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NCT ID: NCT01960348 Completed - Clinical trials for Amyloidosis, Hereditary

APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis

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

The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.

NCT ID: NCT01960127 Completed - Cirrhosis Clinical Trials

Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2

Start date: October 15, 2013
Phase: N/A
Study type: Interventional

Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact on morbidity and mortality. Regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. The effect of this training has not yet been evaluated in the decompensated cirrhosis patient population. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity, functional performance, and muscle mass in decompensated cirrhosis patients.

NCT ID: NCT01960049 Completed - Postoperative Pain Clinical Trials

Novel Technique of Analgesia Following Open Liver Resection

Start date: October 2013
Phase: Phase 4
Study type: Interventional

Abdominal wall incisions used for liver surgeries are associated with significant postoperative pain and disability. Epidural analgesia is often contraindicated in these patients due to common bleeding problems. Furthermore, drugs such as acetaminophen and opioids are often inadequate and can lead to detrimental side-effects. Abdominal wall (AW) catheters can be placed during surgical closure along the incision line and can be used to administer local anesthetics for postoperative pain. The study is a multi-centre, double-blind, randomized controlled trial involving 120 patients undergoing elective liver surgery. Patients will be randomly assigned to AW catheter group treated with drug or control treated with saline. Treatment group will receive AW catheters with ropivacaine plus standard patient controlled analgesia (PCA). Control group will obtain AW with normal saline and no local anesthetics and PCA. Patients are followed for 6 months post-operatively for pain scores, side-effects, chronic pain and complications.

NCT ID: NCT01959529 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

DEVOTE
Start date: October 29, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.

NCT ID: NCT01959334 Completed - Diabetes Mellitus Clinical Trials

Evaluate the Immunogenicity of a Novel Glucagon Formulation

Start date: September 2013
Phase: Phase 3
Study type: Interventional

This study provides information on immunogenicity of Nasal Glucagon (AMG504-1) with regards to the potential development of treatment-emergent anti-glucagon antibodies.

NCT ID: NCT01959282 Completed - Colitis, Ulcerative Clinical Trials

A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis

Start date: November 15, 2013
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT01958788 Completed - Clinical trials for Generalized Anxiety Disorder

Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder

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

Generalized Anxiety Disorder (GAD) is an anxiety disorder characterized by excessive and uncontrollable worry. Our research group has developed a cognitive-behavioural treatment (CBT) for GAD centered upon intolerance of uncertainty, a dispositional characteristic that arises from a set of negative beliefs about uncertainty and its consequences (Dugas & Robichaud, 2007). This CBT protocol has demonstrated good efficacy over four previous clinical trials: approximately 70% of participants fully remit from GAD following treatment and maintain these gains over extended follow-up periods. These results, while positive, do suggest that a substantial minority of individuals do not fully benefit from the existing treatment protocol. Across our randomized clinical trials, individuals who do not achieve diagnostic remission of GAD continue to endorse elevated levels of intolerance of uncertainty. This suggests that the current CBT protocol does not effectively reduce intolerance of uncertainty in some treated individuals. To address this, we have developed a modified version of the original CBT protocol that targets intolerance of uncertainty more directly. The goal of the current proposal is to determine whether this newly developed CBT protocol with fewer components can deliver comparable or superior GAD symptom reduction. A total of 7 participants with a primary diagnosis of GAD received the newly developed CBT protocol over 12 weekly sessions. Measures of GAD symptoms, psychopathology, and intolerance of uncertainty were administered at pre-, mid-, and post-treatment, as well as at 3- and 6-month follow-ups. The proposed study will provide information about the efficacy of this new CBT protocol in reducing GAD symptoms.

NCT ID: NCT01958775 Completed - Dyslipidemia Clinical Trials

Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon Like Peptide 2

Start date: March 2012
Phase: Phase 3
Study type: Interventional

1. To assess whether Glucagon like peptide 2 (GLP-2) affects lipoprotein production (study A) 2. To assess whether GLP-2 affects the release of preformed chylomicrons (study B)

NCT ID: NCT01958021 Completed - Clinical trials for Advanced, Metastatic Breast Cancer

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)

MONALEESA-2
Start date: December 17, 2013
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blinded, placebo controlled trial.

NCT ID: NCT01957852 Completed - Clinical trials for Peritoneal Carcinomatosis

FloSeal in CRS and HIPEC

Start date: January 2008
Phase: N/A
Study type: Observational

Introduction Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy (HIPEC) performed at the time of surgery. It is considered a high risk procedure and post-operative intra-abdominal bleeding is a major issue as it can delay recovery and promote intra-abdominal infections. In most severe cases (10 to 20% of patients), a second surgery to control the bleeding will be necessary. Major causes of bleeding are : radical resection, extensive peritonectomy, length of surgery, massive transfusion and use of HIPEC. To reduce the risk of intra-abdominal hemorrhage, many strategies have been tried and one of these is the liberal use of FloSeal, but there is no data in this particular field of interest. Over the last 18 months, the investigators have started to use FloSeal in all their cases with large PC and they have observed a dramatic reduction in the rate of reoperation for bleeding and probably secondarily, in the use of blood products, but this has not been measured. Hypothesis FloSeal can reduce the risk of bleeding after CRS and HIPEC procedure. Primary objective To evaluate if the use of FloSeal can reduce the risk of reoperation after CRS and HIPEC procedure in the treatment of PC. Secondary objectives - To evaluate if the use of FloSeal can reduce operative blood loss. - To evaluate if the use of FloSeal can reduce the need of blood products after CRS and HIPEC procedure. - To evaluate if the use of FloSeal can have an impact on other common surgical complications (which can be indirectly bleeding related). - To evaluate if the use of FloSeal can have an impact on length of hospital stay.