cyrilzakka/clinical-trials huggingface dataset:
Mindfulness With Biofeedback

The purpose of this research study is to determine if using HeartMath's biofeedback with emWave Pro daily mindfulness practice: is a practical and effective intervention to improve job satisfaction and performance of physicians, advance practice clinicians, and nurses; improves patient satisfaction; and affects resting blood pressure and heart rate when comparing baseline to follow-up measures.

This research study seeks to determine if using a daily mindfulness practice with EmWave Pro HeartMath helps to achieve coherence through various standardized, interactive mindfulness techniques, such as guided meditations focusing on positive emotions, breathing, and imagery. The investigators seek to determine if using HeartMath's biofeedback with emWave Pro daily mindfulness practice: is a practical and effective intervention to improve job satisfaction and performance of physicians, advance practice clinicians, and nurses; improves patient satisfaction; and affects resting blood pressure and heart rate when comparing baseline to follow-up measures.

All participants will attend a one-time one-hour training session to explain cardiac coherence and how to use emWave Pro. Participants will be randomized to be either in the treatment group or the control group. Participants will use emWave Pro for at least one 5-minute session daily, Monday through Friday. The treatment participants will use it daily for all 12 weeks. The control participants will use it daily only for weeks 7-12. The treatment group will have the added component of weekly visits during the first 6 weeks of the study from an investigator and the research coordinator. The purpose of the weekly visits is focused on reinforcing accountability and achievement of coherence.

The participants will also complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance. Participants' blood pressure and heart rate will be collected at those three time points. Additionally, information about participants' use of HeartMath, sick days, and patient satisfaction will be collected after week 12.

Eligibility Criteria:
Inclusion Criteria:

* Individuals (physicians, Advanced Registered Nurse Practitioner (ARNPs) \& Physician Assistants \[advance practice clinicians\], and nurses) working at the two research sites: Hampton Oaks and Haile Plantation at UF Health

Exclusion Criteria:

* Anyone not working at Hampton Oaks and Haile Plantation at UF Health
Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression

Volunteers will receive a weight-based opioid (remifentanil) infusion for 10 minutes. In the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery period afterwards. After a washout period, the experiment will be repeated in each subject (second run). The two runs differ only by presence versus absence of verbal interaction.

Healthy volunteers aged 20-55 will receive a weight-based opioid (remifentanil) infusion for 10 minutes. Vital signs including SpO2, transcutaneous CO2, and respiratory rate will be continuously measured.

In the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery period afterwards. After a washout period, the experiment will be repeated in each subject (second run). The two runs differ only by presence of ongoing verbal interaction versus complete avoidance of verbal interaction.

Incidence of respiratory depression will be compared in the two protocols with or without verbal interaction. Correlation between pupil diameter and pupillary unrest with estimated opioid concentrations will be determined by regression. Difference between pupil measurement versus opioid concentration regressions will be compared by chi2.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Able to provide informed consent

Exclusion Criteria:

* Active substance use disorder
* Prior opioid use disorder
* Opioid use within 30 days.
Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

A post market, prospective, non-randomized, multi-center, open-label, clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Titan Modular Shoulder System 2.5 when used for primary shoulder arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* For total shoulder arthroplasty, subjects must meet a, b, or c below:

  1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
  2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
  3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. -revision of a failed primary component)
* For shoulder hemiarthroplasty, subjects must meet any of the sub-criteria a - g below:

  1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
  2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
  3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. -revision of a failed primary component)
  4. Ununited humeral head fractures
  5. Avascular necrosis of the humeral head
  6. Rotator cuff arthropathy
  7. Deformity and/or limited motion

Exclusion Criteria:

* Absent, irreparable or nonfunctional rotator cuff or other essential muscles.
* Have an active local or systemic infection.
* Have inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
* Have poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
* Have a muscular, neurologic, or vascular deficiencies that compromise the affected extremity.
* Have a known sensitivity or allergic reaction to one or more of the implanted materials.
* Have a condition that may impair proper wound healing.
Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure

This study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure. Patients admitted to hospital with acute respiratory failure (ARF) will be assessed for hypercapnic ARF by normal hospital protocols. Patients requiring noninvasive ventilation (NIV) will be set up on NIV as prescribed per standard of care. Enrollment onto the investigation will occur after the patient has been allowed to stabilize on NIV . Patients that meet the inclusion/exclusion criteria will be approached for consent. Investigation participants will receive two masks in random order;

1. NIV for one hour with the investigational mask (Vela)
2. NIV for one hour with the standard mask (Nivairo).

Participants will have their physiological respiratory parameters recorded.

This is a simple study. Patients who are already on noninvasive ventilation (NIV) for acute respiratory failure will be approached for the study within the first 24 hours on NIV therapy.

The study will be conducted as described above. After the study patients will be able to choose which mask they continue their NIV on. They will continue NIV as part of their normal hospital care.

Eligibility Criteria:
Inclusion Criteria:

* Have type II acute respiratory failure (ARF) and have been prescribed NIV
* Arterial blood gas (ABG) Partial pressure of arterial carbon dioxide greater or equal to 6.0 kilopascals (45 millimeters of mercury)
* Arterial blood gas acidity greater or equal to 7.35 prior to bilevel commencement
* On NIV for 24 hours or less
* Negative Covid-19 test
* Are 18 years or older

Exclusion Criteria:

* Contraindicated for NIV
* On NIV in Emergency Department/ ward for more than 24 hours, within the last 48 hours
* NIV is likely to fail and/or intubation be required, at the doctor's discretion
* CPAP or bilevel pressure of 25 centimeters of water or more is required
* Unable to tolerate NIV for the duration of the investigation
* Do not fit the investigational mask or the standard mask
* Pregnancy (tested under standard care)
* Agitated
* Unable to understand the consent process
Effect of Water Rinsing After Topical Fluoride Application on Dental Plaque pH

The aim of this study was to determine whether rinsing with water or cleansing teeth after topical fluoride therapy affect the dental plaque pH.


Eligibility Criteria:
Inclusion Criteria:

* healthy people (Without any systemic disease)
* normal unstimulated salivary rate

Exclusion Criteria:

* Active dental caries
* taking any medication with any effect on saliva rate
* taking antibiotic (or antibacterial mouth rinses) during last 4 weeks
* usig fluoride mouth rinses during last 2 weeks.
VR-Based Preoperative Rehabilitation Program for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction

Between April 2, 2024, and October 1, 2024, a study will be conducted at the Department of Orthopedics in the First Affiliated Hospital of Shantou University Medical College involving 120 patients who will undergo anterior cruciate ligament reconstruction surgery. They will be randomly divided into two groups: an experimental group and a control group.

The control group will receive standard nursing care, while the experimental group will receive an enhanced preoperative rehabilitation program incorporating Virtual Reality (VR) technology. This program will include patient assessments, personalized exercise prescriptions, and VR-based educational videos covering psychological support, nutritional guidance, and exercise instructions.

Patients in the experimental group will use VR headsets for preoperative and postoperative interactive training sessions, as well as for viewing postoperative educational videos. The intervention will start upon admission and will continue until discharge.

Primary outcome measures will include knee joint range of motion and the Lysholm knee function score. Secondary measures will encompass anxiety, depression, pain scores, activities of daily living, time to ambulation, postoperative complications, and patient satisfaction.

Statistical analysis will be conducted to compare outcomes between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Individuals eligible for inclusion in the study are those who undergo their initial anterior cruciate ligament (ACL) reconstruction surgery, aged between 18 and 60 years, possess adequate hearing and vision, have clear consciousness, and demonstrate proficient language communication skills.

Exclusion Criteria:

* Individuals with cognitive impairments, severe hearing or vision impairments, limb paralysis, or non-compliance with the experiment will be excluded from participation.
The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting Stent Study in Twente

The TWENTE Study is a single center prospective single-blinded randomized study. Randomization will involve the type of Drug-Eluting Stent (DES) used in study population. Patients will be blinded to the type of DES they will receive. The general practitioner of the patient will be requested not to disclose this information to the patient. Analysts who perform the data analyses will be blinded to the type DES used as well.

Primary research questions

To investigate whether the clinical outcome following the randomized implantation of the Endeavor Resolute® versus XIENCE V® drug-eluting stent is similar, as assessed in a non-inferiority setting by comparing target-vessel failure (TVF) of both stents. We want to compare for both drug-eluting stents the combined endpoint of death, myocardial infarction or revascularization related to the target-vessel, as well as death or myocardial infarction that cannot be related to a significant flow obstruction in another vessel or to another cause. According to current literature, non-inferiority of Endeavor resolute ® and XIENCE V® is expected. But the non-inferiority of Endeavor resolute and XIENCE V® is not tested in a controlled randomized trial yet.

Eligibility Criteria:
Inclusion Criteria:

* Indication for PCI with DES implantation based on VVC/ESC guidelines and/or clinical decision of interventional cardiologist
* Age ≥ 18 years and mentally capable to give an informed consent
* Signed informed consent

Exclusion Criteria:

* Patients with ST-elevation myocardial infarction (STEMI) or an ST- elevation myocardial infarction equivalent requiring primary PCI or rescue PCI
* Patients in whom the revascularization procedure is planned to be performed in a staged approach
* Renal failure requiring haemodialysis
* Patient is currently participating in an investigational drug or device study that has been not completed
* In the investigators opinion patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
* Life expectancy less than 1 year
* Patients in whom during PCI there is no indication for DES use and/or if the operator chooses not to use a DES based on the clinical situation, the patient will be excluded.
* If the choice of DES is dictated by logistic reasons e.g. the required DES dimensions is provided by one manufacturer only.
Target Site Pharmacokinetics of Ertapenem After Multiple Doses in Diabetes Patients With Soft Tissue Infection

Background/rationale: Ertapenem is an innovative antimicrobial agent, which is approved in the European Union for diabetic foot infections of the skin and soft tissue. Although its antimicrobial spectrum and activity against ESBL-strains are promising to treat infected ulcers associated with diabetes, there is a lack of data on tissue pharmacokinetics of ertapenem in this patient population. However, for antimicrobial efficacy it is important to show that the antibiotic achieves sufficient concentrations at the site of infection, i.e. in tissue. A recent clinical study by Burkhardt et al. (Journal of Antimicrobial Chemotherapy, 2006) using the microdialysis technique showed that the free tissue concentrations after a single dose of 1 g ertapenem are sufficient and adequate to kill most relevant bacteria, suggesting efficacy of ertapenem for soft tissue infections. It is well known that there is no accumulation of ertapenem in plasma after multiple doses of 1 g every 24 h in patients without significantly impaired renal function. The single dose study by Burkhardt et al. also suggests that only negligible drug accumulation can be expected in soft tissues of healthy young volunteers after multiple doses. However, it was shown for other antibiotics that tissue PK may be significantly different under pathologic conditions, leading to impaired penetration, but subsequent accumulation after multiple doses due to a longer tissue half life than in healthy volunteers. Since the properties of inflamed tissue may diverge from those of healthy tissue it is important to evaluate which concentrations of ertapenem are reached in inflamed tissue after multiple doses.

Clinical study: In the present study we will measure the concentrations of ertapenem over time in plasma and infected tissue of 10 diabetes patients after multiple doses. The microdialysis technique will be used. The ertapenem concentrations will be measured in inflamed tissue and in non-inflamed subcutaneous tissue to identify the effect of inflammation on pharmacokinetics. The findings of the present study will help to confirm the efficacy of ertapenem for the indication of diabetic soft tissue infections.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged between 18 and 85 years
* Diagnosis of Diabetes mellitus
* Clinically diagnosed skin or soft tissue infection and/or infected ulcers of the leg, requiring antimicrobial therapy
* Prescription of ertapenem for therapeutic reasons
* Willingness and ability to comply with the protocol
* Signed informed consent

Exclusion Criteria:

* HIV, Hepatitis B or C positive
* Allergy or hypersensitivity against study drug
* Severe renal impairment, defined by a serum creatinine level \> 1.6 mg/L
* Pregnancy, or women of child bearing potential not willing to apply adequate contraception during study period
* Any disease considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator
The Effect of Humidification on Mucus Rheology

In this study the investigators will collect mucus from mechanical ventilated patients and patients with COPD to study the effect of temperature and humidity, on the biophysical properties of the airway mucus. It is hypothesised that changes in inspired gas temperature and humidity (over time) may affect the biophysical properties of the airway mucus and reduce the airway's ability to clear mucus, resulting in deleterious clinical affects.

Expectorated sputum samples are collected and used to measure the biophysical properties of mucus secretions. The samples are later exposed to different temperatures and humidity levels during bench experiments.

Eligibility Criteria:
Mechanically Ventilated Patients

Inclusion Criteria:

Any Subject Mechanically Ventilated and producing sputum.

Exclusion

* None

COPD Group

Inclusion Criteria:

* 40 to 90 years of age suffering from COPD
* History of mucus production

Exclusion Criteria:

* None
Soluble B7-H3 as a Biomarker for Osteosarcoma

Increasing data has indicated an association between increased soluble B7-H3 (sB7-H3) levels and unfavorable prognosis in patients with malignancies. However, the level of sB7-H3 and its clinical significance in osteosarcoma are not well known. In this present study, we investigated whether sB7-H3 levels in serum could be as a biomarker for osteosarcoma treatment.


Eligibility Criteria:
Inclusion Criteria:

* High Grade osteosarcoma verified with pathologic diagnosis.
* systemic treatment-naive before the first time Blood drawing.
* ECOG 0 or 1 and all the other imagings indicate that patients could tolerate standard PKUPH-OS-02 protocol neoadjuvant chemotherapy.
* All radiographs are complete for clinical evaluation.

Exclusion Criteria:

* Patients who Can't tolerate blood drawing.
* Patients without complete medical records in PKUPH system.
* Patients who can't tolerate PKUPH-OS-02 neoadjuvant chemotherapy.
* other conditions that investigators think are not suitable for this study.
Noninvasive Respiratory Support in COVID-19 (CATCOVID-AIR)

COVID-19 pneumonia can cause severe acute hypoxemic respiratory failure. The usefulness of noninvasive respiratory support (NIRS), by means of nasal high-flow oxygen (NHFO), continuous positive airway pressure (CPAP), or noninvasive ventilation (NIV), established outside the intensive care unit, is unknown. The aim of this multicenter, retrospective, longitudinal study is to compare the effectiveness of these treatments to prevent death or endotracheal intubation at day 28, and what factors, related to the disease or to the characteristics of the treatment itself, can condition its success or failure.

Multicenter, retrospective, longitudinal study in consecutive adult COVID-19 patients with acute respiratory failure, requiring noninvasive respiratory support (NIRS) outside the intensive care unit (ICU) in 10 hospitals in Catalonia (Spain). Demographic, laboratory, clinical and noninvasive respiratory support data will be collected and analyzed according to the primary outcome (death or endotracheal intubation at day 28) and secondary outcomes (see the dedicated section).

During the hospitalization, patients were treated according to the standard procedures of the participating centers. This study is observational and no randomization have been performed.

Patients were followed up to either 28-days or hospital discharge if still hospitalized at day 28 from NIRS initiation.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 pneumonia confirmed with polymerase chain reaction (PCR).
* Acute respiratory failure.
* Treated by noninvasive respiratory support (nasal high-flow oxygen, CPAP or noninvasive ventilation), initiated outside the intensive care unit.
* Age \> 18 years

Exclusion Criteria:

* Acute respiratory failure not related to COVID-19
* Hypercapnic acute respiratory failure
* Early intolerance to treatment
* Nosocomial infection
* Pregnant woman
Development a Rhesus Type Compatibility Test by Means of an Antibody Able to Recognize RH1 Antigen Grafted on a Biochip

Every year, several millions of red cell concentrates are transfused. For each of them, a pretransfusional compatibility test is performed. In France, an ABO compatibility test at the patient's bedside is performed, but rhesus compatibility is not yet checked. However, rhesus antigens are very immunogenic and could lead to Rh incompatibility or Rh disease.

The objective of ABORDAGE project is to develop another biochip that specifically captures RBCs according the presence of the RH1 antigen (also known as D antigen) at their surface.

Every year, several millions of red cell concentrates are transfused. For each of them, a pretransfusional compatibility test is performed. In France, an ABO compatibility test at the patient's bedside is performed, but rhesus compatibility is not yet checked. However, rhesus antigens are very immunogenic and could lead to Rh incompatibility or Rh disease. Rh incompatibility occurs when a woman with Rh-negative blood type is exposed to Rh-positive blood cells. This exposure leads to the sensitization of the women who develop anti-Rh immunoglobulin G (IgG). This immunization is one cause of the hemolytic disease of newborns (HDN). HDN results from an incompatibility between mother's blood and fetus' blood. It happens when fetal red blood cells (RBCs) present antigens inherited from the father but missing from the mother. Consequence of this incompatibility is the fetal RBCs destruction by mother's antibodies. Antibodies could be natural, like immunoglobulin M (IgM) anti-A or anti-B from the ABO system, or from an immunization. Rh incompatibility results from 2 main mechanisms. The first one is when a pregnancy Rh-negative woman is exposed to fetal Rh-positive RBCs. Rh incompatibility leads to anemia (mild to severe) or ultimately to the in utero death. The second occurs when Rh incompatible blood is transfused. This is the subject of this communication.

The investigators previously develop biochips and optical device to realize automatic ABO compatibility test at the patient's bedside (references to the Citation field). Based on this previously project, the goal of ABORDAGE project is to develop another biochip based on selective blood capture. The ABORDAGE chip has to specifically capture RBCs according the presence of the RH1 antigen (also known as D antigen) at their surface.

Eligibility Criteria:
Inclusion Criteria:

* Donor inclusion criteria will be those of the Etablissement Français du Sang

Exclusion Criteria:

* Donor exclusion criteria will be those of the Etablissement Français du Sang