cyrilzakka/clinical-trials huggingface dataset:
18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes

This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters.

Additionally, the data will serve as preliminary data to plan a larger study to investigate study objectives.

This five-year pilot study will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters. Techniques that can identify specific increases in calcification activity are therefore likely to provide important insights into predicting the longevity of TAVR valves and guidance towards subsequent interventions.

Twenty patients whom have undergone either TAVR or surgical bioprosthetic aortic valve replacement will be invited to participate in an 18F-NaF PET scan (baseline) and CT scan imaging (baseline and Year 2). Baseline, Year 1 and 2 will also include clinical assessment, labs and echocardiograms. Telephone contact at Years 3, 4, and 5 will provide follow up for major cardiovascular adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥60 years
* Patients between 1 month and 5 years following transcatheter aortic valve replacement (TAVR) or surgical bioprosthetic aortic valve replacement

Exclusion Criteria:

* Inability to provide informed consent
* Creatinine \>1.5 mg/dL
* History of severe allergy to iodine contrast agents
* Active atrial fibrillation
* Paget's disease
* Metastatic malignancy
STOP Persistent AF

To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation (AF).


Eligibility Criteria:
Inclusion Criteria:

* Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
* Failure or intolerance of at least one Class I or III antiarrhythmic drug
* Age 18 or older (or older than 18 if required by local law)

Exclusion Criteria:

* Left atrial diameter \> 5.0 cm (anteroposterior)
* Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
* Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
* Presence of any pulmonary vein stents
* Presence of any pre-existing pulmonary vein stenosis
* Pre-existing hemidiaphragmatic paralysis
* Presence of any cardiac valve prosthesis
* +3 and +4 mitral valve regurgitation or stenosis
* Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the consent date
* Unstable angina
* New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. Transthoracic echocardiogram (TTE))
* Primary pulmonary hypertension
* Rheumatic heart disease
* Thrombocytosis, thrombocytopenia
* Any condition contraindicating chronic anticoagulation
* Active systemic infection
* Hypertrophic cardiomyopathy
* Cryoglobulinemia
* Uncontrolled hyperthyroidism
* Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date
* Any woman known to be pregnant or breastfeeding, or any woman of child bearing potential who is not on a reliable form of birth regulation method or abstinence
* Life expectancy less than one year
* Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
* Known allergies or hypersensitivities to adhesives
* Known drug or alcohol dependency
* Unwilling or unable to comply fully with study procedures and follow-up
CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis

The aim of our research is to evaluate the curative effect and safety of CyberKnife stereotactic body radiation therapy in treating small hepatocellular carcinoma (HCC) patients with decompensated cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
* Unfeasible or refusing to undergo other treatments;
* Residual normal liver volume ≥700 cc;
* With decompensated cirrhosis (Child-Pugh B or C classification);
* Without portal vein tumor thrombus;
* Eastern Cooperative Oncology Group (ECOG) score 0-1;
* Distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm；
* Rejecting other therapies such as resection, liver transplantation, etc.
* Platelet count≥50 × 109/L, white blood count≥1.5 × 109/L;
* Patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.

Exclusion Criteria:

* With Tumor thrombus；
* With extrahepatic metastasis;
* With lymph node involvement.
Cardiopulmonary Effects of Particulate Exposure

The aim of this study is to assess cardiac rate and respiratory responses and rhythm after workplace exposure to combustion particulates. A repeated measurement study is being performed on acute boilermakers (apprentices and journeymen). A stratified analysis is then done on those with and without chronic bronchitis, after adjustment for relevant covariates.

Population-based epidemiologic studies of communities in the United States have revealed a consistent association between ambient particulate air pollution and increases in morbidity and mortality. The observed increases result from both respiratory and cardiovascular diseases. Similar associations have been observed for rates of hospital admissions for respiratory and cardiovascular diseases for subjects over age 65. These ambient exposures are to low levels of particulates, many times lower than occupational exposures faced by workers in a variety of industries, including manufacturing, construction, transportation and electric-power generation. The objective of this proposal is to investigate the role of occupational exposure to particulates in the development of respiratory and cardiac responses in boilermakers. We will employ a detailed, continuous-exposure assessment to PM2.5 with repeated measures of biologic and physiologic markers of response. Specific hypotheses to be tested will include: (1) occupational exposure to fuel-oil ash particulates induce airway inflammation as reflected in increased expired NO, and airflow obstruction as reflected in decreases in peak flow (PEFR) and FEV1; (2) particulate exposure will result in acute changes in cardiovascular function, as reflected in changes in heart rate, heart-rate variability and blood pressure; (3) particulate exposures result in increased serum fibrinogen levels, a known risk factor for cardiovascular disease; and (4) chronic bronchitis predisposes particulate-exposed workers to changes in cardiac function. The results of this study will have important implications for preventive efforts aimed at reducing morbidity and mortality from occupational exposure to respirable particulates.

Eligibility Criteria:
Adults; Over 18; Boilermakers
Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis

This prospective imaging study investigates the diagnostic ability of Gallium-68 DOTA-TOC (68Ga-DOTA-TOC) positron emission tomography/computed tomography (PET/CT) in the clinical work-up of patients with 1) clinically suspected acute myocarditis (n=30-40) and 2) clinically suspected cardiac sarcoidosis (n=30-40) using clinical diagnostic criteria as well as endomyocardial biopsy as reference. Furthermore, 68Ga-DOTA-TOC PET/CT findings will be compared with results from contrast-enhanced magnetic resonance imaging (MRI) and in case of cardiac sarcoidosis even Fluorine-18 fluorodeoxyglucose (18F-FDG) PET/CT, which are both performed as part of the clinical routine work-up.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate in the study
* Provision of written informed consent
* All patients between the age of 18 and 85 of both genders
* Newly clinically suspected acute myocarditis or newly clinically suspected cardiac sarcoidosis with or without known extra-cardiac sarcoid

Exclusion Criteria:

* Pregnancy or lactation
* Severe obesity (limited by the scanner)
* Other known significant cardiac disease, including previous myocarditis
* Known tumour disease, especially (neuro)endocrine tumours
* Terminal disease(s), advanced psychiatric disease and/or significant dementia
* Recent or current immunosuppressive treatment
* Recent or current somatostatin analogue (octreotide) therapy
* Known relative/absolute contraindications for contrast-enhanced MRI and/or PET/CT imaging
* Known contraindications for endomyocardial biopsy
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes

The goal of this clinical trial is to test the effect of 12 weeks of 1.5 cups per day of fresh mango on glucose control, insulin resistance, lipids, inflammation, oxidation and body composition in individuals with prediabetes. The main questions it aims to answer are:

* What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of glycemic control including fasting glucose and HgbA1c?
* What is the effect of 1.5 cups per day of fresh mango over 12 weeks on fasting blood insulin and insulin resistance (HOMA-IR)?
* What is the effect of 1.5 cups per day of fresh mango over 12 weeks on lipids including LDL-cholesterol, total cholesterol, HDL-cholesterol and triglycerides?
* What is the effect of 1.5 cups per day of fresh mango over 12 weeks on oxidative stress including oxidized LDL-cholesterol and 8-iso-PGF2-alpha?
* What is the effect of 1.5 cups per day of fresh mango over 12 weeks on markers of inflammation including c-reactive protein, e-selectin, ICAM, VCAM, TNF-alpha and IL-beta?
* What is the effect of 1.5 cups per day of fresh mango over 12 weeks on percent body fat, fat mass, and lean mass?

Participants will be asked to:

* Consume 1.5 cups of mango per day for 12 weeks, take a 4 to 8 week break, and then avoid consuming mangos for 12 weeks
* Attend a prerandomization clinic prior to study
* Attend three (3) clinics where blood will be drawn during weeks 0, and 12 of the first phase and last week of the second phase of the study
* Attend eight (8) clinics where anthropometric measurements (height, weight, body composition) will be conducted and interaction with study clinicians will occur during weeks 0, 4, 8, 12 of each phase of the study
* Complete questionnaires and surveys in person and remotely, including six (6) 24-hour dietary recalls.

Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in glycemic indicators, insulin resistance, lipids, inflammation, oxidation and body composition between the two time periods.


Eligibility Criteria:
Inclusion Criteria:

* HgbA1c of 5.7 to 6.4% indicative of prediabetes
* Abdominal obesity as defined as a waist circumference \>102 cm for men or \>88 cm for women

Exclusion Criteria:

* Self-reported chronic disease history (diabetes, heart disease, cancer, kidney disease, inflammatory bowel disease, etc.)
* Pacemaker
* Mango allergies
* Latex allergies (cross-reactive with mango)
* Smoking, use of tobacco, or high alcohol intake (\>2 drinks/day for men or \>1 drink per day for women)
* Recent significant weight loss (\>5% within 6 months of study enrollment)
* BMI \>35 kg/m\^2
* Pregnancy or lactation
* Use of medication and/or supplements affecting glycemic indicators or lipids
* Habitual mango intake of \>3 servings per week and/or habitual fruit intake of \>2 servings per day
* Not able to read and/or communicate in English
Effects of Virtual Music Therapy on Burnout Syndrome Among Healthcare Workers in Tertiary Hospital

The goal of this clinical trial is to learn about burnout syndrome among healthcare workers in tertiary hospital. The main questions It aims to answer are the effects of music therapy on burnout syndrome among healthcare workers. Participants will get examined using Maslach Burnout Inventory-Human Service Survey and Heart Rate Variability device before and after music therapy intervention.

The goal of this clinical trial is to learn about burnout syndrome among healthcare workers in tertiary hospital. The main questions It aims to answer are what kind of music therapy used as a non-pharmacological intervention for health workers with Burnout Syndrome, Maslach Burnout Inventory and Heart Rate Variability score in health workers with Burnout Syndrome before and after music therapy, and does music therapy improve Maslach Burnout Inventory and Heart Rate Variability score in health workers with Burnout Syndrome. Participants will get examined using Maslach Burnout Inventory-Human Service Survey and Heart rate variability device before starting the music therapy. Music therapy will be conducted in two groups, one using 3 session a week for 4 weeks and the second group will get 5 session a week for 2 weeks. After all the session are done, participant will get their Maslach burnout inventory and heart rate variability score evaluate. Researchers will compare the results with neutral group without any music therapy to see if there are any positive effects of music therapy to Maslach burnout inventory and heart rate variability score.

Eligibility Criteria:
Inclusion Criteria:

* Agreed to participate in this study by signing an informed consent sheet
* Age above 18 years old
* Working as a healthcare workers at RSUP dr Kariadi and RSUPN dr Cipto Mangunkusuma, these include doctors, nurses, and other supporting healthcare workers

Exclusion Criteria:

* Refuse to participate in this research
* Have chronic diseases such as cancer, thyroid, and cardiovascular disease
* Taking drugs that affect central nervous system
* Hearing loss and disorder
* Psychosis disorder
* Pregnant women
* Does not like music
EMD 1201081 + 5-FU + Cisplatin + Cetuximab in Subjects With Recurrent / Metastatic Squamous Cell Carcinoma of the Head and Neck

The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN).
* Recurrent and/or metastatic SCCHN, not suitable for local therapy.
* At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) (according to RECIST 1.0).
* Karnofsky performance status (KPS) of ≥ 70 / Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at trial entry.

Exclusion Criteria:

* Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry.
* Nasopharyngeal carcinoma.
* Medical history of diagnosed interstitial lung disease.
* Known hypersensitivity against any of the components of the trial treatment.
* Previous treatment with experimental or non-approved epidermal growth factor receptor (EGFR) targeting therapy or experimental or nonapproved EGFR signal transduction inhibitors (prior treatment with cetuximab is allowed).
* Relevant cardiovascular co-morbidities.
* Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy, steroid use ≥ 10 mg prednisone equivalent.
* Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B.
Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy

Application of multi-center, prospective study on the severity of postoperative cholangitis biliary atresia classification, according to the degree of cholangitis targeted therapy, to improve the therapeutic effect of postoperative cholangitis biliary atresia, decrease the overuse of antibiotics related complications.

Cholangitis patients post-kasai Portoenterostomy were grouped by cholangitis severity score, according to the severity was divided into mild, moderate, severe cholangitis, all levels of cholangitis patients were divided into subgroups by age and post-kasai Portoenterostomy jaundice matching design of experiment, then they were randomly divided into control group and experimental group, and all the control group unified antibiotic treatment, the experimental group was graded antibiotic treatment according to the severity cholangitis, after three days treatment，evaluate each treatment effect, average hospitalization days, the average hospitalization expenses, antimicrobial drug use strength to evaluate the therapeutic effect of postoperative cholangitis biliary atresia.

Eligibility Criteria:
Inclusion Criteria:

1. Age 3 months to 2 years old, gender is not limited.
2. Patients with cholangitis post-kasai Portoenterostomy.
3. No other treatment before entering the group.
4. The patient must sign an informed consent form and can actively cooperate with the treatment and follow-up.

Exclusion Criteria:

1. Patients with other infectious lesions.
2. Patients with other severe deformity.
3. Patients with end-stage liver failure.
4. Patientsn with liver transplantation.
5. Patients with mental symptoms or other disease.
Deprescribing in a Long Term Care Facility

This study will develop, implement and evaluate a deprescribing initiative at a Canadian Long Term Care (LTC) Facility. Residents currently undergo an annual medication review as part of the clinical pharmacy services provided in the LTC facility. For this study, eligible residents will be randomized to receive either a deprescribing focused medication review or usual care.

The deprescribing focused medication therapy assessments will be done on half of the 143 residents residing on the second and third floors of the facility. The other half of residents will serve as the control group and continue to receive their annual medication review and regular care from the attending physicians and nurses.

The deprescribing intervention will be delivered by final year pharmacy students completing their practice experiences, under the supervision of clinical pharmacists at the LTC facility and clinical pharmacists from Memorial University's Medication Therapy Services (MTS) Clinic. Currently the clinic has a well developed procedure for providing in depth medication therapy reviews for residents of the community, upon referral by their primary care physician. Students will adapt this model of medication review to have a stronger deprescribing focus and be applicable to elderly residents of a LTC facility. The intervention will consist of an in depth medication therapy review with a focus on identifying any medications that may no longer be required or are deemed to be inappropriate or potentially unsafe in the elderly based on currently guidelines/criteria. The students will work closely with members of the resident's care team on a daily basis, as well as the resident and their family, to develop and implement a deprescribing plan.


Eligibility Criteria:
Inclusion Criteria (all of the following):

1. Over 65 years of age
2. Reside in St. Patrick's Mercy Home (2nd or 3rd floor units)

Exclusion Criteria (any of the following):

1. Do not take any regularly scheduled medications
2. Are receiving palliative care
3. Resident's physician or nursing team do not support participation
4. Resident or their substitute decision maker decline participation
RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough

Objective:

To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.

Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.

Main selection criteria:

Inclusion criteria

* Chronic kidney disease stage 3 to 4,
* ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
* History of hypertension or proteinuria \> 0,5 g/24h or g/g créatininurie.

Exclusion criteria

* Office blood pressure ≥ 160/100 mmHg,
* Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.

Evaluation criteria:

Primary: Serum aldosterone levels at one year.

Secondary:

* Serum aldosterone/renin ratio,
* 24h urine aldosterone,
* Significant aldosterone breakthrough defined by a \>10% increase of serum aldosterone levels over baseline values,
* Aldosterone breakthrough defined by an increase of serum aldosterone levels over baseline values,
* HbA1c,
* Urinary albumin/creatinine ratio (UACR) on spot morning urine samples,
* Systolic home blood pressure (SBP),
* Estimated glomerular filtration rate (eGFR) using the MDRD equation.

Rational:

Serum aldosterone levels may increase despite blockade of the renin angiotensin system (RAS) with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). This aldosterone breakthrough might be associated with bad outcomes: left ventricular hypertrophy, proteinuria and progression of renal failure. Antihypertensive drugs are given either on awaking or at bedtime. RAS is stimulated during nighttime. RAS blockers and diuretics given on awaking may stimulate aldosterone synthesis, and favor aldosterone breakthrough.

Objective:

To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.

Duration of the study: Inclusion 2 years, follow-up one year, total 3 years

Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease stage 3 to 4,
* ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
* History of hypertension or proteinuria \> 0,5 g/24h or g/g creatininuria,
* Adult with social security insurance,
* Informed consent signed.

Exclusion Criteria:

* Office blood pressure ≥ 160/100 mmHg,
* Pathology with life expectancy \< 1 year,
* Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.