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NCT ID: NCT02552043 Completed - Cystic Fibrosis Clinical Trials

Video Game Exercise Effectiveness of a Domiciliary Pulmonary Rehabilitation Program in Cystic Fibrosis Patients

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

The aim of this study is to evaluate the efficacy of a long-term domiciliary exercise program using the Wii video game platform as a training modality in Cystic Fibrosis (CF) patients. Investigators hypothesize that an exercise program performed by active videogames (AVG) will produce an improvement in exercise tolerance and muscular strength to be maintained over time in young CF patients.

NCT ID: NCT02551991 Completed - Pancreatic Cancer Clinical Trials

Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Start date: October 19, 2015
Phase: Phase 2
Study type: Interventional

This is an open-label, phase 2 non-comparative study to assess the safety, tolerability, and preliminary efficacy of nal-IRI in combination with other anticancer therapies in patients not previously treated for metastatic pancreatic adenocarcinoma. This study will assess the following regimen: • nal-IRI + 5-fluorouracil (5-FU)/leucovorin (LV) + oxaliplatin The study will be conducted in two parts: Part 1, consisting of an initial dose exploration (Part 1A) followed by dose expansion (Part 1B) of the irinotecan liposome injection +5-FU/LV + oxaliplatin regimen and Part 2, consisting of a comparison of irinotecan liposome injection-containing regimen versus nab-paclitaxel plus gemcitabine. The comparative Part 2 was removed in a protocol amendment, dated 11 April 2018 (Version 6.0), before it was initiated, as this comparative part of the study is being undertaken as a stand-alone phase III study D-US-60010-001. This CSR only pertains to the single-arm dose exploration and dose expansion Part 1 results and no further reference is made to the comparative Part 2.

NCT ID: NCT02551874 Completed - Clinical trials for Type 2 Diabetes Mellitus

A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

Start date: October 20, 2015
Phase: Phase 3
Study type: Interventional

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

NCT ID: NCT02551159 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer

KESTREL
Start date: October 15, 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

NCT ID: NCT02550873 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Start date: September 1, 2015
Phase: Phase 2
Study type: Interventional

This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with IPF.

NCT ID: NCT02550769 Completed - Rectal Cancer Clinical Trials

Study of NOTES-TME Versus L-LAR in Rectal Cancer

NOTESvsL-LAR
Start date: April 2015
Phase: N/A
Study type: Interventional

INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach. MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results. METHODOLOGY: A prospective multicenter randomized controlled study of patients with rectal cancer that, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The sample calculation is 58 patients per group.

NCT ID: NCT02550652 Completed - Lupus Nephritis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

Start date: November 13, 2015
Phase: Phase 2
Study type: Interventional

This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

NCT ID: NCT02550639 Completed - Clinical trials for Kidney Transplantation

Prospective, Randomized Study for Predicting Human Cytomegalovirus (hCMV) Infection Based on Baseline hCMV Specific T-cell Response in Kidney Transplant

RESPECT
Start date: February 2014
Phase: Phase 4
Study type: Interventional

The aim of this prospective, randomized study is to assess a subject's immunological status against hCMV before kidney transplantation by an hCMV-specific interferon (INF)-γ ELISPOT technique confirming previous results and establishing their statistical validity in order to determine whether this test could be used routinely in clinical practice to assess the risk of developing hCMV infection after renal transplantation and, ultimately, identify the most effective individual antiviral therapeutic strategy against hCMV.

NCT ID: NCT02550249 Completed - Clinical trials for Glioblastoma Multiforme

Neoadjuvant Nivolumab in Glioblastoma

Neo-nivo
Start date: June 2015
Phase: Phase 2
Study type: Interventional

Neoadjuvant nivolumab will be administered to patients with primary and recurrent glioblastoma multiforme that require surgery. Nivolumab will be continued following surgery.

NCT ID: NCT02549170 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Start date: December 15, 2015
Phase: Phase 3
Study type: Interventional

The aim of this study is to learn more about the following treatment options in adults with CIDP: - Subcutaneous self-infusion with HyQvia. - Intravenous infusion with Gammagard/Kiovig. Gammagard and Kiovig are the brand names for the same immunoglobulin compound. The study is in two parts. In Part 1, participants receive either HyQvia or a placebo subcutaneously. In Part 2 (only for participants who have a CIPD relapse during Part 1), participants will receive Gammagard Liquid/Kiovig intravenously. US participants will receive Gamunex-C. The first SC infusion will be given in the study clinic. The remaining SC infusions may be given in the study clinic or the participant's home. This will be decided by the study doctor and whether the participant or their caregiver can do the self-infusion.