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NCT ID: NCT05514054 Recruiting - Breast Neoplasms Clinical Trials

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

EMBER-4
Start date: October 4, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

NCT ID: NCT05511337 Recruiting - Urolithiasis Clinical Trials

Gut Microbiota in Patients With Urolithiasis

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

Urolithiasis (UL) is the presence of kidney stones in different compartments such as ureters, bladder and/or urethra. Based on its incidence and prevalence it is considered a public health problem worldwide. In Mexico, especially in Yucatan state, is considered an endemic area of UL with a prevalence of 5.5%. There are several risk factors associated with the development of UL, among which are genetics, age, sex, excess weight, diet, and gut microbiota. In the diet there is promoters and inhibitors of stone formation, such as oxalates and citrates respectively. The gut microbiota is the set of microorganisms that inhabit the gastrointestinal tract, which have been related to the regulation of metabolic processes such as production of short-chain fatty acids (SCFA), vitamin K synthesis, and stimulation of the immune response. However, alterations in the composition of the microbiota have been associated with the development of various pathologies including UL. Recent studies have shown that the intestinal microbiota of people with kidney stones have a lower diversity and a different bacterial composition compared with healthy people, suggesting that interactions in the gut-renal axis could have a direct effect on the development of UL. Furthermore, these modifications could modulate oxalate and citrate transporters. Dietary modifications may decrease the risk of UL formation through increased consumption of citrate-rich foods (>40 mEq per day) and decreased consumption of oxalate-rich foods (< 40mg per day). It is known that dietary modifications can modulate the gut microbiota, however there is no evidence about the effect of a dietary intervention with oxalate and citrate control on the modulation of the microbiota in patients with UL. Thus, it is important to search for strategies to reduce UL, as well as the complications associated with them like chronic kidney disease. The main of the study is evaluate the effect of a dietary intervention with oxalate and citrate control on the composition and diversity of the intestinal microbiota of adults with UL.

NCT ID: NCT05509400 Recruiting - Migraine Clinical Trials

Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Start date: October 18, 2022
Phase: Phase 4
Study type: Interventional

This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).

NCT ID: NCT05507216 Recruiting - Ulcerative Colitis Clinical Trials

ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

Start date: December 21, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

NCT ID: NCT05507021 Completed - Clinical trials for Elevated Blood Lead Levels

Effect of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in Young Women of Child-bearing Age

Start date: November 3, 2022
Phase: N/A
Study type: Interventional

We hypothesize that Lactobacillus Plantarum DSM 33464 reduce lead levels. Approximately 200 women 18 to 40 will be screened for blood lead levels. From that pool of subjects, 40 healthy women aged 18 to 40 years will participate in this randomized, placebo controlled pilot clinical trial. Each participant will receive 1 sachet of Lactobacillus Plantarum DSM 33464 (2g) per day for 8 weeks. The participants will be evaluated for several health measures, e.g. Blood, urine and hair will be collected and analyzed for lead (Pb) as the primary target compound and other chemicals as secondary target compounds. Adverse events will be recorded throughout the trial. Stool samples will also be collected at the beginning and end of the study to undertake a microbiome analysis.

NCT ID: NCT05506995 Completed - Vitiligo Clinical Trials

Tissue-resident Memory T Cells Expression Among the Repigmentation Patterns Induced by NB-UVB Phototherapy in Vitiligo

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

Vitiligo is the most commonly acquired depigmentation disorder characterized by selective destruction of melanocytes resulting in well-circumscribed achromic macules. Tissue-resident memory T cells (TRM) are memory T lymphocyte subsets that reside in the skin, lack recirculation, proliferate locally, produce cytokines, and may be implicated in relapses. NB-UVB Phototherapy induces repigmentation in certain patterns. The aim of this study was to determine the levels of TRM cells on vitiligo lesions, and after phototherapy by repigmentation pattern.

NCT ID: NCT05506865 Completed - COPD Clinical Trials

Efficacy and Safety of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass Exposure

EMERALD2
Start date: September 2012
Phase: Phase 4
Study type: Interventional

Chronic Obstructive Pulmonary Disease (COPD) is a disease that produces a high rate of social and economic health mortality and morbidity not only in our country but in the international field. The causes of this disease are well-known, being smoking what produces the major portion and the less (but no less important) frequently, biomass exposure (when people cook or warm the house). It is described that the COPD secondary to biomass exposure it is approximately a third half of all the cases in cohorts in patients with this disease. Patients clinical affection with COPD by biomass is different from the one described in patients by smoking, being the most frequent the affection peripheral airway, with major proportion of symptoms such as dyspnoea, cough and expectoration (Phenotype "chronic bronchitis"), major frequency of exacerbations, as well as, major affection in the quality of life related to health and a minimum emphysema proportion. Currently, there is a trend of paying attention on the outcomes based on patients, such as symptoms, quality of life and the risk prevention (exacerbations) as it is exposed in the strategy GOLD 2011. In that way, the bronchodilators use as a pillar in the COPD due to the utility for the exacerbation prevention, symptomatic improvement and in quality of life, predominating the utility of ultra long-acting bronchodilators, such as tiotropium. Recently, it is available more information on new bronchodilators as indacaterol, demonstrating at least no inferiority effect on FEV1, inspiring capacity (in fact, discreet superiority on the last one) and symptoms. A functional outcome clinically important is the capacity of exercising; Six-Minute Walk Test (6MWT) has been widely used to predict prognosis of COPD secondary to smoking. This test has not been evaluated in predicting the response to the specific treatment in patients with COPD secondary to biomass exposure. Long-acting bronchodilators have been demonstrated a benefit to the patients with COPD by smoking, in the exercising capacity measured by 6MWT. There are several reasons why this outcome could be more relevant especially in this population: inhabit in rural areas where people walk long distances, most of them are women and they are usually in charge of all the housework. Almost all the studies reported until now exclude patients with COPD due to some cause other than smoking. Due to the lack of information on this item and the particularities in this clinical and functional characteristics observed in this kind of patients, it is considered that these patients will be benefit with the use of ultra long-acting bronchodilators, to long period and, potentially can be observed additional benefits in the decrease of the frequency of the exacerbations and symptomatology as well as other important outcomes such as the functional, respiratory capacity among others.

NCT ID: NCT05506293 Recruiting - Quality of Life Clinical Trials

European Multicentre Registry of Percutaneous Paravalvular Leak Closure

EuroPVL
Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis. Percutaneous closure of para-prosthetic leaks has been developed as an alternative to surgery in high-risk patients. These procedures remain technically challenging with a significant risk of failure and complications, but this risk is improved since the development of dedicated prostheses and the increased experience of the operators. The data in the literature concerning percutaneous leak closure remain limited and disparate and mostly retrospective.The impact of the procedures on the quality of life of patients is not known. Beyond the technical aspects and the follow-up of major cardiovascular events, investigators also wonder what is the impact of these procedures on the quality of life of patients. Investigators hypothesize that even a partial reduction in paraprosthetic leakage may be associated with an improvement in quality of life through reduction of transfusion needs and/or reduction of dyspnea. A prospective study is warranted to assess the technical and clinical and clinical results of these procedures, together with the evaluation of the the possible benefit on the quality of life of the patients.

NCT ID: NCT05503303 Completed - Metabolic Syndrome Clinical Trials

T1D, Metabolic Syndrome and Insulin Resistance

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

Patients with type 1 diabetes (T1D) and metabolic syndrome (MS) require high doses of insulin to achieve a glycemic control, due to insulin resistance (IR). The investigators identified the presence of metabolic syndrome and insulin resistance in patients with T1D in a population of southeast Mexico. The sampled population was recruited from the Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo A. Rovirosa Pérez"; from August 2021 to February 2022, graduated physicians interviewed patients previously diagnosed with T1D. This study included patients older than 18 years and at least six months after being diagnosed with T1D. The interviewers excluded patients who did not attend regular consultations and those who did not agree to participate or to give a blood sample. A diabetologist evaluated and diagnosed all patients based on the World Health Organization (WHO) criteria. Fasting glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols were determined in blood serum using a Clinical Chemistry System from Random Access Diagnostics. The reasearch team determined glycated hemoglobin concentrations by an enzymatic immunoassay method.

NCT ID: NCT05502237 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

STAR-121
Start date: October 12, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on progression-free survival (PFS) and overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.