Salvaging a threatened limb is the key therapeutic objective for patients with critical limb ischemia, and the achievement of limb salvage is an independent predictor of patient morbidity and mortality. Despite successful primary endovascular or surgical intervention, the corresponding symptoms of rest pain and/or non-healing ulceration in some patients may continue, and amputation in these patients is unavoidable. It is hypothesized that the functional integrity of the peripheral vascular microcirculation may be impaired in these patients. However, there are currently no techniques that allow direct quantification and visualization of the microcirculation due to the micro-vessel invisibility under angiography.
In the coronary circulation, coronary flow reserve (CFR) indicates the capacity for maximal hyperemic blood flow and reveals impaired coronary microvascular function. Studies have shown the clinical significance of measuring microvascular resistance to predict myocardial salvage after myocardial infarction. The study will explore whether this concept of coronary flow reserve can be applied peripherally to patients with critical limb ischemia in order to determine whether measuring peripheral vascular flow reserve can determine the integrity of the microcirculation to predict limb salvage after endovascular intervention.

Start Date25 Nov 2024

Sponsor / Collaborator

Ocean Medical Center Association, Inc.

[+1]

NCT04220190 / Not yet recruitingPhase 2/3

Phase 2/3 Trial of Autologous Hybrid TREG/Th2 Cell (RAPA-501) Therapy for Amyotrophic Lateral Sclerosis

RAPA-501-ALS is a phase 2/3 expansion cohort study of RAPA-501 autologous hybrid TREG/Th2 cells in patients living with amyotrophic lateral sclerosis (pwALS).

Start Date01 Sep 2024

Sponsor / Collaborator

Rapa Therapeutics LLC

[+2]

NCT05726383 / RecruitingPhase 2IIT

MISTOSUS: Iscador® P (Mistletoe) Immunotherapy To Improve Event Free Survival In Patients With Relapsed Osteosarcoma After Resection Of Pulmonary Metastases

This will be a phase II, single arm study of osteosarcoma patients with fully resected pulmonary metastases. The MTD corresponds to the dosage recommendations of the manufacturer of Iscador® P which is licensed in Sweden, New Zealand, South Korea, Germany and Switzerland for the treatment of solid tumors and precancerous lesions.
The study population includes patients with relapse of osteosarcoma in the lung following surgical resection of all gross disease (2nd or greater CR). Following completion of final thoracotomy, they will be treated with Iscador® P at concentrations up to the MTD with surveillance imaging via CT scan to monitor for relapsed disease.

Start Date14 May 2024

Sponsor / Collaborator

Ocean Medical Center Association, Inc.

[+1]

100 Clinical Results associated with Ocean Medical Center Association, Inc.

0 Patents (Medical) associated with Ocean Medical Center Association, Inc.

Literatures (Medical) associated with Ocean Medical Center Association, Inc.

01 Oct 2019·American Journal of Gastroenterology

2398 Are Herbal and Dietary Supplements Really Safe?

Author: Garg, Chandi ; Shrimanker, Isha ; Nookala, Vinod ; McLaughlin, John ; Goel, Siddharth ; Debnath, Dipanjan

INTRODUCTION:The use of herbal and dietary supplements (HDS) has been on a rise in the United States in the last couple of decades with roughly one half of the population consuming it. Artemisinin is found in the leaves of Artemisia annua and has been in use for a long time for its medicinal purposes. It is also a key ingredient in HDS and is generally considered safe and effective with no major side effects but very rarely, may lead to liver injury. Due to the HDS being unregulated, its increased use has led to an increase in adverse effects with hepatic injury being the most notable one. Here we present a case of HDS causing severe hepatic injury.CASE DESCRIPTION/METHODS:A 63-year-old female with a past medical history of generalized anxiety disorder and recurrent major depression, and with a recent history of over the counter supplement Microb-Clear consumption, presented with pruritus and generalized rash, of one week duration, associated with malaise, anorexia, intermittent nausea, yellow discoloration of the skin, dark urine and light stools. Her physical examination was significant for jaundice and diffuse maculopapular rash. Laboratory investigations revealed direct hyperbilirubinemia (7.3 mg/dl) with a cholestatic pattern of liver injury, with an upward trend in direct bilirubin and alkaline phosphatase noticed during the treatment course. The patient improved following discontinuation of the over the counter supplement, leading to a diagnosis of exclusion of HDS induced liver injury.DISCUSSION:The current regulations regarding supplements are inadequate and irrational. The general perception about safety and easy availability without the requirement of a medical prescription is one of the major causes of their misuse. They have unpredictable pharmacokinetics and pharmacodynamics as well as unknown drug interactions, increasing the probability of toxicity. As with our patient, discontinuing the supplements caused rapid symptomatic relief with improvement in liver function, which points towards a causal relationship between consumption of artemisinin-containing supplements and hepatic injury. The mechanism of the liver injury caused by artemisinin is still unknown. Further studies are required to study the relationship between HDS consumption and hepatic injury. A high index of suspicion is required to identify and minimize such adverse reactions in the future.

01 Oct 2019·American Journal of Gastroenterology

2515 Rise of the Aminotransferases: A Liver's Call for Help!

Author: Shrimanker, Isha ; Biswal, P. ; Malini, G. ; Singh, Pratiksha ; Banerjee, Namita

INTRODUCTION:Acute liver failure is characterized by a biochemical diagnosis of liver damage along with coagulopathy defined by international normalized ratio (INR) >2.0 despite intravenous vitamin K replacement or INR >1.5 with encephalopathy, without any chronic liver disease. It is a rare occurrence in a previously healthy adolescent. We report the case of acute severe hepatitis culminating into acute liver failure with suspected Wilson disease (WD).CASE DESCRIPTION/METHODS:A 14-year-old Asian female presented with hematemesis, watery stools and abdominal pain in the right upper quadrant for two days. The patient had 2-3 episodes of vomiting consisting of semi-digested food particles, watery in consistency that gradually progressed to one episode of emesis containing bright-red blood, about 15-20 ml in quantity associated with six episodes of watery stools, without any blood or mucus. She had consumed food cooked outside a few days prior. On admission, she had a pulse of 70 beats/minute, and blood pressure of 98/50 mm Hg. Physical examination revealed icterus, tenderness in the right hypochondriac region and palpable liver, about 3 cm below the costal margin. Laboratory investigations revealed hemoglobin of 10.7 gm/dl, aspartate aminotransferase of 9018 U/L, alanine aminotransferase of 6637 U/L, alkaline phosphatase of 261 U/L, total bilirubin of 2.8 mg/dl with a direct component of 1.6 mg/dl, prothrombin time of 32 seconds, partial thromboplastin time of 39 seconds, international normalized ratio of 2.69. Workup for viral markers was negative. Ultrasound of the abdomen revealed altered echotexture of the liver. The ophthalmologic examination did not reveal any abnormality. The serum ceruloplasmin level was 13 mg/dL. The patient was diagnosed with acute severe hepatitis with acute liver failure with suspected underlying WD. She was treated with intravenous doses of antibiotics including ciprofloxacin and amikacin, vitamin K, and octreotide, oral lactulose and ursodeoxycholic acid and was transfused two units of fresh frozen plasma. A gradual decrease of liver enzymes (Figure 1) and coagulation profile (Figure 2) was seen and she was followed up on an outpatient basis.DISCUSSION:The management of acute liver failure can be arduous requiring early diagnosis and aggressive treatment to improve better prognosis. Physicians should maintain a high amount of suspicion of concomitant disease in the setting of a young patient such as ours presenting with fulminant liver disease.

100 Deals associated with Ocean Medical Center Association, Inc.

100 Translational Medicine associated with Ocean Medical Center Association, Inc.

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