cyrilzakka/clinical-trials huggingface dataset:
EndoTic - Endothelium and Ticagrelor

Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells) in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1 month).

ACS Patients in both treatment groups will be assessed:

Baseline, 48h and 1 month cell counts will be done for CECs and EPCs Platelet Function at 48h and 1month Adverse Events, ECG and blood testing result will be also collected

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign Informed Consent Form
* 18 yr or older
* Male and female (post menopause or contraception treatment)
* ACS diagnosed with elevation of myocardial infarction biomarkers (as of 3rd Universal Definition of MI)
* Planned invasive strategy (coronariography performed within 72hrs after admission)

Exclusion Criteria:

* Aspirin, clopidogrel or ticagrelor allergy.
* Hemorrhagic diathesis or very high risk of bleeding.
* Current treatment with oral anticoagulants, thienopyridines or ticagrelor.
* Limited life expectancy.
* Elective surgery planned.
* High chance of not being able to complete the follow-up period.
Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty

The hypothesis is that computer simulated bony impingement of the bone surrounding the spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional (3-D) computed tomography (CT) imaging analysis is predictive of the location of clinical scapular notching that develops following reverse total shoulder arthroplasty (TSA).

The Specific Aims are:

* Determine the relationship between lateral glenoid offset and the development of scapular notching following reverse TSA
* Determine the ability of 3-D preoperative planning tools to define areas of scapular bony impingement on kinematic simulated shoulder range of motion that predict the development of scapular notching
* Compare the precision and accuracy of plain radiographs (2-D) versus CT (3-D) for measurement of scapular notching and postoperative implant position following reverse TSA (2-D versus 3-D)
* Determine the implant and anatomic factors that best correlate with clinical outcome following reverse TSA by retrospective analysis

Eligibility Criteria:
Inclusion Criteria:

* All patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and a minimum of two years out from surgery

Exclusion Criteria:

* All patients having undergone reverse TSA at the Cleveland Clinic with no preoperative CT or a low quality preoperative CT of the operative shoulder and/or less than two years from surgery
Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate

The investigators hypothesize software-based fusion/navigation will be accurate to within 3 mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of prostate US/MRI software-based fusion/navigation technology.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for ultrasound-guided gold seeds prostate fiducial placement prior to radiotherapy

Exclusion Criteria:

* eGFR \< 45 mL/min/1.73m2
* recent (within 4 weeks) kidney or liver transplant
* contraindication to prostate MRI
* patient with cardiac pacemaker
M-Tapa Block for Laparoscopic Cholesistectomy

Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery.

Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery.

M-TAPA block provides analgesia at the level of T5-T11 in the abdominal region. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen. Analgesia occurs in several dermatomes thanks to the cephalocaudal spread of the local anesthetic solution. There are studies in the literature investigating the effectiveness of M-TAPA block for post-operative pain management in bariatric surgery.

In this study, the investigators aimed to evaluate the effectiveness of M-TAPA block for postoperative analgesia management after laparoscopic cholecystectomy surgery.Primary aim is to compare the postoperative pain scores (VAS), and secondary aim is to compare the postoperative rescue analgesic use and postoperative opioid consumption, and the side effects (allergic reaction, nausea, vomiting) associated with opioid use.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* Scheduled for laparoscopic cholesistectomy surgery under general anesthesia

Exclusion Criteria:

* Bleeding diathesis
* Receiving anticoagulant treatment
* Known local anesthetics and opioid allergy
* Infection of the skin at the site of the needle puncture
* Pregnancy or lactation
* Patients who do not accept the procedure
Novel BP Monitoring Methods to Study the Association Between Sleep BP Patterns and BP Values in Daily Life

Out-of-office blood pressure (BP) measurement by means of ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM) is recommended for the diagnosis and management of hypertension in the latest guidelines. Ambulatory BP values are more strongly associated with target organ damage and cardiovascular (CVD) events than office values. In particular, nocturnal blood pressure level and reduction of BP during the night (dipping) have been recognised as predictors of cardiovascular complications. However, in current clinical practice, these parameters are derived from ABPM. HBPM represents an inexpensive alternative to ABPM, is preferred by patients and provides a more realistic assessment of BP during an individual's daily life. However, until recently, HBPM did not offer the possibility to measure nocturnal BP or dipping.

The development and validation of new BP devices, such as the NightView (OMRON Healthcare, HEM9601T-E3) could overcome this limitation, offering the possibility of home night-time BP measurements with minimal sleep disturbance. On the other hand the use of wearable devices such as HeartGuide (OMRON Healthcare, HEM-6411T-MAE) could provide BP values in daily life conditions. Compared with conventional HBP, typically measured in resting conditions at home, values obtained with wearable devices might be closer to daytime ABP values.

Combining nocturnal HBP, with daytime BP from wearable device could therefore allow the estimation of dipping status comparable with that provided by ABPM.

In order to compare HBP-derived dipping estimate with the gold standard ABPM-derived value, it is aimed to enrol patients with hypertension, assess their blood pressure profile with ABPM and provide them with both NightView and HeartGuide devices for 7 days. Then diurnal and nocturnal BP and dipping derived from standard 24-hour ABPM will be compared and the combination of NightView/HeartGuide in order to understand whether the latter can offer a reliable assessment of 24h BP pattern.

For a better phenotypization of nocturnal BP and dipping status the following determinants of nocturnal BP and dipping status will be also investigated: sleep quality, sleep duration, the presence of sleep disorders, salt consumption, catecholamine phenotype.

This study will offer the unique opportunity to understand whether such new HBP devices can be offered in alternative to ABPM in the assessment of 24h BP profile in patients with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* arterial hypertension defined as office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg or the presence of antihypertensive treatment
* antihypertensive treatment stable over 2 weeks preceding enrolment
* written informed consent

Exclusion Criteria:

* atrial fibrillation/flutter of frequent ectopic beats
* pregnancy and lactation
* terminal malignant disease, life expectancy \<6 months
* limb amputation
* dementia
Influenza Vaccine To Prevent Adverse Vascular Events:Pilot

A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.

Cardiovascular disease is a major cause of morbidity and mortality. There is recent evidence that infection due to influenza may precipitate vascular events such as myocardial infarctions and strokes. There is some evidence that influenza vaccination may prevent such events but the data are inconclusive. The investigators propose a randomized controlled trial to assess whether influenza vaccination will prevent vascular illness. Adults with clinical heart failure will be randomized to inactivated influenza vaccine or saline placebo. This pilot study will provide needed data to establish the feasibility of a larger study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and NYHA functional class II, III and IV

Exclusion Criteria:

* Anaphylactic reaction to a previous dose of TIV
* Known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
* Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
* Anaphylactic reaction to neomycin
* Patients who have had influenza vaccine in two of the three previous years
Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part A

The target population for this project will be men-who-have-sex-with-men (MSM) at high risk of HIV acquisition

225 high risk MSM will be interviewed to understand the knowledge and acceptability of pre-exposure prophylaxis (PrEP) in this population in Puerto Rico. A 187 item questionnaire will administered which will evaluate socio-demographic information, sexual conducts, PrEP knowledge and PrEP acceptability.

Eligibility Criteria:
INCLUSION CRITERIA;

Study subjects who meet the following inclusion criteria will be considered for enrollment for Part A:

1. age 21 years or older
2. understand and sign the informed consent form and willing to participate in the study
3. male or transgender female
4. has one of the following risk factors:

   * a high risk MSM as defined by:
   * having unprotected sexual intercourse with at least two male partners in the past 6 months, or
   * diagnosed with an STI in the past 6 months.

PART A - EXCLUSION CRITERIA:

Subjects with any of the following will not be considered for enrollment in Part A:

1. Age younger than 21 years old
2. Unable or unwilling to provide an informed consent
3. Female gender at birth
4. Do not meet the high risk criteria
A Single-Dose Study of MK6349 in Patients With Type 2 Diabetes (6349-002)

A single dose study to assess the safety, tolerability, pharmacokinetics and pharmacokinetics of MK6349 in Type 2 Diabetics.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a non-smoking male or female (females must be postmenopausal, had a tubal ligation or a hysterectomy) between 18 to 55 years of age
* Subject has Type 2 Diabetes and is currently being treated with diet and exercise alone or with less than 3 oral diabetes drugs

Exclusion Criteria:

* Subject is on insulin or a PPAR agonist medication
* Subject has Type 1 diabetes
Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients

To investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.

Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients is an academic,independent, pragmatic , prospective, multicenter, observational registry study. The acute ischemic stroke patients undergone endovascular therapy will be enrolled in stroke centers. Baseline information and clinical follow-up information at 90 days of stroke onset are collected. Data collected include demographics, comorbidities, pathogenesis, blood pressures, stroke severity on admission, time intervals, reperfusion condition, and functional outcome, et al. The study aims to investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Acute ischemic stroke;
2. Brain imaging confirmed intracranial large vessel occlusion: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);
3. Initiation of any type of endovascular treatment, including mechanical thrombectomy, aspiration, angioplasty, and stenting;
4. Informed Consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent

Exclusion Criteria:

1. Acute intracranial haemorrhage
2. No evidence of large vessel occlusion on digital subtraction angiography.
3. Patient bedridden or presenting from a nursing home
4. Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) -
Diagnostic Value of CircRNA-Uck2 for Acute Myocardial Infarction

This is an observational diagnostic study that aims to evaluate the diagnostic value of circRNA-Uck2 in Acute Myocardial Infarction (AMI) in adults as compared to healthy and unstable angina controls. Rapid and adequate diagnosis of AMI is of great importance to enable a rapid start of treatment, save large tracts of dying myocardium, reduce the infarct size,and thereby decrease the risk of subsequent heart failure.

RATIONAL acute myocardial infarction (AMI) is the leading cause of sudden death and heart failure worldwide. And about 10% of all emergency department consultations are with symptoms suggestive of AMI, however, only 10% to 20% of them are diagnosed as experiencing an AMI. Rapid and accurate identification of AMI is of paramount clinical importance for subsequent timely and effectively treatment and management.

Recently, the investigators identified microarray analysis and real-time polymerase chain reaction (PCR) from AMI animal models and small samples of AMI patients, a molecular signature of AMI involving 5 circRNAs (circRNA_006877, circRNA_015350, circRNA_002969, circRNA_013240, circRNA_004682) was found significantly change in AMI patients and likely serves as candidate serum biomarkers of AMI. Among the 5 circRNAs, circRNA_006877 name of circRNA-Uck2 (cUck2) has more close association with AMI.

TYPE OF STUDY : multicenter diagnostic evaluation Study MAIN PURPOSE OF THE STUDY : To evaluate the diagnostic value of circRNAs in AMI in adults as compared to healthy and unstable angina controls

SECONDARY OBJECTIVES :

assess the ability of cUck2 to discriminate a AMI disease from unstable angina patients in adults.

explore the relationship between cUck2 and heart function after myocardial infarction PRODUCTS OF THE STUDY diagnostic kit of AMI in quantitative polymerase chain reaction (qPCR) NUMBER OF PATIENTS : 3 groups with 169 patients will be included Group 1: 66 AMI adult patients Group 2: 56 unstable angina adults Group 3: 56 Witnesses healthy adults INCLUSION LENGTH 36 months DURATION OF THE STUDY 42 months

Eligibility Criteria:
Inclusion Criteria:

* Health Control Group:Pepole who have normal ECG, deny the history of cardiovascular disease can be included in the healthy control group.
* Acute Myocardial Infarction Group:Clinical diagnosis of acute myocardial infarction
* Unstable Angina Group:Clinical diagnosis of unstable angina.
* Sign informed consent.

Exclusion Criteria:

* Myocarditis, hypertrophic cardiomyopathy, ablation.
* Malignant hypertension, severe arrhythmia.
* Chronic muscle disorders, rhabdomyolysis.
* Severe liver and kidney dysfunction.
* Malignant tumors, acute cerebrovascular disease.
* Severe neurosis, psychosis.
* Patients who had any of the above were excluded.
Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent for de Novo Diffuse Disease Treatment

A Pilot Observational Study to evaluate safety and efficacy of the hybrid approach DES/DCB in treating de-novo diffuse lesions

This is a prospective, non-randomized, single-arm, multi-center, pilot, noninterventional study whose aim is to assess the feasibility and the clinical outcomes of using the Restore DCB (Cardionovum GmbH, Bonn, Germany) in combination ("hybrid approach") with a new generation DES (type at operator's discretion) for the treatment of diffuse CAD encountered in daily clinical practice. The rationale of the proposed strategy derives from the characteristics of DCB in treating the atherosclerotic disease without leaving a permanent structure in the vessel especially in case of diffuse CAD -avoiding a long metallic, permanent cage within extended coronary segments

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse CAD involving segments suitable for a hybrid approach;
* Signed Patient Informed Consent/Data Release Form

Exclusion Criteria:

1. Age \<18 years;
2. Cardiogenic shock;
3. Pregnancy or breastfeeding;
4. Infarct-artery max diameter (within planned device deployment segment) \<2.0 or \>5.0 mm;
5. Comorbidities with life expectancy \<6 months;
6. Severe calcification or/tortuosity proximally or at the DCB target segment;
A Mosque-Based Intervention to Promote Physical Activity in South Asian Muslim Women

South Asian (SA) women living in Ontario have a higher risk of developing type 2 diabetes and coronary heart disease (CHD) compared to the general population. Various explanations for these differences have been established, one of which is based on low levels of physical activity in people of SA origin, particularly in Muslim women.

This pilot trial will test the feasibility, acceptability and effectiveness of a Mosque-based exercise and educational intervention designed for SA Muslim women.

1. What is the feasibility of a mosque-based intervention to promote physical activity that is culturally and gender sensitive to South Asian Muslim women?
2. What is the acceptability of a mosque-based intervention to promote physical activity that is culturally and gender sensitive to South Asian Muslim women?
3. What is the effectiveness of a mosque-based intervention to promote physical activity that is culturally and gender sensitive to South Asian Muslim women?

South Asian (SA) women (people with origins in Pakistan, India, Bangladesh or Sri Lanka) living in Ontario have a higher risk of developing type 2 diabetes and coronary heart disease (CHD) compared to the general population. Various explanations for these differences have been established, one of which is based on low levels of physical activity in people of SA origin, particularly in Muslim women. Studies suggest that they participate in less physical activity or recreational exercise compared to other SA women. Practical barriers (e.g. lack of time, childcare) are often interwoven with cultural barriers, such as restrictions leaving the home alone to enter mixed-gender settings, and lack of socialization into sporting and other outdoor activities) inhibit participation.

The provision of culturally and gender sensitive facilities, such as women-only exercise sessions at mosques could serve as a solution for Ontario SA Muslim women to be more active. Studies indicate health promotion programs in religious institutions (e.g. churches) have demonstrated clinical and psychosocial benefit to women of various ethnic groups. Similar to Canadian churches, mosques have key elements identified in the literature to be beneficial in providing physical activity opportunities for Muslim women: partnerships, available and accessible space and supportive social relationships.

To the investigators' knowledge, mosque-based physical activity interventions for SA Muslim women have not been implemented and evaluated in Ontario. Such interventions are needed to help attenuate the risk of diabetes and CHD in this ethnic group who represent a significant part of the Ontario population.

Eligibility Criteria:
Inclusion Criteria:

* Muslim women attending Madinah Mosque

Exclusion Criteria:

men
Posterior Column Fractures of Tibial Plateau

The goal of this observational study is to learn about the long-term effects of internal fixation methods in patients with posterior column fractures of tibial plateau according to three column concept. The main question it aims to answer is:

Does the internal fixation of posterior column fractures of tibial plateau according to three column concept has a good radiological and clinical outcomes in follow up for 1 year? Participants already having internal fixation for their posterior column fractures will do X ray in their follow up visit and answer survey questions about their joint pain, ROM for 1 year.

The goal of this observational study is to measure the radiological and clinical long term effects of internal fixation methods in patients with posterior column fractures of tibial plateau according to three column concept by using Rasmussen score

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature patients (18 - 60 years old).
* Tibial plateau fracture with posterior column involvement classified by X-ray and CT scan
* Fractures within 3 weeks of trauma

Exclusion Criteria:

* Open fracture grade 3 Gustilo Anderson Classification but not managed by internal fixation within 3 weeks of trauma
* Paediatric fractures.
* Pathological fractures
Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy

Chemotherapy induced peripheral neuropathy is common in tumor patients receiving chemotherapy. Nowaday, CIPN is mainly treated with drugs, but the therapeutic effect is not satisfactory. Previous studies have found that inflammatory immune mechanism plays an important role in neuropathic pain. Vagus nerve stimulation can not only relieve pain by regulating the autonomic nervous system, but also participate in the immune response. Investigators hope that the treatment by vagus nerve electrical stimulation through ear skin can improve the pain and neurotoxicity scores of CIPN patient.If it is proved that vagus nerve stimulation can effectively treat CIPN, it will become a simple and safe non-drug treatment which has good application prospects.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is currently receiving chemotherapy drugs with neurotoxicity
2. New or worsening numbness and / or pain in the hands and / or feet, and no other cause explains the above symptoms

Exclusion Criteria:

1. Patients with sinus bradycardia, long QT syndrome, sick sinus syndrome or other arrhythmias, mental diseases, cardiac pacemakers or other electrical stimulation devices after implantation.
2. Patients taking analgesics due to pain in other parts of the body.