Internal Medicine

Clinical trials for Internal Medicine specialty

  • Sponsor:  Private Foundation

    CSRC Protocol #: 030-14

    Status: Not currently enrolling

    Description:

    The purpose of the study is to determine whether the administration of canine umbilical cord derived mesenchymal stem cells (UC-MSCs) is safe, and if it will reduce kidney injury to a greater extent than the current standard of care. The study will measure kidney values to see if they stay in or return to a normal range as well as overall survival. Secondarily, the study will monitor for any changes in your dog’s likelihood to form blood clots.

    Inclusion Criteria:

    Dogs presenting with protein-losing nephropathy, hypoalbuminemia (<2.0 g/dl), azotemia (creatinine >2.0), thrombocytopenia (platelets < 160,000), and a hypercoaguable state.

    Any gender, and any breed, weighing > 4 kg (8.8 pounds).

    Able to come back for recheck appointments on days 2, 7, 14, 30 and 3, 6 and 12 months post injection.

    Exclusion Criteria:

    Dogs weighing less than 4 kg (8.8 pounds)

    Dogs not expected to live greater than 48 hours, those with cardiac disease, and those with neoplasia.

    Also excluded will be those dogs with an active bacterial urinary tract infection, and those suspected or confirmed to have leptospirosis.

    Client Benefits:

    The study will cover some of the costs that are typically acrued in the diagnostic evaluation of dogs with protein-losing kidney disease including complete blood count, chemistry profile, urinalysis, urine culture, urine protein creatinine ratio, thromboeslatograph (a clotting profile), antithrombin level (to see if your dog is at risk for forming blood clots), ANA (looking for lupus, an autoimmune disease) , serology for tick borne diseases and leptospirosis. It will also cover an abdominal ultrasound examination and the cost of a kidney biopsy. Kidney biopsy is part of the standard diagnostic workup for dogs with protein-losing kidney disease permits it (not too anemic, platelet count adequate, and not hypertensive). The risks associated with kidney biopsy are blood loss from the biopsy site. Your dog will be monitored closely for 4 hours after the biopsy to make sure that any bleeding stabilizes. Heart rate, respiratory rate, mucus membrane color, and blood count will be monitored hourly. Should there be any evidence of sustained bleeding, your dog will be administered intravenous fluids and if needed a blood transfusion. The cost of the blood transfusion will be the responsibility of the owner. The study will also cover the cost for follow up blood work at the scheduled rechecks during the 365 days of the study. Your pet’s participation will also allow us to gain information which will help in the diagnosis/management/treatment of other dogs with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

  •  Sponsor:  Private Foundation

    CSRC Protocol #: 026-14

    Status: Not currently enrolling

    Description:

    Dogs get a disease of the intestine called inflammatory bowel disease (IBD) in which the normal lining of the intestine is replaced by inflammatory white blood cells. This inflammation results in poor digestion,  often manifesting as diarrhea, vomiting, and weight loss, and in some cases, loss of protein through the feces. This leads to a severe protein deficiency in the body, called a protein losing enteropathy (PLE). PLE is typically an indication of very severe intestinal inflammation and dogs with this condition may not respond well to typical medications used to treat IBD. In addition the PLE itself can cause fatal complications such as edema, fluid in the abdominal cavity, and blood clots. There is a need for new therapies to treat dog with PLE secondary to IBD. Based on evidence in the literature from pre-clinical and clinical trials in humans, we hypothesize that treatment of dogs with a PLE from IBD with stem cells isolated from the umbilical cords of dogs will modulate the inflammatory response in the intestine and induce clinical remission.

    The purpose of the study is to determine whether intravenous administration of cells called mesenchymal stem cells can improve your dog’s clinical signs as well as their blood protein levels. It is believed that the benefit of these stem cells is related to their ability to suppress inflammation.

    Inclusion Criteria:

    Dogs will have had incomplete response to therapy with prednisone, budesonide and/or cyclosporine (defined by a clinical score (CCECAI) >5), have intolerable side effects on medication, or have the administration of cyclosporine or chlorambucil be financially unreasonable for the owner, as these are the patients who require alternative therapeutic options.

    Dogs with biopsy confirmed IBD and bloodwork confirmed panhypoproteinemia

    (total protein <5.5 mg/dl) will be enrolled. The biopsies may be performed at Tufts if they are not already available for pathologist review.

    Both male and female dogs weighing greater than 11 pounds and any age will be considered for the study.

    Exclusion Criteria:

    Dogs with a urine protein:creatinine (UPC) ratio of >0.5, a baseline cortisol < 2 ug/dL, and a post- prandial bile acids of > 30 uM will be excluded from the study. This will eliminate dogs with protein loss through the kidneys, abnormal production of protein from the liver, or Addison’s disease. These tests can be performed at Tufts.

    All dogs will have an abdominal ultrasound and those with signs of intestinal or extra-intestinal masses will be excluded.

    Yorkshire Terriers, Soft-Coated Wheaten Terriers, and Boxers will be excluded, as these dogs have unique IBD features that respond differently from the general population of dogs.

    Dogs with congestive heart failure, Cushing’s disease, diabetes mellitus, or cancer will also be excluded.

    Client Benefits:

    Expenses associated with giving the injection of stem cells and in evaluating your dog after the injection will be covered. Some initial testing, recheck examinations, and follow-up blood work will be covered. Your pet’s participation will also allow us to gain valuable information which will help in the management and treatment of other dogs with this condition.

     

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • Description:

    The liver performs an essential role in absorption of dietary vitamin D and synthesis of the active form of vitamin D. Vitamin D deficiency is a known problem in people with liver disease and these patients routinely receive supplementation.  Vitamin D deficiency has not been documented in cats with liver disease.  Our goal is to determine if cats with primary liver disease have low levels of vitamin D.  If they do this finding could lead to the development of clinical guidelines for vitamin D supplementation.

     Inclusion Criteria:

    Cats over 1 year of age with one of the following:

    • Hyperbilirubinemia
    • Elevated ALT and/or ALP
    • Cytologic or histopathologic diagnosis of a primary hepatobiliary disease

    Exclusion Criteria:

    • Hyperthyroidism
    • Acute pancreatitis
    • IRIS Stage 2 chronic kidney disease (creatinine >1.6 mg/dl)
    • Congestive heart failure
    • Hypercalcemia (elevated ionized calcium)
    • Corticosteroid or ursodeoxcholic acid administration within the last 2 weeks

     

    Client Benefits:

    The study will cover the cost of the vitamin D panel. Your cat’s participation will also allow us to gain information which will help in the treatment of other cats with this condition

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

  • Status:  Fully enrolled

    Comparison of histamine bronchoprovocation using respiratory inductive plethysmography (RIP) and forced oscillatory mechanics (FOM) to measure airway hyperreactivity in horses with inflammatory airway disease (IAD)

    Description:

    Inflammatory airway disease (IAD) is a non-infectious lung condition which often manifests as intermittent coughing, nasal discharge, and increased mucus in the airways of horses. IAD, similar to human asthma, affects many horses of varying age, resulting in chronic poor respiratory health and exercise intolerance. Improvements in diagnosing and monitoring responses to treatment of IAD would improve horse welfare and benefit the equine industry.

    IAD is diagnosed by either semi-invasive (bronchoalveolar lavage – BAL or “lung wash”) or non-invasive techniques (lung function testing using FOM/RIP). Forced oscillatory mechanics (FOM) testing is performed to non-invasively measure the horse’s respiratory system resistance as an indicator of airway obstruction or narrowing. In contrast, RIP or “Respiratory Inductive Plethysmography”, non-invasively measures the disparity between the horse’s breathing efforts and the amount of airflow actually moving out of the lungs, which would indicate inflammation or obstruction. Both tests are performed before and after nebulization with histamine for the assessment of airway reactivity or ‘twitchiness’ of the airways, which is a common feature of IAD.

    The use of FOM is limited to the hospital setting; whereas the RIP system is portable and thus highly applicable to clinical field practice and stall-side research use. However, the two methodologies have yet to be compared directly; although each has been validated against a conventional method to measure airway resistance (esophageal balloon-pneumotachography). This study is therefore essential in validating the use of portable lung function testing (RIP) by substantiating that comparable results may be achieved using either RIP or FOM.

    Inclusion Criteria:

    Horses of any sex, aged 2-20 years, and weighing 300-600 kg, with clinical signs suggestive of inflammatory airway disease (poor performance, exercise intolerance, cough or nasal discharge); a condition similar to asthma in people.

    Exclusion Criteria:

    Horses that show signs of infectious disease (as determined by history, fever or physical examination), upper respiratory tract abnormalities (such as increased airway noise during exercise) or recurrent airway obstruction (signs of respiratory abnormalities at rest).

    Client Benefits:

    The study will cover most of the costs associated with any testing related to the study (the overnight stay, both forms of lung function testing, and the lung wash will be covered by the study). You will thus have the benefit of a physical examination, lung function testing, and bronchoalveolar lavage cytology to inform you of your horse’s health status. Your horse’s participation will also allow us to gain information which will help in the diagnosis and management of other patients with IAD.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

     

  • Status:  Currently enrolling

    Description:

    The purpose of the study is to investigate ways to monitor dogs that have been diagnosed with chronic inflammation in their liver so called chronic hepatitis in dogs. We are performing this study to evaluate whether these blood tests correlate with the severity of the dog’s liver disease.

    Inclusion Criteria:

    • Dogs weighing greater than 6 kg (13 lbs)
    • Dogs with histologically confirmed chronic hepatitis

    Exclusion Criteria:

    • history of use of corticosteroids, ursodeoxycholate, NSAIDs, omega-3 or vitamin D supplementation within 2 weeks of enrollment or the use of DDAVP within 24 hours
    • degenerative mitral valve disease, renal disease (Creat >2.0 mg/dL), concurrent active infection, neoplasia, IBD, immune mediated hemolytic anema, pnacreatitis or immune mediated polyarthropathy

    Client Benefits:

    The study will cover the costs of the vitamin D, CRP and von Willebrand factors as well as a complete blood count and serum chemistry at the first recheck appointment.

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

     

     

     

  • Status:  Currently enrolling

    Description

    The goal of this study is to assess the presence and degree of vascular abnormalities which are thought to exist within the eyes of diabetic canines. Diabetes is one of the most common endocrinopathies affecting dogs. In humans, diabetes results in microangiopathies (diabetic iridopathy and retinopathy) which are significant vision threatening sequelae. While noted to occur in diabetic canines, little published information exists regarding its degree and/or severity. This study will perform a diagnostic work up, including a 24 hour blood glucose curve, in addition to, ocular angiography using both sodium fluorescein and indocyanine green, in a total of 8 diabetic canines. Our goal is to document and characterize vasculature changes (vascular leakage, delayed perfusion) which are thought to occur in diabetic dogs and correlate them to disease status and/or duration. Data generated herein, will provide the necessary information for conducting longitudinal studies, correlating the prevalence and severity of these vascular abnormalities to the duration of disease and regulation status. Knowledge regarding the prevalence and severity of these vascular abnormalities could translate into better preventative medicine and/or improved patient outcomes following surgery (i.e. cataract surgery) in our canine patients.

    Inclusion Criteria

    1. New or previously diagnosed canines with diabetes mellitus. A diagnosis of diabetes mellitus is based on a history of polyuria, polydipsia, polyphagia, blood glucose above 250mg/dl, and glucosuria.

    Exclusion Criteria

    1. Diabetic canines exhibiting any signs/symptoms suggestive of concurrent systemic disease(s) will not be considered.  Excluding conditions include diseases that cause insulin resistance such as hyperadrenocorticism and/or those which may be associated with vascular abnormalities (i.e.renal failure, neoplasia, and heart failure)
    • Dogs receiving corticosteroids within the previous 30 days will be excluded.

     Client benefits

    The study will cover the following costs associated with participation in this study: the cost of a complete blood count, serum biochemistry profile, urinalysis and culture. Additionally, costs of conducting a 24 hours blood glucose curve (including hospitalization charges) and a fructosamine level will be covered. For angiographic purposes, canines will be sedated the following day and receive intravenous administration of two commonly employed angiographic dyes. The study will cover the costs associated with conducting ocular angiography.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu