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NCT ID: NCT03638440 Completed - Clinical trials for Opioid Induced Constipation

Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.

NACASY
Start date: August 16, 2018
Phase:
Study type: Observational

This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.

NCT ID: NCT03638323 Completed - Alzheimer Disease Clinical Trials

Age-related Hearing Loss and Lexical Disorders

LOOP
Start date: August 27, 2018
Phase:
Study type: Observational

In France, Alzheimer's disease accounts for 70 to 80% of the causes of neurocognitive disorders, i.e. 600,000 to 800,000 patients. It is a neurodegenerative pathology that causes evolutionary cognitive dysfunction, mainly affecting memory functions. The inability to name familiar objects (lack of the word) is one of the most commonly noted symptoms at an early stage of the disease. Presbyacusis, or age-related hearing loss, is the most common sensory deficit in the elderly which is manifested socially by a progressive discomfort of verbal communication. Presbyacusis remains underdiagnosed and undertreated: 2/3 of the patients are not using hearing aid. In recent years, a link between neurocognitive disorders and hearing loss has been shown by investigating general cognition. In this study, the investigators are investigating lexical disorders.

NCT ID: NCT03636932 Completed - Clinical trials for Chronic Kidney Diseases

RENACTIF: Reduction of the Thrombotic Phenotype in Renal Insufficiency With N-AcetylCysteine

RENACTIF
Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

Chronic Kidney Disease (CKD) is a known risk factor of cardiovascular morbidity and mortality. In CKD, decline of renal function results in the accumulation of uremic toxins in blood and tissue, such as Indoxyl Sulfate (IS). IS plasma level is predictive of mortality and cardiovascular disease (CVD). Patients with CKD have increased oxidative stress and circulating tissue factor (TF) levels. In vitro, IS induces an inflammatory, pro-oxidative and pro-coagulant phenotype on endothelial cells and activates TF. N-acetylcysteine (NAC) protects endothelial cells from the effects of IS. NAC reduces oxidative stress and production of activated TF. A prospective study evaluating an oral NAC treatment versus placebo in chronic hemodialysis patients showed a better cardiovascular outcome but the physiopathology was unclear. The hypothesis is that NAC reduces cardiovascular risk by its effect on uremic toxin-induced pro-coagulant TF production. The primary objective is to compare the effect of NAC intravenously administered at each dialysis session (2gram on 3 dialysis sessions per week) to placebo on circulating TF levels in patients with CKD on chronic hemodialysis after 4 weeks of treatment. The objective is to show a 33% decrease in circulating tissue factor (TF) levels in the NAC group compared to the control group. It is a randomized, double-blind, placebo-controlled crossover trial that includes chronic hemodialysis patients from La Conception Hospital (AP-HM) in Marseilles, France. This is an interventional biomedical research project. 20 patients will be included in each group and will receive during 4 weeks intravenous injection. This study will give a pathophysiological rationale for the use of NAC to reduce thrombotic and cardiovascular risk in patients with CKD. This step will provide the rationale for a clinical trial to reduce the occurrence of major cardiovascular events with IV NAC in hemodialysis (HD) patients.

NCT ID: NCT03636919 Completed - Allergic Rhinitis Clinical Trials

Component Resolved Diagnostics (CRD) and mHealth for Pollen Allergy In Southern Europe.

IT-2020-MC
Start date: January 29, 2018
Phase:
Study type: Observational [Patient Registry]

Pollen allergic rhinitis is a very common condition whose symptomatic treatment is not always sufficient or satisfactory. The indication for allergic immunotherapy (IT) therefore often arises. The indication is based on the interrogation of the patient (chronology and severity of symptoms) and skin tests. But the interrogation, necessarily retrospective, brings often vague information and skin tests can be positive for allergens that have no clinical role (cross allergies). The objective of the project is to help the clinician in the indication of the IT, on the one hand by setting up a prospective and computerized collection of symptoms by a computer logbook accessible by the mobile phone of the patient. on the other hand by performing on the patient's serum a molecular diagnosis allow the identification of the major allergens to which the patient is sensitized. The same study will be conducted in 7 centers in southern European countries in patients aged 10 to 60 years with pollinosis. The examinations added by the research will take place during two routine visits: during a first visit, these patients will answer a standardized questionnaire, have a battery of allergological skin tests and a blood sample for molecular diagnosis. An application will then be loaded on their mobile phone and they will record their symptoms and medication during the pollen season. During a second visit, at the end of the pollen season, the allergist, in view of the data collected in the electronic notebook and the results of the molecular diagnosis will be able to prescribe a possible IT.

NCT ID: NCT03636789 Completed - Multiple Sclerosis Clinical Trials

Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome

OCRIS
Start date: October 26, 2018
Phase: N/A
Study type: Interventional

This study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.

NCT ID: NCT03635983 Completed - Melanoma Clinical Trials

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Start date: September 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

NCT ID: NCT03635944 Completed - Growth Retardation Clinical Trials

Nutritional Care and Head Growth in Preterm Infants

KARLY
Start date: December 1, 2016
Phase:
Study type: Observational

As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units. A retrospective study included extremely low birth weight infants born in Lyon, France or in Stockholm, Sweden. Data on morbidity, treatments, care practices, macro-nutrient intakes and postnatal growth were collected to determine risk factors of extra uterine growth restriction at discharge. By comparing postnatal growth in ELBW infants hospitalized in two European neonatal intensive care units with different nutritional and extra nutritional care,our objective was to evaluate the role of nutrition in this population of preterm infants.

NCT ID: NCT03635346 Completed - Chronic Pain Clinical Trials

Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD

DEMDOU
Start date: June 3, 2016
Phase:
Study type: Observational

prescription opioid misuse in chronic pain is a growing public health concern. few studies got interested in prevalence of misuse and of opiate use disorder in a population of patients with a non cancer chronic pain. the investigators analyzed during 3 months opiate misuse and opiate ude disorder in a population of patients consulting a center specialized in pain management.

NCT ID: NCT03635307 Completed - Clinical trials for Blood Volume Expansion

Ability of Changes in End Tidal Carbon Dioxide to Assess the Stroke Volume Effects of a Volume Expansion of 250ml of Crystalloid in the Operating Room

REVCO2
Start date: August 16, 2018
Phase:
Study type: Observational

Volume expansion is the cornerstone of perioperative hemodynamic optimization. The main objective of volume expansion is to increase and to maximize stroke volume. Despite national and international recommendations, stroke volume monitoring is clearly not widely adopted. This is mostly due to the cost and the invasiveness of the devices allowing stroke volume monitoring. End tidal carbon dioxide is monitored in all patients undergoing general anaesthesia and is totally non-invasive. A strong relationship between stroke volume and end tidal carbon dioxide have been already demonstrated. The aim of the present study is to determine if change in End Tidal Carbon Dioxide can assess the stroke volume effects of a volume expansion of 250ml of crystalloid in the operating room

NCT ID: NCT03634878 Completed - Clinical trials for Prolapse of the Uterus

Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

PROMONOTECHO
Start date: April 2016
Phase: N/A
Study type: Interventional

Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively. These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. There is no data in the literature on the relationship between prosthesis position and postoperative symptoms