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Risk Factors clinical trials

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NCT ID: NCT06441240 Recruiting - Breast Cancer Clinical Trials

Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy.

NEORISK
Start date: November 1, 2023
Phase:
Study type: Observational

INTRODUCTION Breast cancer (BC) is the leading cause of cancer-related death in women. Since the early 1980s, the implementation of screening programs has reduced the number of patients diagnosed with locally advanced breast cancer. Currently, the treatment for these patients involves initial neoadjuvant chemotherapy (NACT) followed by surgical treatment. In recent years, NACT has also been used for highly chemoresponsive tumors such as triple-negative (TN) and HER2-positive (HER2+) breast cancer. The widespread use of NACT has led to additional benefits, including downstaging of breast and axillary neoplasms, resulting in reduced morbidity; improved cosmetic outcomes due to increased use of conservative interventions; and personalized adjuvant chemotherapy treatment. Several studies have shown that response to chemotherapy predicts better systemic outcomes. Complete pathological response (pCR), defined as the absence of invasive neoplastic residue in the surgical specimen, has been predictive of better distant outcomes. Limited evidence exists regarding other predictive factors for distant outcomes. Given the significant impact of disease recurrence on patient prognosis, efforts have been made to understand the factors contributing to recurrence and to predict which patients are more prone to relapse. In this context, the term "Early Disease Recurrence" (EDR) has been coined to define the occurrence of disease recurrence, both locally and distantly, within 3 years after completing treatment. In recent years, the potential of radiomic analysis in aiding diagnostic and therapeutic decision-making processes in BC has been demonstrated. Specifically, radiomic features obtained from Magnetic Resonance Imaging (MRI) images appear capable of predicting tumor receptor status, differentiating tumor subtypes, and predicting response to NACT. Although the role of radiomics in predicting recurrence has been investigated, research is still in its early stages, and there are variations in technology and methodology for extracting radiomic features. Additionally, to date, no studies have evaluated the feasibility and reliability of using radiomic models combined with clinical and radiological variables to predict disease recurrence in BC patients undergoing NACT.

NCT ID: NCT06411496 Completed - Clinical trials for Postoperative Complications

Creation, Implementation and Validation of Intra- and Postoperative Risk Prediction Models

Start date: June 1, 2018
Phase:
Study type: Observational

This project aims to create and validate surgical risk prediction models for the prediction of complications in patients pending surgery during the operation, in the immediate postoperative period and up to one month after discharge. At present there is no risk assessment system in place, except for the ASA scale which is mainly based on the subjective impression of the facultative, who assesses it in the universal preoperative consultations that we have planned in the system. In this project we intend to provide robust models, based on the analysis of data from patients in 4/5 Basque hospitals, i.e. generated in our population.

NCT ID: NCT06374849 Recruiting - Chronic Pain Clinical Trials

Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery

ISPAIN
Start date: March 17, 2024
Phase: Phase 4
Study type: Interventional

Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. These findings highlight a risk factor for CPSP that the anaesthetist can influence on, but they however remain limited to remifentanil. To this day, no study have attempted to evaluate the existence of such an association between the incidence of CPSP and the intraoperative administration of sufentanil doses. Improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk. In the field of CPSP, non-major abdominal surgeries remain poorly studied. This is due to their lower risk of CPSP than other surgeries such as orthopaedic, mammary or thoracic surgery. Nevertheless, they constitute a large number of daily surgical procedures. The estimated incidence of CPSP in non-major abdominal surgery appears in several studies to be between 15 and 20% The aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of CPSP at 3 months in patients undergoing non-major scheduled abdominal surgery.

NCT ID: NCT06340178 Not yet recruiting - Pneumothorax Clinical Trials

CT-guided Lung Biopsy Risk Optimization Method

BROM-I
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled study is to evaluate the extent to which injection of a small amount of fluid in the pleural cavity at the biopsy site may reduce the risk of pneumothoraces, in addition to patient positioning to allow biopsy in gravity-dependent areas of the lung.

NCT ID: NCT06288724 Not yet recruiting - Critical Illness Clinical Trials

MOdifiable facTors to Improve VentilAtion ThErapy in ICU

MOTIVATE-ICU
Start date: March 2024
Phase:
Study type: Observational [Patient Registry]

ABSTRACT Introduction: Invasively ventilated patients in low and middle-income countries (LMICs) experience significantly higher mortality compared to those in High income countries (HICs). Direct application of HIC strategies to LMICs maybe ineffective due to context-specific challenges. This study aims to leverage the Intensive Care Registry of Uganda (ICRU) to identify ICU structural and process-related modifiable factors that impact patient outcomes in a low income country. Methods: The MOTIVATE-ICU is a prospective multicentre observational study in invasively ventilated patients. It involves a registry-embedded component examining patient- and process-related factors and a cross-sectional survey on ICU organizational structures. Inclusion criteria encompass patients aged ≥ 15 years undergoing IMV in Ugandan ICUs. Primary outcomes are ICU mortality, ICU length of stay (LOS), and duration of ventilation. Secondary outcomes include ventilator-associated complications, non-pulmonary organ support. tTracheostomy outcomes will be explored in a pre-planned substudy. Factors potentially associated with outcomes will be categorized into two groups; non-modifiable factors and potentially modifiable. Non-modifiable factors will include patient-related factors like age, comorbidities and illness severity; potentially modifiable factors include processes of care (e.g. sedation levels) and ICU organizational structure (e.g. staffing patterns). Multilevel multivariable logistic regression will be utilized to study associations, with both patient and ICU level fixed effects considered. Ethics and Dissemination: Given its observational nature, this study seeks a waiver for patient individual informed consent. Data anonymization ensures patient privacy. Following the principles of the Declaration of Helsinki, relevant ethical approvals will be acquired. Study findings will be disseminated through conferences and peer-reviewed journals.

NCT ID: NCT06159699 Recruiting - COVID-19 Clinical Trials

Telecommunication Technology-based Online Survey

Start date: December 2, 2022
Phase:
Study type: Observational

The aim of this study is to identify and assess new health-associated risk factors, including clinical-pharmacological risk factors. The cohort is built using telecommunication approaches. The associations between clinical-pharmacological, social, demographic, behavioral, and environmental characteristics will be assessed. The continuous depersonalized online survey is performed using the original informational resources in the form of specially designed web-site aimed at identification and assessment of population-based pharmacotherapy patterns including characteristics of self-medication, biologically active food supplement intake, polypharmacy, and adverse drug-drug interactions in the people residing in the ecological conditions of various regions of the country. The invitations to participate in the online survey are sent via the SMS messages using the SMS-Target tool provided by OOO T2 Mobile Company. The survey is performed online at www.zdorov.tpu.ru and www.zdorov.expert both specifically designed for questionnaire publication and data accumulation.

NCT ID: NCT06143436 Recruiting - Risk Factors Clinical Trials

TCM Constitution, Pattern Types, and Disease Factors in Primary Lung Cancer.

Start date: December 20, 2023
Phase:
Study type: Observational

Recently, TCM has played an important role in adjuvant therapy for lung cancer. TCM treatment is based on pattern identification, and constitution theory is also used as a tool for TCM to predict the disease progression. Although there have been many researchs related to the pattern identification and constitution of lung cancer, in view of the problems and limitations, further research on lung cancer patients in Taiwan is needed. This study aims to explore the correlation between TCM constitution, pattern identification, and other related factors in patients with primary lung cancer in Taiwan, hoping to reveal the disease characteristics of lung cancer in TCM theory. This study intends to interview subjects through attending physicians in the thoracic ward and outpatient clinic of the CMUH from November 20th, 2023 to May 19th , 2025, and the subjects will be included in this study after the researchers ask the subjects for consent. This study will collect the demographic data of the subjects (sex, age, BMI, smoking history) and disease-related clinical data (tumor stage, pathological type, gene mutation, tumor markers, other comorbidities), and the investigator will ask about the subjects' signs according to the Constitution in Chinese Medicine Questionnaire (CCMQ) , ask the subjects' symptoms according to the pattern identification table, obtain the data to analyze their distribution by descriptive statistics, and then analyze the correlation between them by analysis of variance and Chi-square test.

NCT ID: NCT06118437 Not yet recruiting - Risk Factors Clinical Trials

Establishment and Validation of a Clinical Predictive Model for Gastrointestinal Cancer Screening Based on Patient-related Risk Factors

Start date: November 15, 2023
Phase:
Study type: Observational

Gastrointestinal tumors (esophageal cancer, gastric cancer, colorectal cancer) seriously threaten human health, with a high incidence rate and cancer related hope mortality. Digestive endoscopy is the main method for screening gastrointestinal tumors. Early screening of gastrointestinal tumors can improve the detection of early cancer and improve prognosis. The five-year survival rate of early stage tumors after comprehensive treatment can reach 90%, while the five-year survival rate of late stage tumors is less than 30%. Therefore, the screening of gastrointestinal tumors is very important. Studies have shown that there are similarities in risk factors for gastrointestinal tumors, such as age, gender, family history, smoking, alcohol consumption, etc. Currently, established digestive malignancies are targeted at a single malignant tumor. At present, there is a lack of understanding of the overall risk factors associated with gastrointestinal tumors and the establishment of relevant risk prediction models. Therefore, we conducted a prospective, multicenter cross-sectional study to explore the independent risk factors of combined gastrointestinal tumors and establish a risk prediction model for combined screening of gastrointestinal tumors.

NCT ID: NCT06036628 Recruiting - Intensive Care Unit Clinical Trials

Resistant Bacteria in Children in France

BREF
Start date: April 1, 2023
Phase:
Study type: Observational

This study is observational, multicenter and prospective study for surveillance of the use of new antibiotics in pediatrics for treated pediatrics infections due to multi-resistant bacteria

NCT ID: NCT05916287 Recruiting - Clinical trials for Cardiovascular Diseases

FAMILY INHERITANCE, GENE-GENE AND GENE-ENVIRONMENT INTERACTIONS IN THE FIELD OF CARDIOVASCULAR AND RENAL DISEASES. Fifth Visit of the STANISLAS Cohort

Start date: July 13, 2023
Phase: N/A
Study type: Interventional

The Stanislas Cohort is a monocentric familial longitudinal cohort originally comprised of 1006 families consisting of two parents and at least two biological children and deemed healthy, recruited in 1993-1995 at the Centre for Preventive Medicine of Nancy. This cohort was established with the primary objective of investigating gene-gene and gene-environment interactions in the field of cardiovascular diseases. The 5th visit of the STANISLAS Cohort will allow a better evaluation of the cardiovascular ageing of the population and the transition toward cardiovascular or renal diseases in relation with their genetic profile and environment.