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NCT ID: NCT02428179 Completed - Mortality Clinical Trials

Impact of Structured Communication in the OR on Surgical Site Infections: Prospective Observational Clinical Trial

StOP
Start date: April 2015
Phase: N/A
Study type: Observational

Surgical site infection (SSI) is the most frequent complication in patients that undergo abdominal surgery. A previous prospective observational study in 167 patients undergoing elective open abdominal procedures showed that case-relevant communication protects from organ/space SSI whereas case-irrelevant communication during the last 20 minutes of the procedure is a risk factor for incisional SSI. Therefore, the introduction of a clinical applicable intervention "structured briefing using the StOP protocol" has been developed and was tested in pilot experiments. This intervention aims at improving case-relevant communication during the procedure and to reduce excess case-irrelevant communication at the end of an operation. The hypothesis is: structured briefings during an operation reduce the incidence of SSI after surgery.

NCT ID: NCT02425891 Completed - Clinical trials for Triple Negative Breast Cancer

A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)

Start date: June 23, 2015
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.

NCT ID: NCT02425332 Completed - Spinal Cord Injury Clinical Trials

Validation of a Novel Robot-aided Assessment of Gait Ability

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

The aim of this study is the validation of a novel gait assessment method implemented in the Lokomat gait trainer with respect to established clinical gait assessment methods. The walking assessment method is based on the progressive reduction of the support of the device. The outcome measures of this algorithm will be the support needed in the different gait phases (guidance force of hip and knee joints) and the support required to the body weight support system (unloading). The hypothesis is that the guidance force and the support of the device will converge to a profile individual for each subject that is representative of one's impairment in the different gait phases. The reliability of the method will be tested collecting data from two sessions of Lokomat training. The validity of the method will be tested comparing the outcome of the assessment task with established clinical walking assessment measures.

NCT ID: NCT02425319 Completed - Arthroplasty Clinical Trials

CapFlex-PIP© Motion

Start date: November 14, 2017
Phase:
Study type: Observational

The purpose of this study is to describe and to compare the motion analysis parameters, i.e. motion and stability of proximal interphalangeal joints, which were treated with a CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion analysis of untreated healthy hands.

NCT ID: NCT02423135 Completed - Clinical trials for Transfusion Reaction

Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion in Anti-doping

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

The aim of the proposed project is to perform a clinical study in which volunteers will receive autologous blood transfusions in DEHP-free blood bags.

NCT ID: NCT02422615 Completed - Clinical trials for Advanced Breast Cancer

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

MONALEESA-3
Start date: June 9, 2015
Phase: Phase 3
Study type: Interventional

The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.

NCT ID: NCT02422355 Completed - Hip Fracture Clinical Trials

A Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures

FR_FNS
Start date: September 30, 2017
Phase:
Study type: Observational [Patient Registry]

In comparison to previous implants, the Femoral neck system (FNS) is an approved implant by the competent authorities (CE mark). It is designated to stabilize medial femoral neck fractures in a minimal invasive technique. The implant combines an angular stable device with screw in screw technology for rotational stability. Therefore the purpose of this focused registry is to investigate how the newly developed and approved implant called FNS is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome.

NCT ID: NCT02421510 Completed - Clinical trials for Type 1 Diabetes Mellitus

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

inTandem2
Start date: May 2015
Phase: Phase 3
Study type: Interventional

This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

NCT ID: NCT02421172 Completed - Clinical trials for Hidradenitis Suppurativa (Acne Inversa)

Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients

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

This is a randomized, double blind, multicenter study in patients with moderate to severe chronic hidradenitis suppurativa in parallel groups, to determine the efficacy and safety of multiple doses of CJM112 in comparison to placebo. The study has two periods to explore preliminary dose effects.

NCT ID: NCT02420444 Completed - Tuberculosis Clinical Trials

A Study for Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults

C-013-404
Start date: January 2011
Phase: Phase 1
Study type: Interventional

70 subjects received BCG intradermally at Study Day -42, then at Study Day 0 were randomized to receive AERAS-404 50 mcg H4/500 nmol IC31 intramuscularly as a 3-dose (N=30) or 2-dose (N=30) regimen, or placebo (N=10). Subjects were vaccinated on Study Days 0, 56, and 231, and followed through Study Day 259.