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NCT ID: NCT02369874 Completed - Clinical trials for Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN

Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer

EAGLE
Start date: September 9, 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.

NCT ID: NCT02369679 Completed - Lymphedema Clinical Trials

Effectiveness of Two Compression Methods in the Treatment of Upper Limb Lymphedema

Start date: October 13, 2014
Phase: N/A
Study type: Interventional

Treatment of lymphedema is based on a combined program called complex decongestive therapy. The components of the complex decongestive therapy are skin care, kinesiotherapy, manual lymphatic drainage and compression. The compression with multilayer bandage has proved to be the most effective of these therapies when analyzed separately.The multilayer bandage produces a gradient compression on the limb where distal pressure is higher than proximal pressure. Several materials are needed for the multilayer bandage, including tubular bandage lining, digit bandages, foam under-cast padding and multiple layers of short-stretch bandages to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient through a Velcro system. The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid) with the multilayer compression bandages in the treatment of the upper limb lymphedema.

NCT ID: NCT02369484 Completed - NSCLC Clinical Trials

Afatinib in NSCLC With HER2 Mutation

NICHE
Start date: September 16, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the control of disease in pretreated patients with advanced non small cell lung cancer (NSCLC) harbouring HER2 exon 20 mutations as well as the safety and tolerability (how severe the side effects are) of the treatment with afatinib.

NCT ID: NCT02369471 Completed - Epilepsy Clinical Trials

A Study of GWP42006 in People With Focal Seizures - Part A

Start date: March 2015
Phase: Phase 2
Study type: Interventional

To evaluate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo, in the presence of other antiepileptic drugs (AEDs).

NCT ID: NCT02369393 Completed - Clinical trials for Major Depressive Disorder

Efficacy of Two Internet Delivered Intervention Programs for Depression: Behavioral Activation vs Physical Activity

PROMETEOII
Start date: November 2, 2021
Phase: N/A
Study type: Interventional

To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with depressive symptomatology with a wait list control group (WL) in Spanish population.

NCT ID: NCT02369120 Completed - Low Back Pain Clinical Trials

Influence of a Educational Internet-based Intervention in Chronic Low Back Pain Patients: A Mixed Methods Approach

Start date: January 2015
Phase: N/A
Study type: Interventional

Aim: The aim of this project is to identify chronic low back pain patients´ beliefs about the origin and meaning of pain for developing a biopsychosocial web-based educational intervention. The other aim of this project is to assess the effectiveness of this web-based educational intervention for chronic low back pain patients on pain cognitions, pain intensity, and disability. Methods: Mixed methods design, combining both qualitative and quantitative methodologies. For the qualitative part of this study, the investigators will use qualitative in-depth semi-structured interviews. For the quantitative phase we will use an experimental study design. Subjects: Chronic low back pain patients between 18-65 years old, attending a primary care setting in the city of Lleida. Expected outcomes: The investigators expect to change and modify chronic low back pain patients´ cognition by using our web-site educational intervention, with the further outcome of reducing pain and disability.

NCT ID: NCT02368457 Completed - Osteoradionecrosis Clinical Trials

Management of Mandibular ORN: PENTO as Medical Treatment

PENTO
Start date: February 2016
Phase: Phase 4
Study type: Interventional

Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic and irreversible complication after head and neck radiotherapy with no medical treatment to limit or reduce symptoms. Different clinical trials have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis. This study proposes to use this drugs to determine if there is healing of mandibular osteoradionecrosis and/or a symptomatic improvement as well.

NCT ID: NCT02367963 Completed - Clinical trials for Cardiovascular Diseases

Peer-group-based Intervention Program

Fifty-Fifty
Start date: September 2013
Phase: N/A
Study type: Interventional

Cardiovascular disease is the leading cause of death in Spain and worldwide. Interventions targeting dietary patterns, weight reduction and new physical activity habits often result in impressive rates of initial behavior changes, but frequently these are not translated into long term maintenance. We hypothesize that a peer-group intervention, addressing multiple facets of cardiovascular disease risk factor can be successfully implemented improving the adherence of participants to healthy habits. A multicenter, randomized control trial scheme was adopted. A peer-group based intervention approach in which community members support each other to promote health-enhancing changes was chosen. Around 600 participants from 7 Spanish municipalities received a 12h initial training and were randomly allocated to intervention or control groups for a 12-month peer intervention. Baseline measurements took place before and after the initial training. Follow-up measurements will be taken at the end of the intervention and 1 and 2 years after the end of the study. The primary outcome is the improvement in a newly defined score combining 5 individual variables. Secondary outcomes are 1, 2 and 3 years variations in anthropometric parameters and/or healthy behaviors. The project seeks the empowerment of subjects from 25 to 50 years of age to improve their overall health habits and self-control of risk factor through peer education. The initiative is being developed in cooperation with the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN). This study will allow the economic and feasibility evaluation of the intervention, which will enable policy makers to consider its potential wider implementation for a real community-based intervention.

NCT ID: NCT02367794 Completed - Clinical trials for Squamous Non-Small Cell Lung Cancer

A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

Start date: June 11, 2015
Phase: Phase 3
Study type: Interventional

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

NCT ID: NCT02367781 Completed - Clinical trials for Carcinoma, Non-Squamous Non-Small Cell Lung

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

IMpower130
Start date: April 16, 2015
Phase: Phase 3
Study type: Interventional

This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).