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NCT ID: NCT04021290 Completed - HIV Infections Clinical Trials

Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)

Start date: November 11, 2019
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine if virologically suppressed Human Immunodeficiency Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC). The main objective of the study is to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks in virologically suppressed adults living with HIV-1. The study will also evaluate information regarding the safety and health related quality of life. The study will include Screening Phase (up to 28 days), a Randomization Phase (up to Week 52) and a Continuation Phase (post Week 52). The Continuation Phase is not applicable for participants in Sweden and Denmark. Approximately 490 participants will be randomized in 1:1 ratio to receive DTG/3TC FDC once daily for up to 52 weeks or continue their CAR for 52 weeks. Participants in the DTG/3TC FDC arm who successfully complete up to 52 weeks of treatment will have the opportunity to continue receiving DTG/3TC FDC once daily in Continuation Phase.

NCT ID: NCT04021264 Withdrawn - Liver Diseases Clinical Trials

The Impact of an Epidural Anesthetic on the Consumption of Sevoflurane in Major Abdominal Surgery

Start date: August 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Major abdominal surgery - like non-laparoscopic bowel resection, liver, gastric, or pancreas surgery - is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed before surgery has the potential to substantially reduce the amount of inhaled anesthetic given to the patient during surgery. This can benefit the patient with being more awake and crisp more quickly after surgery. It can also reduce cost to the system. A further benefit which has received very little attention so far, is that reducing the amount of inhaled anesthetic given also lowers the environmental footprint created by the anesthetic. The investigators of the proposed study plan to quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the epidural block is applied before or after surgery. Patients will have a nerve block catheter (epidural catheter) placed prior to the induction of general anesthetic by an experienced regional anesthesiologist. The epidural catheter will be bolused with a solution to which the anesthesiologist is blinded which will either be local anesthetic or dextrose (sham). The general anesthetic will be conducted according to a the protocol with the aim of maintaining a standard anesthetic depth monitored by patient state index (PSI). Measurements of the MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes and will be noted down by a blinded observer. At the end of the case the anesthesiologist blinded to the solution will inject another solution (now a dextrose (sham) or local anesthetic before the patient is woken up.

NCT ID: NCT04021069 Active, not recruiting - Breast Cancer Clinical Trials

Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

Start date: August 30, 2018
Phase:
Study type: Observational

This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.

NCT ID: NCT04021017 Withdrawn - Anorexia Nervosa Clinical Trials

PRE-GAiN Bone Health Pilot Study

PRE-GAiN
Start date: January 21, 2020
Phase: Phase 1
Study type: Interventional

This study will assess the affects of an estradiol hemihydrate transdermal system on bone health in 24 adolescent females aged 12-19 years old with anorexia nervosa. Participants in this study will be randomized 1:1 into 2 groups. One group will receive treatment with a transdermal estrogen patch and the other group will not.

NCT ID: NCT04020939 Completed - Trauma Clinical Trials

The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.

Start date: March 16, 2020
Phase: N/A
Study type: Interventional

Background: Intestinal resections are commonly performed in the pediatric population. Perfusion of the bowel is one of the most important factors determining the viability of an intestinal anastomosis. Up to date, no ideal method to assess intestinal perfusion has proven its superiority. Objectives: Primary: The aim of this study is to establish the feasibility and impact of the use of indocyanine green technology on intestinal resection margins during elective and emergency pediatric surgeries. Secondary: The secondary outcomes of interest include collection of adverse events and difficulties encountered with the use of the indocyanine green (ICG) technology. Postoperative surgical complications will also be recorded. Study Design: An open observational clinical study will be performed by using a clinical drug (indocyanine green) and medical device (SPY Fluorescence Imaging) to assess intraoperatively intestinal perfusion in a specific pediatric population.

NCT ID: NCT04020601 Terminated - Clinical trials for Rotator Cuff Injuries

The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty

Start date: August 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Total arthroplasty surgery of the shoulder is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed before surgery has the potential to substantially reduce the amount of inhaled anesthetic given to the patient during surgery. This can benefit the patient by minimizing the opioid usage after surgery and also reduce cost to the system in terms of duration of hospital stay. The purpose of the study is to investigate whether the inclusion of a nerve block to the general anesthetic for total shoulder arthroplasty surgery will also reduce the amount of inhaled anesthetic and thereby lowering the environmental footprint from the anesthetic. The investigators of the proposed study plan to quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the nerve block is applied before or after surgery. Patients will have a nerve block catheter (interscalene catheter) placed under ultrasound-guidance prior to the induction of general anesthetic by an experienced regional anesthesiologist. The nerve block catheter will be bolused with a solution to which the anesthesiologist is blinded which will either be local anesthetic or normal saline (sham). The general anesthetic will be conducted according to a the protocol with the aim of maintaining a standard anesthetic depth monitored by patient state index (PSI). Measurements of the MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes and the total amount of volatile anesthetic (in ml and ml/kg) will be noted down by a blinded observer. At the end of the case the anesthesiologist blinded to the solution will inject another solution (now a saline (sham) or local anesthetic before the patient is woken up.

NCT ID: NCT04020484 Completed - Quality of Life Clinical Trials

Making Mindfulness Matter© in Children With Epilepsy

M3Epilepsy
Start date: December 2, 2019
Phase: N/A
Study type: Interventional

Epilepsy is a debilitating condition characterized by spontaneous, unprovoked seizures. Up to 80% of children with epilepsy (CWE) may face cognitive, psychiatric, and/or behavioral comorbidities with significant unmet mental health needs. Mindfulness-based interventions may provide an ideal vector to target unmet mental healthcare needs in patients with epilepsy and their families. The investigators propose the Making Mindfulness Matter© (M3) program as an intervention to improve health related quality of life and mental-health for CWE and their parents. M3 is live-online parent and child program that incorporates mindful awareness, social-emotional learning skills, neuroscience, and positive psychology. This pilot RCT is needed to refine the implementation of the intervention to families with a child with epilepsy, and collect information pertaining to the feasibility and effectiveness of the intervention in preparation for a subsequent multi-centred trial across Canada. Note: Due to COVID-19, the format has been modified for online delivery (from community-based) and the intervention has been restarted.

NCT ID: NCT04020172 Recruiting - Clinical trials for Perioperative Tissue Oxygenation

Improving Tissue Oxygenation in Breast Reconstruction Surgery

Start date: July 12, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Breast reconstruction is an integral part of breast cancer care. There are two main types of breast reconstruction: alloplastic (using implants), and autologous (using patient's tissue). The latter creates a more natural breast mound, and avoids long-term concerns requiring surgical re-intervention associated with implant-based surgery. The deep inferior epigastric perforator (DIEP) flap is the gold standard technique in autologous breast reconstruction. Complications, however, do occur with DIEP flap surgery and often stem from poor flap perfusion/oxygenation. Hence, the development of strategies to enhance flap perfusion (e.g., optimal perioperative fluid therapy) is essential. Current perioperative fluid therapy is usually guided by subjective criteria which leads to wide variations in fluids administered. We will randomly assign DIEP flap patients to receive optimal (cardiac output-guided) fluid therapy in combination with dobutamine (a medication which has potential to improve flap oxygenation) versus the current standard of care. Flap oxygenation will be monitored via near-infrared spectroscopy in all patients for up to 48 hours postoperatively. Optimal fluid therapy in combination with dobutamine may improve flap oxygenation and thereby, reduce complications.

NCT ID: NCT04019951 Completed - Overweight Clinical Trials

The Effect of a Propionate Colon Release Form on ad Libitum Eating and Appetite Perception

METABIOTIC
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The present study aims to investigate the effect of a standardized liquid breakfast containing a food grade propionate colon release form on ad libitum eating and appetite perception in healthy overweight humans using a double-blinded, randomized, cross-over study design

NCT ID: NCT04019925 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Hip

Assessing the Wear Rates of the ADM/MDM Hips Using 3D X-ray Analysis

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

A common complication post hip replacement is hip dislocation or hip instability which can lead to the hip implants being revised. A new generation of Dual Mobility hips was designed to minimize hip dislocation/hip instability and polyethylene wear thus increasing the longevity of the hip prosthesis and reducing the number of re-operations for a patient. In this study we will be assessing 2 dual mobility hips manufactured by Stryker Orthopaedics Inc. The ADM and the MDM.