louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01089816: Rapid Diagnostic Test for Influenza
Official title: Clinical Validation of the Point-of-Care MSD Influenza Test in Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Influenza infections
Orthomyxoviridae infections
Influenza Human
Lead sponsor: Meso Scale Diagnostics, LLC.
Sponsor class: INDUSTRY
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2010-03-19
Enrollment: 569
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: Individuals visiting a health care facility.

Brief summary: The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).

Detailed description: This is a multicenter, prospective study to evaluate the performance of the MSD Influenza Test for the detection and differentiation of influenza A (including A/H1, A/H3, and A/H5 subtypes) and influenza B. Nasal swabs from subjects presenting at the clinical care facility with ILI will be collected and tested on the MSD Influenza Test. Results from the Test will be compared to results obtained from viral culture performed on a second nasal swab at a reference laboratory.

Eligibility criteria: Inclusion Criteria:

* Any subject (all ages) presenting with ILI (defined as fever \[subjective or documented\] and cough or sore throat), and suspected of having influenza.
* Subject (parent, guardian, or authorized legal representative) gives informed consent to the study, and provides signed authorization for use and disclosure of protected health information.

Exclusion Criteria:

* Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.
* Unable to collect nasal and throat swab.
* Severely ill patient without a family relative to provide informed consent.

Primary outcomes:
measure: To determine the sensitivity and specificity of influenza A and B, and subtypes A/H1 and A/H3 with nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross-section of the general population
timeFrame: 4 months
Secondary outcomes:
measure: To determine the specificity of influenza subtype A/H5 in nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross section of the general population.
timeFrame: 4 months
Other outcomes:
Locations:
city: Ha Noi
country: Vietnam
facility: National Hospital of Pediatrics
city: Ho Chi Minh City
country: Vietnam
facility: Children's Hospital #2
city: Ho Chi Minh City
country: Vietnam
facility: Children's Hospital 1
city: Ho Chi Minh City
country: Vietnam
facility: Hospital for Tropical Diseases
Study officials:
affiliation: Meso Scale Diagnostics
name: Jacqueline Perodin, PhD, CCRP
role: STUDY_DIRECTOR
References:
Clinical trial NCT04696016: Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients
Official title: Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nociceptive Pain
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Opioid administration in mechanically ventilated patients in the intensive care unit (ICU) is essential to maintaining patient respiratory and hemodynamic stability. Mechanical ventilation is a persistently nociceptive event that can continuously causes discomfort in the trachealy intubated patient. This can lead to patient-ventilator dyssynchrony, tachycardia, hypertension, and their associated complications. Opioids blunt respiratory drive, which facilitates mechanical ventilation, and decrease the sympathetic response to nociception. However, excessive opiate administration is associated with many adverse events, including respiratory depression, delirium, ileus, nausea, and vomiting. Currently, the standard administration in our institution of sufentanil, a potent opiate, consists of continuous infusions of 0.15µg/kg/h to 0.3µg/kg/h.

Mechanically ventilated patients are unable to speak and are often sedated. This greatly impacts the patient's capacity to communicate pain. The use of a nociceptive monitor may be a possible solution. Skin conductance monitoring (Pain Monitor, Med-Storm, Norway), measures the peaks per second of electrical conduction. This non hemodynamic monitor uses skin conduction as a surrogate to nociception (i.e., the patient's unconscious response to a noxious stimulus). It may consequently guide opioid administration in ICU patients towards and avoid the consequences of excessive or inadequate antinociception.


Eligibility criteria: Inclusion Criteria:

* Adult patient admitted to the ICU requiring endotracheal intubation, antinociception, and sedation

Exclusion Criteria:

* Traumatic brain injury
* use of ketamine, dexmedetomidine, or clonidine
* pregnancy

Primary outcomes:
measure: Concentration of sufentanil requirements
timeFrame: one day to 2 weeks
Secondary outcomes:
measure: Concentration of propofol requirements
timeFrame: one day to 2 weeks
measure: Concentration of noradrenaline requirements (concentration of)
timeFrame: one day to 2 weeks
measure: Intubation time
timeFrame: one day to 2 weeks
measure: Composite post extubation related complications
timeFrame: one day to 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Université Libre de Bruxelles
name: Fabio Taccone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01687816: Nasal Specimen Collection Study in Patients With ILI and/or ARI in an Outpatient Setting
Official title: Prospective, Nasal Specimen Collection Study in Patients Presenting With Influenza Like Illness and/or Acute Respiratory Infection in an Outpatient Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Influenza-like Illness
Influenzal Acute Respiratory Infection
Keywords: Influenza-Like-Illness
nasal swabs
Detection of influenza
sensitivity of detection assays
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ILI will present with a sudden onset of symptoms and at least one of the following four symptoms: fever or feverishness, malaise, headache, myalgia and at least one of the following three respiratory symptoms: cough, sore throat, shortness of breath.

Patients with ARI will present with a sudden onset of symptoms and at least one of the following four respiratory symptoms: cough, sore throat, shortness of breath, coryza and the GP's judgment that the illness is due to an infection.

Brief summary: This is a prospective specimen collection study targeting patients presenting with Influenza Like Illness (ILI) and/or Acute Respiratory Infection (ARI) in an out-patient setting. A non-invasive, user friendly sampling technique, using midturbinate flocked swabs will be used. These nasal swabs will be collected in different volumes of viral transport media (0.5mL and 3.0mL), for different dilution range of the viruses present in the collected biological specimen. The collection of nasal swabs samples will support the optimization of point of care detection methods for respiratory viruses responsible for ILI and/or ARI.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* All Ages
* Valid Informed Consent and/or Assent, where applicable
* Onset of ILI and/or ARI within the last 3 days (≤ 72h)
* Patient presented with ILI and/or ARI

Exclusion Criteria:

* Invalid Informed Consent and/or Assent
* Onset of ILI and/or ARI was \> 3 days (\> 72 h)
* Patient did not presented with neither ILI or ARI
* Patient received intranasal attenuated influenza virus in last 3 weeks (example FluMist®, Fluenz®)
* Patient received treatment with influenza direct antivirals in the last 7 days

Primary outcomes:
measure: Nasal swab collection of left and right nostril
timeFrame: 1 day
Secondary outcomes:
measure: Completion of questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University of Leuven (KUL)
Study officials:
affiliation: Rega Institute, Clinical Virology, Minderbroedersstraat 10, 3000 Leuven
name: Marc Van Ranst, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Potter CW. A history of influenza. J Appl Microbiol. 2001 Oct;91(4):572-9. doi: 10.1046/j.1365-2672.2001.01492.x. No abstract available.
Clinical trial NCT00591916: New Treatment for Donor Sites
Official title: New Treatment for Donor Sites
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Burn
Keywords: burn
donor site
grafting
scar
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary research questions/Purpose of the Research.

1. Determine the short term (epidermal regeneration, reduction of pain, infections and length of stay) and long term (scarring, long term recovery, and cost of treatment) outcomes of Microbial Nanocellulose (NC) and fine mesh gauze impregnated with hyaluronan and thrombin (HT).
2. Determine if donor site treatment with NC and HT is as safe as the use of Scarlet Red ointment dressing.

   b. Describe the importance of the knowledge that you expect to gain from the research.

   To find a donor site dressing that has outcomes equal or better than that of scarlet red.


Eligibility criteria: Inclusion Criteria:

* Ages 0-90 years.
* Any patient admitted to the hospital with burn injury requiring grafting and a donor site.

Exclusion Criteria:

* Patient with severe burn injuries expected to die.

Primary outcomes:
measure: epidermal regeneration (donor site healing)
timeFrame: Days 3-14 post surgery
Secondary outcomes:
measure: Infection
timeFrame: Days 0-21 post surgery
measure: reduction in pain of donor site
timeFrame: Day 0-21 post surgery
measure: Scarring
timeFrame: Day 7 post surgery to 2 years post surgery
measure: Costs
timeFrame: Admission post burn injury to 2 years post burn injury
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05828316: The Impact of a Resilience-based Intervention on Emotional Regulation, Grit and Life Satisfaction: A Comparative Study Between Egyptian and Saudi Nursing Students
Official title: The Impact of a Resilience-based Intervention on Emotional Regulation, Grit and Life Satisfaction: A Comparative Study Between Egyptian and Saudi Nursing Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Resilience-based Intervention, Emotional Regulation, Grit and Life Satisfaction
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Nursing students may be perceived as having a stable college experience because they have a relatively clear career goal and a higher employment rate than students in other majors, but they consistently report that their heavy study loads, frequent exams, and clinical practice cause them to feel more stressed and depressed than students in other majors (Chernomas \& Shapiro 2013, Lee \& Jang 2021). Focusing on emotional events that have a direct impact on nursing students' learning and the college experience is crucial to their psychological wellbeing (Lee \& Jang 2021). In order to improve the emotional experiences and life satisfaction of nursing students, it is crucial to determine the factors that affect their emotions.

Detailed description: A constructivist and grounded theory design was recently used to create a model of resilience for nursing students (Reyes et al. 2015). Three steps represent how resilience is experienced, according to the "Pushing Through" model of resilience: first, "stepping into," or embracing, the adversity. The second is "staying the course," or understanding that they must keep working toward their objectives. Finally, "acknowledge" what they have learned from their difficulties and how they feel prepared to face new challenges. Additionally, students had brief obstacles, such as 'disengaging' from class because they felt overburdened. This paradigm serves as a lens to illustrate how, despite facing challenges, resilience can be developed over time. There is early support for encouraging resilience in nursing students before they begin their professions given the data linking resilience to burnout in nursing students

Eligibility criteria: Inclusion Criteria:

* nursing students who are willing to participate in the study and don't have any psychiatric illnesses

Exclusion Criteria:

* Those who refuse to participate in the study, nursing students with psychiatric illnesses

Primary outcomes:
measure: The Emotion Regulation Questionnaire (ERQ)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
References:
Clinical trial NCT00285116: The Correlation Between Fasicitis Plantaris and Hallux Rigidus
Official title: The Correlation Between Fasicitis Plantaris and Hallux Rigidus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hallux Rigidus
Fasicitis Plantaris
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Comparison between 3 groups:

* group I has hallux rigidus. Is fasicitis plantaris present?
* group II has fasicitis plantaris. Does the hallux have limited mobility?
* group III does not have hallux rigidus or fasicitis plantaris


Eligibility criteria: Inclusion Criteria:

* Hallux rigidus or fasicitis plantaris or healthy volunteer

Exclusion Criteria:

-

Primary outcomes:
measure: Objective evidence of hallux rigidus being a cause of fasicitis plantaris.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Ghent
name: Rene Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04870216: Evaluation of Practices, Knowledge and Expectations of Medical Students for Intimate Protection
Official title: Evaluation of Practices, Knowledge and Expectations of Medical Students for Intimate Protection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intimate Protections
Keywords: Intimate protections
Medical student
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical student

Brief summary: Intimate protections, designed to absorb menstrual flow during menstruation, are classified into two categories: internal intimate protections (tampon, menstrual cup) and external intimate protections (disposable or washable sanitary pads, panty liner, menstrual panty).

Recently, women's expectations have changed with a demand for transparency regarding intimate protection's composition and potential health risks.

The choice and use of a type of intimate protection will depend on multiple factors specific to each woman. The cost of intimate protectioncould influence patient choice, as disposable sanitary pads are often less expensive.

Detailed description: The primary objective is to describe medical students 's intimate protection practices.

Eligibility criteria: Inclusion Criteria:

* Female
* Medical student
* Aged more than 18
* Presenting menstrual cycles
* Agreeing to participate in the study

Exclusion Criteria:

- Aged less than 18

Primary outcomes:
measure: Use of internal intimate protections
timeFrame: Day 0
measure: Use of external intimate protections
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Université de Reims Champagne-Ardenne
Study officials:
affiliation: Université de Reims CHampahne-Ardenne - CHU de Reims
name: Emilie RAIMOND
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02885116: Effect of Nasal Highflow on Right Heart Function
Official title: Hemodynamic Effects of Nasal Highflow on Patients With Chronic Respiratory Insufficiency and Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: NHF
pulmonary hypertension
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study effect of NHF on pulmonary thermodynamic parameters will studied.


Eligibility criteria: Inclusion Criteria:

* stable disease
* hypoxemic respiratory disorder

Exclusion Criteria:

* decompensation
* acute illness

Primary outcomes:
measure: changes in mean pulmonary pressure (PAPm)
timeFrame: 20 min
Secondary outcomes:
measure: changes in wedge pressure (PC)
timeFrame: 20 min
measure: changes in cardiac index (CI)
timeFrame: 20 min
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Department of Respiratory Medicine
state: Sachsen
Study officials:
affiliation: Department of Respiratory Medicine
name: Hubert Wirtz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04017416: Controlled Trial of the I-PLAN Intervention
Official title: Controlled Trial of the I-PLAN Intervention to Promote Hearing Aid Use Among First Time Adult Hearing Aid Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Aid
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study recruited adult patients who were first-time hearing aid users.

Brief summary: That is a need for intervention to promote hearing aid use among adult patients with hearing aids. The aim of the present study was, for the first time, to evaluate the efficacy of the I-PLAN intervention to promote hearing aid use.

Detailed description: The I-PLAN is a behaviour change theory-based intervention to promote hearing aid use. It consists of; 1. information on consequences of using and not using a hearing aid, 2. a physical prompt as a reminder to hearing aid use and 3. a behavioural plan to use a hearing aid. The aim of this study was to test efficacy of the I-PLAN intervention, delivered face-to-face by study audiologists. 160 first-time hearing aid users were recruited at the hearing aid fitting appointment. Adult patients were allocated either to the I-PLAN group or Standard Care group. Adult patients were allocated to the groups based on the clinic schedules of study audiologists.

Eligibility criteria: Inclusion Criteria:

* had no previous personal experience of using a hearing aid
* were aged 18 years old or above
* attended initial hearing aid fitting appointment with study audiologists
* were native English speakers or had good understanding of English
* had sufficient mental capacity to provide informed consent based on audiologist's opinion were eligible to take part in this study

Exclusion Criteria:

* inability to complete the questionnaires due to age-related problems (for example; dementia) based on audiologist's opinion
* presence of medical contraindications for hearing aids as described by the British Academy of Audiology (BAA 2007)

Primary outcomes:
measure: Subjective hearing aid use based on Glasgow Hearing Aid Benefit Profile questionnaire
timeFrame: 6 weeks
Secondary outcomes:
measure: Objective hearing aid use
timeFrame: 6 weeks
measure: International Outcome Inventory for Hearing Aids
timeFrame: 6 weeks
measure: Self-reported Hearing Handicap Inventory for the Elderly and for Adults - Screening version
timeFrame: 6 weeks
measure: Self-regulation in relation to hearing aid use
timeFrame: 6 weeks
measure: Habit formation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Audiology Clinic
Study officials:
affiliation: Manchester Centre for Audiology and Deafness
name: Piers Dawes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01044316: Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China
Official title: A Phase III Observer-Blind, Randomized, Controlled, Single-Coordinating Center Pediatric Study in China Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Using a Local Dosing Regimen in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b (Hib) Infection
Keywords: Haemophilus influenzae type b (Hib)
Vaccine
Booster
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-01-07
Enrollment: 670
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.


Eligibility criteria: Inclusion Criteria:

* Infants 6-12 months of age.

Exclusion Criteria:

* Prior Hib vaccine administration.
* History of serious reaction(s) following vaccination.
* Any vaccination within 14 days of study vaccination.
* Known or suspected immune impairment.
* For additional entry criteria please refer to the protocol.

Primary outcomes:
measure: Anti-PRP antibody levels at day 31 post last vaccination
timeFrame: 30 days after last vaccination
Secondary outcomes:
measure: Solicited local and systemic reactions, AEs, and SAEs
timeFrame: 30 days post last vaccination
Other outcomes:
Locations:
city: Hebei Province
country: China
Study officials:
References:
citation: Jun L, Yuguo C, Zhiguo W, Jinfeng L, Huawei M, Xiuhua L, Yonggui Z, Yanhua X, Kong Y, Hongtao L, Yuliang Z. Assessment of immunogenicity and safety following primary and booster immunisation with a CRM197 -conjugated Haemophilus influenzae type B vaccine in healthy Chinese infants. Int J Clin Pract. 2013 Oct;67(10):971-8. doi: 10.1111/ijcp.12267. Epub 2013 Aug 22.