cyrilzakka/clinical-trials huggingface dataset:
Improving Lifejacket Wear Among Boaters on Lake Albert, Uganda

A cluster randomized trial will be conducted for six months. To avoid covariate imbalance at baseline, stratified permuted block randomization with a 1:1 allocation ratio will be done. At least 387 boaters across 7 clusters per arm will be interviewed post baseline to give a 90% power to detect the effect of the intervention if such effect exists. A mixed effects multi-level modeling at 5% alpha level will be done using logical model building procedures

Given that the intervention will be at the community level, a cluster randomized controlled trial is considered most appropriate for testing the hypothesis of this study. The intact groups/clusters of individuals (boaters) rather than individuals themselves, will be randomized to either intervention or control arm. The landing sites herein referred to as clusters, will be the randomization unit. This is because it is difficult to randomize individuals to behavioral intervention since they mix within the cluster. This study will be conducted using an etic epistemological approach guided by a realist ontology in order to objectively measure the effect of the intervention without the influence of the researchers.

To reduce covariate imbalance and increase comparability at baseline, clusters will be randomized to either intervention or control arm using stratified permuted block randomization, with landing sites (clusters) as the randomization unit. The clusters will be stratified by estimated population size and baseline prevalence of lifejacket use as compared with the overall average prevalence. All individuals in the intervention cluster will receive the intervention. The main aim of the stratified randomization is to ensure that the clusters are as comparable as possible at baseline. The other factors that might be considered for stratification will be identified at baseline and, in the opinion of the investigator, might interfere with the objectives of the study. Because there are few clusters per arm (7), two strata will be formed. The stratification variable will be the baseline prevalence of lifejacket wear in the landing sites.

The risk of contamination (one of the major threats to this study) will be reduced by ensuring that at least one cluster which is not part of the study acts as a buffer. From each stratum, one cluster will be randomly allocated to the intervention arm and the other to the control arm using stratified permuted block randomization with a 1:1 allocation ratio. The allocation will be generated using the 'sealed envelope TM' web-based application by an independent statistician who has no interest in the study. The block sizes will be masked/blinded to increase the randomness.

Eligibility Criteria:
Inclusion Criteria:

* The landing sites (clusters) should not be flooded, should not be receiving any known educational/behavior related intervention except the routine marine police messages

Exclusion Criteria:

* Landing sites that are inaccessible because of the bad terrain and poor security
Bupivacaine HCl PK and Safety in Augmentation Mammoplasty

This is a Phase 4, randomized, open-label study of bupivacaine HCl administered either by instillation into the surgical site or by injection into the surgical site in subjects undergoing bilateral submuscular augmentation mammoplasty under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Is scheduled to undergo primary bilateral submuscular augmentation mammoplasty with saline or silicone smooth implants with a volume of 300 to 500 mL, inclusive.
* Has an American Society of Anesthesiologists Physical Status of I, II, or III.
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion Criteria:

* Has a planned concurrent surgical procedure (eg, mastopexy).
* Has a planned concurrent reconstructive procedure status post breast cancer therapy.
* Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the augmentation mammoplasty.
* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
* Has been administered bupivacaine within 5 days prior to the scheduled surgery.
* Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
* As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
* Has uncontrolled anxiety, psychiatric, or neurological disorder.
* Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study.
* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
* Has undergone 3 or more surgeries within 12 months.
* Has a body mass index (BMI) \>35 kg/m2.
Computed Tomography Arteriograms (CTA) Volume Dose Reduction Study

The purpose of the study is to determine if the dose of contrast (Omnipaque) administered for Computed Tomography Arteriograms (CTA) can be reduced without degradation of image quality. The hypothesis is that there is no difference in image quality using ultra-low dose contrast in CTA exams compared to routine, standard of care dose exams.

Any adult patient age 18 and above, scheduled for routine CTA (Computed Tomography Arteriograms) of the chest or chest, abdomen and pelvis meeting inclusion criteria and not meeting any exclusion criteria will be included in the study. The patient will be administered a low dose of intravenous contrast based on the study examination as described below.

CTA of the chest: 40 mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.

CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast (Omnipaque) at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.

Following the examination, the primary investigator (PI) or team members will evaluate the images obtained with low contrast dose and each patient's prior CTA examination performed with routine contrast dose, 100mL at a rate of 4mL/sec. This will be done by quantitative and qualitative measures. For the quantitative portion, the PI or team members will place regions of interest on predetermined arterial locations to obtain measure the degree of opacification. For qualitative measurement, the images will be presented in a blind fashion to two thoracic trained board certified radiologists and a board certified interventional radiologist to determine the quality of the images based on a Likert numerical scale. Qualitative and quantitative data for the images obtained with low contrast dose and those for the prior CTA examinations performed with routine contrast dose will be compared. This data along with details of the scan protocol (dose, dose rate, scanning parameters etc.) and demographic data (such as sex, age and BMI at the time of examination) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient scheduled for a computed tomographic arteriogram (CTA) of the chest or chest, abdomen and pelvis who had undergone a prior CTA performed with the standard contrast dose (100 mL) at this institution will be included in the study
* The follow-up scan will be routine standard of care, no emergency imaging patient will be approached for this research

Exclusion Criteria:

* Patients with no prior CTA imaging for comparison
* Any pediatric patient (age \<18)
* BMI \>40
* Inability to follow instructions
* Allergy to intravenous contrast
* GFR less than 30 mL/min/1.73 m2
Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design

The goal of this observational study is to learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months.

This is a retro-prospective, post-marketing observational study of a CE-marked medical device. The efficacy and safety of the Asqelio monofocal intraocular lens (IOL) model QLIO130C from AST Products, Inc, Billerica, USA, will be studied in patients implanted according to standard clinical practice. Twelve-month follow-up data will be collected from the medical records of the patients included in the study, and after 24 months they will be scheduled for a review.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with ASQELIO monofocal model QLIO130C.
* Subjects for whom postoperative emmetropia (±0.5 D spherical equivalent) was planned.

Exclusion Criteria:

* Any pathology that reduces the potential Visual Acuity (VA) with its best correction beyond 0.30 logMAR.
* Previous corneal surgery.
* Rubella or surgery due to traumatic cataract.
* Ocular trauma or refractive surgery.
* Any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study
High Resolution Ultrasound in Pancreatic Ductal Adenocarcinoma

Pancreatic cancer patients at UHN who have had a CT at UHN and have surgery planned will undergo a high resolution ultrasound pre-operatively and intra-operatively. This study is being done to see if using high resolution ultrasound before and during surgery will help the doctors accurately diagnose pancreatic ductal adenocarcinoma and identify if the disease has spread to other areas of the body.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females \> 18 y
2. PDAC diagnosed by typical imaging findings or pathology
3. Scheduled for surgical resection
4. Contrast enhanced CT scan performed locally at UHN

Exclusion Criteria:

1) Inability or unwillingness to provide informed consent
Technique Optimization With Whole-body Diffusion-weighted MRI

Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique that characterizes tissue by probing changes in water diffusion secondary to differences in the tissue microstructure. These changes in water diffusion result in differences in signal intensity on diffusion-weighted images that are quantified with the apparent diffusion coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be diminished, due to the increased number of cells. This will restrict water diffusion, identified by increased signal intensity (SI) on native diffusion-weighted images and low ADC. Contrary, in tissue with low cellularity, like benign lesions and treatment induced necrosis, the EES will be enlarged due to the lower density of cells, or in case of necrosis, the complete absence of cellular organization. This will facilitate water diffusion, leading to absent SI on native diffusion-weighted images and high ADC.

The purpose of this study is to image anatomy and lymph nodes in healthy volunteers with whole body diffusion-weighted imaging. This way maps of normal anatomy can be created on the whole body diffusion-weighted images which can be used as a reference in further studies with patients scanned with the same whole body diffusion-weighted imaging scan protocol.

A group of 30 healthy volunteers will receive a whole body diffusion-weighted imaging scan on a 3 Tesla T-MRI system.

A total scan session will take about 30 minutes. Contrast administration is not required and patients will not be exposed to radiation.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* no severe illness in the past
* no current infection/inflammation
Clinical and Economic Outcomes of Oral Anticoagulants in Non-valvular Atrial Fibrillation

The primary objectives of this study are to compare the risk of major bleeding and stroke/systemic embolism (SE) events among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating OAC warfarin or apixaban or dabigatran or rivaroxaban treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Had 1 or more pharmacy claim for apixaban or warfarin or dabigatran or rivaroxaban during the identification period (01-Jan-2013 to 30-Sep-2015). The first OAC pharmacy claim date during the identification period will be designated as the index date
2. Patients 18 years old or older as of the index date
3. At least 1 diagnosis of atrial fibrillation prior to or on index date, identified by any medical claim
4. At least 12 months of baseline period prior to index date with continuous enrollment

Exclusion Criteria:

1. Evidence of valvular heart disease, transient atrial fibrillation, venous thromboembolism during the 12-month baseline period or on the index date
2. Evidence of pregnancy during the study period
3. Had a pharmacy claim for warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 12-month baseline period
4. Had more than 1 oral anticoagulant claim on the index date
Study of the Use of Humidified Warmed Gas and the Effect on Post-Operative Pain in Laparoscopic Cholecystectomies

Double blind RCT comparing elective laparoscopic cholecystectomy using warmed, humidified gas (new) against laparoscopic cholecystectomy with cool, dry gas (usual). Sample size of 200 patients. Outcome measures are postoperative opiate analgesia use, and post operative numerical pain scores.


Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic cholecystectomy
* 18 years of age or over

Exclusion Criteria:

* under 18 years of age
* prisoners
* converted to open operation
* secondary invasive procedure during operation
* unable to give consent for whatever reason
Effect of Mediterranean Diet in Inflammatory Bowel Disease

The effects of diet on inflammatory bowel disease is an under-studied area of research. The investigators are interested in further investigating the role that diet contributes to inflammatory bowel disease severity. The investigators will collect blood and stool samples from patients with inflammatory bowel disease (IBD) before and after diet changes. The stool samples will be analyzed using metabolomics and microbiome analysis to determine changes after the new diet has been implemented. The investigators will then compare changes in the patient's overall disease state by measuring markers of inflammation including C-reactive protein (CRP) and fecal calprotectin to determine how this diet affects the disease state.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Meet classification criteria for inflammatory bowel disease including those with mild to moderate Crohn's Disease as defined by a Crohn's disease activity index between 150-450, with fecal calprotectin\>250, within 1 month of enrollment.

Exclusion Criteria:

* Unable to provide informed consent
* History of or current drug abuse
* Pregnancy
* Start or change in dose of standard-of-care treatment within 12 weeks of the screening
* Known allergy to any component of the proposed diet
* Subjects with significant other medical or psychiatric comorbidities and /or medication use which in
* physician's clinical judgment might difficult the interpretation of the results
* Patients that are not on a stable dose of medications, for instance, steroids, in between samples collection
* Patients on antibiotics
* Patients with C difficile infection within 4 weeks of enrollment
Development of an Interactive Web-based Teaching Tool for in Vitro Fertilization (IVF) Patients

The purpose of this study is to evaluate an interactive web-based teaching tool in IVF patients. Patients will be randomized to participate in web-based IVF teaching or a didactic lecture. A knowledge questionnaire will be completed both prior to and following the teaching intervention. Both groups will also complete stress and satisfaction surveys throughout the IVF treatment cycle. Groups will be compared at the completion of the study for demographics, level of knowledge, stress and satisfaction. The web-based group will be evaluated for web usage.


Eligibility Criteria:
Inclusion Criteria:

* Subject \>18 years of age
* Able to provide informed consent
* First cycle of IVF
* English speaking and reading
* Internet access at home or work (that is easily accessible for personal use)

Exclusion Criteria:

* Failure to complete a baseline knowledge questionnaire prior to IVF consent signing
* Previous attendance at an IVF teaching session
* Previous IVF treatment (at the Ottawa Fertility Centre or any other IVF clinic)
* Undergoing Natural Cycle IVF (these patients do not generally participate in teaching sessions, as they undergo one-on-one teaching)
Food4GutMarKIT - Evaluation of a Tailored Personalized Food Concept for a Healthy Gut Microbiota and Validation of Biomarkers for Monitoring of Its Effects

The overall aim in this "proof-of-concept" study is to evaluate if a diet concept, based on foods that have individually been reported to beneficially affect gut microbiota in fact has an effect on gut microbiota composition and activity among healthy and obese subjects and whether the effects are associated with altered cardiometabolic risk factors. The aim is further to investigate if such alterations are reflected in changes of the fecal and plasma metabolome. In total, 40 men and women, who meet all the inclusion criteria and none of the exclusion criteria will be invited to participate in the study. The participants will follow an intervention diet for 6 weeks and a control diet for 6 weeks, with a 6-week wash-out period in between and will be randomized to either begin with the intervention diet or the control diet.

The study will be running over 18 weeks (including a 6-week wash-out period) and it will include 9 visits at the clinic.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 18 - 70 years
* BMI 18,5-25 for normal weighed and BMI 25-39 for overweighed/obese
* Hb ≥ 120g/L
* Serum TSH \<4,0 mIU/L
* Signed informed consent

Among the overweighed, they need to have waist circumference \> 102 cm/88 cm for men and women respectively. All overweighed participants must have one of the following risk factors for cardiovascular decease, whereas the normal weighed could have or not elevated risk factors:

* LDL ≥ 3,0 mmol/L
* HDL ≤1.04 mmol/L
* Total cholesterol ≥ 5.0 mmol/L
* Triglycerider ≥1.69 mmol/L
* Blood pressure ≥130/85 mmHg
* Fasting glucose ≥6.1 mmol/L.

Exclusion Criteria:

* Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
* Following any weight reduction program or having followed one during the last 6 months
* Food allergies or intolerances
* Vegetarian or other diet restrictions (due to the standardized meal plan)
* History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
* Previous major gastrointestinal surgery
* Pregnant or lactating or wish to become pregnant during the period of the study.
* Unable to understand written and spoken Swedish
* Lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or PI.
* Pharmacological medication with drugs known to affect the microbiota, e.g. antibiotics, within 6 months prior to baseline.
* Intake of probiotics within 6 months prior to baseline.
* Have type I diabetes
* Receiving pharmacological treatment for type II diabetes (treatments based on life style interventions are acceptable, as long as it is compatible with the study protocol)
* Using nicotine products on a daily basis (including chewing gum, patches, snus etc.)
* History of heart failure or heart attack (TIA) within 1 year prior to screening
* Thyroid disorder
Detection of Brown Adipose Tissue by Magnetic Resonance Imaging

The primary goal of this study is to assess the accuracy of conventional fat fraction proton MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using 18F-2-fluoro-2-deoxy-D-glucosefluorodeoxyglucose -PET as gold standard.

In this pilot study, MRI and PET imaging of BAT of healthy adult volunteers will be performed on a combined PET/MRI scanner under mild cold condition.

In the fight against obesity, brown adipose tissue (BAT) is considered to be the newest target. The hypothesis is that this tissue is partially responsible for the imbalance between energy intake and energy expenditure that keeps lean people lean and obese people obese.

The detection of this tissue in adult humans represents an unmet need. BAT is difficult to detect and measurements of tissue fat fraction performed by magnetic resonance imaging have been proposed as a mean to differentiate the highly hydrated brown fat from the less hydrated white adipose tissue and from muscle.

To this end, the objective of this study is to assess the accuracy of magnetic resonance fat fraction measurements for the detection of BAT volume in adult humans, while using PET with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose as gold standard.

For this study subjects will undergo a combined MRI/PET scan. The scans will be done during stimulation of thermogenic activity by mild cold exposure.

Eligibility Criteria:
Inclusion Criteria:

* Each subject must be fully informed and have signed consent.
* BMI \< 34
* Normal neurological and psychological development / able to give consent
* Willingness to participate in this study

Exclusion Criteria:

* Subjects less than 18 years of age
* Severe claustrophobia
* Women who are pregnant, nursing an infant or planning to become pregnant in the next 30 days
* People who have a condition that makes MRI unsafe for them (for example, cardiac pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clip, iron filings in your eyes or metal halo devices)
* Have had radiation therapy or chemotherapy in the 2 months prior to PET scan
* Subjects are taking medications that may interfere with BAT detection