cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Pulse Oximeters With Profound Hypoxia

The goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. The study is designed in accordance with ISO 80601- 2-61,2ed:2017-12 \& 2018-02.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

Pregnancy -
Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block

The primary aim of this study is to compare needle tip visibility between the coracoid approach and retroclavicular approach for infraclavicular brachial plexus block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the differences between the two groups in the needle shaft visibility, sensorial block success rate, block performance time, block performance related pain, motor block success rate, surgical success rate, complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.

Infraclavicular blocks are performed with different approaches. Infraclavicular block is usually traditionally performed at coracoid approach. Different approaches has been described for this block such as vertical approach. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with traditionally coracoid approach for infraclavicular brachial plexus block. 100 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Coracoid approach for infraclavicular block (Group I), retroclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 10 minutes until 30min after local anesthetic injection.Success rate of each nerve sensory block, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects, the needle tip and shaft visibility, procedure time,duration of the block's effect, use of supplemental local anesthetic, use of analgesic.are compared with both groups.

Eligibility Criteria:
Inclusion Criteria:

* patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
* American Society of Anesthesiologists class 1 to 3
* Ability to consent

Exclusion Criteria:

* History of allergic reaction to local anaesthetics
* Peripheral neuropathy
* Renal or hepatic insufficiency
* Coagulation disorders
Examining the Impacts of Parent-Child Interactive Activities

The purpose of this study is to demonstrate the effects of online and offline play of games on the Mightier game platform, in comparison to the effects of Mightier online play alone.

Mightier is a mobile app-based biofeedback video game platform that facilitates emotion regulation skill-building among children ages 6-14. The technology behind Mightier's mobile app has been validated in two independent sham-controlled randomized controlled trials, where the investigators have seen decreases in clinical symptoms of aggression and disruptive behaviors, as well as lowered family stress without adverse events.

Mightier will soon introduce offline Mightier Family Games to its product line. Mightier Family Games will include offline, interactive components that have not previously been incorporated into Mightier play. Studies have shown that improvements in child behavior and child-parent relationships are among the many benefits of family play.

For the proposed study, families with no prior Mightier exposure will engage in different types of Mightier play for six weeks, to demonstrate the effects of online and offline Mightier play in comparison to the effects of Mightier online play alone. Mightier will recruit families through social media, then Mightier will randomly assign participants to one of two groups: a Mightier online play only group, and a Mightier online and offline play group. The investigators will aim to enroll 20 participants in each group.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-12 at the time of screening
* Regular access to WiFi (for Mightier gameplay device connection)

Exclusion Criteria:

* Prior Mightier use
* Diagnosed Intellectual Disability (by history)
* Planned medication changes during the 6-week study period
A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment of GERD

The aim of this study was to determine the effectiveness of endoscopic full-thickness plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in comparison to a sham procedure.

Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary endpoint was ≥ 50% improvement in GERD-HRQL score. Secondary endpoints included medication use and esophageal acid exposure.

Patients achieving ≥ 50% improvement in GERD-HRQL score at 3-months versus baseline off-meds were considered responsive to their assigned procedure. Patients who failed to reach this level of improvement at 3-months were considered non-responders. Analysis of these dichotomized variables (responder/non-responder) was done using Fisher's exact test comparing the proportion of responders between the active and sham groups. Intent-to-treat analysis was also performed. The null hypothesis was that the proportion of responders was the same in both the active and sham groups. Testing was done at the 5% level of significance (alpha=0.05).


Eligibility Criteria:
Patients 18 years or older with a history of heartburn or regurgitation symptoms requiring daily PPI therapy were recruited.

Inclusion Criteria:

* GERD-HRQL score ≥ 15 while off PPI therapy, and at least 6 points higher than on-PPI score
* Pathologic esophageal acid exposure, defined as pH\<4.0 ≥ 4.5% of a 24- or 48-hour monitoring period or a DeMeester score \> 14.7
* Lower esophageal resting pressure of at least 5mmHg; and
* Suitability for surgery (American Society of Anesthesiologists Physical Status Classification I or II).

Exclusion Criteria:

* Significant esophageal dysmotility as determined by manometry
* Esophagitis grade III or IV (Savary-Miller)
* Barrett's epithelium
* Hiatus hernia \> 2cm
* Persistent dysphagia, weight loss, esophageal bleeding, vomiting, gas or bloating
* Esophageal or gastric varices
* Previous endoscopic or surgical anti-reflux procedure
* Other esophageal or gastric surgery
* Chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis); and
* Pregnancy.
Role of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies

The aim of the study is to evaluate the role of subcutaneous negative pressure drain placed for 10 days on wound healing in female obese patients undergoing midline exploratory laparotomies for ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* BMI more than 30kg/m2
* midline laparotomies
* ovarian cancer

Exclusion Criteria:

* associated medical disorders
Remineralization Efficacy of Gum Arabic Varnish.

The aim of this study is to evaluate the remineralizing capacity of Gum Arabic varnish and its implementation into clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with initial carious lesions.
* Proper Oral hygiene.

Exclusion Criteria:

* Patients with a compromised medical history.
* Patients with active severe periodontal disease.
* Patients with hypoplastic or hypomineralized teeth.
Comparative Analysis of Large Macular Hole Surgeries

This study compares the anatomical and visual outcomes in a large series of patients affected by idiopathic macular holes larger than 400 µm treated using pars plana vitrectomy and gas tamponade combined with internal limiting membrane (ILM) peeling or the inverted internal limiting membrane flap technique. A part of the participants will receive internal limiting membrane peeling,whil the other will receive the inverted internal limiting membrane flap technique.

Vitrectomy is the standard treatment for idiopathic macular holes (IMHs) and is combined with removal of the internal limiting membrane (ILM) to improve anatomical outcomes.However, surgical closure is not achieved after a single operation in all cases, and patients with long-standing MHs or highly myopic eyes are challenging to treat.Various surgical strategies have been introduced to improve postoperative outcomes for these cases. Michalewska et al. have reported an inverted ILM flap technique for large MHs. The ILM around the MH was left to cover or fill the hole and showed a better anatomical closure rate and visual outcome than ILM peeling for large MHs. Nevertheless, the functional and anatomic outcomes of the ILM flap technique have not been investigated as extensively as the ILM peeling technique and have yet to be confirmed by research comparing the ILM flap technique with the conventional procedure.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic MHs, a minimum hole diameter of ≥ 400 μm, and follow-up for at least 3 months after vitrectomy.

Exclusion Criteria:

* High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, \>21 mm Hg) or glaucoma, severe cataract, severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery.
Lymphatic Function in Patients With a Fontan-Kreutzer Circulation

The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an extremely important step in the prevention of edema. The Fontan-Kreutzer procedure has revolutionized the treatment of univentricular hearts. However, it is associated with severe complications such as protein-losing enteropathy (PLE) and peripheral edema that may involve the lymphatic circulation.

Our hypothesis is that patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE.

The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF. The anatomy is described using non-contrast MRI and the capillary filtration rate is measured using plethysmography.

Background:

The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an extremely important step in the prevention of edema. The Fontan-Kreutzer procedure has revolutionized the treatment of univentricular hearts. However, it is associated with severe complications such as protein-losing enteropathy (PLE) and peripheral edema that may involve the lymphatic circulation.

Hypothesis:

Patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE.

Material and Methods:

The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF. The anatomy is described using non-contrast MRI and the capillary filtration rate is measured using plethysmography. The study population is patients with Fontan-Kreutzer circulation operated at Aarhus University hospital. Exclusion criteria is BMI\>30 and age (years) \< 18. The Fontan-Kreutzer group will be compared with an age, gender and weight matched control group of healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Fontan-Kreutzer circulation

Exclusion Criteria:

* BMI\>30,
* Age\<18
* Mental illness
Reducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes

Pilot of a novel video-based telemedicine intervention to reduce fear of hypoglycemia in parents of young children with type 1 diabetes.

This was a two group randomized controlled study using a wait-list control design. All participating parents had the opportunity to receive 10 video-based telemedicine sessions administered over 13 weeks. Study assessments took place at baseline, post-treatment, and 3 month followup. Study outcomes included parent reported hypoglycemia fear, parenting stress, diabetes distress, and child glycated hemoglobin.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children, between 1-6 years old, with type 1 diabetes for at least 6 months, on either multiple daily injections or an insulin pump, and parents speak English

Exclusion Criteria:

* Families of children who are older than 6 years-old and or do not have type 1 diabetes; children follow a conventional insulin regimen
Knee Connect: Measuring Range of Motion and Gait Metrics After Total Knee Arthroplasty

The main goals of total knee replacement (TKR) surgery are to relieve pain and to allow patients to remain active. Sunnybrook is working with Kineris Inc.to advance a wearable device, the Knee Connect, aimed at tracking the physical recovery of patients after total knee replacements. After surgery, patients experience a gradual progression in function as their knee range of motion (ROM) increases and their gait patterns normalize. Goals for these metrics are well documented after the patient is fully recovered. However, there is a lack of detailed information available about the week by week improvements patients make in these metrics. The main objective of this study is to determine the accuracy of the Knee Connect device in quantifying the weekly improvements in ROM and gait parameters of patients recovering from surgery.

A research assistant will conduct in person data collections on 36 patients using the Kineris wearable device. The device is an electronic goniometer connected to a smart phone application. Patients will be recruited from the "Patient Orientation Program" (POP) at the Sunnybrook Holland Centre. Data collection will occur preoperatively, at the end of each physiotherapy Knee Class session, and at the three month postoperative clinic visit. The research assistant will help fit and attach the wearable device to each patient's knee. Patients will be asked to bend their knee (flexion and extension) while wearing the device which will measure patients range of motion. The research assistant will also measure knee range of motion using a handheld protractor. Afterward, patients will be asked to walk 10 steps, using any walking aids or techniques they typically use at home. There will be 15 collections per patient requiring ten minutes per session. Chart reviews will also be conducted to determine patient reported outcomes which will be then correlated with the functional measures.

All data will be extracted and input into an excel file. For both the ROM tests, the accuracy of the Knee Connect device will be compared against the plastic goniometer. This will be done by using a paired t-test and calculating interclass correlation coefficient. The data will then be analyzed using a repeated measures ANOVA and Bonferroni post-hoc analysis to determine differences in the variables week to week. Additionally, a regression analysis will be used to estimate the week by week improvements in these variables.

Eligibility Criteria:
Inclusion Criteria:

* Be currently on the waiting list for a primary TKR
* Be enrolled for the "Knee Class" postoperative physiotherapy at the Sunnybrook Holland Centre with the expectation of attending the class through the duration of the class.
* Be able to provide informed consent.

Exclusion Criteria:

* Revision total knee arthroplasty
* Neuromuscular disorder
* Bilateral TKR procedures
Continuous Glucose Monitoring for Emergency Laparotomy

CLUE trial aims to determine the feasibility and predictive value for surgical site infection (SSI) of continuous glucose monitoring (CGM) in emergency laparotomy patients with diffuse peritonitis.

Hyperglycaemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications. Therefore, the investigators predict that number of hyperglycaemia episodes could be a predictor of SSI.

Continuous glucose monitoring allows for a minimally invasive real-time remote glycemia control, yet it has not been applied in an emergency surgery setting. Intraoperative glycemia monitoring would allow to determine the effect of specific interventions during a surgical procedure that may provoke hyperglycaemia.

CLUE is a single-centre prospective observational study held in an academic tertiary medical centre in Poland. Adult patients qualified for an emergency laparotomy for peritonitis in University Clinical Centre (UCC) Division of Oncological, Endocrine and General Surgery, with class ≥ III wounds according to Centers for Disease Control and Prevention (CDC) classification, will be eligible for the CLUE trial. Patients who will be unable or will refuse to express informed consent will be excluded. Patients will be co-enrolled in PRISTINE randomized health services study that aims to compare the effectiveness of negative pressure wound therapy (NPWT) and primary closure (PC) in surgical site infection prevention.

On admission day, patients will have a Dexcom G6 system placed on the outer part of the upper arm. Patients will undergo standard surgical procedures and perioperative care. Patients will be randomized to NPWT or PC according to PRISTINE protocol. Glycemia will be continuously monitored for 10 days.

Eligibility Criteria:
Inclusion Criteria:

* emergency laparotomy for peritonitis
* written informed consent

Exclusion Criteria:

- open abdomen treatment
Correlation Between Changes in Sex Hormone Levels and Stress Urinary Incontinence in Women

The goal of this observational study is to learn about the relationship between stress urinary incontinence and endogenous steroids in women, especially its occurrence and severity with androgens and estrogens. The main questions it aims to answer are:

* Association between stress urinary incontinence and endogenous steroids in women
* Risk factors associated with stress urinary incontinence in women Participants will be asked to provide basic clinical information as well as results of measurements of serum steroid hormone levels.

Researchers will compare Stress urinary incontinence group and control group to see if the changes of sex hormone levels were statistically significant.

By comparing the differences of six hormones between female patients with stress urinary incontinence (SUI) and non-SUI patients (patients without pelvic floor muscle dysfunction and lower urinary tract dysfunction) aged ≥20 years, especially the changes of androgen and estrogen levels, the correlation between the changes of hormone levels and stress urinary incontinence was obtained. Multivariate logistic regression analysis was used to analyze the relationship between hormones and urinary incontinence, and further correlation analysis was performed for statistically significant hormones. Estrogen and androgen were divided into four groups: normal estrogen/normal androgen group, decreased estrogen/normal androgen group, normal estrogen/decreased androgen group, decreased estrogen/decreased androgen group. Stratified analysis was performed to analyze whether there was an interaction between the two hormones and exclude confounding effects. Finally, the data were further analyzed by sensitivity analysis of baseline characteristics, and the known risk factors were verified in this trial, including age, parity, menopausal status, genetic factors, obesity, and on this basis, the correlation between pelvic surgery history, diabetes, hypertension, smoking and stress urinary incontinence was explored.

Eligibility Criteria:
Inclusion Criteria:

- Experimental Group

1. women aged ≥20 years
2. Stress urinary incontinence diagnosed in our hospital;
3. Six hormone tests were performed in our hospital; Control group

(1) women aged ≥20 years; (2) diseases other than stress urinary incontinence diagnosed by our hospital; (2) Six hormone tests were performed in our hospital;

Exclusion Criteria:

1. Pelvic organ prolapse, overactive bladder, urge urinary incontinence, overflow urinary incontinence, mixed urinary incontinence;
2. patients who received hormone replacement therapy within 6 months;
3. estrogen-dependent diseases, such as endometriosis, uterine leiomyoma, ovarian tumors;
4. the presence of gynecological malignant tumors or other diseases affecting hormone secretion;
5. the presence of nervous system diseases.
Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy

Study the interest of hypnosis techniques by virtual reality based on the use of a virtual reality headset with the AQUA® application on the reduction of pre-operative stress in patients candidates for total thyroidectomy


Eligibility Criteria:
Inclusion Criteria:

* Patient\> 18 years old
* Man or woman
* Patient candidate for a total thyroidectomy, or a thyroid totalization
* Preoperative Euthyroidism
* Can justify outpatient care: score of the American Society of Anesthesiology (ASA) 1, 2 or 3 stable; accompanied for return at home; can be watched by a loved one the night after returning home; reachable by telephone; living within an hour of transportation from a hospital and having a good level of understanding.
* No history of parathyroid or recurrent pathology
* Signature of informed consent before any specific procedure related to the study
* Subject affiliated with a health security system

Exclusion Criteria:

* Patient with a submerged goiter (lower edge of the thyroid not seen on the preoperative cervical ultrasound)
* Patient with uncontrolled infectious pathology
* Pregnant or breastfeeding woman or lack of contraception during genital activity
* Patient with illnesses or conditions that hinder their ability to understand follow and / or comply with study procedures
* Patient with personality disorders and / or psychiatric pathology
* Patient deprived of liberty or placed under the authority of a guardian
Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy

Sleep problems are more common and more severe in children with epilepsy. The purpose of this study is to develop and evaluate the effect of a clinic-based and technology-supported sleep intervention for improving sleep and health in children with epilepsy and their parents.

Participants in the intervention group will receive a standard pediatric neurology care plus a hybrid in-person and digital sleep education program.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 1.5 and 9 years with a confirmed diagnosis of epilepsy.
* Parents with sufficient Chinese language skills to fully comprehend the trial and complete questionnaires.

Exclusion Criteria:

* Children with cerebral palsy or those who are bedridden.
* Children with a documented sleep disorder, such as obstructive or central sleep apnea and sleep-related movement disorders
* Children born with a congenital, genetic, or orthopedic abnormality that limit their activities of daily living or impair their physical activity.