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NCT ID: NCT05840159 Recruiting - Clinical trials for Chlamydial Infection

A Study of Doxycycline to Treat Chlamydial Infection

Start date: December 15, 2023
Phase: Phase 4
Study type: Interventional

This is a Phase 4 blinded, randomized, active-controlled, non-inferiority trial. Persons of any gender identity will be eligible. Final evaluable population will include a minimum 596 individuals: 298 persons assigned female sex at birth (AFAB) with confirmed urogenital chlamydia (CT) and 298 persons assigned male at birth (AMAB) with confirmed rectal chlamydia (CT). Approximately 664 participants will be enrolled to achieve a minimum 596 participants who contribute primary outcome data. Randomization will be stratified by study site and sex at birth: 332 persons assigned female sex at birth (AFAB) and 332 persons assigned male sex at birth (AMAB). Participants will be randomized 1:1 to a 3-day regimen of doxycycline or a 7-day regimen of doxycycline. The study blind will be maintained by providing 7 days of identical pre-filled blister packs, one with 3 days of active treatment and 4 days of placebo, and the other with 7 days of active treatment. Participants will be asked to return 28 days after randomization (at day 29), at which time they will be re-tested for chlamydia (CT) using a laboratory-based chlamydia (CT) nucleic acid amplification test (NAAT).

NCT ID: NCT05840081 Recruiting - Inflammation Clinical Trials

Dairy Fat and Fermentation Study

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

The purpose of the study is to compare the effect of consuming full-fat (regular) and fat-free (skim) milk, as well as full-fat and fat-free yogurt (a fermented dairy product), on microorganisms in your gut as well as the products produced by the gut microbes. We will also determine whether consuming these dairy products affects risk factors for heart disease.The findings of the study will help us determine if heart disease risk factors are modified by the fat content and fermentation of milk. The results may facilitate refinement of public health dietary guidance for cardiovascular disease risk reduction.

NCT ID: NCT05835219 Recruiting - Clinical trials for Recurrence of Clostridium Difficile Infection

REBYOTA™ Prospective Registry

ROAR
Start date: June 19, 2023
Phase:
Study type: Observational

This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA™ is at the treating physician's discretion and independent from the decision to enroll the patient in the study. Data will be collected from patients' medical records after obtaining informed consent. Data about clinical history, CDI events (primary and recurrent: severity, treatment), CDI-related symptoms, treatments, medical procedures, Adverse Events(AEs), and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of REBYOTA™ administration.

NCT ID: NCT05835102 Recruiting - COVID-19 Clinical Trials

Influence of Nutritional Indices on the Prognosis of Patients With SARS-CoV-2 Infection

Start date: February 1, 2023
Phase:
Study type: Observational

With the decline of virulence after the mutation of the SARS-CoV-2 , based on the national life and health and national development needs, the domestic SARS-CoV-2 infection epidemic prevention policy has changed, and the number of people infected by the SARS-CoV-2 has increased. Nutritional status is an indicator of human health and plays an important role in fighting disease. Malnutrition has been found to correlate with prognosis in patients infected with the SARS-CoV-2 infection . Timely identification and assessment of the patient's nutritional status and early implementation of relevant nutritional intervention are conducive to the recovery of the patient's condition. In clinical practice, it is necessary to improve nutrition as an aspect of the comprehensive diagnosis and treatment of patients with SARS-CoV-2 infection, but there is still a lack of relevant nutritional indicators or models to simply and accurately assess the nutritional status of patients.The purpose of this study was to evaluate the effects of PNI, NRI, GNRI, albumin level, vitamin D, chest muscle area and density on the clinical characteristics and prognosis of patients with SARS-CoV-2 infection, to find the nutritional predictors of severe disease in patients with SARS-CoV-2 infection, and to establish a simpler and more accurate nutritional evaluation model. To provide evidence for targeted nutritional interventions in patients with SARS-CoV-2 infection.

NCT ID: NCT05832164 Recruiting - HIV Infections Clinical Trials

Effectiveness of a Multifactorial Intervention in Frailty Individuals With HIV Infection: HIDRA360

HIDRA360
Start date: December 15, 2022
Phase: N/A
Study type: Interventional

The goal of this quasi-experimental before/after study without equivalent control group is to to describe the prevalence of frail, pre-fragile and robust individuals in the study group before and after a multifactorial intervention in in frail HIV patients. The main questions it aims to answer are after a multifactorial intervention: 1. To describe the sociodemographic, viroimmunological and ART exposure factors of fragile individuals compared to pre-fragile and robust individuals. 2. To describe adherence to the Mediterranean diet in frail individuals compared to pre-frail and robust individuals. 3. To describe the presence of anxiety and depression in frail individuals with respect to pre-fragile and robust individuals. 4. To describe the analytical parameters and inflammatory markers of frail individuals with respect to pre-fragile and robust individuals. 5. To describe the diversity and composition of the intestinal microbiota of frail individuals with respect to pre-fragile and robust individuals. 6. To describe the body composition of frail individuals with respect to pre-fragile and robust individuals. 7. To describe the factors associated with progression to frailty or robustness after six months of a multifactorial intervention.

NCT ID: NCT05831189 Recruiting - Clinical trials for Clostridium Difficile Infection Recurrence

A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection

CDI-SCOPE
Start date: April 21, 2023
Phase: Phase 3
Study type: Interventional

This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy. More specifically, the purpose of this trial is to explore the safety and clinical effectiveness of RBX2660 when delivered by colonoscopy to adults with rCDI. The experience of physicians will be documented through a physician-experience questionnaire to explore the usability of RBX2660 in clinical practice for colonoscopic administration. Furthermore, to explore the patient-experience of RBX2660 treatment, each trial participant will be offered to undergo a structured interview.

NCT ID: NCT05830357 Recruiting - Clinical trials for Helicobacter Pylori Infection

Prevalence and Risk Factors of Helicobacter Pylori Infection in Children and Young Adults

Start date: May 1, 2023
Phase:
Study type: Observational

Helicobacter pylori is a gram-negative bacterium that resides in the stomach and can cause inflammation leading to long-term effects, such as gastric ulcers, cancer, and lymphoma of the stomach mucosal linings Previous research and analysis of H. pylori prevalence in populations have examined common risk factors that increase the likelihood of acquiring the bacteria. Some of the most commonly identified risk factors across various studies in different geographic populations are larger family size, less education, lower socioeconomic status, less frequent hygiene practices, and lower sanitation with specific emphasis on sources of water and defecation. aim of the work: Studying prevalence of Helicobacter Pylori infection and its related risk factors in children and young adults in Sohag governorate.

NCT ID: NCT05830162 Recruiting - Infections Clinical Trials

Oral Antibiotics After Obstetric Perineal Tear

REPAIR
Start date: March 21, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate if 3 dose of oral antibiotics administrated the first day after a vaginal delivery with a second degree obstetric tear will decrease the risk of infection and/or wound dehiscence compared to women with 3 doses of placebo treatment.

NCT ID: NCT05824988 Recruiting - Clinical trials for Gram-Positive Bacterial Infections

Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease

Start date: April 14, 2023
Phase:
Study type: Observational

The incidence and prevalence of nontuberculous mycobacteria (NTM) infections have gradually increased over the years worldwide (1-3). In China, Mycobacterium avium complex (MAC) was the most prevalent NTM specie (4), while challenged by long treatment duration, frequent drug-induced adverse events, lack of treatment alternatives, poor treatment outcome and high recurrence rate (5, 6). In order to maximize the efficacy of the few available drugs and prevent the development of drug resistance, ensuring adequate plasma drug concentrations are of importance. Despite the role of pathogen susceptibility, determined by minimum inhibitory concentration (MIC), is non-negligible, the evidences regarding its association with treatment outcome are limited, especially for rifamycin and ethambutol. The difficulties in explaining the clinical values of MIC might partially be attributed to the lack of in vivo drug exposure data, which cannot be accurately predicted by the dose administered because of between-patient pharmacokinetic variability (7). Therapeutic drug monitoring (TDM) is a strategy to guide and personalize treatment by measuring plasma drug concentrations and pathogen susceptibility, which might have the potential to improve treatment response to MAC lung disease. In this observational study, the hypothesis is that the drug exposure and/or MIC of antimycobacterial drugs are correlated to the treatment response of MAC lung disease, which is assessed from the perspective of treatment outcome, mycobacterial culture negative conversion, lung function, radiological presentation and self-reported quality of life. Consenting adult patients with culture-positive MAC lung disease will be recruited in study hospital. Respiratory samples (sputum and/or bronchoalveolar lavage fluid) will be collected regularly for mycobacterial culture on the basis of BACTEC MGIT 960 system and MIC will be determined using a commercial broth microdilution plate. Drug concentrations will be measured at 1 and/or 6 months after treatment initiation using liquid chromatography tandem mass spectrometry (LC-MS/MS). The final treatment outcome is recorded at the end of MAC treatment and defined according to an NTM-NET consensus statement (8).

NCT ID: NCT05821946 Recruiting - Clinical trials for Kidney Transplantation

Web-Based Multi-Resource Training on the Prevention of Urinary Tract Infections in Adult Kidney Transplant Recipients

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

Purpose: The study aims to examine the effect of web-based multi-source training on the prevention of urinary tract infections in adult kidney transplant recipients on clinical outcomes. Design: The study is a single-center, parallel-group, single-blind, pretest, and posttest randomized controlled experimental study. Methods: A total of 90 kidney transplant recipients, 45 in the control group and 45 in the intervention group will be included in the study. Kidney transplant recipients will be randomized on the day of discharge. Before discharge, the Patient Socio-Demographical/Descriptive Characteristics Form and the Discharge Readiness Scale will be applied to the control and intervention groups. Routine training and aimed at preventing urinary tract infections web-based multi-source training will be provided to the intervention group. The developed educational material was evaluated by experts in terms of literacy, reliability, and information quality. As multiple resources on the web: there will be written and visual texts of the educational material, as well as podcasts and animation videos. Web page usability will be evaluated with the System Usability Scale. Individuals will be able to benefit from each of these multiple educational resources according to their preferences. The control group will be directed to the organ transplantation handbook on the website of the routine education and organ transplant center. After discharge, the follow-ups of the intervention and control group were carried out during the first 6-month post-transplant standard follow-up process of the center (2. day; once a week for the first month; every ten days for up to 1-3 months; every three weeks for the next 3-6 months) will be performed. When patients come to their controls, the results of routine examinations (complete urinalysis, urine culture taken when necessary, hospitalization, emergency application, and other data) will be taken from the Hospital Information Management System. In addition, the recipients' opinions in the intervention group on the Web-Based Multi-Resource Training Program will also be received at the end of the 6th month. The research adhered to the Standard Protocol Items: Recommendations for Interventional Trials-SPIRIT (2013) and Consolidated Standards of Reporting Trials-CONSORT (2018) checklists.