Clinical trials: sponsored by Indiana University
Surgical Wound Infection, Cesarean Section
Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial
The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic…
- Trial name
- Prevena-C (NCT03009110)
- Testing
- Prophylactic NPWT, Standard Dressing
- Where
- 6 sites in United States
- Volunteers
- 1,624 people, healthy volunteers welcome
- Sponsor
- Indiana University
Heart Failure
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
In the U.S., 5.7 million people have heart failure (HF), 915,000 new cases are diagnosed each year, and both incidence and prevalence are increasing due to the aging of the population and to better survival from ischemic heart…
- Trial name
- NCT03615469
- Testing
- Transcutaneous electrical stimulation, Neuromuscular electrical stimulation
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Indiana University
Kidney Failure
Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function
Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the nephrotoxicity side effects of Tacrolimus.
- Trial name
- NCT04258423
- Testing
- Tacrolimus, Everolimus
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Indiana University
Breast Cancer
Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer
The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer.
- Trial name
- NCT00656669
- Testing
- sunitinib alone, sunitinib plus paclitaxel, doxorubicin and cyclophosphamide
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Indiana University
Kidney Failure
Everolimus Monotherapy as Immunosuppression After Liver Transplant
Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the nephrotoxicity side effects of Tacrolimus.
- Trial name
- NCT04063865
- Testing
- Tacrolimus, Everolimus
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Indiana University
Opioid Use, Traumatic Injury
Opioid Use After Traumatic Injury in Adolescents
Currently, 1 in 8 adolescents continue to receive prescription opioids a year or more after injury. By longitudinally surveying patients, we can identify risk factors and pathways to nonmedical opioid use.
- Conditions
- Opioid Use, Traumatic Injury, Adolescent Behavior, Substance Abuse Disorder
- Trial name
- NCT03628846
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Indiana University
Cancer
Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)
The goals of this study are to assess initial or booster vaccine performance (safety and efficacy) and to collect serum and peripheral blood mononuclear cells (PBMCs) pre and post-vaccination to assess immune and other response…
- Trial name
- NCT04930055
- Testing
- COVID-19 Vaccination
- Where
- 2 sites in United States
- Volunteers
- 2,206 people, healthy volunteers welcome
- Sponsor
- Indiana University
Colorectal Surgery
Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery
The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a colorectal surgery
- Trial name
- NCT03702621
- Testing
- liposomal Bupivacaine, Bupivacaine Hydrochloride
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Indiana University
Renal Insufficiency, Chronic, Hypertension
Chlorthalidone in Chronic Kidney Disease
It is estimated that in the United States there are approximately 8 million individuals who have moderate to severe chronic kidney disease (CKD).
- Trial name
- CLICK (NCT02841280)
- Testing
- Chlorthalidone
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Indiana University
Negative Pressure Wound Therapy, Cesarean Section; Infection
The Invia Motion at Cesarean Study
To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at cesarean delivery.
- Trial name
- NCT04365452
- Testing
- Invia Motion
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Indiana University
Hypertension
Prevention of Severe Postpartum Hypertension
The purpose of this study is to determine whether postpartum administration of furosemide to women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or elevated blood pressure in the first 24 hours…
- Trial name
- NCT02450773
- Testing
- Furosemide, Potassium chloride
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Indiana University
Prostate Cancer
PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk…
- Trial name
- NCT03429244
- Testing
- 68Ga-PSMA-11 PET-MRI
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Indiana University
Fetal Alcohol Spectrum Disorders
Dissecting the Genetics of Fetal Alcohol Spectrum Disorders
The purpose of this study is to help scientists understand why some people who were exposed to alcohol in the womb have special facial features but other people do not.
- Trial name
- DiGFASD (NCT04072809)
- Testing
- No intervention
- Where
- United States
- Volunteers
- 751 people, healthy volunteers welcome
- Sponsor
- Indiana University
SARS-CoV-2
Rapid SARS-CoV-2 IgG Antibody Testing in High Risk Healthcare Workers
The purpose of this study is to validate the use of a rapid, at home, point-of-care (POC) SARS-CoV-2 IgG antibody test in high risk healthcare workers.
- Trial name
- COVID-Antibody (NCT04334876)
- Testing
- SARS-CoV-2 IgG Antibody Testing Kit
- Where
- United States
- Volunteers
- 571 people
- Sponsor
- Indiana University
Metabolism and Nutrition Disorder
Prospective Evaluation of the Incidence of PICS
Advances in modern medicine and critical care interventions have greatly impacted survival of critically ill patients, but these interventions are not without consequences.
- Trial name
- ProsPICS (NCT03584399)
- Testing
- PICS in critically ill pediatric population
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Indiana University
Schizophrenia, Schizophreniform Disorder
rTMS in First Episode Psychosis
This study proposes to examine the application of rTMS for the treatment of cognitive dysfunction in FEP. This is an important population for study because if effective, rTMS may represent a preventative treatment for the…
- Conditions
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- Trial name
- EmeraldThunder (NCT02131129)
- Testing
- rTMS
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Indiana University
Kidney Calculi
ShockPulse-SE vs. Trilogy Trial: Comparing the Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi
The purpose of this study is to measure how well two different devices work to break up and remove kidney stones. We are comparing a newer device to an older one to see which one is faster at breaking up kidney stones.
- Trial name
- NCT03959683
- Testing
- Trilogy Lithotrite, The ShockPulse-SE Lithotripsy System
- Where
- 4 sites in United States, Canada
- Volunteers
- 100 people
- Sponsor
- Indiana University
Bioequivalence
Effects of Altered Formulation on the Bioequivalence of Tacrolimus in Healthy Female and Male Volunteeers
Amorphous solid dispersion (ASD) formulations are increasingly used by the pharmaceutical industry to develop poorly water-soluble drugs into effective oral dosage forms.
- Trial name
- ASDBioequiv (NCT02341274)
- Testing
- Tacrolimus
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Indiana University
Prader-Willi Syndrome
Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory
The Polyvagal Theory focuses on how function and structure changed in the vertebrate autonomic nervous system during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state.
- Trial name
- NCT03101826
- Testing
- Listening Project Protocol
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Indiana University
Anxiety, Anxiety Disorders and Symptoms
Possible Therapy by Phone for Caregivers
Caregivers of adults with dementia report higher stress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases.
- Conditions
- Anxiety, Anxiety Disorders and Symptoms, Caregiver Burnout
- Trial name
- TACTICs (NCT04634396)
- Testing
- ACT Acceptance and Commitment Therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Indiana University
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