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NCT ID: NCT03608384 Completed - Drug Use Clinical Trials

Characteristic of Drug Users Chronic Wound

TOXIPO
Start date: August 1, 2018
Phase:
Study type: Observational

The aim of this study is to describe demographic, clinical, etiological characteristic and evolution of drug addict's chronic wounds .

NCT ID: NCT03607942 Completed - Premature Infant Clinical Trials

Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants

Start date: August 6, 2018
Phase: N/A
Study type: Interventional

This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups. The experimental group will receive a neonatal supplement containing 2 specific HMOs. The control group will receive a placebo neonatal supplement that does not contain any HMOs, but matched to the experimental product in energy content. This study will include a total of approximately 86 male and female preterm infants born between 27 and 32 weeks' gestational age with birth weight ≤1700 g, who are younger than 7 days of age. The primary objective of the study is to demonstrate the safety and tolerance of HMOs in preterm infants by monitoring weight gain rates in both of the two randomized groups.

NCT ID: NCT03607474 Completed - Hypercorticism Clinical Trials

Patient and Partner Perception After Remission of Cushing's Syndrome

CUSHING
Start date: March 30, 2018
Phase:
Study type: Observational [Patient Registry]

Hypercortisolism leads to long term physical and cognitive sequelae. This also holds true for quality of life, even several years after remission. This altered quality of life, highly subjective, is however, badly evaluated by the family of the patient. This could lead to misunderstanding, avec worsen the general physical and mental health of the patient. To our knowledge, this theoretical difference of perception has never been evaluated up to now. The aim of our study is to evaluate the difference of perception of the quality of life and body image between patients in remission of hypercortisolism, and their caregivers. Secondary objectives will be to evaluate the quality of life of the caregivers, the coping strategies, and the depression/anxiety parameters of both the patient and the caregiver. Patients and methods: the study is Observative, prospective and non-randomized. Inclusion criteria will be patients, aged more than 18, with hypercortisolism in remission for at least 1 year. Self-questionnaires on quality of life, body image, coping, depression and anxiety will be provided to the patient and his/her caregiver. Fulfilling will be blind between the patient and his/her caregiver. Inclusion period will be 12 months. Results will be compared between the patient and his/her caregiver. Expected results: investigators anticipate that some caregivers will have a different perception of the general physical and mental condition as stated by the patient. The first time that the quality of life of the caregiver would be also altered. This original project might lead to modify the management of Cushing's syndrome, by considering both the patient and his/her caregiver on a long term basis after remission.

NCT ID: NCT03607162 Completed - Clinical trials for Fever Without Source

Impact of a PCT(Procalcitonin) Rapid Test -Based Approach on ATB (Antibiotics) Use in Children With Fever Without Source

DIAFEVER
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Because a newly available point-of-care test may have real interest especially for children in the Emergency Department (ED) setting, by limiting painful and stressful venipunctures and decreasing the length of stay in the ED, the investigators hypothesize that integrating this new capillary Procalcitonin (PCT) rapid test in the DIAFEVER CPR (Clinical Prediction Rules) could represent a highly valuable diagnostic tool to identify a group with low Invasive Bacterial Infection (IBI) risk and could limit unnecessary exams and antibiotic prescriptions. The aim of this present study is to demonstrate the impact of this new PCT rapid-test-based CPR on antibiotic prescription rate in young children with Fever Without Source (FWS) presenting to the ED and on morbidity and mortality

NCT ID: NCT03607149 Completed - Clinical trials for Non-small Cell Lung Cancer

Pemetrexed in Maintenance in Patients With Impaired Renal Function, 2 Dose Calculation Strategies

PKAPIR
Start date: April 6, 2017
Phase: Phase 4
Study type: Interventional

Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs. The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.

NCT ID: NCT03607032 Completed - Clinical trials for Acute or Chronic Respiratory Pathologies

Use of RespinPAD in Elderly Patients

RESPINPAD
Start date: January 4, 2019
Phase: N/A
Study type: Interventional

Secretive (or obstructive), acute or chronic pathologies are common in an increasing number of elderly patients. The medical teams are confronted with difficulties in the management of these patients: they do not benefit from optimal respiratory physiotherapy, whether manual or mechanical, due to functional deficiencies, cognitive functions that are sometimes limited or poorly adapted equipment. The objective of this pilot study is to evaluate the effectiveness of a new RespinPAD device in the bronchial de-encapsulation of elderly patients who cannot benefit from optimal physiotherapy compared to conventional treatment (nasal or bucco-tracheal aspiration and aerosols). The study will include 20 non-dementia patients and 20 dementia patients who will benefit from the use of RespinPAD and 20 patients who will benefit from conventional therapy. All the patients included will be over 70 years old and will be recruited when they are admitted to hospital in the geriatric hospital of the CHU de Nice. They will be included if they present a bronchial obstruction secondary to a respiratory pathology secreting whatever the etiology and for which optimal respiratory physiotherapy is not possible after evaluation by a physiotherapist. Patients using the RespinPAD device will benefit from a 20-minute session twice daily for 5 days. The primary endpoint (quantitative criterion) will be the measurement of oxygen consumption (VO2) and carbon dioxide production (VCO2) volumes for each patient included before and after each session of RespinPAD use or conventional treatment for the control group. Secondary judging criteria will be a heteroassessment of the SEVA (Airway Overcrowding Score), the Borg Scale and the Algoplus or Digital Comfort Scale. For the effectiveness assessment, the SEVA score will allow for a qualitative assessment to complement the primary endpoint. The collection of volumes of secretions, pulse oximeter, mean length of stay, O2 withdrawal time and drug aerosols will also be used to compare results with previous studies. With regard to secondary safety and feasibility criteria, hemodynamic constants, electrocardiogram and the actual duration of the sessions will be recorded.

NCT ID: NCT03607019 Completed - Clinical trials for Socioeconomic Factors

Social Deprivation Features in Intensive Care Unit Patients

PRECAREA
Start date: March 5, 2018
Phase:
Study type: Observational

Socioeconomic inequalities are increasingly recognised as an important public health issue, and it is now well established that patients with socioeconomic deprivation (SED) features demonstrate higher mortality and morbidity. The epidemiology and impact of SED on the specific population of ICU patients has been insufficiently investigated. In this prospective multicenter study of patients admitted to 9 ICUs of the Paris area, the investigators aim to explore the epidemiology of SED features, and its impact on mortality and length of stay.

NCT ID: NCT03606798 Completed - Clinical trials for Frontotemporal Lobar Degeneration

Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.

DLFT
Start date: June 21, 2018
Phase: N/A
Study type: Interventional

Fronto-Temporal Lobar Degeneration (FTLD) refers to 3 categories of neurodegenerative diseases generally occurring between 55 and 65 years: Fronto-Temporal Dementia(FTD), Primary Progressive Aphasia (PPA), Semantic Dementia (SD). Clinical expression is substantially variable among individuals, but in most cases, behavioural disorders and personality changes are prominent. FTLD is poorly known by general public including health care professionals. Currently, the French health system does not meet the needs and expectations of patients and their families

NCT ID: NCT03606499 Completed - Crohn Disease Clinical Trials

Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases

TENOR
Start date: September 26, 2018
Phase:
Study type: Observational

The purpose of this study is to assess the effectiveness of ustekinumab on extra-intestinal manifestations (EIMs) and immune-mediated inflammatory diseases (IMIDs) associated with inflammatory bowel disease (IBD) (both Crohn's Disease [CD] and Ulcerative Colitis [UC]).

NCT ID: NCT03606408 Completed - Cushing's Syndrome Clinical Trials

Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699

Start date: October 5, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators' judgement, will continue benefiting with its administration.