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NCT ID: NCT04070326 Completed - Clinical trials for Hereditary Angioedema

A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children

SPRING
Start date: August 19, 2019
Phase: Phase 3
Study type: Interventional

The main aims of this study are to learn how lanadelumab moves through a child's body and if the children have any medical problems from lanadelumab. Other aims are to learn if prophylactic treatment with lanadelumab reduces the number and severity of HAE attacks in children, how lanadelumab affects the child's body, and if the children develop antibodies to lanadelumab. The study doctors will treat acute HAE attacks according to their standard practice. Participants will receive lanadelumab for up to 52 weeks. When they start treatment, participants will visit their clinic every week for the first 4 weeks. Then, they will visit their clinic every 4 weeks during treatment.

NCT ID: NCT04070209 Recruiting - Clinical trials for Metastatic Prostate Cancer

Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)

Start date: October 19, 2020
Phase: Phase 2
Study type: Interventional

This is the first pilot phase II trial assessing the response of SBRT layered on Darolutamide (BAY1841788) on RPFS and deferring palliative second line systemic therapy in M0CRPC with oligoprogression.

NCT ID: NCT04070079 Recruiting - Clinical trials for Hepatitis B, Chronic

Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B:

Start date: January 29, 2019
Phase: Phase 4
Study type: Interventional

The objective of this study is to identify immunological mechanisms that contribute to normalization of liver inflammation in chronic hepatitis B (CHB) patients starting the antiviral nucleoside analogue, Tenofovir alafenamide (TAF).

NCT ID: NCT04070053 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) Pathway

TheraPPP
Start date: August 23, 2019
Phase: N/A
Study type: Interventional

Treatment of patients with Hypoxemic respiratory failure (HRF) and Acute Respiratory Distress Syndrome (ARDS) is complex. Therapies that have been shown to save the lives of patients with HRF and ARDS are available but they are not always provided. To reduce practice variation and improve adherence to evidence-informed therapies, the investigators developed the Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway. The purpose of this pilot study is to test the feasibility and acceptability of the TheraPPP Pathway. To assess feasibility, the investigators will test the ability to measure adherence to the pathway as well as patient and economic outcomes. To assess perceptions about the acceptability of the TheraPPP Pathway, the investigators will conduct a survey to clinicians who used the Pathway.

NCT ID: NCT04069481 Recruiting - Chronic Stroke Clinical Trials

Dance for the Improvement of Balance and Gait After Stroke

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

Stroke can drastically impact the ability to walk and keep your balance. In addition people with chronic stroke feel social isolated, become less satisfied with their walking and lose confidence in their ability to move without falling. Ned new treatments are needed for walking and balance. Dancing is a fun, social activity that has similar benefits to traditional exercise. Another benefit of dancing is the use of music, which improves mood, increases motivation and can even improve motor performance. Finally, moving in synchrony with other people during dancing can make people feel connected. We believe that dance classes can benefit people with stroke, but few studies have been done. The objective of our project is to conduct a randomized controlled trial to test whether dance can improve balance and walking for people with chronic stroke. The investigators are also interested in whether dancing improves people's confidence in their ability to do activities without losing their balance (i.e. balance confidence), decreases their feelings of isolation and increases their quality of life.

NCT ID: NCT04069260 Terminated - Genetic Disease Clinical Trials

A Phase 2 Study of ELX-02 in Patients With Nephropathic Cystinosis

Start date: August 2, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2 open label study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 in patients with cystinosis with nonsense mutation in at least one allele. Six patients will be enrolled in the trial. The study will comprise of the following periods for each patient: - A screening period of up to 6 weeks - A total treatment period of 4 weeks - A safety follow-up period of 4 weeks after the last treatment Each patient will receive three escalating doses as follows: - Treatment period 1: ELX-02 0.5 mg/kg SC daily for 7 days (total dose not to exceed 3.5 mg/kg for this week; the daily dose will be individualized to achieve the target weekly exposure of about 47.5 µg*h/mL) - Treatment period 2: ELX-02 1.0 mg/kg SC daily for 7 days (total dose not to exceed 7.0 mg/kg for this week; the daily dose will be individualized to achieve the target weekly exposure of about 95 µg*h/mL) - Treatment period 3: ELX-02 2.0 mg/kg SC daily for 14 days (total dose not to exceed 14 mg/kg for these two weeks; the daily dose will be individualized to achieve the target weekly exposure of about 190 µg*h/mL)

NCT ID: NCT04069169 Completed - Clinical trials for Scoliosis; Adolescence

IV Lidocaine Analgesia in Pediatric Scoliosis Surgery

P-IVLT
Start date: December 18, 2019
Phase: Phase 3
Study type: Interventional

Surgical correction of scoliosis in children is a long procedure, with an equivalently long recovery time, that is commonly performed at BC Children's Hospital. Treating pain immediately after the procedure is a priority for children during recovery. Morphine is one medication that can be used to manage post-operative pain, but unfortunately, its use is accompanied by a number of side effects which can affect recovery. These include nausea, vomiting, pruritus, sedation, dysphoria, respiratory depression, constipation, ileus, and urinary retention. In order to control pain and reduce morphine consumption, intravenous lidocaine is being investigated. This therapy has been beneficial in adult populations undergoing abdominal surgery and has been associated with decreased post-operative pain, decrease use of opioids including morphine, and ileus. These all contribute to shorter lengths of stay in the hospital and better recovery in the adult population. Intravenous lidocaine is used by some anesthesiologists at BC Children's Hospital to manage post-operative pain in children receiving surgical correction for scoliosis, but this is not a standard of practice. We now propose to conduct a double-blind randomized controlled trial to determine if intravenous lidocaine, infused from start of anesthesia up to 48 hours post-operatively, will reduce morphine use and improve post-operative pain in the pediatric population.

NCT ID: NCT04069156 Completed - Heart Failure Clinical Trials

The ARIES HeartMate 3 Pump IDE Study

Start date: July 14, 2020
Phase: N/A
Study type: Interventional

Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo

NCT ID: NCT04069052 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

The Effect of Inhaled Nitric Oxide on Deadspace in COPD

Start date: September 1, 2021
Phase: Early Phase 1
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is a progressive disease of the respiratory system that generally develops as a result of smoking. Most people with COPD are classified as having "mild" disease severity and may not have significantly impaired lung function (e.g. flow) as measured by traditional lung function tests. However, multiple studies have shown that patients with mild disease already have significant damage to the small airways and blood vessels of the pulmonary system. This results in a considerable portion of the lung that does not participate in gas exchange, a phenomenon called physiologic dead space. Mild COPD patients develop symptoms of intolerable breathlessness early in exercise compared with healthy individuals. Previous studies have shown that pulmonary vasodilators, which locally increase blood vessel radius, may improve gas exchange and reduce symptoms of breathlessness in patients with mild COPD. Therefore, the objective of this study is to determine the effect of reducing dead space with a pulmonary vasodilator on the intensity of breathlessness during exercise in patients with mild COPD. This five visit, double-blinded, placebo-controlled crossover study will test the impact of inhaled nitric oxide, a direct vasodilator, during cardiopulmonary exercise on dead space and breathlessness intensity. Use of an esophageal catheter during testing will additionally permit measurement of neural drive to breathe and pulmonary mechanics throughout the protocol. Though patients with mild COPD represent the majority of the COPD population, their symptoms remain poorly managed by current, inefficient standard of care. The proposed study will examine dead space reduction as a novel therapeutic target for improving breathlessness and exercise tolerance in patients with mild COPD.

NCT ID: NCT04069026 Completed - Clinical trials for Advanced Solid Tumors

A First-in-Humans Dose Finding Study for an Aryl Hydrocarbon Receptor Inhibitor (AhRi) in Patients With Advanced Cancer

Start date: August 15, 2019
Phase: Phase 1
Study type: Interventional

In this study researchers want to gather relevant information regarding the safety of BAY2416964 and how well the drug works in participants with a type of solid tumors that cannot be cured by currently available drugs. Researchers want to find the highest dose of BAY2416964 that participants could take without having too many side effects, how the drug is tolerated and the way the body absorbs, distributes and gets rid of the study dug. BAY2416964 is a small molecule which blocks the Aryl Hydrocarbon Receptor (a protein involved in immune cell reaction to tumor cells) allowing the body to use its immune response against the tumor cells.