Internal Medicine

Clinical trials for Internal Medicine specialty

  • 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:

    Hyperammonemia has been documented in several disease states in cats, but no studies have systematically evaluated blood ammonia levels in cats with renal azotemia.  The objective of this pilot study will be to document blood ammonia levels in cats that present for evaluation of renal azotemia. We hypothesize that fasting blood ammonia will correlate with the blood urea nitrogen and creatinine in these cats.

    The blood ammonia level will be available for interpretation by the investigator within 2-3 hours of blood collection. If hyperammonemia is documented, we will enact therapy to decrease the blood ammonia level during the hospitalization stay.  We will also be measuring serum B12 (cobalamin) levels and if these are low, we can supplement the cats. Beyond benefit to the enrolled cats, this study will direct the design of a future study to evaluate if the results are repeatable in a larger population

    Inclusion Criteria:

    Cats with the confirmed presence of renal azotemia on labwork (IRIS Stage ≥ 2: creatinine ≥ 1.6 mg/dL) that either have a history of previous kidney disease, or are newly diagnosed.

    Exclusion Criteria:

    Cats with previously diagnosed concurrent disease states known to have increased ammonia levels will be excluded from the study (e.g. congenital portosystemic shunts, previously documented cobalamin deficiency); however, cats will be screened for a cobalamin deficiency in the event the deficiency is undiagnosed.                                    In addition cats on medications known to decrease blood ammonia (antibiotics, lactulose) will be excluded.

    Client Benefits:

    The cost of the blood ammonia and cobalamin levels will be covered by the study.Your pet’s participation will also allow us to gain information which could help in the diagnosis, management, and 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

  • CSRC protocol #: G2016.33

    Status:  Currently enrolling

    Description:

    To determine if telmisartan, a medication used to reduce protein loss through the kidneys, is broken down and processed differently in dogs with kidney disease compared to healthy dogs.

    To compare the ability of telmisartan to control protein loss through the kidneys in dogs with protein-losing kidney disease (protein-losing nephropathy, or PLN) with benazepril, one of the medications in the class of medications (angiotensin-converting enzyme inhibitors) that is currently standard therapy for this disease.

    We hypothesize that the processing of telmisartan in dogs with PLN will be altered compared to the patterns previously established in healthy dogs, and that telmisartan will be equally or more effective than benazepril at treating PLN.

    This study serves to evaluate telmisartan, a medication commonly used in human medicine, for its role in helping to treat protein-losing nephropathy, a potentially devastating disease in dogs.  If successful, this may open a new option for treatment of dogs with PLN who don’t respond to standard therapies, such as benazepril.  In addition, the pharmacokinetics of telmisartan (or any angiotensin-receptor blocker) in dogs with PLN has not been previously evaluated.

    Inclusion Criteria:

    Dogs who have been diagnosed with protein-losing nephropathy (as defined by having a urine protein:creatinine ratio >2.0 with no evidence of non-renal causes of proteinuria).

    Client benefits:

    The direct benefit from this study for your dog is that he or she will receive one of two promising therapies for protein-losing kidney disease with close monitoring of his or her response to therapy.  The direct benefit to you is that the costs of either medication (benazepril or losartan) will be covered for the duration of the study (6 months).  You will be responsible for the costs of the preliminary diagnostic tests (including ultrasound) and the costs of the recheck appointments and urine and blood testing at these rechecks.

    Contact information:

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

     

     

  • Status:  Currently enrolling

    Description:

    We hypothesize that the orally administered drug, bexagliflozin, will improve glycemic control in poorly regulated diabetic cats. The primary objective of this study is to determine if mean blood sugar and fructosamine concentrations decrease by ≥10% with administration of bexagliflozin over a two week period. The secondary objective is to determine if bexagliflozin is well tolerated by poorly regulated diabetic cats.

    Inclusion Criteria:

    Cats with unregulated diabetes mellitus based on history of persistent hyperglycemia(>250 mg/dl) and appropriate clinical signs, including polyuria, polydipsia and weight loss

    Exclusion Criteria:

    Cats with documented azotemia, elevated bilirubin, ALT >2.5x the upper limit of normal, diabetic ketoacidosis, urinary tract infection, use of corticosteroids within the past 8 weeks, heart disease requiring medication and uncontrolled hyperthyroidism based on preliminary laboratory testing

    Client benefits:

    The study will cover the costs of blood work and urine tests required for the study, blood pressure measurement, day boarding as well as the cost of the medication.  We will be teaching you how to monitor your cat's blood glucose levels at home with a hand held glucometer that will be loaned from our hospital for the duration of the study.

    Contact information:

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

  • Sponsor: Private Foundation

    IACUC Protocol # G2016-134

    Status:  Enrollment currently on hold

    Description:

    Dogs develop inflammatory bowel disease (IBD) spontaneously, which results in persistent or recurring signs such as weight loss, vomiting, and/or diarrhea, and is characterized by inflammatory cell infiltration in the intestine.

    In both humans and dogs, IBD is considered to be an idiopathic, chronic, relapsing immune-mediated inflammatory disorder of the GI tract that involves the interplay between genes, diet, and the microbes in the intestine. The treatment for IBD in both dogs and humans is similar, and relies on diet, immune suppression.

    The goals of this experiment are: 1) to evaluate the gene expression of the white blood cells in the intestine and the blood of dogs with inflammatory bowel disease compared to normal dogs, and 2) to evaluate the in vitro response to activation of the T cells in the blood and intestine of dogs with IBD and normal dogs, and 3) to determine in vitro if extracellular vesicles (EV) derived from canine mesenchymal stem cells (MSC) or the MSC themselves are able to reduce the inflammation seen in dogs with IBD.

    MSC are cells derived from the tissue around the umbilical cord, which are known to have anti-inflammatory and regenerative properties. EV are nanoparticles released from the MSC, which contain many signaling molecules that are also potentially capable of anti-inflammatory properties.

    Inclusion Criteria:

    IBD group:

    Dogs over 1 year of age and weighing > 5 kg undergoing upper gastrointestinal endoscopy for evaluation of a history of chronic gastrointestinal signs of at least 3 weeks duration (vomiting, diarrhea, and/or weight loss) will be considered. These dogs will have no identifiable cause for their clinical signs on routine diagnostic evaluation (complete blood count, serum chemistry, urinalysis, baseline cortisol). Dogs will need to have had a veterinarian-recommended diet trial for at least 1 week with incomplete resolution of signs, as well as be incompletely responsive to an antibiotic trial with metronidazole or tylosin. Eligible dogs will have had a negative fecal floatation and Giardia ELISA or negative zinc sulfate floatation, or be non-responsive to a treatment course with fenbendazole (50 mg/kg daily for 3 days).

    Control dogs for blood and GI tissue acquisition will include otherwise healthy dogs undergoing endoscopy for foreign body retrieval and weighing > 5 kg. Dogs will have no evidence of systemic disease (change in weight, thirst, urination, activity level), and no history of gastrointestinal signs unrelated to recent foreign body ingestion.

    Exclusion Criteria:

    Dogs with cancer detected on physical examination or diagnostics performed will be excluded. Dogs cannot be on topical or oral short acting steroid therapy (prednisone or prednisolone), other oral immunosuppressants (i.e., azathioprine, cyclosporine), or oral non-steroidal anti-inflammatory (i.e., Rimadyl, Deramaxx) medication for at least 1 week prior to biopsy. Antibiotic therapy will not exclude a patient from enrollment.

    Client Benefits:

    Fees associated with histopathology (microscopic evaluation of the intestinal tissue) performed during the study will be covered during your participation in the study. Costs incurred by additional anesthesia time over that needed for diagnostic biopsy collection or foreign body removal will be covered by the study.

    In the event any complications arise during endoscopy, their management will be covered by you.

    Contact Information:

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

     

     

  • IACUC & CSRC # G2016.169

    Status: Currently enrolling

    Description:

    The goal of this project is to measure the development of antibiotic resistance in pet dogs treated with antibiotics and their owners. We will measure the number of resistant organisms in the stool of dogs and their owners both before treatment and after the dog receives two weeks of antibiotics.  This project will begin investigating the relationship between small animal antibiotic use and the development of antibiotic resistance in both the dogs and humans in close contact with their pets. Since antibiotic resistance is becoming a global threat to both human and animal health, such studies investigating the interrelationship of resistance development and potential hazards of veterinary antibiotic use are essential.

    We hypothesize that antibiotic treatment will result in the measurable development of resistance in both dogs and owners in close contact with their pets.

    Inclusion Criteria:

    Dogs receiving a 14-day course of either Clavamox or Baytril for any reason are eligible for participation in the study. The owners must also enroll in a concurrent trial with IRB approval to collect stool samples from themselves.

    Exclusion Criteria:

    No additional antimicrobials or other medications can be administered to your dog along with the course of antimicrobials. This includes antacids, probiotics, and anti-inflammatory medications.

    In addition, neither you or anyone in your household (human or animal) can have received antibiotics within the 2 months prior to study enrollment.

    Client Benefits:

    There are no costs associated with sample collection for this study. In the event any complications arise during the study period, their management will be covered by you, the owner. Antibiotics are being recommended for treatment of your pet independent of this study being performed, and adverse events are uncommon.

    In return for participation in this study, you will be given a $200 Visa® gift card once all samples have been collected for both your dog and yourself.  Both samples for your pet and yourself must be returned to the Foster Hospital for Small Animals to receive the gift card.

    Your participation will allow us to gain important information about the risk for developing antibiotic resistance in dogs and in people in close contact with dogs. 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

     

     

  • CSRC protocol # 003.17

    Status:  Currently enrolling

    Description:

    Gallbladder mucoceles (GBM) are a common and significant cause of biliary disease in dogs.  We hypothesize that dogs with GBM will have coagulation parameters compatible with a hypercoagulable state. We hope to determine if there is a correlation between these coagulation parameters and known risk factors for mortality in dogs undergoing cholecystectomy for GBM, clinical course and ultrasonographic findings associated with gallbladder rupture.

    Inclusion criteria:

    • Ultrasonographically diagnosed gallbladder mucocele (GBM).
    • Dogs must have had a complete blood count, chemistry and urinalysis within 24 hours of the ultrasound diagnosis
    • Body weight greater than 5 kg

    Exclusion criteria:

    • Administration of vitamin K, blood productions or any other medications known to affect coagulation (nonsteroidal anti-inflammatory medications, corticosteroids, heparin, clopidogrel, free fatty acids or hydroxylethyl starch) within 2 weeks of the sample collection
    • Greyhounds will be excluded

    Client Benefits:

    The study will cover the costs of coagulation testing (prothrombin time, partial thromboplastin time, factor VIII activity, fibrinogen, Ddimer, thromboelastrography, protein C activ ity, antithrombin activity and von willebrand factor activity). We will share the results of the thromboelastography with you. The other coagulation tests will not be performed immediately. Your pet's participation will also allow us to gain information regarding the coagulation status in dogs with gallbladder mucoceles which may help in the management 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

     

     

     

  • IACUC Protocol # G2016-161

    Status: Currently enrolling

    Description:

    To develop tests to measure lymphocyte function in healthy animals, which will then be able to be used to monitor disease in sick dogs and rabbits. Lymphocytes are a type of white blood cells that function as part of the immune system. Normally, they respond properly to foreign invaders in the body. When the lymphocytes do not act properly diseases may occur.

    Once adequately developed and validated, the proposed tests will allow us to evaluate immune function in dogs and rabbits with diseases affecting their immune systems. The various applications of these tests include evaluating rabbits with Encephalitozoon cuniculi, an infection also affecting humans, and measuring the effects of immune suppressing drugs taken by both dogs and humans.  To be able to measure immune responses in sick patients, we must first develop the tests in blood from healthy animals.

    Inclusion Criteria:

    Healthy dogs weighing more than 5 kg and between the ages of 1 and 12

    Healthy rabbits weighing more than 1 kg and between the ages of 1 and 6

    Exclusion criteria:

    Dogs: weighing < 5 kg

    < 1 year old or > 12 years old

    Pregnant

    Rabbits: weighing < 1 kg

    < 1 year old or > 6 years old

    Pregnant

    Contact information:

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

     

  • IACUC protocol #: G2017-28

    Status:  Currently enrolling

    Description:

    Immune-mediated hemolytic anemia (IMHA) is an important disease in dogs that causes anemia (a low red blood cell count). We would like to be able to identify how a patient is responding to therapy using a blood test.  We hope to identify how long it takes to see suppression of the immune markers in a blood sample during therapy and see if this varies by treatment regimen used.  We will be looking at three different  lymphocyte responses during treatment for IMHA. Our goal is to identify if one of these markers decreases more rapidly in response to immunosuppressive treatment, and if one treatment is best associated with patient survival at 1 month.

    Inclusion Criteria:

    Dogs diagnosed with immune-mediated hemolytic anemia weighing more than 6 kg.

    Client Benefits:

    As part of the study, you will receive a free 2 and 4 week recheck with our Internal Medicine service. Cost of the blood draw will be covered by the study, as will the cost of the recheck red blood cell test (PCV).

    Contact Information:

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