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NCT ID: NCT04846972 Recruiting - Breast Cancer Clinical Trials

Facilitate and Sustain Return to Work After Breast Cancer

FASTRACS-RCT
Start date: May 21, 2021
Phase:
Study type: Observational

Breast cancer is the most frequent cancer in women in France, with an estimated 50,000 new cases each year. Prognosis is good, with a standardized survival rate of 85% at 5 years from diagnosis. Half of the women affected are of working age. Return to work after breast cancer faces barriers pertaining to the patients and their environment. There are social disparities in employment. Women with a lesser education and older women are at higher risk to lose their job. No intervention, to date, has demonstrated its effectiveness to facilitate return to work and reduce social disparities in employment after breast cancer. Current limitations of the interventions are to be over-medicalized and hospital-centered, to lack of theoretical foundations, and to be at risk of implementation failure. In a previous phase of the FASTRACS project, an intersectoral Community Advisory Board involving the different categories of stakeholders was launched to perform a needs analysis and build the logic model of the FASTRACS intervention with the Intervention Mapping protocol. The main objective of the FASTRACS intervention is to facilitate sustained return to work (RTW) after breast cancer. Secondary objectives are to improve work-related quality of life and to decrease social disparities in employment after breast cancer. Eligible patients are women: (1) aged between 18 and 55 years; (2) in paid employment; (3) diagnosed with a locally invasive non-metastatic first breast cancer (4) treated by surgery and chemotherapy in an adjuvant or neoadjuvant situation. Recruitment will take place in six investigating centres (centre hospitalier Lyon Sud, hôpital de la Croix-Rousse, hôpital femme-mère-enfant, centre Léon Bérard, hôpital Jean Mermoz, Clinique Charcot), after surgery and before the beginning of the chemotherapy. Women will be randomized between 2 groups (intervention vs control) with a stratification on the including centre, age, and socioprofessional category. The intervention is founded on a multilevel logic model addressing the social determinants of health. It is composed of 4 successive steps during which 4 tools will be used. The first step involves an interview at the end of chemotherapy with a nurse, during which the patient is given a guide to returning to work. The second step is a transitional consultation in the month following the end of radiotherapy (or chemotherapy for patients without radiotherapy), with the general practitioner (GP), with a checklist designed to individualise the patient's care. The third step is a pre-RTW visit to the occupational physician (OP) at a time deemed appropriate by the patient and her GP, with a checklist to facilitate the accomodation of the workstation and the job retention strategy. The fourth and final step will only occur for patients who have not returned to work 10 months after inclusion, and will involve an interview with an OP specialised in return-to-work (RTW) coordination. The last tool is an employer's guide that will be given by the patient to her OP and her manager, with practical advice for managers and colleagues to facilitate the RTW process. The evaluation of the intervention will be performed with mixed-methods by a realist randomized controlled trial including 210 patients in each group. For the effect evaluation, the primary outcome is a composite endpoint including: (a) a sustained return to work 12 months after oncological treatments (OT) ; and (b) the number of days on sick leave 12 months after oncological treatments. Secondary outcomes will include the patients' perspective (quality of life, anxiety, depression, RTW self-efficacy, social support, physical activity, work role functioning, work conditions), process outcomes (transition visit with the GP, pre RTW visit with the OP, other visits), and implementation outcomes (reach and use of the intervention tools). Expected public health impact: Provided it is acceptable, effective and sustainable, the innovative intervention developed in this project is likely to decrease the impact of breast cancer on employment, and to decrease social disparities in employment after breast cancer. According to the mechanisms activated in each context under study (centres, workplaces), it could be scaled-up but also adapted to fit the needs of patients with other cancers or other chronic health conditions.

NCT ID: NCT04846881 Active, not recruiting - Schizophrenia Clinical Trials

Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)

Start date: June 7, 2021
Phase: Phase 3
Study type: Interventional

This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia. Participants are put into two groups randomly, which means by chance. One group takes Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia. During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups. Participants are in the study for about 8 months. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT04846855 Completed - Surgery Clinical Trials

Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population

RATAPED
Start date: October 14, 2020
Phase: Phase 4
Study type: Interventional

Peripheral loco-regional anesthesia (LRA) for anesthetic purposes is a technique widely used in adults for upper limb surgery. In pediatrics, LRA is not classically considered on its own. It is usually performed for analgesic purposes during sedation or general anesthesia. It is entirely possible to carry out awakened peripheral blocks in communicating children, of school age, thus avoiding the issues of GA in pediatrics, in particular in an emergency context. The use of Emla anesthetic skin patches for punctures (perfusion and LRA) as well as the viewing of cartoons on touch tablets during treatment can improve the perception of painless care such as LRA and treatment. In pediatrics, only ropivacaine at a concentration of 0.2% has Marketing Authorization in pediatrics in children under 12 for the production of peripheral blocks. On the basis of the experience of the Claude Galien Private Hospital in this area, it seems interesting to assess the feasibility of upper limb surgery under anesthetic LRA alone with a dose of ropivacaine at the concentration 0.35% in communicating children, of school age.

NCT ID: NCT04846764 Recruiting - Clinical trials for Central Nervous System

Rapid Declarative Neocortical Declarative Learning in Aging and Memory Diseases (ANéRAVIMM)

ANéRAVIMM
Start date: April 28, 2021
Phase: N/A
Study type: Interventional

Learning a person's name, new words, or simply remembering where the last conversation with a friend was held are examples of associative memory, frequently disturbed in brain pathologies, but also by aging. Although typically dependent on the hippocampus in the brain, a series of findings suggest that associative memory may persist, under certain circumstances, despite hippocampal damage. The ANéRAVIMM project aims to reveal this learning system, its cognitive and cerebral bases, and to evaluate its potential in patients with memory disorders.

NCT ID: NCT04846738 Completed - Brain Damage Clinical Trials

Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors in Brain Damaged Patients Admitted to Intensive Care Unit

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

Transcranial Doppler is performed daily in Intensive Care Unit in brain damaged patients. For a few years now, the measurement of the photomotor reflex by quantitative Pupillometry has been routinely performed in Intensive Care Units. The objective of this work is to see if Transcranial Doppler recorded parameters and Pupillary parameters are correlated to the neurological prognosis evaluated at 9 months by the Modified Rankin Score (mRS) and the Glasgow Outcome Scale Extended (GOS-E).

NCT ID: NCT04846725 Completed - Clinical trials for Venous Thromboembolic Disease

Predictors of Attempted Inferior Vena Cava Filters Retrieval.

Start date: October 1, 2019
Phase:
Study type: Observational

The InferiorVena Cava (IVC) with filters has been recommended when there is a contraindication or a failure of anticoagulation. Due to the side effects related to the filters, it is recommended to remove them as soon as possible. It's a retrospective study in a French hospital to evaluate the retrieval rate and predictors of filter removal. All the data of consecutive patients who had a retrievable InferiorVena Cava Filter (IVCF) inserted in the investigator center between April 2012 and November 2019 are included.

NCT ID: NCT04846712 Recruiting - Ankle Sprains Clinical Trials

Interest of Ultrasound in the Diagnosis of Severity of Lateral Ankle Sprain

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

Ankle sprain is a frequent and widely trivialized trauma. Misdiagnosed or poorly treated, it can recur and thus develop into chronic ankle instability. It can be associated with complications which, if not detected early, can lead to long-term sequelae.

NCT ID: NCT04846686 Completed - Preeclampsia Clinical Trials

Placental Expression of EG-VEGF and Its PROKR1 and PROKR2 Receptors in Preeclampsia Patients.

PRE-EVE
Start date: June 1, 2022
Phase:
Study type: Observational

The pathophysiology of preeclampsia (PE) is thought to be endothelial dysfunction responsible for the maternal signs of de novo hypertension and proteinuria after 20 weeks. Current concepts suggest that the pathophysiology of preeclampsia and intrauterine growth retardation results from an imbalance of angiogenic factors. A new angiogenic factor EG-VEGF (Endocrine Gland- Derived Vascular Endothelial Growth Factor) also known as Prokineticin 1 (PROK1) appears to be emerging in the pathophysiology of PE. EG-VEGF is a circulating factor which belongs to the family of prokinetics. Dr Alfaidy's MAB2 team at the Cancer and Infections Biology Laboratory (U1292 Biosanté INSERM / UGA / CEA, CEA Grenoble) demonstrated its key role in the control of key processes in placental development and provided evidence through the development of an animal model of preeclampsia. EG -VEGF is directly involved in the development of Pre-Eclampsia. Few studies have evaluated the expression of EG-VEGF in the human placenta.

NCT ID: NCT04846647 Completed - Clinical trials for Unexplained Hypophosphatemia

Study of the Inappropriate Secretion of FGF23 in Patients Followed in Hospital in a Context of Hypophosphatemia

IFEH
Start date: October 5, 2021
Phase:
Study type: Observational

The discovery of FGF23, the missing link in the long researched and finally found phosphate metabolism, marked a turning point in the understanding and physiopathology of specific hypophosphatemia. By inhibiting the renal reabsorption of phosphate and the production of calcitriol, FGF23 behaves like a hypophosphatemia hormone. Hypersecretion of FGF23 can occur in the case of genetic abnormalities (X-linked hypophosphatemic vitamin-resistant rickets, recessive or dominant hypophosphatemic rickets, McCune-Albright syndrome ...) or acquired abnormalities (oncogenic osteomalacia). Oncogenic osteomalacia can be induced by hyperproduction of FGF23 by benign tumours of mesenchymal origin. But more recently, several cases of malignant tumours secreting FGF23 have also been described (prostate, colon, breast, ovarian and lung cancers, pulmonary carcinoma, etc.)

NCT ID: NCT04846608 Completed - Clinical trials for Behavioral Disorders

Descriptive Study of Emergency Room Visits From Nursing Home Residents for Behavioral Problems at the Nancy University Hospital: Place of the Advanced Practice Nurse

Start date: April 14, 2021
Phase:
Study type: Observational

The demographic evolution of old age is a reality. After the age of 75, 2 out of 3 people living in institutions have neurocognitive disorders. Behavioural disorders such as physical aggression, agitation, hallucinations, sleep disorders, generate difficulties in the management of these patients and lead to unscheduled emergency hospitalizations. Non-pharmacological management of behavioral disorders is recommended as a first-line treatment because of its low risk and potential improvement (Haute Autorité de Santé 2009). However, this management is not simple and obvious to put in place, especially since not all elderly people with Behavioural disorders are in adapted structures. The advanced practice nurse specializing in geriatrics has a place in this care pathway. Because of her skills, she could "organize multi-professional care, set up analyses of practices within the nursing homes, train caregivers appropriately, and limit hospitalizations due to behavioral problems" (SALIEGE L. 2020). Advanced practice nursing is in its infancy in France, and everything remains to be done (International Council of Nurses- directive). The aim of the study is to identify the number of emergency room visits by people aged 75 and over for behavioral problems in nursing home during a 6 month-period.