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NCT ID: NCT06017518 Recruiting - Osteosarcoma Clinical Trials

An Observational Study of Local Relapse After High Grade Osteosarcoma

OSTEO LR
Start date: June 13, 2022
Phase:
Study type: Observational

multicenter retrospective and prospective study in patients with high-grade osteosarcoma

NCT ID: NCT06016946 Recruiting - Friedreich Ataxia Clinical Trials

Friedreich Ataxia Global Clinical Consortium UNIFIED Natural History Study

UNIFAI
Start date: June 28, 2023
Phase:
Study type: Observational [Patient Registry]

This project is a global, multicenter, prospective, longitudinal, observational natural history study that can be used to understand the disease progression and support the development of safe and effective drugs and biological products for Friedreich ataxia.

NCT ID: NCT06016868 Recruiting - Cervical Cancer Clinical Trials

Identification of a MOLecuLar Signature in Locally Advanced Cervical Cancer Patients

MOLLY
Start date: August 1, 2023
Phase:
Study type: Observational

The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive CTRT. The previously validated three-gene signature may enable stratification in LACC patients treated with the current standard of care, represented by exclusive CTRT.

NCT ID: NCT06016842 Recruiting - Clinical trials for Primary Biliary Cholangitis (PBC)

A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis

ELFIDENCE
Start date: August 31, 2023
Phase: Phase 3
Study type: Interventional

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC). Participants will also have inadequate response or intolerance to ursodeoxycholic acid (UDCA) a drug used to treat PBC. PBC is a disease that progresses slowly. It causes damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many people with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment). Each participant will be in the study up to about 7 years. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.

NCT ID: NCT06016738 Recruiting - Breast Cancer Clinical Trials

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

OPERA-01
Start date: November 16, 2023
Phase: Phase 3
Study type: Interventional

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

NCT ID: NCT06015789 Enrolling by invitation - Clinical trials for Inflammatory Bowel Diseases

Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care

Start date: September 4, 2023
Phase:
Study type: Observational

The Inflammatory Bowel Disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract including Crohn's disease and Ulcerative Colitis. The course of IBD is frequently progressive and can be hardly predictable, with sudden exacerbations of intestinal symptoms. Epidemiological studies have shown that IBD has an increasing prevalence to reach 10 million people in 2030. These diseases require frequent interactions between patients and the healthcare system, or symptom management with continuous therapies, gastroenterological visits, surgery, contacts for resolution of urgent symptoms from telephone and email, access to the emergency, hospitalizations, nutritional counseling, psychological interventions and follow-up controls. An IBD can completely disrupt a family's ability to function normally and often imposes a strain on family members' relationships. In the model of self-care in chronic diseases, according to Riegel's "Middle Range Theory", there are external factors, predictive factors that can influence and limit the patient's attitude and therefore his self-esteem, the ability to implement decision-making behaviors to improve and increase his self-care. There are also factors that influence a person's self-care decisions: the particular caregivers. In this process, the role of the caregiver and the dyad he establishes with the patient can influence the whole process of self-confidence and self-care. The objectives of the study are to investigate and describe self-care in patients with IBD and how their caregivers in dyadic interaction can contribute.

NCT ID: NCT06015737 Not yet recruiting - Clinical trials for Cutaneous Lupus Erythematosus

A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

LAVENDER
Start date: June 17, 2024
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).

NCT ID: NCT06013969 Recruiting - Clinical trials for Generalized Pustular Psoriasis

A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares

Start date: October 11, 2023
Phase: Phase 4
Study type: Interventional

This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares. During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT06013241 Recruiting - Clinical trials for Chronic Rhinosinusitis Without Nasal Polyps

A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

BiRCh
Start date: October 30, 2023
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to evaluate the efficacy of brensocatib at 10 and 40 milligrams (mg) once daily (QD) compared with placebo in improving clinical symptoms of CRSsNP.

NCT ID: NCT06013124 Recruiting - Clinical trials for Maternal and Child Health

Patient/Caregiver Perceived Quality of Care

Start date: January 26, 2021
Phase:
Study type: Observational

Hospitals quality, safety, and staff workload problems are common in all countries. Findings from the multicountry Nurse forecasting in Europe (RN4CAST) cross sectional study show that patient risk of mortality within a 30 days of hospital stay increases of 7% when a patient is added to the nurse-patient 1:6 proportion in a surgical unit; in Italy, the ratio was found to be 9.5 patients per nurse. Organizational environment, health workers wellbeing and work satisfaction were also found to impact patient safety and perceived patient satisfaction; hospitals nurses high workload, work dissatisfaction and burnout were found related to poor patients outcomes. In a systematic review and meta-analysis, an association of more than 60% between physicians and nurses development of burnout and patient safety in pediatric settings was found; when health workers wellness and teamwork in wards was poor lower perceptions of safety culture was found. Moreover, occupational exposure to medically complex children and their families along with direct care providers unexpressed grief further increase pediatric settings staff risk of developing burnout syndrome and compassion fatigue. Recent findings of Covid-19 pandemic negative impact on health workers well-being worldwide also enhances the risk of compromising the quality of care provided. The aim of this study is to evaluate factors that affect health workers well-being, their perception of work environment and patient/caregiver satisfaction and perceived quality of care in a maternal and child health hospital.