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NCT ID: NCT06251167 Recruiting - Knee Osteoarthritis Clinical Trials

A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis

MULTIWEDGE
Start date: March 4, 2024
Phase: N/A
Study type: Interventional

Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.

NCT ID: NCT06250829 Recruiting - Clinical trials for Non-small Cell Lung Cancer Stage IB (Resectable)

Model to Predict pCR and IrAEs in Early Stage Non-small Cell Lung Cancer

Pre-PLaN
Start date: October 12, 2023
Phase:
Study type: Observational

Lung cancer is the chief cause of cancer death. The new standard-of-care (SOC) in operable lung cancer combines chemotherapy and an immune-stimulating drug before the surgery (neoadjuvant approach). This results in a large increase in complete cancer clearance rates compared to chemotherapy alone (±30% with combination vs ±4% with chemotherapy alone), leading to much better long-term survival and probably many more cures. However, most still don't achieve complete clearance, and a few have increases in, or spread of, their tumors while on treatment. Therefore, we need to understand why some patients benefit (responders) and others don't benefit (non-responders) on an immunotherapy-based treatment. Also, some patients unpredictably develop severe immune-type side effects related to the immunotherapy drug, although such side effects may be associated with improved anti-cancer effects. In short, the same treatment can result in complete cancer clearance in one patient, and in a worst-case scenario may result in severe toxicity or fail to control spread/growth thus precluding surgery. The immune system obviously plays a key role in both benefit and harm, yet most of the research in this field has focused only on the cancer. We plan an in-depth study in 60 patients, focusing on the cancer as well as the patient's immune system, pre-surgery. This will enable us to identify factors predicting complete cancer clearance, and the occurrence of immune-type side effects. Using highly sophisticated resources available to us here in London, we will develop predictive models enabling better patient management (including possible avoidance of surgery), and identification of key biological differences between major responders and non-responders, to highlight important new targets for the development of even newer and better therapies.

NCT ID: NCT06249555 Recruiting - Crohn's Disease Clinical Trials

VOICE-Early Response to Vedolizumab and Ustekinumab in Participants With Crohn's Disease: A Prospective Observational Study

VOICE
Start date: March 20, 2024
Phase:
Study type: Observational

The primary aim of this study is to explore the time course of response to Vedolizumab in participants with CD as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-short form (SF), as well as other PROMIS domain SFs (fatigue, anxiety, depression, sleep disturbance, physical function, and ability to participate in social roles and activities); other PRO measures will also be assessed.

NCT ID: NCT06247878 Recruiting - Clinical trials for Obstructive Sleep Apnea

Skiin-PSG Sleep Apnea

Start date: February 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to develop new algorithms to detect apnea and/or hypopnea to provide additional insights to Skiin users and to their circle of care to validate and/or improve the current algorithms of the Skiin system for extraction of biological metrics during sleep based on the Skiin ECG and accelerometry data.

NCT ID: NCT06247449 Recruiting - Breast Cancer Clinical Trials

MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer

Start date: November 29, 2023
Phase: N/A
Study type: Interventional

The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage II or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are: 1. What proportion of patients with stage II or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (or computed tomography when Magnetic resonance is not possible) of the brain? 2. How do patients feel about undergoing brain imaging to screen for asymptomatic Brain metastasis? 3. What clinical and tissue-based biomarkers are associated with asymptomatic detection of Brain metastasis? Participants will undergo a brain imaging, collect one blood sample to perform ctDNA analysis, and fill the Testing Morbidities Index (TMI) after imaging is done. Procedures must take place within one year of initial diagnosis, either prior to or after completion of (neo)-adjuvant systemic therapy.

NCT ID: NCT06242977 Recruiting - Local Anesthesia Clinical Trials

Efficacy of EMLA Cream Assisted Loco-sedation for Office-based Andrology Procedures

Start date: January 25, 2024
Phase: Phase 3
Study type: Interventional

Scrotal, urologic surgery has traditionally been conducted in the hospital setting, typically with the use of sedation, spinal anesthesia or general anesthesia. There has been a recent push to move certain scrotal urologic surgeries out of the hospital operating room into a ambulatory, outpatient basis with recent literature demonstrating this in many centers. The use of local anesthesia alone poses numerous benefits. The investigators wish to compare patients who are undergoing invasive scrotal surgery under local anesthetic to those who additionally have a topical anesthetic cream (EMLA) applied to the scrotum to determine if this further increases patient tolerability of these procedures.

NCT ID: NCT06242912 Recruiting - Cancer Clinical Trials

Evidence Development in Cancer Treatment - Real World: PREDiCTrw

Start date: January 22, 2024
Phase: N/A
Study type: Interventional

This pilot clinical trial aims to assess the real world quality of life and survival of patients treated with therapy that has preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or cost effectiveness in subjects with cancer. The goal of this study is to collect real world evidence with respect to quality of life and outcomes to support decision making.

NCT ID: NCT06242717 Recruiting - Quality of Life Clinical Trials

Postpartum Screening for Anxiety and Comorbid Conditions

PPA
Start date: November 9, 2023
Phase:
Study type: Observational

The goal of this project is to facilitate the design of individualized postpartum anxiety (PPA) screening strategies in British Columbia (BC), Canada. A cohort of postpartum people (n=550) will be invited to complete the following seven questionnaires at 4-8 weeks after delivery: 1. State-Trait Anxiety Inventory 2. Edinburgh Postnatal Depression Scale 3. Multidimensional Scale of Perceived Social Support 4. PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anger, Short Form 5-a 5. Short Form Brief Pain Inventory 6. WHOQOL-BREF for assessing quality of life 7. PROMIS Sleep Disturbance Short Form 8-b and PROMIS Sleep-Related Impairment Short Form 8-a The investigators will evaluate the feasibility of screening for postpartum anxiety and comorbid conditions through a web-based platform in a diverse BC population. They will assess the usability of the platform and questionnaires through 12-15 follow-up interviews with study participants and responses to the System Usability Scale. Their analysis will also identify patient characteristics and comorbidities (e.g., anger, pain, sleep disturbance) associated with a positive screen for postpartum anxiety.

NCT ID: NCT06241573 Recruiting - Clinical trials for Hidradenitis Suppurativa (HS)

A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab

Start date: April 16, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

This study is open to people with hidradenitis suppurativa (HS) who have completed another study with spesolimab (study 1368-0098 (NCT05819398) or study 1368-0100). The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks. Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.

NCT ID: NCT06241209 Recruiting - Visual Impairment Clinical Trials

Hemianopsia Rehabilitation After Stroke or Brain Injury

Start date: January 25, 2024
Phase: N/A
Study type: Interventional

In patients with hemianopsia following stroke or brain injury, we will determine if stimulating the visual field with images from a PowerPoint slide set can increase the visual field.