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NCT ID: NCT02943460 Completed - Clinical trials for Primary Sclerosing Cholangitis

Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis

Start date: November 29, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (PSC).

NCT ID: NCT02942576 Completed - Atrial Fibrillation Clinical Trials

Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation

ELIMINATE-AF
Start date: March 21, 2017
Phase: Phase 3
Study type: Interventional

There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.

NCT ID: NCT02941926 Completed - Breast Cancer Clinical Trials

Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

COMPLEEMENT-1
Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

NCT ID: NCT02941627 Completed - Clinical trials for Hearing Loss, Sensorineural

The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults

Start date: February 2, 2017
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the efficacy and the safety profile of the Neuro Cochlear Implant System (CIS) in adults with severe-to-profound hearing loss.

NCT ID: NCT02940951 Completed - Chronic Disease Clinical Trials

Quality of Life Assessment and Practice Support System in Home Care Services for Older Adults

QPSS
Start date: March 12, 2018
Phase: N/A
Study type: Interventional

Older adults living with incurable and advancing life-limiting illness frequently desire to spend as much time as possible comfortably at home, rather than in hospital. They often have complex problems that not only affect their ability to function, but also their and their family caregivers' overall quality of life (QOL). Routine assessment of their perceived health care needs and their self-reported QOL is necessary to ensure that patients' and family caregivers' concerns are visible to home care clinicians so that they can be effectively monitored and addressed. These types of assessments involve asking people to respond to questions about their symptoms, their physical, psychological, social and existential/spiritual wellbeing, and their experiences with health care. Electronic information systems are increasingly used and recommended to facilitate such QOL assessments. However, there is a need for information about how such systems are best translated into practice improvements that ultimately may improve patient- and family-centred outcomes. This study is about the implementation of an innovative, electronic health care information and practice support system, the Quality of life Assessment and Practice Support System (QPSS), into routine care provided by home care services for older adults with life-limiting illnesses and their family caregivers. Eight home care sites in Canada are participating. At each site the investigators will first adapt the QPSS to the local context and develop a plan for its local implementation. Then home care staff will be asked to use it in practice and the investigators will evaluate the process of using the QPSS and its effect on patient and family caregiver quality of life, health, and satisfaction with care as well as the cost consequences of its integration into practice. The effect of its use will be studied in a randomized trial, which is the part of the study described in this registry. Patients and their family caregivers will be randomly assigned to 1) have their home care team use the QPSS in their care or 2) not to use it, instead receiving care as usual. The effect of using the QPSS will be measured using questionnaires completed by the participating patients and family caregivers every two months. If using the QPSS improves quality of life, health, or satisfaction with care, the last stage will explore how to scale up use of the QPSS in practice and its integration with existing health information systems.

NCT ID: NCT02940158 Completed - Healthy Clinical Trials

Various Serving Sizes of Lentils on Blood Glucose and Insulin

Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of starchy foods (corn, macaroni, white potato, white rice).

NCT ID: NCT02939989 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study

MAGELLAN-3
Start date: November 21, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.

NCT ID: NCT02939690 Completed - Clinical trials for Central Venous Catheterization

Umbilical Venous Catheter Insertion Depth in Neonates

Start date: October 2016
Phase: N/A
Study type: Interventional

In this randomized clinical study, neonates who require umbilical venous catheter (UVC) insertion as part of their routine care at anytime during their NICU admission will be randomized to one of the 2 formulas for estimation of the pre-insertion UVC depth (umbilicus to the nipple in cm minus 1 (UN - 1) or birth weight based formula ([(3× birth weight (Kg) + 9)/2+1)]. UVC will be inserted under sterile condition as per unit protocol. To verify the UVC tip position, a thoracoabdominal radiograph will be taken. In addition, the investigators will do a ultrasound of the heart to assess the exact location of the catheter tips as soon as possible but within 6 hours of insertion.

NCT ID: NCT02939209 Completed - Pain Clinical Trials

Pre-emptive Opioid Treatment to Prevent Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block

Start date: April 20, 2017
Phase: Phase 4
Study type: Interventional

Arthroscopic shoulder rotator cuff repair and acromioplasty are associated with severe postoperative pain. The interscalene block (ISB) is commonly used for this type of surgery, providing analgesia by anesthetizing the nerves that supply the shoulder. Although the nerve block provides extremely effective analgesia for the first 6-8 hours, patients experience severe pain once its effect has regressed. This study will assess whether a single dose of oral hydromorphone controlled release, given to overlap the waning of the ISB, will improve postoperative pain control and reduce the incidence of rebound pain. Seventy patients undergoing rotator cuff repair will receive standardized ISB and general anesthesia for the surgery. Six hours (+/- 1 hour) after ISB, the patients will randomly receive either a single oral dose of 2 mg Hydromorphone (immediate release formulation) or placebo. The patient will be then discharged home with a prescription for multimodal analgesia, which is the standard of care. Patients will be given a diary to record their pain scores and track use of analgesic medications for 24 hours. Twenty-four hours after the ISB, the patients will receive a phone call from a nurse as per the standard of care. During this phone call, questions will be asked about their pain control. If a single dose of pre-emptive hydromorphone is demonstrated to be safe and effective, it will lead to change in practice of how we manage pain after rotator cuff repair. Furthermore, the finding of this study may apply to similar surgical procedures (such as elbow, knee and ankle repairs) that are associated with rebound pain when the nerve block wears off.

NCT ID: NCT02939183 Completed - Clinical trials for Relapsed or Refractory Multiple Myeloma

Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma

INTREPID-1
Start date: January 17, 2017
Phase: Phase 1
Study type: Interventional

A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.