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NCT ID: NCT06268483 Completed - Clinical trials for Urinary Tract Infections, Recurrent

Effect of Hyaluronic Acid Oral Supplementation on Sexual and Urinary Symptoms of Women With Recurrent Urinary Tract Infections

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

Uncomplicated urinary tract infections (UTI) are one of the most common bacterial infections globally, causing a significant proportion of medical consultations in primary and outpatient settings. Recurrent UTI (rUTI) have a detrimental impact on the patient's quality of life, causing a negative effect on women's social relationships, self-esteem, as well as irritability and tiredness. Moreover, several real-life studies have shown that reproductive-aged women with rUTI more frequently experience sexual dysfunction as compared to controls without infections. The glycosaminoglycan layer of the bladder urothelium, mainly composed by chondroitin sulfate (CS) and hyaluronic acid (HA), provides a protective barrier against the penetration of bacteria. A deficiency of this layer facilitates bacterial adherence, leading to recurrent infection. Treatment to restore this layer with intravesical instillation of HA has been proven to reduce the incidence of rUTI episodes. Furthermore, intravesical instillation with HA has been associates with sexual function improvement in women with rUTI and painful bladder . Therefore, in conditions where the glycosaminoglycan layer of the bladder is impaired, such as rUTIs, treatment with HA to restore it appears to have a beneficial effect on urinary and sexual symptoms. Recently, a randomized control trial has demonstrated that an oral formulation of HA, CS, quercetin and curcumin was effective in improving urinary symptoms in women undergoing intravesical chemotherapy for bladder cancer. However, there are no studies investigating the impact of the oral administration of HA and CS on the sexual and urinary symptoms of women with rUTI. Since rUTI are highly prevalent in sexually active women and exert a detrimental impact on women's quality of life, sexual and urinary symptoms, the identification of oral treatments that could alleviate these bothersome consequences is of primary clinical importance. Therefore we will conduct this randomized, cross-over trial to evaluate the efficacy of an oral preparation of HA, CS, N-Acetylglucosamine and vitamin C in improving sexual and urinary symptoms in a cohort of reproductive-aged women with rUTI. Methods: Pre-menopausal, sexually active women referred to our center for symptomatic rUTIs. At the time of enrollment, participants were randomized with a 1:1 allocation ratio by means of a computer-generated random list in two groups: intervention (I) and control (C) (Figure 1). Inclusion and exclusion criteria We included sexually active, reproductive-aged women with symptomatic rUTIs. Exclusion criteria: younger than 18, if they had used combined hormonal contraception during the previous 6 months; pregnant, breastfeeding or trying to conceive, if they had symptoms of upper UTI, a history of urinary tract anomalies/vesicoureteral reflux, stress urinary incontinence, interstitial cystitis, diabetes, urinary tract stones, neurologic conditions, clinical depression or depressive symptoms. All women will be assessed with a thorough medical and sexual history. To psychometrically quantify sexual function impairment all participants completed The Female Sexual Function Index (FSFI) questionnaire at baseline and at each follow up assessment. Treatment Protocol Group I: an oral preparation (capsule) of HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg once a day in the morning plus an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months. Group C: an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months. After three months of treatment (follow up 1) all women were evaluated with medical and sexual history. Participants also completed the FSFI and IPSS questionnaires. At this point the treatment was reversed (crossover scheme) for additional three months. At 6 months follow up (follow up 2) participants were again investigated with medical and sexual history and the IPSS and FSFI were completed. Figure 2 report the complete study design. Monthly phone calls were performed to check for adherence to treatment. Statistics: The sample size consisted of 25 participants in each group, calculated by using the two-sample t-test analysis. Baseline clinical and psychometric scores will be compared between I and C groups. Second, potential differences in FSFI values at 3-6 months follow-up assessment will be evaluated between and within groups. Potential predictors of FSFI improvement will be evaluated.

NCT ID: NCT06267287 Completed - Joint Infection Clinical Trials

Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period

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

Background. Infection is the most common complication of complications after joint arthroplasty. During the COVID-19 pandemic increased used antibacterial drugs by adults, this could change the spectrum of infectious agents and their antimicrobial resistance. The purpose of the study is to evaluate the microbial diversity of pathogens of periprosthetic infection in the pre- and post-Covid period, determining the sensitivity of the leading pathogens to antibiotics. Materials and methods. A comprehensive comparative retrospective study was carried out on 342 cases of monomicrobial and polymicrobial periprosthetic infection (PPI) of limb joints with microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods.

NCT ID: NCT06265714 Completed - Stroke Clinical Trials

The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia

Start date: July 23, 2021
Phase:
Study type: Observational [Patient Registry]

Patients in the Intensive Cardiovascular Care Unit (ICCU) often present with cardiovascular disease (CVD) issues accompanied by various non-cardiovascular conditions. However, a widely applicable scoring system to predict patient outcomes in the ICCU is lacking. Therefore, developing and validating scores for predicting ICCU patient outcomes are warranted. The aims of the IndONEsia ICCU (One ICCU) registry include developing an epidemiological registry of ICCU patients and establishing a multicentre research network to analyse patient outcomes.This nationwide multicenter cohort will capture data from patients receiving cardiovascular critical care treatment in 10 Indonesian hospitals with ICCU facilities. Recorded data will encompass demographic characteristics, physical examination findings at hospital and ICCU admission, diagnoses at ICCU admission, therapy, intervention, complications on days 3 and 5 of in-ICCU care, in-hospital outcomes, and 30-day outcomes. The One ICCU is a large, prospective registry describing the care process and advancing clinical knowledge in ICCU patients. It will serve as an investigational platform for predicting the mortality of ICCU patients.

NCT ID: NCT06265493 Completed - Geriatrics Clinical Trials

Postoperative Infectious Complications Calculator for Elderly Patients

Start date: June 1, 2021
Phase:
Study type: Observational

The investigators established a first-ever convenient scoring system for clinicians to assess the risk of Postoperative infectious complications (PICs) for elderly patients. Our scoring system can aid in the early detection of potential risks for postoperative infections. Higher-score patients were more likely to experience postoperative infections.

NCT ID: NCT06252831 Completed - Dysbacteriosis Clinical Trials

Study of the Safety and Tolerability of the Broad-spectrum Probiotic Medicine "AS-Probionorm"

Start date: September 2, 2023
Phase: Phase 1
Study type: Interventional

The subject of this clinical trial is the medicine "AS-Probionorm". Pharmacological group - Antidiarrheal drugs. Antidiarrheal microorganisms. Microorganisms that produce lactic acid. The investigational probiotic medicine "AS-Probionorm" was created on the basis of an association of lactic acid bacteria with targeted action for oral use for the treatment of inflammatory and infectious diseases of the human gastrointestinal tract. The first phase of a clinical trial is the first test of a medicine conducted on healthy volunteers to establish tolerability and safety. According to the goal and objectives of the phase I clinical trial, the main parameter is to study the safety and tolerability of the medicine throughout the entire study period. Phase I of the clinical trial of the medicine included 20 healthy subjects of both sexes aged 18-50 years. Clinical and laboratory parameters to characterize the safety of the medicine: medical history, physical examination, ECG, general and biochemical blood tests, urine and stool tests. Selection and Exclusion of Subjects: Prior to inclusion in a clinical trial, each trial subject must first sign an Informed Consent Form for Participation in the Study, followed by a screening examination of each subject, including a variety of procedures, medical history, and physical examination. Each subject participating in the survey will be assigned an identification number. Study design: open-label, single-center, phase I of clinical trial. Dosage regimen - 1 sachet (1 g) 2 times a day with an interval of 12 hours. The total duration of study subjects' participation in the study is 21 days. Tolerability of the study drug: Tolerability of the drug will be assessed based on subjective symptoms and sensations reported by patients and objective data obtained by the investigator during the study. The frequency of occurrence and nature of adverse reactions are also taken into account. The degree of tolerability of the study drug will be determined in three gradations: intolerance, absence of undesirable drug reactions (side reactions), undesirable drug reactions (side effects) not classified as serious. Ethical and Legal Issues in Clinical Research: This clinical trial will be conducted in accordance with the principles set forth by the 18th World Medical Assembly (Helsinki, 1964) and the ICH guidelines for good clinical practice (GCP), and in accordance with all international and national laws and regulations.

NCT ID: NCT06250634 Completed - Clinical trials for Helicobacter Pylori Infection

Esomeprazole/Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection

Start date: February 10, 2024
Phase: N/A
Study type: Interventional

This study intends to collect the clinical data of patients with Helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate traditional quadruple therapy or Vonoprazan + amoxicillin double high-dose double therapy and Vonoprazan + amoxicillin + clarithromycin triple therapy ). The eradication rate of Helicobacter pylori was compared between the two different regimens respectively, and the efficacy, safety and compliance of different regimens were compared. It provides a new reference for clinical treatment of Helicobacter pylori, and has great clinical value and significance for simplifying the anti-Helicobacter-pylori treatment plan, increasing patient compliance, and exploring efficient anti-Helicobacter-pylori therapy suitable for the Chinese population.

NCT ID: NCT06244836 Completed - Rectal Cancer Clinical Trials

Comparison of Two Bundles of Care to Reduce Surgical Site Infection in Colorectal Surgery (CCR-VINCat 2)

CCR-VINCat2
Start date: January 1, 2011
Phase: N/A
Study type: Interventional

There is controversy about the maximum number of elements to be included in a surgical site infection (SSI) prevention bundle and the possibility of its implementation at a multi-center level. This study analyzes SSI rates in colorectal surgery after the implementation of two preventive bundles. The investigators hypothesized that the thorough introduction of a well-designed large bundle of best practice preventive measures would result in good adherence and greater reduction of SSI rates after colorectal surgery.

NCT ID: NCT06239987 Completed - Intensive Care Unit Clinical Trials

The Effect of Care-oriented Practical Training on Nurses' Intensive and Critical Care Competency and HAIs Indicators

Start date: October 16, 2023
Phase: N/A
Study type: Interventional

It was aimed to evaluate the effect of care-oriented practical training on the intensive and critical care competencies of nurses, the hand hygiene compliance rate of nurses and care support staff, and HAI indicators.

NCT ID: NCT06239337 Completed - Tuberculosis Clinical Trials

Evaluation of Xpert MTB/RIF Ultra in Stools and Urine to Improve Tuberculosis Diagnosis in Children

Start date: June 26, 2019
Phase:
Study type: Observational [Patient Registry]

Tuberculosis (TB) diagnosis in children is challenging in low and middle-income countries where access to TB culture and X-ray is limited. More than half cases of childhood TB remain undiagnosed every year. A delay in TB diagnosis can lead to an increase in preventable morbidity and mortality. This study aims to provide evidence on the diagnostic accuracy of Xpert MTB/RIF Ultra in stools and urine for TB diagnosis in children.

NCT ID: NCT06231056 Completed - Clinical trials for Genitourinary; Infection, Complicating Pregnancy

Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Streptococcus agalactiae, a Group B β-hemolytic streptococcus (GBS), is the leading cause of severe neonatal infection in developed countries. There is growing scientific interest in probiotic supplementation in pregnancy as possible prophylaxis for GBS infections and urine culture positivity.