Clinical trials: Injury, Radiation
Radiodermatitis
Topical Use of Difinsa53™ to Prevent Radiation Dermatitis
Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.
- Trial name
- NCT02534129
- Testing
- Difinsa53, Aquaphor
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- ProTechSure Scientific, Inc.
Radiosensitivity, Pediatric Cancer
Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology
Analysis of the individual radiosensitivity in pediatric oncology
- Conditions
- Radiosensitivity, Pediatric Cancer, Radiation Toxicity
- Trial name
- FOCUSO (NCT06033183)
- Testing
- Blood sample
- Where
- 2 sites in France
- Volunteers
- 100 people
- Sponsor
- Neolys
Oral Mucositis Due to Radiation, Radiation Dermatitis
Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis…
- Trial name
- SafePBM (NCT03988556)
- Testing
- Photobiomodulation using CareMin650 at 6 Joules (curative intent), Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)
- Where
- 5 sites in France
- Volunteers
- 72 people
- Sponsor
- NeoMedLight
Radiodermatitis
Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients
This study, a nonrandomized open-label Phase I safety and exploratory study, will evaluate the safety of topical norepinephrine in post-surgical breast cancer patients who are undergoing radiation therapy.
- Trial name
- NCT01263366
- Testing
- Norepinephrine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- ProCertus BioPharm, Inc
Sunburn, Sun Damaged Skin
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
The purpose of this study is to assess how human skin reacts and how sunscreens and sun protection fabrics protect in natural sunlight compared to their labeled claims, indoor testing methods (existing or modified) and…
- Conditions
- Sunburn, Sun Damaged Skin, Overexposure to Sun Rays
- Trial name
- NCT03007589
- Testing
- otc sunscreens, sun protection fabrics, Optical Filters
- Where
- 5 sites in United States, Chile and 1 more
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sun Protection Foundation
Acute Radiation Syndrome
A Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011
This trial is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic of KMRC011 injection in healthy adult volunteers.
- Trial name
- NCT03585803
- Where
- South Korea
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Intron Biotechnology, Inc.
Mucositis, Nephrotoxicity
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients.
- Conditions
- Mucositis, Nephrotoxicity, Ototoxicity
- Trial name
- NCT03480971
- Testing
- Tempol
- Where
- 9 sites in United States
- Volunteers
- 120 people
- Sponsor
- Matrix Biomed, Inc.
Radiodermatitis, Quality of Life
Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®
To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients.
- Trial name
- NCT03255980
- Testing
- Xonrid® gel, Standard of Care
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Helsinn Healthcare SA
Oral Mucositis, Quality of Life
Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.
The use of a novel topical mucosa composition (XCM-OM118) comprising 2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid…
- Conditions
- Oral Mucositis, Quality of Life, Mucositis, Pain
- Trial name
- STOPOMP (NCT05635929)
- Testing
- XCM-OM118 Composition comprising olive oil, betaine and xylitol
- Where
- Spain
- Volunteers
- 63 people
- Sponsor
- Mucosa Innovations, S.L.
Cardiotoxicity, Heart Failure
MyoStrain CMR for the Detection of Cardiotoxicity
The Prefect Pilot Study evaluates the use of the EC approved MyoStrain SENC CMR Imaging System to detect cardiotoxicity from drugs used to treat cancer (e.g. Breast Cancer and Lymphomas).
- Conditions
- Cardiotoxicity, Heart Failure, Chemotherapeutic Toxicity
- Trial name
- Prefect (NCT03543228)
- Testing
- MyoStrain
- Where
- Germany
- Volunteers
- 63 people
- Sponsor
- Myocardial Solutions
Cardiotoxicity, Heart Failure
Novel On-body Evaluation of Cardiac Health for Oncology
The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function.
- Trial name
- NOECHO (NCT07158450)
- Where
- 11 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Skribe Medical
Fracture
Clinical Validation of Boneview for FDA Submission
The goal of this clinical validation is to assess comparative performances of physicians with and without the assistance of BoneView for the diagnosis of fractures on radiographs.
- Trial name
- NCT04532580
- Testing
- Diagnosis of fracture on X-Ray Radiographs
- Where
- United States
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Gleamer
Radiation-induced Lung Injury, Immune-related Pneumonia
Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia
Radiation-induced lung injury (RILI) is one of the most common thoracic-radiotherapy complications, with an incidence as high as 31.4 %.
- Trial name
- NCT07388680
- Testing
- Pirfenidone Capsules （400 mg）, Pirfenidone Capsules（600mg）, Pirfenidone Capsules（0mg）
- Where
- 36 sites in China
- Volunteers
- 298 people
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Radiodermatitis, Dermatitis, Radiation-Induced
Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.
This is a post marketing, interventional, randomized, single-center, prospective, controlled study, for the evaluation of the clinical performance and tolerability of a cream-based medical device (DermoRelizemaTM cream) in the…
- Trial name
- DRESDA (NCT04483856)
- Testing
- DermoRelizema cream, Dexeryl
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Relife Italia S.r.l.
Radiation Dermatitis
LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
The study will evaluate the safety, tolerability and efficacy of LUT014 gel topically administered in breast cancer patients who developed radiation dermatitis.
- Trial name
- NCT04261387
- Testing
- LUT014 Gel
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- Lutris Pharma Ltd.
Radiotherapy Side Effect, Pelvic Cancer
AI as an Aid for Weekly Symptom Intake in Radiotherapy
The study investigates the use of artificial intelligence (AI) and large language models (LLMs) to enhance the efficiency and accuracy of weekly treatment consultations (OTVs) in radiotherapy.
- Conditions
- Radiotherapy Side Effect, Pelvic Cancer, Patient
- Trial name
- NCT06525181
- Testing
- Generative Artificial Intelligence, Standard weekly symptom intake
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- jaide
Radiation Pneumonitis, Lung Cancer
Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 on Radiation Pneumonitis in Non-small Cell Lung Cancer Patients
The purpose of this clinical trial is to evaluate the safety when HL301 is administered to unresectable non-small cell lung cancer patients who receive chemoradiotherapy with Paclitaxel and Carboplatin and to search for a…
- Trial name
- NCT04632342
- Testing
- HL301 tablet 300mg
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- Hanlim Pharm. Co., Ltd.
Breast Cancer
Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis
This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs.
- Trial name
- ARD (NCT01923220)
- Testing
- HO/02/02 20µg, Aloe Vera Jel
- Where
- Israel
- Volunteers
- 90 people
- Sponsor
- HealOr
Healthy, Osteopenia
Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break.
- Conditions
- Healthy, Osteopenia, Osteoporosis
- Trial name
- POROUS-preFX (NCT06567054)
- Testing
- Measurements with the POROUS R3C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine, DXA-based Vertebral Fracture Assessment (VFA)
- Where
- 6 sites in Austria, Germany and 1 more
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH
Radiation Injuries
Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory
Our hypothesis is that improved line of sight to patient data, ergonomics, and headset lead shielding in the CCL will lead to behavioral changes in the CCL personnel that will reduce radiation exposure to all members of the team.
- Trial name
- MRCCL (NCT05063773)
- Testing
- Mixed reality heads up display
- Volunteers
- 150 people
- Sponsor
- SG Devices LLC