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NCT ID: NCT06105632 Recruiting - Clinical trials for Advanced or Metastatic Breast Cancer

A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment

Start date: January 9, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body. This study is seeking female and male participants who: - are 18 years of age or older; - are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; - have advanced or metastatic breast cancer after taking other treatments before this study; - have not taken or need to take medications that are not allowed by the study protocol; - do not have any medical or mental conditions that may increase the risk of study participation. Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be: - Fulvestrant alone taken as shot into the muscle. - Everolimus along with exemestane taken once daily by mouth. This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective. Participants will receive study treatment and/or will be in the study until: - imaging scans (such as an MRI and/or CT) show that their cancer is getting worse. - the study doctor thinks the participant is no longer benefitting from the study medicine. - has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. - the participant chooses to stop taking part.

NCT ID: NCT06104384 Recruiting - Chronic Pain Clinical Trials

Characteristics of Injury Claims by Chronic Pain Patients

Start date: January 2, 2018
Phase:
Study type: Observational

Chronic pain is associated with injuries and disabilities. This prospective observational study explores the injury or disability claims made by chronic pain patients. It evaluates the socio-demographics of the patient population. It explores the impact of pain clinic services on the patients' injury rehabilitation, insurance claim outcome, and socioeconomic situation.

NCT ID: NCT06104306 Recruiting - HIV-1-infection Clinical Trials

Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

Start date: December 13, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical study is to learn how safe and effective it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels. The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12.

NCT ID: NCT06103864 Recruiting - Breast Cancer Clinical Trials

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

Start date: November 23, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

NCT ID: NCT06103123 Recruiting - Myocarditis Clinical Trials

MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study

MYCOVACC
Start date: April 23, 2023
Phase:
Study type: Observational

Myocarditis is inflammation of the heart muscle. Pericarditis is inflammation of the lining surrounding the heart muscle. Symptoms of these conditions can include pain in the chest and rapid or irregular heartbeat. There are many different causes for myocarditis and pericarditis including COVID-19 infection. The MYCOVACC study will identify patients using local screening strategies, including research communications, care provider referrals, and medical record review. The retrospective component of the study will collect information about patients suffering from vaccine associated myopericarditis and COVID-19 associated myopericarditis. Consenting patients will then be prospectively followed according to standard of care protocols. The main objectives of MYCOVACC are to describe the rate of major adverse cardiovascular events, functional outcomes including quality of life, and myocardial recovery through imaging.

NCT ID: NCT06102811 Recruiting - Clinical trials for Arthroplasty, Replacement, Hip

Low Concentration Local Anesthesia Fascia Iliaca Block for Total Hip Arthroplasty

HALF
Start date: October 23, 2023
Phase: N/A
Study type: Interventional

Fascia iliaca compartment block (FICB) is a documented option for postoperative analgesia for total hip arthroplasty (THA) surgery. FICB is demonstrated to be effective in terms of analgesia and opioid requirements decrease, however it causes quadriceps motor weakness. Current available motor sparing techniques are not as effective as FICB for analgesia. Low concentration local anesthetics (LCLA) are used with excellent results for pain control with no or minimum motor block effect, in other scenarios (highlighted in obstetric anesthesia) and techniques (epidural anesthesia, for instance). This study proposes that LCLA-FICB can offer the benefit of peripheral nerve blocks mediated analgesia, while at the same time avoiding motor blockade and muscle weakness. The investigators hypothesize that LCLA-FICB, when compared to conventional high concentration local anesthetics (HCLA) FICB, provides similar postoperative analgesia in the first 24 hours following primary THA, while at the same time preserving quadriceps muscle group strength.

NCT ID: NCT06102733 Recruiting - Inguinal Hernia Clinical Trials

Chronic Pelvic Pain in Females and Males

Start date: January 2, 2018
Phase:
Study type: Observational

Pelvic pain is under-reported in healthy adults. Many patients with pelvic pain under-estimate the problem. Chronic pelvic pain can be managed properly, if diagnosed promptly. This is a quantitative analysis of prospective clinical data. It evaluates the management of pelvic pain in a cohort population, and analyzes the treatment outcome.

NCT ID: NCT06102174 Recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV

Start date: February 15, 2024
Phase: Phase 1
Study type: Interventional

The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months. These children have Lower Respiratory Tract Infection (LRTI) caused by Respiratory Syncytial Virus (RSV). LRTI is the infection to the lower airways such as lungs. This study will help inform the amount of sisunatovir to be used in future studies of sisunatovir in children. This study is seeking for participants who: - Are 1 day to less than or equal to 60 months of age - weigh more than or equal to 2.5 kilograms to less than or equal to 23 kilograms. - Have been tested to have RSV by medical tests. - show signs of LRTI. All participants in the study will receive many amounts of sisunatovir or placebo. Placebo is a pill that does not have any medicine in it. Up to 7 visits are required for the study. Some of these visits include checking participants health over the phone and/or a visit at home. The study will compare the experiences of infants and children receiving sisunatovir to identify the amount of sisunatovir to be used in future studies in infants and children.

NCT ID: NCT06101849 Recruiting - Breast Cancer Clinical Trials

Chronic Cancer Pain Management Program

ICMP
Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The goal of this research study is to evaluate an online inter-professional pain management program for survivors of breast cancer. The main questions it aims to answer: 1. whether this treatment will help address the pain management concerns of patients, 2. whether it is feasible to offer this treatment in the future as multi-centre randomized controlled trial (RCT). Participants will be asked to attend a 6-week online pain management group sessions (1h/week). Participants will also be asked to fill out questionnaires before and after the program completion.

NCT ID: NCT06101784 Recruiting - Inflammation Clinical Trials

Single and Multiple Ascending Oral Doses of Avenanthramide

AvenActive
Start date: December 9, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Avenanthramides (AVA) are di-phenolic compounds found only in oats and are of interest due to suggested bioactivities, including antioxidant and anti-inflammatory effects in vitro and in vivo. Published data suggests that polyphenols can work as modifiers of signal transduction pathways to elicit their beneficial effects. These natural compounds express anti-inflammatory activity by modulation of pro-inflammatory gene expression such as cyclo-oxygenase, lipoxygenase, nitric oxide synthases and several pivotal cytokines, mainly by acting through nuclear factor-kappa B and mitogen-activated protein kinase signaling. The biomarkers of inflammation in blood, i.e., pro-inflammatory cytokines, chemokines, as well as other inflammatory markers (i.e., high sensitivity C-reactive protein) are of particular interest. Primary Objectives: - To assess the safety and tolerability of single ascending oral doses of avenanthramide in healthy subjects. - To assess the safety and tolerability of multiple ascending oral doses of avenanthramide in healthy subjects and subjects with elevated waist circumference and low-grade inflammation. Secondary Objectives: - To determine the pharmacokinetics of avenanthramide following single ascending oral doses in healthy subjects. - To compare the pharmacokinetics of avenanthramide following single oral dose in healthy subjects under fasting and fed conditions. - To determine the pharmacokinetics of avenanthramide following multiple ascending oral doses in healthy subjects. - To determine the pharmacokinetics of avenanthramide following multiple ascending oral doses in subjects with elevated waist circumference and low-grade inflammation.