cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of EPASS With Hot AXIOS System

A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)

Primary objective is to investigate the safety and effectiveness of the AXIOS™ lumen-apposing Metal Stent used in the EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for the management of symptoms associated with gastric outlet obstruction (GOO) secondary to malignant unresectable neoplasm.

Primary Endpoint is GOOSS 3 rate without MAE at 30 days post procedure.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable malignant duodenal obstruction confirmed by biopsy
* Eligible for endoscopic intervention
* GOOSS score of 0 or 1
* 18 years of age or older
* Willing and able to comply with the study procedures or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study

Exclusion Criteria:

* GOO symptoms are not expected to improve after the index procedure
* Life expectancy is about 3 months or less, which is not assumed applicable for surgical GJ
* Prior metallic stent placement for GOO
* Contraindicated to surgery and general anesthesia
* Neoplasm invading the target site of puncture in gastric and/or jejunum
* Abnormal coagulation INR \> 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation
* Bleeding diathesis
* Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic drainage
* Presence of ileus caused by peritoneal carcinomatosis, or expected to present within 30 days post procedure
* Intervening gastric varices or vessels at the target site of stent insertion
* Ascites that may interfere the safety of the index procedure
* Biliary tract obstruction requiring treatment at the same day of the index procedure
* Allergic to any of the device materials
* Contraindications to use of electrosurgical devices
* Pregnancy, breastfeeding or intending to become pregnant during the study period
* Subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the study sponsor)
* Vulnerable subject
* Subject has other reason not to be eligible for this study per investigators' discretion
* Guidewire doesn't cross the area of GOO
* EP-DB doesn't advance to the target site in jejunum
* The distance between the gastric wall and jejunal wall when visualized on ultrasound after saline is introduced into the space between the two inflated balloons of EP-DB is deemed about 2 cm or more
The RESPLASH Study

To assess the safety and effectiveness of renal artery denervation with subsequent splanchnic nerves denervation via catheter-based radiofrequency ablation in improving blood pressure and glycemic control in patients with resistant hypertension and type 2 diabetes.

The investigators propose a multicenter, prospective, single blind, randomized controlled pilot study. Patients with treatment-resistant hypertension and diabetes mellitus type 2 will be enrolled to undergo renal artery denervation with subsequent splanchnic nerves denervation for lowering blood pressure and glycemic levels.

20 patients will be randomly selected from outpatient cardiology clinics and will be assigned (1:1) to receive an FDA approved catheter-based denervation (CDN) of the renal arteries or CDN of the renal arteries with subsequent CDN of the splanchnic nerves at the level of the celiac artery and SMA. All patients will receive non-selective renal and mesenteric artery angiography prior and post CDN. All patients will undergo office systolic and diastolic blood pressure measurements, glycemic indices (HbA1c, fasting plasma insulin, C-peptide), and other laboratory assessments (plasma norepinephrine, renin, aldosterone, angiotensin II, lipids, and liver biochemistry) at baseline and outpatient follow-up visits (months 1, 3 and 6 post procedure).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75.
* History of Type 2 Diabetes Mellitus at least 5 years prior to enrollment.
* HbA1c level ≥6.5%. (is there an upper limits cutoff?)
* Use of at least 1 oral antidiabetic agent and no changes in the last 30 days.
* History of essential hypertension with systolic Blood pressure of 160 mmHg or more (≥150 mmHg in patient with Type 2 Diabetes Mellitus), despite compliance with three of more antihypertensive drugs.
* Stable drug regimen of at least 3 antihypertensive medications with no changes for 2 weeks before enrollment.

Exclusion Criteria:

* Estimated glomerular filtration rate of less than 30 mL/min per 1.73m2.
* Type 1 diabetes mellitus.
* History of aortic pathologies such as aneurysm or dissection confirmed by immediate preprocedural angiography that would preclude the Endovascular Denervation (EDN) procedure.
* Orthostatic hypotension.
* Acute or severe systemic infection.
* History of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 3 months.
* History of previous renal artery CDN.
* Pregnancy or planned pregnancy during the study period.
* Unable to provide informed consent.
Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Temperature Monitoring

Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring.

Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported such as bleeding, infection rate, cardiac complications, prolonged wound healing and patient discomfort. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring. Measurements are performed with the SpotOn® sensor by Arizant Healthcare, Inc..

Eligibility Criteria:
Inclusion Criteria:

* elective surgery in gynecology or trauma surgery
* planned surgery time \> 60 min
* patients older than 16 years

Exclusion Criteria:

* emergency surgery
* need for post-surgery ventilation
* patient's denial to take part in the study
Using Electronic Medical Record Data to Improve HIV Primary Care

This cluster randomized control trial examines whether an audit and feedback study improves care of patients living with HIV/AIDS in a family health team setting.

This cluster randomized control trial will use electronic medical record (EMR) data from the St. Michael's Hospital Academic Family Health Team to examine whether the quality of HIV care provided to patients can be improved through an audit and feedback (A\&F) intervention. Our objective is to examine whether A\&F targeting family physicians caring for people living with HIV/AIDS (PHLA) using EMR data can improve laboratory monitoring, engagement in primary care and the uptake of preventive interventions.

Eligibility Criteria:
Inclusion Criteria:

* Family physicians at the St. Michael's Hospital Academic Family Health Team who have at least 20 PLHA.

Exclusion Criteria:

* None
A Study of Postsurgical Pain Control for Lower Extremity Fractures

Postsurgical pain may effectively be treated with a multimodal approach that incorporates the use of local anesthetics. Bupivacaine is a local anesthetic that has been proven to be effective at reducing postsurgical pain. Furthermore, this local anesthetic has been shown to reduce opioid use, improve functional outcomes, allow for early mobilization, and decrease hospital length of stay. However, local anesthetics, via wound infiltration, are often short-acting and do not meet the duration of postsurgical pain due to their solubility and protein-binding properties. ExparelTM is an FDA-approved liposomal formulation of bupivacaine that allows for 72 hours of postsurgical analgesia with a single injection. This formulation has been shown to have little to no adverse effects; although some studies have reported adverse effects with the use of ExaprelTM, most frequently being nausea, vomiting, and dizziness. The occurrences of these adverse events were still less than the placebo cohort.

All patients undergoing surgical fixation of a lower extremity fracture(s) will be offered the opportunity to enroll in the study. Patients undergoing unilateral or bilateral surgical fixation would be included. Written, informed consent to enrollment will be recorded and included in the patient record. The study is designed around the standard of care for postsurgical pain management. There are no additional costs to the patient strictly related to this study.

Patients will undergo surgical fixation of a lower extremity fracture(s) by one of surgical investigators at a single institution. A sealed, opaque envelope, selected in the pre-operative holding area, will accompany each patient participant to the operating room. The envelope will be opened at the conclusion of the fracture fixation to reveal patient assignment to either study Group 1 or Group 2. Once the total numbers of patients have completed their procedures and follow-up, the study will close.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Preoperative diagnosis of lower extremity fracture(s) requiring surgical fixation

Exclusion Criteria:

* Allergy to ExparelTM or certain other local anesthetic agents
* Surgery performed at an outside institution or by a different surgeon
* Chronic analgesic users (defined as use of opioid medication \>14 days in the past 3 months, or use of non-opioid pain medication \>5 times per week
* Pregnant females or females who think they may become pregnant
* Peripheral neuropathy
* Major psychiatric disease
* Inability to comprehend the nature of the study
* Unwillingness to provide signed informed consent
* Markedly abnormal kidney function or renal disease
* Non-English speaking
* Signs or symptoms of compartment syndrome
Live Stream of Prehospital point-of Care Ultrasound During Cardiopulmonary Resuscitation

Background: Point-of-care ultrasound (POCUS) has been suggested as a useful tool in out-of-hospital cardiac arrest (OHCA) for diagnosis and treatment of reversible causes. However, in prehospital emergency medicine performing ultrasound and the translation of the findings can be challenging. As new prehospital ultrasound devices offer the possibility for remote supervision, the impact of tele-supervision on the performance of POCUS during OHCA is unclear.

Aims: This prospective observational study aims to evaluate if POCUS with tele-supervision can be performed during CPR without any additional hands-off periods longer than 5 seconds.

Methods: In total 30 patients with OHCA, where POCUS is considered, will be included in this study.


Eligibility Criteria:
Inclusion Criteria:

Patients with prehospital cardiac arrest, where POCUS is considered during cardiac pulmonary resuscitation, will be included.

Exclusion Criteria:

* under the age of 18,
* if POCUS is not considered or if POCUS will lead to a delay of live-saving treatment or transportation.
* pregnant patients
* patients with a body-mass-index (BMI) above 35 kg/m2
Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism

This is a randomized, controlled, double-blind clinical trial. The main objective is to evaluate the immediate effect of the mandibular muscle-energy technique on pain, functionality and kinesiophobia in subjects suffering from temporomandibular dysfunction and bruxism.

In the experimental group the jaw muscle-energy technique will be applied and in the control group a placebo technique will be applied. The intention is to see the immediate effects of the intervention and two evaluations of the pre- and post-intervention outcome variables and a follow-up of kinesiophobia one week later will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Patients who agree to participate in the study by signing the informed consent form.
* Patients attending maxillofacial consultation with pain, temporomandibular dysfunction and bruxism.
* Pain of at least 3 months of evolution.

Exclusion Criteria:

* Patients with congenital malformations or cervical spine pathology.
* Infectious or inflammatory disease in its acute phase.
* Patients with vertigo or vestibular alterations.
* If there is a contraindication to the technique or phobia on the part of the patient.
* Physiotherapy treatment (manual therapy or electrotherapy) in the last month before their incorporation in the study.
* Pharmacological treatment (analgesics, relaxants and anti-inflammatory drugs) in the last 24 hours before the initial evaluation.
The Thrombotic Potential of Heart Chambers in the Presence or Absence of Atrial Fibrillation.

The investigators aim to test the thrombotic potential of various heart chambers including left atrium, left atrial appendage, right atrium and peripheral veins. Blood samples will be taken from the different chambers in 50 patients admitted for standard pulmonary vein ablation and compared to patients without atrial fibrillation admitted for left sided supra ventricular tachycardia or mitral clip. Thrombin generation parameters will be assessed by the calibrated automated thrombogram.

Atrial fibrillation is the most common arrhythmia, there is a strong correlation between atrial fibrillation and embolic stroke. In order to lower the risk for embolic stroke anticoagulation is recommended for patients with CHADS-VASC score equal or above 2. The mechanism for thrombus formation in the left atrium is thought to be caused by various factors 1. blood stasis due to the loss of atrial kick 2. endothelial dysfunction 3. blood hemostatic alteration leading to procoagulant state.

Previous studies demonstrated increased thrombin generation in the left atrium in patients with atrial fibrillation, when compared to other heart chambers and when compared to control group in patients with structurally normal heart.

In recent years calibrated automated thrombogram (CAT) is considered a good indicator for total thrombotic activity in hypercoagulable states.

In the current study the investigators aim to test the thrombotic potential of various heart chambers including left atrium, left atrial appendage, right atrium and peripheral veins. Blood samples will be taken from the different chambers in 50 patients admitted for standard pulmonary vein ablation without changing the course of the procedure. Thrombin generation parameters will be assessed by the calibrated automated thrombogram. A control group composed of 50 patients admitted for standard left sided supra ventricular tachycardia ablation or patients admitted to mitral clip procedure without the presence of atrial fibrillation.

In addition demographic data,CHADS-VASC score, atrial fibrillation burden, echocardiographic and cardiac CT parameters will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* Pulmonary vein ablation, SVT ablation or mitral clip.
* Informed consent

Exclusion Criteria:

* Left atrial thrombus
* Pregnancy
* Active malignancy
* Thrombophilia
* Anticoagulants 24 hours before procedure
* Active infectious disease
* Chronic kidney disease (eGFR\<30)
Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

Helium-oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome in previous studies，but the evidence was limited．The aim of the study was to assess the effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70% helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in meconium aspiration syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Subject has the diagnosis of neonatal meconium aspiration syndrome
* Subject has Synchronous instruction ventilation

Exclusion Criteria:

* History of congenital or hereditary disease
Resynchronization for Ambulatory Heart Failure Trial in Patients With Preserved LV Function

This trial will compare two management strategies for HF patients with preserved LV function in sinus rhythm and LBBB. The control group will be treated with practice guideline optimal medical therapy for HF. The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with NYHA class II-IVa HF symptoms and are on diuretic therapy
* LVEF \> 35% (stratify by LVEF 36-49% and LVEF ≥ 50%), and recovered LVEF (previously LVEF ≤ 35%, but improved to LVEF \> 35% with medical therapy)
* Patients with LVEF ≥ 50% must also have either left atrial enlargement (any of the following: LA diameter ≥3.8 cm, LA length ≥5.0 cm, LA volume ≥55 ml, LA volume index (LAVi) ≥29 mL/m2) or LV hypertrophy (LV mass index (LVMI) ≥115 g/m2 for males and ≥ 95g/m2 for females)
* LBBB and QRS duration ≥ 140 msec. for men or ≥ 130 msec. for women, and with mid-QRS notching or slurring in ≥ 2 leads
* Patients may have permanent RV pacing with a QRS duration ≥180ms
* Patients may have permanent atrial fibrillation with good rate control defined as a resting heart rate of ≤80 bpm at rest and ≤110 bpm with 6-minute walk test
* NT-proBNP ≥ 600 pg/ml on stable medical therapy without previous heart failure hospitalization in the last 12 months, or ≥400 pg/ml on stable medical therapy if there was a heart failure hospitalization within the previous 12 months
* Appropriate pharmacological treatment of HF and co-morbidities.
* Stable diuretic and other HF medications for at least four weeks

Exclusion Criteria:

* Serum creatinine \>180 μmol/L; or estimated glomerular filtration rate \[eGFR\] ≤30 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease formula
* In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care
* Acute coronary syndrome (including MI) \<4 weeks
* Coronary revascularization (CABG or PCI) \< 3 months
* Uncorrected or uncorrectable primary valvular disease
* TAVI \< 3 months
* Restrictive, or reversible form of cardiomyopathy, cardiac amyloidosis
* Severe primary pulmonary disease such as cor pulmonale, primary pulmonary hypertension (may include secondary pulmonary hypertension, if mean pulmonary pressure is ≤ 70 mm Hg)
* Expected to undergo cardiac transplantation within one year (status I)
* Patients with a life expectancy of less than one year from non-cardiac cause.
* Patients included in other clinical trials that will affect the objectives of this study
* Patients who are pregnant/intend to get pregnant
* Those unable or unwilling to provide informed consent
Randomized Trial of Vaginal Self Sampling for Human Papillomavirus (HPV)

Up to 30% of Canadian women do not participate in Pap smear screening for cervical cancer prevention despite many being members of family practices and having access to family physicians. One reason is reluctance to undergo pelvic examination.

The investigators purpose is to determine whether the offer of vaginal self sample collection for oncogenic human papillomavirus (HPV) testing increases participation in cervical cancer screening compared to repeat reminder for Pap smear testing among female family practice members who have not previously responded to invitations for Pap testing.

Pap smear screening for cervical cancer precursors has substantially reduced the incidence of invasive cervical cancer in Canada. While regular Pap screening can give up to 90% protection against cervical cancer, about 30% of Canadian women do not participate in regular screening.

Pap screening in Ontario is opportunistic. There are women who have family doctors and regularly present for other medical issues at their physician's office but forego Pap smear testing.

Numerous studies have shown that women are able to self collect vaginal samples, and that these samples can be tested for the presence of oncogenic human papillomavirus. A recent meta-analysis showed that HPV testing through physician collected samples had a sensitivity of 80%-90% for detection of cervical intraepithelial neoplasia (CIN) 2 or worse, and a specificity of 86%-95%. In comparison, a meta-analysis of self collected vaginal samples tested for HPV showed a sensitivity of 74% and a specificity of 88%.

Studies have reported that women find self collection acceptable. However, we have found that many women are more comfortable if a health care professional is available to help if needed, and so this option should be provided for self-testing.

We are proposing a randomized controlled trial to see whether (a) the offer of a vaginal self collection kit together with a second reminder for Pap testing will increase cervical screening participation amongst "never-screened" and "hard to reach" women, as compared to (b) a second reminder letter alone.

Eligibility Criteria:
Inclusion Criteria:

* members of consenting family physicians identified through OSCAR EMR
* overdue for Pap smear testing
* have not presented for Pap smear screening after 1 reminder letter

Exclusion Criteria:

* currently attending colposcopy clinic
* institutionalized
* without a cervix
Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and in the view of the investigator, would not benefit significantly from other Crohn's therapies but would benefit from use of PROCHYMAL.

The study is not placebo-controlled or randomized.


Eligibility Criteria:
Inclusion Criteria:

* currently active moderate-to-severe Crohn's disease
* exhausted standard-of-care options
* age 18 to 70 inclusive
* body weight between 30 and 150 kg
* adequate renal function
* not at risk for tuberculosis (TB) activation or re-activation

Exclusion Criteria:

* biologic therapy for Crohn's within last 8 weeks
* confirmed adverse reactions during prior PROCHYMAL study participation
* alcohol or substance abuse, current or within past 6 months
* active HIV or hepatitis B or C infection
* surgery or trauma with 6 weeks
* allergy to bovine or porcine products
* elevated serum liver enzymes
* elevated serum bilirubin
* active malignancy within 5 years (other than some resected skin cancers)
* bacteremia or other serious bacterial or fungal infection within 3 months
* colonic dysplasia
* unstable arrhythmia or serious heart condition