cyrilzakka/clinical-trials huggingface dataset:
Growth of High-Quality Oxides on The Inner Surface of ECMO Circuit by ALD to Reduce Thrombus Formation

This study evaluate thermal ALD (T-ALD) and plasma-enhance ALD (PE-ALD) processes modified cardiopulmonary bypass (CPB) tubing to investigate anticoagulation properties.

ECMO is a technique which is currently being used worldwide for providing life support for patients experiencing both pulmonary and cardiac failure. Though ECMO can effectively rescue life at the initial scene, being invasive, complex, resource intensive, and serious related complications developing on the following days of ECMO support have greatly restricted it use. The major causes of ECMO-related mortality and morbidity are serious coagulopathy, either bleeding (7-34%) or thrombosis (8-17%). Contact of high extracorporeal blood flow and the large artificial surfaces plays a critical role leading to the subsequent coagulopathy. Systemic heparin and heparin-bonded circuits is usually used to reduce thrombus. However, non-urgent invasive procedures should be avoided or minimized during that support and regular clinical monitoring to guide the adjustment of optimal dosage is mandatory making the clinical care intensive. Whereas the pharmacological interventions may bring the risk of critical imbalance between hemostasis and thrombosis, efforts to modify the ECMO system focusing on improvement of biocompatibility seem a fundamental way particularly regarding the extended periods of ECMO use. ZrO2 and Al2O3 are more excellent biocompatible and hemocompatible materials compared with PVC (polyvinylchloride) which is the current material of ECMO circuit. Despite the broad applications of ZrO2 and Al2O3 in artificial implants, traditional thin-film coating techniques are unable to deposit these hemocompatible oxides on the inner surface of the PVC tubing in ECMO circuit. In this subproject, the investigators will apply a new technique of atomic layer deposition (ALD) to coat biocompatible and hemocompatible ZrO2/Al2O3 nanolaminate thin films on the inner surface of ECMO tubing to suppress the device-induced coagulopathy. ALD is a thin-film deposition technique for preparing high-quality oxides with atomic-layer accuracy. It offers many benefits including accurate thickness control, excellent conformality, high uniformity, low defect density, good reproducibility, and low deposition temperature. These characteristics clearly accounts for the feasibility to deposit high-quality hemocompatible oxide thin films on the whole surface of complex 3-D structures, such as the inner surface of ECMO tubing, using the ALD technique. The newly-prepared ECMO circuit will then undergo in vitro tests and animal study to carefully examine the safety and effectiveness of improvement of hemocompatibility.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Weighing more than 50 kg

Exclusion Criteria:

* Pregnancy
* Smoking
* Chewing betel nut
* History of any blood or cancer
* Taking anticoagulants
Programa PUEDES Infancia

The purpose of this study was to evaluate whether an intervention directed at promoting parental self-efficacy and skills, based on a positive parenting framework, improves parental competences and healthy practices in families with children aged 2 to 5 years old.

This study has designed implemented and evaluated an intervention to promote parental competence and healthy practices in families with children aged 2 to 5 years old, addressing parental self-efficacy an skills. This research followed the first three stages of the Medical Research Council framework for complex interventions: the theoretical, modeling and exploratory trial phases. A randomized control trial with parents of children better 2 to 5 years old was conducted. The program consisted of two hour long four sessions. Parents were grouped in small groups (7-8 participants) and guided by a facilitator whose role was to provide a participative and trusting atmosphere to share opinions and experience in healthy lifestyles and parenting. Data collection was performed at three time points (pre-intervention, post-intervention and follow-up) to asses the preliminary efficacy, acceptability and feasibility of the program.

Eligibility Criteria:
Inclusion Criteria:

* Be father or mother of at list one child between 2 to 5 years old
* Be over 18 years old
* Sign the informed consent

Exclusion Criteria:

* Fathers or mothers that could have special necessities that could prevent the course of the sessions
* Participants the could understand or speak spanish
Efficacy of Whole Extract of Licorice in Neurological Improvement of Patients After Acute Ischemic Stroke

Stroke is one of the most important causes of mortality and disability both in developed and developing countries. The only food and drug administration (FDA) approved therapy for acute stroke is recombinant tissue plasminogen activator (rtPA). But narrow therapeutic window has limited the usefulness of thrombolytic therapy. Therefore, finding effective neuroprotective drugs for the patients for whom thrombolysis is contraindicated or not feasible seemed to be mandatory in the world of cerebrovascular medicine.

Licorice, extracted from root of a plant scientifically known as Glycyrrhiza glabra, is used in food industries. Certain medical properties has been contributed to licorice and specifically to its active chemical components such as flavonoids and glycyrrhizic acid (GA). GA has been revealed to assert its anti-inflammatory effect by suppression of NF-κB, a key component of lipopolysaccharide-induced inflammatory response. Neuroprotective characteristics of GA has been widely investigated in recent studies.

In the present study, the investigators verified the efficacy and safety of oral administration of two different doses licorice extract in the patients with acute ischemic stroke, in a double-blind randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of acute ischemic stroke
* ROSIER score higher than 2
* Confirmation of ischemic brain damage in CT scan

Exclusion Criteria:

* Clinically relevant preexisting neurological deficit or previous CVA
* Primary intracerebral hemorrhage
* Coma (level of consciousness more than 2 in NIHSS scale).
* Negative swallow test
* Patients undergoing hemicraniectomy
* History of epilepsy
* Clinical seizure at onset of stroke
* Systolic BP is \>160 mmHg, diastolic BP\>110 at onset of stroke (if a rise in blood pressure occurred in the course of study it was controlled according to medical guidelines)
* Atrial fibrillation or other tachy/bradyarrythmias at time of allocation or in the middle of intervention
* Ejection Fraction less than 45%
* Potassium less than 4 mEq/dl at onset of stroke
* Malignancy or premalignant state within 5 years
* Myocardial infarction in previous month
* Significant kidney disease (creatinine higher than 1.8 mg/dl)
* Significant liver disease (Bilirubin \> 20 mmoll/L)
* Significant lung disease (FEV1 \< 1.5 L, pO2 \< 70 in room air, pCO2 \> 45)
* Psychiatric illness requiring hospital admission
* Warfarin intake
* Digoxin intake
* Pregnancy
* Breast feeding
* Inability to have follow/up
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland

Vedolizumab is a medicine that helps to reduce sensitivity and pain in the digestive system for participants with UC or CD.

In this study, adults with UC or CD will be treated with vedolizumab according to their clinic's standard practice. Participants will receive vedolizumab as either an infusion or an injection just under the skin (subcutaneous). The main aim of the study is to observe real-world treatment patterns in participants treated with vedolizumab.

The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

This is a non-interventional, prospective study of participants with moderately to severely active IBD (UC or CD) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab in the real world setting.

The study will enroll approximately 100 participants. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

* Participants with IBD

This multi-center study will be conducted in Switzerland at specialized gastroenterology centers. The overall duration of the study will be 24 months (104 weeks). Data will be collected at baseline, at 3 months (12 weeks) after induction, and every 6 months (24 weeks) after that, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months (48 weeks).

Eligibility Criteria:
Inclusion Criteria:

1. Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.

Exclusion Criteria:

1. Prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC.
2. Current or planned participation in an interventional clinical trial for CD or UC.
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy

The primary research objective is to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).

The study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female subjects with non-malignant or malignant pain requiring opioids to assess analgesic efficacy and symptoms of constipation secondary to opioid treatment. Subjects will be randomised to two treatment groups and will be treated with OXN PR or OxyPR for up to 5 weeks. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and an extension phase.

Eligibility Criteria:
Inclusion Criteria

* Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain.
* Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy

Exclusion Criteria

* Females who are pregnant or lactating.
* Subjects with evidence or significant structural abnormalities of the gastrointestinal tract.
* Subjects with evidence of impaired liver/kidney function upon entry into the study.
Prevention of Delirium in ICU Using Multimodal Interventions

This study was designed to evaluate the impact of non-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit.

Delirium significantly increases not only the length of the intensive care unit stay and overall mortality, but also the likelihood of persistant cognitive impairment after recovery. However there is no definitive treatment for delirium, thereby it is important to prevent delirium before it occur. Researches also have focused on the prevention of delirium or the reduction of duration of delirium.

Several studies evaluated the effect of non-pharmacological treatment, such as improvement of orientation, prevention of sensory deprivation, active pain control and prevention of dehydration, to reduce the occurrence of delirium and the results were inconsistent depending on the patients included. However, there have been no randomized clinical trials that have tested the effect of prevention of delirium by applying non-pharmacological multimodal approaches in the intensive care unit for Korean patients.

A randomized controlled trial was planned to evaluate the impact of on-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit in Korea.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 50 years who are expected to spend more than 24 hours in the intensive care unit

Exclusion Criteria:

* Patients who developed delirium before entering the intensive care unit
* Patients with cognitive impairment
* Patients who have hearing or vision deficits, or have difficulty in communication
* Patients who are expected to die within 24 hours or do not want life-sustaining treatment
Pilot Study With the Aim to Quantify a Stress Protein in the Blood and in the Urine for the Monitoring and Early Diagnosis of Malignant Solid Tumors

Recent studies shows that extracellular vesicles (named "exosomes") released by cancer cells exhibit at their membrane the stress protein HSP70, contrary to exosomes released by normal cells. These exosomes ("HSP70-exosomes") have a very important role in intercellular communication and have specific biological functions that can promote tumor progression. They are found in the different biological fluids such as blood and urine.

We have developed a protocol able to isolate exosomes in blood and urine. We also demonstrated that only exosomes derived from cancer cell have HSP70 at their membrane. Those results strongly suggest that we can only identify exosomes with HSP70 at the membrane in patients with cancer.

Detection of HSP70-exosomes in the diagnosis of patients is a promising pathway of research. Because a cancer cell can releases a large amount of exosomes (several billion) and since its appearance, our approach will allow to earlier detect cancer with respect to the use of imaging and circulating tumor cells (CTCs), which remains a rare event (about one CTC of 1 billion cells).

The aim of this study is to demonstrate that HSP70-exosomes could be used for early diagnosis of patients with malignant solid tumor. In order to demonstrate this, the objective of the study is to study blood and urine samples from 60 subjects with a malignant tumor and 20 healthy subjects (witness).


Eligibility Criteria:
Inclusion criteria for patients

* Women newly diagnosed with either:
* Infiltrating non-metastatic breast cancer (positive or negative HER2 status or hormone therapy)
* Breast cancer with a first metastasis evolution (positive or negative HER2 status or hormone therapy).
* Ovarian cancer stage III and IV,
* Men and women who are newly diagnosed non-small cell lung cancer metastatic,
* Age ≥18 years
* Affiliation to a social security system,
* Signed Informed consent.

Exclusion Criteria for patients:

* Patient with another synchronous tumor,
* Men with breast cancer,
* Positive HIV and / or HBV and / or HCV serology
* Patients unable to undergo a medical monitoring for geographical, social or psychological condition,
* Pregnant or nursing women,
* People enjoying a major protection system (including trusteeship and guardianship).

Inclusion criteria for healthy volonter

* Men or women aged 50-70 years (mean age of onset of various cancers in the study)
* Affiliation to a social security system,
* Signed Informed consent.

Exclusion criteria for healthy volonter

* history of cancer,
* Positive HIV and / or HBV and / or HCV serology
* Pregnant or nursing women,
* People enjoying a major protection system (including trusteeship and guardianship).
The Use of Ligasure (r) for Hydrocelectomy Surgery

Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy.

Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy. during the study, males, 18 - 81 who suffer from hydrocele underwent hydrocelectomy using Ligasure (20 cm) without using sutures.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 81 males
* Diagnosed with unilateral hydrocele

Exclusion Criteria:

* Bilateral hydrocele
* infected hydrocele
* hydrocele secondary to tumor
Guelph Family Health Study: Pilot Study

The overall objective of the proposed study is to test, among Canadian families, the comparative effectiveness of 2 different versions (doses) of a family-based obesity prevention intervention that is tailored to families' behavioural risk profile.

To achieve this objective, we will conduct a randomized controlled trial of families with children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1) Monthly emails with general health information (Attention Control), 2) Tailored weekly emails and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home visits (Email +4). The intervention will last 6 months, with follow-up at 12-months post-intervention (18 months from baseline). We will examine the impact of the intervention on the children's body composition, weight-related behaviours, and biomarkers of diabetes and cardiovascular disease risk.

We hypothesize that, compared to children in the Attention Control, children in the Email +2 and Email +4 conditions will achieve:

1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass index (BMI),over a 6-month intervention period.
2. higher frequency of family meals, child's sleep duration, physical activity, and fruit and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary behaviour over a 6-month intervention period. (secondary outcomes)
3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein, trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a 6-month intervention period.

We further hypothesize that there will be no significant difference in these outcomes between children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.


Eligibility Criteria:
Inclusion Criteria:

* families who have a child aged 18 months through 5 years
* live the Guelph area
* have a parent who can respond to questionnaires in English

Exclusion Criteria:

* families who plan to move during the study period
* children with severe health conditions (such as severe cerebral palsy) that would prohibit them from participating in study activities
Research Abstract Usefulness in Clinical Decision-making

To better understand the extent to which family nurse practitioners (FNPs) might use research abstracts in shaping their clinical decision-making under simulated conditions. A secondary point is to examine if and how FNPs might use full-text manuscripts (associated with the abstracts) if made available to them.

The study will recruit the approximate 25 - 1st year and 25 - 2nd year family nurse practitioner students of the Graduate School of Nursing. After being presented an overview of the study and informed consent document, those electing to participate will draw a sealed envelope indicating whether they are assigned to group A (intervention group) or group B (control group). The participant will proceed to the associated room, be provided a brief clinical case (appropriate to their training), an iPad device with pre-loaded EBN-Search engine, and a questionnaire. The EBN-Search engine for the intervention group will include 9 research abstracts associated to the case. The EBN-Search for the control group will include both the research abstracts and full-text versions of the manuscripts. The participants will be provided 20 minutes to complete the questionnaire using the information available to them. The questionnaire will require the participant to indicate treatment plan, respond to questions regarding the usefulness of research abstracts, questions regarding the usefulness of full-text (control group only) and recommendations on improving EBN-Search.

Eligibility Criteria:
Inclusion Criteria:

* Matriculated family nurse practitioner graduate students of USUHS 2010/2011 academic year

Exclusion Criteria:

* None
Patient Experiences on the Stroke Unit

In this study we want to develop and validate a PREM for patient with ischemic stroke.

Patient Reported Experience Measures (PREMs) assess patient's perception of health care. Currently, there is no suitable PREM tool for patients with ischemic stroke. Therefore, we aim to develop and validate a PREM for this patient population. This PREM will be validated in a multicentre study, in 10 Flemish hospitals. We want to investigate the feasibility of our new questionnaire, as well as the usefulness. In addition we well analyse the results of the questionnaires and use this information to improve the quality of the care program for stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* ischemic stroke
* stayed at least one day at the stroke unit

Exclusion Criteria:

* not able to read the questionnaire
* not able to answer question orally
* are not proficient in the dutch language
Nasal Carrying by Staphylococcus Aureus ST398 Strains in Community and Hospital Settings

The aim of this study was to compare the prevalence of nasal carrying of SA ST398 strains in community and hospital settings, identify the factors associated with colonization of SA ST398, determine the distribution of imported and acquired cases among SA ST398 hospital cases and characterize the genetic structure of the ST398 SA population involved in colonization.

Staphylococcus aureus (SA) is a ubiquitous bacterium, part of the human commensal flora. The mucosa of the anterior nasal cavities represents the preferred site of colonization of SA. The SA ST398 clone, belonging to CC 398, was initially described as a zoonotic agent initially identified in France and the Netherlands. In fact, ST398 strains are separated into two distinct populations: a methicillin-resistant SA population (SAMR) with notion of contact with animals and a more virulent methicillin-sensitive SA population (SAMS) than its counterpart, isolated from serious human infections and without notion of exposure to farm animals. Recently, we have shown that, in SA bacteremia, all strains of SA ST398 are sensitive to methicillin and that the prevalence of ST398 among all SAMS responsible for bacteremia at Besançon University Hospital increased between 2009 and 2014, increased from 4 to 15%. However, we were unable to study nasal colonization to support the mode of acquisition of SA ST398 (community vs. healthcare acquisition).

Eligibility Criteria:
For community patients :

Inclusion Criteria:

* the selection criteria for blood donation
* age ≥ 18 years old
* No refusal of the person

Exclusion Criteria:

* None

For hospitalized patients :

Inclusion Criteria:

* age ≥ 18 years old
* hospitalization in one of the services participating in the study
* no refusal of the person

Exclusion Criteria:

* None