cyrilzakka/clinical-trials huggingface dataset:
Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease

The study will include patients with acute coronary syndrome without ST segment elevation and multivessel CA lesion, who are subject to surgical treatment according to KG data (Syntax Score 23 - 32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). The patient should be suitable for both CABG and PCI (confirmed by an X-ray surgeon and a cardiac surgeon). An X-ray surgeon and a cardiac surgeon, within the framework of planning the volume of revascularization, strives for the fullest feasible volume. Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of \> 2.5 mm, that is, residual coronary artery stenosis of no more than 60%). Thus, patients will be randomized into groups in a ratio of 1:1. Each group will need to include 230 patients (a total of 460). In the main group, revascularization will be performed by PCI, in the control group by CABG.


Eligibility Criteria:
Inclusion Criteria:

1. Acute coronary syndrome without ST segment elevation of high risk: unstable angina pectoris or myocardial infarction requiring revascularization within 24 hours based on the risk of an unfavorable outcome (increase or decrease in the concentration of cardiac troponin in the blood that meet the criteria of MI; dynamic ST segment displacement or changes in T; risk on the GRACE scale \>140 points)
2. The patient is suitable for both CABG and PCI, confirmed by an interventional cardiologist and surgeon (multivessel lesion with a Sintax score of 23-32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery).
3. Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of \> 2.5 mm, that is, residual coronary artery stenosis of no more than 60%).
4. Signed informed consent
5. Age over 18 years.

Exclusion Criteria:

1. Myocardial infarction with ST segment elevation
2. Stable angina pectoris
3. Patients with OSN Killip II-IV class
4. Patients required an immediate PCI procedure (e.g. electrical instability)
5. A history of hemorrhagic stroke one year before the procedure
6. Ischemic stroke or TIA in the last 6 weeks
7. The final stage of chronic renal failure requiring dialysis.
8. Preliminary PCI for any other coronary artery lesion within 1 year prior to randomization.
9. Pre-CABG at any time prior to randomization.
10. The need for concomitant cardiac surgery, except for CABG (for example, valve surgery, aortic repair, etc.). Patients who require additional surgery (cardiological or extra-cardiac) for 1 year.
11. Non-cardiac concomitant diseases with a life expectancy of less than 1 year (for example, oncological diseases).

13. The left ventricular ejection fraction is less than 40%. 14. Severe degree of COPD
A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with dapagliflozin in subjects with type 2 diabetes mellitus with inadequate glycemic control using metformin.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-75 age years, both inclusive;
2. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
3. HbA1c 7.5-11.0% (both inclusive) at screening;
4. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening.

Exclusion Criteria:

1. Known or suspected allergy to the investigational drug or its components or excipients.
2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
5. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
Back to School COVID-19 Simulation Study

This will be a prospective study simulating return to school for two full days prior to the start of the school year in September. Volunteer students and teachers from six grade ranges will be recruited to participate in the study. In each grade range, there will be two classes that will participate, one that will be assigned to wear face masks/coverings at all times (experimental group/class) and the other that will not wear face masks/coverings at all times (control group/class). Students will be randomized to either the masking at all times (experimental across all grades) or no masking (control across JK-Grade 4) / masking only when physical distance can be maintained (control across Grade 5-Grade 12) class in their appropriate grade. Personal behaviours and person-to-person interactions will be recorded using video cameras. In addition, a safe biological indicator will be applied to the hands to simulate potential asymptomatic infection in a subset of students. Other students will have sanitizer applied so that students are blinded to who has the indicator. Cameras will be used to document how the indicator moves throughout the classroom.

Grade ranges will include 1) Senior Kindergarten (children who have just completed JK or SK in the 2019-2020 year), 2) Grades 1-2, 3) Grades 3-4, 4) Grades 5-6, 5) Grades 7-8 and 6) high school. A total of 14 teachers and up to 240 students will be recruited. Final class sizes will be in accordance with Ministry of Education and public health guidelines.

Eligibility Criteria:
Inclusion Criteria:

• To be included in the study, students must have attended a structure learning environment during 2019-2020 school year and provide informed consent (student in Grade 7 or older) or parental consent (SK - Grade 6) and assent (if appropriate). To be included in the study, teachers must be certified teachers and provide informed consent to participate.

Exclusion Criteria:

* require additional resources or support beyond what can be provided by the single class teacher
* have been exposed to an individual that has tested positive for COVID-19 in the 14 days prior to the simulation
* test positive for COVID-19 in the 14 days prior to the simulation
* have signs or symptoms of COVID-19, as identified on the screening form (See Screening Form) before the simulations
* travel outside Canada in the last 14 days
* known hypersensitivity or allergy to the biological indicator (Fluorescein dye/GloGerm)
Community Based Strategies for Early Detection of Melanoma

The purpose of this study is to pilot the use of community education and digital dermatology to increase the early detection of curable melanomas.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* \>1mm lesion thickness with ulceration (T2b) or \>2mm lesion thickness (T3/T4)
* Low socioeconomic status (SES) Non-Latinx White individuals (according to Yost's index SES level based on a principal components analysis)
* Latinx individuals
* Individual resides in semi-rural area, including zip codes within Antelope Valley in Southern California and Salinas in Northern California
* Individual speaks and reads English or Spanish
* Voluntary willingness and comprehension to consent

Exclusion Criteria:

Exclusion criteria is stage 0, I, IV, or unstaged diagnosis, or any individual who does not meet the above stated eligibility criteria will be excluded from the study.
Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer

The purpose of this study is to evaluate of gender differences on the psychosocial and economic impact in patients with advanced non-small cell lung cancer.

Multi-centre, prospective follow-up post-authorisation study of two patient cohorts with metastatic NSCLC (men and women). It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts. The clinical procedures for assessing the tumour and the treatment response will be performed according to the site's standard practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with stage IV NSCLC who are going to commence first line treatment
* Patients over the age of 18
* ECOG 0-3
* Patients who have granted their informed consent, preferably in writing, but otherwise, verbal with witnesses who are independent of the research team
* Life expectancy of over three months
* Speak fluent Spanish, in order to be able to complete the study questionnaires
* Patients able to read and write with no problems

Exclusion Criteria:

* Previous systemic treatment for metastatic NSCLC. The administration of neoadjuvant or adjuvant radiotherapy and/or chemotherapy is permitted provided it was completed major or equal 6 months prior
* Dementia or a significantly altered mental state that could affect comprehension or the ability to grant informed consent
Percutaneous Nephrostomy Versus Stent In Sepsis Trial

Randomized control trial to compare the efficacy and safety of percutaneous nephrostomy with retrograde ureteric stenting for emergency renal decompression in cases of obstruction and sepsis associated with ureteric calculi.

The obstructed kidney in the setting of urosepsis is a urological emergency. Stone manipulation in the setting of active, untreated infection with concomitant urinary tract obstruction can lead to life-threatening sepsis. Therefore, urgent decompression of the collecting system is warranted.

There are two options for urgent decompression of an obstructed collecting system:

1. Image-guided percutaneous nephrostomy tube placement
2. Cystoscopic retrograde placement of a ureteric stent

This strategy allows drainage of infected urine and penetration of antibiotics to the affected renal unit. Definitive stone manipulation should be delayed until the infection is cleared following an appropriate course of antimicrobial therapy.

Both the European Association of Urology (EAU) and the American Urological Association (AUA) provide guidelines for management of an obstructed kidney. Both organisations provide evidence-based statements of the highest recommendation that urgent decompression of the kidney is mandated in the setting of sepsis. However, neither organisation recommend one decompression modality over the other. There is a lack of high quality up-to-date evidence to support a consensus view that one method of decompression is superior to the other.

This study aims to determine the most effective method of renal decompression in cases of obstruction and sepsis associated with ureteric calculi.

Eligibility Criteria:
Inclusion Criteria:

* Ureteric calculus with proximal hydronephrosis confirmed on CT KUB
* White cell count \>12,000mm3 and/or temperature \>38C

Exclusion Criteria:

* Uncorrected coagulopathy
* Urethral or ureteric stricture disease
* Urinary diversion
* Pregnancy
Immunotherapy Using Autologous T Cell-Engineered With CD19-specific Chimeric Antigen Receptor for the Treatment of Recurrent /Refractory B Cell Leukemia

Objectives:

The purpose of this study is to evaluate the safety and prognosis of New Cluster of Differentiation Antigen 19-chimeric Antigen Receptor T (nCAR19-T) Cells in the treatment of recurrent/refractory B-cell tumor and the Optimal dosage of nCAR19-T cell therapy.

Methods:

This study designs a novel therapy using nCAR19-T. 20 patients will be enrolled. Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4 days (day-6,-5,-4,-3); nCAR19-T transfusion：day 0(5×10※5/kg，1×10※6/kg，3×10※6/kg). According to the National Cancer Institute (NCI) standard (CTCAE), they will be observed 24 weeks long. Follow-up survey after the clinical study: within 1 months, once a week; then once a month for 1 years; and then once a year, a total of 15 years.

A total of 20 patients may be enrolled over a period of 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, male or female
2. Karnofsky≥60%
3. At least 2 courses of chemotherapy were performed
4. Creatinine is less than 2.5mg/dL;alanine aminotransferase (ALT) / aspartate aminotransferase(AST) less than 3 times of the normal bilirubin is less than 3mg/dL
5. Adequate venous access, isolation, and white blood cell production without other taboos
6. Signed informed consent
7. Patients with fertility are willing to use contraceptive method.
8. At least two months after infusion of T cells

Exclusion Criteria:

1. Need to use glucocorticoid therapy
2. Need immunotherapy
3. Creatinine \> 2.5mg/dL; ALT / AST \> 5 times of the normal; bilirubin \> 3mg/dL
4. Forced expiratory volume at one second (FEV1)\<2 L,diffusing capacity of the lung for carbon monoxide (DLCO)\<40%
5. congestive cardiac failure (III or IV, NYHA); Significant hypotension; Coronary heart disease Can not be controlled; DLCO\<40%
6. human immunodeficiency virus (HIV), hepatitis B virus (HBV),hepatitis C virus (HCV) patients
7. Had received gene therapy
8. Significant encephalopathy / new focal neurologic impairment
9. Blood culture positive or radiographic evidence of infection
10. Other drugs, or other biological treatment, chemotherapy or radiotherapy are performed within a month
11. The history of allergic reactions in cell therapy and cetuximab similar compounds.
Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix.

The purpose of this study is to evaluate the use of a hemostatic gelatine-thrombin matrix during athermal nerve-sparing prostate resection compared to conventional hemostasis using electrocautery in patients with localized prostate cancer and to investigate effects on postoperative erectile function and continence.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \>18
* Histologically proven prostate cancer ( Gleason \<8; PSA\<10ng/ml)
* Disease confined to prostate in clinical examination
* Preoperative IEEF-5-Score\>20
* Patient is able to give informed consent

Exclusion Criteria:

* ASA IV-V
* Prior extensive abdominal surgery
* Signs for metastatic disease
* Known allergy against bovine material
* Patient is unable to give informed consent
PDT Study for Exudative AMD With PCV

The purpose of this study is to evaluate and conduct an exploratory comparison of the efficacy and safety of indocyanine green angiography (ICGA) guided photodynamic therapy (PDT) and fluorescein angiography (FA) guided PDT for exudative age-related macular degeneration (AMD) accompanied with polypoidal choroidal vasculopathy (PCV).

PDT with verteporfin has been proven beneficial for patients with AMD. The laser spot size is decided based on FA finding (FA guided PDT). ICGA is needed to detect PCV lesions, such as polypoidal lesions or abnormal network vessels. In clinical practice, PDT based on ICGA (ICGA guided PDT) has and is being conducted for the treatment of AMD with PCV. However, there are no reports on the outcomes of prospective research of PDT for PCV in Japanese patients. Furthermore, there are no reports comparing FA guided PDT and ICGA guided PDT.

We propose to conduct this clinical research in order to investigate the efficacy and safety of PDT for PCV in Japanese patients, and to compare results of FA guided PDT and ICGA guided PDT.

Eligibility Criteria:
Inclusion Criteria:

* Japanese patients aged 50 years old or older
* Exudative AMD with subfoveal PCV
* Eyes with PCV meets the definite criteria of PCV issued from Japanese study group of Polypoidal Choroidal Vasculopathy
* PCV lesion with subfoveal hemorrhage or exudation
* Lesion size (GLD) of less than 12 MPS Disc area measured by FA and IA.
* Decimal BCVA of 0.1-0.5 at baseline period.

Exclusion Criteria:

* Patients who have RPE tear, vitelliform retinal dystrophy, and central Serous Chorioretinopathy.
* Patients who have other ocular disease with irreversible VA
* Study eyes unable to be taken fundus photos of CNV
* Study eyes received surgery operation within 2 months of the participation to this study or ND:YAG operation within one month
* Pathological myopia
* PCV with cleary identified subsensory retinal CNV (on the RPE) at the baseline examination
* Study eyes which have received any treatments for CNV, such as PDT, transpupillary thermotherapy, laser photocoagulation, and so on.
* Patients who have any physical problem for using angiography or PDT (such as systemic debility, significant diabetes mellitus, significant heart disease, and so on)
* Medical history of porphyria, porphyrin sensitivity, or hypersensitivity to sunlight or bright light.
* Patients with medical history of hypersensitivity to ingredients of Visudyne
* Patients with medical history of hypersensitivity to ingredients of fluorescein or indocyanine green injection
* Patients with hypersensitivity to iodine
* Patients judged inappropriate for this study by the investigator
Comparison of the Effects of Retro Laminar Block (RLB) and Erector Spina Area Block (ESP) on Postoperative Recovery Quality and Pain in Lumbar Spinal Surgery

The aim of this study is to compare the efficacy of erector spinae plane block (ESPB) and Retrolaminar Block on postoperative recovary quality and pain after lumbar spinal surgery

The study was designed as a double-blind, prospective randomized controlled trial.

Blindness; The healthcare professionals who will monitor the patient's pain in the post-operative period will not know which of the ESP or RLB block is applied. Randomization of the patients was planned using computer aided. It was envisaged to include 40 participants each in the ESP block and RLB block groups. The current pain status of the patients in the ESP block and RLB block groups in the postoperative period was determined by NRS (Numerical rating scale) at rest and motion at certain hour intervals (30 .min,1.,6.,12.,24. hours) will be done, when the patients' NRS scores are 4 and above, an additional intravenous analgesic will be administered and the number of bolus doses with PCA in the first 24 hours will be recorded. The recovery quality of the patients who underwent both ESP block and RLB block at the postoperative 24th hour will be evaluated with a (QoR-40) scoring system. In addition, the hemodynamic values of the patients will be recorded in these intervals.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lumbar spinal surgery under elective conditions
* ASA I-III
* Between 18-75 ages

Exclusion Criteria:

* refuse during registration
* request to be dismissed from study
* failure to give informed consent
* emergency surgery
* bleeding diathesis
* Presence of contraindications to the LA agents used in this study chronic use of opioids psychiatric disorders the presence of infection at the injection site
Feasibility and Initial Clinical Impressions of Predictive Monitoring Integrated With the RACE Team

Rapid response teams (RRTs) have been adopted by hospitals to provide urgent critical care to hospitalized patients who require quick intervention to prevent further deterioration. Early warning scores (EWS) serve as a method to identify patients requiring RRT assessment by analyzing routinely collected data such as vital signs and laboratory results. The Visensia Safety Index (VSI) is an EWS that uses continuous vital sign monitoring and machine learning to identify the likelihood of deterioration and can be integrated with existing hospital data infrastructure. Initial studies of the VSI have both validated the system and found that patients monitored using VSI had a shorter duration of any instability and fewer episodes of serious and persistent instability. The investigators' recent retrospective analysis at The Ottawa Hospital (TOH) identified that implementation of an EWS could have detected earlier deterioration in over half of the patients identified, potentially preventing subsequent ICU admission, severity of illness, and/or mortality. Thus, this study aims to determine the feasibility and potential impact of implementing a portable continuous monitoring system with a VSI trigger at TOH to identify patients at high risk of deterioration.


Eligibility Criteria:
Inclusion Criteria:

Adult patient (greater than or equal to 18 years of age) designated for the most aggressive levels of potential intervention (Category 1 status - Full Care) who belong to one of the following groups:

* Patients who have undergone high risk elective surgery (Whipple procedures, high risk vascular surgery, high risk general surgery, among others)
* Malignant haematology or oncology patients at high risk for deterioration
* Patients with infection admitted from the Emergency Department (ED) to the ward
* Other high-risk patients determined at the discretion of RACE physician with agreement from the patient's most responsible physicians (MRP)

Exclusion Criteria:

* Patients admitted to a unit with higher level monitoring (Neurological Acute Assessment Unit, Acute Monitoring Area, Trauma Step-Down, Intensive Care Unit)
* Patients with Category II (Full Care except CPR), III (Full Care except Respiratory or Hemodynamic Life Support, or CPR) or IV status (Comfort Care)