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Edema clinical trials

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NCT ID: NCT04308603 Recruiting - Clinical trials for Non-Immune Hydrops Fetalis

Multicentric Prospective Study to Screen Inborn Errors of Metabolism in Non-immune Hydrops (NIH) Fetalis by Massively Parallel Sequencing

ANAMETAB-PRO
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

A fetal hydrops, also called a fetal anasarca, is the buildup of fluid in the serosa and / or fetal subcutaneous tissue. The diagnosis is made by ultrasound, possibly from the first trimester of pregnancy. The etiologies of hydrops can be immune or non-immune. The historically classic immune causes are linked to fetal-maternal alloimmunizations in erythrocyte blood groups. The implementation of systematic prevention of these anti rhesus immunizations since the 1970s has significantly reduced the incidence of immune hydrops Non-immune hydrops (NIH) now represent 90% of fetal hydrops. Known causes of NIH can be classified in several ways depending on the mechanism or organ involved. The prognosis for NIH is closely linked to the cause. Fetal anemia due to maternal-fetal infections can heal spontaneously or give rise to in utero transfusions. Cardiac rhythm abnormalities are accessible to medical treatment. Chylothorax compressions may benefit from in utero drainage, but chromosomal or metabolic causes cannot benefit from antenatal care. The term of pregnancy in which the hydrops is discovered also has an impact on survival, which however remains poor. In France, certain pathologies can be considered as particularly serious without the possibility of treatment and give rise to a request for medical termination of pregnancy. This possibility is subject to acceptance by two practitioners who are members of a multidisciplinary prenatal diagnostic center (CPDPN). This preliminary multidisciplinary reflection participates in the development of prenatal counseling with the greatest precision in diagnostic hypotheses. This prenatal advice is essential for a couple on the decision to make a pregnancy in progress but also for future pregnancies, given the 25% risk of recurrence due to the autosomal recessive mode of transmission. Thus the current screening strategy for inherited metabolic diseases on amniotic fluid is fragmented. The resulting subdiagnosis explains the objective of the study of using the new high throughput sequencing techniques (NGS) in this indication. This approach should make it possible to reduce the number of cases classified as idiopathic, to allow the parents concerned to receive suitable genetic counseling with a view to new pregnancies, and to refine the knowledge of the prenatal epidemiology of these pathologies.

NCT ID: NCT04307615 Recruiting - Lung Diseases Clinical Trials

O2 Versus CPAP Treatment Of Patients Undergoing SIPE Therapy (OCTOPUS)

OCTOPUS
Start date: July 2, 2022
Phase: N/A
Study type: Interventional

In swimming induced pulmonary edema (SIPE), there is a lack of knowledge regarding optimal treatment. The present study was designed to assess the benefit of continuous positive airway pressure (CPAP) compared to oxygen as a first line treatment of SIPE in the out-of-hospital environment.

NCT ID: NCT04303065 Recruiting - Clinical trials for Traumatic Brain Injury

Dexamethasone for the Treatment of Vasogenic Pericontusional Edema.

DEXCON-TBI
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

The DEXCON-TBI trial is a multicenter, pragmatic, randomized, triple-blind, placebo controlled trial to quantify the effects of the administration of dexamethasone on the prognosis of TBI patients with brain contusions and pericontusional edema. Adult patients who fulfil the elegibility criteria will be randomized to receive dexamethasone or placebo. Patients who have suffered a head injury and have one or more cerebral contusions with visible pericontusional edema in the CT scan can be included in the study. The doses of dexamethasone will be a short and descending course: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days). The primary outcome is the Glasgow Scale Outcome Extended (GOSE) performed one month and 6 months after trauma. Other secondary outcomes are: compare the number of episodes of neurological deterioration; compare the symptoms associated with TBI; compare the presence of adverse events during treatment; compare the volume of pericontusional edema before and after 12 days of treatment in both groups of patients; and compare the results of the neuropsychological tests between the two groups of patients one month and 6 months after the TBI. The main analysis will be on an ''intention-to-treat´´ basis. A descriptive analysis of the baseline variables will be made for each treatment group. Logistic regression will be used to estimate the effect of dexamethasone and placebo on GOSE at one month and at 6 months, dichotomized in unfavorable outcome (GOSE 1-6) and favorable outcome (GOSE 7-8). Since the severity of the initial injury will determine significantly the final outcome of the patient, to assess the effect of dexamethasone, efficacy will also be analyzed using the 'sliding dichotomy'. A subgroup analysis will be carried out by stratifying the patients as they present more or less than 10mL of pericontusional edema in the preinclusion CT. We will perform an interim analysis with the patients included during the first year to calculate the conditional power. An independent statistician will blindly perform this analysis. At the same time a safety analysis will be also perfomed. A study with 600 patients would have about 80% power (two sided alpha=5%) to detect a 12% absolute increased (from 50% to 62%) in good outcome.

NCT ID: NCT04296838 Terminated - Macular Edema Clinical Trials

Effects of Conbercept in Refractory Uveitic Macular Edema and VEGF

Start date: October 12, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

As a primary exploratory study, this study aims to evaluate the short-term effectiveness of intravitreal Conbercept injection in UME, and to explore the correlation between inflammatory factors like VEGF and the responsiveness to treatment.

NCT ID: NCT04292912 Completed - Macular Edema Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema

Start date: September 7, 2020
Phase: Phase 1
Study type: Interventional

The study will be composed of 3 periods for all participants: Screening, 28-day Treatment period, and Follow-up visit (approximately 28 days after the final dose).

NCT ID: NCT04288219 Recruiting - Hypoxia Clinical Trials

Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

NCT ID: NCT04278404 Recruiting - Hypertension Clinical Trials

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

POPS or POP02
Start date: March 5, 2020
Phase:
Study type: Observational

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

NCT ID: NCT04254536 Not yet recruiting - Clinical trials for Diabetic Macular Edema

Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema After Conbercept Treatment

Start date: February 1, 2020
Phase:
Study type: Observational

Eyes with diabetic macular edema requiring conbercept treatment will be followed up for one month. Before treatment, one week after treatment and one month after treatment, the eyes will be examined by optical coherence tomography (OCT) and optical coherence tomographic angiography (OCTA). The changes of macular edema will be observed and analyzed by OCT leakage mapping software, and the relationship between the changes of macular edema and visual acuity will be analyzed.

NCT ID: NCT04234438 Completed - Clinical trials for Retinitis Pigmentosa

Management of Cystoid Macular Edema Secondary to Retinitis Pigmentosa Via Subliminal Micropulse Yellow Laser

SL-MPL
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Purpose: To investigate the effects of subliminal micropulse yellow laser application on central macular thickness and best corrected visual acuity in cystoid macular edema secondary to retinitis pigmentosa patients.

NCT ID: NCT04225611 Recruiting - Clinical trials for Cystoid Macular Edema

Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema

ContactLens
Start date: March 15, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The main aim of the pilot study is to determine preliminary estimates of the safety, tolerability, and comfort of a dexamethasone-eluting therapeutic contact lens drug delivery system (TCL-DDS) for the treatment of recurrent cystoid macular edema. Secondarily, feasibility of the TCL-DDS system will be investigated. 1. Safety: To establish that a topical dexamethasone delivery system has an acceptable safety profile by determining the incidence and severity of ocular adverse events, as identified by eye examination through day 28 following treatment initiation. 2. Comfort and tolerability: to establish the subject tolerability and comfort of the TCL-DDS. 3. Feasibility: To establish- that a topical dexamethasone delivery system is a feasible treatment for recurrent cystoid macular edema.