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Research

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Research

Currently Enrolling Studies

Plantar Fasciitis Study

A Comparative Study of Injectable Human Amniotic Allograft (ReNuTM) versus Corticosteroids for Plantar Fasciitis: A Prospective, Randomized, Blinded Study.

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Inclusion Criteria:

  • Ages 18 to 75 inclusive
  • Diagnosed with plantar fasciitis in either foot.
  • Reporting heel pain of >6 on a verbally administered 1-10 pain scale (1 being no pain, 10 being extreme pain)
  • Has completed a minimum of two (2) months of conservative non-injection treatment/therapies (i.e., activity modification, icing, NSAIDs, orthotics, physical therapy, etc.)

Exclusion Criteria:

  • Prior surgery on the affected foot
  • Prior injection treatment for plantar fasciitis within the past 6 months with steroids or tissue engineered materials just in the site seeking treatment
  • Presence of comorbidities that can be confused with or can exacerbate the condition including, but not limited to the following:
    • Calcaneal stress fracture
    • Nerve entrapment syndrome, such as Baxter’s Nerve Entrapment or Tarsal Tunnel Syndrome
    • Plantar Fascial rupture
    • Systemic disorders associated with enthesiopathy, i.e., Gout, Reiters syndrome, rheumatoid arthritis, etc.
    • Achilles tendonitis
    • Fat Pad Atrophy
    • Fibromyalgia
    • Diabetic Neuropathy

Type 1 Diabetic Study

The aim of this study is to demonstrate similar efficacy and safety between MYL-1501D products produced from two manufacturing processes (Process V and Process VI) in combination with insulin lispro in patients with type 1 diabetes mellitus (T1DM).

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Main Inclusion Criteria:

  1. Written and signed informed consent needs to be provided by subjects or their legal representatives before starting any protocol-specific procedures.
  2. Male and female subjects between the ages of 18 to 65 years.

Main Exclusion Criteria:

  1. History of ≥1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
  2. History of drug or alcohol dependence or abuse during the 1 year prior to screening.
  3. Subjects using the following in the 3 months prior to screening:
    1. Insulin pump therapy
    2. Any anti-diabetic drugs other than the study insulins allowed by the protocol

Crohn’s Disease

A Phase 3, Randomized, Placebo-controlled, Double-blind, Multicenter, Induction Study to Investigate the Efficacy and Safety of GED-0301 For the Treatment of Subjects With Active Crohn’s Disease.

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Purpose

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn’s disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn’s disease.

After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study.

Eligibility

Inclusion Criteria:

  • Subjects must satisfy the following criteria to be enrolled in the study:
  • Male or female ≥ 18 years
  • Active Crohn’s disease
  • Subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.

COPD / Asthma Phone App Study

The purpose of this study is to see if COPD and Asthma patients can benefit from a smartphone application.

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The study tests an at-home decision support application that tracks patients’ symptoms, signs, and medical history and offers guidance when patients are concerned about their health.  The app is free for Apple and Android phones. The app gives on-demand decision support to patients, which may help them to manage their health in a timely and accurate manner.

Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis.

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Purpose

The purpose of this study is to evaluate the safety of different doses of ABT-494 and determine how well it works, as well as the pharmacokinetics (PK) (how drug is absorbed, distributed, and eliminated in the body over time) of ABT-494 in subjects with moderate to severe Ulcerative Colitis (UC).  If you have been diagnosed with Ulcerative Colitis and are experiencing symptoms such as bloody diarrhea, abdominal pain and a sudden and constant feeling that you have to move your bowels. Additionally, you are unable to tolerate or you have had insufficient response to treatment with medications that help reduce the inflammation associated with your disease, such as corticosteroids, immunosupressants, and/or biologics, you may be eligible.

Eligibility

Inclusion Criteria:

  • Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
  • Ages Eligible for Study: 18 Years to 75 Years
  • Demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunosuppressants, and/or biologic therapies.
  • Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.
  • Male participants must agree to follow protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 90 days post last dose of study drug.

What is The Research Department?

Modern medicine is driven forward through research at every level—biomedical, experimental, clinical, and many others. From tried and true approaches, to new paradigms, medical research touches nearly every component of medicine, and can involve public health, biochemistry, clinical research, microbiology, physiology, oncology, and surgery, plus research into communicable and non-communicable diseases.

About Clinical Trials

A clinical research trial is a partnership and a commitment between doctors and volunteer patients. It is the final test in a series of many carefully controlled scientific studies. We recruit for clinical trials and studies in the following areas:

  • Diabetes – Type I and Type II
  • Rheumatoid arthritis
  • Hypoparathyroidism
  • Ulcerative Colitis
  • Pediatric vaccines
  • Follow-up extension studies that ensure the quality and safety
  • Crohn’s Disease
  • Ankylosing Spondylitis

Research Department Staff

Medical Director for Research: Marcia Sparling, MD

Department Manager: Laurie Swanson

Coordinators:
Nicole Gentes, MA, CRC
Mary Madura, MA, CRC

Contact Information:
Phone: 360-397-3388
Fax: 360-604-1752
Email: research@tvc.org

Research Providers

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Christina L. Orr, MD

Endocrinologist
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Jason Etzel, MD

Gastroenterologist
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Katherine Vaughn, MD

Pediatrician
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Marcia Sparling, MD

Rheumatologist
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Nicholas Wysham, MD

Pulmonologist
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Sally Williams, MD

Infectious Disease Physician
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Stacey Condren, MD

Endocrinologist
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Theresa Karplus, MD

Rheumatologist

Research Locations

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87th Avenue Clinic
700 NE 87th Ave
Vancouver, WA 98664
360-882-2778

Information about Research

Participation

Making the Decision to Participate

There are two reasons to participate in a clinical research trial: to help yourself and to help others.

It is possible the treatment being tested will improve your health. A new drug or new procedures may reduce pain or perhaps even cure your illness. All clinical research trial patients receive a great deal of personal medical attention.

You may also decide to participate in a clinical research trial for the satisfaction that comes from being a part of scientific research. Many people hope for a breakthrough treatment that will make coping with an illness easier or eliminate it altogether. Clinical research trial volunteers help make those discoveries available to people all across the country and around the world.

Being a volunteer is a serious commitment. Deciding to participate in a clinical research trial means weighing possible benefits against possible risks. You should only make the commitment to participate in a clinical research trial after you have carefully discussed all the facts with your doctor and/or the research study coordinator.

FAQS

Who conducts clinical research trials?
Pharmaceutical companies, research institutions, or other health organizations sponsor a clinical research trial. Sponsors are responsible for funding and for designing the trial protocol (the set of detailed guidelines that investigators follow in order to conduct the same clinical research trial at different locations). Trained doctors, nurses, and medical researchers conduct the trials.

What is a clinical research trial like?
Participating in a clinical research trial is much like a regular visit to a doctor’s office, but with even greater personal attention. The success of any trial depends on its volunteers. Patients are treated professionally and with care.

What are the risks?
Risks vary from trial to trial. Known risks and discomforts will be explained by the study physician prior to each patient’s participating in the study. In addition to the known risks, there may be unknown risks such as medication side effects. While it is possible that some side effects could be permanent or even life threatening, most are temporary and will go away as soon as the treatment is stopped.

Will I be compensated?
There are no patient charges for medical services rendered to participants of clinical research studies. Medical tests and physician services associated with the study, in addition to the substance, procedure, or device being tested, are provided to participating patients. Some studies also include a stipend paid to participants for their involvement in the project as reimbursement for time and travel. This amount varies, depending on the nature of the study and the patient involvement.

Are there requirements for volunteers?
Each trial has certain requirements (for example: diagnosis, medical condition, and age), and patients must meet these requirements. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate. Once a patient is enrolled in the trial, there are very specific guidelines which must be followed.

For the eligibility requirements for a particular trial, contact the Research Department at Vancouver Clinic to speak to the coordinator for that study.

What is expected of volunteers?
Volunteers need to be at appointments on time, to follow instructions carefully, to return phone calls from the study coordinator, and especially to take any medication exactly as told. This is needed in order to collect the information necessary for a successful study.

What can volunteers expect from the clinical research trial team?
Prior to enrolling in a trial, volunteers should expect to receive complete information about the trial. They should not participate in any clinical research trial unless their questions have been reasonably answered.

Study procedures, risks and benefits are explained to volunteers during the informed consent process. This is required by law to make sure volunteers understand what is involved in a trial.

Volunteers can also expect complete information about the schedule and duration of the trial, directions to the trial location, and the name of someone to contact with questions or problems.

Are volunteers protected?
As patients under doctor’s supervision, volunteers are protected by the same laws and ethics that normally regulate the medical profession. Informed consent helps protect volunteers by making sure they have been given all the necessary information about a trial. An institutional review board (IRB) reviews the general progress of the trial. The IRB also regulates clinical research trial advertisements to reduce misleading claims.

Can volunteers change their minds after a clinical research trial starts?
Volunteers are always free to change their minds and stop participating in a trial at any time. They should keep in mind, however, that when even a few patients stop participating mid-trial (because of disinterest or other reasons), there may not be enough patients remaining to achieve reliable results.

How do you become a medical researcher?
The field of medical research continues to grow, thanks in part to innovation that leads to new treatments and tools for prevention and health maintenance. There are a number of pathways you can follow for a career in medical research, including certain MD-PhD programs that provide training for students who wish to become research physicians (or physician investigators). Another path involves receiving a PhD in biomedical sciences.

What type of person becomes a medical researcher?
Medical researchers tend to have a keen interest in contributing to the greater body of medial knowledge available to professionals for the sake of their patients. Medical researchers must possess a sharp intellect, in addition to the emotional strength it takes to complete an advanced degree. The best researchers also possess strong communications skills, which helps them draft grant proposals and communicate their findings.

What’s driving the growth of medical research as a career?
Many people point to the simple fact that we’re living longer as to why medical research, as a field, continues to grow. Here’s another thing to consider: humans have been trying to make ourselves better for as long as we’ve been getting sick. In that way, medical research goes back to the beginning of time. In the first half of the 20th century, it led to countless breakthroughs—vaccines for measles and polio; insulin treatment for diabetes; antibiotics that any number of illnesses. More recently, medical research has improved HIV/AIDS treatments, has spurred new surgical techniques such as microsurgery, and has forged successful treatments for types of cancer that, a quarter century ago, were almost always fatal. As challenges remain, medical researchers continue to step forward and meet them head-on.

Questions to ask your doctor before participating in a clinical research trial:

  • What is the purpose of the trial?
  • What treatments will be done and how?
  • How will patient safety be checked?
  • What are the possible side effects and risks of this treatment?
  • How could this treatment benefit me?
  • What treatments, other than the one being tested, are available for the same condition?
  • How will the trial affect my daily life?
  • How long will the trial last?
  • Who is sponsoring the trial?
  • Will I have to pay for anything?
  • What happens if I am harmed by the trial?
  • Will I be able to stay on this treatment when the trial is over?
Sponsor Info

Our Facilities
The Vancouver Clinic is the largest multi-specialty group practice in Vancouver, Washington. There are 250+ physicians and mid-level providers in five locations in Clark County. Vancouver is located along the Columbia River adjacent to the Portland, Oregon metropolitan area and 12 miles from the Portland International Airport.

Diagnostic services include fully accredited laboratory, full imaging services (diagnostic radiology, mammography, ultrasound, CT, MRI, bone densitometry (DEXA)), ECG and monitoring services, an infusion center, pulmonary function lab, cardiac testing (treadmill, Holter, nuclear studies), Ambulatory Surgery Center and a 10-bed Sleep Center.

Patient Demographics
The population of Clark County is approximately 400,000. The Clinic’s active patient population (seen in the last 2 years) is roughly 125,000 patients.

Hospital Affiliations
Physicians at The Vancouver Clinic are affiliated with PeaceHealth Southwest Medical Center, located four blocks from the main Clinic campus. Many physicians are also affiliated with Legacy Salmon Creek Hospital, located approximately 8 miles from the main Clinic campus.

Industry Services
Secure and controlled building access and patient areas
Secure, climate-controlled drug storage
Patient management database and electronic medical record
Excellent FDA audit record
We utilize central IRBs
-20 C freezer
Refrigerated centrifuge

Research Department Staff
Medical Director for Research: Marcia Sparling, MD

Department Manager: Laurie Swanson

Coordinators:
Nicole Gentes, MA, CRC
Mary Madura, MA, CRC
Marty O’Quin, MA, CCRC

Contact Information:
Phone: 360-397-3388
Fax: 360-604-1752
Email: research@tvc.org

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