cyrilzakka/clinical-trials huggingface dataset:
EnSite Precision 2.1 Feasibility Study

The objective is to demonstrate feasibility of new 'Magnetic Primary' catheter tracking algorithms within the Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1

The secondary objective is to evaluate catheter rendering in the VRP system.

This is an acute, multi-center, observational, prospective feasibility study with up to 80 patients at up to 5 centers in Europe.

Data will be simultaneously collected on both the EnSite Precision 2.0.1 and VRP mapping systems for the entire duration of the EP mapping and ablation procedure. This study will not require significant change to the current clinical workflow of the mapping and ablation procedure. The VRP operator will observe both displays in real-time and will enter extensive electronic annotations to the VRP data stream to facilitate retrospective analysis. Examples of annotations include drug administration, patient movement, and the introduction of devices such as an intracardiac Echography (ICE) catheter which are not visible on the EnSite mapping system.

If/when the VRP operator notices events which might be better understood with additional data, he/she might ask the physician to hold a catheter in a stable position for an extra few seconds and/or move the catheter to another position. Examples of such events include catheters appearing outside the 3D model and unrealistic catheter shapes on either display. Compliance with such requests is optional and subject to physician preference.

Retrospective data analysis will focus on characterization of the following:

* Occurence rates and potential causes for Shift and Drift.
* Frequency and severity of discrepancies between impedance and magnetic coordinates.
* Positions of catheters relative to the 3D model.
* Positions of catheters relative to each other, comparing to fluoroscopic images when available.
* Shapes of catheters on the research system as the catheters are moved to different locations.
* Final geometry apprearance on the VRP.
* Voltage and timing maps appearance on the VRP.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for a cardiac EP study and ablation procedure using a 3D mapping system.
* Over 18 years of age
* Ability to provide informed consent for study participation and be willing and able to comply with the protocol described evaluations.

Exclusion Criteria:

* Pregnant or possibly pregnant patients
Fentanyl Test and A Short OSAS Screening Scale for Severe Obstructive Sleep Apnea

The aim of this study was to estimate and compare the value of the preoperative fentanyl test and the short OSAS screening scale to diagnose severe obstructive sleep apnea；and to observe the required amount of hydromorphone and the adverse respiratory events after adenotonsillectomy.

The results of polysomnography were obtained before adenotonsillectomy, and the short OSAS screening scale was completed by the subjects' parents in preoperative interview. All children were induced by sevoflurane inhalation. After eyelash reflex disappeared and pharyngeal airway insertion, giving 1 mcg/kg fentanyl when the End-tidal concentrations of sevoflurane were maintained at 3.0 and the spontaneous respiratory frequency was stable, observing the changes of respiratory rate. Severe OSAS was diagnosed as respiratory rate decreased by more than 50%. Anesthesia was maintained with desflurane and 60% nitrous oxide in oxygen. The children were transferred to the PACU after extubation. The postoperative pain and agitation were assessed according to the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and The Pediatric Anesthesia Emergency Delirium (PAED) score, and all children were given hydromorphone for pain relief according to our protocol.

Eligibility Criteria:
Inclusion Criteria:

1. The American society of anesthesiologists (ASA) class Ⅰ \~ Ⅱ
2. Age greater than or equal to 3 years
3. Children were diagnosed by polysomnography and plan to adenotonsillectomy.

Exclusion Criteria:

1. craniofacial malformations
2. mental retardation
3. BMI \> 30 kg/m2
4. Combined with other neuromuscular diseases
5. a recent history of opioid use
Significant Activities in the Integrated Person-centered Care Model

The increasing life expectancy and global aging population necessitate changes in long-term gerontological services based on Person-Centred Care approaches. This study aims to improve Person-Centred Care in geriatric centers through meaningful activities and the role of occupational therapists and direct care professionals in developing these activities. A descriptive cross-sectional quasi-experimental design was proposed, with 10 participants.

Background: Increasing life expectancy means that the ageing of populations globally is on the rise. It is therefore important to promote changes in long-term gerontological services based on Person-Centred Care approaches, in which meaningful occupation serves as a basis and is supported by appropriate professional support, such as the occupational therapist and the direct care professional.

Objective: To improve Person-Centred Care in a geriatric centre, through the use of meaningful activities and to identify the role of the occupational therapist and direct care professional in the development of these activities.

Methods: A descriptive cross-sectional quasi-experimental pre-post single-group design is proposed. A total of 10 participants. The methodology used will be mixed. The data collection techniques and tools will be the PDC evaluation instrument pre and post intervention and a survey at the end of the project.

Eligibility Criteria:
Inclusion Criteria:

* That the direct care worker has a degree as a nursing assistant, dependency care technician, geroculturist or certificate of professionalism.
* The worker must speak and understand Spanish.
* The residence must offer service during the day, in the morning or afternoon shift.
* Workers must have been with the department for more than 4 months.

Exclusion Criteria:

* Workers who work night shift only.
* Workers on rotating shifts in all departments of the residence.
* Workers absent at the time of the study due to temporary leave, vacations or other causes.
Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers

This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.


Eligibility Criteria:
Key Inclusion Criteria:

* 19kg/m2 ≤ BMI \<40kg/m2.

Key Exclusion Criteria:

* A history of thyroid disease.
* History of, or current liver disease.
Time to Diagnosis of Glenohumeral Joint Dislocations in the ED- Traditional Radiography vs. POC Ultrasound

This is study to compare the time to diagnosis of glenohumeral joint dislocation using two imaging methods, traditional x-ray and point-of-care ultrasound. Participants who present at the emergency department complaining of shoulder injury and who are suspected of having a possible glenohumeral shoulder dislocation will be eligible for the study. A reduction of the joint will be performed if imaging findings so indicate. All participants will receive a post-reduction x-ray and be referred to appropriate follow-up care.

This is a prospective comparison study evaluating the time to diagnosis of glenohumeral joint dislocation using two imaging modalities, traditional x-ray and point-of-care ultrasound. Eligible participants will include those who present to the emergency department with complaints of shoulder injury who are suspected by triage nursing of having a possible glenohumeral shoulder dislocation. Eligible participants will be consented by participating physicians and randomized into ultrasound or x-ray groups. If indicated based on the imaging findings, a reduction of the joint will be performed. All patients will receive a post-reduction x-ray and be referred to appropriate follow-up care based on the findings of their evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (19 and older in state of Nebraska) who present to the emergency department with shoulder pain/injury and potential shoulder dislocation

Exclusion Criteria:

* Injury sustained in major traumatic event (trauma activation), unable to consent, in extremis, less then 19 years of age
Attitudes and Knowledge of Acne in Mexican Adolescents

Acne is a chronic inflammatory disease that affects almost 100% of the teenagers worldwide. The peak incidence is between 12 and 18 years old, although it can be present in adults. There are many different beliefs about what can cause or exacerbate acne, and also about treatment.

In Mexico, 26.4% of the population is between 15 and 29 years old, which represents that more than 25% of the population is at risk for presenting acne. In our country, the different beliefs about the causes and treatment of acne among general adolescent population have not been explored. The objective of the present study is to determine the possible causes for which young Mexicans do not go to the dermatologist to receive treatment for acne. Our main hypothesis is that the lack of knowledge of the disease is responsible for this behavior.

Acne is a chronic inflammatory disease that affects almost 100% of the teenagers worldwide. The peak incidence is between 12 and 18 years old, although it can be present in adults. There are many different beliefs about what factors can cause or exacerbate acne, as well concerning treatments.

In Mexico, 26.4% of the population is between 15 and 29 years old, which represents that more than 25% of the population is at risk for presenting acne. In our country, there are diverse beliefs about the causes and treatment of acne among general adolescent population which have not been explored before. The objective of the present study is to determine possible causes that are involved in the low use of health system with the intention to receive treatment for acne. The investigators' main hypothesis is that the lack of knowledge of the disease is responsible for this behavior.

The investigators are going to explore health, educational, family and economic issues in the search of association by multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* Mexican subjects
* Age between 12 and 25 years
* Both genders
* Sign informed consent

Exclusion Criteria:

* None
Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)

The purpose of this study is to determine if a single dose of IL-10 compared to placebo is safe and effective in reducing the incidence of post-ERCP acute pancreatitis for subjects with increased risk.


Eligibility Criteria:
Inclusion criteria:

Adults weighing up to 125 kg who are undergoing ERCP for any of the following:

* Evaluate recurrent abdominal pain;
* Evaluate unexplained recurrent pancreatitis;
* Evaluate prior post-ERCP pancreatitis;
* Treatment of pancreatic disorders;
* Treatment of Common Bile Duct Stones (without jaundice)

Exclusion criteria:

* Active (acute) pancreatitis;
* Chronic pancreatitis (moderate and severe cases);
* ERCP to perform a second procedure on biliary tract;
* Patients who previously had pancreatic sphincterotomy;
* Known or suspected pancreatic cancer or cancer of Papilla of Vater;
* Known or suspected other malignancy;
* History of, or current clotting or bleeding problems;
* Moderate and severe Anemia;
* Low platelet counts
Improvement Image Quality for SuperSonic® MACH Ultrasound System

The aim of this Study is to collect radiologist feedback to support the further development and improvement of the imaging modes implemented on the embedded software in the SuperSonic® Ultrasound System (including the probe).


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years old and is able to understand and sign the informed consent form.
* Subject is a minor \< 18 years old and the legal representative has signed the informed consent form.
* Subject is scheduled for at least one or more routine ultrasounds.
* Subject is affiliated to National Social Insurance or a Health Insurance Regimen.

Exclusion Criteria:

* Subject is unable or unwilling to adhere to Study procedures.
* Subject or his/her legal representative if a minor is unable to express or understand informed consent.
* Subject is under legal protection
* Subject is deprived of liberty by judicial or administrative decision
* Subject undergoes psychiatric treatment under constraint
* Subject is admitted to a health or social establishment for purposes other than research
* Subject has latex allergy.
* Subject has an open wound, cut, and/or a rash which would preclude an ultrasound imaging procedure
A Study of ProQuad™ in Healthy Children in Korea (V221-023)

This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster

Exclusion Criteria:

* Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination
* Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity
* Subject has a history of seizure disorder
* Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks
* Subject has received an inactivated vaccine within the past 14 days
* Subject has received a live vaccine within the past 30 days
* Subject has received immune globulin within the past 5 months
* Subject has a recent history of fever (within the last 72 hours)
Muscle Strength Training for Older Adults With Type II Diabetes

This randomised controlled trial aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM).

60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group.

Muscle strengthening group will receive resistance training 3 times per week (1 hour/session).

The control group will not receive any training but can continue usual medical care and daily activities.

Primary outcomes: glycemic control and lipid profile Secondary outcomes: muscle mass and strength, and functional capacity Data will be collected at baseline (pre-test) and after a 4-month intervention (post-test).

This study aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM).

This is a single-blinded, randomized controlled trial. 60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group.

Information on demographic characteristics, body composition, muscle strength, functional capacity and glycemic control will be collected at baseline (pre-test) and after a 4-month intervention (post-test). Muscle strengthening group will receive resistance training 3 times per week (1 hour/session).

The control group will not receive any training but can continue usual medical care and daily activities.

Eligibility Criteria:
Inclusion Criteria:

* T2 DM
* 60-75 years old
* ability to perform exercise

Exclusion Criteria:

* Advanced hypertension (≥ 160/100 mm Hg)
* severe obesity (BMI ≥ 48kg/m2)
* insulin pump user
* coronary heart disease history
* chronic obstructive pulmonary disease
* advanced neuropathy
* learning or mental disorder, or
* any other diseases that prevent subjects from exercising safely.
* Those who participate in regular resistance or aerobic exercises will also be excluded.
An Intuitive, Non-intrusive, Approach to Reduce Patient Harm From Inappropriate Dosing of High-risk Drugs in Older Adult Patients Across an Urban Safety Net Hospital System

This study will assess whether a modification in the default dose and frequency (the first option a provider sees) during electronic prescribing of a high-risk drug can impact prescribing behavior and subsequent changes in average dose for the targeted high-risk drug, when prescribed to a hospitalized patient aged ≥65 years. In this cluster randomized crossover (CRXO) trial we will randomize a non-intrusive "nudge" intervention, which involves modifying the default dose for high-risk drugs when prescribed electronically to hospitalized patients aged ≥65 years. The CRXO trial involves 10 sites in an urban health system: five sites will start the trial under the intervention/control during a first time period (T1) after which they switch intervention/control status (T2). The primary outcome is prescription rate of a lower default dose (i.e. the geriatric standard) for 8 high-risk drugs. This study will inform the effectiveness of EHR-based "nudge" interventions to reduce inappropriate prescribing of high-risk drugs for elderly patients.

Analyses ongoing, expected to finalize spring 2023


Eligibility Criteria:
Inclusion Criteria:

* a patient must be hospitalized
* 65-years old or older
* receive one of the targeted medications

Exclusion Criteria:

- none
Epidemiological Investigation and Cohort Study on Food Allergy in Children Aged 3 to 6 Years in Wenzhou and Taizhou Urban Areas

Objective

1. To investigate the status of food allergy among children aged 3 to 6 in Wenzhou and Taizhou urban areas.
2. To obtain the self-reported rate of parents or guardians of food allergy among children aged 3 to 6 in Wenzhou and Taizhou urban areas.
3. To obtain the prevalence of food allergy among children aged 3 to 6 in Wenzhou and Taizhou urban areas by conducting skin prick test (SPT), blood eosinophil (EOS) count, total immunoglobulin E (tIgE) measurement and serum specific IgE (sIgE) determination in children who self-reported food allergy, and conducting the open food challenge (OFC) if it is needed for further diagnosis.

Methods The preschool children aged 3 to 6 from kindergartens in Wenzhou and Taizhou urban areas were selected by cluster sampling and random sampling to conduct a preliminary screening questionnaire. Then telephone interviewe the children who had diseases or problems caused by certain food or certain types of food. Make them finish further food allergy questionnaires, SPT, EOS, tIgE detection, sIgE detection. SPT has 17 kinds of food allergens including milk, egg white, egg yolk, shrimp, crab, wheat, mackerel, perch, cod, peanut, cashew nut, soybean, peach, pineapple, mango, orange and kiwifruit. sIgE has 10 kinds of food allergens including milk, egg white, shrimp, crab, soybean, peanut, wheat, nut mixed group and food mixed group. Children whose results of SPT and/or sIgE didn't meet the diagnostic criteria and children whose results of SPT and sIgE were negative but its history strongly supported food allergy need to conduct OFC. Descriptive analysis and risk factor analysis were carried out on the results, and SPSS 18.0 statistical software was used in statistics analyzation.


Eligibility Criteria:
Inclusion Criteria:

* The date of birth is in the range of 2011.9.1-2015.8.31

Exclusion Criteria:

* The date of birth is not in the range of 2011.9.1-2015.8.31 or the children who's parents cannot cooperate
VClip Post-Market Study

Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial appendage of the heart during concomitant cardiac procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is greater than or equal to 18 years of age.
2. Subject who received the AtriClip FLEX-V or PRO•V implant during a non-emergent cardiac surgical procedure
3. Subject is willing and able to provide written informed consent
4. Subject is willing and able to return for scheduled follow-up visit and imaging (CTA or TEE)

Exclusion Criteria:

1. Inability, unwillingness, or contraindication to undergo TEE or CTA imaging
2. Subjects who are pregnant or breast feeding
3. Subjects with active COVID-19 infection
Contrast-enhanced CT-based Deep Learning Model for Preoperative Prediction of Disease-free Survival (DFS) in Localized Clear Cell Renal Cell Carcinoma (ccRCC)

This study aims to preoperatively predict DFS of patients with localised ccRCC using a deep learning prognostic model based on enhanced contrast CT images, validate it's predictive ability in multicentre data and compare it's predictive ability with traditional models.


Eligibility Criteria:
Inclusion Criteria:

* underwent partial/radical nephrectomies
* histologically diagnosed as ccRCC
* with complete clinical data and preoperative CT image data

Exclusion Criteria:

* with incomplete clinic-pathological data
* lack of preoperative contrast-enhanced CT images or the image quality was unsuitable for analysis
* who received pre-surgery neoadjuvant or adjuvant therapies
* with multiple renal tumors or/and had synchronous metastasis
IVL and RA in Treatment of Balloon-crossable Severely Calcified Coronary Lesions

This study to compare periprocedural safety, angiographic success as well as short and long term outcomes of intravascular lithotripsy and rotational atherectomy as a method of severely calcified coronary lesion preparation before DES implantation.

Coronary artery calcification (CAC) occurs in over 90% of men and 67% of women older than 70 years old .

Severe coronary calcification may be present in about 20% of patients undergoing percutaneous coronary intervention (PCI) .

Coronary calcification may impair stent delivery and expansion and damage the polymer/drug coating, resulting in impaired drug delivery and predispose to restenosis and stent thrombosis.

Intravascular imaging as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are good tools to assess calcium burden, distribution and thickness. Among the two imaging techniques, OCT was found to be more accurate than IVUS in defining calcium burden, calcium area , thickness and calcium length.

Rotational atherectomy (RA) as a method of severely calcified lesions modification before Drug-Eluting-Stent (DES) implantation has shown good outcomes in recent studies. However, its efficacy is reduced in presence of deep calcification.

Recently, intravascular lithotripsy (IVL) has been introduced as a novel modality for severely calcified coronary lesion preparation with good preliminary outcomes .

Currently the two techniques are regularly being used in combination in order to achieve optimal results . Whether IVL is a method equally good (or superior) to rotablation in cases where anatomy does not exclude the use of either technique (for example balloon-crossable, heavily calcified lesions) has not yet been discussed.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years undergoing PCI because of stable angina (uncontrolled symptoms on optimal medical treatment) or post stabilized acute coronary syndrome (ACS).
* Patients have severe calcification: defined either angiographically or by OCT (or IVUS) as calcium arch \>180º in at least one cross section , calcium length \>5mm, calcium thickness \>0.5 mm (2, 6).
* Vessel diameter ≥2.5mm and ≤4.0mm .
* Heavily calcified lesion length less than 40mm.
* All patients must have been discussed in the heart team of the hospital and accepted for coronary intervention

Exclusion Criteria:

* Severe coronary calcification with lesion uncrossable from a balloon.
* PCIs in the setting of STEMI or NSTEMI with persistent complains.
* Patients in cardiogenic shock.
* Heart failure New York Heart Association (NYHA) class IV.