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NCT ID: NCT06171750 Recruiting - Solid Tumor Clinical Trials

Phase I Study of ANK-101 in Advanced Solid Tumors

ANCHOR
Start date: January 19, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase 1, multicenter, open-label dose escalation study to determine the safety and tolerability of intratumoral (IT) injection of ANK-101 in participants with advanced solid tumors who have progressed during or after receiving standard of care (SOC) therapy or who will not benefit from such therapy. The study will be conducted in two parts; Part 1 will enroll participants with superficial lesions and Part 2 will enroll participants with visceral lesions.

NCT ID: NCT06170658 Recruiting - Myopia Clinical Trials

1 Week Crossover Dispensing Study Between Two Soft Contact Lenses

Start date: December 11, 2023
Phase: N/A
Study type: Interventional

The objective of this investigation is to compare the visual clinical performance of a silicone hydrogel daily disposable investigational contact lenses to a hydrogel daily disposable commercially available contact lenses.

NCT ID: NCT06170385 Recruiting - Neoplasms Clinical Trials

Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia

PEACE
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the feasibility and acceptability of a hybrid in-person and virtual individualized physiotherapy program using the Healthy Eating and Active Living (HEAL-ME) online platform for children diagnosed with acute lymphoblastic leukemia. We would like to know if this type of hybrid program delivery model is feasible, and if children and their parents are willing and able to participate in the program. We will do this by recording how many, and what type of physiotherapy sessions (in-person or virtual) are completed, what resources offered on the platform are accessed, and how many children complete the assessments.

NCT ID: NCT06168474 Recruiting - Clinical trials for Staphylococcus Aureus Bacteremia

Evaluating Simplified Layered Consent for Clinical Trials

SIMPLY-SNAP
Start date: November 28, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial (the SIMPLY-SNAP trial) is to compare a simplified layered consent form to a full-length consent form for use during the informed consent process for a larger clinical trial of treatment of Staphylococcus aureus bloodstream infection (the SNAP trial). The main questions it aims to answer are: - Does use of a simplified layered consent form lead to an increased recruitment rate to the SNAP trial? - Does use of a simplified layer consent form lead to increased participant understanding of the SNAP trial and increased participant satisfaction with the informed consent process? Participants will be randomized to either the full-length informed consent form or the simplified layered consent form containing links to optional supplementary information or videos. Research staff will use the assigned form to explain the SNAP trial to participants. After consent, participants will be evaluated on their understanding of the SNAP trial and satisfaction with the consent process using a questionnaire.

NCT ID: NCT06168409 Recruiting - Clinical trials for Resistant Hypertension

A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

Bax24
Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

NCT ID: NCT06166628 Recruiting - Knee Osteoarthritis Clinical Trials

Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthritis

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The genicular artery embolization vs nerve ablation intervention (GENI) knee OA study is a three-arm randomized controlled trial to evaluate symptoms of knee osteoarthritis (OA) in patients after receiving one of three interventions: sham procedure, geniculate artery embolization (GAE) or genicular nerve phenol nerve ablation (PNA). The main question[s] the study aims to answer are: - Does GAE or genicular nerve PNA result in OA symptom alleviation compared to sham procedure? - Are there molecular or imaging biomarkers that aid in predicting treatment response for GAE or genicular nerve PNA? Subjects (N=150) patients with knee OA, resistant to non-surgical treatment for at least 3 months will be randomized 1:1:1 to either after GAE, genicular nerve PNA or sham procedure. Clinical outcomes will be measured using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 11-point numerical rating scale (NRS) for pain completed at baseline, 1 month, 3 months, and 6 months and then every 6 months for either two years or until the time of total knee arthroplasty (TKA) surgery.

NCT ID: NCT06166394 Recruiting - Anesthesia, Local Clinical Trials

Spinal Hypobaric Local Anesthetic Study

Start date: June 9, 2023
Phase:
Study type: Observational

The length of hospital stay after total hip and knee arthroplasty is determined based on the successful mobilization of the patients post surgery. Fast track pathways involving early mobilization and discharge of the patient on the same day of surgery, shortens the hospital stay and reduces the risk of adverse effects. The long acting LA (bupivacaine) is most commonly used in spinal anesthesia for arthroplasty surgeries and is associated with a prolonged motor and sensory block. In contrast, hypobaric bupivacaine and hypobaric mepivacaine helps in achieving the desired block level with smaller dosage and shorter onset time and faster recovery when compared to long acting local anesthetics. The aim of the study is to observe the effects of hypobaric local anesthetics ( bupivacaine and mepivacaine ) in patients undergoing unilateral total hip or knee arthroplasty in terms of time to onset and time to recovery of the block and also its effect on hemodynamic stability and time to mobilization after surgery. This study will allow the investigators to recommend optimal dosing strategies that in turn will help in faster recovery from spinal anesthesia and early mobilization thereby reducing harmful outcomes.

NCT ID: NCT06163625 Recruiting - Clinical trials for Major Depressive Disorder

The Impact of Working Memory and Reward Markers on DLPFC Activity in Treatment-resistant Depression

Start date: May 2024
Phase: N/A
Study type: Interventional

Major Depressive Disorder (MDD) is a very common illness that is usually treated with antidepressant medication. Depression can be caused by many things such as childhood experiences, genetics, and changes in the way the body and brain function. For those with depression where medication and psychotherapy have limited benefit, repetitive transcranial magnetic stimulation (rTMS) is an effective treatment. rTMS is a treatment that involves stimulating certain areas of the brain with magnetic field pulses. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region. This can be helpful in treating some kinds of psychiatric and neurological disorder, including MDD. It is not fully known how rTMS changes brain activity to improve symptoms of depression. However, certain brain areas responsible for behaviours impacted by depression are underactive in those with depression. One of those brain regions called the dorsolateral prefrontal cortex (DLPFC), and the investigators will target this region using rTMS. By increasing the activity of these regions, rTMS could potentially improve depression symptoms. For participants receiving rTMS, the investigators will be using the participant's brain scan to better understand brain activity of the brain region stimulated by rTMS before and after treatment. In this study, the investigators will be collecting detailed information about participants' psychiatric history and depression symptoms, as well as brain scans and saliva samples. The saliva samples will undergo proteomic (having to do with proteins) analyses to identify biological markers ("biomarkers": biological features (e.g.: gene, protein) that can be measured to indicate factors related to rTMS response. The investigators' goal is to use this information to help us understand whether improvement to rTMS depends on brain activity or proteomic factors localized to two specific behaviours impacted by depression: reward processing and working memory (the capacity to hold information temporarily, such as holding a person's address in mind while listening to instructions about how to get there).

NCT ID: NCT06163612 Recruiting - Clinical trials for Major Depressive Disorder

Effect of Suicidality on Social Cognition

Start date: September 1, 2022
Phase:
Study type: Observational

Major Depressive Disorder (MDD) is a very common illness that is usually treated with antidepressant medication. Depression can be caused by many things such as childhood experiences, genetics, and changes in the way the body and brain function. It is most likely caused by a combination of several of these factors. The prevalence of suicide attempt in Major Depressive Disorder (MDD) is about 20%. Risk for suicide attempt can be increased by many things such as negative life events, genetics, and changes in the way the body and brain function. It is most likely caused by a combination of several of these factors. In this study, the investigators will be collecting detailed information about participants' psychiatric history and depression symptoms, as well as brain scans. The goal is to use this information to help us determine what predicts suicide attempt history.

NCT ID: NCT06163326 Recruiting - Vitiligo Clinical Trials

A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

Tranquillo LTE
Start date: January 19, 2024
Phase: Phase 3
Study type: Interventional

This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV). Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin. Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show: - if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo) - Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study - Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study. This study is seeking for participants who: - have non-segmental vitiligo (either active or stable) and - received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it. All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. At week 4 (or if it cannot be done then, at week 8) study visit, you must take the medication at the study site, and not at home. Participants may receive the study medicine or placebo for up to 52 weeks. The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo. Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study. Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.