Clinical trials: High Risk Surgery
Cardiac Surgery, Sternal Wound Infection
Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal…
- Trial name
- NCT00600483
- Testing
- gentamicin-collagen sponge dipped in saline
- Where
- 43 sites in United States
- Volunteers
- 1,502 people
- Sponsor
- Innocoll
Intraoperative Hypotension
Hypotension Prediction Index for Blood Pressure Management
Design: Single-center randomized comparison of invasive arterial pressure monitoring vs. arterial pressure monitoring combined with Acumen Hypotension Prediction Index (HPI) software guidance on intraoperative hypotension…
- Trial name
- HPI (NCT03610165)
- Testing
- Acumen HPI-enabled EV1000 screen, Control
- Where
- United States
- Volunteers
- 214 people
- Sponsor
- The Cleveland Clinic
Intraocular Lens Replacement, Intraoperative Floppy Iris Syndrome
Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery
The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative Floppy Iris Syndrome in patients at risk.
- Trial name
- NCT02093689
- Testing
- Part 1 OMS302, Part 2 OMS302
- Where
- 2 sites in Austria, Germany
- Volunteers
- 18 people
- Sponsor
- Omeros Corporation
HER2/Neu Positive, Progesterone Receptor Positive
Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer
This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer.
- Conditions
- HER2/Neu Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IA Breast Cancer AJCC v7
- Trial name
- NCT01275677
- Testing
- Cyclophosphamide, Docetaxel, Doxorubicin
- Where
- 1,283 sites in United States, Canada and 2 more
- Volunteers
- 3,270 people
- Sponsor
- National Cancer Institute (NCI)
Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer
High or Standard Intensity Radiation Therapy After Gemcitabine Hydrochloride and Nab-paclitaxel in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery
This randomized phase II trial studies how well high or standard intensity radiochemotherapy after gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) work compared with…
- Trial name
- NCT01921751
- Testing
- low intensity radiation therapy, Capecitabine, Gemcitabine
- Where
- 46 sites in United States
- Volunteers
- 20 people
- Sponsor
- Radiation Therapy Oncology Group
Prostate Cancer
A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer.
- Trial name
- NCT01667536
- Testing
- Drug: 99mTc-MIP-1404
- Where
- 35 sites in United States, Belgium and 6 more
- Volunteers
- 105 people
- Sponsor
- Molecular Insight Pharmaceuticals, Inc.
Pneumocephalus
Ventilation With High Oxygen Content and Postoperative Pneumocephalus
The aim of this study is to compare the incidence and volume of postoperative pneumocephalus in patients receiving ventilation with 100% oxygen during the last stage of surgery versus a conventional 1:1 oxygen/air gas mixture.
- Trial name
- NCT02722928
- Testing
- Controlled Ventilation with 100% oxygen
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Ohio State University
Coronary Artery Disease, Heart Valve Disease
A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery
The purpose of this study is to compare a new high vacuum pressure chest drainage system (NO-NUMO™) with the standard low vacuum pressure drainage system already in use in cardiac surgeries.
- Trial name
- NO-NUMO (NCT00581399)
- Testing
- NO-NUMO™ High Vacuum Body Cavity Drainage System, PVC Chest Tube
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- University of California, Irvine
Diabetes, Morbid Obesity
Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing
The primary objective is to assess the frequency of a wound healing complication, in a closed incisional wound in a "high risk" surgical incision when treated with Negative Pressure Wound Therapy versus a highly absorbent…
- Conditions
- Diabetes, Morbid Obesity, Lymphedema, Orthopedic Disorder
- Trial name
- NCT05427916
- Testing
- Avance Solo, Optifoam
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Lactic Acidosis, Blood Glucose, High
Nitroglycerin Infusion During Cardiac Surgery
Hypothermic cardiopulmonary bypass results in peripheral vasoconstriction and heparin trapping. Hypoperfusion and ischemic-reperfusion injury are associated with systemic inflammatory response, while insufficient and delayed…
- Trial name
- NCT01901419
- Testing
- Nitroglycerin infusion
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- Tri-Service General Hospital (TSGH)
Malignant Bone Tumors
Effect of High Doses of Radiation on Bone Structure and Metabolism
This study is designed to characterize the effects of high energy radiation on bone breakdown, with a specific interest in reducing the rate of sacral fractures.
- Trial name
- NCT02323295
- Testing
- Radiation (Surgical Arm), Radiation (Non-surgical Arm), Malignant Tumor Surgery
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Massachusetts General Hospital
Acute Kidney Injury
Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI
Acute kidney injury (AKI) occurs in up to 30% of patients undergoing coronary artery bypass graft (CABG) surgery, and often requires patients to go on dialysis.
- Trial name
- NCT03810417
- Testing
- Digoxin Antibodies Fab Fragments, Baseline EO > 360 pM, EO < 360 pM
- Where
- 2 sites in United States
- Volunteers
- 267 people
- Sponsor
- University of Maryland, Baltimore
Carotid Artery Disease
Proximal Protection With The Mo.Ma Device During Carotid Stenting
The objective of the ARMOUR study is to evaluate the safety and effectiveness of the Mo.Ma proximal flow blockage cerebral protection device for patients at high surgical risk for carotid endarterectomy who undergo carotid artery…
- Trial name
- ARMOUR (NCT00744523)
- Testing
- Mo.Ma cerebral protection device
- Where
- 2 sites in United States
- Volunteers
- 262 people
- Sponsor
- Medtronic Endovascular
Breast-Conserving Surgery
Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision
This clinical trial evaluates the safety and efficacy of High Purity Type I Collagen scaffold for breast volume restoration following breast-conserving surgery (BCS).
- Trial name
- NCT07219316
- Testing
- High Purity Type I Collagen Scaffold (Regenerative Matrix)
- Where
- 2 sites in India
- Volunteers
- 40 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Lung Cancer
Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer.
- Trial name
- NCT00107172
- Testing
- surgery, brachytherapy
- Where
- 38 sites in United States, Canada
- Volunteers
- 224 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Stage III Prostate Cancer, Stage IV Prostate Cancer
Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer
This randomized phase II trial studies how well axitinib works in treating patients with high-risk prostate cancer before undergoing surgery.
- Trial name
- NCT01385059
- Testing
- axitinib, therapeutic conventional surgery, enzyme-linked immunosorbent assay
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- City of Hope Medical Center
Intraocular Retinoblastoma
Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
This phase III trial is studying vincristine, carboplatin, and etoposide to see how well they work compared to observation only in treating patients who have undergone surgery for newly diagnosed retinoblastoma.
- Trial name
- NCT00335738
- Testing
- liposomal vincristine sulfate, carboplatin, etoposide
- Where
- 56 sites in United States, Australia and 3 more
- Volunteers
- 331 people
- Sponsor
- Children's Oncology Group
Head and Neck Squamous Cell Carcinoma
Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence
This randomized phase II trial studies how well giving afatinib after chemoradiation and surgery works in treating patients with stage III-IV squamous cell carcinoma of the head and neck at high-risk of recurrence.
- Trial name
- NCT01824823
- Testing
- afatinib
- Where
- 272 sites in United States
- Volunteers
- 3 people
- Sponsor
- ECOG-ACRIN Cancer Research Group
Advanced Chronic Rhinosinusitis
Total Intravenous Anesthesia in Sinus Surgery
Utilization of total intravenous anesthesia (TIVA) has been proposed as a method to improve visualization during endoscopic sinus surgery (ESS), largely due to its physiologic decrease in cardiac output without the peripheral…
- Trial name
- NCT02578862
- Testing
- Propofol, Sevoflurane
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Ochsner Health System
PONV
Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV
The purpose of this study is to determine if subjects who receive Palonosetron plus Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive Palonosetron alone.
- Trial name
- PONV (NCT00952133)
- Testing
- Palonosetron only, Palonosetron with Dexamethasone
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- NYU Langone Health