cyrilzakka/clinical-trials huggingface dataset:
TearCare System to Treat Dry Eye Disease

In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease.

NOTE: All sites have been selected for this study. We are not seeking additional sites at this time.


Eligibility Criteria:
Key Inclusion Criteria:

* At least 22
* Subject has dry eye symptoms and uses artificial tears/lubricants regularly
* Subject has moderate to severe symptoms based on a dry eye questionnaire
* Subject has an abnormal tear break-up time
* Subject's eyelid glands secrete a low amount of meibum
* Best corrected visual acuity 20/100 or better
* Willing and able to comply with protocol
* Willing and able to provide consent
* English-speaking

Key Exclusion Criteria:

* Use of medications that treat dry eye disease or that are known to cause ocular dryness.
* Use of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, NSAIDs
* Prior office-based dry eye treatment within the past 12 months, gland expression within the past 6 months, debridement within the past 3 months, punctal plus within 30 days, TrueTear within the past 2 weeks, or meibomian gland probing.
* History of eyelid, conjunctival or corneal surgery within the past year.
* Contact lens use within past 2 weeks
* Ocular conditions or diseases that could limit the safety or effectiveness of the study treatment.
Prospective Observation of Wound Healing With Prevena Incision Management System

This study aims to assess the quality of wound healing in abdominal scars with and without the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved wound healing with less swelling, bruising, and inflammation, as well as less potential for infection, seroma, and dehiscence.

The quality of wound healing can be of the utmost importance for patients undergoing large abdominal surgery. Incisional negative pressure wound therapy has been observed to decrease seroma and infection rates in high risk patients. This study aims to quantify the effect, if any, that negative pressure wound therapy has on closed incisions. The technology may provide benefits even in lower risk patients.

Eligibility Criteria:
Inclusion Criteria:

* abdominal procedure with incision \>20cm
* must be \>18 years of age

Exclusion Criteria:

* \<18 years of age
* history of allergy or reaction to adhesives
* pregnant or anticipated pregnancy within 6 months
Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue

This study aims to evaluate the effect of transcranial direct current stimulation and cognitive behavioural programme on fatigue and its related outcomes among people with stroke.

This study will adopt a randomized controlled trial. Participants will be randomized into one of the 3 groups. One group will receive transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. Another group will receive sham transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. One group will receive home-based physical training only.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with stroke at least 6 months ago
* Fatigue Assessment Scale score ≥20
* cognitively intact

Exclusion Criteria:

* Unstable medical conditions leading to fatigue
* Under any clinical trials
* with any other neurological diseases
* history of transient ischemic attack
* Contraindications to tDCS
Compare Effects of Ultrasound Therapy With High Intensity Laser Therapy for Treatment of Lumbar Disc Herniation.

The aim of this study is to assess and compare the effects of ultrasound therapy and High Intensity Laser Therapy, as the treatment option in case of lumbar disc herniation.

A randomized control trail will be conducted in Safi teaching hospital near Riphah international university, after approval of synopsis. To evaluate the comparison and effect of Ultrasound therapy and High Intensity Laser Therapy, 30 patients will be randomly assigned to High Intensity Laser Therapy and Ultrasound group. Patients will be selected according to predefined inclusion and exclusion criteria. All the patients will be evaluated by computed tomography scan or magnetic resonance of lumbar spine. Non-probability convenient sampling will be used to approach the patients in hospital. Participants received 15 treatment session of High Intensity Laser Therapy and Ultrasound therapy over a period of three consecutive weeks (five days/week). Two types of tools will be used to evaluate the find out the comparison of both groups Visual analog scale and Oswestry lowback pain disability questionnaire. Data will be collected pre-treatment and post-treatment after 15 days. Data will be analyzed by Statistical Package of Social Sciences Version 20. Difference between pre-treatment to post treatment between group will be analyzed by Mann-Whitney test, and Within group difference will be analyzed by Wilcoxon signed- rank test. The level of statistical significance will be set as p\< 0.05

Eligibility Criteria:
Inclusion Criteria:

* Patient above age 18 and adult
* Patient with lumbar disc herniation diagnosed by MRI
* Patient with no history of trauma and congenital abnormalities

Exclusion Criteria:

* If patient received anesthesia or corticosteroid within 4 week
* Patient with osteoporosis
* Patient with surgery or previous fracture of spinal stenosis
* A history of acute trauma like osteoarthritis, myofascial pain syndrome, inflammatory rheumatic disease, systemic lupus erythematosus, diabetes mellitus type 1 and 2, thyroid dysfunction, obesity, pacemaker, neurological pathologies and anxious- depressive syndrome.
* Pregnant women
Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia

Canadian multicentre prospective cohort study of 40 patients with ischaemic heart disease and therapy from an implantable cardioverter defibrillator (ICD).

Paced Electrogram Feature Analysis is employed to elucidate VT isthmus sites and target Type I sites for ablation to prevent recurrent VT/VF.

The trial hypothesis is: catheter ablation employing PEFA will, in comparison to published data, reduce the composite outcome of death at any time, appropriate ICD shock, ventricular tachycardia storm or treated sustained ventricular tachycardia below the detection rate of the ICD or incessant VT for patients with prior myocardial infarction and sustained ventricular tachycardia or fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years of age
* Ischaemic heart disease and prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury)
* Eligible for catheter ablation as standard of care
* Implantable Cardioverter Defibrillator

Exclusion Criteria:

* Unable or unwilling to provide consent
* Both mechanical aortic and mitral valve
* LV thrombus,
* NYHA class IV heart failure symptoms
* Contraindication to heparin
* Survival limited to \<1 year in estimation of attending care team,
* Prior VT ablation Exclusion to standard of care VT catheter ablation procedure such as
* Active ischaemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug- induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.
* Non-ischaemic cardiomyopathy because of reduced ablation success and PEFA has not been examined in the context of a non-ischaemic cardiomyopathy
Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20)

The general objective of this study is to improve the Quality of Life (QoL) of selected patients with advanced carcinoma of the lung. The specific objective is to evaluate the effect of treatment with epoetin alfa (recombinant human erythropoietin) on anemia related QoL and anemia in non-small cell lung cancer patients with advanced stage disease and underlying anemia of malignancy.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed non-small cell lung cancer (squamous cell, large cell, adenocarcinoma, or some combination of these), with clinical or pathological stage III or IV, or recurrent disease; and
2. Hemoglobin level at or below 120 g/L; and
3. At least 18 years of age;

Exclusion Criteria:

1. Systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months;
2. Patients previously treated with high dose thoracic radiation (\>10 fractions), or surgery, without objective evidence of disease recurrence;
3. Planned high dose thoracic radiation therapy (\>10 fractions);
4. A clinically active malignancy, other than the underlying lung cancer which is expected to influence QoL;
5. Expected survival of three months or less;
6. ECOG Performance status of 3 or 4 (see Appendix D);
7. Multiple CNS metastasis or a single CNS lesion that does not demonstrate radiographic stability (Screening CT of head required only if symptomatic, no radiographic follow-up of single resected lesions required);
8. Blood transfusions within the last 14 days;
9. Previous use of erythropoietin;
10. Anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding);
11. Evidence of untreated folate or vitamin B12 deficiency;
12. History of uncontrolled hypertension or diastolic blood pressure greater than 100 mm Hg;
13. History of seizure disorder;
14. Known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug;
15. Pregnancy, lactation or parturition within the previous 30 days;
16. Unwillingness or inability to complete the required QoL questionnaires;
17. Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires;
18. Geographically inaccessible for treatment or follow-up evaluations;
19. Currently enrolled in an ongoing therapeutic study;
Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast

Point-of-care (POC) creatinine devices allow rapid measurement of creatinine levels and calculation of estimated glomerular filtration rate (eGFR) which give an indication of renal function. The focus of this assessment is to validate POC measurements to assess kidney function before intravascular iodinated contrast administration in patients with severe renal insufficiency (eGFR \< 30 ml/min/1.73m2). It will be evaluated whether discrepancies between POC measurement values and values obtained from standard laboratory assays lie within an acceptable range using Bland-Altman analysis.

Measurement of creatinine to determine eGFR before intravascular iodinated contrast administration is indicated to assess whether a patient is at risk of contrast-induced acute kidney injury (AKI). For patients with reduced eGFR intravenous hydration can be offered before the scan to reduce the risk of AKI. If no recent eGFR measurement is available, contrast procedures could be cancelled and rescheduled while a creatinine test is processed in the laboratory. Using POC creatinine tests before contrast-enhanced procedures could minimise the risk of kidney injury, and may reduce the number of cancelled scans. The question is whether POC creatinine assay is accurate and beneficial in this setting compared to the standard laboratory assay.

The i-STAT Alinity POC creatinine device is one of three devices which calculate estimated glomerular filtration rate (eGFR) recommended in clinical practice guidelines to assess kidney function to guide decisions on the use of intravascular iodinated contrast in adults. In the study, i-STAT Alinity POC measurements of creatinine will be performed using already available blood samples of patients with estimated eGFR\<30 ml/min/1.73m2 and mean difference between eGFR and serum creatinine measurements using POC and standard laboratory assays will be calculated. Results will be used to evaluate the agreement between of POC and laboratory assays on risk stratification (i.e., the percentage of patients with eGFR\<30 according to both laboratory and POC assays) and post-contrast acute kidney injury (AKI; i.e., the percentage of patients with post-contrast acute kidney injury according to both laboratory and POC assays). Finally, the number of elective procedures which are delayed (including delayed planning) or cancelled because a serum creatinine assay is required and unavailable will be prospectively evaluated for Maastricht UMC+ in this study.

Eligibility Criteria:
Inclusion Criteria:

* Standard care venous blood samples for which eGFR measurement at Maastricht UMC+ Central Diagnostic Laboratory results in a value below 30 ml/min/1.73m2 (including all standard care venous blood samples from patients with GFR \<30 ml/min/1.73m2 referred for an elective procedure with intravascular iodinated contrast at Maastricht UMC+)

Exclusion Criteria:

-
RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

The purpose of this trial is to determine if by structured telephone based health coaching programme supported by remote monitoring system among type 2 diabetes, coronary artery disease and heart failure patients the investigators are able to improve their quality of life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among those type 2 diabetes patients who had elevated value of HbA1c when recruited.

RENEWING HEALTH is a project covering 9 different European States. It aims at evaluation of innovative telemedicine services using a patient-centred approach and a common rigorous assessment methodology. In 9 European regions in the implementation of health-related information and communication technologies service solutions are already operational at local level for the remote monitoring and the treatment of chronic patients suffering from diabetes,chronic obstructive pulmonary disease or cardiovascular diseases. The services are designed to give patients a central role in the management of their own diseases, fine-tuning the choice and dosage of medications, promoting compliance to treatment, and helping health care professionals to detect early signs of worsening in the monitored pathologies. Every area will designed its own real-life trial with certain common elements.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Capability of filling in questionnaires in Finnish language.
* Be able to use Remote Patient Monitoring System
* Be able to use the devices provided
* Has adequate cognitive capacities to participate
* In their medical records, one or both of the following diagnoses:

  a) Type 2 Diabetes, for enrolment
* diagnosed over 3 months prior to the enrolment and
* HbA1c \> 6,5 % b) Heart Disease, for enrolment
* Ischemic heart disease or
* Heart Failure or
* Atrial fibrillation or
* Other arrhythmia
* Be able to walk

Exclusion Criteria:

* Not willing to participate (e.g., not willing to sign the consent)
Electronic Health Record (EHR)-Based Intervention for Gastroesophageal Reflux Disease (GERD) and Chronic Non-steroidal Anti-inflammatory Drug (NSAID) Use

The purpose of the study is to examine the impact of augmented, high-quality physician-coordinated care executed via an electronic health record (EHR)-based intervention on quality of care for gastroesophageal reflux disease (GERD) and for gastroprotection for patients on chronic non-steroidal anti-inflammatory drugs (NSAIDs) at increased risk for upper GI tract ulcers and ulcer related complications.


Eligibility Criteria:
Inclusion Criteria:

* Eligibility as determined by criteria for participation in studies as part of the MQIC
* Agreement of participating clinical practices to undergo training in the electronic health record (EHR) intervention designed for this study

Exclusion Criteria:

* Based on voluntary participation by MQIC practices, so practices were excluded if they decided to opt out
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

This is a prospective, single-arm, multi-center study to be conducted in the US and outside the US (OUS). Approximately 250 subjects are planned to be enrolled to obtain long term data from 101 subjects at 8 years post implant of the Magna mitral valve. Of these 250, approximately 38 (15%) are anticipated to be simultaneous aortic and mitral replacements. Subject enrollment will not start in the US before obtaining FDA approval of this post market study.

Assessments will be obtained for the preoperative and operative visits, and postoperatively at discharge, six months, 1-year and annually thereafter for a minimum of 8 years. Subject's demographics (date of birth, sex), physical assessment (heart rate, height, weight, systolic and diastolic blood pressures), New York Heart Association (NYHA) functional class, cardiac rhythm, cardiovascular medical history/risk factors, non-cardiovascular conditions, previous cardiovascular procedures/interventions, antithromboembolic and lipid lowering medications and coagulation profile. Blood data will be collected from each subject preoperatively, at 6 months and annually post implant through 8 year follow-ups. Echocardiographic evaluation required for each subject preoperatively, at discharge, 6 months (between 3-6 months), 1, 2, 4, 6, and 8 year follow-ups. A QOL survey (EQ-5D) will be completed by the subject pre-operatively and at the 6-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* The patient requires, as indicated in the preoperative evaluation, a replacement mitral valve.
* The patient has signed and dated the subject informed consent form prior to surgery.
* The patient is expected to survive the surgery and be discharged.
* The patient is geographically stable and agrees to attend follow-up assessments.
* The patient is 18 years or older.

Exclusion Criteria:

* The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
* The patient presents with active endocarditis within the last 3 months.
* The patient is pregnant or lactating.
* The patient is an intravenous drug abuser.
* The patient is currently a prison inmate.
* The patient is currently participating in a study of an investigational drug or device.
* The patient requires replacement of a native or prosthetic tricuspid or pulmonic valve.
* The patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve (i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)\*.
* The patient was previously enrolled in the study.
* The patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ.
Bupivacaine and Epinephrine Injection Study

Endoscopic sinus surgery (ESS) is a common otolaryngologic procedure that aims to remove the partitions that separate the sinus cavities, remove inflamed tissue, and optimize the sinuses for topical medication use. In this procedure, the surgeon will inject a combination of drugs, local anesthetics, and vasoconstrictors, to reduce bleeding and improve visualization. However, previous studies have shown similar results when injected with only saline. In this study, investigators want to determine if the injection of local anesthesic+vasoconstrictor compared to no injection at all makes any difference in improving the surgeon's visualization during an ESS.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 years or older
* Scheduled for primary ESS (including septoplasty)

Exclusion Criteria:

* Cystic fibrosis
* Systemic vasculitis or any bleeding disorders
* Known or suspected hypersensitivity to bupivacaine or epinephrine
* Previous sinus surgery
* Inhaled drug use (i.e., cocaine) in the preceding 6 months
* Nasal tumors
* Patients on antiarrhythmics.
* Patients with history of severe liver illness.
* Patients identified as high-risk for complications during preoperative assessment with the anesthesiologist (e.g. untreated hypertension, ischemic heart disease, cerebral vascular insufficiency, heart block, peripheral vascular disorder, uncontrolled hyperthyroidism and diabetes)
ncRNAs in Exosomes of Cholangiocarcinoma

Exosomes are part of extracellular vesicles(EVs), and can be secreted into the environment by many types of cells. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced.Exosomes contain proteins,RNAs and lipid,which may transfer biological information and activities from donor cells to receptor cells. Non-coding RNAs are involved in many biological activities including tumor growth and metastasis.

In this prospective translational study, preclinical and clinical phases have been designed. On the first step, the main goal is to characterize the ncRNAs of cholangiocarcinoma derived exosomes. This exosome biomarker may provide a useful diagnostic tool. As a second step, the study will evaluate the prognostic and predictive value of cholangiocarcinoma exosomes levels in plasma in a prospectively recruited cohort of cholangiocarcinoma patients before and after surgical resection.


Eligibility Criteria:
Inclusion Criteria:

* 1.Provide signed informed consent. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of any study-specific procedures.

  2.Men or women aged \>= 18 years. 3.Histology- or imaging-confirmed bile duct stricture. 4.Metastatic disease or locally advanced disease not amenable to curative surgery.

  5.Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria.

  6.Life expectancy of at least 8 weeks from the time of enrollment. 7.No other malignancy within the past 5 years. 8.No prior chemotherapy for advanced disease.

Exclusion Criteria:

- 1.Pregnant or lactating females. 2.Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.

3.Active Hepatitis B or C or history of an HIV infection. 4.Active uncontrolled infection.
Effectiveness of a VAP Prevention Bundle in the PICU

This observational monocentric prospective study aims to evaluate the efficacy of new measures for ventilator associated pneumonia (VAP) management in the pediatric population in the pediatric intensive care unit (PICU) of Fondazione Policlinico Agostino Gemelli of 8 beds. The investigators will compare the incidence of VAP in the group of patients in which this protocol has been implemented to a retrospective control group of patients before the new protocol implementation. VAP bundle includes oral care hygiene measures (i.e chlorhexidine swab), to keep clean and dry ventilator circuits and head positioning at 45 degrees.


Eligibility Criteria:
Inclusion Criteria:

* age \< 18 years
* patients receiving mechanical ventilation for more than 48 hours

Exclusion Criteria:

* no informed consent
* pregnancy
* previous endotracheal antibiotic therapy