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NCT ID: NCT03904511 Completed - Anxiety Clinical Trials

Safety, Tolerability and Behavioural Effects of Souroubea-Platanus in Healthy Volunteers

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

Souroubea sympetala extracts have shown anxiolytic properties in animal models. Souroubea and its active principle betulinic acid appear to exert these effects by acting as an agonist for the benzodiazepine (BZD) binding site of the GABAA receptor with no withdrawal effects on food intake, locomotor activity, or other symptoms typically associated with BZD agonism. As such, this may offer a valuable source for an alternative anti-anxiety treatment. The primary objective of this study is to (1) to evaluate the safety and tolerability of a single daily dose of an extract of a mixture of Souroubea spp. leaf and small branch material and Platanus spp. bark when administered orally over two weeks in healthy volunteers. Based on its safety in canine trials, we hypothesize that Souroubea-Platanus (SP) preparation will be well tolerated with adverse event profile similar to placebo. The secondary objective is (2) to establish whether some of the anxiolytic properties of Souroubea-platanus seen in animal models will translate to human participants. We hypothesize that Souroubea-Platanus preparation will demonstrate anxiolytic and/or stress-reduction properties as indicated by salivary cortisol levels and self-report measures of anxiety.

NCT ID: NCT03903822 Completed - Atopic Dermatitis Clinical Trials

Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

Start date: May 13, 2019
Phase: Phase 2
Study type: Interventional

This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.

NCT ID: NCT03903770 Completed - Stroke Clinical Trials

Personalized Upper Extremity Rehabilitation for Persons With Stroke

SUPER
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Approximately 80% of individuals with chronic stroke present with long lasting upper extremity (UE) impairments. Advances in rehabilitation technology, such as robotics, virtual reality (VR) and neuromuscular electrical stimulation (NMES), have separately demonstrated their effectiveness in improving UE function of individuals with stroke. The potential to influence recovery may be further enhanced by combining these modalities in order to target motor deficits of the individual. Research has shown that not all persons with stroke may be able to recover hand function. In particular, such recovery depends on the integrity of the corticospinal tract (CST), which links the motor areas of the brain to the UE (and hand) musculature. Instead of using a 'one-size-fits-all' approach to UE rehabilitation, CST integrity will be assessed through transcranial magnetic stimulation (TMS), a non-invasive approach, and match the intervention to the individual's specific impairments. The perSonalized UPper Extremity Rehabilitation (SUPER) intervention is proposed, which combines robotics, VR activities, and NMES. The objectives of this study are to determine the feasibility of the SUPER intervention in individuals with moderate/severe stroke. Stroke participants will receive a 5-week intervention (3x per week) combining robotic therapy and VR activities, based on their functional level. Those with low potential for hand recovery will receive an intervention focussing on elbow and shoulder movements. For those with a good potential for hand recovery, the last 30 minutes of the robotic or VR session will be complemented by muscle-triggered NMES. Feasibility indicators associated with process, resources, management and treatment will be measured. Outcomes of UE and hand function will include the Fugl-Meyer upper extremity assessment, the Box and Block test and the ABILHAND. It is expected that feasibility criteria will be met and that the SUPER intervention will lead to significant improvements in UE impairment compared to a waitlist group.

NCT ID: NCT03903484 Completed - Polypharmacy Clinical Trials

Deprescribing in Primary Health Care

Start date: April 26, 2019
Phase: N/A
Study type: Interventional

Medications can help older adults but can also harm them. Frail older adults tend to have many health problems that require treatment, but are also at risk of harm from the medications prescribed. This makes it hard to get older adults the treatments they need and keep them safe from the harms from medications. It ends up that a lot of visits to emergency rooms and hospitals are due to medications, especially for older adults. Previous research has shown the benefits of stopping medications older adults no longer need. Even so, healthcare professionals do not always do this as well as they could. Our goal is to make a collection of resources for pharmacists who work with doctors and nurses in primary settings that will help support older adults as they safely stop medications that are no longer needed. The investigators will use knowledge and tools that are already known and published. In the first six months the team, which includes older adults and their families, pharmacists, doctors, nurses, and healthcare policymakers developed a framework and resource toolbox that pharmacists can use to help older adults stop medications that are no longer needed. In the remaining 10 months, the investigators will use the resource toolbox in primary healthcare teams and nursing homes. Overall, the investigators expect that by using the resources the pharmacists will be able to support patients stop medications they no longer need and help reduce the number of pills people take, reduce drug costs, reduce harms from medication use and improve quality of life for frail older adults and their loved ones.

NCT ID: NCT03902834 Completed - Clinical trials for Lung Cancer, Nonsmall Cell

Move for Surgery (MFS): Evaluating the Use of Wearable Technology for Preconditioning Before Thoracic Surgery

Start date: November 30, 2017
Phase: N/A
Study type: Interventional

Wearable technology is increasingly being used to promote healthy behaviour. In this study, the investigators propose the development and evaluation of Move for Surgery, which utilizes a wearable activity bracelet (Fitbit) and proven behavioural change techniques, for preconditioning of patients prior to lung cancer surgery. The primary outcome of this study will be compliance with Move for Surgery, as a surrogate measure for feasibility. Secondary outcomes, including accrual rates, perioperative pulmonary complications, cost per patient, and patient satisfaction, will also be collected. The investigators have partnered with the Canadian Partnership Against Cancer (CPAC) and Lung Cancer Canada (LCC) to develop Move for Surgery. The ultimate goal of this preliminary study is to lay the groundwork for a subsequent comparative trial to evaluate the impact of Move for Surgery on postoperative complications in the thoracic surgery population.

NCT ID: NCT03902782 Completed - Lung Cancer Clinical Trials

Erector Spinae Plane Block Versus Intercostal for VATS

Start date: June 26, 2019
Phase: N/A
Study type: Interventional

The Erector Spinae Plane (ESP) block is a new interfascial regional anesthesia technique recently described by Forero et al. Currently the literature shows the ESP block being used for analgesia after thoracic surgery, breast surgery, abdominal surgery (visceral abdominal analgesia in bariatric surgery, ventral hernia repair, cholecystectomy), thoracic vertebral surgery and for pain relief in rib fractures. Taking in consideration the excellent clinical experience, but the lack of strong and high-quality evidence, supporting the use of ESP block for pain management in patients undergoing VATS procedures, there is a specific interest to develop a prospective study. Comparing the effect of the current pain relief strategy at the MGH (intercostal nerve block by the surgeon at the end of the procedure ) versus ESP block after VATS, seems warranted to improve current clinical results.

NCT ID: NCT03902080 Completed - Overactive Bladder Clinical Trials

Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

Start date: March 26, 2019
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.

NCT ID: NCT03901339 Completed - Clinical trials for Metastatic Breast Cancer

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer

TROPiCS-02
Start date: May 8, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

NCT ID: NCT03900039 Completed - Clinical trials for Arthroplasty Complications

An Assessment of 4 Different Bearing Types in Hip Replacement Types to Analsye the Lowest Wear Rates of Polyethylene

Start date: July 26, 2005
Phase: N/A
Study type: Interventional

The aim of the study is to assess the ideal bearing surfaces in hip replacement by comparing 4 different combinations. In a hip replacement this means what the head and the socket liner are made of.

NCT ID: NCT03899285 Completed - Clinical trials for Major Depressive Disorder

Citalopram Titration in Early Non-responder Patients With Major Depressive Disorders

CRY-MOOD
Start date: January 8, 2018
Phase: Phase 2
Study type: Interventional

Major depressive disorder is a common mental disorder and the leading cause of disability worldwide. According to the Canadian Network for Mood and Anxiety Treatment, early improvement following an antidepressant treatment is correlated with response and remission. Escalation of an antidepressant dose after 2 weeks, as opposed to 4 to 8 weeks, is proposed to favor early improvement. However, this has never been tested systematically in a controlled study involving major depressive disorder patients that are non-responders to their antidepressant treatment.