Clinical Trials Logo

Filter by:
NCT ID: NCT05954013 Completed - Parkinson Disease Clinical Trials

Advance Care Planning and Care Coordination for People With Parkinson's Disease

PD_Pal
Start date: August 6, 2020
Phase: N/A
Study type: Interventional

Background: People with Parkinson's disease (PD), including parkinsonisms, experience complex motor and non-motor symptoms, which become more hindering in the advanced stages of PD. Advance care planning (ACP) enables individuals to define goals and preferences for future medical treatment and serves to ensure that people receive treatment and care that is in line with their preferences during serious chronic illness. The effectiveness of ACP for PD is currently unknown. Methods: The investigators will evaluate the effectiveness of a multicenter, open-label randomized controlled trial, with a parallel group design in seven European countries (Austria, Estonia, Germany, Greece, Italy, Sweden and United Kingdom). The "PD_Pal intervention" comprises (1) several consultations with a trained nurse who will perform ACP conversations and support care coordination and (2) use of a patient-directed "Parkinson Support Plan-workbook". The intervention group will be compared to a care-as-usual group. Documented ACP-decisions in the medical records/patient's central file assessed at 6 months after baseline will be the primary endpoint. Secondary endpoints include patients' and family caregivers' quality of life, perceived care coordination, patients' symptom burden, and cost-effectiveness. Assessments will take place at baseline, 6 months after baseline and 12 months after baseline. In parallel, we will perform a process evaluation, to understand the feasibility of the intervention. Hypothesis: The investigators hypothesize that the PD_Pal intervention will result in an increased number of participants with ACP documentation in the medical records/patient's central file, as compared to care-as-usual. Secondly, the investigators expect that, due to the PD_Pal intervention, patients and their FC will experience better care coordination, better quality of life, a reduced patient symptom burden and the FC will experience a reduction in caregiver burden.

NCT ID: NCT05952557 Recruiting - Clinical trials for Breast Cancer, Early Breast Cancer

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

CAMBRIA-2
Start date: October 5, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.

NCT ID: NCT05947903 Not yet recruiting - Cancer Clinical Trials

Validation of the European Oncology Quality of Life Toolkit

Start date: April 1, 2024
Phase:
Study type: Observational

The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs. A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking. The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages. This is a multicentre observational study, with the following aims: - The primary aim is to perform the psychometric validation of the EUonQoL-Kit. - Secondary aims are to assess its acceptability, to validate the CAT version, and to provide estimates of QoL across different European countries. The EUonQoL-Kit will be administered to a sample of cancer patients and survivors from 46 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C). Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,600 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire: - EORTC QLQ-C30, to test concurrent validity. - Live-CAT version, to test the feasibility of such implementation. - EUonQoL-Kit, 2-7 days after the first completion, to assess test-retest reliability.

NCT ID: NCT05926349 Not yet recruiting - Urgent Surgery Clinical Trials

A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

ANNEXA-RS
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

NCT ID: NCT05909722 Recruiting - Hypophosphatemia Clinical Trials

Validation of the GIDS and Description of Phosphate Disorders

GUTPHOS
Start date: January 8, 2024
Phase:
Study type: Observational

This study will address two specific research questions simultaneously: 1. validation of the GastroIntestinal (GI) Dysfunction score (GIDS). 2. description of epidemiology, risk factors, and management of phosphate disorders. The aim is to recruit 20 ICUs and 1500 ICU patients. Sites will recruit all consecutive adult patients to a maximum of 120 patients or a maximum recruitment period of 8 weeks, whichever comes first. Daily data collection on gastrointestinal signs and symptoms as well as phosphate values and management will be collected during ICU stay for maximum of 7 days. 28 and 90 day mortality and days free of organ support will be the main outcomes. Secondary outcomes include prevalence of hypo- and hyperphosphatemia and description of their management.

NCT ID: NCT05887908 Recruiting - Clinical trials for Acute Pyelonephritis

Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis

Integral-1
Start date: May 23, 2023
Phase: Phase 3
Study type: Interventional

Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).

NCT ID: NCT05882877 Recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-ASCEND
Start date: May 31, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.

NCT ID: NCT05856227 Recruiting - Neonatal Sepsis Clinical Trials

Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age

Start date: August 6, 2023
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.

NCT ID: NCT05855200 Recruiting - Colonic Neoplasms Clinical Trials

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

AZUR-2
Start date: August 2, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.

NCT ID: NCT05850520 Recruiting - Clinical trials for Macular Edema Secondary to Retinal Vein Occlusion

A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)

QUASAR
Start date: May 15, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO). In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema. When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry. The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease. Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg. The main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept and those that received standard of care. To learn how safe the study treatment is in the participants, the researchers will count the number of participants from study start and up to 64 weeks later that have: - adverse events - serious adverse events "Adverse events" are any medical problems that the participants have during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatments. An adverse event is considered "serious" when it leads to death, puts the participants' lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important. Dependent on the treatment group, the participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study will consist of a test (screening) phase, a treatment phase and an end of study phase. Each participant will be in the study for up to 64 weeks. One visit to the study site is planned during the screening phase, followed by visits approximately every 4 weeks (16 in total) during treatment and one visit at the end of the study. During the study, the study doctors and their team will: - check patients' eye health using various eye examination techniques - measure patients' eye vision (BCVA) - take blood and urine samples - do physical examinations - check vital signs - examine heart health using electrocardiogram (ECG) - do pregnancy tests in women of childbearing age In addition, participants will be asked to fill a questionnaire on vision-related quality of life.