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

     

     

     

  • 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

     

     

  • 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

     

  • Protocol# G2017.35

    Status: Currently enrolling

    Description:

    Acute kidney injury (AKI) is a serious state in dogs, cats as well as in humans that is underdiagnosed due to a lack of diagnostic tools. This study is designed to test whether newly developed biomarkers correlate with declined kidney function in dogs. We hope to find biomarkers that detects kidney injury at an earlier stage compared to the ones currently being used, thus helping us to identify and treat patients at an early stage in order to improve outcome.

    Inclusion criteria:

    • Dogs that are likely to develop an AKI due to e.g. intoxications, sepsis, heatstroke
    • Dogs that are acutely azotemic (have elevated BUN and creatinine values) due to e.g. leptospirosis, intoxications, pyelonephritis, sepsis, heatstroke
    • Body weight greater than 4.5 kg

    Exclusion criteria

    • A known history of kidney disease

    Client Benefits:

    The study will cover the costs of blood work, including complete blood count, chemistry and Snap 4DX plus (test for vector- borne diseases) and urinalysis for the first four days of hospitalization, then every second day until discharge from hospital. It will also include free control visits at 4 weeks and 3 months from discharge with the laboratory work listed above.

  • Status:  Currently enrolling

    Description:

    Poor control of the glucose levels in diabetic dogs can alter how the drugs behave in the body, which can result in drug toxicities. The changes in blood proteins caused by diabetes can significantly affect the disposition of the many protein-bound drugs used in diabetic patients. This study will explore a model that will allow identification of changes in protein binding that will improve the safety of giving different medications to diabetic patients. This study has the potential to help diabetic dogs to receive appropriate medical care and have a better quality of life.

    Inclusion Criteria:

    Well diabetic adult dogs that weigh at least 3 kg (6.6 lbs) of any age and breed will be included in the study.

    Exclusion Criteria:

    Sick dogs, those receiving drugs known to be highly protein bound, and hypoalbuminemic dogs will not be included in the study.

    Client Benefits:

    The study entails having 2-3 teaspoons (12-15 ml) of blood drawn from your dog.  As an incentive, the study will cover the cost of a blood chemistry profile that would be performed as part of your dog's visit.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials office: clinicaltrials@tufts.edu

     

     

     

     

     

     

  • CSRC protocol # 115.16

    Status: Currently enrolling

    Description:

    The goal of this study is determine if a human stem cell-based therapy can be used to treat perianal fistulas, a condition that occurs in dogs but also occurs in some humans suffering from Crohn’s Disease. The current treatments (steroids and cyclosporine) are ineffective in a high percentage of patients and the disease relapses frequently. Also, cyclosporine is very expensive and has many side effects. We want to investigate if human stem cells (hESC-MSCs) injected in the fistulas can induce remission of the diseaseSpecifically, we would like to determine if a second injection of hESC-MSCs can close any fistulas that may re-appear after the initial closure of fistulas (ie, if the effects of the first injection wear off). The hESC-MSC can have some advantage compared with autologous stem cells, for instance, namely: (1) ease of use (no need to extract bone marrow, high numbers easily generated in the lab); (2) well defined and constant property (no variability) (3) higher anti-inflammatory properties. The trial is therefore of high interest not only for this specific disease but also for other diseases that may benefit from treatment with hESC-MSCs in humans.

    This trial is also being conducted at Massachusetts Veterinary Referral Hospital in Woburn, MA

    Inclusion Criteria:

    Adult dogs (either gender, any breed) with a clinical diagnosis of anal fistulas (presence of chronic peri-anal fistula(s) with clinical signs of tenesmus, dyschezia) and present with partial or complete relapse from cyclosporine A therapy.

    Exclusion Criteria:

    Dogs younger than 1 year or older than 12 years will be excluded; dogs with other severe diseases (severe osteoarthritis, cardiac disease, neoplasia, skin diseases) apart from anal furunculosis will be excluded. Dogs that had surgery (cryosurgery, anal sac resection, tail amputation) to treat the anal fistulas will not be included.

    Client Benefits:

    Once enrolled, all costs associated with this study (e.g., cyclosporine, sedation medication, stem cell treatment, check-ups, blood draws) will be covered for the duration of the follow-up period (i.e., for 6 months after the last MSC injection). Treatment related complications (such as localized infection, allergic reaction) will be covered up to $1000 by the sponsor. Costs incurred due to unrelated complications will not be covered. Your pet's participation will also allow us to gain information which will help in the diagnosis 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

  • Status: Currently enrolling

    Description:

     To evaluate ampicillin pharmacokinetics in dogs with mild to moderate kidney disease. This study will help establish dosing recommendations for an important class of antimicrobials in dogs with kidney disease. It will also give insight into the variability of renal clearance in dogs with mild to moderate kidney disease, and how high ampicillin blood concentrations become in this subset of dogs.

    Inclusion criteria:

    • Body weight greater than 6kg
    • Blood creatinine levels between 2-4 mg/dL on NOVA or Istat due to acute kidney injury, acute on chronic kidney disease, or chronic kidney disease that are being prescribed ampicillin or ampicillin + sublactam.

    Exclusion criteria:

    • Known comorbidities such as neoplasia, congestive heart failure, or those suspected to have Addison’s disease based on a supportive sodium potassium ratio.
    • Dogs which are likely to have fluid responsive azotemia based on a USG > 1.020 prior to fluid administration.

    Client Benefits:

    The study will cover the costs of the sampling catheter and serum chemistries at hospitalization and 24 hours later. Your pet’s participation will also allow us to gain information regarding ampicillin dosing in dogs with mild to moderate kidney disease.

    Contact Information: 

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

  • IACUC protocol # G2018.33

    Status: Currently enrolling

    Description:

    Acute kidney injury (AKI) is common in dogs and is associated with high morbidity and mortality. How to enhance kidney recovery is the main question in the management of our patients that develop AKI. Monitoring of treatment response is currently based on serum creatinine levels, a biomarker of kidney function.

    The aim of this study is to describe urinary Neutrophil-­‐Gelatinase-­‐Associated Lipocalin (uNGAL), urinary NGAL to Creatinine Ratio (UNCR) and serum creatinine in dogs recently diagnosed with AKI and follow their progression during the first 3 days of therapy.

    The ultimate goal of our study is to determine if uNGAL and/or UNCR as a biomarker of kidney damage will provide a better assessment of kidney recovery and a better monitoring tool for the treatment response in every day clinical practice in comparison with serum creatinine levels.

    Inclusion criteria:

    -­‐ Dogs either presenting to our hospital or hospitalized patients that develop AKI within 48 hours of monitoring.

    -­‐ The dogs will have to have a urine analysis and culture prior to any antibiotic treatment

    -­‐ Dogs already started on any type of treatment for less than 24 hours will be included.

    -­‐ The dogs will require hospitalization for at least 3 days after the diagnosis of AKI and initiation of treatments.

    -­‐ Body weight greater than 5 kg.

    Exclusion criteria:

    -­‐ Dogs with AKI diagnosed/already treated for more than 24 hours.

    -­‐ Dogs with AKI related to post-­‐renal obstruction or neoplastic infiltration.

    Client Benefits:

    The study will cover the costs of the additional daily serum creatinine (measured every 12 hours for 3 days instead of every 24 hours), the costs of the urine creatinine measured every 12 hours for 3 days and the costs of the urinary NGAL measured every 12 hours for 3 days. These tests will not be performed immediately. Your dog’s participation will allow us to gain information regarding the levels of this new biological marker which may help in the management of other dogs with this condition in the future. You understand that your animal’s participation in this study will not improve or  cure his/her condition.

    Contact information:

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

  • Protocol #G2018-31

    Status: Currently enrolling

    Inclusion Criteria: Dogs with histopathologically diagnosed Stage II splenic hemangiosarcoma (HSA) following splenectomy with no evidence of disease at the time of enrollment based on thoracic radiographs and abdominal ultrasound, and intention to treat with 5 cycles of a doxorubicin-based chemotherapy protocol. 

    Exclusion Criteria: Dogs that have received therapies known to affect coagulation, including Vitamin K, blood products, non-steroidal anti-inflammatories, clopidogrel, heparin, rivaroxaban, epixaban, Yunnan Baiyao, or hydroxylethyl starch within 7 days of enrollment. Greyhound dogs and patients with confirmed diseases that affect coagulation, including immune-mediated disease, protein-losing nephropathy, protein-losing enteropathy, and hyperadrenocorticism will also be excluded. 

    Data Collection: Measurement of coagulation profiles will coincide with a routine re-staging schedule during a doxorubicin chemotherapy protocol; prior to initiation of chemotherapy, at the time of the third and fifth doxorubicin treatments, and monthly thereafter until recognition of metastatic disease. A complete blood count and t-PA TEG will be run at each of the aforementioned timepoints; samples for PT/PTT, fibrinogen, and D-dimers will be frozen for batch analysis. If metastatic disease is detected at any intermediate timepoint, a final coagulation sample will be collected. 

    Benefit: All coagulation testing (t-PA TEG, PT/PTT, fibrinogen, and D-dimers) will be covered by the study. Owners will be expected to pay for the complete blood count, as it is part of the standard chemotherapy protocol.

    Contact information:

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