louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03599687: Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics
Official title: Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics (SATIATED): A Randomised Controlled Manikin Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
Intubation, Intratracheal
Laryngoscopy
Vomiting
Lead sponsor: Yorkshire Ambulance Service NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: College of Paramedics
First posted: 2018-07-26
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be NHS staff who are employed by Yorkshire Ambulance Service NHS Trust, and who are Health and Care Professions Council (HCPC) registered paramedics.

Brief summary: In more than one-in-five cases of out-of-hospital cardiac arrest, airways are blocked by vomit and blood. Sometimes, paramedics cannot clear the airway using methods they have been taught. If the airway cannot be cleared, the patient will die.

Usually, these patients will have a breathing tube placed into their windpipe (intubation), as this provides protection from vomit and blood. To do this, the paramedic needs to be able to see the entrance to the windpipe.

A new method of clearing the airway called SALAD has been used in patients to help insert a breathing tube, but it is not known whether the method can help paramedics. This study will use a manikin to see if paramedics can insert a breathing tube more often on their first attempt, using SALAD.


Eligibility criteria: Inclusion Criteria:

* Aged 18 and over
* HCPC registered paramedic employed by Yorkshire Ambulance Service
* Authorised to intubate within Yorkshire Ambulance Service
* No SALAD training in the last 3 months

Exclusion Criteria:

* Not an HCPC registered paramedic employed by Yorkshire Ambulance Service
* Not authorised to intubate within Yorkshire Ambulance Service
* Allergy to artificial 'vomit' ingredients
* Unwilling to provide consent
* SALAD training in the last 3 months

Primary outcomes:
measure: Difference in First-pass Intubation Success Rates Before and After SALAD Training
timeFrame: pre- and post-training as part of 2 hour study session
Secondary outcomes:
measure: Difference Between Mean Time Taken (in Seconds) to Perform a Successful Intubation on the First- Attempt, Before and After SALAD Training Approximately 30 Minutes Apart.
timeFrame: seconds
measure: Difference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt
timeFrame: pre- and post-training as part of 2 hour study session
Other outcomes:
Locations:
city: Wakefield
country: United Kingdom
facility: Yorkshire Ambulance Service NHS Trust
state: West Yorkshire
Study officials:
affiliation: Yorkshire Ambulance Service NHS Trust
name: Richard Pilbery
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00941187: Evolution of Pulmonary Capillary Blood Volume
Official title: Evolution of Pulmonary Capillary Blood Volume (Vc) in Patients After a First Episode of Pulmonary Embolism.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Keywords: pulmonary embolism
pulmonary capillary blood volume
double diffusion NO/CO method
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2009-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a first episode of symptomatic pulmonary embolism

Brief summary: The purpose of this monocentric, preliminary study is to assess the evolution of pulmonary capillary blood volume (Vc), measured by the double diffusion nitric oxide/carbon monoxide (NO/CO) method (Guenard et al.; Respir Physiol 1987), from the starting of the anticoagulant therapy to 6 months after, and to search correlations with the evolution of clinical (dyspnea and results of the 6 minutes walking test), biological (BNP; Troponin), echocardiographic (right ventricular dysfunction, pulmonary arterial pressure) and ventilation/perfusion lung scan data.


Eligibility criteria: Inclusion Criteria:

* Patient with a first episode of symptomatic pulmonary embolism, treated with anticoagulant
* Age from 18 to 75 years-old

Exclusion Criteria:

* Confirmed pulmonary embolism in the past
* Massive pulmonary embolism, thrombolytic treatment
* Confirmed left heart systolic dysfunction
* Confirmed asthma, chronic obstructive pulmonary disease or pulmonary fibrosis
* Expected life below 6 months
* Pleural effusion with indication of evacuation
* Bronchopulmonary cancer
* Pulmonary surgery with resection of two lobes minimum
* Predictable incapacity to complete the 6 minutes walking test

Primary outcomes:
measure: difference of pulmonary capillary blood volume (Vc) from J0 to 6 months
timeFrame: from the starting of the anticoagulant therapy to 6 months after
Secondary outcomes:
measure: correlations with the evolution of clinical (dyspnea and results of the 6 minutes walking test), biological (BNP; Troponin), echocardiographic (right ventricular dysfunction, pulmonary arterial pressure) and ventilation/perfusion lung scan data
timeFrame: from the starting of the anticoagulant therapy to 6 months after
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Departement of pneumology, CHU Saint-Etienne
city: Saint-etienne
country: France
facility: Department of Medicine and Therapeutic, CHU Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Laurent BERTOLETTI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02191787: Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers
Official title: Pharmacokinetic-pharmacodynamic Assessment of Seresis® o.d.: an Open, Uncontrolled, Non-randomised Intraindividual Pilot-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and the optimal time for blood sampling


Eligibility criteria: Inclusion Criteria:

The subjects to be enrolled are healthy volunteers, defined as follows:

* Healthy men or women between 18 and 30 years old
* Non-smokers
* Fit for work
* Having given informed consent and signed the form

Exclusion Criteria:

* Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, hypervitaminosis A, psychic disorder etc.).
* Treatment with other drug that might interfere with the evaluation of the safety of the test drug
* Known hypersensitivity to any of the ingredients of the study drug
* Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive
* Drug and alcohol abuse
* Participation in another trial
* Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are not medical objections)
* Specific dietary requirements that do not allow the volunteers to meet the dietary guidelines set out for this study

Primary outcomes:
measure: Changes in total antioxidant activity of Seresis®
timeFrame: Baseline, Day 2
Secondary outcomes:
measure: Changes in total antioxidant activity of Seresis®
timeFrame: Day 2, day 6
measure: Assessment of tolerability on a 4-point scale
timeFrame: Day 14
measure: Number of patients with abnormal changes in laboratory parameters
timeFrame: up to day 14
measure: Number of patients with adverse events
timeFrame: up to day 14
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00859287: Omepral® Tablets Special Clinical Experience Investigation in Patients With Erosive Esophagitis
Official title: Omepral® Tablets Mega-study to Investigate the Efficacy on Various Type of Acid Reflux Related Symptoms and QOL, and Epidemiology in Patients With Erosive Esophagitis in Daily Medical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reflux Esophagitis
Keywords: Reflux esophagitis
Omepral®
QOLRAD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-11
Enrollment: 10703
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients endoscopically diagnosed as erosive esophagitis accompanied with either two days or more heartburn or acid taste in the mouth of any severity

Brief summary: This open label, non-interventional study is to compare the efficacy of Omepral® tablet and any other treatments excepting proton pump inhibitors (PPIs) for the treatment of various type of acid reflux related symptoms in patients with reflux esophagitis.


Eligibility criteria: Inclusion Criteria:

* Patients newly diagnosed as erosive esophagitis or history of erosive esophagitis confirmed by endoscopy.
* Patients who answered questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
* During the past 1 week , patients who have either two days or more with heartburn or acid taste in the mouth of any severity

Exclusion Criteria:

* Patients receiving treatment with proton pump inhibitors, which make stomach acid decreased during the last 4 weeks prior to enrolment.
* Patients who cannot answer questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
* Patients included previously in this study.

Primary outcomes:
measure: Patients symptom evaluated by investigator
timeFrame: at entry, 4 weeks and 8 weeks
measure: Patients reported symptom
timeFrame: at entry, 4 weeks and 8 weeks
Secondary outcomes:
measure: Patients reported outcome score
timeFrame: at entry, 4 weeks and 8 weeks
measure: Adverse event
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Japan Medical Director MD
role: STUDY_DIRECTOR
References:
citation: Yoshida S, Nii M, Date M. Effects of omeprazole on symptoms and quality of life in Japanese patients with reflux esophagitis: final results of OMAREE, a large-scale clinical experience investigation. BMC Gastroenterol. 2011 Feb 28;11:15. doi: 10.1186/1471-230X-11-15.
Clinical trial NCT01777087: Functional Brain Imaging of Pain Phenotype and Genotype
Official title: Brain Imaging of Pain Phenotype and Genotype With Novel Scanning Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Functional Magnetic Resonance Imaging
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study has two purposes: first, to locate and identify the "brain activation" (the areas of the brain) which respond to pain; and second, to look at how brain activation is influenced by a person's genetics (the traits they inherited from their parents). A Magnetic Resonance Imaging (MRI) scanner will be used to gather pictures of the brain (similar to an x-ray, but based on different scientific principles) that will be used to determine which areas are active. The hypothesis is that the variation in brain activity between people can be partially explained by genetic differences. This study consists of an two pain tasks applied during a one time visit to the MRI suite. There are no followup visits.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 50
* Right-handed
* Male or female
* Healthy individuals not taking any medication.

Exclusion Criteria:

* Pregnancy
* Diagnosed with any treated or untreated medical or neurological conditions
* Using any prescription drugs, including antidepressants, pain medications, sedative medications, blood pressure medications, seizure medications, or antipsychotics. Oral contraceptives are permitted
* Using any over-the-counter medications including aspirin, Tylenol, or herbal supplements
* Using any illicit substances
* Contraindications to magnetic resonance imaging.

Primary outcomes:
measure: Areas of brain activity from a transcutaneous painful stimulation
timeFrame: At the conclusion of the 1 hour scanning session; Visit one
measure: Areas of brain activity from a 45 minutes Capsaicin cream application
timeFrame: At the conclusion of the 1 hour scanning session; Visit 1
Secondary outcomes:
measure: Pain phenotyping
timeFrame: After the 45 minute Capsaicin cream application; Visit 1
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: James W Ibinson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balaban CD, McBurney DH, Affeltranger MA. Three distinct categories of time course of pain produced by oral capsaicin. J Pain. 2005 May;6(5):315-22. doi: 10.1016/j.jpain.2005.01.346.
citation: Campbell CM, Edwards RR, Carmona C, Uhart M, Wand G, Carteret A, Kim YK, Frost J, Campbell JN. Polymorphisms in the GTP cyclohydrolase gene (GCH1) are associated with ratings of capsaicin pain. Pain. 2009 Jan;141(1-2):114-8. doi: 10.1016/j.pain.2008.10.023. Epub 2008 Dec 9.
Clinical trial NCT01856387: The Effect of neutrophil-to Lymphocyte Ratio in Preeclampsia- Eclampsia
Official title: the Predictive Value of neutrophil-to Lymphocyte Ratio on Preeclampsia- Eclampsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Eclampsia
Keywords: preeclampsia
eclampsia
prediction
neutrophil-to Lymphocyte ratio
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: first trimester pregnant

Brief summary: Neutrophil/lymphocyte ratio (NLR) is a marker of systemic inflammation and endothelial dysfunction. In recent years, it has been reported that the individual components of the differential white cell count, specifically the neutrophil and lymphocyte counts,may have clinical utility in predicting diseases. An elevated NLR has been shown to be a prognostic indicator in various malignancies. İn the literature, many studies have been shown that NLR have predictive value in determining the prognosis of various diseases (cardiac or noncardiac diseases ). However, little is known about the predictive values of NLR in pregnancy complications. This study aimed to evaluate the potential predictive value of NLR in preeclampsia- eclampsia.

Detailed description: In recent years, have been reported that the individual components of the differential white cell count, specifically the neutrophil and lymphocyte counts, may have clinical utility in predicting diseases.

An elevated NLR has been shown to be a prognostic indicator in various malignancies. İn the literatüre have been shown that NLR have predictive value in determining the prognosis of various diseases (cardiac or noncardiac diseases.However, little is known about the predictive values of NLR and PLR in gestational DM, preeclampsia and the other pregnancy complications.

Retrospective data were collected for patients who was diagnosed with , preeclampsia- eclampsia, The NLR was defined as the absolute neutrophil count divided by the absolute lymphocyte count.

Eligibility criteria: Inclusion Criteria:

pregnant women who developing preeclampsia eclampsia at pregnancy

Exclusion Criteria:

Known chronically maternal disease multiple pregnancy older than 40 years old

Primary outcomes:
measure: the effect of neutrophil lymphocyte ratio in preeclampsia eclampsia
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: ayse kirbas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03828487: Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates
Official title: Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Regional Saturation of Oxygen (rSO2)
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2019-02-04
Enrollment: 8
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data collected from the cutaneously placed forehead sensors. Due to the design of the systems, the devices will be used serially instead of concurrently. Because of this timing, changes in patient state may not be reflected in measurements collected by both devices.


Eligibility criteria: Inclusion Criteria:

* Less than 10 kg
* Subjects less than or equal to 28 days old

Exclusion Criteria:

* Underdeveloped skin at sites of sensor placement
* Jaundice or bilirubin levels out of normal range
* Subject has skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, or substantial skin breakdown that would prevent monitoring of oxygenation levels during the study
* Subject deemed not eligible based on Principal Investigator's judgment

Primary outcomes:
measure: Number of Participants With rSO2 Collected
timeFrame: Data collection period; alternating sensors every 5 minutes for up to 20 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
References:
Clinical trial NCT02108587: Optical Coherence Tomography in Staging Patients With Upper Tract Urothelial Cancer
Official title: Staging of Upper Tract Urothelial Cancer With Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney/Urinary Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies how well optical coherence tomography works in staging patients with upper-tract urothelial carcinomas. Staging describes the severity of a person's cancer based on the size and/or extent (reach) of the original (primary) tumor and whether or not cancer has spread in the body. It also helps the doctor plan the appropriate treatment. Optical coherence tomography is a procedure that uses infrared light waves to give three-dimensional pictures of structures inside tissues and organs. The pictures are made by a computer linked to the light source. Optical coherence tomography may be effective in staging patients with upper-tract urothelial carcinomas.

Detailed description: PRIMARY OBJECTIVES:

I. To test the feasibility and imaging ability of optical coherence tomography (OCT) to stage upper-tract urothelial carcinomas (UTUC).

OUTLINE:

Patients undergo optical coherence tomography over 10-15 minutes.

After completion of study, patients are followed up at 3 months.

Eligibility criteria: Inclusion Criteria:

* Patients must have radiographic evidence of upper tract urothelial cancer by computed tomography (CT), magnetic resonance imaging (MRI) or intravenous pyelogram (IVP) in order to undergo this procedure
* Patient who will undergo standard of care clinical staging for UTUC
* Patient ability to read and comprehend the informed consent document

Exclusion Criteria:

* Patient who has a contraindication to endoscopy
* Patient who is pregnant

Primary outcomes:
measure: Feasibility of optical coherence tomography (OCT) images in staging upper-tract urothelial carcinomas (UTUC)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Imaging Analysis
timeFrame: Up to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Donald Bodner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00514787: Be SMART NIS, Moderate to Servere Asthma Patient Observation
Official title: Be SMART NIS, Moderate to Servere Asthma Patient Observation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
NIS
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-08-10
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE

Brief summary: Screen for moderate to severe asthma patients with suboptimal asthma control (as defined by GINA-Guidelines). Document current asthma control status. Re-evaluate asthma therapy and document new therapy if applicable.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe asthma with suboptimal control

Exclusion Criteria:

* Intermittent or mild asthma, patient with good asthma control

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Research Site
Study officials:
affiliation: Executive Board OGP (Austria Society of Pneumology
name: Wolfgang Pohl, PHD
role: STUDY_CHAIR
References: