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Edema clinical trials

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NCT ID: NCT05122702 Recruiting - Macula Edema Clinical Trials

An Innovative Chinese Herbal Formula for Macular Edema

Start date: July 12, 2022
Phase: Phase 2
Study type: Interventional

Macular edema (ME) is caused by hyperpermeability of retinal vessels and/or decreased efflux of fluid across the retinal pigment epithelium induced by outer/inner blood-retinal barrier dysfunction (BRB). It is most commonly seen following many diseases such as diabetes mellitus (DM), intraocular surgery, uveitis, retinal vein occlusion, and posterior segment inflammatory disease. An estimated 11% of patients with DM develop diabetic macular edema (DME). While the overall prevalence of DME among patients with DM aged 20 to 79 years is approximately 7.5%, the risk increases over time. Currently, there is no cure for ME. Chinese medicine (CM) is widely used to manage ME in China and other East Asian countries. Among them, Shenling Baizhu San (SBS) is one of the most commonly used formulae. In this proposal, a randomized, double-blind, placebo-controlled, multicenter clinical trial will be undertaken to evaluate the efficacy and safety of modified SBS (mSBS) developed by the project team for the treatment of ME. Eligible subjects will be recruited and assigned randomly to receive orally mSBS or placebo twice a day for 12 consecutive weeks, with follow-up for another 4 weeks after stopping the treatment to observe the duration of efficacy.

NCT ID: NCT05069675 Recruiting - Clinical trials for Cystoid Macular Edema

Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment

Start date: July 12, 2021
Phase:
Study type: Observational

To investigate the incidence of cystoid macular edema in eyes with primary rhegmatogenous retinal detachment successfully treated with vitrectomy with gas tamponade, and to evaluate the clinical variables associated with its development.

NCT ID: NCT05049889 Recruiting - Pulmonary Edema Clinical Trials

Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

RFSI-OPI
Start date: August 17, 2022
Phase: N/A
Study type: Interventional

Immersion Pulmonary Edema (IPE) is a relatively new form of hemodynamic pulmonary edema. The number of cases has been increasing over the last ten years and it has become the second most common cause of hospitalization for military divers, after decompression sickness. The pathophysiological mechanisms of IPE are not completely known. Its occurrence is linked to a combination of factors related to the environmental constraints of diving, as well as to the diver's equipment. The main external factors are increased hydrostatic pressure, cold, intense effort and emotional stress. The impact of internal factors is not known. At this time, no severe forms of IPE have been identified in the military. However, it is important to identify this pathology at an early stage, even if the signs appear minor, because the continuation of underwater activity can significantly worsen the clinical picture. The risk of recurrence (greater than 15%) could result in a severe or even lethal accident.

NCT ID: NCT05042492 Recruiting - Clinical trials for Osteoarthritis, Knee

The Post-operative Effect on Formation of Oedema After Total Knee Arthroplasty With or Without the Use of a Nerve Stimulator (the gekoTM Device)

Start date: January 14, 2021
Phase: N/A
Study type: Interventional

This study will investigate whether the recovery of muscle function of total knee arthroplasty is accelerated with the use of the gekoTM device along with its effect on reducing symptoms such as oedema and inhibition of the muscle function.

NCT ID: NCT04963127 Recruiting - Fractures, Bone Clinical Trials

Prospective Study of Diagnostic Accuracy of Spectral CT for the Detection of Bone Marrow Edema

Start date: July 15, 2021
Phase:
Study type: Observational [Patient Registry]

Dual-Energy/Multi-Energy/Spectral-CT can visualize bone marrow edema associated with fractures, however, current scientific evidence is mostly derived from to retrospective analyses. Our prospective study systematically analyzes the diagnostic accuracy of the visualization of bone marrow edema by including patients who are scheduled for a CT scan to exclude or further characterize a fracture. After giving informed consent, the CT scan will be performed using a dose-neutral Dual-Energy-/Multi-Energy-/Spectral-CT acquisition technique. If the patient undergoes MRI of the same region within 7 days, this scan will be used as a gold-standard for bone marrow edema. This will allow the quantification of diagnostic accuracy.

NCT ID: NCT04955171 Recruiting - Macular Edema Clinical Trials

BEOVU Versus Eylea in the Treatment of Diabetic Macular Edema

Start date: January 12, 2021
Phase: Phase 3
Study type: Interventional

Diabetic macular edema degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management

NCT ID: NCT04927234 Recruiting - Surgery Clinical Trials

Foot and Ankle Post-operative Oedema Management Using Geko™

Start date: October 7, 2022
Phase: N/A
Study type: Interventional

The multicentre randomised geko™ Foot and Ankle Trial will prospectively and systematically collect clinical data on patients randomised, on a 1:1 basis, to either standard care or standard care plus geko™ therapy to assess oedema management and patient outcomes during a follow-up period of up to three months post-surgery.

NCT ID: NCT04910503 Recruiting - Clinical trials for Diabetic Macular Edema

Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema

EMMA
Start date: October 29, 2021
Phase: Phase 4
Study type: Interventional

Diabetic macular oedema (DME) is the main cause of visual impairment (or visual acuity) in patients with diabetic retinopathy, as it leads to progressive thickening of the retina, which in the long term leads to progressive death of the photoreceptor cells. It is therefore important to continue to treat macular oedema that has been progressing for several months or even years (resistant DME). The management of DME necessarily involves controlling diabetes (improving glycated haemoglobin levels) and blood pressure, but this is often not enough. Thus, when DME is significant and leads to a decrease in visual acuity, treatments are administered directly into the eye (intravitreal injections). For some years now, corticosteroids have been injected into the vitreous body (the gel that fills the eyeball) through the white of the eye for their anti-inflammatory properties. Indeed, these drugs improve the permeability of the retinal vessels and thus reduce oedema. These intravitreal implants are most often used in patients who have already undergone cataract surgery (pseudophakic) because corticosteroids also tend to aggravate a cataract. Currently, there are two implants containing corticosteroids that can be injected: the dexamethasone implant and the fluocinolone acetonide implant. These two implants have different properties, particularly with regard to their duration of action. Today, the overall management at 3 years and the quality of life associated with the treatments deserve to be evaluated. This study is the first multicenter controlled trial comparing the two reference corticosteroid treatments in terms of overall cost of treatment and follow-up and patient quality of life, while considering their efficacy and side effects. This evaluation will make it possible to precisely define the respective place of each implant in the management of resistant DME.

NCT ID: NCT04895228 Recruiting - Bone Marrow Edema Clinical Trials

Impact of Sacroiliac Joint Injection on Bone Marrow Edema

Start date: May 15, 2021
Phase: N/A
Study type: Interventional

SpA is a chronic, debilitating inflammatory rheumatic disease that affects axial and peripheral joints, internal organs, and other tissues. Sacroiliitis is a hallmark of axial SpA. Sacroliliitis has a great effect on spine pain, function and cephalic progression of the disease . The prevalence of SpA ranged from 9 to 30 per 10,000 persons in Caucasian populations, Europe or the United States . The management of axial SpA is really challenging. The traditional disease-modifying anti-rheumatic drugs (DMARDs) were ineffective in controlling the axial disease. Biological agents such as tumor necrosis factor alpha (TNFα) inhibitor and anti-interleukin 17 have shown promising results in achieving remission or low disease activity for axial SpA . Magnetic resonance imaging (MRI) is established as the imaging method of choice for the early diagnosis and follow-up of SpA patients. Although a positive imaging detection of the axial skeleton is no longer obligatory based on the new Assessment of Spondyloarthritis International Society (ASAS) classification criteria 2010, MRI imaging still plays a crucial role, especially in the early diagnosis arm. MRI has a high sensitivity in detection of acute inflammatory processes as well as the high-resolution visualization of anatomical alterations. The lack of radiation exposure makes MRI ideal for monitoring response to treatment .Bone marrow edema (BME) not only showed high sensitivity for detection of early sacroilitis, but also its reduction was a worthy indicator for disease remission. Intra Articular (IA) injections of SIJ with corticosteroids and anesthestics are often performed for pain relief. Although this technique is relatively old, it was not used on a lrage scale in axial SpA patients. Further, its effect on disease outcome measures were not well elucidated. To the best of our knowledge there is no single study have evaluated effect of steroid and local aneshestic injection on improvement of BME . Image guidance of the SIJ injection is fundamanetal, due to the complex anatomy of the joint causing a low accuracy when performed using blind technique .

NCT ID: NCT04847869 Recruiting - Clinical trials for Retinal Vein Occlusion

Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema

NIRVO
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

This pilot study aims to establish that treatment with near infrared light (NIR) reduces cystic macular oedema in patients with a retinal vein occlusion.