cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment

To assess the efficacy of the NaviAid™ BGE Device, while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine.

Smart Medical Systems has developed the NaviAid™ Balloon Guided Endoscopy (BGE) Device, an innovative medical device for the GI tract diagnosis and treatment. The Balloon Guided Endoscopy (BGE) is a procedure intended for the examination of the small intestine, which utilizes the NaviAid™ BGE Device in conjunction with a standard endoscope.

The objectives of this prospective controlled study are to evaluate the safety and efficacy of using the NaviAid™ BGE device in the examination of the small intestine in conjunction with a standard endoscope.

Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female aged between 18-80 years (inclusive).
* Subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators.
* Symptomatic subject defined as having at least one of the following signs or symptoms:

  * Abdominal pain
  * Cramps
  * Bloating
  * Diarrhea
  * Nausea
  * Vomiting
  * Unexplained Anemia
  * GI bleeding from an unknown source
  * Small bowel abnormality on any imaging study
* Subject able to comprehend and give informed consent for participation in this study
* Signed Informed Consent Form

Exclusion Criteria:

* Pregnancy
* Acute bowel obstruction
* Concomitant Coumadin or warfarin use
* Severe diverticulitis
* Recent (within the last 3 months) coronary ischemia or CVA (stroke)
* Any chronic unstable disease
* Bleeding disorders
* Needing emergency surgery
* Any patient condition deemed too risky for SBE by the investigator
* Known cognitive or psychiatric disorder
* Physician objection
* Concurrent participation in any other clinical trial
'Fitness To Fly' Tests In Children With Type II Respiratory Failure

The conventional hypoxic challenge test might not predict 'fitness-to-fly' equally well in all patients. Patients at risk of hypercapnia with supplemental oxygen are not well studied. Th investigators will study children who have either neuromuscular weakness or central hypoventilation and who require nocturnal or intermittent daytime ventilator support.

The study also aims to assess feasibility of a randomised controlled trial (RCT) comparing the standard hypoxic standard test to a modified test designed to better suit children with type two respiratory failure.

This study will assess feasibility of pulse oximetry (SpO2), end tidal carbon dioxide (ETCO2) and transcutaneous carbon dioxide partial pressure (TcCO2) measurement during a modified Hypoxic challenge test (HCT) in 12 children with neuromuscular weakness and 12 with central hypoventilation.

Eligibility Criteria:
Inclusion Criteria:

* ≤18 years
* Neuromuscular weakness or central hypoventilation
* Established nocturnal or intermittent daytime ventilatory support

Exclusion Criteria:

* Unable to sit in the plethysmograph
* Cardiac anomaly with right-to-left shunt
Thoracoabdominal Asynchrony and Respiratory Distress

The investigators hypothesize that a simple 3-point tracking device that uses motion sensors attached to the abdomen and chest of a child will provide information regarding thoracoabdominal asynchrony (TAA), a major component of respiratory distress, and ultimately help guide a clinician to initiate, escalate, de-escalate, or stop respiratory support interventions.

AIMS To determine if the TAA-monitoring device can be used to detect differences in respiratory synchrony in a manner that is clinically applicable. The investigators hope that the device will detect 1) major asynchrony events in a timely manner so as to prompt clinician intervention during future use; and 2) asynchrony events that may be less visible to the naked eye that may be precursors to more severe events.

Respiratory diseases are a major global cause of morbidity and mortality in children. Of patients admitted into a pediatric intensive care unit (PICU), respiratory illnesses have been identified as the leading principal admission diagnosis in every age group, accounting for 37.9% of patients under 12 months of age and 28.5% of PICU patients across all age groups. Continuous monitoring of respiratory status is important for the guidance of respiratory support escalation and de-escalation decisions in the PICU. A clinical metric that has been suggested as a signature of breathing effort is thoracoabdominal asynchrony (TAA), the non-coincident motion of the rib cage and abdomen during breathing. A reliable, objective assessment tool for continuous monitoring of respiratory effort could allow for a more complete understanding of patients' real-time respiratory status and provide an additional indication or contraindication for the utilization of various levels of respiratory support. Limiting the use of invasive ventilatory support by early detection of respiratory distress would decrease clinical risk to patients and has the potential to decrease the cost of patient stays in the PICU. The investigators have developed a non-invasive TAA-sensing device designed for use by clinicians to indirectly quantify respiratory effort among pediatric patients (henceforth referred to as the "TAA-monitoring device"). The device utilizes motion-tracking sensors that capture data that is then processed to provide a quantitative indication of a patient's respiratory status. Given the promising yet inconclusive nature of the evidence supporting the use of TAA as an indicator of respiratory effort, clinical validation of this device is a necessary step to take to support its continued development.

Eligibility Criteria:
Inclusion Criteria:

1. patients 28-days to 17-years of age
2. who have respiratory distress and those who do not have respiratory distress

Exclusion Criteria:

Hardware, clinical care, or dermal injury that would preclude the application of TAA device
Vision-based Assessment of Joint Extensibility in Ehlers Danlos Syndrome

Ehlers Danlos Syndrome (EDS) is a heterogenous group of genetic disorders with 13 identified subtypes. Hypermobile EDS (hEDS), although the most common subtype of EDS, does not yet have an identified genetic mutation for diagnostic confirmation. Generalized joint hypermobility (GJH) is one of the hallmark features of hEDS. The scoring system used in measurement of GJH was described by Beighton. The Beighton score is calculated using a dichotomous scoring system to assess the extensibility of nine joints. Each joint is scored as either hypermobile (score = 1) or not hypermobile (score = 0). The total score (Beighton score) can vary between a minimum of 0 and a maximum of 9, with higher scores indicating greater joint laxity.

While there is moderate validity and inter-rater variability in using the Beighton score, there continue to be several challenges with its widespread and consistent application by clinicians. Some of the barriers reported in the literature include:

i) In open, non-standardized systems there can be significant variation in the method to perform these joint extensibility tests including assessing baseline measurements, ii) Determining consistent and standard measurement tools/methodology e.g. goniometer use can vary widely iii) Assessing the reliability of the cut off values and, iv) Performing full assessment prior to informing patients of possible classification of GJH positivity (low specificity and low positive predictive).

Inappropriate implementation of tests to assess GJH results in inaccurate identification of GJH and potentially unintended negative consequences of making the wrong diagnosis of EDS. The objective of this study is to create a more robust and valid method of joint mobility measurement and reduce error in the screening of EDS through use of a smartphone-based machine learning application systems for measurement of joint extensibility.

The project will:

i) Create a smart-phone enabled visual imaging app to assess the measurement of joint extensibility, ii) Assess the feasibility of using the smart-phone app in a clinical setting to screen potential EDS patients, iii) Determine the validity of the application in comparison to in person clinical assessment in a tertiary care academic EDS program. If successful, the smart-phone application could help standardize the care of potential EDS patients in an efficient and cost-effective manner.


Eligibility Criteria:
Inclusion Criteria:

* All patients seen in the GoodHope EDS clinic at Toronto General are eligible for inclusion, regardless of their presenting diagnosis or the results of their assessments

Exclusion Criteria:

* Patients who do not consent to participate will not be included (participants may withdraw consent at any time)
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol

Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on the other hand on the dosage (i.e., calcineurin-inhibitors). Based on the encouraging results of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. A conversion to a SRL-based therapy is effective in immunosuppression and safe regarding graft and patient survival.

This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.

Patients who meet all inclusion criteria will be included into the study and randomised. If converted to SRL, patients will take SRL according to the investigator's instructions and medication label, once daily preferably 4 hours after calcineurin-inhibitor medication or in case without calcineurin-inhibitor co-medication in the morning. The dose of SRL will be correlated to the former immunosuppressive therapy according to the study's conversion protocol.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma and/or premalignant neoplastic skin lesions
* Age 18 years and older
* Minimum period of 6 month after renal transplantation
* Stable renal function and a calculated creatinine clearance of at least 40 ml/min
* Written informed consent
* Proteinuria ≤ 800 mg/d at time of enrolment
* Successfully treated solid tumor (no recurrence or metastasis in the last 2 years)

Exclusion Criteria:

* Current Sirolimus- or Everolimus- intake
* Instable graft function (creatinine clearance \< 40 ml/min)
* Graft rejection within the 3 previous months
* Proteinuria \> 800 mg/d
* Non-controlled hyperlipidemia (Cholesterol \>7,8 mmol/l, Triglycerides \> 4)
* Leucopenia \< 2500/nl
* Thrombocytopenia \< 90/nl
* Pregnancy or breastfeeding
* Women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year))
* Known allergy to macrolides
* Current participation in other studies
* Refusal to sign informed consent form
* Neoplasm other than defined as inclusion criteria
* All contraindications to SRL (see package insert, appendix)
* Persons who are detained officially or legally to an official institute
Evaluate the Safety, Tolerability and PK of Different Formulations of Orally Administered Solabegron in Healthy Male Subjects

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of different formulations of orally administered solabegron in healthy male subjects.

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of different formulations of orally administered solabegron in healthy male subjects. Eligible male subjects will be enrolled into 2 cohorts of 12 subjects each conducted in parallel. The study is a single blind (subjects), randomized, cross-over design in 3 study periods.

Eligibility Criteria:
Inclusion Criteria:

* Body weight greater than or equal to 50 kg, inclusive, and body mass index (BMI) 18.0 - 32.0 kg/m2, inclusive
* In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis.
* Adequate venous access to allow for repeated blood sampling
* Ability to understand and comply with the study requirements
* Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).

Exclusion Criteria:

* Any clinically relevant abnormality identified on the screening physical examination, clinical laboratory tests, 12-lead ECG, or any other medical condition or circumstance which would make the subject unsuitable for participation in the study based on the Investigator's assessment
* Resting heart rate greater than or equal to 100 beats per minute (BPM) after 5 minutes rest (as above) at the screening visit
* QTcF interval (Fredericia's correction factor) greater than 450 msec (males subjects) at screening
* History of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
* History of smoking, including e-cigarettes, within 3 months of the study and/or a positive urine cotinine at screening
* Regular alcohol consumption averaging ≥ 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of the first dose of study medication.
* Positive urine drug or alcohol test at screening
* Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
Cardiology Research Dubrava Prospective Registry

Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with ICD, CRT and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy.

Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with ICD, CRT and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy.

In this long-term follow-up registry we plan to collect data on clinical status, standard laboratory results including lipidogram values, NTproBNP values after specific interventions (in.ex. TAVI implantation, SGLT2inh prescripition), bleeding complications, and every major cardiovascular event, including cardiovascular death and all cause death.

Eligibility Criteria:
Inclusion Criteria: patients implanted with CIED, or with VTE, or with ACS or with TAVI -

Exclusion Criteria: non compliance, not undergoing follow-up at this center

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Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA

The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.

A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with GlaxoSmithKline (GSK) Biologicals' two-dose oral live attenuated human rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or given separately (at 3 and 5 months of age).

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.

Exclusion Criteria:

* Allergic reaction to vaccine components;
* clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
* immunocompromised.
The Effect of a Low FODMAP Oral Nutrition Supplement On Breath Hydrogen Response In Healthy Human Subjects

The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of different types of low FODMAP oral nutrition supplements. This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over a 4 hour time period.

This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen and methane analysis at various time points over a 4 hour time period. Subjects will also be asked to rate gastrointestinal symptoms via a questionnaire at various time points throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65 years with a body mass index between 18-29 kg/m2.
* Demonstrates spoken and written English literacy and able to provide written, informed consent after review of study protocol and procedures.

Exclusion Criteria:

* Use of enemas, proton pump inhibitors, or antibiotics within the past 3 months
* Smoker
* Not a regular breakfast eater
* Self-reported history of a past or current gastrointestinal disease
* High fiber eater (\> or = to 3 servings of high fiber foods per day)
* Concurrent or recent (within 30 days) participation in an intervention trial
* Recent weight fluctuations
* Allergies to any of the test products
Feasibility of Simulation in Therapeutic Patient Education for Adult Diabetic Patients Using the Freestyle Libre® Device

The benefits of Therapeutic Patient Education (TPE) have long been proven, but its implementation remains insufficient. It is only accessible to a part of the population and is too often limited to the acquisition of knowledge. TPE consists of supporting the patient in making decisions about his or her health, managing his or her life with the disease and treatment through the acquisition or maintenance of skills.

Simulation is a pedagogical method of creating fictional or reconstructed environments in order to develop skills, know-how and abilities for which direct instruction is impossible for ethical, economic or technical reasons. To date, it is recommended for the development of caregiver skills, and has been the subject of two studies among family caregivers. It seems likely that simulation will add value to the methods currently used in TPE.

To our knowledge, no studies have been conducted on simulation-based TPE (S-TPE) with patients.

A consensus conference, which is a rigorous method of comparing the opinions of experts in TPE, simulation, patient experts and caregivers, was held in order to determine the learning that could be developed through simulation and the conditions of use. However, since the patient is a specific type of learner, we hypothesize that there may be some additional conditions for the use of S-TPE. And the value of this approach remains to be demonstrated. Since the use of S-TPE has never been studied with patients, a feasibility test would make it possible to evaluate, in the context of care, the possibility of its use and its acceptance by both patients and caregivers. This is necessary before considering a multicenter trial that demonstrates an interest in developing patient skills. It was decided to carry out this study in patients with diabetes, a condition for which TPE is a precursor. Caregivers will be able to objectify the advantages and limitations of using S-TPE.


Eligibility Criteria:
Inclusion Criteria:

* Adult who has provided non-opposition to participate in the study
* Insulin-dependent diabetic patient who has participated in a complete TPE program (3 sessions) for the implementation of a FreeStyle Libre®.

Exclusion Criteria:

* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to limited judicial protection
* Pregnant, parturient or breastfeeding woman
* Adulat patients unable to provide consent
Effects of Systemic Lidocaine on Postoperative Quality of Recovery After Robot-assisted Thyroidectomy

Systemic lidocaine infusion may improve the patients' recovery quality and chronic post surgical pain after robot-assisted thyroidectomy


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-65
* ASA class I and II
* Thyroid cancer patients who are scheduled for elective robot-assisted thyroidectomy

Exclusion Criteria:

* Allergy to local anesthetics or contraindication to use of lidocaine
* Pregnancy
* Severe cardiovascular disease
* Renal failure
* Liver failure
* Neurologic and psychologic disease
* Chronic treatment with analgesics