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NCT ID: NCT02895373 Terminated - Clinical trials for Respiratory Distress Syndrome, Adult

PGE1 as Additive Anticoagulant in ECMO-Therapy

ECMO_PGE1
Start date: July 2016
Phase: Phase 2
Study type: Interventional

Bleeding complications and thromboembolic complications are frequent during extracorporeal membrane oxygenation (ECMO). Retrospective data suggest that platelet inhibition using prostaglandins, in this case PGE1, may reduce thromboembolic complications without increasing the bleeding risk. This randomized, double-blind trial aims to investigate the effects of PGE1 on bleeding risk, thromboembolic complications and the function of the ECMO.

NCT ID: NCT02894554 Terminated - Clinical trials for HBsAg-positive Renal Allograft Recipients

Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment.

Start date: July 2014
Phase: Phase 4
Study type: Interventional

The hepatitis B virus (HBV) infection rate among renal transplant recipients was reported from 3% to 20.9%. And patient survival and graft survival rates following renal transplantation may be worsen in HBsAg-positive carriers than in HBsAg-negative recipients. Due to viral replication in asymptomatic HBV carriers induced by post-transplant immunosuppression, liver-related complications, such as liver failure and bleeding, account for 37% to 57% of the mortality cases in HBsAg-positive renal allograft recipients. Since the late 1990s, Lamivudine has been recognized as an effective and well-tolerated antiviral drug for chronic HBV infection. Lamivudine treatment among HBsAg-positive renal allograft recipients has significantly improved patient survival rates during short-term follow-up. Telbivudine is another approved nucleoside antiviral agent for patients with chronic hepatitis B (CHB). Recently, it was shown that eGFR was improved in HBV-related decompensated cirrhosis patients after 52 weeks Telbivudine treatments. Additional eGFR increase was also observed in Lamivudine experienced CHB patients after switch to Telbivudine treatment. However, limited results were known about the renal function affected by oral anti-HBV drugs when patients received kidney transplantation. Therefore, we would like to conduct this study to evaluate the renal function of Lamivudine long term used HBsAg positive patients received kidney transplantation after switch to Telbivudine treatment. The clinical and virological outcomes will provide valuable insights of clinical practice.

NCT ID: NCT02893826 Terminated - Clinical trials for Subarachnoid Hemorrhage, Aneurysmal

Safety/Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With aSAH

Start date: September 2016
Phase: Phase 1
Study type: Interventional

Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.

NCT ID: NCT02893332 Terminated - Clinical trials for Stage IV EGFR Mutated Non-Small Cell Lung Cancer

Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas)

Sindas
Start date: January 15, 2016
Phase: Phase 3
Study type: Interventional

To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to TKI alone.

NCT ID: NCT02892864 Terminated - Clinical trials for Unilateral Peripheral Facial Paralysis

Virtual Rehabilitation Program in Peripheral Facial Paralysis

RVPF
Start date: October 24, 2017
Phase: N/A
Study type: Interventional

Facial palsy can be divided into supranuclear lesion (central facial palsy) and infranuclear lesion such as Bell's Palsy, an idiopathic disease. The peripheral facial paralysis (PFP) is a frequent but little-known pathology (20 / 100 000 inhabitants in France a year). Oro-facial functions and the ability to convey emotional facial information are seriously affected by facial palsy, thereby reducing patient's quality of life. The PFP can have several repercussions on the functional, aesthetic, social, occupational and psychological levels. Evolution and prognosis depend not only on its etiology and gravity, but also on the precocity and the quality of the medical and paramedical care. It is essential to assess functional and psychological issues before beginning an adapted global therapeutic care. If these depressive symptoms can be explained by multiple factors, the inability to smile would be one of the triggering factors of depression. The facial feedback hypothesis could be one of many explications because smiling induces a positive emotional state and a feeling of well-being. In PFP, patients must cope with their difficulties to smile. Their facial behaviour affected their own emotional experiences. The main purpose of the present study is to determine if virtual rehabilitation program is relevant compared to standard therapy. The second aim is to characterize the efficiency by analysing the time required to obtain a stable score of 4 in the Sunnybrook test. A secondary objective will be to decrease the functional and social repercussions of the facial paralysis with an intensive and targeted therapy of the smile. Furthermore, a virtual rehabilitation program will be implemented in an interactive platform. To this end, a parallel randomized controlled trial (RCT) of the two groups will be conducted: standard therapy versus virtual rehabilitation program. RCT involves a treatment in which active participation of the patient is necessary so only the assessment will be blinded. Facial motor skills (tongue, mouth and face motricity) are measured using electronic devices, objective and subjective evaluation with pragmatic fields such as communication, emotion and quality of life. The severity of patient's facial paralysis is appraised by the House and Brackmann scale. This global assessment will be conducted before the beginning of the therapy and every 3 months during 18 months. The patients will be recruited within the Ear, Nose, and Throat (ENT) service after a baseline assessment. Simple randomization will be used in order to establish both therapeutic groups with 45 patients in each group. Group A: Patients taken care in consultation within the ENT service which provides oro-myo-functional classical rehabilitation. Group B: Patients taken care in external consultation who receive oro-myo-functional rehabilitation through a virtual rehabilitation program targeted at the smile, in their place of living in virtual conditions. The patients must have been diagnosed with unilateral peripheral facial palsy, according to House and Brackmann international classification. Inclusion time : 18 months Between-two-groups analysis will be conducted in order to compare a targeted and intensive implementation-intention rehabilitation such as virtual rehabilitation program to standard therapy. This virtual therapy will consist in repeating mentally movement desired, so that it will be more spontaneously executed in the every-day-life situation.

NCT ID: NCT02892734 Terminated - Clinical trials for Stage IV Breast Cancer

Ipilimumab and Nivolumab in Treating Patients With Recurrent Stage IV HER2 Negative Inflammatory Breast Cancer

Start date: September 18, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to look at the efficacy (the effect on tumor) and the safety (the effect on body) of the study drugs when given as a combination in patients with metastatic recurrent epidermal growth factor receptor 2 (HER2) negative inflammatory breast cancer. This is a phase II study of 2 drugs used in combination: nivolumab and ipilimumab. The combination of these drugs is already approved by the Food and Drug Administration (FDA) to treat advanced melanoma (a type of skin cancer). Nivolumab and ipilimumab are not approved by the FDA for patients with metastatic recurrent HER2 negative inflammatory breast cancer, hence the treatment is considered experimental or investigational.

NCT ID: NCT02892682 Terminated - Clinical trials for Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency

The Role of the Coagulation Pathways in Recurrent Angioedema

Angiocoag
Start date: May 31, 2016
Phase: N/A
Study type: Interventional

Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways.

NCT ID: NCT02892201 Terminated - Clinical trials for Head and Neck Squamous Cell Carcinoma

Pembrolizumab in HNSCC With Residual Disease After Radiation

Start date: September 8, 2016
Phase: Phase 2
Study type: Interventional

This is a phase II study for patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation (with or without systemic therapy). Patients must be diagnosed with residual disease within 24 weeks of completion of radiation therapy. Residual disease must be biopsy proven before the patient can consent to the trial, and can be either from lymph nodes in the neck, or from the primary tumor site. Prior to beginning study therapy patients are evaluated by an ENT to determine if they have disease amenable to surgical resection. Both resectable and unresectable patients will be eligible for participation in the study.

NCT ID: NCT02891265 Terminated - Clinical trials for Focus: Smoking Cessation as it Relates to Fracture Healing

Smoking Cessation Intervention Within the Fracture Clinic

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

Tobacco use is the leading preventable cause of death contributing to more than 5 million estimated deaths per year globally. The longterm negative effects of smoking are well established. Complications due to smoking, from an orthopaedic perspective include impair bone and wound healing, and increased risk of infection and osteomyelitis. The primary outcome of this research is smoking cessation in patients attending the orthopaedic fracture clinic. This is a unique environment whereby previously healthy patients are faced with the impact of disability. This impetus to abstain from the benefit of fracture outcomes provides an opportunity for previously unattained early intervention and thus a greater potential for decreased patient morbidity and mortality. Furthermore it is a high volume clinic that, given the unique nature of traumatic injuries consists of a high proportion of males, ages 24-34 years old, obliged to follow up. This population is traditionally regarded as unattainable from primary prevention smoking cessation strategies. The investigators hypothesize that The Ottawa Hospital Fracture Clinic will serve as an effective environment to employ established primary prevention smoking cessation interventions, reducing the incidence of complications associated with fracture and surgical healing, and result in greater long-term cessation rates.

NCT ID: NCT02890381 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants 6 to 24 Months of Age

LID
Start date: October 5, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single intranasal dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age. This study was a companion study to CIR 312.