cyrilzakka/clinical-trials huggingface dataset:
Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis

The purpose of this study is to compare the microbiological cure rate of doripenem versus a comparator antibiotic in the treatment of patients with complicated urinary tract infection or pyelonephritis. The study will also characterize the safety and tolerability of treatment with doripenem in patients with complicated urinary tract infection or pyelonephritis.

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multi-center, randomized, prospective, double-blind study of doripenem versus comparator in the treatment of complicated lower urinary tract infections (UTI) or pyelonephritis in adults. After the screening, patients are randomized to receive either doripenem or comparator. Patients are hospitalized, but subsequently, patients may be treated as outpatient or through home-based therapy at the investigators' discretion. Conventional laboratory data are collected from all patients at specified times throughout the study. The primary endpoint is microbiological response measured at test of cure visit. The patients receive either doripenum or comparator; duration of therapy is 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of complicated lower urinary tract infection or pyelonephritis

Exclusion Criteria:

* Women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control
* History of moderate or severe hypersensitivity reactions to antibiotic medications
Outcome of Resection Anastomosis and Long Term Stenting With Montgomery Tube Operations in Management of Grade 3 Benign Laryngotracheal Stenosis

Laryngotracheal stenosis is a challenging problem in the field of laryngology. In the majority of patients, acquired stenosis of the larynx and trachea is due to accidental trauma, prolonged intubations, or tracheostomy. Congenital stenosis, caustic injury, and granulomatous diseases are also etiological factors in laryngotracheal stenosis (Grenier PA et al, 2009).

Tracheal stenosis can occur following tracheostomy or endotracheal intubation with inappropriate cuff pressure. It is due to pressure necrosis at the site of the cuff. Initially, there is inflammation of the damaged mucosa with increased secretion and secondary infection. Prolonged ischemia and secondary infection cause necrosis of the tracheal wall and exposure and sequestration of the cartilaginous rings. This damage results in the formation of granulation tissue and collapse of the tracheal wall (Satish Nair et al, 2014).

The tracheal stenosis is classified as simple, which is a soft, short segment web-like narrowing often limited to the mucosa only or complex stenosis, which is a hard, long-segment stricture with destruction of tracheal cartilages and fibrosis. Post tracheostomy stenosis occurs most commonly at the stoma site or less commonly at the site where the tip of the tube has impinged on the tracheal mucosa (Liu J et al, 2015).

The symptoms are generally insidious. Most arise 1 to 6 weeks after extubation, and early symptoms are often not recognized. The most common symptoms include shortness of breath, cough, recurrent pneumonia, wheezing, stridor, and cyanosis over time. Dyspnea is often the symptom until the tracheal diameter is 50% smaller than normal. When the tracheal diameter is 25% of its normal size, dyspnea and stridor may occur even at rest. These symptoms can be confused with other respiratory diseases (Rubikas R et al, 2014).


Eligibility Criteria:
Inclusion Criteria:

- patients who are diagnosed with layngotracheal stenosis either post tracheostomy or post intubation

Exclusion Criteria:

* The exclusion criteria will be patients who underwent laryngeal split and cartilaginous grafting; patients who underwent carinal resection; patients with incomplete records; and resection due to conditions other than post intubation tracheal stenosis (e.g., airway tumors, idiopathic stenosis, trauma, Wegener' granulomatosis and chronic relapsing polychondritis).
Digital Air Leak Monitoring for Patients Undergoing Lung Resection

Often the decision for chest tube removal or trial of chest tube clamping is based on subjective assessment. This can lead to delay in chest tube removal. Recently, monitoring and recording of air leaks has been done using digital pleural drainage devices. This provides us with objective and continuous recording of air leaks as well as changes in pleural pressure. Our hypothesis is that the use of the ATMOS digital pleural drainage system will result in shorter hospital stay in comparison to traditional pleural drainage systems.

Technology has become a driving force in surgery. From robotics to digital monitoring of oxygen saturation, it has revolutionized the way we care for patients. However, new technology comes at a cost to our healthcare system. It is therefore important to ensure that new devices actually improve outcomes. One example of this is minimally invasive surgery, which decreases morbidity to patients and reduces length of hospital stay. Unfortunately, despite this advance in lung surgery, delays in discharge from hospital are still prevalent due to prolonged air leaks. Many intra-operative methods have been explored in order to limit this issue with underwhelming success. This is why we are proposing a randomized controlled trial comparing a digital pleural collection system by ATMOS to traditional pleural collection devices by Atrium.

Our research question is: Can the use of a digital air leak monitoring system decrease hospital stay in patients undergoing anatomical lung resection when compared to traditional pleural drainage systems?

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 or older
* Patients undergoing a lobectomy or segmentectomy

Exclusion Criteria:

* Patients under the age of 18
* Patients undergoing pneumonectomy, wedge resection or bullectomy
* Patients who require additional procedures to control intraoperative air leak
* Patients who require mechanical ventilation post-operatively
Blood Sugar Responses by Physical Activity Level and Intensity

This observational study is designed to examine the glycaemic responses (of sedentary, active and very active healthy individuals) to a 50gram dose of glucose.

3 groups of participants fulfilling the criteria for: sedentary (\< 30mins phys activity p/day) active (\>30 mins phys act p/day) and very active (\> 60 mins phys act p.day) will be invited to attend a laboratory session on two separate occasions separated by one week and asked to: fast overnight before having a baseline and then six further capillary (finger-prick) blood samples taken over a period of two hours following consumption of 50 grams of glucose. The blood samples will produce a standard glucose 'curve' and this will be used to calculate incremental area under the curve to identify similarities or differences between the three groups responses. Hypothetically it may be that the different levels and intensities of physical activity will affect the results with active individuals producing flatter better-controlled blood sugar responses than the inactive subjects. The Null-hypothesis would be no difference in response. it is possible, for instance, that such a low-dose of glucose in an otherwise healthy group of individuals has no discernible affect on such a curve. Physical activity will be assessed by questionnaire and interview. Anthropometric measures (height, weight and body composition) will be taken using a stadiometer and bio-electrical impedance unit (Bodystat 1500, Body Stat: Isle of man UK) at the time of the laboratory measures. No participants will have data taken of any kind before they have read a participant information sheet and signed informed consent.

Eligibility Criteria:
Inclusion Criteria:

* male and female.
* age:19-59
* inactive, active or very active according to criteria outlined.

Exclusion Criteria:

* Diabetics other chronic condition likely to affect blood sugar
* \<19\>59 age
Comparison of Patients With and Without Foreign Body Aspiration After Bronchoscopy.

To compare patients under 5 years of age with foreign body aspiration and without foreign body aspiration with radiological and blood gas results.

Foreign body aspiration in children is a serious cause of mortality and morbidity. It is a preventable and treatable disease. Difficulties in diagnosis arise in non-radiopaque foreign body aspirations. Recently, when there is a suspicious history, bronchoscopy is recommended. Bronchoscopy is used to both diagnose and treat foreign body aspiration. Bronchoscopy seems to continue to be performed in suspicious cases until a method to establish a definitive diagnosis of foreign body aspirations before the operation is invented. In our study, to compare patients under 5 years of age with foreign body aspiration and without foreign body aspiration with radiological and blood gas results.

Eligibility Criteria:
Inclusion Criteria:

Suspected foreign body aspiration

Exclusion Criteria:

infection, trauma
EKO SENSORA: Detecting Clinically Significant Murmurs

The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023).

The Eko SENSORA will be tested in the emergency department. Chest pain, fatigue, shortness of breath and syncope are all symptoms that could indicate a cardiac dysfunction.

The hypothesis is that this device will allow us increased ability to detect valvular heart disease that is clinically significant.


Eligibility Criteria:
Inclusion Criteria:

* Chief complaint of chest pain, shortness of breath, difficulty breathing, or syncope/near-syncope.
* Patients with chief complaint of Weakness would be eligible if over the age of 50 and have a history of at least two of hypertension, BMI\>/= 30, diabetes, hyperlipidemia, atrial fibrillation, heart attack, stroke/Transient ischemic attack, prior cardiac surgery or angiography

Exclusion Criteria:

* Contact isolation patients
* Pediatric patients under the age of 18
Contextual Coaching Versus Training Workshop for Assistants in Special Education.

Special Need Assistants/paraprofessionals serve an essential role in special education to support children with multiple disabilities, but they often lack adequate training and supervision. The study aims to examine the effects of the coaching program for assistants compared to a workshop outside working hours and evaluate the outcomes in students and assistants. The second aim is to measure fidelity implementation of coaching practices and if the intervention was participation-based.

This study addresses the training needs of assistants to minimize participation barriers of the students. The schools will be assigned to one of two groups: both groups will receive a 10 hours training workshop; only the intervention group will receive coaching one-to-one. The duration and number of coaching sessions will depend on the caregivers' time available, daily routines, and goals. Coaching sessions will be recorded for the assessment of treatment fidelity.

Eligibility Criteria:
Inclusion Criteria assistants:

* Special Need Assistant of students between 4-21 years of age.
* Speak, read and comprehend Spanish.
* Be available for workshop and one-on-one coaching.
* Able to verbalize changes in their own performance or their students' participation.
* Written consent.

Exclusion Criteria assistants:

* Have no students involved in the program.

Inclusion Criteria students:

* Present difficulties in Activities of Daily Living (ADLs).
* Have an assistant involved in the study.
* Informed consent signature (parents or legal tutors).

Exclusion Criteria students:

* Independence in activities of daily living.
* 70 or more points in the Care Dependency Scale for Pediatrics (CDS-P).
Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age

The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to \<17 years experiencing mild to moderate acute postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥18 kilograms.
* Mild to moderate acute pain requiring treatment with analgesic medication.
* Willing to have blood samples taken for PK sampling using an indwelling catheter.
* Must be able to swallow capsules and can tolerate oral medication.
* For females: is not of reproductive potential (defined as premenarchal) or is practicing an acceptable method of birth control

Exclusion Criteria:

* Severe acute pain
* Chronic analgesic or glucocorticoid use for any condition within 6 months before dosing with study drug.
* Emergency surgery
* History of allergic reaction, hypersensitivity, or clinically significant intolerance to diclofenac, aspirin, codeine, acetaminophen, or any NSAID
* History of peptic ulcer disease or a GI event (eg, perforation, obstruction, or bleed) within 6 months before screening
* Current use of any medication that may cause a clinically significant drug interaction when co-administered with diclofenac
* Current use of any medication that might affect the pharmacokinetics of diclofenac
* History of bleeding disorders .
* Developmental delay or behavioral problems that would make it difficult to assess pain.
* Impaired liver function
* Clinically significant renal or cardiovascular disease
* Any medical condition that compromises ability to swallow, absorb, metabolize, or excrete the study drug
* Previously received any investigational product or device within 30 days before Screening or scheduled to receive an investigational device or another investigational drug (other than that in this study) during the course of this study.
* Previous participation in this clinical study or currently taking diclofenac.
Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)

This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered once vs twice daily (morning \[AM\] and evening \[PM\]) in adults with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.

Exclusion Criteria:

* Participants with type 1 diabetes mellitus, participants with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.
A Chatbot-Powered G8 Screening Intervention to Facilitate Referrals to a Comprehensive Geriatric Assessment Among Older Adults With Cancer

In this prospective quality improvement study, we will develop and evaluate the feasibility and acceptability of an online patient self-reported G8 screening tool which will allow us to efficiently identify G8 positive older cancer patients to be referred to our Senior Adult Oncology Center (SAOC) for a Comprehensive Geriatric Assessment (CGA).

We will test the feasibility and acceptability of the online G8 screening tool developed. 100 older new established cancer patients who had used the MyChart G8 will be recruited to provide their feedback on the usability of the screening tool and any related referral and SAOC appointment experience. Among patients with G8 scores ≤ 14, they will be referred to a CGA. We will examine CGA attendance compliance, predictive value of the online collected G8 score with the final frailty designation determined by the CGA, and perceived barriers among CGA non-adherent patients via a brief follow up inquiry.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older
* New Patient Visit scheduled for Medical Oncology

Exclusion Criteria:

• Inability to answer or have caregiver answer questions on screening tool.
Pregnancy and Medically Assisted Conception in Rare Diseases

Rare diseases frequently affect women of childbearing age. Pregnancy in these women has become less rare, but remains associated with high levels of complications. One obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective tissue diseases. As a consequence, the management of these pregnancies is non-standardised in terms of treatment, monitoring (frequency of consultations, laboratory tests and ultrasound), and organisation of care.

Moreover, although these women (all diseases combined) are frequently exposed to medications potentially incompatible with pregnancy, little is known about the frequency of these exposures and especially their consequences to mother and child.

For these reasons, researchers and clinicians from different specialties created an interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve the management of these patients' pregnancies. Using a single computer server, the investigators plan to set up a large prospective study of pregnancies in patients with rare diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome, scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse the complications of pregnancies in women with rare diseases and then to improve their management and their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Woman with a rare and/or systemic disease
* Pregnancy confirmed by a positive beta-HCG assay or an obstetric ultrasound OR medically assisted conception procedure
* Patient agreed to participate

Exclusion Criteria:

* Adults under guardianship
* People hospitalised without their consent and not protected by the law
* Persons deprived of their liberty
Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless.

At first, the patient undergoes Stress-Echocardiography testing to identify the hypokinetic areas (ischemic areas). Following that, the ischemic areas sre treated with shockwaves. Several treatments are required for optimal results.

Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with chronic stable angina pectoris. Diagnosis is based on medical history, complete physical evaluation.
* Patient has documented myocardial segments with reversible ischemia.
* Patient is classified in AP CCS of III-IV.
* Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
* Patient demonstrates exercise tolerance capacity of no higher than 125 W on a modified Bruce treadmill exercise test until presence of clinical symptoms (i.e. angina, ST-depression).
* Patient demonstrates exercise tolerance time and stability averaging no more than 25% of each other (the tests will be performed within two weeks and at least a day different between the two).
* Patient has documented epicardial coronary artery disease not amenable to angioplasty or CABG.
* Patient has signed an IRB approved informed consent form.
* Patient's condition should be stable and should have a life expectancy of \>12 months. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.

Exclusion Criteria:

* Patient is pregnant
* Patient has chronic lung disease including emphysema and pulmonary fibrosis.
* Patient has active endocarditis, myocarditis or pericarditis.
* Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine of a competitor company within 3 months of entry into the study.
* Patients who are unwilling or unable to cooperate with study procedure
Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: RCT

During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. The instruments give the surgeons increased range of motion during the surgery, and research demonstrates that RTS has a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy has not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a prospective manner.

There are two major barriers against the widespread adoption of robotic thoracic surgery. The first barrier is the lack of high-quality prospective data. To our knowledge, there are no prospective trials comparing VATS to RTS for early stage lung cancer. The second major barrier to the widespread adoption of robotic technology in thoracic surgery is the perceived higher cost of Robotic lobectomy. To address these barriers, the investigators will undertake the first randomized controlled trial comparing Thoracoscopic Lobectomy to Robotic Lobectomy for early stage lung cancer.

Prospective randomization will eliminate the biases of retrospective data and will serve to determine whether there exist any advantages to Health Related Quality of life (HRQOL) or patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a prospective cost-utility analysis, this trial will provide the highest quality data to evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian health system.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>/= 18 years
2. Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
3. Candidates for minimally invasive pulmonary lobectomy, as determined by the operating surgeon.

Exclusion Criteria:

1. Clinical stage IIIb or IV NSCLC
2. Not a candidate for minimally invasive surgery.