cyrilzakka/clinical-trials huggingface dataset:
Prediction of Fluid Responsiveness in Children Undergoing Major Surgery

The purpose of this study is to evaluate predictability of a respiratory variation in pulse oximeter plethysmography for fluid responsiveness in children undergoing major surgery.

The purpose of this study is to evaluate predictability of a a respiratory variation in pulse oximeter plethysmography (delta POP) for fluid responsiveness in children undergoing major surgery.

When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, the study will be started. At index fingers of both hand, pulse oximeter sensors are applied by gradually increasing the contact force (from 0 to 1.4N, being increased by 0.2-0.3N). Then, pulse oximeter plethysmography (POP) waveforms are obtained for 90 seconds. Then, intravenous crystalloid fluid 10 mL/kg is infused for 15 min.

To evaluate the change of cardiac output, transesophageal or transthoracic echocardiography is performed before and after fluid administration. In addition, hemodynamic parameters including pulse pressure variation, systolic pressure variation, pleth variability index and central venous pressure are also recorded before and after fluid administration.

Finally, patients will be divided into fluid responder group and non-responder group. If stroke volume index measured using echocardiography increases over 15% after fluid administration, the patient will be fluid responder.

Delta POP (%) obtained from each finger with different contact force is calculated as follows;(POPmax - POPmin)/{(POPmax + POPmin)/2}. Using receiver operating characteristic curve, diagnostic power of delta POPs from different contact forces for fluid responsiveness will be evaluated. In addition, difference between delta POP from low contact force and that from high contact force will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

- Children who will be scheduled for major surgery requiring invasive hemodynamic monitoring

Exclusion Criteria:

* renal, hepatic and pulmonary disease
* preoperative infection: increased C-reactive protein, whith blood cell count over 10,000, and with fever
* genetic and hematologic disease
* ventricular dysfunction
* increased intracranial pressure
PROOF: PROtein OverFeeding Effect on Body Weight

This study is designed to determine the effects of dietary protein content on overfeeding.

When body weight increases, the expenditure of energy increases as a mechanism to dissipate the excess calories. The role of diet composition in over-feeding/energy dissipation in humans is unknown. We propose that:

1. High and low protein diet will result in less weight gain as compared to a moderate protein diet during a 56d high fat overfeeding.
2. Increase in energy expenditure and spontaneous physical activity, adjusted for lean and fat mass will be greater in the high and low protein diets as compared to a moderate protein diet.
3. the average size of the fat cells and the pattern of genes expressed in the adipose tissue, skeletal muscle, and peripheral blood mononuclear cells will "predict" which group of subjects will gain the most weight (and fat mass) independent of the level of the protein in the diet.

Eligibility Criteria:
Inclusion Criteria:

* Have a BMI of 19-30kg/m2 A cutpoint of 26kg/m2 will be used to allocate treatment across the three diets. See the statistics section for more detail.
* Are willing to eat all of the study foods even when full
* Are willing to eat only foods provided by Pennington and all of the foods provided
* Are willing to live at Pennington for 10-12 weeks possibly without leaving the metabolic unit the entire time
* Are willing to avoid exercise while in the inpatient phase of the study
* Age 18 - 35

Exclusion Criteria:

Participants are ineligible to participate in the study if they...

* Smoke
* Have Diabetes
* Have claustrophobia
* Have a Fasting Blood Sugar \>110
* Have a history of cardiovascular disease
* Have an average screening blood pressure \>140/90
* Have a history of a major psychiatric, addictive or eating disorder or any psychosocial or scheduling factors that could impede study outcomes
* Post obese (self-reported BMI) must never have had a BMI greater than 32
* Exercise more than 2 hours per week
* Unable to complete VO2 max test.
* Weight gain or loss of \> 3kg in the last 6 months
* Have significant renal, hepatic, endocrine, pulmonary or hematological disease, or a history of gout
* Have had previous GI surgery, Obstructive disease of the GI tract, Hypermotility disorder or a history of problems of impairment of the gag reflex.
* Corticosteroid use in the last 2 Months
* You are pregnant or breastfeeding
* Have Irregular menstrual cycles
* Use Depo-Provera, hormone implant or estrogen replacement therapy
* Have an allergy to PABA (a component of a B-vitamin often found in sunscreen)
Star-Close Versus Angio-Seal for Femoral Artery Hemostasis

This study was designed to evaluate the efficacy and safety of Starclose (Abbott Vascular Devices) for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus (St. Jude Medical).

The growing success of interventions and requirement for day case or outpatient procedures has led to a concomitant rise in the use of arteriotomy closure devices (ACD) to achieve hemostasis and allow early mobilization following arterial punctures. ACD have emerged as an alternative to traditional mechanical compression after percutaneous coronary intervention (PCI). When compared to manual compression, several studies have confirmed patient comfort, reduced time to achieve hemostasis, reduced time to ambulation, and early discharge.

Recently, CLIP Trial was conducted to evaluated the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures. A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n=113), diagnostic (n=208), and interventional (n=275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. This trial demonstrated that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression.

However, there are no studies randomly comparing these two closure devices. Therefore, this study was designed to evaluate the efficacy and safety of Starclose (Abbott Vascular Devices) for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus (St. Jude Medical).

Eligibility Criteria:
Inclusion Criteria:

* The patient must be at least 18 years of age.
* Patients with appropriate arterial puncture in the common femoral artery eligible for percutaneous closure device deployment Patients undergoing PCI (only 7F sheath)
* Patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* Uncontrolled hypertension
* Severe peripheral vascular disease
* Severe femoral artery tortousity and calcification
* Severe obesity (BMI \> 35)
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
* Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
* Patients with cardiogenic shock
* Acute MI patients within symptom onset \< 12 hours needing primary angioplasty
Sensory Basis of Speech Motor Learning

These studies test the hypothesis that sensory areas of the brain participate in the consolidation of speech motor memory by using transcranial magnetic stimulation to suppress activity in somatosensory and auditory cortex following adaptation in order to block retention of learning.

Subjects will train using either altered somatosensory feedback or altered auditory feedback (different groups of subjects). Immediately following adaptation, continuous theta burst magnetic stimulation (cTBS) will be applied to either auditory or somatosensory or motor cortex with the goal of blocking consolidation of motor memory. The logic of applying cTBS to both sensory areas is to test the hypothesis that both areas are involved in motor memory consolidation. Subjects leave the laboratory following cTBS and return 24 hours later to assess retention of learning. Learning is assessed as percentage change in speech sounds or movements relative to baseline. Retention is measured on a 0 to 100 scale relative to the end of learning.

Eligibility Criteria:
Inclusion Criteria:

* right handed adults
* no known physical or neurological abnormalities

Exclusion Criteria:

* patients with:
* cardiac pacemaker
* surgical clips or values on the heart
* implants
* metal or metallic fragments in any part of the body
* pregnancy
* claustrophobia
* a personal or family history of epilepsy
* currently taking antipsychotic drugs
* currently taking antidepressant drugs
* currently taking antianxiety drugs
* history of concussion.
Video Coaching as an Efficient Teaching Method for Surgical Residents

The purpose of this study is to determine if video coaching is an efficient way of teaching surgical skills outside of the operating room for surgical residents.

Coaching relates to a cooperative process between a coach and a coachee, which includes "providing objective and constructive feedback to help a \[coachee\] recognize what works and what can be improved.

In our study the investigators will be filming general surgery residents while making a side to side anastomosis on a dog's cadaveric small bowel. Half of the participants will be randomized in the intervention group and will take part in a half hour coaching session with a surgeon. In this coaching session both resident and surgeon will watch the resident's filmed anastomosis and constructive feedback will be given by the surgeon. An inanimate model of bowel anastomosis will be available at the moment of the coaching to allow the surgeon to demonstrate the desired improvements.

Once all the residents in the intervention group will have completed their coaching session, both control and intervention group will be filmed making a second side to side anastomosis.

All the video taken will then be pooled in a random order. A blinded surgeon will then analyse each video taken with the objective structured assessment of technical skills (OSATS) tool.

The hypothesis is that the residents who received an half-hour coaching session will have significantly improved their OSATS score compared to the control group between the first and second anastomosis.

Eligibility Criteria:
Inclusion Criteria:

* Residents from PGY-1 to PGY-4 in general surgery at Université de Montreal

Exclusion Criteria:

* PGY-5 in general surgery at université de Montreal ( because they are studying for their Board exams )
* Did no sing consent form
Enhancing Cancer Survivorship With Pickleball

The purpose of the study is to evaluate the feasibility and acceptability of a pickleball program for cancer survivors and their family members or friends. The program is designed to increase physical activity, improve wellness, and allow individuals to work together to learn and practice the sport.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* History of a cancer diagnosis excluding squamous and basal cell skin cancers
* Able to speak and read English
* Able to provide informed consent
* Able to pass a 2023 Physical Activity Readiness Questionnaire+ (PAR-Q+) (with appropriate physician clearance(s), as necessary)
* History of cancer diagnosis will be required for cancer survivor group; friend or family partners can be (but do not need to be) cancer survivors.

Exclusion Criteria:

* Screen failure for exercise safety based on 2023 PAR-Q+
* For cancer survivor group, history of squamous and basal cell skin cancers
Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.

This study is being conducted to see if magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life.

Not all ICD shocks are for ventricular arrhythmias. Some patients receive shocks when they have arrhythmias in the atria (top chambers of the heart). These are called inapproriate shocks, but the pain is similar to the pain patients feel with an appropriate shock (a shock for a ventricular arrhythmia). This study is being conducted to determine if taking magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life. Magnesium's impact of the electrocardiogram (ECG) and intracellular magnesium concentrations will also be studied.

Comparison: Magnesium compared to placebo in patients with ICDs to evaluate the number of ICD shocks and patient perceived quality of life.

Eligibility Criteria:
Inclusion Criteria:newly implanted ICD or recent ICD shock (within 6 months) -

Exclusion Criteria:inability to swallow, a non-cardiac disease with a survival prognosis of less than 12 months, hypermagnesemia, a creatinine clearance less than 30mL/min, lactic acidosis or systemic acidosis syndrome, or previous intolerance to magnesium L-lactate.

-
Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ?

PURPOSE. To compare the results between two sites of implantation of the continent catheterizable channel (CCC): native bladder or enterocystoplasty.

METHODS. Retrospective monocentric study of pediatrics and adult patients who underwent a continent cystostomy between 1991 and 2020 with a continent catheterizable channel implanted in the native bladder's detrusor (D group) or the enterocystoplasty (EC group).

This is a monocentric and retrospective study involving adult and pediatric population who underwent the creation of a CCC between June 1991 and January 2020. Two different surgical techniques were performed: on the first hand, the implantation of the channel in the native bladder's detrusor (D group), on the other hand the implantation of the channel by seromuscular plicature on the anterior wall of the enterocystoplasty (EC group).

The CCC were made from the appendix, an ileal or sigmoid segment, an ureter or a skin flap. Bladder augmentation and cervicoplasty (Kropp, Kurzrock, Young-Dees, artificial urinary sphincter, sling suspension of the bladder neck, closure of the bladder neck) were frequently associated.

The following informations were obtained in all included patients by charts reviews: age at surgery, gender, main underlying pathology, details of operative reports with the type of channel, bladder augmentation and/or associated cervicoplasty, early postoperative complications, complications appearing during the follow up period and the requirement of surgical or non-surgical revision, finally the channel continence at the last follow up.

Eligibility Criteria:
Inclusion Criteria:

* Adult and pediatric patients who underwent a surgery for creation of a continent catheterizable channel
* Between 1991 and 2020
* In the pediatric surgery or urology department at Nancy University Hospital

Exclusion Criteria:

* Ghoneim technique used for implantation
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis

The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of atopic dermatitis for greater than (\>) 1 year
* Atopic dermatitis involvement of greater than or equal to (\>=) 10 percent (%) body surface area
* EASI score of \>= 12
* SCORAD of \>= 25
* IGA score of \>= 3
* Effective birth control in line with protocol details

Exclusion Criteria:

* History of anaphylaxis following any biologic therapy
* Hepatitis B, C or human immunodeficiency virus
* Pregnant or breastfeeding
* History of cancer
* Previous receipt of tralokinumab
Individualized Prehabilitation for Enhancing Recovery and Surgical Outcomes in Patients Undergoing Radiotherapy and Surgery for Soft Tissue Sarcoma

This clinical trial evaluates whether patients with deep soft tissue sarcomas who receive a tailored prehabilitation exercise regimen during standard radiotherapy and prior to standard of care surgery have better recovery and surgical outcomes than those who do not. Patients undergoing surgery to soft tissue sarcomas are at high risk for post-operative disability, which is associated with high rates of depression and poor health-related quality of life. Prehabilitation is the practice of exercising before surgery to ensure that the patient is in the best possible condition. It allows patients to prepare their bodies for recovery after surgery, which may result in better surgical outcomes, recovery, and quality of life after surgery.

PRIMARY OBJECTIVES:

I. To determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS).

II. To identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT), wearable Heel2Toe sensor technology, and daily step count.

III. To estimate recruitment, retention, adherence, and acceptability rates.

SECONDARY OBJECTIVES:

I. To compare changes in quality of life over time as a result of the prehabilitation intervention using the Edmonton Symptom Assessment Scale (ESAS), European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L) (Euroqol Group), the Patient Generated Index (PGI).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients perform personalized prehabilitation physical therapy exercises twice a day (BID) 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo magnetic resonance imaging (MRI) and computed tomography (CT) at week 9.

ARM II: Patients receive educational materials and attend a telemedicine visit with a research assistant once a week for 8 weeks while receiving standard of care radiotherapy prior to standard of care surgery. Patients undergo MRI and CT at week 9.

After completion of study, patients are followed up at weeks 2, 6, and 12.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically-proven deep soft tissue sarcoma (STS) of the lower extremity
* Localized
* Adults, 18 and older
* All gender types
* Subjects must be able to provide appropriate consent or have an appropriate representative available to do so

Exclusion Criteria:

* Soft tissue sarcomas that are in a superficial location relative to fascia
* Patients with metastatic disease (distant or nodal)
* Both and upper and lower extremity involvement
Evaluation of Robotic Telesonography

Robotic telesonography, in which an expert remotely performs sonography in real time, has recently emerged as an opportunity to perform sonography at remote centres. Using a robotic system and an assistant with limited training at the remote site, an expert can manipulate an ultrasound probe and generate images in real-time via an Internet connection. This study aims to demonstrate the feasibility of robotic telesonography for obstetric and adult and pediatric abdominal imaging in a centre with established sonography services which will be used as a comparator to robotic telesonography.

Lack of trained sonographers in remote communities limits access to sonography for many patients. As a result, patients must travel or be transported to secondary and tertiary care centres, which often delays diagnosis and subsequent treatment, creates burdens for patients and their families, and increases healthcare costs. Robotic telesonography, in which an expert remotely performs sonography in real time, has recently emerged as an opportunity to provide sonography regardless of the availability of a skilled operator at the site. Studies primarily originating in Europe have demonstrated robotic telesonography in abdominal, pelvic, obstetric, and cardiologic applications in adults. However, the full potential of robotic telesonography across many imaging applications has yet to be explored, and robotic telesonography has not yet been trialed in Canada. This study aims to demonstrate the feasibility of robotic telesonography in a centre with established sonography services which will be used as a comparator to robotic telesonography. Approximately 30 patients will be recruited for each substudy (obstetric, adult abdominal, and pediatric abdominal). All patients will receive both conventional and robotic scans in a crossover design. The sonographer performing the scan will be asked to complete a data collection form which will collect information about duration of the exam and any challenges encountered. Following the completion of both scans, the patient-site assistant will provide a questionnaire to the patient (or for children, a parent/guardian of the patient) regarding his/her experience with the system. A physician will review images generated using either the robotic telesonography or conventional sonography systems and report findings on a standardized reporting form.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to have an abdominal study or second trimester ultrasound study at Royal University Hospital or Saskatoon Medical Imaging.
* Pediatric abdominal substudy: male and female patients 5 years of age or older and less than 18 years of age
* Adult abdominal substudy: male and female patients 18 years of age and older
* Obstetrics substudy: second trimester patients 18 years of age and older

Exclusion Criteria:

* Patients who do not meet the inclusion criteria above
* Patients who are in distress prior to or during the exam
Systane Clinical Experience Study

To evaluate the physical effect of SYSTANE QID in people that have moderate to severe dry eyes and to establish doctor confidence to prescribe Systane.


Eligibility Criteria:
Inclusion Criteria:

* moderate to severe dry feeling eyes

Exclusion Criteria:

* None