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NCT ID: NCT04699474 Recruiting - Clinical trials for Spinal Cord Injuries

Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury

PROMPT-SCI
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

PROMPT-SCI (Protocol for Rapid Onset of Mobilization in Patients with Traumatic SCI) is a single-site single-arm proof-of-concept trial. Forty-five patients aged 18 years or older who have sustained a severe traumatic SCI (American Spinal Injury Association Impairment Scale grade A, B or C) from C0 to L1 and undergoing spinal surgery within 48 hours of the injury will be included. Participants will receive daily 30-minute sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours after spinal surgery. The feasibility outcomes consist of the 1) absence of serious adverse events associated with cycling sessions, 2) completion of at least 1 full session within 48 hours after spinal surgery for at least 90% of participants, and 3) completion of at least 11 sessions for at least 80% of participants. Patient outcomes 6 weeks and 6 months after injury will be measured from neurofunctional assessments, quality of life questionnaires and inpatient length of stay. Feasibility and patient outcomes will be analysed with descriptive statistics. Patient outcomes will also be compared to a matched historical cohort not receiving in-bed cycling.

NCT ID: NCT04699188 Recruiting - Lung Cancer Clinical Trials

Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

KontRASt-01
Start date: February 24, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.

NCT ID: NCT04698915 Terminated - Clinical trials for Unresectable Pancreatic Cancer

Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer

Start date: May 7, 2021
Phase: Phase 2
Study type: Interventional

GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic

NCT ID: NCT04698499 Completed - Clinical trials for Head and Neck Cancer

Swallowing Therapy With the Assistance of a Mobile Health Device in Head and Neck Cancer Patients: a Pan-Alberta Study

Start date: October 27, 2021
Phase: N/A
Study type: Interventional

Dysphagia affects 22% of those over the age of 50, which equates to 250 million people worldwide and 360,000 in Alberta. At high risk are survivors of head and neck cancer (70%). Difficulties with swallowing are not only life threatening and resource-intense, but also socially limiting. To regain swallowing function and avoid or reduce the consequences of dysphagia, patients require regular, intensive therapy over many months to strengthen swallowing muscles and improve swallow coordination. This therapy is often coupled with visual biofeedback that uses surface electromyography (sEMG). Despite evidence that swallowing exercises are effective when provided with an intensive regimen and when coupled with sEMG biofeedback, patients rarely receive it. The primary aim of this work is to determine whether the use of a mobile system equipped with sEMG biofeedback affects adherence to home-based swallowing exercises. The secondary aim of this work is to determine if the exercise program results in improved patient reported outcomes related to dysphagia and nutrition. Our tertiary aim is to determine if previous findings of adherence can be replicated. Sixty adults with oropharyngeal dysphagia secondary to OPSCC treatment will be enrolled in the study. This study will follow a cross over randomized design such that all participants will be provided with both types of treatment: using pen and paper (Treatment Arm A) and using the mobile health system (Treatment Arm B).

NCT ID: NCT04697628 Active, not recruiting - Cervical Cancer Clinical Trials

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

innovaTV 301
Start date: February 22, 2021
Phase: Phase 3
Study type: Interventional

This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

NCT ID: NCT04697472 Completed - Clinical trials for Chronic Spinal Cord Injury

The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury

Up-LIFT
Start date: January 8, 2021
Phase: N/A
Study type: Interventional

The Up-LIFT Study is a prospective, single-arm study designed to evaluate the safety and effectiveness of non-invasive electrical spinal cord stimulation (ARC Therapy) administered by the LIFT System to treat upper extremity functional deficits in people with chronic tetraplegia.

NCT ID: NCT04697160 Completed - Clinical trials for Diffuse Large B Cell Lymphoma

Observational Retrospective Cohort Study of Systemic Therapies for R/R DLBCL

RE-MIND2
Start date: April 1, 2020
Phase:
Study type: Observational

To compare the efficacy outcomes of the L-MIND cohort with the effectiveness in a matched patient population treated with systemic NCCN/ESMO guideline listed regimens administered in routine clinical care.

NCT ID: NCT04696770 Completed - Depression Clinical Trials

Mindful Kangaroo Care: Mindfulness Intervention for Mothers During Skin-to-skin Care

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

Very high levels of stress have been reported in parents with their infants admitted to Neonatal Intensive Care Unit (NICU). Review of literature shows that the symptoms are consistent with Post-Traumatic Stress Disorder (PTSD), Acute Stress Disorder and many parents have depression that lasts longer than a month. Skin-to-skin care offers many benefits to the mother and the infant including reduction of maternal stress. However, it has been observed that mothers giving skin-to-skin care for preterm infants in an NICU environment focus on the cardiorespiratory monitoring and its alarms instead of focusing on the baby and "being in the moment". There have also been other challenges noted with maternal sleep while providing skin-to-skin and parental distraction on hand-held devices while providing skin-to-skin. Mindfulness offers a way to focus on being in the moment and accepting the present moment in a non-judgmental and compassionate manner. Mindfulness has been shown to reduce stress in parents of babies admitted to NICU. To date, they are no studies looking at Mindfulness during skin-to-skin care. This study will explore the feasibility and acceptability of teaching mindfulness skills to mothers providing skin-to-skin care and studying its effects on maternal stress and distraction. This study involves providing Mindfulness-based strategies during skin-to-skin care to NICU mothers for four consecutive weeks. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of the sessions on stress reduction, mental wellness and mindfulness quotient. The participants will also be encouraged to maintain a weekly kangaroo care log. Participants will be asked to fill out an acceptability form at the end of the 4 weeks. The data will be analyzed to study the effect of mindfulness on stress reduction and mental wellness. The study will also help understand the uptake and acceptance of such a course by NICU mothers. The results of this study will lead to a future randomized controlled trial looking at the impact of mindfulness practise during skin-to-skin care on parental stress reduction.

NCT ID: NCT04696627 Completed - Clinical trials for Post-Dural Puncture Headache

Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch.

Start date: February 12, 2021
Phase:
Study type: Observational

The investigators plan to evaluate long-term consequences of unintentional dural puncture in women who had this complication during labor epidural insertion at Mount Sinai Hospital. A dural puncture is the perforation of the dura mater (one of the layers protecting the brain and the spinal cord) by the needle that is used to find and place a catheter in the epidural space. A puncture will cause a leakage of cerebrospinal fluid through the dura that results in an acute and usually self-limited headache in half of patients who have this complication. The usual treatment for this complication is conservative with the use of oral medications like acetaminophen, anti-inflammatory and narcotics. In the severely symptomatic patient, the injection of blood in the epidural space is a more invasive approach performed to "patch" the hole that was created in the dura (epidural blood patch). The objective is to determine whether or not there is a risk of developing long-term effects from the unintentional dural puncture and its treatment by epidural blood patch by comparing women who had a dural puncture during their labour epidural insertion with or without an epidural blood patch with women who received an epidural but did not have a dural puncture during the same period of time. The hypothesis is that women who had unintentional dural punctures during epidural insertion will develop long-term effects such as chronic headache, chronic backache, chronic auditory or visual disturbances and chronic disability more frequently than women who received an epidural but did not sustain a dural puncture. The investigators also hypothesize that the use of epidural blood patch may change the course of these complications.

NCT ID: NCT04695847 Completed - Clinical trials for Non-Small Cell Lung Cancer

M1231 in Participants With Solid Tumors

Start date: January 13, 2021
Phase: Phase 1
Study type: Interventional

This study is to establish a safe and tolerable dose and to investigate pharmacokinetics and the first clinical efficacy signals of M1231 as a single agent in participants with solid tumors (Part 1) and with metastatic Non-small Cell Lung Cancer (NSCLC) and esophageal squamous cell carcinoma (Part 2). Dose escalation will be followed by the dose expansion once the maximum tolerated dose (MTD) or recommended dose for Expansion (RDE) has been defined.