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NCT ID: NCT06370091 Recruiting - Healthy Clinical Trials

Effect of Xylitol-based Chewing Gums, Sugar-free and Sugared, on Salivary Flow and pH in Young Adults

Start date: December 12, 2023
Phase: N/A
Study type: Interventional

This study was planned to evaluate the effects of xylitol-based chewing gums, sugar-free and sugared, on salivary flow and pH in young adults.

NCT ID: NCT06298604 Recruiting - Liver Diseases Clinical Trials

Motorized Fine Needle Biopsy vs Standard Needles

Start date: December 9, 2023
Phase: N/A
Study type: Interventional

Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition. Given the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.

NCT ID: NCT06264466 Recruiting - Clinical trials for Esophageal Achalasia

Safety and Efficacy of a Novel Flexible Bipolar in POEM

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Per-oral endoscopic myotomy (POEM) is a minimally invasive therapy for achalasia. The procedure has demonstrated high technical and clinical success with lower adverse events. Different types of knives have been used for cutting and coagulation during the procedure; however, exchanging accessories is sometimes needed to perform all the stages of POEM. To overcome this disadvantage, the investigators aim to evaluate a single device that integrates in its tip bipolar radiofrequency and microwave, the Speedboat Ultraslim (Creo Medical, UK) for cutting and coagulation during POEM procedure. Some of the promise's advantages derived from its use are: (1) less inflammation, (2) clear differentiation between layers, (3) the use of a single device for the procedure. This single-center, prospective, interventional study will include patients with achalasia submitted to POEM procedure, with or without fundoplication (POEM-F). All stages (mucosal incision, submucosal tunneling, myotomy) of POEM will be performed using the Speedboat ultraslim flexible catheter. Technical and clinical success, along with safety will be the primary endpoints; while, post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index (RSI) and the Northwestern Esophageal Quality of Life (NEQOL), respectively.

NCT ID: NCT06219642 Recruiting - Clinical trials for Symptoms of Depression and Anxiety

Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador

Start date: March 15, 2023
Phase: N/A
Study type: Interventional

The availability of affordable hardware and rapidly growing content that can be freely accessed in the public domain raises the possibility of VR being used across the world globally and, in a very broad range of settings, including low-income populations and middle-income countries. The goal of this study is implement a randomized control trial using a low-cost VR mindfulness intervention within older adults in Quito, Ecuador compared. The control group will only receive a check-in phone call.

NCT ID: NCT06136702 Recruiting - Cervical Cancer Clinical Trials

ELEVATE Acceptability Study

ELEVATE AS
Start date: December 7, 2022
Phase: N/A
Study type: Interventional

This study includes a community-based, two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months. Arm 2 consists of an educational session on sexual health and cervical cancer (screening) and self-sampling, additionally women will be asked to take a self-sample on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users' experiences related to the use of a HPV self-sampling test will be assessed, additionally, the impact on looking for follow up care of self-sampling with standard cervical screening strategies will be assessed and finally the feasibility of an HPV self-sampling in hard-to-reach groups versus educational sessions and standard care will be compared (arm 1 and 2).

NCT ID: NCT06042036 Recruiting - Clinical trials for Respiratory Insufficiency

Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure

SPIRAL
Start date: June 12, 2023
Phase:
Study type: Observational

The goal of this observational study is to estimate the prevalence of the use of protective ventilation with low tidal volume ventilation in the transition of spontaneous ventilation modes in patients with hypoxemic acute respiratory failure in ICUs in Latin America and its association with patient outcomes. The main questions it aims to answer are: - what is the prevalence of the use of low tidal volume ventilation (VT <8 mL/kg of predicted body weight) in the first 24 hours of spontaneous ventilation modes in patients with hypoxemic acute respiratory failure? - Is there an association between the rate of adherence to low tidal volume ventilation in spontaneous ventilation modes and the ability to stay off ventilatory support and mortality? Participants are patients with acute respiratory failure under mechanical ventilation. Investigators will collect data on the ventilatory parameters of participants - 24 hours before they begin to be ventilated with spontaneous modes of ventilation - during the first 24 hours of spontaneous ventilation Investigators will collect several patient-centered clinical outcomes at 28 days after study inclusion, including ventilator-free days and mortality

NCT ID: NCT06038201 Recruiting - Cholelithiasis Clinical Trials

Cholecystectomy vs EUS-guided GBD With Stone Removal

Start date: October 25, 2023
Phase: N/A
Study type: Interventional

In this new era of less invasive procedures, the indications for endoscopic ultrasound (EUS)-guided gallbladder drainage (GBD) are rapidly expanding. Nowadays, the standard treatment for uncomplicated cholelithiasis (symptomatic patients not requiring hospital admission or non-surgically managed during one or more hospital admissions) is elective laparoscopic cholecystectomy. To avoid the complications, difficulties and disadvantages of cholecystectomy, the investigators proposed a single-center study to determine the safety and effectiveness of EUS-guided GBD with electrocautery-enhanced lumen-apposing metal stent (LAMS) (Boston Scientific, Marlborough, MA, EEUU) with stone removal in patients with cholelithiasis, in comparison with the gold standard treatment, the elective laparoscopic cholecystectomy.

NCT ID: NCT05734820 Recruiting - Colorectal Cancer Clinical Trials

Computer-aided Detection During Screening Colonoscopy

Start date: January 11, 2020
Phase: N/A
Study type: Interventional

Nowadays, colonoscopy is considered the gold standard for the detection of lesions in the colorectal mucosa. However, around 25% of polyps may be missed during the conventional colonoscopy. Based on this, new technological tools aimed to improve the quality of the procedures, diminishing the technical and operator-related factors associated with the missed lesions. These tools use artificial intelligence (AI), a computer system able to perform human tasks after a previous training process from a large dataset. The DiscoveryTM AI-assisted polyp detector (Pentax Medical, Hoya Group, Tokyo, Japan) is a newly developed detection system based on AI. It was designed to alert and direct the attention to potential mucosal lesions. According to its remarkable features, it may increase the polyp and adenoma detection rates (PDR and ADR, respectively) and decrease the adenoma miss rate (AMR). Based on the above, the investigators aim to assess the real-world effectiveness of the DiscoveryTM AI-assisted polyp detector system in clinical practice and compare the results between expert (seniors) and non-expert (juniors) endoscopists.

NCT ID: NCT05640401 Recruiting - Clinical trials for Gastrointestinal Diseases

Holographic Screens as a Replacement of Monitors During GI Endoscopies

Start date: November 21, 2022
Phase: N/A
Study type: Interventional

Nowadays, the application and development of spatial technologies have shown an increased interest in different fields of medicine, especially in procedural specialties. Many studies have shown the utility of augmented and virtual reality; however, studies evaluating mixed reality are scarce. In gastroenterology, some proposed advantages of MR are the 3D space guidance, its increased situational awareness, remote assistance, and the reduction of surgical monitors in the units. Based on this, the researchers proposed a multicenter trial to assess the added value of MR through a holographic device during gastroenterology endoscopic procedures.

NCT ID: NCT05561179 Recruiting - Clinical trials for Gastroesophageal Reflux

Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease

Start date: September 30, 2022
Phase: N/A
Study type: Interventional

Gastroesophageal reflux disease (GERD) remains one of the most common pathologies seen among gastroenterologists, surgeons, and primary care physicians. The high prevalence of this condition lead to further investigations in its prevention, diagnosis, and management. For the treatment of this chronic condition, improvement in quality of life and long-term durability should be considered. Nowadays, proton pump inhibitors (PPIs) are considered the mainstay in the treatment of the patients with GERD; however, due to the increasing concern related to its safety in its long-term use and the over prescription of these drugs, new surgical and endoscopic interventions have emerged. A local treatment based on injections of hyaluronic acid, a natural nonimmunogenic mucosal defense, in the lower esophageal mucosa is a tentative treatment option for these patients. Based on this, the investigators pursue to assess the effects of hyaluronic acid in gastroesophageal reflux control.