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NCT ID: NCT05374122 Active, not recruiting - Neoplasms Clinical Trials

AI Guidance for Biopsy in Suspected Cholangiocarcinoma

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

Digital single-operator cholangioscopy (DSOC) has emerged as a medical advance with an important role in the evaluation of indeterminate biliary lesions. This technique has demonstrated higher sensitivity in the guidance for tissue acquisition when compared with standard endoscopic retrograde cholangiopancreatography (ERCP). DSOC-guided biopsy is considered technically safe and successful for tissue collection. Hand in hand with the development of more precise diagnostic techniques, comes the implementation of artificial intelligence (AI) for diagnostic assessment. For the past decade, the role of artificial intelligence (AI) has been increasing at a rapid pace. In the biliary tract, different models have been proposed for the characterization of malignant features. Nevertheless, to date, the discrepancy between the visual impression of the operator and the histological results obtained by cholangioscopy still present, affecting the accuracy the diagnosis. Based on the above, the investigators aim to assess the diagnostic accuracy of AI for the guidance of tissue acquisition with DSOC compared to DSOC without AI for suspected cholangiocarcinoma. As a secondary aim, the investigators pursue to compare quality of AI-guided biopsies samples vs. DSOC biopsies without AI.

NCT ID: NCT05373550 Active, not recruiting - Clinical trials for Prevention of Complications Due to Hysterectomy

Effectiveness of a Nursing Intervention on Quality of Life, Sexual Function, and Self-esteem in Hysterectomized Women

Start date: September 13, 2021
Phase: N/A
Study type: Interventional

Surgical hysterectomy is second only to cesarean section as a surgical procedure in women, causing an impact on sexual function, quality of life, and self-esteem, therefore it is necessary to incorporate a comprehensive care in search of women's welfare. Objectives: To know the meaning of education in the perioperative period, in women submitted to hysterectomy for a benign cause. To determine the efficacy of a nursing educational intervention based on self-care in the improvement of sexual function, health-related quality of life, and self-esteem in women undergoing hysterectomy for benign causes. Subjects and methods: A sequential exploratory mixed-method study. For the qualitative phase, individual interviews will be conducted with women (35 to 65 years old) with the indication of hysterectomy for benign pathology attending the gynecology office, who will be contacted and invited to participate. The interviews will be analyzed using the content analysis technique. The quantitative phase will correspond to a quasi-experimental study design with a non-equivalent control group in women with indications for hysterectomy between 35 and 65 years old in two Obstetric Gynecological Hospitals in Quito. At least 26 women on the waiting list for hysterectomy for the experimental group and 26 for the comparison group will be included. Instruments: Bio-sociodemographic questionnaire, Female Sexual Function Index, SF-36, and Rosenberg Scale. The two groups will receive traditional care and the experimental group will additionally receive face-to-face nursing educational intervention with technological support. Ethical requirements will be considered. Expected results: After the nursing education intervention with technological support, women in the experimental group will improve their sexual function, health-related quality of life, and self-esteem concerning the comparison group

NCT ID: NCT05307861 Active, not recruiting - Clinical trials for Biliary Tract Diseases

Plastic vs Biodegradable Pancreatic Stent in Post-ERCP Pancreatitis Prevention

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Multiple risk factors have been linked with post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP); therefore, it is critical to follow strategies to reduce associated risk, morbidity, and mortality. However, there are also factors, such as pancreatic duct stenting, which have shown evidence of PEP prevention. The investigators pursue to compare plastic vs biodegradable pancreatic stents in the prevention of PEP.

NCT ID: NCT05130944 Active, not recruiting - Stress Clinical Trials

Feasibility of Community Psychosocial Intervention for Women

Start date: September 9, 2021
Phase: N/A
Study type: Interventional

The purpose of the current protocol is to describe a cluster randomized feasibility trial examining the integration of a scalable stress management intervention into Entre Nosotras ('among/between us'), a community-based psychosocial intervention for migrant and host community women in Ecuador and Panamá. Specifically the study aims to: 1. Explore the relevance, acceptability, and feasibility of integrating a stress management intervention into community-based participatory women's group 2. Examine the feasibility of conducting a fully-powered cluster randomized controlled trial evaluating the effectiveness and implementation of integrating a stress management intervention into a community-based participatory women's group as compared to community-based participatory women's groups alone.

NCT ID: NCT05103150 Active, not recruiting - Celiac Disease Clinical Trials

Virtual Chromoendoscopy With Magnification in Coeliac Disease.

Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

High-definition white light endoscopy (HD-WLE) does not usually allow the visualization of duodenal villous patterns and may be inaccurate for assessing coeliac disease (CD). To the best of the knowledge of the authorship, there is no prospective study that has evaluated the accuracy of combining high-definition optical magnification (HD-OM) with i-Scan optical enhancement (OE) virtual chromoendoscopy for evaluation of duodenal villous patterns in the context of CD suspicion. Combining both techniques can also guide better duodenal biopsies. This study pursues to compare diagnostic accuracy between HD-WLE and HD-OM with OE using histology as the gold standard in detecting villous abnormalities in CD.

NCT ID: NCT05095831 Active, not recruiting - Pancreatitis Clinical Trials

EUS Shear Wave for Solid Pancreatic Lesions.

Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

The diagnosis of pancreas diseases is based on a combination of clinical signs, symptoms, and laboratory tests, but mainly on imaging techniques such as computed tomography (CT) and magnetic resonance (MR). However, CT/MR have variable sensitivity and specificity, with certain disadvantages. Endoscopic ultrasound with elastography is an important resource with higher diagnostic accuracy in assessing solid pancreas lesions. Shear wave velocities of healthy parenchyma, acute, chronic and autoimmune pancreatitis, neoplastic lesions of the pancreas must be evaluated and compared.

NCT ID: NCT04646590 Active, not recruiting - Safety and Efficacy Clinical Trials

A Phase III Clinical Trial to Determine the Safety and Efficacy of ZF2001 for Prevention of COVID-19

Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo-controlled international multicenter clinical trial design will be adopted. A total of 29,000 subjects aged 18 years and above are planned to be recruited, including 750 subjects aged 18-59 years and 250 subjects aged 60 years and above in China; 21,000 subjects aged 18-59 years and 7,000 subjects aged 60 years and above will be recruited outside China. Safety and immunogenicity will be evaluated among the Chinese subjects, and efficacy, immunogenicity and safety will be evaluated among the subjects outside China. Among them, 750 subjects aged 18-59 and 250 subjects aged 60 and above from outside China and all subjects from China will be selected as the immunogenicity subgroup for immunogenicity bridging study. The IgG levels of SARS-COV-2 neutralizing antibody and RBD protein binding antibody will be detected by blood sampling before vaccination, 14 days and 6 months after full course of vaccination to evaluate the immunogenicity and immune persistence.

NCT ID: NCT03883334 Active, not recruiting - HIV Infections Clinical Trials

Isoprinosine in HIV Patients With Viral Load > 50 y < 200 Copies/mL

Start date: February 28, 2019
Phase: Phase 4
Study type: Interventional

Virological failure is a complication of treatment in patients with HIV, and it can be as high as 42% to first line treatment or around 18% in second line treatment. The reasons behind this phenomenon are several, including adherence to treatment (self-patient) or those related to the drugs (kinetics, interactions) and the virus itself (resistance patterns). People living with HIV needs treatment for all their lives, another factor to facilitate virus resistance and poor adherence to treatment. For that reason, it is necessary to look for additional therapeutic options to minimize this problem, and the use of immunomodulatory drugs is an interesting topic now. Among those drugs, isoprinosine hs been reported not only improve the immune response, it also has the capability to inhibit the replication of RNA virus. Then, we propose an open label clinical trial to evaluate the effect of isoprinosine in HIV patients with a virological load between 50 and 200 copies/ml.

NCT ID: NCT02237352 Active, not recruiting - Diabetes Mellitus Clinical Trials

Mechanisms of Diabetic Nephropathy in Ecuador

Start date: September 15, 2014
Phase:
Study type: Observational [Patient Registry]

The prevalence of diabetes mellitus (DM) is increasing worldwide, suggesting that 45% of diabetics are undiagnosed. DM induces a kidney disease called diabetic nephropathy (DN) which is the largest single cause of end-stage renal disease and dialysis requirement. In South America the prevalence of DM and chronic kidney disease has increased, and great disparity exists among countries in regards to access to the dialysis treatment. It has been considerate that Hispanic origin increases the risk for DM. The South Americans have distinctive habits, culture, environment, behavior and genetic background and the factors involved in DN have not been defined yet. The early kidney lesions such as neoangiogenesis (pathologic generation of the new blood vessels) and extracellular matrix expansion have been described. The vascular endothelial growth factor A (VEGF) has been linked to angiogenesis, but the role of VEGF in DN has not been elucidated yet. VEGF signals mainly through VEGF receptor 2 (VEGFR2). VEGFR2 interacts with alphaV beta3 integrin (AVB3) in kidney. Additionally tenascin C is expressed in the extracellular matrix. Tenascin C and the tenascin C/AVB3 complex have also been linked to angiogenesis, however their roles have not been unveiled yet in the DN. Investigators hypothesize that VEGF signaling and tenascin C play an important role in DN and that VEGFR2, AVB3 and tenascin C interact. The purposes of this study is to characterize social, environmental and biological factors implicated in the DN in Ecuador and define the role of VEGF signaling and tenascin C in the pathogenesis of the DN. Investigators propose to study factors involved in DN in diabetic and non-diabetic adults from general population, with and without DN. In a single time investigators will evaluate demographics data, habits, personal and family history through a survey. Investigators will measure anthropometrics parameters and blood pressure; investigators will quantify blood glucose, glycosylated hemoglobin A1c and proteinuria. In addition investigators will examine the role of tenascin C and VEGF signaling by analyzing paraffin embedded kidney tissue, plasma and urine samples. Characterizing the factors involved in the DN from Hispanic people is key to establish adequate strategies of prevention, diagnosis and treatment in this population. Furthermore elucidating the role of proteins involved in DN may offer valuable tools for the development of new treatments.

NCT ID: NCT01068522 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Study to Improve Outcomes for Survivors of Traumatic Brain Injury in Latin America

Start date: July 2007
Phase: Phase 3
Study type: Interventional

People who survive severe traumatic brain injury (TBI) live with profound cognitive impairments that alter their developmental course and define their future possibilities. Worldwide, TBI is the leading cause of death and disability among children and adolescents (Murgio, 2000). In the United States, the annual incidence of TBI is six times greater than that of multiple sclerosis, HIV/AIDS, spinal cord injury, and breast cancer combined [Centers for Disease Control, American Cancer Society, National Multiple Sclerosis Society]. The burden of TBI may be even greater in developing countries, due to civil unrest and war, and to the absence of mandated prevention such as seat belt laws. The long-term objective of the investigators' research group is to improve outcomes for survivors of TBI in Latin America. To that end, the investigators have created a structure for professionals and institutions involved in the treatment of TBI to generate research; to facilitate education, standardization, certification, the dissemination of information and resources; and to foster the development of evidence-based guidelines. The structure is the Latin American Brain Injury Consortium (LABIC).