Past Clinical Research Studies 

Below is a complete list of past ARC Clinical Research studies.

• Adult COVID-19 Vaccine Study

  • A two-part research study that examined the safety and efficacy of investigational vaccine booster regimens to prevent COVID-19 (including the delta variant).

• Ankylosing Spondylitis Study

  • The ankylosing spondylitis study was a 16-week study with visits 2 to 4 weeks apart that enrolled patients 18 to 65 years of age.

• Arthritis Studies Study

  • Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee

  Sponsor: Pfizer

  Sponsor Link

•  Atopic Dermatitis Study

  • A study for patients with moderate to severe atopic dermatitis (or eczema). There are more than 3 million cases per year in the US and some may see no relief from topical treatments alone. Symptoms may include inflamed, rough, itchy, or cracked skin. This issue can further lead into complications like skin infections and sleep issues. We are happy to provide this clinical research option to our patients and serve as an ancillary service at Austin Regional Clinic.

•  BaxDuo Arctic Chronic Kidney Disease (CKD) Clinical Study

  • A phase III, randomized, double-blind, active-controlled study intended to assess the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin compared with dapagliflozin alone on chronic kidney disease (CKD) progression in participants with CKD and high blood pressure. Baxdrostat is an experimental treatment, and dapagliflozin is a CKD treatment already approved in many countries.

•  C-Diffense Study 

  • Vaccine study aimed to prevent clostridium difficile, or C. diff, infections. The study is enrolling people over age 50 who are at high risk of catching C. diff, but have no prior history of C. diff infection.

• C-Diffense Vaccine Study

  • Diff Vaccination study, participants will be randomly assigned in parallel in a 1:1 ratio to receive C difficile vaccine (200µg total toxoid) at months 0, 1, and 6 (3-dose group) or at months 0 and 6 (2-dose group). The participants in the 2-dose group will receive placebo (saline) at Month 1.

• Clinical Biospecimen Collection for Alzheimer's & Parkinson's Disease Biomarker Research

  • Biospecimen collection for subjects with clinically established Alzheimer's or Parkinson's disease to support biomarker research.

• Colonoscopy Study

  • The purpose of this study was to collect stool and blood samples to develop a test for screening for colorectal cancer screening.

• Contraception Study

  • The contraception study explored the effectiveness of a study medication for birth control in women ages 13-45.

• COVID-19 Janssen Vaccine Study

  • Austin Regional Clinic was looking for participants from diverse backgrounds to research an investigational vaccine.

  Sponsor: Janssen

• COVID-19 Pfizer Vaccine Study

  • ARC Clinical Research COVID-19 study with Pfizer COVID vaccine teen study evaluating the vaccine among the 12 - 17 year olds. 

  Sponsor: Pfizer 

• COVID-19 Treatment Study

  • ARC Clinical Research COVID-19 study to help people who were showing symptoms of COVID-19 or had been in close contact with someone who has COVID-19.

• COVID-19 Vaccine Pediatric Study

  • ARC Clinical Research study to learn if the COVID-19 study vaccine can produce an immune response against COVID-19, and if it is safe, in children 12 to 15 years old.

• Credo SARS-CoV-2, Flu, and RSV Clinical Study

  • The purpose of this research study was to demonstrate how accurate the VitaSIRO solo™ SARS-CoV-2/Flu/Respiratory Syncytial Virus (RSV) Assay (test) is in detecting and diagnosing SARS-CoV-2, Flu A and B, and/or RSV from symptomatic patients.

• Cytomegalovirus Study

  • The cytomegalovirus study explored the effectiveness of an investigational vaccine in helping the body's immune system recognize and protect itself if it comes into contact with CMV in the future.

•  Discovering New Biomarkers Assays for CRC Detection Study

   

• DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study

  • This clinical study collected blood specimens and a medical record review that would be completed 12 months post-enrollment. Medical history, demographics, diagnostic reports, surgery reports, imaging reports, pathology reports, and/or other diagnostic information was also collected.

• Endocrinology (Diabetes, Lipids) Study

  • Safety and Efficacy Study of Sotagliflozin on Glucose Control in Patients With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control (SOTA-CKD3)

  Sponsor: Sanofi
  Sponsor Link

  • A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia (INDIGO-1)

  Sponsor: Gemphire Therapeutics, Inc.
  Sponsor Link

  • Gan & Lee Insulin Glargine Target Type (2) Evaluating Research (GLITTER 2)

  Sponsor: Gan and Lee Pharmaceuticals
  Sponsor Link

  • Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10)

  Sponsor: The Medicines Company
  Sponsor Link

• Endometriosis and Uterine Fibroids Study

  • This study was looking for women aged 18-49 who are diagnosed with endometriosis and experiencing moderate to severe pain associated to their endometriosis.

• Fibromyalgia Device Study

  • This study was for an investigational smart phone app, intended to reduce fibromyalgia symptoms and help people manage their fibromyalgia more effectively. It did not involve any drugs or medications.

• Gastroenterology Study

  • Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection.

  Sponsor: Sanofi Pasteur
  Sponsor Link

• Guardant LUNAR-2 Lung Cancer Screening Study

  • This study supported the development of a blood test to detect early stages of lung cancer for widespread use among individuals.

•  Gynecology (Women’s Health) Study

  • Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PRIMROSE 1)

  Sponsor: ObsEva SA
  Sponsor Link

• Healthy Participants Study

  • A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza (CAPSTONE 1)

  Sponsor: Shionogi

  Sponsor Link

  • Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications (CAPSTONE 2) 

  Sponsor: Shionogi

  Sponsor Link

  • Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

  Sponsor: ENTvantage Dx

  Sponsor Link

  • An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now

  Sponsor: Exact Sciences Corporation

  Sponsor Link

•  Herediatary Angioedema (HAE) Study

  • Hereditary angioedema (HAE) is caused by a low-level or improper function of a protein called the C1 inhibitor. With HAE, the blood vessels are affected. An HAE attack can result in rapid swelling of the hands, feet, limbs, face, intestinal tract, larynx (voice box), or trachea (windpipe)

•  Hot Flash Study

  • This study was a research trial for a medication to help postmenopausal women suffering from hot flashes.

•  Inflammatory Disease Study

  • This study is for patients who may have been diagnosed with lupus.

• Lung Cancer Screening Study

  • The lung cancer screening study supported the development of a blood test to detect early stages of lung cancer for widespread use among individuals.

•  Melanoma Study

  • A biomarker is an indicator that can be found in blood, stool, urine or other bodily fluids and tissues that may show certain diseases. If accurate, biomarkers can be found for diseases, such as cancer, and could lead to earlier and less invasive discovery. The purpose of this opportunity is to study blood samples to detect biomarkers that could be used to improve melanoma detection. 

•  Melanoma Blood Sample Collection Study

  • The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens from subjects with untreated melanoma to evaluate biomarkers associated with cancer as potential targets for diagnostic assays and to support subsequent assay development activities.

•  Pediatric ASD Diagnosis Study

  • Autism Spectrum Disorder (ASD) is a developmental disorder that affects communication and behavior. As of now there is a guide created by the American Psychiatric Association to help health care professionals diagnose ASD. This test is performed in a secondary care setting and can take several hours to administrate. However, it can still be difficult to diagnose since there’s no defined test such as a blood test.

•  Pediatric Chickenpox Vaccine Study

  • The pediatric chickenpox vaccine study explored the vaccine's effectiveness in preventing chickenpox in children.

•  Pediatric GERD Study

  • This study evaluated the effect of an investigational drug on treating the symptoms associated with GERD.

•  Pediatric Meningococcal Vaccine Study

  • The pediatric meningococcal vaccine study explored the effectiveness of a vaccine for infants between the ages of ≥ 42 to ≤ 89 days.

•  Pediatric Migraine Study

  • This study evaluated the effectiveness of an investigational medication called Lasmiditan in reducing the pain of migraine headaches in children and adolescents.

• Psoriatic Arthritis Study

  • The psoriatic arthritis study is a 48-week biologic naïve study with a possible long-term extension. Visits are every 4 weeks.

• Psoriatic Arthritis With Back Pain Study

  • The biologic naïve psoriatic arthritis with axial disease study is a 60-week study with visits every 4 weeks. Patients must be 18 years or older with no more than 1 non-biologic medication: active plaque psoriasis or history of psoriasis.

• Pulmonology (Asthma) Study

  • Observational Study of Obstructive Lung Disease (NOVELTY) (NOVELTY)

  Sponsor: AstraZeneca
  Sponsor Link

  • A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma

  Sponsor: GlaxoSmithKline
  Sponsor Link

  • A BE Study to Compare Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg and QVAR® 40 mcg, Inhalation Aerosol

  Sponsor: Amneal Ireland Limited
  Sponsor Link

• Oncology (Cancer) Study

  • Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

  Sponsor: Exact Sciences Corporation
  Sponsor Link

• Rapid Bacterial Sinusitis Testing Study

  • ARC clinical study for patients who had sinusitis diagnosis but otherwise healthy.

• Sjogren’s Syndrome Study

  • The Sjogren’s syndrome study is a 36-week study looking for patients with primary Sjogren's disease diagnosis, age 18 to 75 inclusive.

• SQNM COVID-19, Flu, and RSV Swab Sample Study

  • The SQNM swab study was collecting swab samples from patients experiencing symptoms of flu A, flu B, RSV, and/or COVID-19, which will support the development of a test to detect these viruses.

• Stroke Detection Device Study

  • Austin Regional Clinic is doing a study to learn if there are better ways to identify irregular heartbeats and protect older adults from stroke.

• Subacute Cutaneous Lupus Erythematosus (SCLE) and Discoid Lupus Erythematosus (DLE) Study

  • The Subacute Cutaneous Lupus (SCLE) and Discoid Lupus Erythematosus (DLE) study is a 33-week study for patients 18 to 75 years of age with more than 6 months of documented medical history of cutaneous lupus or discoid lupus, confirmed with either a biopsy or photography.

• Systemic Lupus Erythematosus Study

  • The systemic lupus erythematosus clinical study is a 52-week study looking for patients 18 to 75 years of age, taking at least one but not more than two non-biologic medications.

• Trailblazer Alzheimer’s Disease Clinical Study

  • A long-term, real-world study comparing the effectiveness of Donanemab along with usual care to usual care alone in U.S. patients with early symptomatic Alzheimer’s Disease.

• Vagus Nerve Stimulator Device Study

  • The adult vagus nerve stimulator device study evaluated the vagus nerve stimulator for the treatment of rheumatoid arthritis. The first 12 weeks were the primary study which, upon completion, participants may have continued for the long-term phase.

• VAX 31-201 Pediatric Pneumococcal Clinical Study

  A phase II, randomized-double, active-controlled, dose-finding clinical study that evaluated the safety, tolerability, and immunogenicity of the investigational vaccine, VAX-31, in healthy infants. Participants were given four doses at two, four, six, and 12-15 months of age, alongside routine pediatric vaccines.

• Zenith Chronic Kidney Disease (CKD) and High Proteinuria Study

  • A phase III trial to assess the efficacy, safety, and tolerability of zibotentan combined with dapagliflozin, compared to dapagliflozin alone, in participants with chronic kidney disease and high proteinuria.