cyrilzakka/clinical-trials huggingface dataset:
Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a major cause of disability and death worldwide. People with COPD often have cardiovascular diseases (CVDs) that are associated with increased risk for hospitalization and prolonged stay as well as all-cause and CVD-related mortality. Nevertheless, CVDs in patients with COPD are tend to be underestimated in clinical practice. Mechanisms that define the relation between COPD and cardiovascular morbidity include lung hyperinflation, hypoxia, pulmonary hypertension, systemic inflammation and oxidative stress, exacerbation, shared risk factors and COPD phenotypes. Recently, some authors have announced that COPD treatment with dual bronchodilation may not only improve pulmonary function and quality of life, but also have a positive effect on cardiac function in cardiac magnetic resonance imaging (MRI) or two-dimensional cardiac ultrasound for the assessments. The aim of this study is to specify the state of respiratory and cardiovascular systems as well as exercise capacity and quality of life in patients with newly diagnosed moderate-to-severe COPD and to evaluate their changes after short-term treatment with dual bronchodilation. We hypothesize that patients with newly diagnosed COPD and no previous records of cardiac diseases and no apparent signs of heart failure have significantly impaired cardiac autonomic integrity that precedes to increased risk of cardiovascular events. It is believed that cardiac autonomic integrity might significantly improve with dual bronchodilation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Aged 40 years and older
* Smoking index of 10 pack-years and more
* Newly diagnosed chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) 30-79 percent of predicted and forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) less than 70 percent of predicted.

Exclusion Criteria:

* Active lung infection
* Present or previously treated lung cancer
* Alpha-1 antitrypsin deficiency
* Diagnosed interstitial lung disease
* Previously diagnosed asthma
* Diagnosed chronic hypercapnic respiratory failure
* Treatment with systemic glucocorticoids
* Unstable ischaemic heart disease
* Pregnancy
* Present cardiac arrhythmias
* Uncontrolled arterial hypertension
* Dementia and other mental states that determine patient's inability to consent
* Other medical conditions that in the opinion of the investigator disqualify the subject for inclusion
Urinary Bactericidal Activity of 4 Doses of Levofloxacin Against Fluoroquinolone-Resistant E. Coli

Single-dose studies of a fluoroquinolone are indicative of their antimicrobial activity since little accumulation occurs with multiple doses. Single-dose studies have been utilized to determine drug concentrations and time kill activity in serum, urine, and respiratory tissues.

The purpose of this study is to evaluate the Urine Bactericidal Activity (UBA) of levofloxacin (250, 500, 750, and 1000 mg) against FQ-resistant, ESBL positive E. coli isolates. In addition, a susceptibility breakpoint concentration in the urine can also be established for each dose of levofloxacin. Furthermore, urine concentrations and serum pharmacokinetic parameters of levofloxacin can be determined.

Subjects: -10 healthy (from medical history) adult male or female volunteers

* Normal body weight (within 20 %)
* Age range: 18-60
* Not taking any other restricted medications (ie. antibiotics)

Drug : all drugs are a single dose given after a 12 hour fast

* 1000 mg.levofloxacin
* 750 mg. levofloxacin
* 500 mg levofloxacin
* 250 mg levofloxacin

Levofloxacin Pharmacokinetic Study:

A serum sample will be obtained prior to and at 1.5 (peak), 4.0, 8.0, 12 (50% of interval) and 24 (100% of interval) hours after each single dose of levofloxacin (6 time points).

Levels will be determined by an HPLC assay.

Urine Pharmacodynamic Study:

A urine sample will be obtained prior to and at 1.5 (peak), 4, 8, 12 (50% of interval), and 24 (100% of interval) hours after a single dose of each dose of levofloxacin.

A urine pH will be run on each sample.

All urine levels will be determined by a validated HPLC assay.

Study Isolates: E. coli (TRUST isolates):

Levofloxacin MICs:

* 0.125 (sensitive)
* 4.0 (intermediate)
* 8.0 (resistant)
* 16.0 (resistant)
* 32.0 (resistant)
* 64.0 (resistant)

This MIC range of E. coli isolates should be able to define a levofloxacin susceptibility breakpoint for urinary pathogens at each dose studied.

Urine Cidal Activity: Urine samples will be tested against each of the study isolates. A maximum urine cidal titer will be determined for each urine. The median titer at each time period (10 subjects) will determine the urine cidal activity.

The duration of cidal activity for each isolate will be determined and plotted. A 12-h duration will be considered the minimum time necessary for prolonged Urine Bactericidal Activity (MIC breakpoints).

Safety: All patients will be monitored for side effects during the study.

Eligibility Criteria:
Inclusion Criteria:

* healthy (from medical history) adult male or female volunteers
* Normal body weight (within 20 %)
* Age range: 18-60
* Not taking any other restricted medications (ie. antibiotics)

Exclusion Criteria:

* Non-healthy volunteers
* pregnant women
* volunteers on other antibiotics
* body weight over 20% of normal
* Age \<18 or \>60
Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the immediate postoperative period. This randomized controlled study was scheduled to investigate the role of the posterior gastropexy, in combination with laparoscopic Nissen fundoplication, in prevention of paraesophageal herniation and improvement of postoperative results, in surgical treatment of GERD.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Indications for surgical treatment of GERD
* ASA I, II

Exclusion Criteria:

* ASA III, IV
* Previous gastric procedures
* Conversion to open procedure
Dupilumab for Aspirin-exacerbated Respiratory Disease

Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score \> 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD.

This is a single blind, placebo controlled trial to be conducted in adult patients with AERD to determine the efficacy and safety of dupilumab in treating symptoms of chronic rhinosinusitis.

All subjects will be treated with the FDA-approved and the commercially available dose for adult atopic dermatitis of 300 mg every 2 weeks administered subcutaneously, based on the observed efficacy and safety of this dose. In addition to atopic dermatitis, this dose has also been shown to be efficacious in adult asthma.15 Patients will not be treated with a loading dose since other studies of dupilumab in asthma and chronic rhinosinusitis with nasal polyposis have not used a loading dose.

There will be a one month screening period to determine the patient's eligibility and establish symptom control and baseline parameters.

Patients will continue their background medications for chronic rhinosinusitis with nasal polyposis and asthma. These medications may include nasal corticosteroids, nasal antihistamines, systemic antihistamines, leukotriene receptor antagonists, 5 lipo-oxygenase inhibitors, inhaled corticosteroids, long-acting beta agonists, and long acting muscarinic antagonists. These controller medications will not be dispensed or supplied by the sponsor.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years and older with a physician diagnosis of aspirin-exacerbated respiratory disease, as defined by a physician diagnosis of asthma, chronic rhinosinusitis with nasal polyposis, and a convincing clinical history of NSAID sensitivity
2. All subjects must have a SNOT 22 score ≥ 19 despite standard medical therapy. This minimal SNOT 22 was calculated by taking the range of SNOT 22 scores in studies of normal controls plus 8.9, which is the minimal clinically meaningful improvement in SNOT 22 score detected by patients.
3. Able to understand and willingness to sign informed consent
4. Able to comply with study procedures

Exclusion Criteria:

1. Patient \< 18 years of age
2. Pregnancy or breast feeding
3. Current tobacco use
4. Significant, uncontrolled medical conditions
5. Ongoing malignancy or history of malignancy in remission within the past 12 months
6. Current treatment with immunosuppressive medications except chronic oral steroids
7. Currently increasing dose of aeroallergen immunotherapy (patients on stable dose of aeroallergen immunotherapy will be allowed to participate)
8. Treatment with omalizumab, reslizumab, mepolizumab within 4 months of enrollment
MS and NMOSD in African-Americans

This is a prospective study that aims to collect and review neuromyelitis optica spectrum disorder (NMOSD) data from African American patients with a known diagnosis of multiple sclerosis (MS). It is an investigational study, prospective in nature. No randomization of patients will be done. Information collected includes: Age, gender, age at diagnosis, MRI data (access to images), clinical presentation, findings on clinical examination, lab (blood and evoked potentials) and LP test results, eye exam findings if any and treatment, if started. Additional details may include other NEUROLOGICAL diseases which are also diagnosed (if any).

African-Americans with MS are high risk for ambulatory difficulty given aggressive disease phenotype. Disease responsiveness to FDA-approved drugs is also marginal at best.

A positive correlation between the presence of oligoclonal bands (OCBs) and progressive course of MS has been established even when adjusted for ethnicity. It is well documented that the CSF humoral immune response, including a higher IgG index is higher in African-American MS patients. Although MRI lesions, specifically cord and infra-tentorial regions, contribute to disability, the phenotype in African-American populations is also probably linked to HLA-antigen complex. No study has ever collected data as it relates to ethnic background and MS. The University of Kentucky would be the first institution to collect such data.

This is a prospective study that will collect data from patients with the known diagnosis of MS who were later classified as NMOSD from the University of Kentucky's Multiple Sclerosis Clinic. Researchers will use REDCap to store data.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18 and 80
* are African-American
* have a diagnosis of MS and later diagnosis of NMOSD
* have been seen at the University of Kentucky's Kentucky Neuroscience Institute
Analysis of Paediatric Treatments with MultiFiltratePRO

This clinical study evaluates the performance of the MultifiltratePro in pediatric mode for Continuous Venovenous Hemodiafiltration (CVVHD) in children. Its primary aim is to assess the efficacy of the MultifiltratePro in paediatric mode, specifically in achieving at least 80% of the prescribed effluent dose within 72 hours. Additionally, the study focuses on the safety of this mode in a paediatric setting, closely monitoring for clinical adverse events, hemodynamic instability, and electrolyte imbalances. Paediatric patients with body weights between 8kg and 40kg will be treated with the MultifiltratePro for a period of up to 10 days, with the treatment duration and approach being tailored to the severity of each patient's condition.


Eligibility Criteria:
Inclusion criteria:

General:

* Paediatric Patients:
* Informed consent signed and dated by legal representative and investigator/ authorized physician.
* The minors have received the information referred to in Article 63(2) MDR in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children.
* The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator.

Study-specific:

* Estimated life expectancy greater than 3 days
* Children under 18 years
* Body weight ≥8kg and \<40kg
* Patients with clinical indication for CVVHD

Exclusion criteria:

General:

* Any conditions which could interfere with the patient's ability to comply with the study
* Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
* In case of female patients: pregnancy or lactation period
* Participation in an interventional clinical study during the preceding 30 days
* Previous participation in the same study

Study-specific:

* Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II)
* Uncontrolled bleeding and coagulation disorders
* Decision to limit therapeutic interventions
* Inability to establish the required vascular access
Endovascular Repair for the Descending Thoracic Aorta

Most blunt aortic injuries occur in the proximal proximal descending aorta causing acute transection of this vessel. Generally, surgical repair of the ruptured segment of aorta is associated with high rates of morbidity and mortality and in this view endovascular treatment seems to be a valid and safer alternative. Aim of this study is to review the experience of a single center with endovascular approach for the treatment of acute traumatic rupture of descending thoracic aorta

From April 2002 to November 2014, patients referred to our Department with a diagnosis of acute transection of thoracic aorta will be studied by preoperative Computed Tomography (CT) evaluation in order to perform thoracic endovascular aortic repair (TEVAR) with left subclavian artery coverage. Then patients will be followed up with clinical and instrumental (CT, Duplex ultrasound) controls at discharge, 1, 3 and 6 months and yearly thereafter. We will evaluate the presence of major and minor neurological complications, episodes of left arm claudication, cardiovascular, respiratory and bleeding complications. Furthermore we will evaluate the technical success of the technique evaluating the onset of failure, collapse, leak or distal migration of the graft.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of acute transection of thoracic aorta;
* a time frame range from trauma of 1-10 hours.

Exclusion Criteria:

* Patients who do not fall into the above categories
Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care

Hypoglycemia (HG) is common and can be dangerous in diabetes mellitus, so identifying patients at risk may lead to useful preventive strategies and improved quality of care and health outcomes. This study will test the implementation of a computerized alert tool for clinicians.

Diabetes mellitus is one of the most common non-communicable diseases worldwide and is a major cause of morbidity and mortality. An estimated 346 million people had diabetes in 2011, and diabetes is predicted to become the seventh leading cause of death in the world by the year 2030. In the United States, the incidence of diabetes nearly tripled between 1990 and 2010, with 1.9 million new cases diagnosed in 2010. Hypoglycemia (HG) is recognized as a limiting factor in optimal glycemic management of patients with diabetes. This potentially costly condition, occurring in approximately 20% to 60% of patients who receive oral medications for diabetes, threatens patient safety, quality of life, and potentially, cardiovascular health. Investigators have identified risk factors for HG, built a risk calculator for use by clinicians, integrated the calculator into the G3 electronic medical record system, and demonstrated our ability to collect data about outcomes. In this project, investigators studied the outcomes of implementing the risk calculator tool into clinical practice in ambulatory primary care. The findings and tools developed from this project will promote improved patient safety and medical care for diabetes.

Eligibility Criteria:
The study included clinicians who were scheduled to provide primary care during the four-month intervention period.

Inclusion Criteria for patients:

* Being at least 21 years of age
* Have been prescribed or dispensed a drug for diabetes mellitus

Exclusion Criteria for patients:

N/A
Evaluation of Effectiveness and Safety of Synergy XD and Synergy Megatron™ Stent

The objective of this study is to evaluate the effectiveness and safety of Synergy XD stent and Synergy Megatron™ Stent in the "real world" daily practice as compared with the other drug-eluting stents.

This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of Synergy XD stent and Synergy Megatron™ Stents versus other drug-eluting stents (DES) in patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 19 years old
* Patients receiving Synergy XD stent(s) or Synergy Megatron™ stent(s).
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Patients with a mixture of other drug-eluting stents (DESs)
* Terminal illness with life-expectancy ≤1 year.
* Patients with cardiogenic shock
TAU vs m-SBIRT in Primary Care

The goal of this research is to leverage technology in primary care clinics to improve screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and treatment attendance by comparing

1. a text message-based screening, phone-based brief intervention, and referral to treatment by a remote care coordinator (m-SBIRT; intervention arm), versus
2. evidence-based, in-person Screening, Brief Intervention, and Referral to Treatment (SBIRT; Treatment As Usual (TAU); control arm).

Primary Aim is to compare the efficacy of m-SBIRT to TAU in positive screens for substance use. Secondary Aim is to compare m-SBIRT to TAU on Substance Use Treatment Attendance.

This research study is looking at the use of technology in primary care clinics and seeing if it improves screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and attendance to treatment. To do so the study, Investigators will be comparing a text message based substance use screening and treatment program, called Mobile Screening, Brief intervention, and Referral to Treatment (m-SBIRT) to standard of care Screening, Brief Intervention and Referral Treatment which traditionally takes place in-person. Patients at the MUSC Bee Street Primary Care Clinic between the ages of 18-75 may be eligible.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* Attended a primary care visit at the MUSC Family Medicine clinic on Bee St
* English fluency
* Owner of a cell phone with SMS text-message based capability
* Access to WIFI
* A device to allow audio and video teleconferencing if completing informed consent remotely
* Able to provide informed consent.

Exclusion Criteria:

- None
Guided Feedback in an Online Game Impacts Decision Making

The purpose of the study is to evaluate the use of a text-based game as a way to understand decision making and knowledge related to anxiety, stress, and mood states like depression or loneliness. The investigators are interested in identifying whether participants who are given feedback before and during the game will report changes in behavior or depressive symptoms over the course of a one-week period. This is a follow-up to the published study from the researchers.


Eligibility Criteria:
Inclusion Criteria:

* 18+ age
* Eligible to participate in online research
* Able to read and respond in English

Exclusion Criteria:

* None
Sarcopenic Obesity as a Risk of Premature Aging

Recently, numerous signaling proteins derived from adipose tissue and/or skeletal muscle have been described and are involved in the pathogenesis of obesity and the pathophysiology of aging. Current evidence suggests a role for the FGF-Klotho system, circulating cell-free DNA (cfDNA), miR-499, and exosomes not only in the pathophysiology of obesity, but also in the association with sarcopenic obesity (OS) and in a accelerated aging.

The investigator´s hypothesis is that obesity, especially OS, might be the cause of advanced aging, reflected in lower levels of the FGF-Klotho system, higher concentrations of cfDNA and a change in the profiles of miRNAs and exosomes, which could have an impact on risk. cardiovascular and metabolic.

For this, a descriptive cross-sectional study is proposed in 50 patients with obesity, who will be classified as OS or not, and 25 healthy controls, between 50-60 years old. The determinations are made by the IBIOMED of the University of León.

To study the evolution of aging markers over a year of follow-up, a second part of the study will analyze the possible differences according to the treatments assigned to each patient in the context of real life (lifestyle changes, drugs, bariatric surgery).

Descriptive cross-sectional study in patients with obesity attended in the High-Risk Obesity consultation of the University Assistance Complex of León, with a control group of healthy people of the same age group without obesity or cardiovascular risk factors that will be selected among volunteers from the CAULE and University of Leon staff.

The second part of the study will be a one-year prospective longitudinal follow-up study of the patients included in the first part of the study.

Eligibility Criteria:
Inclusion Criteria:

* People, men and postmenopausal women, aged between 50 and 60 years. Diagnosis of central obesity with body mass index greater than or equal to 30 kg/m2 and waist circumference equal to or greater than 102 cm in men and 88 cm in women.

Control group, of healthy individuals with BMI less than 30 kg/m2 and waist circumference \<102 cm in men and \<88 cm in women, of the same age group and matched according to gender.

Able of giving informed consent.

Exclusion Criteria:

* Premenopausal women. Kidney disease with glomerular filtration rate less than 60. Liver disease with plasma GOT/GPT/GGT levels greater than x 2 the upper limit of normal.

Active cancer disease. Heart or respiratory failure requiring pharmacological treatment.