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NCT ID: NCT06200844 Recruiting - Clinical trials for Rotavirus Infection of Children

The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants

Rota5DCHILE
Start date: July 7, 2023
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, phase 3 study to evaluate the Efficacy,Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks. A total of 5800 healthy Chilean infants will be recruited in this study and randomized to receive either vaccine or placebo in 1:1 ratio. Among these participants 300 will be categorized to immunogenicity cohort, 150 from each group, and blood samples will be collected to assess the immune response.

NCT ID: NCT06192719 Recruiting - Gallbladder Cancer Clinical Trials

EULAT Eradicate GBC

EULAT
Start date: December 1, 2019
Phase:
Study type: Observational

Gallstones are relatively frequent in women and constitute one of the main risk factors for gallbladder cancer (GBC). Currently, GBC diagnosis is mainly based on imaging (ultrasound or abdominal CT) associated with invasive examinations (biopsy and surgery), with no marker available to date to accurately predict risk and diagnose the disease early. The only curative treatment for GBC remains surgery with complete resection of tumors in early stages. Given the aggressiveness of GBC and the very limited therapeutic options, as well as the possibility of preventing GBC by cholecystectomy during the 10 to 20 years required for the development of gallbladder tumors, it is imperative to develop effective and efficient prevention strategies based on a prioritization of interventions according to environmental and genetic-molecular risk factors. The investigators aim to identify epidemiological factors linked to the development of GBC, and to identify, validate and functionally characterize genetic-molecular markers in blood, saliva, urine, bile and stool that allow risk prediction, early diagnosis and precision treatment of incidental tumors.

NCT ID: NCT06190860 Recruiting - Smoking, Cigarette Clinical Trials

Platelet Rich Fibrin Treatment for the Alveolar Ridge Preservation in Smokers

Start date: May 29, 2022
Phase: N/A
Study type: Interventional

Bone healing is affected by smoking, particularly healing of extraction sockets, showing deficiencies in vertical and horizontal bone dimensions compared to the healing of non-smokers. Several approaches have been made to stimulate. Bone wound healing, including human autologous blood-derived fractions. One of these fractions is the leukocyte platelet-rich fibrin (L-PRF). L-PRF has been evidenced as potentially beneficial in promoting bone defect filling in alveolar bone and socket preservation in non-smokers. However, scarce evidence is related to this beneficial effect in smokers. This clinical trial aims to study and compare the in vivo effects of L-PRF during bone wound healing and regeneration in smokers. The main question is: Has the L-PRF a beneficial effect during alveolar ridge preservation in smokers? After consent, participants with tooth extraction indications and implant rehabilitation treatment will be enrolled. After randomization, participants will be assigned to an experimental group treated with L-PRF plugs and membranes or a control group (physiological healing). Participants will receive two interventions: - First intervention: Tooth extraction, intraoral scan, and Cone Beam Computed Tomography in the treated zone. - Second intervention (4 months after first intervention): intraoral scan and Cone Beam Computed Tomography in the treated zone

NCT ID: NCT06187545 Recruiting - Deep Sedation Clinical Trials

Clinical Performance of the Automated Closed-loop Minimum Viable Prototype

Start date: December 18, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate a minimum viable prototype for automated closed-loop administration of propofol in deep sedated patients under invasive mechanical ventilation in the ICU. The main question it aims to answer is: • whether the minimum viable prototype for automated closed-loop administration of propofol is effective in keeping patients in deep sedation using the lowest possible dose of propofol Participants will undergo deep sedation using the minimum viable prototype for automated closed-loop propofol administration. The usual practice of sedation will be compared with the practice of sedating with the minimum viable prototype to see if the infusion rate of propofol is decreased

NCT ID: NCT06177912 Recruiting - Clinical trials for Pneumococcal Infection

A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)

STRIDE-13
Start date: January 18, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).

NCT ID: NCT06171243 Recruiting - Neuropathic Pain Clinical Trials

PK of Lidocaine/Tetracaine and PD Derived From a New Topical Formulation for Treatment of Neuropathic Pain.

PK/PDLido
Start date: March 17, 2023
Phase:
Study type: Observational

Post-herpetic neuralgia (PHN) is the most frequent complications related to herpes zoster, and can persist for months or even years, and require extensive treatment. For this purpose, pharmacological therapies based on tricyclic antidepressants (amitriptyline), central nervous system depressants (pregabalin) and also opioids, have been stablished. However, all the drugs mentioned can cause serious systemic adverse effects that worsen the patient's quality of life. To avoid these complications, topical therapies based on Capsaicin or Lidocaine 5% patches have been developed. However, these treatments have shown dissimilar results in controlling PHN, so a mixed formulation of lidocaine/tetracaine could show better results. For these reasons, the main objective of our work is to evaluate the plasma levels of lidocaine derived from the application of a topical formulation of lidocaine derived from the application of a topical formulation of lidocaine 23%/tetracaine 7% in patients with neuropathic pain.

NCT ID: NCT06170788 Recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

Start date: December 15, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

NCT ID: NCT06161116 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)

Start date: December 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with Systemic Lupus Erythematosus. The primary hypothesis is that at least 1 of the MK-6194 arms is superior to placebo in the primary endpoint of percentage of participants with systemic lupus erythematosus responder index (SRI-4) response at Week 28.

NCT ID: NCT06157138 Recruiting - Lung Ultrasound Clinical Trials

Observation of B-lines in Pulmonary Echography, During Open Abdominal Surgery

LUS-SURG
Start date: December 26, 2023
Phase:
Study type: Observational [Patient Registry]

There is no a reliable marker of intraoperative fluid excess or overload. The use of lung ultrasound in other settings, such as emergency room and critical care patients, helps us to determine if a patient has a condition of augmented intrathoracic fluid, that could be related to several circumstances, such as fluid overload, but also to heart failure, in example. Nevertheless, there is no information regarding the basal incidence of this finding, to ascertain if could be eventually used as a potential marker of fluid overload. This protocol looks for the incidence of the finding of B-Lines, which are related to fluid overload, in patients undergoing open abdominal surgery.

NCT ID: NCT06149026 Recruiting - Cirrhosis, Liver Clinical Trials

Comparison of the Effect of Two Interventions on Liver Frailty Index in Pre-frail and Frail Cirrhotic Patients Enlisted for Liver Transplantation

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

The goal of this prospective, double blind randomized clinical trial is to compare the effectiveness of two interventions in improve frailty (measured by Liver Frailty Index) and quality of life (measured by Chronic Liver Disease Questionnaire - CLDQ) in listed patients with cirrhosis. The main questions it aims to answer are: - if the intervention group (physical and nutritional therapy) could improve LFI over control group (physical and nutritional counseling). - if the intervention group could improve secondary outcomes as CLDQ, hand grip and gait velocity. Participants will be evaluated in a registry of basal variables such as demographic factors, weight, height and brachial circumference, comorbidities, MELD and MELD-Na, Child Pugh classification, general blood exams, etiology of cirrhosis, presence of hepatocellular carcinoma, ascites, or hepatic encephalopathy and their basal LFI, gait velocity, hand grip and CLDQ. The participants will be randomized in an intervention group or in a control group at the same time of their first evaluation and will receive the group instructions depending on what group the participants belong, and will be evaluated at 4 weeks, 8 weeks, and 12 weeks with applying LFI, measuring of gait velocity, hand grip and a nutritional survey with the intake in the last 24 hours. Finally, researchers will compare interventional group with control group if the first group could improve frailty, measured by Liver Frailty Index and the secondary outcomes with the nutritional and physical therapy.