cyrilzakka/clinical-trials huggingface dataset:
Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients

Postoperative respiratory failure, particularly after surgery under general anesthesia, adds to the morbidity and mortality of surgical patients. Anesthesiologists inconsistently use positive end-expiratory pressure (PEEP) and recruitment maneuvers in the hope that this may improve oxygenation and protect against postoperative pulmonary complications (PPCs), especially in obese patients. While anesthesiologists tend to use PEEP higher than in non-obese patients. While it is uncertain whether a strategy that uses higher levels of PEEP with recruitment maneuvers truly prevents PPCs in these patients, use of higher levels of PEEP with recruitment maneuvers could compromise intra-operative hemodynamics.

The investigators aim to compare a ventilation strategy using higher levels of PEEP with recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in obese patients at an intermediate-to-high risk for PPCs.

We hypothesize that an intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents PPCs in obese patients at an intermediate-to-high risk for PPC.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for open or laparoscopic surgery under general anesthesia
* Intermediate-to-high risk for PPCs following surgery, according to the ARISCAT risk score (≥ 26)
* BMI ≥ 35 kg/m2
* Expected duration of surgery ≥ 2 h

Exclusion Criteria:

* Age \< 18 years
* Previous lung surgery (any)
* Persistent hemodynamic instability, intractable shock (considered hemodynamically unsuitable for the study by the patient's managing physician)
* History of previous severe chronic obstructive pulmonary disease (COPD) (non-invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of COPD)
* Recent immunosuppressive medication (patients receiving chemotherapy or radiation therapy up to two months prior to surgery)
* Severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias)
* Invasive mechanical ventilation longer than 30 minutes (e.g., general anesthesia for surgery) within last 30 days
* Pregnancy (excluded by anamneses and/or laboratory analysis)
* Prevalent acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
* Severe pulmonary arterial hypertension, defined as systolic pulmonary artery pressure \> 40 mmHg
* Intracranial injury or tumor
* Neuromuscular disease (any)
* Need for intraoperative prone or lateral decubitus position
* Need for one-lung ventilation
* Cardiac surgery
* Neurosurgery
* Planned reintubation following surgery
* Enrolled in other interventional study or refusal of informed consent
Validation of a Wearable Non-invasive Device (the Patch)

BresoTEC has designed and developed a standalone wearable device (the patch), that can record tracheal sounds with a microphone attached just above the suprasternal notch of the subject.

The patch also has a 3-dimensional accelerometer to record body position. Furthermore, the patch records oxygen saturation using an FDA cleared pulse oximeter, Nonin 3150 WristOx2® with Bluetooth Low Energy. We have developed advanced signal processing algorithms to detect apneas and hypopneas. Many of these techniques for analyzing breathing sounds and detecting apneas and hypopneas have been published in peer-reviewed journals.

The goal of this study is to validate the patch against polysomnography (PSG) for use as an aid in the diagnosis of sleep apnea for adult patients. Our primary objective is to assess whether the estimated apnea-hypopnea index (AHI) calculated by the patch agrees with the results of an in-laboratory PSG.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are men and women 18 years and above, who are referred to either the University Health Network (UHN), Toronto Rehabilitation Institute (TRI) or Toronto General Hospital sleep laboratories for overnight PSG because of a suspicion of a sleep disorder. It is intended for the general outpatient population.

Exclusion Criteria:

* Exclusion criteria are patients with suspected complicated co-morbidities including in-hospital patients and those who self-report diagnosis of heart failure, recent stroke, neuromuscular disorders, renal failure, obesity hypoventilation, COPD, or other severe lung diseases.
Safety of Early Discharge Following Low Risk Myocardial Infarction

* Objectives: The primary objective of this study is to evaluate the safety of an early discharge strategy in patients with low risk ST-elevation myocardial infarction (STEMI), treated with primary percutaneous coronary intervention (PPCI), compared to a conventional strategy.
* Methodology: Unicentric, randomized, controlled, non-inferiority and open label clinical trial. The investigators will compare an early discharge strategy (≤72 hours) with a conventional strategy (discharge according to treating physician's criterion). Inclusion criteria will be: low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset. Exclusion criteria will be: arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block), mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis), severe or moderate bleeding (according to the GUSTO criteria), complications related to vascular access of the procedure, acute kidney failure, infection, heart failure. Sample size will be 1558 subjects (n=779 per group). The investigators will study demographic, clinical, biochemical, echocardiographic and angiographic variables. The primary endpoint will be a composite of death, reinfarction, new angina, heart failure, ventricular arrhythmias, stroke and severe bleeding. The secondary endpoint will include each of the items of the primary endpoint and quality of life and functional capacity questionnaire SF-36. Finally, the investigators will analyze the degree of compliance with the European Society of Cardiology guidelines on STEMI and the rate of hospitalization-related complications. Follow up will be at 30 days.


Eligibility Criteria:
Inclusion Criteria:

* low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset
* Informed consent

Exclusion Criteria:

* arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block)
* mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis)
* severe or moderate bleeding (according to the GUSTO criteria)
* complications related to vascular access of the procedure
* acute kidney failure
* infection
* heart failure
Sensitivity of Antibiotics for Urinary Tract Infections Patients Attending Family Physicians

This study is aiming to evaluate the sensitivity of uropathogens isolated in patients with community acquired UTI with Enoxacin in comparison to other antimicrobials. While Secondary objective is to study the spectrum of uropathogens responsible for community acquired UTI in local population

Mid stream , clean catch urine specimens of patients with uncomplicated community acquired UTI sent to microbiology labs by treating consultants from filter clinics for evaluation of pathogens will be utilized for sensitivity analysis.

Only the first positive urine culture obtained per sample will be included in the analysis to eliminate any possibility of recurrence and nosocomial infection. The polymicrobial cultures and cultures with multidrug-resistant uropathogens will not be included in the analysis. Cultures with common contaminants, including coagulase-negative staphylococci and hemolytic streptococci, and cultures with Candida growth will be excluded. .

Data points to be collected will be date of collection, computer generated Lab #, age, gender,list of cultured organisms, sensitivity of organisms with antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Samples from primary care clinics from patients who reports UTI symptoms and in which uropathogens are isolated will be included.

Exclusion Criteria:

* Samples from specialized, hospitalized or catheterized patients.
Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence

The investigators hypothesize that an innovative test device simulating transvaginal tape support will increase the performance and reproducibility of the diagnosis of urethral hypermobility before surgery for urinary incontinence.

The main objective of this study is to compare two prognostic tests in their ability to predict the success (or failure) of the implementation of a suburethral TVT (tension-free vaginal tape) or TOT (trans-obturator tape) treatment for stress urinary incontinence in women. The Q-tip test (test mentioned in the French and international recommendations) is compared to test a new test (clip strip).

Secondary objectives include:

* Compare the prognostic ability of the clip strip test with the Bonney maneuver
* Compare the prognostic ability of the clip strip test with the TVT maneuver
* Compare the maximum intraurethral pressure during various tests
* Compare the quality of life before / after surgery
* Estimate patient satisfaction one year after surgery
* Describe the intra and inter-operator reproducibility of various prognostic tests.
* Estimate the optimal threshold of the Q-tip angle based on surgical results and compare with the reference threshold of 30 ° found in the literature.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 60 weeks of follow-up
* Candidate for stress urinary incontinence surgery by TVT or TOT procedures
* Positive cough or valsalve maneuver test

Exclusion Criteria:

* The patient is participating in another study (except the PISQ-R study)
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a contra-indication for stress urinary incontinence surgery via TVT or TOT procedures.
* The patient has an untreated vaginal or urniary infection
* The patient has a history of allergy to polyurethane and / or Watershed XCX11122
Color Stability of Sectional and Full Glass Ceramic Laminate Veneer

The aim of the study is to evaluate the color stability of full and sectional glass ceramic laminate veneer as esthetic failure is reported to be common failure in laminate following clinical service.

The null hypothesis is that there will be no apparent change in color stability between full and sectional veneer over one year of clinical service

The success of any esthetic restorative material depends primarily on the color match and then on the color stability of the material. color changes by time reduce the longevity and quality of restorations.

This in vivo study planned to evaluate the color stability of full and sectional glass ceramic laminate veneer using a digital shade device The primary objective of the study to evaluate the color stability of sectional glass ceramic veneer compared to full laminate veneer

Eligibility Criteria:
Inclusion Criteria:

Patients seeking for esthetics with the following criteria:

1. Male or female patients age range above 18 years old
2. Minor esthetic defects in anterior region
3. Multiple spacing, diastemas
4. Incisal fracture
5. Initial proximal caries
6. Patients able physically and psychologically to tolerate restorative procedures
7. Patients willing to return for follow-up examinations and evaluation
8. Class I occlusion

Exclusion Criteria:

* Patients free of

  1. Tempromandibular disorders
  2. Para-functional habits
  3. Cracked teeth
  4. Moderate or deep caries
  5. Heavily discolored teeth
  6. Heavy smokers
  7. Enamel defects compromising bonding
  8. Active periodontal disease
  9. Pulpal disease
  10. Mobility
  11. Occlusal disturbances
  12. Class II and III occlusion
DENdritic Cell Immunotherapy for Mesothelioma

This study is to evaluate the overall survival (OS) rate (determined from the time of randomization in the study) of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone.

This is an open-label, randomized Phase II/III study in adult subjects with mesothelioma to evaluate the efficacy and anti-tumor activity of dendritic cell immunotherapy with MesoPher plus best supportive care compared to best supportive care alone. The safety, tolerability, quality of life and immunogenicity of MesoPher will also be evaluated.

The study includes a screening phase, a 7 month open-label treatment phase during which subjects visit the study center for administration of study drug and follow-up evaluations. An end-of-study (EoS) visit will be performed after completion of the study, after which data on survival, subsequent therapies and response to these therapies will be collected.

A target of 230 subjects satisfying all study criteria, will be randomized to receive either dendritic cell therapy plus best supportive care (Arm A) or best supportive care alone (Arm B).

Subjects in Arm A will undergo leukapheresis to obtain monocytes from which dendritic cells will be generated. These dendritic cells will be loaded in vitro with an allogeneic tumor cell lysate (PheraLys). Treatment with autologous dendritic cells loaded with PheraLys is called MesoPher. The treatment with Mesopher will start within 9 to 13 weeks after the last dose of chemotherapy. Subjects will receive 3 bi-weekly injections with MesoPher in addition to BSC. In case of stable disease or partial/complete response, an additional 2 injections will be given at weeks 18 and 30. Subjects will be administered with a maximum of 5 doses of MesoPher.

Subjects in Arm B will be treated with best supportive care according to the discretion of the local investigator.

Eligibility Criteria:
Subjects will only be included with a histologically confirmed diagnosis of pleural malignant mesothelioma, who are non-progressive after 4 to 6 cycles with first line chemotherapy with antifolate/platinum.
Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block

This study aims to compare the alternative current and the direct current signal changes of photoplethysmography between both feet during one side lumbar sympathetic block.

The hypothesis is that signal changes occur earlier than other indices to decide whether it is successful following lumbar sympathetic block on only one-side.


Eligibility Criteria:
Inclusion Criteria:

* Physically examined for complex regional pain syndrome on lower extremity,
* Scheduled for diagnostic lumbar sympathetic blockade.

Exclusion Criteria:

* Graded as ASA 3 or higher,
* Below 18 or above 70 years of age, or
* Had any other contraindication for regional anesthesia.
Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients

The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.

Cytomegalovirus (CMV) disease is an important cause of morbidity in solid organ transplantation recipients and remains the most common opportunistic viral infection in these patients. Standard CMV prevention strategies include universal prophylaxis and pre-emptive therapy with viral load monitoring. However, neither of these strategies has been successful in eliminating CMV disease as seen by high rates of viremia, incidence, and CMV recurrence despite treatment. Recently, the Quantiferon-CMV assay has been shown to predict late CMV reactivation after prophylaxis and to be predictive of viral progression and the need for antiviral therapy in organ transplant recipients who develop low level CMV viremia. The purpose of the current study is to test the clinical strategy of using the Quantiferon-CMV assay in guiding the duration of primary CMV prophylaxis in solid organ transplant patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult kidney, kidney-pancreas, liver transplant recipient, or heart transplant recipient
* CMV D+/R- patient or any R+ patient who received antithymocyte globulin induction therapy

Exclusion Criteria:

* Unable to comply with protocol
* Campath (Alemtuzumab) induction
* Receiving another investigational compound for CMV treatment or prophylaxis.
* Allergy to valganciclovir or ganciclovir
* Receiving an investigational compound for prevention or treatment of rejection, or participating in another interventional study
Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)

Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm combining abdominal sonography, gastroscopy, endosonography in patients with acute right side abdominal pain.

Patients with acute right side abdominal pain will be randomized in one of two groups. In each group all examinations (sonography, gastroscopy, endosonography) will be performed. The study group only defines the order of the examinations. Abdominal sonography will always be performed before endoscopic procedures. In group 1, gastroscopy is first followed by endosonography. In group 2 endosonography is first followed by gastroscopy.

Two physicians will review all results of all examinations, patient charts as well as a follow up visit and establish a clinical diagnosis.

Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.


Eligibility Criteria:
Inclusion Criteria:

* acute right side abdominal pain
* willing participate study

Exclusion Criteria:

* acute disease
* malignancy
* other disease which might cause discomfort
Monitoring of Azathioprine Metabolite Concentrations and Cytokine Levels in Neuromyelitis Optica Spectrum Disorder

Background: The pathogenesis of NMOSD has been linked to the cytokines interleukins (IL) -6, NOD-, LRR-and pyrin domain-containing 3 (NLRP3) and IL-18 that contribute to development of inflammatory reactionsmay. Although azathioprine (AZA) is efficacious in preventing NMOSD recurrence, it may have adverse effects (AEs) maybe related to the plasma concentrations.

Objective: We would monitor the blood concentrations of AZA in NMOSD, and their relationship with cytokines, severity, efficacy, and safety range of the drug.

Methods: A total of 53 NMOSD patients were included in the study, which included 20 patients who had received AZA treatment within 1 month, and 16 patients who had received AZA treatment within 6 months, as well as 17 patients who had received AZA treatment at least 12 months. The patient's immunotherapy regimen was low-dose hormone combined with AZA. AZA was started at small doses and added every two weeks after no AEs, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid. The following clinical data were collected: gender, age, clinical symptoms, EDSS score, number of recurrences and AEs, etc. Healthy controls (HC) comprised 10 individuals. AZA metabolite concentrations 6-thioguaninenucleotides (6-TGN) and 6-methylmercaptopurine nucleotides (6-MMPN) were measured by High-performance liquid chromatography (HPLC). Levels of IL-6, NLRP3 and IL-18 were measured by Enzyme-linked immunosorbent assay (ELISA).

A total of 53 NMOSD patients were recruited from Neurology Department of the First Affiliated Hospital of Guangxi Medical University.According to the duration of AZA treatment, 20 patients were divided into 1 month after AZA treatment, 16 patients in 6 months after AZA treatment and 17 patients over 12 months after AZA treatment. Clinical data of patients were collected, including: gender, age, time of first onset, time of medication, clinical symptoms, number of recurrence, EDSS score, serum and cerebrospinal fluid AQP 4-IgG titers, imaging results, rheumatic immunity-related autoimmune antibodies, comorbidities, related adverse drug reactions, etc. Ten healthy volunteers with physical examination in our hospital were selected as the healthy control (HC) group.Blood (5ml) was collected from peripheral veins of patients and healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

All patients with NMOSD met the international consensus diagnostic criteria for NMOSD published in 2015. Before medication, TPMT activity was normal.

Exclusion Criteria:

Patients with fever, infection, or patients with other autoimmune diseases, uncontrolled malignancies, and other chronic diseases were excluded.
Parental Mental Health After Tracheostomy in Early Childhood

To assess the prevalence of anxiety / depression in post- hospital for parents (mothers and fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012.

The goal of this study is to evaluate the level of anxiety / depression of families and to correlate to the lived parental of tracheotomy and indirectly that of the child (hetero - evaluation).

The information from this study should allow staff to refine and adjust their practices in terms of information and support for families with tracheotomised children. The information given to families before the establishment of a tracheotomy for their child may also be adapted.

Eligibility Criteria:
Inclusion criteria :

Families whose child :

* Has been tracheotomised before the age of 1 year between 2000 and 2012
* Came out of hospital with a tracheotomy tube
* Is or has been followed by one of three centers

Exclusion criteria :

* Children decannulated before hospital discharge .
* Death before the start of the study
Comparing Suicide Prevention Interventions to Guide Follow-up Care: The SPRING Trial

Pragmatic randomized controlled trial to compare the effectiveness of two-way Caring Contacts text messages vs. one-way Caring Contacts text messages vs. enhanced usual care for suicide prevention in adults and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents (12-17 years old) and adults (18+)
* Response of "yes" to at least one item on the Columbia Suicide Severity Rating Scale (C-SSRS) six-item screener at a St. Luke's Health System (SLHS) primary care or behavioral health clinic, or electronic health record or provider note from an eligible encounter indicates suicide risk
* Ability to send and receive text messages
* Ability to receive phone calls
* Ability to receive emails
* Participant and legal guardian (if applicable) speak, read, and understand English
* Accommodations may be made for individuals with impaired hearing

Exclusion Criteria:

* Individuals who participated in a previous randomized controlled trial in the same health system related to Caring Contacts (SPARC Trial or MHAPPS Trial)
* Patients who are unable or unwilling to provide informed consent\*, for example, due to acute or chronic cognitive impairment (i.e.: acute psychosis, intoxication, or intellectual disability).
* Primary Care Provider, Behavioral Health Provider, or Principal Investigator determines that participation in the research is not in the best interest of the patient or the study team.