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NCT ID: NCT05794906 Recruiting - Clinical trials for Biochemically Recurrent Prostate Cancer

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

ARASTEP
Start date: April 3, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: - take blood and urine samples. - measure PSA and testosterone levels in the blood samples - do physical examinations - check the participants' overall health - examine heart health using electrocardiogram (ECG) - check vital signs - check cancer status using PSMA PET/CT scans, CT, MRI and bone scans - take tumor samples (if required) - ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.

NCT ID: NCT05786001 Recruiting - Clinical trials for Chronic Limb Threatening Ischemia

Multimodal Noninvasive Assessment of Peripheral Circulation in Chronic Limb-threatening Ischemia

Start date: June 17, 2024
Phase:
Study type: Observational

Assessment of a novel diagnostic method for screening and diagnosing chronic limb-threatening ischemia (CLTI). Using hyperspectral and thermal imaging, the perfusion and oxygenation in the lower limbs will be studied in healthy and unhealthy individuals.

NCT ID: NCT05782673 Recruiting - Infant Development Clinical Trials

Assessment of Motor Development With a Wearable in Rural and Low-income Settings

MaMa
Start date: May 15, 2023
Phase:
Study type: Observational

The MaMa study aims to assess feasibility and validity of an infant wearable in a rural settings. Altogether N~100 infants will be recruited and measured multiple times at homes from age 6 months to age 18 months. Neurodevelopment of the infants is assessed at 18-24 months of age to compare motor development trajectories with the later neurodevelopmental outcome.

NCT ID: NCT05766202 Completed - Depression Clinical Trials

The MOTIVE (Multiparas Overcoming Childbirth Fear Through Intervention and Empowerement) Feasibility Trial

MOTIVE
Start date: April 27, 2023
Phase: N/A
Study type: Interventional

The purpose of the study is to develop and pilot an intervention for the treatment of fear of childbirth for multiparas and to evaluate the feasibility of the intervention in the treatment of fear of childbirth in multiparas.

NCT ID: NCT05765136 Recruiting - Prematurity Clinical Trials

Care Outcomes in Preterm Infants Following the Implementation of Family-centered Interventions

Start date: September 1, 2021
Phase:
Study type: Observational

The proposed study evaluates the effects of two family-centered interventions on the length of stay and outpatient visits and growth of preterm infants.The interventions are 1) the Close Collaboration with Parents training for the staff and 2) moving from traditional neonatal intensive care unit architecture to single-family room architecture.

NCT ID: NCT05753930 Recruiting - Clinical trials for Kidney Transplantation in Highly Sensitized Patients

Imlifidase Prior to Kidney Transplant in Highly Sensitised Children

DINKY
Start date: June 2, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about the efficacy and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD). The main questions it aims to answer are: - Does imlifidase treatment result in crossmatch conversion that enables transplantation? - How is the function of the transplanted kidney? The participants will be hospitalised in accordance with the normal routines for transplanted patients. The patients will receive medication to prevent rejection of the donor kidney, and because such treatment make the body more vulnerable medications to prevent infections.

NCT ID: NCT05748171 Recruiting - Clinical trials for ACUTE LYMPHOBLASTIC LEUKEMIA

A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL

Start date: May 17, 2023
Phase: Phase 2
Study type: Interventional

This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.

NCT ID: NCT05744583 Recruiting - Hemorrhage Clinical Trials

Finnish Prehospital Whole Blood Study

FinnPHWB
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Up-to-date evidence suggests that blood transfusion initiated as early as possible reduces the likelihood of death from hemorrhagic shock, and the sooner replacement therapy with blood products is initiated, the greater the effect on mortality. Typically, the patient is transfused with one to two units of O RhD (Rh blood group D antigen) negative packed red blood cells (PRBC). Hemostasis accelerating medicines (dry plasma, tranexamic acid, calcium, fibrinogen) as well as crystalloids are also often given. Finnish Red Cross Blood Service is validating cold stored, 0 RhD positive, male donor, leucoreduced, platelet sparing, low blood group ABO antibody titer whole blood product (LTOWB). For this prospective, open, non-randomized clinical study LTOWB will be used in three prehospital emergency medical services that currently use most of prehospital blood products in Finland, while other participating prehospital emergency medical service bases provide controls. Blood transfusions will be given for clinical indication only. The primary goal is to introduce LTOWB and to analyze its feasibility in Finnish prehospital emergency medical service. Study also aims to prove safety of LTOWB, and to analyze coagulation properties of LTOWB compared to currently prehospitally used PRBC transfusions.

NCT ID: NCT05742802 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).

PROSPERO
Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.

NCT ID: NCT05740163 Recruiting - Egg Allergy Clinical Trials

Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16

Start date: December 30, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to determine the efficacy of a 12-month egg oral immunotherapy (OIT) protocol with a cooked whole egg product including yolk and egg white. Study hypothesis: With this method the risk for severe allergic reaction to egg protein is reduced and the diet can partly or completely be normalized.