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NCT ID: NCT05534178 Recruiting - Quality of Life Clinical Trials

Machine Learning Model to Predict HOLS and Mortality After Discharge in Hospitalized Oncologic Patients

PLANTOLOGY
Start date: February 15, 2020
Phase:
Study type: Observational [Patient Registry]

The study aims to understand which are the most relevant parameters at admission which may allow to predict the hospital length of stay (HOLS) and mortality after discharge of oncologic hospitalized patients. This is the first multicentric prospective observational study that tries to understand the complexity of the hospitalized oncologic patients. A comprehensive analysis will be performed with the help of the nutrition, nursery, internal medicine and oncology teams.

NCT ID: NCT05515783 Recruiting - Tumor Clinical Trials

68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies

Start date: May 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

As an new dual targeting PET radiotracer, 68Ga-FAP-RGD is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-RGD in patients with various types of cancer and compared them with the results of 68Ga-FAPI-02 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-RGD.

NCT ID: NCT05506566 Recruiting - Tumor Clinical Trials

68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies

Start date: May 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

As an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.

NCT ID: NCT05505006 Recruiting - Anemia Clinical Trials

Management of Preoperative Anaemia in Surgical Oncology

Start date: March 2, 2021
Phase: Phase 4
Study type: Interventional

Preoperative anemia is detrimental in surgical patients, and its treatment with transfusions can further worsen outcomes, including increased hospital stay and mortality. Transfusions are also highly costly. In 2010, the World Health Organization endorsed the adoption of Patient Blood Management (PBM) programs, i.e., patient-centered multidisciplinary activities, including recognition and treatment of preoperative anemia. While the latter has been proved effective in reducing transfusions in setting like elective orthopedic surgery, widespread adoption is still lacking. Moreover, little is known about surgical oncology, a particular setting posing unique challenging. This change-promoting project attempts to fill this knowledge gap by establishing a multidisciplinary team aimed at optimal management of preoperative anemia in hepatobiliary/pancreas/gastrointestinal/renal surgical oncology. The primary endpoint is the reduction of transfusions, along with safer patient outcomes as compared to the historical series.

NCT ID: NCT05470283 Active, not recruiting - Melanoma Clinical Trials

Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma

Start date: September 7, 2022
Phase: Phase 1
Study type: Interventional

The goal of this clinical research study is to find the recommended dose of OBX-115 in combination with acetazolamide that can be given to patients with metastatic melanoma previously treated with immune checkpoint inhibitors. The safety and tolerability of the study drug combination will also be studied.

NCT ID: NCT05443854 Not yet recruiting - Sepsis Clinical Trials

Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)

Start date: September 2022
Phase: Phase 3
Study type: Interventional

Sepsis remains the leading cause of ICU admission in neutropenic patients. This condition remains associated with a high morbidity and mortality, with hospital mortality of 60% when vasopressors are required. Full protective isolation (including geographic isolation, technical isolation, high-efficiency air filtration, and digestive decontamination) proved to be efficient in patients with profound and prolonged neutropenia with regard to infection rate. However, these studies are biased and were performed up to 40 years ago. More recent studies, performed in patients with less profound neutropenia, or performed without digestive decontamination or with partial protective isolation led however to negative results. More importantly, isolation has been demonstrated to limit access to patients' room and to be associated with suboptimal monitoring, with increased rate of severe and avoidable adverse events. This may explain the uneven use of protective isolation in hematology ward and expert's suggestion to appraise protective isolation benefits using large well conducted RCT. In neutropenic patients with suspected sepsis, urgent broad antibiotic therapy is mandatory and failure to initiate adequate antibiotic therapy within 1 hour has been associated with a 10 fold increase in adjusted mortality. Current IDSA guidelines recommend using preferentially large anti-pseudomonas beta-lactam therapy. Routine antibiotic combination using aminoglycosides is controversial and not recommended. On one hand, meta-analyses suggested not-only a lack of benefit from this association but also increased rate of renal failure and a trend towards a higher mortality rate with aminoglycosides use. On the other hand, subgroup analysis and low-level evidences studies suggest however a benefit from aminoglycosides in critically-ill patients, patients with severe sepsis, or those with documented gram negative infection. Along this line, both the recent Cochran systematic review and the recent French guidelines focusing on neutropenia management in critically-ill patients advocated additional trials in this field focusing in the sickest patients. The current study aims to assess benefits of protective isolation and systematic use of aminoglycosides combination antibiotic therapy in critically-ill patients with cancer-related neutropenia and sepsis or septic shock. To do so, the investigators intend to perform a 2x2 factorial design randomized pragmatic trial comparing on one hand benefits of protective isolation (versus no protective isolation) and in the other hand benefits of systematic aminoglycosides antibiotics combination (versus no systematic combination).

NCT ID: NCT05432232 Recruiting - Kidney Cancer Clinical Trials

The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy

CAIN
Start date: March 23, 2023
Phase: N/A
Study type: Interventional

The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors.

NCT ID: NCT05397522 Not yet recruiting - Tumor Clinical Trials

The Effects of Observer Presence and Type on Patients' Perception of Exercise After Bone Tumor Resection-A Qualitative Study

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

The primary aim of the study is to investigate the effects of supervised exercise, telerehabilitation and home-based exercise on patient perception in patients who have undergone bone tumor resection. The secondary aim of the study is to identify the barriers to starting exercise in these patients.

NCT ID: NCT05368688 Terminated - Colorectal Cancer Clinical Trials

Microbiome in Colorectal Cancer Onset and Progression

Start date: June 30, 2022
Phase:
Study type: Observational

This is an observational study with the goal to improve the robustness of the scientific evidence linking Fusobacterium nucleatum (Fn) and/or other microorganisms to colorectal cancer (CRC) onset and/or progression. This is an approximately three-year study. There are two phases to this study, including: 1) pilot phase, 2) full study. There are also five arms in this study including cancer-free, pre-cancerous, and Colorectal cancer stages (I-III). The pilot study will include the recruitment of 50 participants per group (i.e., total of 250 participants). The full study will have an additional 150 participants per group (total of 1,000 participants). This study will recruit using clinical sites in the United States. There are 5 timepoints in this study. If the participants are found to be medically eligible through diagnosis and medical information, they will provide samples (including: saliva, blood, urine, stool and tumor biopsy) at each timepoint and during the study. They will also answer health and wellness questions during this study. Additional data collection, including medical data, biopsies and other biological samples might happen at interim timepoints in case of adenoma/cancer disease progression (recurrence, metastasis). The participant's healthcare provider will determine if additional biopsies are required as a part of the standard of care. If collected, additional samples will be sent for research purposes.

NCT ID: NCT05273554 Recruiting - Adenocarcinoma Clinical Trials

A Pilot Study to Assess Changes in Tumor Biology Following Second-line Treatment With Pembrolizumab Plus Lenvatinib in Patients With Advanced Pancreatic Ductal Adenocarcinoma

Start date: August 31, 2022
Phase: Phase 1
Study type: Interventional

This is a clinical research study to learn if pembrolizumab in combination with lenvatinib can help to control pancreatic ductal adenocarcinoma.