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NCT ID: NCT03859973 Completed - Schizophrenia Clinical Trials

This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia

Start date: April 15, 2019
Phase: Phase 2
Study type: Interventional

This is a study in adults with schizophrenia. The study tests whether a medicine called BI 425809 together with brain training improves mental abilities. Participants take study medication once a day for 12 weeks. At the start of the study, the participants are put into 2 groups. It is decided by chance who gets into which group. One group gets BI 425809 tablets every day. The other group gets placebo tablets every day. Placebo tablets look like the BI 425809 tablets, but contain no medicine. During the study, all participants do brain training using a computer. The doctors regularly test mental abilities of the participants. The results of the mental ability tests are compared between the groups. The doctors also check the general health of the patients.

NCT ID: NCT03859349 Completed - Clinical trials for Non Small Cell Lung Cancer

The Canada Lymph Node Score: A Feasibility Randomized Controlled Trial

CLNS
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

For patients diagnosed with early stage Non-Small Cell Lung Cancer (NSCLC) on preoperative computerized tomography (CT) and positron emission tomography (PET) scans, surgical resection is usually the preferred method of treatment. However, to be eligible for surgery, current guidelines require that the cancer has not spread to the lymph nodes in the chest cavity. To evaluate these lymph nodes, the standard of care is to undergo an endobronchial ultrasound (EBUS) procedure, where all the visible lymph nodes in the chest are biopsied (sampled) with a needle. Unfortunately, these biopsies are often inconclusive, especially in patients who have no evidence of mediastinal lymph node spread on pre-operative imaging. Currently, the standard of care mandates that inconclusive biopsies should be repeated, either through another EBUS, or through more invasive procedures. Repeat inconclusive biopsies are oftentimes inconclusive as well; leading to a vicious cycle of inconclusive results, a delay in treatment, morbidity for the patient, and increased costs to the healthcare system. To circumvent this issue, the investigators have developed, validated and published a 4-point score, the Canada Lymph Node Score (CLNS), which uses four features observed during EBUS to predict whether the cancer has spread to the lymph nodes or not. Research has demonstrated that lymph nodes which appear benign on both CT and PET scan that also have a CLNS of ≤1/4 are almost certainly benign. As such, it is believed that these "triple normal" lymph do not require biopsy (or repeat biopsy). The investigators are challenging the current standard of care in lung cancer, which mandates that all the lymph nodes in the chest need to be biopsied (i.e. Systematic Sampling) before surgery, by proposing that triple normal lymph nodes can be omitted, and only those with cancer potential should be biopsied (i.e. Targeted Sampling).To prove this hypothesis, a randomized controlled trial comparing Systematic Sampling to Targeted Sampling is required. A feasibility trial is proposed to determine whether this large-scale randomized trial will be possible.

NCT ID: NCT03858439 Completed - Clinical trials for Autosomal Dominant Polycystic Kidney

Dietary Intervention in ADPKD on Tolvaptan

DIAT
Start date: June 6, 2019
Phase: N/A
Study type: Interventional

Autosomal dominant polycystic kidney disease (ADPKD) is the most common inherited renal disorder. Tolvaptan has been approved in Canada as a treatment for ADPKD. Tolvaptan is an arginine vasopressin receptor antagonist which has been shown to decrease the progression of ADPKD. The main side effect of this treatment is increased urine output which leads to cessation of therapy in about 20% of patients. Low solute (low sodium, low protein) diet may alleviate this side effect. This is a single arm before / after study of dietary intervention on urine output and quality of life in ADPKD patients on a stable dose of tolvaptan.

NCT ID: NCT03858257 Completed - Anesthesia Clinical Trials

High Flow Nasal Oxygen During Sedation

Start date: August 7, 2019
Phase: N/A
Study type: Interventional

The primary objective of this study is to test the hypothesis that using high flow nasal oxygen improves ventilation during cardiac implantable electronic device procedures performed with conscious sedation. A randomized controlled trial design will be used with participants randomized in a 1:1 ratio to oxygen supplementation through a standard facemask or high flow nasal oxygen.

NCT ID: NCT03857464 Completed - Clinical trials for Clostridium Difficile

C Difficile Near-patient Diagnostics

Start date: January 15, 2019
Phase: N/A
Study type: Interventional

The investigators will conduct a two-period, two-intervention, cluster randomized crossover (CRXO) designed study at Foothills Hospital in Calgary, Alberta. Each cluster (hospital ward) will receive each of the two interventions in a separate approximately 6-month period of time leading to two "cluster-periods" with associated "wash-in" and "wash-out" periods attached. The two interventions are: 1) a rapid diagnostic test (RDT) using near-patient testing (NPT) for C. difficile infections (CDI); 2) testing for CDI using centralized testing facilities (standard operating procedure, 2 step algorithm). The investigators hypothesize that NPT for CDI will result in reduced patient isolation days in the hospital, decreased morbidity and mortality, reduced unnecessary antibiotic use and overall reduced costs to the health care system, including both hospital and laboratory. Our primary endpoint is to examine the differential effect of NPT on the duration of contact precautions (i.e. patient isolation days). Secondary outcomes will compare turn-around times from specimen submission to result, days of hospitalization, the number of days of antibiotic therapy, the incidence of CDI, severe CDI, and in-hospital mortality. A comprehensive economic evaluation will be performed to determine the cost of testing, patient isolation, and hospitalization for all patients in the control and treatment arms.

NCT ID: NCT03857256 Completed - Hyperlipidemias Clinical Trials

Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.

BetAvena
Start date: May 31, 2019
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the effects of adding beta-glucan (1.5 g, 3 g or 6 g daily) administered three times a day (TID) in divided doses, to atorvastatin (10 mg - 20 mg) once a day or an equivalent dose of another statin on heart disease lipid risk factors.

NCT ID: NCT03856866 Completed - Zellweger Syndrome Clinical Trials

Hydroxychloroquine Administration for Reduction of Pexophagy

HARP
Start date: January 11, 2019
Phase: Phase 2
Study type: Interventional

A series of N-of-1, crossover, randomized, placebo-controlled, double-blinded trial. Hydroxychloroquine (HCQ) and a crossover to placebo (order is randomized and blinded) will be administered in liquid suspension for 84 days (12 weeks) each with an 84 day washout in between. We hypothesize that HCQ will reduce peroxisomal turnover, which will arrest ongoing injury in PBDs caused by PEX1, PEX6 or PEX26.

NCT ID: NCT03856775 Completed - Clinical trials for Non-convulsive Seizures

Detecting Non-convulsive Seizures in the Paediatric Intensive Care Unit

Start date: August 1, 2019
Phase:
Study type: Observational

The objective of this study is to determine if paediatric intensive care nurses and physicians can identify non-convulsive seizures in critically ill children using quantitative electroencephalography (EEG), in real time at the bedside. Quantitative EEG is a computer software tool which summarizes large volumes of brain wave electrical activity, called EEG into simple graphs and patterns. This has helped to shorten the EEG reading time.The study will also describe the neurological outcome of children monitored this way and assess if it's possible to use this approach. The investigators hypothesis is that paediatric intensive care nurses and physicians with focused training should be the first to identify non-convulsive seizures at the bedside using quantitative EEG, with reasonable accuracy and reliability. They should be able to confirm their findings with a neurologist to treat seizures quickly without over treatment. Due to the small numbers in this pilot study, the investigators are unlikely to be able to draw definitive conclusions on the clinical effects of this approach on the short- or long-term outcomes. This proof-of-concept study should, enable the investigators to assess if it's possible to use this method for a future multi-centre controlled study.

NCT ID: NCT03856749 Completed - Caregivers Clinical Trials

Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users

Start date: December 4, 2019
Phase: N/A
Study type: Interventional

Although there have been a small number of studies suggesting the important role that caregivers play in assisting wheelchair users with mobility, there has never been a randomized controlled trial (RCT) looking at the effectiveness or cost-utility of wheelchair skills training for caregivers. The overall goal of this study is to correct this knowledge gap and, triggered by the COVID-19 pandemic of 2020, to conduct the training remotely. The main purpose of this study is to test if providing wheelchair skills training remotely to caregivers of manual wheelchair users enhances caregiver-assisted wheelchair skills ability and confidence in comparison to a control group of participants who are receiving usual care and self-study material on wheelchair skills. The investigators will also study whether the benefits of training are still seen at a 6-week follow-up and assess the health-economic impact of caregiver training.

NCT ID: NCT03856047 Completed - Obesity Clinical Trials

Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.

Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 8 months. Participants will have 12 clinic visits with the study doctor.