study with an intervention group and a control group. A total of 130 patients will be included. Inclusion criteria are patients with depression and/or anxiety in the age of 18-65 years and who have problems with their everyday occupations. Exclusion criteria are individuals with a severe somatic illness or psychosis and/or who have difficulties to understand and fill out self-rating questionnaires. The project implies that doctors will refer appropriate patients to the occupational therapist. After informed consent each patient will be drawn to the TTM or control. Before and after the treatment, as well as 3 and 12 months after finished treatment the patient will meet a project assistant in order to respond to questionnaires regarding psychological symptoms, everyday occupations and health. The study is a collaborative project involving the Region Skåne, Kronoberg County Council, and Jönköping County Council. Doctors will recruit patients and occupational therapists will perform the treatment. The research team comprise of researchers from Kronoberg County Council (B Gunnarsson and K Hedin), Lund University (C Håkansson) and School of Health Sciences in Jönköping (P Wagman).