cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality Simulation for Teaching and Assessment of Anesthesia Crisis Management

In this study, Investigators are going to develop and test a device to apply virtual reality simulation to improve and help for teaching and assessment of anesthesia crisis management.

Competency based medical education (CBME) is an outcomes-based approach to the design, implementation, assessment, and evaluation of medical education. The goals of Competency Based Medical Education are to improve patient safety, patient health outcomes, and enhance the competence and performance of individuals, groups and teams. Simulation-based training is a proven effective method to improve the skills and competency of the student by permit-ting repetitive practice before an actual procedure is performed on real patients.

e Virtual reality simulation has been used successfully to teach technical skills such as laparoscopic surgery, carotid stenting, gall bladder surgery, and knee arthroscopy.

The specific aims of this project are:

1. Build a multi-user, multi-site virtual reality simulator for anesthesia management and team training
2. Evaluate the simulation as a tool for competency based medical education
3. Compare the effectiveness of the simulator with mannequin based simulator for competency based medical education.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesia resident or fellow volunteers from University of Toronto

Exclusion Criteria:

* Unwilling to enter the study
* Previous experience with simulator based teaching on local anesthetic systemic toxicity
Assessment of Daily Disposable Silicone Hydrogel Lens Wear

The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.


Eligibility Criteria:
Inclusion Criteria:

* Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).
* Willing to comply with the study visit schedule.
* Ages 15 to 39.
* Has access to a cellular telephone with text messaging capabilities.
* Has a current pair of spectacles.
* 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'.
* Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC.
* Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.
* Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week.
* They agree not to participate in other clinical research during the duration of this study.

Exclusion Criteria:

* Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.
* Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).
* Systemic disease, which might interfere with contact lens wear.
* Medication usage that may be associated with eye dryness.
* Use of any topical medication such as eye drops or ointment.
* Pregnant or lactating (by self-report).
* Aphakia.
* Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
* Have participated in any other clinical trial or research in the two weeks prior to starting this study.
Metabolomic Fingerprint After Bariatric Surgery

Background: Obesity is associated with multiple diseases. Bariatric surgery is the most effective therapy for severe obesity that cannot only reduce body weight but also obesity-associated morbidity.

Objective: The metabolic alterations associated with obesity and respective changes after bariatric surgery are incompletely understood.

Design: In the longitudinal observational study, the investigator applied a 1H-NMR-based global, untargeted metabolomics strategy on human serum samples that were collected before and repeatedly up to one year after distinct bariatric procedures (sleeve gastrectomy, proximal and distal Roux-en Y gastric bypass; RYGB). For comparison, the investigator also analyzed serum samples from normal-weight and less obesity obese subjects that were matched for 1-year postoperative BMI values of the surgical groups.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>/=35 kg/m2
* at least 2 years of unsuccessful conservative weight loss attempts

Exclusion Criteria:

* \< 18 years of age
* BMI \< 35 kg/m2
* informed consent was not signed by the patient
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged \> 18 years


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age or older

Exclusion Criteria:

* any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days, any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days.No women in breast feeding.
Lymphedema Study for Arm or Leg Lymphedema

This study compares the effectiveness of a study drug versus placebo in the treatment of lymphedema.

Part 1 is feasibility, exploratory, open-label study of ketoprofen, to document effects.

Part 2, is open-label trial of ketoprofen to document histological response. Part 3 is double-blind randomized trial of receive placebo or ketoprofen to evaluate safety and efficacy.

We will try to determine how the study drug affects the body tissue by obtaining tissue biopsies (small pieces of skin from the arm or leg) before treatment and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* a history of lymphedema of one or more limbs (unilateral or bilateral), with a duration of \> 6 months.

Exclusion Criteria:

* Patients with active cancer, infection or bleeding tendency will be excluded.
* We will also exclude patients with medical contraindications to NSAIDs, including history of allergies, know gastrointestinal intolerance, or other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate.
* Minors (\<18 years of age) \*\>90 years of age
Video Distraction to Decrease Use of Sedation in Pediatric Participants During Radiation Therapy

This phase I pilot trial studies how well video distraction works to decrease the use of sedation in pediatric participants during radiation therapy. Radiation treatment requires participants to lie very still (for accuracy). Many children cannot do this without sedation. Watching movies during radiation may distract children so they don't need sedation to complete treatment.

PRIMARY OBJECTIVE:

I. To determine if the use of video distraction during radiation therapy (VidRT) during radiation for patients ages 3 to 13 decreases the rate of sedation use compared to patients previously treated without VidRT.

SECONDARY OBJECTIVE:

I. To determine which variables are associated with decreased need for sedation use. Variables will include patient age, length of treatment time (number of treatments and beam-on time), oncologic diagnosis, use of immobilization devices, pre-existing developmental or psychiatric diagnoses (attention deficit hyperactivity disorder \[ADHD\], dissociative disorders \[DD\], anxiety, depression, developmental delay, learning disability), pain scale ratings at time of first radiation treatment (0-10).

EXPLORATORY OBJECTIVES:

I. To determine the impact of VidRT on patient-reported quality of life prior to starting, during, and at the end of treatment using the pediatric quality of life inventory surveys including the Pediatric Quality of Life Inventory (PedsQL) - 4.0 Core and Peds QL- 3.0 brain tumor questionnaires.

II. To determine the impact of VidRT on patient-reported anxiety throughout radiation treatment as monitored by Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric item bank version (v) 2.0 anxiety questionnaire.

III. To determine if workup assessment category for patient being low, medium, or high risk of needing sedation correlates to actual sedation use.

OUTLINE:

Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.

Eligibility Criteria:
Inclusion Criteria:

* All races and genders will be included.
* Patients with all tumor types will be included.

Exclusion Criteria:

* Patients \< 3 years and \> 13 years of age will be excluded.
* Patients with underlying movement disorders will be excluded.
Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging

The overall objective of this study is to assess if the empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies.

The overall objective of this study is to assess if the SGLT2 inhibitor empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies. This study will evaluate if an acute administration of empagliflozin (tablets of 10 and/or 25 mg) combined with fasting can sufficiently increase the BHB levels, a proxy of myocardial FDG uptake.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 70 years
2. Ability to follow the HFLC diet
3. Ability to provide informed consent

Exclusion Criteria:

1. Treated with SGLT2 inhibitors
2. History of hypersensitivity or allergy to empagliflozin
3. Hypotension with blood pressure \<100/65 mmHg
4. Strict vegan
5. Pregnancy
6. Breastfeeding
7. Type I or type II diabetes
8. Renal failure with Estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.72m2
9. Receiving steroids
10. History of diabetic ketoacidosis (DKA)
11. History of hypoglycemia
12. Any condition that, in the opinion of the investigator, could compromise the participation in the study
An Open-Label, Dose-Escalation Study of AZD2461

This study is being conducted to test study drug AZD2461 to see how it may work to treat solid tumors. The main purpose of this study is to determine the safety and tolerability of AZD2461. This is the first time the drug has been given to humans and is classed as a first time in man study. Its main purpose is to establish a safe dosage of the drug and provide additional information on any potential side effects this drug may cause. The study will also assess the blood levels and action of AZD2461 in the body over a period of time and will indicate whether the drug has a therapeutic effect on solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.
* Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
* Patients must be 18 years of age
* Using adequate contraceptive measures, be surgically sterile or post-menopausal
* Patients entering this study must be willing to provide tissue from a previous tumor biopsy (if available) for correlative testing. If tissue is not available, a patient will still be eligible for enrollment into the study..

Exclusion Criteria:

* Patients currently receiving cancer therapy
* Use of investigation anti-cancer drug or major surgery, radiotherapy or immunotherapy with the last 21 days
* cardiac disease
The Efficacy of Pyridostigmine Therapy After Transurethral Resection of Prostate in Cases with Underactive Urinary Bladder.

The efficacy of pyridostigmine therapy after transurethral resection of prostate in cases with underactive urinary bladder

Underactive bladder is a decrease in detrusor contraction and/or shortening of the contraction time, resulting in an incomplete and/or prolongation of the bladder emptying within the normal time frame. Prolonged bladder outlet obstruction due to prostatic enlargment one of the main causes of bladder hypocontractility. To make a diagnosis, it is necessary to perform a pressure-flow study. Decrease in maximum urine flow rate related to bladder outlet obstruction or poor contractility can be distinguished by pressure-flow study.

parasympathomimetics (cholinergic receptor stimulating agents) could be beneficial for patients with underactive bladder. However, no systematic review with meta-analysis addressing potential benefits or adverse effects exists. Pyridostigmine is a medication used to treat myasthenia gravis and underactive bladder as well.

Patients with underactive bladder after transurethral resection of prostate may still complain of recurrent attacks of obstructive lower urinary tract symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are not younger than 45 or older than 75 years.
* Patients with benign prostatic hyperplasia who are eligible for transurethral resection of prostate.
* Patients who has decreased bladder contractility confirmed by urodynamic study (pressure flow study) and plotted on international continence society (ICS) nomogram.

Exclusion Criteria:

* Patients younger than 45 or older than 75 years.
* Patients who have diabetes.
* Patients with a history of neurological diseases.
* patients with a previous history of pelvic surgery.
Post-Authorisation Safety Study of Lesinurad

Non-interventional population-based prospective cohort study in multiple databases comparing patients with gout who initiate lesinurad in combination with an existing xanthine oxidase inhibitor (XOI) (lesinurad+XOI cohort) to a propensity score-matched cohort of similar patients from the same data source who continue treatment with XOI monotherapy (XOI mono cohort). Study will characterize the cardiovascular safety of lesinurad in combination with XOI in patients with gout aged 18+ years compared with similar patients who continue XOI monotherapy. Primary objective: to assess the relative incidence of major adverse cardiac events plus hospitalization for unstable angina (MACE+ events) in patients with gout in both cohorts. Secondary objectives: to describe the characteristics of the cohorts prior to matching; to assess the relative incidence of hospitalisation for acute kidney injury between the matched cohorts; to assess the relative incidence of individual MACE+ components in the matched cohorts.


Eligibility Criteria:
Inclusion Criteria:

* More than one dispensing/prescription for an xanthine oxidase inhibotor (XOI) within the past 183 days prior to the index date and days' supply extending beyond the index date
* A coded diagnosis of gout at any time in the past or on the index date
* Age 18 years or older
* Continuous enrolment in the database for the past 183 days

Exclusion Criteria:

* Patients on urate-lowering therapy medications within 6 months prior to the index date to manage gout (probenecid, benzbromarone, or pegloticase) other than an XOI (allopurinol, febuxostat) or lesinurad (not including medications to treat gout flares).
* Patients with severe renal impairment defined using clinical diagnostic codes (i.e., a diagnosis code of CKD stage IV, end-stage renal disease, or an indicator that eCrCl is \< 30 mL/min at any time prior to the index date).
Adductor Canal Block and Recovery After Total Knee Replacement Surgery

This study aims to compare the functional recovery of patients undergoing Total Knee Arthroplasty based on the administration of an adductor canal block during their anesthesia treatment

The period after total knee replacement (TKR) surgery is known to be painful for the first 24 hours, lasting up to 3 days in many cases. Successful management of pain after TKR is regarded as necessary to early recovery, rehabilitation and timely discharge. Severe pain following major joint arthroplasty can hinder early rehabilitation, may result in prolonged hospitalization and is a strong predictor of persistent pain beyond 3 months. Adequate analgesia following TKR is paramount to early recovery, rehabilitation and timely discharge. Therefore early postoperative analgesic and rehabilitation goals are intricately related.

Until now, different methods of pain treatment have been used, including intravenous narcotic pain medication, continuous femoral nerve block (numbing medication to a nerve in the thigh) and epidural analgesia (identical to the numbing method for childbirth). These are all effective methods but each is limited by side effects. In recent years, research has focused on administering local anesthetic further down in the leg, trying to minimize quadriceps muscle weakness while giving adequate pain relief after surgery. Local Infiltration Analgesia (LIA) and Adductor Canal Block (ACB) are examples of new farther sites of administration.

The purpose of this study is to determine which combination of analgesic interventions is the most effective treatment for pain and improvement in functional outcome for TKR.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical Status I-III
* 18 - 80 years of age
* BMI 18 - 40
* Scheduled for elective total knee replacement under spinal anesthesia
* Able to ambulate independently with a standard wheeled walker as maximum mobility aid

Exclusion Criteria:

* Revision knee arthroplasty
* Bilateral knee arthroplasty
* Lack of mental ability to provide informed consent
* Neuropathic pain or sensory disorders of the surgical limb
* Contraindication to regional anesthesia (intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)
* Chronic opioid use defined as \> 30 mg of daily oral morphine equivalents
A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication

The purpose of this study is to determine if blood levels of the hormonal emergency contraceptive agent, Plan B, are altered by concomitant use with the HIV medication, efavirenz.

The use of hormonal contraceptive pills in women with HIV is complex due to potential interactions between these agents and HIV medications. HIV-infected women taking efavirenz have an even greater need for effective birth control as this medication may cause severe brain damage to a developing fetus. The use of an emergency contraceptive agent in cases of unprotected sex or condom failure can prevent pregnancy. This study seeks to establish that Plan B can be used effectively and safely in women taking efavirenz.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, HIV-1 seronegative women of child-bearing age.

Exclusion Criteria:

* Current use of hormonal contraception
* Pregnancy/Breast Feeding
* Post-menopausal status
* Obesity
* Hepatitis B or C
* Psychiatric illness
* Active Substance Abuse
Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers

This is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is to observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in groups of healthy individuals and to compare the side effects and tolerability of a single dose of fenobam with placebo.

Treatment regimen 1: Fenobam \[1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate\], oral administration of one 50 mg gelatin capsule.

Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule.

Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule.

Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule.

Eligibility Criteria:
Inclusion Criteria

1. 18-50 yr old
2. Good general health with no remarkable medical conditions (e.g liver, kidney, heart, or lung failure), BMI\<33 and no known drug allergies.
3. Willing to comply with study guidelines as outlined in protocol
4. Willing to provide informed consent.

Exclusion Criteria

1. Medication use (prescription or non prescription medications, vitamins, herbals, dietary and mineral supplements and grapefruit products during or within 14 days prior to study participation; excludes contraceptives)
2. History of addiction to drugs or alcohol (prior or present addiction or treatment for addiction)
3. Pregnant or nursing female
4. Lactose intolerance
5. Smokers
Diffuse Fibrotic Lung Disease

To determine the effects of cyclophosphamide compared with prednisone, dapsone, or high-dose intermittent 'pulse' therapy with methylprednisolone in patients with idiopathic pulmonary fibrosis. Also, to evaluate the use of intermittent, short-term, high-dose intravenous corticosteroids in patients with sarcoidosis. There were actually four separate clinical trials.

BACKGROUND:

The fibrotic lung diseases represent 15 to 20 percent of the non-infectious disorders of the lung. Idiopathic pulmonary fibrosis, one of the 10 general groups of fibrotic lung disorders, is a chronic and devastating illness resulting in death within an average of 4 to 5 years from the onset of symptoms. Although 5 to 10 percent of these patients respond to corticosteroids, there is no known treatment for the remainder.

Sarcoidosis, a generalized disorder characterized by epithelioid cell granuloma formation in affected organs, especially the lung and lymphoid tissue, has a clinical course that varies considerably from patient to patient and, in some cases, resolves spontaneously. In other cases, intermittent pneumonitis develops, which may result in a permanent loss of lung function. Large intermittent doses of corticosteroids might be superior to conventional high-dose corticosteroids in patients with pulmonary sarcoidosis which has not resolved spontaneously.

DESIGN NARRATIVE:

In the randomized, non-blind cyclophosphamide versus prednisone trial, 25 to 50 patients with idiopathic pulmonary fibrosis were assigned to treatment with prednisone or cyclophosphamide. At the end of 52 weeks of drug therapy, both groups were treated using conventional medical therapies. In the non-randomized dapsone trial, 10 fibrotic patients were treated with dapsone and prednisone for one year. In the double-blind, randomized methylprednisolone trial, 25 to 50 patients were given low-dose methylprednisolone, and, in addition, all patients were randomized to either high-dose methylprednisolone treatment or to placebo at weekly intervals for one year. In the randomized, double-blind, high-dose corticosteroid trial, 25 to 50 patients with pulmonary sarcoidosis were given a short intense course of high-dose methylprednisolone or a placebo for 6 weeks.

The study completion date listed in this record was inferred from the last publication listed in the Citations section of this study record.

Eligibility Criteria:
No eligibility criteria