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NCT ID: NCT05070988 Completed - Rare Diseases Clinical Trials

Oral Health Related Quality of Life of Patients With Rare Diseases: a Qualitative Approach

RaroDentAXE3
Start date: October 20, 2021
Phase:
Study type: Observational

The main objective of the study is to assess the oral health-related quality of life of patients with rare diseases and followed in the rare disease centers of expertise at Necker Hospital in Paris by semi-structured interviews.

NCT ID: NCT05070975 Completed - Bronchiolitis Clinical Trials

Severity of RSV Infections in Twins

TwinSeVeRS
Start date: November 5, 2021
Phase:
Study type: Observational

Respiratory syncytial virus (RSV) infection is the most common cause of severe lower respiratory tract infection (LRTI) in the pediatric population worldwide. Age at the time of infection, prematurity, multiparity, exposure to smoke and the level of passive immunity transmitted at birth are the main risk factors for lower respiratory infection associated with RSV. Other factors, including the innate immune response, respiratory microbiota, and intra-host viral heterogeneity, may also affect outcomes but are not fully considered in RSV infection. Exploring the impact of these factors is difficult due to the heterogeneity of the population which makes statistical adjustment difficult. Thus, twin models are useful in understanding the impact of the host on the environment, as twins often share similar exposure to infection and many risk factors, but not all are ie different prenatal and postnatal conditions, differential transfer of maternal antibodies and the genetic makeup of heterozygotes.

NCT ID: NCT05070897 Completed - Cancer Clinical Trials

Health Literacy and Digital Health in Cancer Patients.

LICAPA
Start date: September 27, 2021
Phase:
Study type: Observational

This is a multicentric, prospective, observational, transversal study, aiming to evaluate the health literacy of cancer patients using the approved French version of the Functional, Communicative and Critical Health Literacy (FCCHL) scale in 2 populations: - Population A: patients age 65 and over treated in an oncology or oncogeriatric outpatient clinic, or seen in an oncology or oncogeriatric consultation. - Population B: young patients age 18 to 64 treated in an oncology or outpatient clinic, or seen in an oncology consultation. The following questionnaires: - Approved French version of the FCCHL scale - Questionnaire on the use of digital tools adapted from the questionnaire on digital tools, will be completed once only. It will be completed by the participant during the oncology or oncogeriatric consultation or outpatient clinic appointment, in self-questionnaire mode or face to face, assisted if necessary by a family member or member of the medical team.

NCT ID: NCT05070208 Completed - Clinical trials for Acute Myeloblastic Leukemia Core Binding Factor

Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor

RETRO-CBF
Start date: September 22, 2021
Phase:
Study type: Observational

Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Their management now follows the reference pattern from the French trial CBF-2006 closed to inclusions since November 2010. This includes intensive chemotherapy and intensification by allogeneic marrow transplant depending on the residual disease measured by RT qPCR . These leukemias have not been the subject of multicenter clinical trials since that date. The results of this treatment regimen need to be evaluated. Known prognostic factors such as signaling mutations, clonal interference or residual disease follow-up (MRD) will be analyzed and updated in this recent cohort. The interaction between residual disease and mutational profile will be evaluated on the prognosis. Treatment with gemtuzumab-ozogamycin and first-line allogeneic transplantation will be investigated, depending on prognostic factors including associated mutations and residual disease. The course and early treatment of molecular relapses will be analyzed. The treatment and prognosis of cytological relapses will be described with in particular the role of tyrosine kinase inhibitors and therapeutic intensification.

NCT ID: NCT05069662 Completed - Cancer Clinical Trials

Impact of the COVID-19 Pandemic on Drug Use and Monitoring of Cancer Patients

ONCORAL-Covid
Start date: October 5, 2021
Phase:
Study type: Observational

The COVID-19 pandemic has profoundly changed the organisation of care. Teleconsultation has replaced hospital medical consultations in order to reduce the risk of patient exposure to the virus. Within the framework of the Oncoral multidisciplinary outpatient / hospital program of follow-up, carried out by the Hospices Civils de Lyon for ambulatory patients treated with oral anticancer drugs, interviews with the pharmacist and/or nurse, which were previously organised face-to-face, have been replaced by telephone interviews, ensuring continuity of follow-up for patients without having to come to the hospital. This study focuses on a telephone survey to describe the impact of the COVID-19 pandemic health crisis on the drug exposure of cancer patients followed in the Oncoral program, their treatment management, their perception of teleconsultation and their IT resources for remote monitoring.

NCT ID: NCT05069584 Completed - Prostate Cancer Clinical Trials

TransPERineal Fusion Biopsy Versus transrECTal

PERFECT
Start date: January 17, 2022
Phase: N/A
Study type: Interventional

Comparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.

NCT ID: NCT05068219 Completed - Surgery, Cardiac Clinical Trials

Contract-Relax (CR) Technique in the Management of Diaphragmatic Paresis After Cardiac Surgery

COREDIA
Start date: November 25, 2021
Phase: N/A
Study type: Interventional

Postoperative respiratory complications are common complications of patients after cardiac surgery and increase morbidity and mortality and hospital length of stay. Diaphragmatic dysfunction accounts for between 2 and 15% of these complications. Diaphragmatic paresis is one of these dysfunctions and could be due to an intra-operative phrenic nerve injury or harvesting of a mammary artery responsible for diaphragmatic devascularization. It alters the ventilatory mechanics and causes acute respiratory distress often requiring the use of mechanical ventilation. The diagnosis of this dysfunction can be made by thoracic ultrasound with assessment of diaphragmatic excursion. For patient with paresis, ultrasound criteria is an excursion < 25 mm after deep inspiration for at least one of the two hemidiaphragms. This dysfunction is most often transient in the postoperative period, but it can also become persistent. Contract-Relax (CR) physical therapy technique can be applied to any muscle, providing muscle strengthening, neuromotor stimulation, and a gain in joint amplitude. Currently, post-cardiac surgery management of respiratory physiotherapy is the same for a patient with or without paresis. Moreover, the CR technique of the diaphragm is not part of this "standard" rehabilitation. The objective of this study is to determine if the CR technique associated with the current respiratory management allows an early rehabilitation of patients with diaphragmatic paresis after cardiac surgery.

NCT ID: NCT05066464 Completed - Septic Shock Clinical Trials

Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments

FRESSPED
Start date: November 29, 2021
Phase:
Study type: Observational

With 25.2 million children affected and 3.4 million deaths in 2017, paediatric sepsis is the leading cause of under-five mortality worldwide and has recently been described as "significant global health threat" by the World Health Organization. In addition to early antibiotics, fluid bolus therapy (FBT) is one of the cornerstones of management, due to the theoretical improvement of cardiac output, oxygen delivery and organ perfusion. In the absence of a consensual and operational definition to date, the latest international guidelines of the Surviving Sepsis Campaign 2020 (SSC-2020), refers to children (≥ 37 weeks gestation at birth to 18 years old) with severe infection leading to cardiovascular (i.e., "septic shock") or non-cardiovascular organ dysfunction (i.e., "other sepsis-associated organ dysfunction" or former "severe sepsis"). The SSC-2020 specifies the modalities for paediatric sepsis management, particularly concerning FBT, with, for example, the preferential use of balanced crystalloids, and a target volume of 40-60ml/kg at one hour of recognition using boluses of 10-20ml/kg in children who have access to a paediatric intensive care unit (PICU) in their health system. Further, it is now well established that compliance with international guidelines is associated with improved outcomes in paediatric sepsis. Despite the importance of awareness and implementation of the SSC-2020, there are, to our knowledge, no studies evaluating its application in children. We prospectively conducted the Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments (FRESSPED) study in 25 hospitals over five weeks between November 2021 and March 2022, whose principal objective was to assess doctors adherence to the SSC-2020 guidelines when performing FBT in infants and children with suspected sepsis in French paediatric emergency departments.

NCT ID: NCT05065658 Completed - Clinical trials for COVID-19 Respiratory Infection

Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

POSACOVID
Start date: March 1, 2020
Phase:
Study type: Observational

COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory syndrome)-CoV-2 infection admitted to the ICU (intensive care unit) in a multi-center case-control study in Europe.

NCT ID: NCT05064839 Completed - Clinical trials for Transthyretin Cardiac Amyloidosis

Imaging for the Evaluation of Transthyretin Cardiac Amyloidosis Prevalence of Patients Over 65 Hospitalized in Cardiology Wards (the IMPACT Study)

IMPACT
Start date: October 6, 2021
Phase: Phase 3
Study type: Interventional

Heart failure with preserved ejection and hypertrophic cardiomyopathy are common diseases and often associated with transthyretin cardiac amyloidosis (TTR-CM), especially in elderly people. Nevertheless, research of TTR-CM is recommended in patients with ventricular hypertrophy without other cause such as valvular disease or hypertension. Therefore, the exact prevalence of TTR-CM remains unknown. We aim to determine the prevalence of TTR-CM in patients with ventricular hypertrophy and aged ≥ 60 years old, hospitalized in our cardiology department (CHU de Poitiers) by performing bone scintigraphy and research of AL amyloidosis.