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NCT ID: NCT05543681 Recruiting - Depression Clinical Trials

IGC-AD1 Trial on Agitation in Dementia Due to Alzheimer's

IGC-AD1-P2
Start date: October 11, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of an oral medication, IGC-AD1 that is a natural THC-based (Tetrahydrocannabinol) formulation, administered in micro doses, twice a day, on symptomatological Agitation, in patients with mild to severe dementia from Alzheimer's.

NCT ID: NCT05543200 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

BPH Global Registry

Start date: March 13, 2023
Phase:
Study type: Observational [Patient Registry]

Benign prostatic hyperplasia (BPH) is one of the most common performed surgical procedures in urology. Over the past few decades there have been an increasing development of newer surgical treatment options. Additionally, the outcome parameters for BPH treatments have been standardized. While data are available for the initial pivotal studies, post-market release data are lacking. Under the umbrella of uCARE, we have started a prospective, ongoing international registry for recording demographics and outcomes for patients undergoing surgical treatments for BPH.

NCT ID: NCT05543044 Recruiting - Eating Disorders Clinical Trials

Impact of Peer Mentors on Individuals Transitioning to Adult Eating Disorder Treatment

Start date: March 28, 2023
Phase: N/A
Study type: Interventional

Participants will be males and females aged 16-24 with an eating disorder (ED) diagnosis who are transitioning to adult-oriented ED treatment in Nova Scotia, New Brunswick, or Prince Edward Island. Youth participants will be recruited from community-based clinics, hospital programs, and private practices where ED treatment is delivered. Youth who are interested in participating and provide written consent will be invited to take part in a screening meeting to determine eligibility to participate. Eligible participants will be paired with a peer mentor for a 3-6 month intervention to guide them through the transition to adult-oriented ED treatment. Participants will be asked to complete questionnaire packages before beginning the intervention, after completing the intervention, and 12 months after beginning the intervention. Some youth participants, as well as some of their carers and the peer mentors, will be asked to participate in one-on-one interviews about their experiences with transitions in ED care and the peer mentor intervention. The investigators are conducting this study to determine whether the use of peer mentors is an effective and acceptable means of transition support for youth with EDs. The investigators are also interested in better understanding the experiences of carers and peer mentors who are supporting youth with EDs during their transition in care.

NCT ID: NCT05541432 Recruiting - Osteoporosis Clinical Trials

Finding the Optimal Resistance Training Intensity For Your Bones

Start date: September 13, 2022
Phase: N/A
Study type: Interventional

Osteoporosis is a bone disease that can result in fractures, disability and an increased risk of premature death. Exercise is recommended for fall and fracture prevention, but health care professionals often recommend walking or lower intensity community exercise classes, which may not be effective for building bone. Further, individuals with osteoporosis are often told to avoid lifting or moving in certain ways, which creates fear and activity avoidance. Conversely, research suggests that to stimulate bone, you need higher loads on bone, with either higher intensity resistance training or impact exercise - the types of things people with low bone mass are told to avoid. Our study will examine different types of exercise intensity and how they translate to building bone in people with low bone mineral density (BMD).

NCT ID: NCT05541354 Recruiting - Clinical trials for Occupational Injuries

Simulation for Operating Room Ergonomics

SORE
Start date: October 2023
Phase:
Study type: Observational

Ergonomics is the study of how people interact with, and work within an environment. This idea is especially important in a setting such as the operating room (OR), which can be both physically and mentally challenging. Poor ergonomic practices lead to physical discomfort and injuries in >50% of OR staff (surgeons, anesthesiologists, and nurses), impacting OR staff quality of life and leading to staff burnout and early retirement. The end result of which is reduced access to care for patients. Furthermore, the added mental effort of dealing with discomfort and pain can also increase the risk of errors and complications, affecting patient outcomes. Despite high ergonomic stresses in the OR, and the existence of proven recommendations to address them, only a small number of OR staff are aware of ergonomic solutions and how to apply them. To bridge this gap between knowledge and application, we will assess the ergonomic needs of OR teams and develop an educational simulation curriculum to teach ergonomic recommendations to OR teams (surgery, anesthesiology, and nursing staff and trainees).

NCT ID: NCT05538871 Recruiting - Scoliosis Clinical Trials

Body Structure and Capacity Evaluation of Adults With Scoliosis

Start date: May 6, 2019
Phase:
Study type: Observational

Adults with scoliosis have not been the focus of much research in physical therapy despite their prevalence being very important. Adults with idiopathic scoliosis have a reported prevalence of about 2-11%. This includes adolescents with idiopathic scoliosis who have become adults but still have a scoliosis. They do not get much treatment as the adolescent treatment focuses on preventing worsening of the curvatures and the risk of progression is significantly reduced once a person reaches skeletal maturity. Still some patients experience self-image, function and pain issues which may be amenable to treatment using specific exercises as was recently shown. With ageing population a growing number of adults with de novo degenerative scoliosis is observed. This is a spinal misalignment due to spine degeneration. Adult degenerative scoliosis with pain is thought to affect about 24% of the ageing adults. This population has not been investigated very much. Before planning conservative treatments for adults with scoliosis it would be important to describe what deficit these adults present that may be targeted by physical therapy. The objective of this study is to compare samples of patients with adults degenerative scoliosis, adult idiopathic scoliosis to matched healthy controls (for age, height and weight). Participants will complete questionnaires and a physical exam to identify which limitations they present that may be amenable to treatment with physical therapy. This information will assist planning trials to address the needs of these two neglected patient populations.

NCT ID: NCT05538130 Recruiting - Colorectal Cancer Clinical Trials

A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors

Start date: November 30, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) administered as a single agent and in combination with other study medications in people with solid tumors. This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799544. PF-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this could change to once daily or another frequency). Depending on the part of the study, participants may also receive another study medicine. - In the first part of the study, people with melanoma or other solid tumors may also receive encorafenib. Encorafenib comes as a capsule and is taken once per day. - In the second part of the study, people with melanoma or other cancers with abnormalities in a gene called "BRAF" will receive PF-07799544 with other study medicines (for example, PF-07799933). Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

NCT ID: NCT05537740 Recruiting - Clinical trials for Advanced Solid Tumors

A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors

Start date: October 11, 2022
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced solid tumors. Advanced solid tumors are solid cancers that may have spread to nearby tissue, lymph nodes and/or to distant parts of the body and that are unlikely to be cured or controlled with currently available treatments. A new therapy available for advanced solid cancers is immunotherapy with PD-1/PD-L1 inhibitors. This drug class stimulates immune cells to kill cancer cells by blocking a protein called PD-1. Although PD-1/PD-L1 inhibitors have shown benefits in treatment of cancer, only a subset of patients benefit from the initial therapy, while in others the cancer comes back. One reason could be that the ability of the patients' immune systems to kill cancer cells is weakened by so-called regulatory T cells which have a suppressive effect on the immune system. The study treatment BAY3375968 is an antibody that binds to a protein called CCR8 which is located on the surface of regulatory T cells. This leads to a reduction in regulatory T cells and further inhibits their immune suppressive activity, so that the immune response against cancer can be strengthened as observed in animal models. Animal studies also showed that BAY3375968 may add more anti-cancer effect to immunotherapy with PD-1/PD-L1 inhibitors when used in combination. All of these previous observations need to be confirmed in humans. The main aims of this study are to find for BAY3375968 alone and in combination with pembrolizumab (a PD-1 inhibitor): - how safe it is - the degree to which overt medical problems caused by the treatment(s) can be tolerated - the highest amount of BAY3375968 that can be given alone or in combination with pembrolizumab. - how it moves into, through, and out of the body. To do this, researchers will collect and analyze data about: - the number and severity of participants' medical problems after taking their treatments - the best dose of BAY3375968 that can be given - the highest level in the blood (Cmax) and the total level (AUC) of BAY3375968. Doctors keep track of all medical problems (also called adverse events) that participants have during the study, even if they do not think that they might be related to the study treatment. The researchers will also study the activity of BAY3375968 alone and in combination with pembrolizumab against the cancer. The study will have 2 parts. Part 1 (dose escalation) focuses on tumor types that respond to immunotherapy. It will help to find the best dose for BAY3375968 alone and in combination with pembrolizumab that can be given in part 2. For this, the participants will receive one specific dose of several increasing BAY3375968 doses tested in part 1. Dose escalation of BAY3375968 alone will be done prior to the dose escalation of the combination with a fixed dose of pembrolizumab. The participants of part 2 (dose expansion), will receive the best dose of BAY3375968 alone or in combination with pembrolizumab found in part 1. This part of the study focuses on certain cancer types of the lung, breast, head and neck cancer, and melanoma. The total duration of the study will be approximately 4 years and 7 months. Each participant in the study will visit the study site twice before starting their treatment. Once the treatment starts, the frequency of visits is 5 times per week in the first treatment week and 1 to 3 times per month in later treatment periods. Another visit will be scheduled for the participants within 30 days after the last treatment in the study. During the study, the study team will: - take blood and urine samples - do physical and vital signs examinations - examine heart health using ECG and Echocardiogram - check the tumor status and if the participants' cancer has grown and/or spread using imaging techniques - take tumor samples - ask questions about the impact of the disease on the participants' general well-being and activities of daily life. About 90 days after the participants receive their last treatment and discontinued the study, the doctors will check the participants' health. In case a new anticancer therapy has been started, medical problems will be recorded via a phone call. The study team will continue to check the participants' cancer status about every 12 weeks until their cancer gets worse, the start of a new anti-cancer therapy, or withdrawal of consent. In addition, every 6 months for up to 24 months after the last participant left the study the study team will check the participants' survival and subsequent anticancer treatment by phone until the end of this study.

NCT ID: NCT05537220 Recruiting - Clinical trials for Retinitis Pigmentosa

Oral N-acetylcysteine for Retinitis Pigmentosa

NAC Attack
Start date: October 11, 2023
Phase: Phase 3
Study type: Interventional

Retinitis pigmentosa (RP) is an inherited retinal degeneration caused by one of several mistakes in the genetic code. Such mistakes are called mutations. The mutations cause degeneration of rod photoreceptors which are responsible for vision in dim illumination resulting in night blindness. After rod photoreceptors are eliminated, gradual degeneration of cone photoreceptors occurs resulting in gradual constriction of side vision that eventually causes tunnel vision. Oxidative stress contributes to cone degeneration. N-acetylcysteine (NAC) reduces oxidative stress and in animal models of RP it slowed cone degeneration. In a phase I clinical trial in patients with RP, NAC taken by month for 6 months caused some small improvements in two different vision tests suggesting that long-term administration of NAC might slow cone degeneration in RP. NAC Attack is a clinical trial being conducted at many institutions in the US, Canada, Mexico, and Europe designed to determine if taking NAC for several years provides benefit in patients with RP.

NCT ID: NCT05536804 Recruiting - Obesity Clinical Trials

A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

TREASURE-CKD
Start date: February 8, 2023
Phase: Phase 2
Study type: Interventional

We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D). The study will last about 56 weeks and include up to 12 visits.