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Hypoxia clinical trials

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NCT ID: NCT04168320 Terminated - Clinical trials for Unresectable Malignant Solid Neoplasm

SBRT-based PArtial Tumor Irradiation of HYpoxic Segment

SBRT-PATHY
Start date: October 30, 2018
Phase: Phase 1
Study type: Interventional

This study uses an unconventional radiotherapy schedule developed at our institute, consisting of a short course high-dose partial irradiation targeting exclusively the hypoxic segment of a bulky tumors, which in our preliminary study has shown to be capable of inducing abscopal and bystander effects. This approach is delivered by using a stereotactic radiotherapy technique so as to spare nearby organs at risk including the peritumoral immune microenvironment from irradiation as much as possible. Our approach consists of a single or up to 3 radiotherapy doses of at least 10 Gy per fraction prescribed to the 70% isodose line encompassing the hypoxic target volume. Radiotherapy will be administered at the precise timing determined specifically for each patient based on the serially mapped homeostatic immune fluctuations by monitoring the blood levels of the cytokines and inflammatory markers over the 2 weeks prior to irradiation. This is done in order to synchronize the radiation treatment with the favorable, most active anti-tumor immune system phase, so as to stimulate and increase anti-tumor immune system activity. This is a monocentric, prospective, two-arm, phase I proof of principle study in which the investigator will enroll subjects with oligometastatic and/or locally advanced (N+) cancers with at least one "bulky" lesion (maximum diameter of at least 6 cm or greater). Patients with life expectancy of at least 3 months, who are ineligible for systemic therapy or experience disease progression with systemic therapies will be included. Radiotherapy will be administered to arm 1 at an estimated "less favorable time-position in immune cycle", while the second arm will have it administered at the estimated "most favorable time-position in immune cycle". The primary endpoint will be the response rate of the non-targeted effects both bystander (local, at the level of the partially treated bulky tumor) and abscopal (distant, at the non-treated metastatic sites), defined as a tumor regression of at least 30%. Secondary endpoints will be safety, survival and analysis of the best timing for the administration of radiotherapy.

NCT ID: NCT04072484 Terminated - Cardiac Arrest Clinical Trials

Effectiveness of Chest Compressions Under Mild Hypoxia

Start date: August 16, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of breathing a slightly reduced amount of oxygen will have on a rescuer's ability to provide chest compressions during CPR.

NCT ID: NCT03877198 Terminated - Hypoxia Clinical Trials

Comparison of Oxygen Controllers in Preterm InfanTs

COCkPIT
Start date: February 19, 2019
Phase: N/A
Study type: Interventional

Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Automatic titration by a controller has been proven to be more effective. However, to date the performance of different controllers has not been compared. The proposed randomized crossover trial Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT) is designed to compare the effect on time spent within target range. The results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.

NCT ID: NCT03835039 Terminated - Clinical trials for HIE - Perinatal Hypoxic - Ischemic Encephalopathy

The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy

Start date: January 3, 2019
Phase:
Study type: Observational

A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed at two different time periods, at discharge and again at 2 years of age.

NCT ID: NCT03730077 Terminated - Soft Tissue Sarcoma Clinical Trials

FMISO PET/CT Imaging Trial for Assessing Hypoxia in Soft Tissue Sarcomas

Start date: February 1, 2019
Phase: Phase 1
Study type: Interventional

Subjects with known or suspected primary soft tissue sarcoma of the extremities may be eligible for this study. Subjects may participate in this study if they are at least 18 years of age. Most participants will be receiving care at the clinical practices of the University of Pennsylvania Health System. Positron emission tomography (PET/CT) imaging will be used to evaluate soft tissue sarcoma hypoxia using an investigational radiotracer, 18F-FMISO Subjects will also undergo an 18F-FDG PET/CT scan close to the time of their initial hypoxia PET/CT to compare in vivo measures of hypoxia to 18F-FDG uptake. The FDG PET/CT may be performed as part of standard clinical care or as a research scan. Both PET/CT scans will occur prior to starting new therapy.

NCT ID: NCT03665259 Terminated - Anesthesia Clinical Trials

Lower Inspiratory Oxygen Fraction for Preoxygenation

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

During the induction period of general anesthesia, surgical patients are inevitably experienced a short period of apnea for endotracheal intubation or other airway manipulation. In order to minimize the risks of hypoxemia during the establishment of artificial airway, pure oxygen (FiO2=100%) is commonly applied to the patients throughout the preoxygenation and induction period. However, high concentration of oxygen therapy has been shown to result in hyperoxemia and substantial oxygen exposure during perioperative period or critical care. There is currently no clinical evidence indicating that preoxygenation with a lower oxygen partial pressure (such as FiO2=60%) during the induction of anesthesia increases the incidence of hypoxemia or other complications. The findings of this proposed clinical study may provide fundamental evidence for the use of different oxygen concentrations in clinical anesthesia during the induction period, and determine the effects of inspired oxygen concentrations on the general postoperative outcomes during general anesthesia.

NCT ID: NCT03573986 Terminated - Clinical trials for Recurrent Glioblastoma

Pilot Study of 18F-FMISO PET/CT and MRI Imaging to Explore Tissue Hypoxia and Arteriovenous Shunting in Subjects With Recurrent Glioblastoma Before and After Bevacizumab Treatment

Start date: April 18, 2018
Phase: Phase 1
Study type: Interventional

Subjects with recurrent glioblastoma who are candidates for bevacizumab treatment according to standard of care will be eligible for this study. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer [18F]FMISO to image the brain and evaluate for hypoxia pre and post therapy.. Subjects will also undergo up to three Brain MRIs.

NCT ID: NCT03550469 Terminated - Hypoxia Clinical Trials

Computer-assisted Oxygen Therapy Weaning in Critically Ill Children

Start date: November 2, 2018
Phase: N/A
Study type: Interventional

The study is designed to evaluate the feasibility, safety and clinical utility of using an adaptive model to wean oxygen by computer assistance. Investigators hypothesize that weaning oxygen using this model will decrease duration of exposure to hyperoxia, decrease duration of exposure to hypoxia, decrease exposure to increased oxygen requirement, and decrease the number of manual fraction of inspired oxygen (FiO2) adjustments as compared to manual weaning of oxygen therapy.

NCT ID: NCT03466034 Terminated - Endometrial Cancer Clinical Trials

The Role of Hypoxia as a Selective Pressure for TP53 Mutations

Start date: February 6, 2018
Phase:
Study type: Observational

The study aims to develop scans that tell the investigators about the oxygen content of tumours using Magnetic Resonance Imaging (MRI) and seeing whether regions of low oxygen content are related to mutations in cancer genes such as TP53. MRI is a method of obtaining pictures of inside of the body that shows the appearance and structure of soft tissues. To get the information about the oxygen content of tumours, MRI is carried out while breathing 100% oxygen. The variation of oxygen supply to different regions of the tumour will help the investigators to predict tumour behavior and tumour response to treatment.

NCT ID: NCT03365076 Terminated - Prostate Cancer Clinical Trials

Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)

EXIPOX
Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Previous research into metabolic and hypoxic markers has found evidence of preclinical impact of exercise on prostate tumor blood flow and oxygenation in rodents . As radiotherapy is a frequently used and effective therapy for and that sufficient oxygenation is decisive to the effect of radiotherapy, an underlying hypothesis that aerobic exercise might improve treatment efficacy of radiotherapy in prostate cancer is put forward. This study has a potential challenging intervention, but a potential very high gain as it includes active patient participation to significantly improve outcome of radical radiotherapy.