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NCT ID: NCT04559217 Recruiting - Neuroblastoma Clinical Trials

68Ga-DOTATATE Neuroblastoma Imaging Pilot

Start date: December 6, 2021
Phase: Phase 2
Study type: Interventional

Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Staging of the disease can be done by different imaging strategies (CT, MRI, scintigraphy and PET/CT). Discrepancies may be observed among these different strategies resulting in different treatment strategies. The goal of this study is to assess the feasibility and safety of 68Ga-DOTATATE and to compare it to 123I-MIBG when investigating neuroblastoma.

NCT ID: NCT04558879 Recruiting - Parkinson Disease Clinical Trials

Exercise and Sleep in Parkinson's Disease

Start date: September 15, 2021
Phase: N/A
Study type: Interventional

This study will investigate the impact of two common exercise modalities, cardiovascular and resistance training, on sleep quality and architecture in persons with Parkinson's disease (PD), and whether these potential positive changes in sleep are associated with improvements in brain plasticity and different quality of life (QoL)-related aspects. Participants will perform either cardiovascular training (CT) or resistance training (RT) for 12 weeks, at least two times/week. The assessments will be performed at baseline and after training by an assessor blinded to the participants' group allocation.

NCT ID: NCT04558593 Recruiting - Complex Renal Cyst Clinical Trials

Surveillance of Complex Renal Cysts - The SOCRATIC Study

SOCRATIC
Start date: February 2, 2021
Phase:
Study type: Observational

One third of individuals aged >60 years will be diagnosed with at least one renal cyst following abdominal imaging. These cystic lesions are categorized according to the Bosniak classification which categorizes cysts according to their degree of complexity and risk of malignancy. Growing evidence suggests that a significant proportion of Bosniak III and IV cysts are benign and that the malignant ones present low metastatic potential. Since renal surgery carries substantial morbidity (20%) and potential mortality (0.5%), active surveillance has gained attention as a potential tradeoff to surgery to overcome overtreatment. Therefore, prospective studies of long-term follow-up are needed to confirm the oncologic safety of this strategy for patients with Bosniak III/IV cysts. This is an multicenter prospective observational longitudinal study. The main objective is to compare the 5-year follow-up cancer-specific survival between the active surveillance and the surgical groups.

NCT ID: NCT04557462 Recruiting - Clinical trials for Primary IgA Nephropathy

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

Start date: September 20, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.

NCT ID: NCT04553419 Recruiting - Cystic Fibrosis Clinical Trials

Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF

ASAP-CF
Start date: July 27, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blinded study that aims to assess the effect of an oral antibiotic called Cephalexin (150 mg/kg/day) compared to placebo in clinically stable children with cystic fibrosis who have grown a bacteria called MSSA (methicillin-susceptible Staphylococcus aureus) over the course of 2 weeks. A sensitive technique called MBW (multiple breath washout) will be used to look at how well the participants lungs are functioning during the study and to see if the antibiotic improves function. The primary outcome of the study will be the relative change in the MBW measurement (LCI2.5) between day 0 and day 14 of study treatment.

NCT ID: NCT04550117 Recruiting - Clinical trials for Spinal Cord Injuries

Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study

Start date: June 23, 2020
Phase: N/A
Study type: Interventional

Intraspinal pressure monitoring has been advanced as a potential technique for evaluating spinal cord perfusion after traumatic spinal cord injury. In this study, the investigators aim to validate the technique for insertion of a fiberoptic pressure monitoring device in the subarachnoid space at the site of injury for measurement of intraspinal pressure and spinal cord perfusion pressure. The primary objective of this study is to validate the methodology of invasive intraspinal pressure monitoring to derive parameters for optimal spinal cord perfusion pressure, spinal cord reserve capacity and spinal reactivity index using data obtained during the patient's stay in the intensive care unit. Secondary objectives of this study will be to a) evaluate the safety of invasive intraspinal pressure monitoring, b) prospectively evaluate the overall relationship between spinal cord perfusion pressure and functional outcomes in patients with acute traumatic spinal cord injury and c) evaluate the relationship between spinal cord perfusion pressure, motor evoked potentials and functional outcomes after incomplete spinal cord injury.

NCT ID: NCT04549636 Recruiting - Healthy Clinical Trials

COVID-19 Related Lung Ventilation and Perfusion Injury

Start date: October 18, 2020
Phase:
Study type: Observational

Little is currently known about the immediate and long-term effect of COVID-19 on lung ventilation (delivery of air to the lungs) and lung perfusion (delivery of blood to the lungs). Some people who survive COVID-19 may have lung ventilation and/or perfusion injury that persists following COVID-19 recovery. This lung injury may be related to inflammation in the lung, breathlessness, exercise limitation and reduced quality of life. Therefore, towards the goal of understanding the effects of COVID-19 on lung health, the purpose of this study is to characterize and understand the clinical relevance of COVID-19 related lung ventilation and perfusion injury and associated inflammatory status, ≤4 weeks and 6-months following COVID-19 recovery in an asthmatic and healthy population. To do this, an asthmatic and healthy population who have, and have not, been previously diagnosed with COVID-19 will be studied.

NCT ID: NCT04549207 Recruiting - Breast Cancer Clinical Trials

Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer

Start date: October 9, 2020
Phase: Phase 4
Study type: Interventional

The investigators propose is to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and castration-resistant prostate cancer

NCT ID: NCT04548713 Recruiting - Clinical trials for Catheter Complications

CLiCK in the Critical Care Unit

CLiCK
Start date: March 22, 2022
Phase: N/A
Study type: Interventional

Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADss are prone to complications such as infection, bacterial biofilm production, and catheter occlusion due to a thrombus. A CVAD is placed in up to 97% of patients in the intensive care unit, exposing this vulnerable population to risk of nosocomial infection and occlusion. Current standard of care involves use of normal saline (for CVCs and PICCs) or citrate (for hemodialysis catheters) as a catheter locking solution. CVAD complications remain a problem with current standard of care. 4% tetrasodium Ethylenediaminetetraacetic acid (EDTA) fluid (KiteLock Sterile Locking Solution) possesses antimicrobial, anti-biofilm, and anti-thrombotic properties and is approved by Health Canada as a catheter locking solution. As such, it may be superior CVC locking solution than the present normal saline or citrate lock. To our knowledge, the efficacy of an EDTA catheter locking solution has not yet been investigated in the intensive care patient population. Our team proposes to fill this knowledge gap by performing a multi-centre, cluster-randomized, crossover study evaluating the impact of KiteLock Sterile Locking Solution on a primary composite outcome of CLABSI, intraluminal occlusion, and alteplase use in the ICU of six ICU's compared to the standard of care saline lock.

NCT ID: NCT04548661 Recruiting - Clinical trials for Surgical Site Infection

Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation

Start date: August 2, 2023
Phase: N/A
Study type: Interventional

A surgical site infection (SSI) is an infection that occurs after a surgical procedure. Despite a variety of infection prevention strategies, SSIs still occur often and impose a significant burden on patients and the healthcare system. Intraoperative irrigation (or washing of the surgical incision before closure) may reduce SSIs, but this is uncertain. The Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation (CLEAN Wound) trial aims to determine if incisional wound irrigation with an antiseptic or salt water solution can reduce SSIs within 30 days of surgery compared to no wound irrigation. 2,500 patients aged 18 years or older who are planned to undergo an abdominal or groin open or laparoscopic procedure will be randomly assigned to incisional wound irrigation with povidone-iodine solution; or incisional wound irrigation with saline; or no irrigation and followed for 30 days after surgery to assess the incidence of SSIs, with additional outcomes collected up to 90 days after surgery. Even with significant advances in medicine over the past decades, there are still many fundamental issues in perioperative care that remain unclear due to lack of evidence. If this trial were to demonstrate that intraoperative wound irrigation reduces the incidence of SSI, these practice-changing findings could greatly benefit patients worldwide.