cyrilzakka/clinical-trials huggingface dataset:
Evidence-based Leadership in Nurse Leaders-FI

This study protocol describes a randomised feasibility trial that will evaluate the feasibility and preliminary effectiveness of the training course to improve evidence-based leadership competencies among nurse leaders working in hospitals in Finland.

This study will include a 6-months training intervention for nurse leaders working in hospital settings in Finland. About 140 nurse leaders fulfilling the eligibility criteria will be randomly allocated (1:1) to participate in the online training course about evidence-based leadership or conventional leadership training course (reading material only).

Eligibility Criteria:
Inclusion Criteria:

* Official managerial role in the study organisation (hospital, clinic, ward level), which give them an authority to act as a nurse leader and monitor, develop and evaluate the care
* Being in full time or part time position
* All sex
* Aged up to 65 years
* Working in the study sites at the time of the recruitment
* Ability to read and write Finnish language
* Willingness to join the study based on their own free will
* Informed consent obtained

Exclusion Criteria:

* Non-nursing professionals in leadership position (e.g. physician, psychologist, pharmacist, dietician/nutritionist, dentist, physiotherapist, radiation therapist, paramedic, occupational therapist, social worker, or disability worker)
* Speaking only other languages than Finnish (e.g. Swedish or English)
* Out of duty during the recruitment period for family leave, long term sick leave, study leave or any other reason
Effectiveness of a Physiotherapy Treatment for Temporomandibular Hyperlaxity

A 14-day physiotherapy treatment for temporomandibular joint hyperlaxity is established. Pre-intervention measurements and intermediate and end-of-treatment measurements are taken. Range of movement, algometry and muscle balance are assessed.


Eligibility Criteria:
Inclusion Criteria:

* Woman with temporomandicular joint pain for six months and diagnosed with hyperlaxity in the joint.

Exclusion Criteria:

* Men
* No temporomandibular joint pain or hyperlaxity
Blood Pressure and Obstructive Sleep Apnea

Bidirectional and causal relationship exists between obstructive sleep apnea (OSA) and hypertension in a dose-response manner, independent of confounding variables such as age, smoking, and body mass index. OSA is conventionally diagnosed and graded by apnea-hypopnea index (AHI). The relationship between AHI and changes of blood pressure deserves further investigation.

Approximately 50% of patients with obstructive sleep apnea (OSA) have hypertension; up to 30% of patients with hypertension have OSA, and the prevalence is even higher in those of resistant hypertension. OSA is conventionally diagnosed and graded by apnea-hypopnea index (AHI). This retrospective study aimed to determine if OSA severity and AHI have effect on blood pressure measurements and the nocturnal changes following an overnight sleep.

Eligibility Criteria:
Inclusion Criteria:

(1). Individuals who underwent full-night polysomnography at Taipei VGH for symptoms related to obstructive sleep apnea, such as snoring and daytime somnolence; (2). Feasibility to measure BP via wrist monitors; (3). Confirmation of wakefulness through electroencephalography.

Exclusion Criteria:

(1). Failure to measure BP via wrist monitors; (2). Age younger than 18 years; (3). Sleep efficiency less than 50%; (4). Central sleep apnea ≥ 50%
Valproic Acid and Platinum-based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma

The purpose of this study is to evaluate if the addition of valproic acid to standard platinum-based chemoradiation as definitive treatment of locally advanced Head and Neck squamous cell carcinoma can improve treatment outcomes, such as response rate.

Valproic acid is a known histone deacetylase inhibitor. In addition to activating apoptosis pathways, cell differentiation and downregulating expression of growth factors, it also promotes radiosensitization.

Most patients with Head and Neck squamous cell carcinoma are diagnosed with locally advanced disease, in which long term disease control is still a challenge. The incorporation of epigenetic regulation into standard treatment could improve results of definitive platinum-based chemoradiation in such patients.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable Oropharyngeal or oral cavity squamous cell carcinoma
* Candidate for definitive chemoradiation
* No previous treatment
* Measurable disease according to RECIST v 1.1
* Previous neoplasia, other than Head and Neck, with more than five years without evidence of disease; basocellular carcinoma of the skin and in situ cervical dysplasia if resected
* Age under 60 years
* ECOG performance status 0-2
* Ability of understanding and giving informed consent
* Adequate renal and hepatic function
* Adequate bone marrow function
* Normal serum magnesium
* Absence of QTc prolongation
* Life expectancy of over 12 weeks

Exclusion Criteria:

* Pregnancy
* Distant metastasis
* Hypersensibility to valproic acid or other antiepileptic drugs
* Valproic acid chronic use
* Severe neurologic impairment
* Uncontrolled comorbidity
* Hypoalbuminemia
* Known history of hepatitis B, C or HIV
U01-Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer

This is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue and normal tissue.

This is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue, normal tissue. Biospecimens collected through this protocol will be shared with collaborators in the Pancreatic Cancer Detection Consortium to support projects funded through an NIH U01 grant. Participants will be enrolled when they present for clinically indicated surgical procedures for their possible tumor or pancreas resection or cyst resection, or at a clinically indicated follow-up appointment after their procedure.

This protocol supports this effort by providing investigators with access to a wide variety of pancreatic tissues and biospecimens for translational studies in pancreatic cancer. This protocol covers the collection of clinical data and biospecimens (blood; malignant, benign, or precancerous pancreatic tumor; and adjacent normal tissues) from patients with, or suspected to have, pancreatic cancer. Additionally, saliva and cyst fluid, may be collected in the future from patients with pancreatic cysts. These will be shared with the Pancreatic Cancer Detection Consortium for further analysis.

Eligibility Criteria:
Inclusion Criteria:

* Males or Females ≥ 18 years of age who have been diagnosed with Pancreatic Cancer (PDAC), Pancreatic Neoplasms (PNs - IPMMs, PanINs and MCNs), pancreatitis and diabetes or no disease/healthy.
* Individuals undergoing or have previously undergone a diagnostic procedure (i.e. EUS or ERCP) evaluation or surgery.
* Willingness and ability to donate biospecimens for the purpose of research.
* Subjects must have had diagnostic procedure or surgery after September 1, 2017.

Exclusion Criteria:

* Individuals under 18 years of age.
* Inability to donate biospecimens.
* Females pregnant or lactating.
DASH Diet in Heart Failure Outpatients

The purpose of this study is to refine the classification of the effectiveness of the DASH diet for outpatient heart failure (HF) management, using behavioral, clinical, and laboratory correlative science approaches.

The overall objective of this pilot study is to refine the classification of the effectiveness of the DASH diet for outpatient HF management using behavioral, clinical, and laboratory correlative science approaches. The investigators will integrate the use and evaluation of DASH diet nutrition education in a clinical population using a pragmatic study approach. The investigators will assess dietary behavior change. The investigators will assess the medical effectiveness of the DASH diet to improve patient symptomology and clinical biomarkers. Exploratory investigations will involve metabolomics analyses of plasma samples for biomarker discovery of clinical phenotypes in HF patients, to characterize metabolic profiles related to dietary exposure.

Eligibility Criteria:
Inclusion Criteria:

* Heart Failure diagnosis
* Guideline directed medical therapy optimization on stable regimen at least 30 days

Exclusion Criteria:

* BMI \< 18/5 kg/m squared
* cardiac cachexia
* end-stage renal disease or dialysis
* acute inflammatory condition
* uncontrolled arrhythmias or ischemia
* status post heart transplant or implanted left ventricular assist device
Actigraphy to MEasuRe Intensive Care Unit Activity

This study is to determine whether accelerometry can be used to measure physical activity occurring during routine clinical care in a diverse population of patients with medical or surgical critical illness.

Patients that meet inclusion criteria will have a wristwatch size, lightweight ActiGraph GT3X+ placed at each of three body sites, the dominant-side wrist, right hip and dominant-side ankle to objectively measure physical activity. Patients will wear the ActiGraph devices during two 30-minute periods of direct observation. To compare activity counts measured by the ActiGraph devices with directly observed purposeful physical activity, we will record the time and type of physical activity performed by patients such as sitting at the edge of the bed, sitting in a bedside chair, transferring to a chair, standing and ambulating. The data acquired from this observational (AMERCIA) study will seek to establish the feasibility of using accelerometers to measure activity in a diverse population of patients with medical or surgical critical illness.

Eligibility Criteria:
Inclusion Criteria:

Patients will be included if they are:

1. adult patients,
2. admitted to the medical or surgical ICU,
3. receiving or have received invasive or non-invasive mechanical ventilation for respiratory failure or vasopressors for shock (i.e., cardiogenic, hemorrhagic, septic or undifferentiated shock) within the last 48 hours, and
4. who are receiving routine physical and occupational therapy.

Exclusion Criteria:

Patients will be excluded if they meet any of the following criteria:

1. Those who have severe physical disability that prevented independent living prior to their illness,
2. Those unable to speak and communicate in English,
3. Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by the family or medical team (i.e., likely to withdraw life support measures within 24 hours of screening),
4. Inability to obtain informed consent from authorized surrogate;
Evaluation of a Dietary Supplementation Combining Proteins and Pomegranate Extracts in Older People

The objective of this safety study is to evaluate the safety of a combination of proteins and pomegranate extracts in healthy subjects aged 65 years or more after 21 days of supplementation.

The aim of the Delicen's project is to find an effective solution to avoid undernutrition in the elderly by proposing an assortment of food products for people who are undernourished or at risk of undernutrition. These products will be enriched with proteins and pomegranate extracts. Before to realize the impact study to test products enriched with proteins and pomegranate extracts, a safety study will be carried out.

The objective of this safety study (double-blind randomized clinical trial) is to evaluate the safety of a combination of proteins and pomegranate extracts in healthy subjects aged 65 years or more in comparing a control group consuming 20g of proteins (100% of lactoserum proteins) and 650mg of maltodextrin to a test group consuming 20g of proteins (100% of lactoserum proteins) and 650mg of pomegranate extracts after 21 days of supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Woman and man, aged ≥ 65 years;
* BMI from 20 to 30 and from 21 to 30 for a person aged \>70 years;
* In good general health as evidenced by medical history and physical examination;
* Provision of signed and dated informed consent form;
* Stated willingness to comply with all study procedures and availability for the duration of the study;
* Fluent French speaking.

Exclusion Criteria:

* Severe psychiatric disorder or disease within 6 months before inclusion (depression, bipolar disorder, severe anxiety, psychosis, schizophrenic disorders, dementia...) or severe neurologic trouble (Alzheimer's, autism, Parkinson's disease, ...);
* Cancer within less than 3 years before the screening visit (except basal cell skin cancer or squamous cell skin cancer), which in the Investigator's opinion could interfere with the results of the study;
* Subjects presenting severe gastro-intestinal, severe hepatic, severe respiratory, severe kidney or severe cardiovascular disorder or severe infection (e.g., HIV, hepatitis, ...);
* Uncontrolled hormonal disorders (example: thyroid problems or Cushing's syndrome);
* Uncontrolled type 1 or 2 diabetes;
* Any clinically significant disease which in the Investigator's opinion could interfere with the safety of study participants or with the results of the study;
* Allergy or intolerance to one of the components of the administered products;
* Subjects with medications/products incompatible with the study according to the investigator (i.e: medications that could interfere with nutrient absorption);
* Subjects having participated in another clinical trial (with an investigational product) one month before the screening;
* Mental or legal incapacity, unwillingness or inability to understand or not being able to participate in the study;
* Subjects consuming ONS or protein supplements one month before the screening.
Effect of the Known Antihypertensive Drug Telmisartan on Red Blood Cells and Circulation in the Smallest Blood Vessels

The hypothesis of the presented study is: Telmisartan induces an increase of eNOS activity in RBC resulting in an enhanced intravascular NO bioavailability, an ameliorated RBC deformability and a reduction of RBC and platelet aggregation. This could be a potential mechanism of the improvement of microcirculatory disorders, especially in patients with diabetes mellitus and arterial hypertension, treated with Telmisartan.

Recently, it could be shown that the renin-angiotensin-system (RAS) influences different signal transduction pathways within the red blood cells (RBC). This includes the Na+/H+ exchange activity, the Ca2+-ATP-ase mediated Ca2+efflux, the erythropoietin- dependent production of RBC, the RBC deformability, RBC aggregation and the interaction of RBC and platelets. Recent studies and experiments, done by our group, focus on the oxidative and nitrosative metabolism of NO within the blood. The interactions of the RAS and endothelial NO are well known and described in detail. Based on a wide experience in this research field of NO metabolism, we characterized recently an active endothelial-type NO-synthase in RBC on the biochemical, functional and molecular level. Erythrocyte-derived NO formation serves important regulatory functions essential for adequate passage of blood through the vasculature. Here we aimed to treat patients with diabetes mellitus and arterial hypertension with Telmisartan as an angiotensin receptor antagonist. Efficacy parameters studied in this study should be: i) RBC deformability, RBC aggregation, ii) RBC dependent production of nitric oxide as well as detection of eNOS activity in RBC and iii) indices of microcirculatory perfusion. This project could broaden the view of effects of Telmisartan in the treatment of microcirculatory disorders in patients with diabetes mellitus and arterial hypertension, who exhibit a reduced NO bioavailability and RBC function.

Eligibility Criteria:
Inclusion Criteria:

* Men older than 18 years
* Diabetes mellitus type 2 defined according to the criteria of the American Diabetes Association Arterial hypertension defined according to the criteria of the Joint National Committtees (JNC 7)
* Given informed consent

Exclusion Criteria:

* Serve heart failure
* Serve aortic valve stenosis or hypertrophy obstructive cardiomyopathy
* Relevant cardiac arrhythmias
* Acute myocardial infarction within the last 4 weeks
* renal failure
* bilateral renal artery stenosis
* liver diseases
* primary hyperaldosteronism
* orthostatic hypotension (systolic blood pressure \<100mmHg)
* hypokalemia, hyponatremia, hypercalcemia, symptomatic hyperuricemia
* inflammatory disease
* malignant disease
* previous intolerance to AT1 receptor antagonists and/or sulfonamides
* current therapy with insulin sensitizer
* current therapy with digoxin
* known abuse of alcohol or drugs
S-Adenosylmethionine Therapy for Non-Alcoholic Steatohepatitis

The purpose of this study is to examine the effect of S-adenosylmethionine therapy in those patients with non-alcoholic liver disease in the form of steatohepatitis (NASH). This will be accomplished by development of a database of these patients, all of whom will have biopsy documented NASH. A placebo controlled trial will then examine the effect of S-adenosylmethionine over time on clinical outcome in these patients. It is expected that this agent will slow or halt the progression of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Men with biopsy proven non-alcoholic steatohepatitis from the liver disease clinic or referred from other physicians from the VAMC-Louisville.
The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children

This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN with mild proteinuria in children.

Henoch-Schonlein purpura nephritis (HSPN) is one of the most common complications of Henoch-Schonlein purpura, and has become one of the main causes of chronic kidney disease in children. However, the diagnosis and treatment of HSPN is still based on the clinical experience, lacking of evidence-based support. This study is performed to explore the biological markers for early prediction of the prognosis and evaluate the efficacy and safety of various measures in the treatment of HSPN in children.

The patients who are proved to get HSPN by renal biopsy will be randomized to receive either prednisone p.o. or angiotensin-converting enzyme inhibitor(ACEI) p.o. We will follow up them for about 2.5 years and compare the efficacy and safety of both measures by monitoring several indexes.

Eligibility Criteria:
Inclusion Criteria:

* Renal biopsy proved HSPN (ISKDC class II)
* Proteinuria \< 25 mg/kg/d

Exclusion Criteria:

* The children with congenital diseases
* Proteinuria≥25 mg/kg/d
Electroencephalogram During Desflurane Anaesthesia

To study the behavior of EEG during changing desflurane concentrations.

The concentration of desflurane will be increased to burst suppression EEG level, and thereafter decreased.

Eligibility Criteria:
Inclusion Criteria:

* adult patients

Exclusion Criteria:

* pediatric patients
Comparison of Gene Mutations in Matched Samples in Advanced Nonsquamous NSCLC Using NGS

The objective of the study was to compare the gene mutation status among the primary tumor, matched metastatic lymph node (LN) and peripheral blood in advanced nonsquamous non-small cell lung cancer (NSCLC) using next-generation sequencing (NGS).

Many gene mutations have been detected in lung cancer, which might differ between the primary tumor and the metastases in a same patient. One may cause by the heterogenicity of the tumor, another may cause by the sensitivity of the detection technique. So we determine to use NGS, which is a more sensitive technique, to detect the different gene mutations among the primary tumor, metastatic LN and peripheral blood in advanced nonsquamous NSCLC.

The study was designed as a prospective and single center study. Thirty five patients will be enrolled into the study and the clinical data of the patients, including his smoke history, cancer history, occupation exposure and so on, will be collected and recorded in a case report form. For the patients recruited in the study, the primary tumor and metastatic lymph nodes will be obtained by interventional pulmonology technology. And about 10ml peripheral blood will be collected at the same time. The tissue will be sent to Pathology Department of Shanghai Chest Hospital and will be processed with paraffin-embedded, and for those diagnosed with nonsquamous NSCLC, the rest tissue will be extracted with DNA and performed NGS for the qualified DNA sample using Illumina Nextseq500 sequencer.The matched peripheral blood will also be extract with DNA and performed NGS using Illumina Nextseq500 sequencer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are suspected with nonsquamous non-small cell lung cancer according to the clinical, lab examination and imaging data and had never been diagnosed as primary lung cancer before will be enrolled into the study.
2. The clinical stage of the patients should be in stage IIIA-IV judged by the imaging data and can't receive surgery initially,
3. There exist at least one primary tumor and at least one enlarged LN which can be biopsied by minimally invasive techniques.

Exclusion Criteria:

1. The patient is highly suspected to benign lesion, small cell lung cancer and squamous cell carcinoma according to the clinical data.
2. Surgery was considered to be the primary treatment.
3. Patients who are diagnosed with lung cancer and received treatment with drugs or recurrent with lung cancer will be excluded.
Effect of Oral Curcumin Supplementation in Dry Age-related Macular Degeneration (AMD) Patients

Nutrition plays an important role in preventing progression of dry age related macular degeneration (AMD), a disease of aging that leads to drusen deposits in the macula causing significant decrease in vision. Drusen contains amyloid protein which is inhibited by curcumin, a natural plant based antioxidant. Oral Longvida curcumin has been shown to accumulate in the retina of human subjects within 10 days of supplementation. This study aims to investigate the duration of oral curcumin supplementation needed to see clinical impact in reducing volume and number of drusen and decreasing choriocapillaris density loss or flow impairment in dry AMD patients. Patients will be given a 12-month course of oral Longvida curcumin and clinical impact will be measured by multimodal retinal imaging (fundus photos, OCT and OCT-A) at day 0, month 3, month 6, and month 12 of supplementation. Previous small studies have shown change in drusen size within 4 6months of curcumin supplementation, given that drusen can naturally fluctuate in size, we want to have a longer study period with a control group to better understand the effects of curcumin on drusen characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years old BCVA 20/20 to 20/400 Dry AMD with many large (\>300 μm in diameter and more than 100 μm in height) soft drusenoid PEDs

Exclusion Criteria:

* presence (or history) of significant geographic atrophy or choroidal neovascularization in either eye; history of eye surgery (other than cataract extraction) within 90 days, history of BRVO/CRVO, Macular hole, pathologic myopia, uveitis, pseudovitelliform maculopathy will be excluded.