cyrilzakka/clinical-trials huggingface dataset:
Retrospective Analysis of Nephrotoxicity During Daptomycin Versus Vancomycin Treatments in High Risk Patients

Acute kidney injury (AKI) is a frequent complication that occurs in 15 to 25% of patients after vascular surgery, and up to 40% of patients after cardiac surgery. AKI compromises seriously short and long-term prognosis of critically ill patients. Several AKI risk factors have been identified including a chronic pathology of the patient such as kidney failure or diabetes, acute kidney injury related to hemodynamic disorders during surgery, including cardiopulmonary bypass, or sepsis, and the use of nephrotoxic agents such as some antibiotics, colloids or iodine contrast agents. Avoiding nephrotoxic agents is therefore strongly recommended in ICU patients, to reduce the incidence of AKI, or to reduce its severity.

The aim of this cohort study was to assess whether the use of daptomycin, was associated to a lower incidence of AKI than vancomycin in cardiovascular ICU patients, with similar efficacy.

This is a retrospective observational study with a propensity score adjustment to reduce the bias of selection for a comparative analysis between two antibacterial treatments used in routine care.

Since treatments were not randomized, the investigators used the propensity score method for primary endpoint analysis. For this, the investigators included the covariates potentially related to treatment and outcome in a multivariate logistic model explaining the choice of treatment. This propensity score was used in the second model as an adjustment covariate included in the multivariate analysis to determine factors independently associated with the primary endpoint (AKI within 7 days).

The main hypothesis is the first line antibiotic treatment with daptomycin leads to less nephrotoxicity than vancomycin in a population known at high risk for AKI and with at least a similar efficacy on clinical success rate.


Eligibility Criteria:
Inclusion criteria:

* Patient older than 18 years
* Admitted in ICU from January 2010 to December 2012
* Suspected or proven cardiac, vascular or profound surgical site infection with Gram-positive cocci (GPC) methicillin-resistant (MR) strains (including probabilistic treatment for patients with acquisition of MR risk factors)
* Treatment duration greater than or equal to 48 hours (at least 2 doses of daptomycin administered or 2 days of vancomycin infusion)
* Antibiotic treatment started in peri-operative (from 48 hours before the onset of surgery) or in postoperative period (during ICU stay)

Exclusion criteria:

* Prophylaxis indication of antibiotics
* Kidney disease on chronic dialysis
* Acute onset of RRT before initiation of DAP or VAN treatment
* Staphylococcus pneumonia
Edwards SAPIEN 3 PPI Registry

There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.

Retrospective pooling of 6 datasets already available at participating centres (4 sites in Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden).

Additional assessment of calcifications using a CT data core lab. Statistical analysis of the obtained dataset with respect to the objectives of the registry.

Permanent pacemaker implantation is a widely recognized clinical event associated with TAVI becoming evident within a few days after the procedure.

While a number of registries have documented the rates of PPI with different valves, much less evidence has been provided for 1) patient based characteristics (e.g. RBBB etc.) affecting the likelihood of PPI and for 2) procedural variables (e.g. implantation depth, valve size etc.) that should be considered to perform an as safe and minimal invasive procedure as possible.

Prior research To date there are 7 published reports on pacemaker rates and predictors associated with the use of the Edwards SAPIEN 3 THV (see Table). These studies suggest that the need for pacemaker implantation in single centers ranges between 14.4 and 20.4% derived from patient numbers between 131 and 335. These analyses resulted in the identification of pre-existing conduction disturbance / aortic valve calcification as patient related and implantation depth /oversizing as procedure related variables associated with Edwards SAPIEN 3 THV TAVI. Furthermore a scoring algorithm for patient related factors has been proposed from a dataset of 240 patients to predict the likelihood of PPI after THV .

Limitations of prior research Current evidence though is limited by patient numbers versus event rates (with a max. of 62 PPI considered in any of the available datasets) resulting in a limited power in multivariable analyses, the single center design of these ventures, the lack of a consistent definition of variables potentially associated and the unexplained differences in the number and type of variables identified.

Aims For this reason the investigators consider it necessary to 1) to retrospectively pool data from all of these 7 datasets to arrive at a more comprehensive picture of patient related variables (retrospective part I), to 2) assess procedural variables in a prospective multicenter registry (prospective part II) and 3) to potentially validate the identified variables in a future prospective cohort.

Eligibility Criteria:
Inclusion Criteria:

* Patients that already underwent Edwards SAPIEN 3 implantation because of aortic stenosis

Exclusion Criteria:

* Patients with prior pacemaker or intended valve in valve implantation
Lipoprotein Interactions and Platelet Function in Healthy Individuals and Those with Lipid Disorders

This study looks at how lipoproteins, which are particles in the blood that transport cholesterol, influence heart and blood vessel health. Beyond just their levels, the way these particles function plays a key role in preventing or contributing to disease. In some conditions, like high cholesterol or diabetes, lipoproteins may not work properly, increasing the risk of clogged arteries and other complications.

The investigators aim to study these changes in people with lipid disorders to better understand their impact on blood health and to find new ways to prevent and treat heart disease.

Traditionally, lipoproteins have been associated with cardiovascular protection, but emerging research indicates that their functionality may be a more critical factor than their levels in evaluating cardiovascular risk. Lipoproteins, such as HDL, LDL, and VLDL, play vital roles in processes like reverse cholesterol transport and demonstrate anti-inflammatory, antioxidative, and antiplatelet properties. However, in conditions like atherosclerosis, diabetes, and dyslipidemia, these lipoproteins often become dysfunctional, and the mechanisms behind this dysfunction remain incompletely understood.

This study aims to thoroughly investigate the pathogenic roles of lipoproteins by examining their structural and functional modifications and their influence on platelet activity in individuals with lipid disorders.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Abnormalities in lipid panels
* Able to provide informed consent
* Between the age of 18 and 69

Exclusion Criteria:

* Drug or alcohol abuse within 6 months or significant mental/psychological impairment
* Current smokers
* Subjects with known bleeding disorders (for example, hemophilia)
* Subjects requiring regular transfusions for any reason
* No ethnic/racial groups will be excluded
Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, Bomedemstat (MK-3543, formerly called IMG-7289), in patients with essential thrombocythemia.

This study investigates the following:

* The safety and tolerability of Bomedemstat
* The pharmacodynamic effect of Bomedemstat

This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy and pharmacodynamics of Bomedemstat administered orally once daily in patients with essential thrombocythemia (ET). Patients will be dosed with Bomedemstat for 169 consecutive days in the Initial Treatment Period (ITP). Qualifying patients may continue to receive Bomedemstat in the Additional Treatment Period (ATP).

Safety will be evaluated by clinical assessments of safety parameters i.e., safety laboratory testing, adverse event reporting, physical examination and vital sign assessments. Pharmacodynamics will be evaluated by hematology assessment, patient reported symptom burden, change in spleen size by palpation and other measures.

To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms.
* Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis.
* Have failed at least one standard therapy
* Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation.

Exclusion Criteria:

* Has undergone major surgery ≤4 weeks prior to starting study drug or has not recovered from side effects of such surgery.
* Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).
* Uncontrolled active infection.
* Current use of prohibited medications
* Known HIV infection or active Hepatitis B or Hepatitis C virus infection
* Other hematologic/biochemistry requirements, as per protocol
* Use of investigational agent within last 14 days
* Pregnant or lactating females
Effects on the Qt Interval of COVID-19 Coronavirus Infection

The present study aims to evaluate the impact of COVID-19 disease and its treatment on ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to the critical care unit.

Coronavirus infection of Severe Acute Respiratory Syndrome COVID-2 is characterized by a broad clinical spectrum ranging from asymptomatic infection, mild upper respiratory tract disease and severe viral pneumonia with respiratory failure and even death, with many patients hospitalized with pneumonia. In addition, the infection can have a direct impact on cardiovascular disease including the development of arrhythmias, although the exact incidence is not known. Treatments administered for COVID-19 infection have the potential to produce adverse cardiovascular effects including prolongation of the QT interval and development of arrhythmias.

Relevant clinical data that may affect the QT interval and specifically the medication the patient has received will be recorded. The specific treatment administered for COVID-19 will be recorded as the concomitant medication of the critical patient that may have an impact on the QT interval. Analytical data will also be collected on plasma levels of ions such as potassium, calcium and magnesium, blood gases, renal and hepatic function parameters and cardiac markers.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to intensive care units for COVID-19 infection with an ECG record

Exclusion Criteria:

* Patients in critical care unit without COVID-19 infection
Predictive algoRithm for EValuation and Intervention in SEpsis

In this prospective study, the ability of a machine learning algorithm to predict sepsis and influence clinical outcomes, will be investigated at Cabell Huntington Hospital (CHH).


Eligibility Criteria:
Inclusion Criteria:

* All adult patients visiting the emergency department, or admitted to the participating intensive care unit (ICU) wards of Cabell Huntington Hospital will be eligible.

Exclusion Criteria:

* All patients younger than 18 years of age will be excluded.
Assessing Gastric Motility and Distention in Postoperative Gastrointestinal Surgery Using Bedside Gastric Ultrasound: Predicting Risk of Aspiration Pneumonia, Ileus, Return of Bowel Function

Point-of-care gastric ultrasound will be used to measure stomach contents postoperative in patients who underwent colorectal surgery. Stomach volume and status (empty or full) will be compared retrospectively to the standard clinical criteria for diet advancement to determine if stomach volume via ultrasound is associated with successful diet advancement, nausea/vomiting, nasogastric tube replacement, length of stay, and other clinical outcomes. Clinicians performing clinical care will be blinded to the ultrasound exam results.

Patient population: Patients undergoing colorectal surgery will be enrolled prospectively (both cancer and non-cancer patients).

Inclusion Criteria:

* Patients aged \> 18 years of age
* Patients undergoing colorectal surgery (both cancer and non-cancer)

Exclusion Criteria:

* Patients \< 18 years of age
* Patients with previous gastric surgery

  * Patients with inadequate or difficult baseline gastric ultrasound images
  * Any other patient deemed a poor study candidate by the treating physicians

Research Design/Protocol: We will perform postoperative point-of-care ultrasound examinations in colorectal surgery patients and will record gastric volumes at set time points, including preoperative and the morning of postoperative day 1. The surgical team, who will be blinded to the results of the ultrasound exam, will make decisions to advance diet, remove nasogastric tube, and begin oral medications based on standard clinical criteria. At the completion of the study we will determine if there is any association between gastric volume on ultrasound and patient complications, such as nausea/vomiting, replacement of nasogastric tube, aspiration of gastric contents, inability to tolerate solid diet, prolonged admission/length of stay, and other clinical outcomes.

Outcomes: Our exploratory outcome measures will be tolerance of diet, replacement of NG tube, nausea/vomiting, time to flatus, aspiration pneumonia/pneumonitis, and length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 years of age
* Patients undergoing colorectal surgery (both cancer and non-cancer)

Exclusion Criteria:

* Patients \< 18 years of age
* Patients with previous gastric surgery

  * Patients with difficult or poor ultrasound images at baseline
  * Any patient deemed a poor candidate by the treating physicians
A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device in Adult Participants for the Appearance of Cellulite

Cellulite is the rippling or dimpling of the skin most commonly located on the thighs and buttocks of women. Its appearance and texture are often likened to that of "cottage cheese" or an orange peel. Rapid Acoustic Pulse (RAP) is an electrohydraulic (EH) device developed to improve the appearance of cellulite through microscopic disruption of the connection between the skin and underlying tissue leading to a reduction in the severity of dimples and ridges. The purpose of this study is to assess adverse events and effectiveness of RAP in adults seeking treatment of cellulite.

RAP is an FDA approved device for the long-term improvement in the appearance of cellulite in the buttocks and thighs. Participants 18-50 years of age seeking treatment of cellulite will be enrolled. Up to 60 participants will be enrolled in the study at 4 sites in the United States.

Participants will receive 2 separate cellulite treatment sessions. Each treatment session will consist of RAP treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides. The study duration is up to 60 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participants seeking treatment of cellulite in the thigh and/or buttock areas.
* Areas of moderate to severe cellulite on bilateral thigh and/or buttock using the Cellulite Dimple - At Rest Scale at Baseline with grades of 2 or 3 based on review of photos taken under the same lightening conditions planned for the trial.
* Participant will not have had invasive or energy-based cellulite (liposuction, subcision, RF, laser, ESWT, cryo-lipolysis, muscle stimulation, etc.) treatments in the treatment areas in the prior 12 months.
* Participant will not have used topical based cellulite treatments for prior 3 months and will not use during the trial
* Participant will not have used spray-on tanning treatments for 3 months prior to or during the term of the trial.

Exclusion Criteria:

* Metal or plastic implants (vascular stent, or implants in the hips, knees, etc.) in the treatment areas.
* Active electronic implants such as pacemakers, defibrillators
* History of coagulopathy and/or on anticoagulant medication
* Skin disorders (skin infections or rashes, psoriasis, etc.) in the treatment areas.
* Medical disorder that would hinder wound healing or immune response.
* Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study.
* Any other condition/disease/situation which, as deemed by the PI, would preclude participant from safely participating in or completing the study visits or that may confound study results.
Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

The purpose of this research is evaluate the results with laparoscopic ALPPS procedure in a single center. The validity, feasibility and limitations were assessed objectively through our clinical prospective study.The investigators expect laparoscopic ALPPS is safe, effective and feasible.

Background: Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a breakthrough in the field of hepatobiliary surgery in recent years，which stimulates the remnant liver volume(RLV) grew by 74%-87.2% in 9 to 13 days。The published literature reported that the two stages of ALPPS are the conventional laparotomy surgery，Patients need to undergo the injury of two open operations in a short time. The incidence of postoperative complications and mortality rate is as high as 53% -73% and 12%-27%.The aim of this study was to evaluate the results with laparoscopic ALPPS procedure in a single center, with special emphasis in validity, feasibility and limitations.

Results:

Clinical data include: operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function, long-term curative effect and survival time were collected and analysed.

Statistical method:groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank survival curves were used.

Eligibility Criteria:
Inclusion Criteria:

* Patients with marginally resectable or primarily non-resectable locally advanced liver tumors
* Insufficient future liver remnant (FLR) either in volume or quality

Exclusion Criteria:

* Unresectable liver metastases in the future liver remnant or unresectable extrahepatic metastases
* Severe portal hypertension
* High anesthesiological risk
* Unresectable primary tumor
Stent Placement and the Risk of New-onset AF in Patients With AMI

The benefit of a drug-eluting stent (DES) in patients with acute myocardial infarction (AMI) is controversial. This study will aim to observe the effect of a DES on the risk of new-onset AF in patients with AMI.

Acute myocardial infarction (AMI) is the leading cause of mortality in the world. Early invasive strategy with percutaneous coronary intervention (PCI) has been demonstrated to be the most effective strategy to treat AMI. Although drug-eluting stent (DES) has not shown benefits to reduce mortality rate among AMI patients compared with bare-metal stent (BMS), the use of DES in real-world is increasing because of reduced restenosis rates. AMI patients are at higher risk to develop atrial fibrillation (AF) than general population. However, whether early PCI with DES implantation is related to a reduced risk of AF still remains unclear. The purpose of this study is to investigate the association of DES implantation and the risk of AF among patients with AMI treated by early PCI.

Eligibility Criteria:
Inclusion Criteria:

* Patients were enrolled by primary diagnostic coding as acute myocardial infarction and treatment coding as receiving PCI between 2007 and 2013 in Taiwan National Health Insurance Research Database (NHIRD)

Exclusion Criteria:

1. Less than 20-years-old; Unknown sex and age
2. Not residents in Taiwan
3. Died during AMI admission
4. Previous history of AF
5. Receiving coronary artery bypass grafting (CABG), ventricular assist device (VAD), extracorporeal membrane oxygenation (ECMO), and heart transplantation during observational and/or database period
6. No stent implantation during PCI
7. Unknown stent types
Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients

The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients

Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the safety and efficacy of escitalopram and an active comparator in severely depressed patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet DSM-IV criteria for Major Depressive Disorder.
* Patients must have severe depression.
* MADRS greater than or equal to 30

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
* Patients who are considered a suicide risk.
* Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia.
* Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder.
* Patients with history of any psychotic disorder or any psychotic feature.
Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome

The main objective of this study is to evaluate the decrease of inflammation of adipose tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by continuous positive airway pressure (cPAP).

An interim analysis will be performed when 40 patients will be included.

Inflammation of adipose tissue will be evaluated by RT-PCR on mRNA of pro and anti-inflammatory cytokines (IL-1, IL-6, IL-4, IL-10, IL-12, RANTES, TNFa, leptin, adiponectin, CD68).

Eligibility Criteria:
Inclusion Criteria:

* Male between 18 and 70 years old
* Apnea Hypopnea Index \> 30/h and \> 5% TST with SaO2 \< 90%
* patients obese (BMI \> 33kg/m2) or non obese (BMI \< 27kg/m2)

Exclusion Criteria:

* Female
* coronary ischemic disease, past history of CVA
* chronic pulmonary disease measured by arterial gasometry (PaO2 \< 60mmHg and/or PaCO2 \> 45mmHg)
* known hepatic disease
* alcohol consumption \> 3 units/day
* sleepiness considered to be dangerous by the investigator
* patient having an hazardous work regarding to awareness
* patient being under anticoagulant, antiplatelet drug or having an active stent or bleeding disorder
* patient having an inflammatory syndrome (C-reactive Protein \> 10)
* any allergy to local anaesthetics
* chronic muscle pain
* contraindication to MRI