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NCT ID: NCT04671433 Active, not recruiting - Clinical trials for X-Linked Retinitis Pigmentosa

Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene

Start date: December 4, 2020
Phase: Phase 3
Study type: Interventional

A clinical trial of AAV5-RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)

NCT ID: NCT04670783 Completed - Surgery Clinical Trials

Surgery and Neuroablative Procedures in Spasticity

Start date: September 15, 2020
Phase:
Study type: Observational [Patient Registry]

For many patients with spasticity, traditional therapies have not achieved maximal outcomes. Due to common complaints such as pain, limb positioning and hygiene concerns, there has been an increase demand for other adjunctive therapies like surgeries and other interventions. This spasticity multidisciplinary clinic consisting of a physiatrist, plastic surgeon and anesthesiologist is performing a novel approach to refractory spasticity to triage and designed a treatment plan for them as routine medical care. This study will document the efficacy of this novel designed multidisciplinary approaches for intervention in complex spasticity patients, and will develop a decision-making algorithm in spasticity including both traditional treatment (i.e. botulinum toxin , bracing) and novel treatments(i.e. neurectomy , cryoneurotomy).

NCT ID: NCT04670016 Recruiting - Radiation Toxicity Clinical Trials

HRQL and Symptom Assessment for Patients With DIPG or Recurrent and Re-irradiated Brain Tumours and Their Caregivers

Start date: July 2, 2020
Phase:
Study type: Observational [Patient Registry]

Although many children with brain tumours are successfully cured of their disease, a substantial proportion of patients suffer disease recurrence and require further treatment. This therapy may involve a repeat course of radiation (RT2). Based on retrospective data, re-irradiation may provide palliative and even potentially curative benefit. However, such retrospective data are subject to bias, which may over-report survival and under-report toxicity. Furthermore, we do not know how re-irradiation affects patients' HRQOL. The goal of this research is to prospectively describe the HRQOL of patients diagnosed with DIPG and recurrent brain tumors and their families before and after re-irradiation to more accurately assess the benefit versus the toxicity of this treatment. In addition, if we are able to demonstrate the feasibility of collecting HRQOL information on a routine basis we will be able to justify the need to conduct this research further and implement HRQOL screening as a standard of care for these patients. Re-irradiation for children with DIPG and recurrent brain tumours will not cure these children from their disease but may improve neurological function and wellbeing. We postulate that the opportunity of more time to say the final good bye and creating memories will facilitate bereavement and prevent psychological dysfunction of parents and siblings. A greater understanding of what helps these families may enable clinicians to better support these children and their families in this difficult disease course. Ultimately our goal is to improve the psychological experience of these patients and their families.

NCT ID: NCT04669015 Recruiting - Covid19 Clinical Trials

Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19

NOVATION-1
Start date: June 10, 2021
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blind, multicenter, placebo-controlled trial to evaluate the safety and efficacy of a novel therapeutic agent, Novaferon, in hospitalized adult patients diagnosed with COVID-19. The study is comprised of two cohorts: - Cohort A: This is a blinded safety lead-in comprising two arms. 40 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus Standard of Care (SOC) - Cohort B: This is the main portion of the study, which comprises two arms. Up to 874 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC

NCT ID: NCT04668950 Completed - Covid19 Clinical Trials

Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2)

Start date: December 22, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. People around the United States and Canada can participate.

NCT ID: NCT04667377 Completed - Obesity Clinical Trials

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

Start date: March 8, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine. Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.

NCT ID: NCT04666974 Recruiting - Anxiety Disorders Clinical Trials

Delivering iCBT to Address Mental Health Challenges in Correctional Officers and Other Public Safety Personnel

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Public safety personnel (PSP) have regular and often intense exposure to potentially traumatic events at work and are at higher risk for developing mental health problems such as posttraumatic stress disorder (PTSD). Studies have shown up to 4 times higher suicidal ideation, attempt and death among this population compared to the general population. Despite the high rate of mental health problems among PSPs, their willingness to receive mental healthcare support is fairly low, mainly due to the stigma attached to these disorders. Those who are willing to seek help face unique barriers including their irregular shift hours, limiting their access to resources otherwise available to the public. Given these challenges and the critical contribution of PSPs to public safety, developing innovative solutions to address their mental health must be a healthcare priority. This proposal aims to study the efficacy of using an innovative approach in delivering mental health online, to address mental health problems among correctional workers (CW), who are especially prone to mental health problems given the high rate of workplace violence. It is hypothesized that using an online platform to deliver cognitive behavioural therapy (CBT), would lower the stigma of receiving care in a secure and confidential environment, easing CW's concerns about stigma from co-workers. The content is delivered through interactive and engaging therapy modules, designed for specific groups of CWs and customized by situational examples to make therapy more relatable. These online modules would provide CWs with 24/7 access to therapy content, solving the irregular work hour problem. The online CBT modules developed in this study would provide high quality and clinically validated resources to address mental health problems of CWs all across Canada. Knowledge acquired through this project could also be beneficial to using iCBT in general for addressing mental health challenges among other PSPs.

NCT ID: NCT04666831 Completed - Binge Eating Clinical Trials

Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction

AMI+CBTforFA
Start date: March 7, 2021
Phase: N/A
Study type: Interventional

Food addiction is the concept that individuals can be "addicted" to foods, particularly highly processed foods. This concept has attracted growing research interest given rising obesity rates and the engineering of food products. Although food addiction is not a recognized mental disorder, individuals do identify as being addicted to foods and self-help organizations have existed since 1960 to purportedly treat it (i.e., through abstinence). However, little research has been conducted on how abstinence approaches work. Such methods may even be harmful given the risk of disordered eating. Currently, there are no empirically supported treatments for food addiction. However, evidence-based treatments do exist for addictions and eating disorders, such as motivational interviewing and cognitive behavioural therapy, which may prove beneficial for food addiction, given neural similarities between addictions and binge eating. The current study proposes a randomized controlled trial using a four-session adapted motivational interviewing (AMI) and cognitive behavioural therapy (CBT) intervention for food addiction. This intervention combines the personalized assessment feedback and person-centred counseling of AMI with CBT skills for eating disorders, such as self-monitoring of food intake. The aim is to motivate participants to enact behavioural change, such as reduced and moderate consumption of processed foods. Outcome measures will assess food addiction and binge eating symptoms, self-reported consumption of processed foods, readiness for change, eating self-efficacy, and other constructs such as emotional eating. The intervention condition will be compared to a waitlist control group. Both groups will be assessed at pre- and postintervention periods, as well as over a 3-month follow-up period to assess maintenance effects. Based on a power analysis and previous effect sizes following AMI interventions for binge eating, a total sample size of n = 58 is needed. A total of 131 individuals will be recruited to account for previous exclusion and withdrawal rates. Participation is estimated to take place from March 2021 to March 2022. All intervention sessions will be conducted virtually over secure videoconferencing technology or telephone, expanding access to all adult community members across Ontario, Canada. Twenty randomly selected session tapes will be reviewed for MI adherence.

NCT ID: NCT04666558 Completed - Cancer Clinical Trials

Heal-Me Personalized Online Nutrition and Exercise Routines

PiONEeR
Start date: November 30, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease. Participants will be randomized to one of three groups: (i) standard care, (ii) a personnel-light app-based intervention, (iii) a personnel-intensive app-based intervention. Participants randomized to standard care will receive exercise and nutrition resources as well as a Garmin watch. Participants in the experimental groups will receive standard care, plus a 12-week multidisciplinary app-based personalized program involving 12 weeks of exercise programming and 10-weeks of nutrition programming. Participants in study group 3 will receive additional one-on-one care. The Research Ethics Board at the University of Alberta has approved this study. The protocol will measure patient-related outcome measures including physical function, quality of life, social isolation, and anxiety, as well as measures of acceptability and cost. 216 participants will take part in this study (n=72 per arm). Analyses: fitness testing and patient-reported outcomes will be administered before and after the intervention. Fitness and patient-reported outcomes will be compared using linear mixed models with random effects. App acceptability will be compared between groups using Chi-Square.

NCT ID: NCT04666545 Active, not recruiting - Clinical trials for Living Donor Kidney Transplantation

Multidisciplinary Support To Access Living Donor Kidney Transplant-Pilot

MuST AKT
Start date: May 12, 2021
Phase: N/A
Study type: Interventional

For patients with kidney failure the two treatment options are kidney transplantation or dialysis. Transplantation offers longer survival, better quality of life and provides cost savings for the health system (>$60,000/year per patient). Unfortunately, there are not enough organs available and 20% of patients die on dialysis waiting for a deceased donor kidney. Living kidney donation is a safe and proven treatment that leads to even better patient and health system outcomes than deceased donor kidney transplant. The Kidney Health Strategic Clinical Network (KH-SCN) identified increasing living kidney donation as a priority and in 2015 established the Living Donor Kidney Transplant Working Group (LDKTWG) comprised of patients, donors, health care professionals, researchers, and administrators. In an evidenced review published by the investigators, the intervention with the best evidence and greatest impact was personalized support provided by a multidisciplinary team to inform and educate the patients' social network. This intervention increased living kidney donations by 34%. The investigators confirmed through a province wide survey that many patients with kidney failure are unable to find a living kidney donor and find it difficult to approach potential donors due to lack of skills, supports, and resources and these issues are particularly apparent in vulnerable populations. The investigators have developed the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention to support patients in identifying and communicating with their social networks. The investigators will test the effectiveness of this intervention.