cyrilzakka/clinical-trials huggingface dataset:
Anticoagulation in Stent Intervention

Objective:

The main objective is to evaluate the pattern of dual antiplatelet therapy (aspirin, 300 mg / day + clopidogrel 75 mg / day) compared to the use of the triple regimen (Acenocoumarol as control + acetylsalicylic acid 100 mg / day + Clopidogrel 75 mg / day) in patients with atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2) who are undergoing PCI-S.

Design:

Randomized, parallel, with two arms, blind evaluation by third parties.

Patients:

304 patients undergoing PCI-S with atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2), which requires prevention of thrombosis


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes older than 18 years.
* Patients with permanent atrial fibrillation, persistent or paroxysmal (at least one episode), documented electrocardiographically and receiving oral anticoagulation. Patients with acute coronary syndrome or stable angina who are undergoing PCI-S.
* Patients who have previously given their informed consent to participation in the study.

Exclusion Criteria:

* Patients who can not be followed by the research team during the 12 months provided for monitoring.
* Patients with renal failure or serum creatinine above 2 mg • dL-1, neurological deficits, active ulcer or epigastric pain.
* Patients who continue regular treatment with NSAIDs or other analgesics or corticosteroids.
* Patients undergoing reoperation.
* Patients who during the study period, should receive, according to medical criteria, other adjuvant drug treatment than that specified in this protocol.
* Pregnant women.
* Use of investigational agents or not registered within 30 days of entry into the study.
* Patients with a history of allergy to study drugs or excipients.
* Patients with severe valve disease.
* Patients with CHADS\> 2.
* Patients who can not use the study drug orally.
Fibroblast Growth Factor-23 (FGF-23) is Independently Associated With Left Ventricular Mass Index (LVMI) and Myocardial Performance Index (MPI) in Haemodialysis Patients

Serum FGF-23 levels will be measured in patients with a history of coronary artery disease and aortic valve calcifications.It will be searched whether patients with MPI\>0.47 had higher or lower serum FGF-23 levels than those with MPI\<0.47. Correlations will be examined between log FGF-23 levels and LVMI and MPI. Uni and Multivariable-adjusted regression analyses regarding whether increased log FGF-23 concentrations are independently associated with increased left ventricular mass index and increased MPI, will be performed.

Fibroblast growth factor 23 (FGF-23) is a phosphorus-regulating substance. Circulating FGF-23 levels increase markedly in dialysis patients and are independently associated with increased risk of mortality. Given the fact that cardiovascular disease is the leading cause of death in dialysis patients, the aim of this study was to test if elevated FGF-23 levels might be associated with left ventricular mass index (LVMI) and left ventricular index of myocardial performance (MPI) in maintenance haemodialysis patients.

Methods: In this cross-sectional study, plasma FGF-23 concentrations are measured using a C-terminal human enzyme-linked immunosorbent assay kit and echocardiography is performed in maintenance haemodialysis patients.

Serum FGF-23 levels will be measured in patients with a history of coronary artery disease and aortic valve calcifications.It will be searched whether patients with MPI\>0.47 had higher or lower serum FGF-23 levels than those with MPI\<0.47. Correlations will be examined between log FGF-23 levels and LVMI and MPI. Uni and Multivariable-adjusted regression analyses regarding whether increased log FGF-23 concentrations are independently associated with increased left ventricular mass index and increased MPI, will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Adult hemodialysis patients (age\>18 years old)

Exclusion Criteria:

* Malignancy, active infection
Saline Instillation Before Tracheal Suctioning and the Incidence of Ventilator Associated Pneumonia

Compare the incidence of ventilator associated pneumonia with or without tracheal isotonic saline instillation before tracheal suctioning


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients foreseen to receive mechanical ventilation for more than 72 hours

Exclusion Criteria:

* Previous mechanical ventilation in the last month
* Mechanical ventilation for more than 6 hours before arrival at ICU,
* Contraindication to bronchoscopy and
* Be expected to die or undergo withdrawal treatment within 48 hours-
Effect of High Dose Insulin on Infectious Complications Following Major Surgery

Despite improvements in surgical techniques and perioperative care, the high incidence of postoperative surgical site infections remains a major problem in patients undergoing major abdominal surgery (liver, pancreatic and colorectal surgery).

Using the hyperinsulinemic-normoglycemic clamp technique, i.e. continuous infusion of insulin combined with dextrose titrated to "clamp" blood glucose between 4 and 6 mmol/L, we successfully established and preserved normoglycemia during the perioperative period. Our objective of this study is to determine if the maintenance of perioperative normoglycemia by a hyperinsulinemic normoglycemic clamp reduces the rates of incisional and space/ surgical site infections following abdominal surgery (liver, pancreatic and colorectal surgery).

This randomized, open-label, controlled trial will be performed in adult (\>18 years old) patients scheduled for elective open abdominal aortic aneurysm repairs and open hepatobiliary procedures including liver resections, pancreatectomies, duodenectomies, gastrojejunostomies, choledochojejunostomies and hepaticojejunostomies) at the Royal Victoria Hospital (RVH), McGill University Health Centre (MUHC), Montreal, QC, Canada.

Inclusion criteria: above 18 years old, scheduled for elective open abdominal aortic aneurysm repairs and open hepatobiliary procedures.

Exclusion criteria: inability to give consent, current wound infection, previous surgery at the same site within the preceding 30 days, allergy to insulin.

RECRUITMENT

Initial contact prior to surgery will be made by a research team member not involved in the care of the patient who will explain the research project and obtain written consent.

Consenting patients will then be randomized with the assistance of a computerized randomization system.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* elective liver, pancreatic or colorectal surgery
* ability to give informed consent

Exclusion Criteria:
An Online Intervention to Address Barriers to IBD Medication Adherence

Background Inflammatory Bowel Disease (IBD) is a group of lifelong and relapsing inflammatory conditions that usually affect the colon and the small intestine. Between 30 to 45% of patients with IBD do not take their treatment as prescribed by their health care team (Jackson, Clatworthy et al. 2010). The Perceptions and Practicalities Approach (PAPA) provides a theoretical framework to develop adherence interventions that are patient-centred (Horne, 2001). Unintentional non-adherence occurs when the patient wants to take the medication but there are barriers beyond their control, such as not understanding the instructions (practical barriers). Intentional non-adherence is the result of the beliefs affecting the patient's motivation to continue with treatment (perceptual barriers).

Aims

1. To develop an internet-based intervention to address perceptual and practical barriers to adherence to medicine for IBD.
2. To determine whether the intervention is effective based on change in both types of barriers.

Plan of Investigation The inclusion criteria are: age 18 or over; diagnosis of IBD; currently prescribed azathioprine, mesalazine, and/or adalimumab.

240 participants identified via Crohn's and Colitis UK and through two NHS IBD clinics will take part in the study. An online pilot Randomised Controlled Trial will allocate the participants either to a Cognitive Behavioural Therapy (CBT) based online intervention or Treatment as Usual group. On first visiting the website, participants will be screened for eligibility and asked for consent before answering the questionnaires. The website will assign intervention modules to be completed based on an individual's profile.

Outcomes: Beliefs about Medicines scores will be measured at baseline, 1 month and 3 month follow-ups.

Potential Impact A CBT based online intervention tailored to personal needs and concerns may benefit a large number of patients with low costs for the national healthcare services. A website can be accessed at a time and place convenient to the patient.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over.
* Diagnosis of IBD (Crohn's Disease or Ulcerative Colitis or Indeterminate Colitis).
* Currently prescribed one or more of the following medications for IBD: azathioprine, mesalazine, and adalimumab.

Exclusion Criteria:

* We will exclude people who are for any reason unable to make an informed decision about taking part and people who do not wish to complete follow-up questionnaires.
* People who declare that they do not understand written English. This is a pilot feasibility study that aims to assess the effectiveness and acceptability of an online CBT based intervention in English.
Precision Medicine Intervention in Severe Asthma (PRISM) Study

The Korea-UK Precision Medicine Intervention in Severe Asthma (PRISM) study aims to identify molecular phenotypes of severe asthma by analyzing multi-omics data including genomics, epigenomics, transcriptomics, proteomics, metagenomics, and metabolomics.

This is a prospective, observational cohort study. The participants are composed of the patients having severe asthma treated with biologic agents or conventional medication. Once enrolled, regular evaluation of clinical characteristics and obtainment of samples for omics analysis is conducted to identify clinically relevance molecular signals in severe asthmatics.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged between 18 years and 80 years
* Give written informed consent prior to participation in the study including all procedures
* Comply with study protocol requirements
* Able to read, comprehend, and write at a sufficient level to complete study related materials
* Able to complete the study and all measurements
* All patients have been through a severe asthma protocol that have ascertained the diagnosis of severe asthma, maximised treatments and ensured adherence to therapy.
* Stable asthma therapy for at least a month before screening

Exclusion Criteria:

* As a result of medical interview, physical examination or screening investigation the investigators consider the subject unfit either because of risk to the subject due to the study or the influence this may have on the study results.
* A history of recreational drug use or allergy which in the opinion of the investigators contraindicates their participation.
* Participation within 3 months in any a trial testing a new molecular entity or drug.
* Those, in the opinion of the investigator, who may prove non-compliant with study procedures.
* Within 4 weeks of screening visit been hospitalized or required high dose oral corticosteroid (\>30 mg prednisolone per day) therapy, asthma not been stable.
* Patients who have had prior treatment with bronchial thermoplasty, defined as completion of all thermoplasty treatment sessions within 6 months of screening
* History of significant pulmonary disease other than severe asthma.
* History of pulmonary eosinophilic syndrome or hyper eosinophilic syndrome.
* History of bronchopulmonary aspergillosis
Validation of the ProSomnus® RPMO2 Device

The purpose of the study is to:

1. Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter.
2. Evaluate the pulse rate performance simultaneously collected over the SpO2 range.

Testing will be performed with participants semi-recumbent, under non-motion conditions. SpO2 accuracy of the test device will be determined by a controlled desaturation study with measurements taken over the full range of SaO2 values for which accuracy is to be claimed +3% of the lower value and -3% of the upper value. Participants will be desaturated to achieve six plateaus between 100-70% SaO2.

Arterial blood draws within the hypoxic plateaus will be performed, with draws occurring no less than 30 seconds after reaching a plateau and no less than 20 seconds apart. Five blood draws will be taken at each plateau. Plateaus will be determined using the reference transmittance pulse oximeter and are defined as a change in SpO2 on the reference pulse oximeter of no more than 1% over a duration of 20 seconds. Sampling will not continue if the blood oxygen saturation destabilizes between blood draws.

Time in low O2 saturation decades (i.e., 70-80% and 80-90%) will be limited to the minimum amount of time required to obtain test data and will not exceed 10 minutes. The saturation level at each plateau and the number of plateaus may vary among participants. Arterial pressure, ECG, heart rate, EtCO2, respiratory rate, and FiO2 will be monitored during testing. Extra samples may be collected at the discretion of the PI. The controlled desaturation protocol is expected to take approximately 30 to 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥ 18 and \< 50 years.
* In good health with no evidence of medical problems.
* Ability to provide informed consent and willingness to comply with the study procedures.
* Ability to undergo controlled hypoxemia to the levels outlined in the desaturation profile.
* Adequate dentition for an oral appliance.
* Ability to breathe through the nose comfortably.

Exclusion Criteria:

* Obesity (BMI \> 40 kg/m2).
* Known history of heart, lung, kidney, or liver disease.
* Diagnosis of asthma or sleep apnea.
* Diagnosis of diabetes.
* Presence of a clotting disorder.
* Presence of hemoglobinopathy or history of anemia that, in the opinion of the PI, makes the individual unsuitable for participation.
* Current smoker.
* History of fainting or vasovagal response.
* History of sensitivity to local anesthesia.
* Unacceptable collateral circulation based on exam (Allen's test).
* Pregnancy or lactation.
* Resting heart rate \> 120 bpm.
* Systolic BP \> 150, diastolic BP \> 90.
* Carboxyhemoglobin level \> 3%.
* Presence of any other condition that, in the opinion of the PI, makes the individual unsuitable for participation.
Comparison of 2 Methods to Achieve Tight Glucose Control in Cardiovascular ICU Patients

There is current evidence that maintaining ICU patient's blood sugar between 4.4-6.1 saves lives. However, this is difficult to do in the ICU and carries risks of lowering the blood sugar too much. In addition, the best way to achieve this control is not known. Many strict nomograms that provide a standardized approach for nurses have been developed and validated, including one here at SMH. However, these nomograms cannot apply to all patients at all times, especially ICU patients whose needs are rapidly changing. ICU nurses are at the bedside constantly, are very familiar with their patient's needs, and have decades of experience in titrating medication doses without a nomogram to achieve a pre-determined response (i.e. medications to achieve pre-selected blood pressure). Indeed, once the bedside nurse has bought into the importance of the concept of tight glucose control and have been introduced to the nomogram here at SMH, their experience and intuition may be more adaptable to the changing needs of the patient than an inflexible paper nomogram. This study will compare glucose control using our current standard nomogram versus no nomogram (i.e. nurse directed) in order to determine whether the nomogram should continue to be used.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* adult CVICU pts
* requires insulin therapy for glucose greater than 8 mmol/L
* anticipated ICU stay \> 24 hrs
* not in DKA/HHNK
* mechanically ventilated

Exclusion Criteria:

* MD refusal
* no IV access for insulin
* allergy to insulin
* DNR or moribund as determined by the clinical team
Qualitative Research to Explore Treatment Preference in Pulmonary Arterial Hypertension (PAH) Subjects

GlaxoSmithKline (GSK) is embarking on a clinical program to assess the treatment of PAH with an Angiotensin converting enzyme 2 (ACE2). This new treatment may require subcutaneous administration, in comparison to current treatments which are taken orally. Hence, GSK would like to conduct this qualitative interview study with PAH subjects to explore subject's perspective and preferences for various modes of treatment administration (daily or weekly subcutaneous injection versus current treatment options). This will be a qualitative study comprising the conduct of semi-structured telephone concept elicitation interviews with 8 to 10 PAH subjects (each approximately 30 minutes in duration) in the United States (US).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age.
* Subject is willing and able to provide written informed consent.
* Subject must have a diagnosis of symptomatic Pulmonary Arterial Hypertension Type I as per the World Health Organization (WHO) clinical classification system.
* Subject must have the cognitive and linguistic capabilities sufficient to allow them to actively participate in an interview lasting 30 minutes.

Exclusion Criteria:

* Subject has a diagnosis of other cardiac or pulmonary disease.
* Subject has a Type II-V diagnosis of PAH, as per the WHO clinical classification system.
* Subject is currently receiving treatment for PAH via modes of administration other than intravenously or orally.
Blood DdPCR for Early Identification and Dynamic Surveillance of Pathogenic Bacteria in ICU Septic Patients: a Single-centre, Prospective, Observational Study

The purpose of this study is to investigate the efficacy of droplet digital PCR (ddPCR) in identifying pathogenic organisms in ICU sepsis patients, aiming to find a method that allows early identification of pathogenic organisms and dynamic surveillance in order to assess the association between pathogenic species and loads and clinical characteristics and outcomes.

This is a monocentric observational study. Patients admitted to the ICU with a first diagnosis of sepsis will be dynamically monitored for nucleic acid loads of pathogenic bacteria in the blood using ddPCR at different time points until the last blood sample is taken on day 28-30 or the patient is discharged from the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Patients with first diagnosis of sepsis after ICU admission

Exclusion Criteria:

* Age under 18 years
* Do not meet Sepsis 3.0 diagnostic criteria
* Refusal to sign informed consent
Children With Aluminium Contact Allergy: Oral Exposure Study

Aluminium allergy is predominantly seen in children with small itchy nodules in the skin after vaccinations, so-called granulomas. We want to do an exposure study where aluminium allergic children have to eat aluminium pancakes for a short period of time. The purpose is to investigate whether a worsening of the children's symptoms can be detected, both itching of the granuloma, allergic rash on the skin and also the symptoms that are not measurable, such as headache, stomach ache and general agitation. We also want to examine the concentration of aluminium in the urine, which reflects the absorption of aluminum from the gastrointestinal tract.

Parents of aluminium allergic children have reported that children may react with increased itching of their granulomas, skin symptoms in the form of redness, itching and rash, as well as symptoms such as headache, abdominal pain and agitation, by ingesting aluminium-containing foods.

Children are predominantly exposed to aluminium via the diet as they do not yet use aluminium-containing cosmetic products, stomach acid medicines or deodorants. The amount of aluminium in children's diet varies between 0.22-0.90 mg/kg body weight/week, depending on their age. In older children and adults, the intake is less related to the aluminium in infant formula, breakfast cereals and dried fruit, which is consumed more by children than adults.

With this study, we want to create an exposure study where children have to eat pancakes for a limited period of time, where aluminium has been used as baking soda, and for two control periods eat pancakes without aluminium.

Any symptoms occurring during periods could be used to investigate whether children with aluminium allergies generally react after intake of aluminium-containing foods and whether as such it is a consequential condition in some children or whether it is isolated cases. It is a very important issue to clarify with a view to proper advice, both with regard to the possible avoidance of specific foods and in the case of future vaccinations.

Eligibility Criteria:
Inclusion Criteria:

* Children with contact allergies to aluminium, demonstrated by patch tests
* Activity (itching) of the granulom within the last six months
* Written consent obtained from all custodians

Exclusion Criteria:

* a detected food allergy for the remaining products in the pancakes (including wheat flour, eggs and milk)
* Children treated with topical and/or systemic steroid preparations during and up to 1 week before the start of the study.
* Children treated with systemic immune suppression during and up to 1 week before the start of the study.
* Children with kidney or bone disease.
* Children vaccinated during the study period
* Treatment with acid neutralising medicines during and up to 1 week before the start of the study
* Another reason for inability to cooperate, including lack of language skills in Danish or English in parents.
Clinical Evaluation of Proclear Toric and Biofinity Toric

The aim of this study is to compare the short-term clinical performance of two Toric contact lenses.

The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.

Eligibility Criteria:
Inclusion Criteria:

1. Are at least 17 years of age and has full legal capacity to volunteer.
2. Have understood and signed an information consent letter.
3. Are willing and able to follow instructions and maintain the appointment schedule.
4. Are an adapted soft toric contact lens wearer.
5. Do not habitually wear either of the two study lens types.
6. Have a vertex-corrected contact lens prescription with a spherical component of +4.00D to -9.00D in combination with astigmatism of no less than -0.75D and no more than -2.25D in each eye.
7. Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye.
8. Can be fitted with and achieve a distance visual acuity of +0.18 logMAR or better in each eye with the study contact lenses.

Exclusion Criteria:

1. Are participating in any concurrent clinical or research study.
2. Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use.
3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable.
4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.
5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study.
6. Have a history of not achieving comfortable CL use (5 days per week; \> 8 hours/day)
7. Are an employee of the Centre for Ocular Research \& Education directly involved in the study (i.e. on the delegation log).