cyrilzakka/clinical-trials huggingface dataset:
Establishment, Verification and Clinical Application of Chinese Version of Surgical Risk Assessment System

The goal of this observational study is to establish and verify the Chinese version of surgical risk assessment system and explore its clinical application. The main questions it aims to answer are: The process of establishing a Chinese version of surgical risk assessment system; What is the accuracy of the system; How can the system be used in clinic; How does this system compare with other systems (such as NSQIP). Participants will comprehensively collect the general information, examination and pathological information of the patients, using machine learning and artificial intelligence methods for data processing. Finally, the Chinese version of the surgical risk assessment system will be established. After the system is established, investigators will evaluate the accuracy of the system and compare it with other related systems.

The research process is as follows:

1. Determine the collection index and the complications to be evaluated, and retrospectively collect the preoperative clinical data (including preoperative medical records, examination and examination results) of patients with postoperative complications of gastric and colorectal cancer in our hospital in the past ten years. Preliminary construction of surgical risk assessment system (gastrointestinal surgery)
2. Retrospective or prospective collection of gastric cancer and colorectal surgery cases (not included in the system)
3. The occurrence of postoperative complications was observed until 1 month after discharge. Compare the evaluation results of the system with the actual situation and feedback to further improve the system.
4. The same batch of patient data can be input into NSQIP to re-evaluate and predict the occurrence of patient complications, and then compare the results of the two systems.
5. The incidence of postoperative complications (number of cases and accuracy) of the two groups were counted respectively, and the accuracy and practicability of the evaluation of the two systems were compared to further improve the system.

Eligibility Criteria:
Inclusion Criteria:

* Preoperative colonoscopy and biopsy confirmed gastric and colorectal cancer.
* Laparotomy or laparoscopic radical resection of gastric or colorectal cancer.
* No postoperative complications such as pneumonia, venous thrombosis, cardiovascular and cerebrovascular accidents occurred before operation.
* There was no serious organ dysfunction before operation.
* Complete auxiliary examination and the availability of examination and examination data were carried out before operation.

Exclusion Criteria:

* Complicated with malignant tumors of other organs.
* Unresectable tumors.
* Distant metastasis.
* Severe organ system dysfunction before operation.
* Patients with non-operative treatment.
AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater
* Bilateral condition (cataracts or Presbyopia) for which phacoemulsification and posterior IOL implantation has been planned for both eyes
* Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
* Clear intraocular media other than cataract
* Normal OCT of the macula
* No evidence of Keratoconus or significant irregular astigmatism on Preoperative topography
* No evidence of Epithelial Basement Membrane Dystrophy on Slit lamp Exam
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Use of systemic or ocular medications that may affect vision
* Uncontrolled systemic or ocular disease
* History of ocular trauma
* History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction)
* Amblyopia or strabismus
* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
* Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/25 or worse
* Subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy)
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* Contact lens usage within 2 months for PMMA contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses
Intestinal Sweet Taste Receptor Function and Adaptation to Dietary Sugars and Sweeteners

The purpose of this study is to collect data that will help researchers better understand the various causes of obesity and diabetes; particularly to understand how consumption of NCASs affects the way the body uses nutrients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years inclusive;
2. Men and women;
3. Able to provide written, informed consent;
4. Weight stable (± 3 kg) during the 3 months prior to enrollment;
5. BMI ≤ 25 kg/m2

Exclusion Criteria:

1. Diagnosed with any of the following co-morbidities: a) coronary artery disease, angina or heart failure, b) diabetes, c) bleeding disorders, d) infections, e) hepatitis and/or cirrhosis, f) severe asthma or chronic obstructive pulmonary disorder, g) renal insufficiency, h) bariatric surgery, i) inflammatory bowel disease or malabsorption, j) cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ), k) psychiatric or eating disorders, l) untreated or inadequately controlled thyroid or other endocrine disorders, m) active rheumatoid arthritis or other inflammatory rheumatic disorder;
2. Consumption of more than a can of diet beverage or a spoonful of non-caloric artificial sweeteners weekly (or each equivalent from foods) during the past month.
3. Pregnant or nursing women;
4. Current smokers (smoking within the past 3 months);
5. Known hypersensitivity to saccharin, lactisole, and acetaminophen or any of its exipients;
6. History of difficult blood sample collections or unfavorable anatomy of venous access;
7. Use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, g) other drugs known to affect immune or metabolic function and h) orlistat, phentermine or other weight loss or anorectic agents.
8. Blood pressure greater than or equal to 160/100 or less than or equal to 100/50 at screening.
Assessment of Child Psychological Attributes for Prediction of Child Behavior at First Dental Visit

One of the most prevalent chronic diseases worldwide is mental disorder, including social, emotional, and behavioral problems, and it is the fifth main cause of global disability . In Egypt, it is estimated that 20.6% of children aged from 6-12 years had behavioral problems

Behavioral and emotional problems may affect deeply child's quality of life, such as impairment of school life (high absence), They may cause nutritional imbalance and even suicidal thoughts. Therefore, both the dentist and the family should be adequately prepared to deal with those children who come seeking dental treatment.

Recently, studies proved the association between the psychological characteristics and the behavior of children in dental setting. There was a study that showed that there is a relation between psychological functioning of the child, dental anxiety and his/her behaviour during dental appointment. Furthermore, it was found that there is a correlation between the temperamental difficulties or emotional problems of the child and the non-cooperative behavior during the process of injection of the local anesethia.

These studies ensures the importance of understanding the effect of mental disorders on the behavior of children during dental treatment, as it would help the professionals to properly plan the clinic appointments without any delay or cancellation of the appointment and allows him to render effective and efficient dental treatment.

this study aims to acknowledge the different psychological attributes among children seeking dental treatment at young age and to assess the association between child psychological attributes and his/her behavior in dental clinic.

Eligibility Criteria:
Inclusion Criteria:

* Children: school aged children (4 to 7) years old
* Teeth: carious teeth requiring a simple dental treatment (cavity preparation with restoration)

Exclusion Criteria:

* Children:

  * Medically compromised children.
  * Children with previous dental history.
  * Refusal of participation.
LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS

The objective is to assess the effectiveness of permanent exclusion of the LAA with the LARIAT RS Suture Delivery Device and accessories in AF patients.

Prospective, observational, single-center, non-randomized study of a stand-alone procedure for the exclusion of the LAA with the LARIAT RS in patients with atrial fibrillation. Completed LAA exclusion will be assessed by TEE.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 years
2. Diagnosed non-valvular atrial fibrillation
3. Current CHADS2 score ≥ 2
4. Poor candidate (e.g., contraindicated, labile INR, non-compliant, etc.) for anticoagulation (e.g., warfarin, dabigatran, apixaban, and rivaroxaban)
5. Life expectancy of ≥ 1 year
6. Willing and able to provide written informed consent
7. Willing and able to come to and comply with scheduled follow-up visits

Exclusion Criteria:

1. Previous cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery)
2. Prosthetic heart valve or ring in any position
3. Current NYHA Class IV heart failure symptoms
4. Current right heart failure
5. Myocardial infarction or unstable angina within last 3 months
6. Current cardiogenic shock or hemodynamic instability
7. Current symptomatic carotid disease
8. Need for an intra-aortic balloon pump or intravenous inotropes
9. Embolic stroke or transient ischemic attack (TIA) within the last 30 days.
10. Current diagnosis of active systemic infection
11. Need for emergent cardiac surgery (e.g., cardiogenic shock)
12. Current renal failure requiring dialysis
13. Current clinical evidence of cirrhosis
14. Any history of thoracic radiation
15. Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases
16. Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders)
17. Any history of pericarditis
18. Pectus excavatum (clinically defined by treating physician)
19. Severe scoliosis
20. Pregnancy or desire to get pregnant within the next 12 months.
21. LVEF \< 30%
22. Current participation in a clinical investigation that involves an active treatment arm.
23. Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study
24. Any other criteria, which would make the patient unsuitable to participate in this study as determined by clinical site Principal Investigator (e.g., an uncontrolled drug and/or alcohol addiction)
Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder

This is a retrospective study to identify the prognostic factors of the good outcomes in patients who presented with upper GI bleeding from tumor and received Hemospray via endoscopy for hemostatic control. The good outcomes were assessed by immediate hemostasis, rebleeding at 72 hours as well as 7, 14 and 30 days following presentation at initial bleeding episode and also 6-month survival rate.

Tumor-related gastrointestinal (GI) bleeding is increasing due to the advancement of treatment in oncology. However, conventional endoscopic hemostatic methods are not reliable to control bleeding. Surgery, embolization, and radiotherapy can served as the salvage hemostasis; though, a bridging endoscopic therapy is required during resuscitation and stabilization of the patients. Hemospray is a recent novel endoscopic hemostatis powder which has a trend to be an effective instrument for controlling the active upper GI tumor bleeding from a match-pair, case-control study by the author's recent publication. Consequently, the authors hypothesized that there are some prognostic factors related to the outcome of Hemospray treatment in tumor bleeding.

Eligibility Criteria:
Inclusion Criteria:

* All patients seen in the emergency room and/or hospitalized for malignant gastrointestinal haemorrhage from 2011 to 2017

Exclusion Criteria:

* Age \< 18 years
Multi-CAR-T Cells Targeting B Cell Lymphomas

This study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting B cell surface molecules including CD19 and alternative CARTs as booster and consolidation treatment for patients with highly resistant B cell lymphomas, including primary mediastinal B cell lymphoma (PMBCL) and BCL involving central nervous system (CNS-BCL). Clinical response and development of a simplified and standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Chimeric antigen receptor (CAR) T cell therapy has proven effective in treating B cell malignancies. However, post CD19-CART relapses occur at high rate due to the CD19 antigen loss or the exhaustion of CART cells. Furthermore, the success of treating relapsed/refractory B cell lymphoma (BCL) such as primary mediastinal B-cell lymphoma (PMBCL) and CNS-involved BCL has been limited. To overcome tumor escape and prolong in vivo CART efficacy, we have developed a novel multiple CAR-T therapy regimen including booster and consolidation CART applications to to target highly-refractory cancer. Selected patients will be enrolled after target antigen confirmation including CD19, CD20, CD22, CD70, CD13, CD79b, GD2 and PSMA through immunostaining of their tumor specimens. The aim is to evaluate safety and long term efficacy of the multiple CART therapy strategy in the BCL patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age older than 6 months.
2. Primary B cell lymphoma surface expression of CD19 and/or CD22/CD70/PSMA/ CD13/CD79b/GD2 molecules.
3. The KPS score over 80 points, and survival time is more than 1 month.
4. Greater than Hgb 80 g/L.
5. No contraindications to blood cell collection.

Exclusion Criteria:

1. Accompanied with other active diseases, and difficult to assess response after treatment.
2. Bacterial, fungal, or viral infection, unable to control.
3. Living with HIV.
4. Active HBV and HCV infection.
5. Pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment.

7. Prior failed CAR-T treatment.
Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure

A prospective, randomized, controlled single-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS) at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be randomized in a 1:1 treatment device to control ratio into one of two (2) different study arms:

1. AIS with an insufflation pressure target of 9mmHg ±1mmHg; or
2. AIS with an insufflation pressure target of 15mmHg ±1mmHg.

The study is designed and powered to demonstrate superiority of the AIS at low pressure vs. at higher pressure on a single key effectiveness measure: Incidence of shoulder pain. Patients will be randomized 1:1 to either AIS with an insufflation pressure target of 9mmHg ±1mmHg or to AIS with an insufflation target pressure of 15mmHg ±1mmHg.

Secondary outcome measures include severity of shoulder pain measured using a VAS scale and medication use, length of hospital stay, aspects of anesthesia management including end tidal CO2 and the frequency of adverse events. These outcomes will be evaluated in a controlled population undergoing laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric subjects (\<21 years of age)
2. \> 20 kg in weight;
3. Capable and willing to provide parental Informed Consent and patient Assent;
4. Acceptable candidate for laparoscopic surgery;

Exclusion Criteria:

1. Active cutaneous infection or inflammation;
2. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
3. Uncontrolled diabetes mellitus
4. Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline INR(international normalized ratio) ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
5. Severe co-existing morbidities having a life expectancy of less than 30 days;
6. Currently involved in any other investigational clinical Studies;
7. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
8. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
9. Extreme morbid obesity (BMI greater than 45 kg/m2)
10. Patients presenting with Ascites
Validation of Smart Garments for Gait Classification

The aim of this study is therefore to validate Myant SKIIN garments for the purpose of gait and balance assessment. To achieve this, we recruit young healthy adults from the University of Waterloo to wear Skiin products (see Fig. 1). Participants will be asked to perform a number of scripted gait and balance tasks.

Specific objectives of this study are:

1. To validate Skiin gait characterization algorithm (based on single garment solutions - already developed based on a literature and a previous study conducted at the University of Waterloo);
2. To develop algorithms for multi-garments solutions that aim to extract additional kinematic parameters such as joint angles.

Gait metrics from Skiin garments will be compared to metrics from a gold standard measurement (Vicon motion capture) to indicate accuracy, precision and reliability.

Eligibility Criteria:
Inclusion Criteria:

- Healthy male and female adults aged 18y - 64y old

Exclusion Criteria:

- Self-reported lower limb conditions, neurological disorders, history of concussion/brain trauma, and/or condition limiting exercise is to mitigate additional risk for injury and/or adverse reactions associated with exercise.
Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to AIEC

The M2iSH laboratory showed with two previous clinical trials that Crohn's Disease (CD) macrophages present i) a defect to control Adherent-Invasive Escherichia coli (AIEC) infection related to polymorphisms associated with CD; ii) a CD - specific cytokine secretion profile after an AIEC infection and intestinal inflammation dependent; iii) a modification of the response of CD macrophages at a basal state and after the AIEC infection. These results consolidate the hypothesis of a defect specific to CD macrophages.

That's why, the primary purpose of this study is to realize a proteomic analysis of macrophages of CD patients infected or not with AIEC and to compare them to Ulcerative Colitis (UC) patients and healthy volunteers.

The macrophages characterization will be realized at a basal state and in response or not to AIEC.

Investigator aimed to 1) better understand the differences between macrophages of CD patients, UC patients and healthy volunteers but also the impact of AIEC infection on these macrophages to provide key informations to detect and characterize the defect of these macrophages; 2) highlight one or several protein in CD macrophages that could represent, in a long term, a potential therapeutic target of CD.

Eligibility Criteria:
Inclusion Criteria:

* - Crohn's Disease or ulcerative colitis or healthy volunteers
* Age \> 18 years
* Patients benefiting from the health insurance plan
* Patients who can read and attest to understanding the information note and informed consent

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Under guardianship or curatorship
* Refusing the genetic part of the study
Evaluation of the Duration of Bupivacaine Spinal Block in Orthopedic Procedures With and Without Epinephrine Wash

Bupivacaine spinal is commonly performed as the primary anesthetic for orthopedic procedures. In some cases the duration of the block is inadequate. An epinephrine wash is sometimes performed to prolong the duration of the block. The epinephrine wash may prolong the duration of the block, and if it does, to what extent?


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patients scheduled for total hip or knee replacement

Exclusion Criteria:

* Patients taking anticoagulation
* Infection at or near the intended needle insertion site
* Patients with sacral decubitus ulcer at or near the intended needle insertion site aortic stenosis
* Complex spine anatomy
* ASA class greater than III
* Failed SAB as determined by the staff anesthesiologist