cyrilzakka/clinical-trials huggingface dataset:
A Novel Mobile Phone Application ( OptiBP) for Blood Pressure Monitoring

Evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in surgical patients in the post-anesthesia care unit

The purpose of the study is to compare the blood pressure values measured by a novel mobile phone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the oscillometric brachial cuff).

All patients scheduled for noncardiac surgery at Erasme Hospital Brussels, Belgium will be recruited and their pressure will be measured with both mesurement methods. (novel smartphone application versus upper arm cuff oscillometry) at 5 time points (each 20-30 minutes)

The OptiBP Application is a mobile application installed on a mobile phone which is a non-invasive data-logger intended to acquire physiological data from patients. By applying the patient's finger on a smartphone's camera, a movie is generated and transformed into values of diastolic, mean and systolic blood pressure.

Three measures will be taken (spaced by one minute) with both methods after a period of 3 minutes of rest at each time point.

The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (the oscillometric brachial cuff).

Then, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the novel mobile application.

The goal is therefore to compare blood pressure values as obtained by the analysis of the data recorded by the OptiBP Mobile Application, against simultaneous measurements provided by the oscillometric brachial cuff

Eligibility Criteria:
Inclusion Criteria:

* Patients (Men or women) older than 18 years old scheduled for a noncardiac surgery and admiited in the post-anesthesia care unit after the surgery
* Informed Consent as documented by signature (signed before surgery)

Exclusion Criteria:

* Minor patients
* Patients unable to participate due to the illness.
* Patients that cannot sign informed consent
* Blood pressure difference between the two arms of more than10mmHg inter-arm difference)
Novel Association of Cholesterol Ester Storage Disease Due to Lysosomal Acid Lipase Deficiency and Non-Alcoholic Fatty Liver Disease: A Prospective Clinical Study

Non-alcoholic fatty liver disease (NAFLD) is a world-wide problem with a global prevalence estimated at 1.5 billion people. It is characterised by significant diversity and phenotypic heterogeneity. Morbidity rates are estimated at 20% to 30% in Western adults, increasing to 90% in patients who are morbidly obese or diabetic. Risk factors in non-obese NAFLD patients are of especial practical and theoretical importance. Cholesterol Ester Storage Disease (CESD) is an autosomal recessive chronic disease of variable phenotype, caused by a deficiency in lysosomal acid lipase (LAL) and characterized by accumulation of fat in tissues and organs. Hepatic accumulation of fat in this disorder can cause hepatomegaly with varying degrees of damage varying from steatosis to fibrosis, elevated aminotransaminases, and isolated splenomegaly. Since the contribution of LAL deficiency to non-obese NAFLD is poorly understood, the investigators propose to evaluating the association between NAFLD and LAL deficiency in a prospective study in our population.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80 years;
* BMI 25-40;
* Fatty liver disease (bright liver, hepatomegaly by ultrasound (Liver span \> 15 cm mid clavicle line), splenomegaly (\>13 cm) or both.

Exclusion Criteria:

* Alcohol abuse\>30 gm/day, or \> 70 gram per week;
* Soft drink abuse;
* Drugs known to cause fatty liver;
* Chronic hepatitis (B and C);
* Biliary liver disease;
* Autoimmune hepatitis;
* HIV;
* Genetic/Metabolic liver disease (Wilson, alpha-1 antitrypsin, CF);
* Failure to give informed consent
Systematic Assessment of Vascular Risk

It is hypothesized that patients with vascular disease are undertreated for modifiable risk factors, leading to increased morbidity and mortality in this population.

The objective of this study is to develop a comprehensive database that will demonstrate the current adequacy of risk factor management in this high risk population, and that will provide needed guidance for future treatment options.


Eligibility Criteria:
Inclusion Criteria:

All patients who attend the Vascular Surgery Clinic at Toronto General Hospital, St. Michael's Hospital, and St. Joseph's Health Centre who have PAD, cerebrovascular disease (CBVD), or aneurysms will be eligible for this study. Patients who are currently enrolled in other clinical studies are eligible for this study; however proper adherence to the other study will take precedence over of the current proposal.
Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population

Patients with type 2 diabetes have many complications in different organs. These complications are extremely frequent and severe: cardiovascular and renal disease, visual impairment, and, more recently, complications affecting bone such as fractures. Conventional methods for the evaluation of fracture risk are based on the Bone Mineral Density (BMD) or FRAX (algorithm for the prediction of osteoporotic fracture risk) are not sufficient in the context of diabetes. Several metaanalyses have shown that, paradoxically, a higher BMD in patients with type 2 diabetes compared to patients not suffering from this disease, independently of body mass index (BMI). The paradoxal increase in fracture risk, despite a high BMD has led to the hypothesis that diabetes induces a modification of the quality and not the quantity of bone. However, there is a lack of data as to bone quality in patients with type 2 diabetes as studies of bone biopsies from patients with type 2 diabetes are extremely rare.

The objective of the study is to compare bone quality in patients with type 2 diabetes to that in patients who do not suffer from type 2 diabetes: evaluation of vertebral fractures by osteodensitometry, measurement of Trabecular Bone Score (TBS), and analysis of bone quality in biopsies (advanced glycation end products (AGE), contents of bone matrix and analysis of mineralization).

The results will then be correlated with blood/urinary markers with the objective to determine one/several non-invasive biomarkers for bone status in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged greater than 40 years
* Patients requiring surgery of the lower limb
* With a bone mineral density considered normal (T-score ≥ -2)
* Stage 1, 2, or 3 glomerular filtration rate (\> 30 mL/min)
* For diabetic patients the diagnosis will have previously established by an endocrinologist

Exclusion Criteria:

* Subjects treated with drugs known to interfere with bone metabolism, including steroids, anticonvulsants, diuretics, and bisphosphonates
* Patients with severe renal disease (\< 30 ml/mn); previous history of caner except skin cancer; myocardial infarction; uncontrolled hypertension; untreated hyperthyroidism; hyperthyroidism; malabsorption; bone metabolism diseases; rheumatoid arthritis or collagen diseases
* Pregnant or lactating woman
* Contraindication to taking tetracycline hydrochloride:

  * Known hypersensitivity to antibiotics of the tetracycline family or any of the excipients in the medicine
  * Severe chronic renal failure
  * Chronic liver failure
  * Systemic lupus erythematosus
  * Concomitant prescription of retinoid or vitamin A (risk intracranial hypertension)
* Psychiatric pathology seriously hampering understanding
* Difficulty understanding oral French
* Not a beneficiary of a social security scheme
Increasing the Effect of a School-based Prevention Program by Teacher Involvement

Cluster-Randomized Clinical trial, which includes the development and activation of an intervention program among young adolescents and their teachers. Study hypothesis is that the intervention program will yield improvement in adolescents whose teachers participated in the program, in comparison with the adolescents whose teachers weren't involved in the intervention. Results will be measured using the study questionnaire, to be filled out by the participants before, after, and three months after the completion of the program. The questionnaire will include validated questionnaires with good psychometric qualities. The study protocol was approved by Tel Hai College institutional review board. Parents of all student participants in the intervention and in the control group, as well as teachers involved in the program, received information about the program and the study and were asked to provide informed consent.

Early adolescent (10-13 years) is characterized by hormonal changes and accelerated physiological growth. Significant risk factors for the physical and mental health of children and adolescents include, among other things, disordered eating patterns, overweight and reduced physical activity, low self-esteem and negative body image.

"In Favor of Myself" is a preventive intervention program. The program's primary goal is to increase adolescents' self-esteem and to prevent negative self-image and body image, as well as to development media literacy. In this study, the investigators will focus on the "Young In Favor of Myself " program, designed for ages 10-12, grades 5 and 6, and its main goal is the development of self-care behaviors, media literacy, positive self-esteem, and body-image. To increase the effect of "Young In Favor of Myself " program, on the adolescents, the investigators have developed a teacher component as an addition to the school-based intervention, usually delivered by college students. The study will first assess the teachers' influence on the program, and then evaluate the difference in adolescent outcomes from the program with or without this supplement.

Results will be measured using the study questionnaire, to be filled out by the participants (both teachers and adolescents) before, after, and three months after the completion of the program. The questionnaire will include validated questionnaires with good psychometric qualities. The study protocol was approved by Tel Hai College institutional review board. Parents of all participants, in the intervention and in the control group, as well as teachers involved in the program, received information about the program and the study and were asked to provide informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

Teachers of elementary school classes 10-12-year-old students of participating teachers Participants who filled out the questionnaires before and after the program Participants whose parents signed a letter of informed consent.

Exclusion Criteria:

* Participants who didn't complete the questionnaires at baseline or at least twice.
Biomarkers of Acute Kidney Injury Following Cardiac Surgery

Acute kidney injury occurs in up to 30% of patients undergoing cardiac surgery. Cardiac surgery associated-acute kidney injury (CSA-AKI) is characterized by a sudden and sustained decrease in renal function with insufficient elimination waste products. The problem is that postoperative diagnosis of CSA-AKI is delayed because it relies solely upon the slow and unreliable rise in serum creatinine (SCr) levels that may lead to delayed start in treatment and increased risk of adverse outcomes. We hypothesize that Matrix Metalloproteins (MMPs) -2, -9 and Neutrophil gelatinase-associated lipocalin (NGAL) are associated with and earlier detectors of CSA-AKI compared to levels of SCr.

Cardiopulmonary bypass (CPB), although essential to the performance of most cardiac operations, has been shown to cause injury to other organs, particularly to the kidneys and brain. Matrix Metalloproteins (MMPs) are ubiquitous proteolytic enzymes that degrade extracellular matrix and have been shown to be involved in injury to transplant kidneys. To date, no interventions are available to decrease the risk of cardiac surgery associated-acute kidney injury (CSA-AKI).

NGAL is a known indicator of injury to kidney, thus making it a promising biomarker for CSA-AKI. It may be that a single biomarker will not be sensitive and specific across the spectrum of CSA-AKI. This research investigates MMP-2, -9 and Neutrophil gelatinase-associated lipocalin (NGAL) and their association with and earlier detection of CSA-AKI compared to levels of SCr.

We hypothesize that increased activity of MMPs are associated with CSA-AKI. Furthermore, MMP-2 and/ or -9 may be predictors and/ or biomarkers for the early detection of CSA-AKI compared to serum levels of creatinine.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria consisted of both sexes, 18-85 years of age, undergoing elective or urgent cardiac surgery with a hemoglobin (Hgb) \>100 g/L.

Exclusion Criteria:

* The exclusion criteria included were patients for emergent surgery, pre-existing chronic kidney disease (eGFR\<30 mL/min) on dialysis or prescribed nephrotoxic mediations.
Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer

Incidence of positive surgical margins after curative gastrectomy ranges from 1% to 20%. It has been suggested that positive surgical margins is an adverse prognosis factor, with a higher local recurrence and worse overall survival (OS). However, the management of these patients remains unclear.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital.

Exclusion Criteria:

* distant disease (including patients with positive cytology), early postoperative mortality (within 30 days after surgery) and follow-up data not available. Resections in patients with palliative intent were also excluded.
Kid STRIDE: Exploring Participation in a Family-based Intervention

The aim of this qualitative study is to explore parental and child perceptions of participating in a family-based behavioral intervention targeting healthy behaviors.

Children ages 9-14 have been participating in the Kid STRIDE study which is a family-based behavioral intervention for obese children. Participants will be divided into 3 groups according to their change in weight: 1) children who lost greater than 5% of body weight; 2) children who lost less than 5% of body weight or gained less than 1% of body weight; 3) children who gained greater than 1% of body weight. We will invite five families from each of groups 1 and 3 to participate in an open-ended interview.

Eligibility Criteria:
Inclusion Criteria:

* Completed the 15-week primary intervention phase of Kid STRIDE
Remote Weight Management Program for Obese Women

The purpose of the research project is to see if counseling on the Mediterranean diet combined with motivational interviewing via a telemedicine platform (Zoom) while using smart technology ("smart" scales and tape) improves participants' weight loss, reduces waist circumference, and improves satisfaction with their care.

The investigators will evaluate a formal remote weight management and follow-up program, utilizing a technology-based intervention using the Renpho application paired with a smart scale and smart tape measure. The primary communication technologies will be the REDCap and Zoom platforms.

Renpho's smart body fat scale and tape measure are health applications that sync with fitness applications such as Apple Health, MyFitnessPal, Fitbit, and Samsung Health. The Renpho Bluetooth-enabled smart scale and smart tape devices will allow participants to sync with the Renpho application on their smartphone to automatically upload data such as weight, BMI, and WC to their phone. The project leader will review participants' self-reported weights and WC fortnightly. The participants will be asked to complete a post-participation satisfaction survey that includes a 5-point scale ("strongly agree", "agree", "neutral", "disagree:", to "strongly disagree") Likert-style questions.

Expected Outcomes. The primary outcomes for this eight-week intervention are to achieve a clinically significant reduction in weight of at least 5-10 % and at least 2.5 inches reduction in WC per participant from baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Women with a clinical diagnosis of obesity (BMI ≥30 kg/m2),
2. Age of 18 years or older,
3. English-speaking participants with access to a smartphone device
4. At least one cardiovascular risk factor (at least one clinical diagnosis of the following conditions: hypertension, dyslipidemia, type 2 diabetes, pre-diabetes, sleep apnea, family history of heart disease, cigarette smoking, inactivity, preeclampsia, gestational diabetes, gestational hypertension, preterm birth, rheumatological diseases, or premature menopause).

Exclusion Criteria:

1. Must not be taking medications specifically for weight loss or currently participating in a weight loss program,
2. Must not be pregnant or breast-feeding,
3. Women without a clinical diagnosis of obesity (BMI \< 30 kg/m2)
4. Must not have lost \>3 kg body weight or dramatically changed physical activity patterns within the past six months,
5. Clinical diagnosis of eating disorders
6. Clinical diagnosis of uncontrolled hypertension or neurological or psychological disorders
7. Must not have any obesity-related surgery within the past six months (i.e., gastric bypass).
Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?

The purpose of this study is to investigate whether intake of protein supplement just before meals lowers the blood sugar levels after the meals. It is believe that pre-meal administration of a high-protein supplement can effectively improve glycemic control in type 2 diabetes (DM).

11.3% of the population aged 20 years or older (25.6 million individuals) has diabetes. In the population aged 65 years or older, the prevalence of diabetes reaches to 26.9%.

Type 2 DM is caused by insulin resistance accompanied by insufficient compensatory insulin response. Therefore insulin secretagogues are a significant component of the therapeutic armamentarium. Insulin secretagogues, such as sulphonylureas and meglitinides, are routinely prescribed to lower post prandial glucose levels in type 2 DM. However, these medications are cleared by the liver and the kidneys and cannot be used in the presence of relevant co-morbidities. These medicines can also cause side effects, including hypoglycemia. Limitations of these medicines are likely to lead diabetic patients and their health care providers to seek alternate methods to treat postprandial hyperglycemia. Thus, our research which aims to identify an alternate insulin secretagogue is important and timely.

Whey protein (WP), a rich source of essential and branch chain (BC) amino acids (AA), is a potent insulin secretagogue. Although it is well known that protein and/or AA intakes stimulate insulin secretion, protein supplements are not being used clinically in order to lower post-prandial glycemia. WP can be a satisfactory alternative to the pharmaceutical insulin secretagogues.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with type 2 DM; age: 25 to 70y; BMI: 25 - 40 kg/m2; on no drug treatment or on metformin alone; HgBA1 6.5 - 8.5%; urinary microalbumin \< 30 mg/g cr.

Exclusion Criteria:

* Systemic disease (liver, renal, untreated hypothyroidism, etc); in the last 2 mo: \> 5% weight change, smoking, alcohol intake \> 4 /wk; restricted diets; medications or herbals affecting insulin secretion/sensitivity . Pregnant women, prisoners, individuals who cannot provide informed consent.
Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis

The purpose of this study is to compare adhesion prophylaxis with polylactide-caprolactone-trimethylenecarbonate copolymer to icodextrin 4% in terms of safety, side effects and usability in addition to gaining early evidence of the effectiveness of polylactide-caprolactone-trimethylenecarbonate copolymer.


Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years
* sex female
* laparoscopic myomectomy indicated
* ability and intention to conform to the study protocol
* written informed consent

Exclusion Criteria:

* pregnancy
* indication for laparotomy
* inflammatory bowel disease
* additional surgical interventions
* known or suspected intollerance or hypersensibility to the interventions
* chronic pain
* systemic corticoids or irradiation
* alcohol abuse or other substance abuse
* clinical signs of malignancy
* psychiatric or neurological disease
* participation in another clinical trial within 30 days
* inability to understand the purpose of the trial or to conform to the study protocol
* absence of written informed consent
* inflammation of pelvic organs
* presence of adhesions which lead to a conversion from laparoscopy to laparotomy
* concurrent therapy with corticoids, anti-neoplastic agents or irradiation
* maintenance therapy with non-steroidal anti-inflammatory drugs or analgesics
An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically proven diagnosis of non-small cell lung cancer
* positive for the ALK fusion gene (test provided by a central laboratory)
* must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
* tumors must be measurable

Exclusion Criteria:

* prior treatment with PF-02341066
* current treatment in another clinical trial
The SORT OUT IX STEMI OCT Trial

The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX STEMI OCT is to compare early vascular healing of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI).

SORT OUT IX STEMI OCT is a randomized 1:1 study comparing the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent patients with STEMI treated with primary PCI.

Vascular healing index (uncovered stent struts, malapposed stent struts, maximal intima coverage and accumulated extra-stent lumen volume) assessed with optical coherence tomography (OCT) 1 month after primary PCI.

Patients will be enrolled by the investigators and randomly allocated to treatment groups after diagnostic coronary angiography and before primary PCI. A web based Trial Partner randomization system will be used.

OCT will be performed with the frequency-domain OPTIS OCT system and Dragonfly™ Imaging Catheter during the index procedure and after 1 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or over with STEMI, requiring treatment with a drug-eluting stent.

Exclusion Criteria:

* life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, biolimus or sirolimus; participation in another randomized trial; chronic renal disease; or inability to provide written informed consent.