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NCT ID: NCT05099003 Recruiting - Glioblastoma Clinical Trials

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Start date: May 31, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink tumors in this patient population. Glioma is a type of cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when it is growing and spreading quickly. The term, risk, refers to the chance of the cancer coming back after treatment. DIPG is a subtype of HGG that grows in the pons (a part of the brainstem that controls functions like breathing, swallowing, speaking, and eye movements). This trial has two parts. The only difference in treatment between the two parts is that some subjects treated in Part 1 may receive a different dose of selinexor than the subjects treated in Part 2. In Part 1 (also called the Dose-Finding Phase), investigators want to determine the dose of selinexor that can be given without causing side effects that are too severe. This dose is called the maximum tolerated dose (MTD). In Part 2 (also called the Efficacy Phase), investigators want to find out how effective the MTD of selinexor is against HGG or DIPG. Selinexor blocks a protein called CRM1, which may help keep cancer cells from growing and may kill them. It is a type of small molecule inhibitor called selective inhibitors of nuclear export (SINE). Radiation therapy uses high energy to kill tumor cells and shrink tumors. The combination of selinexor and radiation therapy may be effective in treating patients with newly-diagnosed DIPG and H3 K27M-Mutant HGG.

NCT ID: NCT05098574 Recruiting - Bipolar Disorder Clinical Trials

Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder

Start date: November 30, 2022
Phase: Phase 2
Study type: Interventional

This study is a pilot, randomized, placebo-controlled trial evaluating the treatment of Premenstrual Dysphoric Disorder comorbid with Bipolar Disorder using combined oral contraceptives. Lay Summary: This study is being done with the hope of finding a safe and effective treatment for individuals who experience both bipolar disorder and severe premenstrual symptoms. As part of this clinical trial, participants will receive either a combined oral contraceptive (i.e. oral birth control pills) as a treatment for severe premenstrual symptoms or a placebo (a pill without any active components - similar to a sugar pill). People that are enrolled in this study will either receive the treatment or the placebo for a period of 90 days. During this time, people that are participating in the study will fill out some questionnaires, and their mental and physical health will be monitored by the study physicians. One of the goals of this study is to also understand whether it is feasible (practical) to do a larger clinical trial using this treatment in this group of people.

NCT ID: NCT05098535 Recruiting - Risk Clinical Trials

Remembering Risk Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery

Start date: October 28, 2021
Phase: N/A
Study type: Interventional

Disclosure of anticipated risks to individuals considering undergoing an elective operative procedure is an important aspect of informed consent process. Recent Canadian Guidelines have highlighted the importance of perioperative risk discussion within the context of preoperative assessment but there is little prior research into potential interventions to optimize the communication of risks. Myocaridal injury (MINS) is the most common complication and this study is focused on determining the effectiveness of current communication strategies in our presurgical consultations and to quantifying the impact of introducing a visual aid and scripted risk discussions has on patients ability to recall their individualized perioperative risk of myocardial injury.

NCT ID: NCT05098028 Completed - Sickle Cell Disease Clinical Trials

Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease

Start date: March 22, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study in sickle cell disease participants with a history of Vaso-occlusive Crises (VOCs). Approximately 60 participants with sickle cell disease will be enrolled and randomized: 12 participants in each of four active novel formulation rifaximin groups and 6 participants in each of 2 placebo groups.

NCT ID: NCT05097586 Recruiting - Pregnancy Clinical Trials

RCT of At-Home tDCS for Depression in Pregnancy

Start date: November 8, 2021
Phase: N/A
Study type: Interventional

This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum

NCT ID: NCT05097430 Active, not recruiting - Clinical trials for Hazardous Alcohol Use

PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)

Start date: September 28, 2021
Phase: N/A
Study type: Interventional

The present investigation entails a pilot randomized controlled trial to explore whether a stand-alone, alcohol-reduction, brief intervention (with a module on substance use and depression) would be feasible, acceptable, and potentially efficacious within the context of HIV pre-exposure prophylaxis (PrEP) treatment.

NCT ID: NCT05097287 Recruiting - Asthma Clinical Trials

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

ATLAS
Start date: December 16, 2021
Phase: Phase 4
Study type: Interventional

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

NCT ID: NCT05097222 Completed - Clinical trials for Mild Traumatic Brain Injury

Impact of Photobiomodulation on Objective, Physiological Measures of Brain Function in Individuals With Post-Concussion Syndrome

Start date: January 27, 2022
Phase: N/A
Study type: Interventional

Photobiomodulation therapy (PBMT) uses light to influence the mitochondria of cells. PBMT of the brain enhances the metabolic capacity of neurons and stimulates anti-inflammatory, anti-apoptotic, and antioxidant responses, as well as neurogenesis and synaptogenesis. Its therapeutic role in disorders such as dementia and Parkinson's disease, as well as to treat stroke, brain trauma, and depression has gained increasing interest. BioFlex is a form of PBMT consisting of light-emitting diodes (LEDs) and laser diodes. BioFlex utilizes red and near infrared light which penetrates tissues up to a certain tissue depth and studies have shown stimulates tissue growth and repair at the cellular level. PBMT has been proven useful for the treatment of soft tissue pain. Several studies have shown benefit in using PBMT in the treatment of certain neurological conditions, including chronic, mild traumatic brain injury (mTBI). The purpose of this exploratory investigation, therefore, is to examine efficacy of BioFlex laser therapy on measures of brain function in patients suffering from PCS after mild-moderate, closed-head, traumatic brain injury cases.

NCT ID: NCT05096403 Suspended - Clinical trials for Cold Agglutinin Disease

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)

Start date: October 20, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine the efficacy of pegcetacoplan administration compared to placebo in increasing hemoglobin (Hgb) level from baseline and avoiding transfusion in participants with primary cold agglutinin disease (CAD).

NCT ID: NCT05096195 Recruiting - Kidney Diseases Clinical Trials

PRevEnting FracturEs in REnal Disease 1

PREFERRED-1
Start date: June 11, 2022
Phase: Phase 4
Study type: Interventional

PREFERRED-1 is a pilot study for a large randomized, pragmatic, open-label, comparative-effectiveness trial. The pilot study will enroll at least 60 patients from at least 6 different hemodialysis centres in Ontario, Canada. Patients on outpatient maintenance hemodialysis at high risk of fragility fracture, will be randomized 1:1 to a denosumab care pathway vs. usual care