louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06098703: CARD for Community Pharmacy Vaccinations
Official title: CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaccination Reaction
Vaccination Pain
Community Pharmacy
Keywords: Vaccination reaction
Vaccination experience
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
name: Wholehealth Pharmacy Partners
First posted: 2023-10-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster trial involving at least 24 community pharmacies allocated to CARD or control (standard care) in a 1:1 ratio. Eligible pharmacies belonging to Wholehealth Pharmacy Partners from across Ontario, Canada, will be included.
Primary purpose: TREATMENT

Brief summary: To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.

Detailed description: It is estimated that 1 out of 5 children and adults are not vaccinated because of concerns about pain and fear. The CARD (Comfort Ask Relax Distract) system is a new vaccine delivery system proven to reduce pain, fear and immunization stress-related responses. Improving the vaccination experiences of patients can improve attitudes about vaccination and increase vaccine acceptance.

The objective of this cluster randomized trial is to evaluate scaling of CARD across community pharmacies on patients vaccination symptoms, beliefs and attitudes and pharmacy staff beliefs and attitudes.

Eligibility criteria: Inclusion Criteria:

* vaccine clients being vaccinated in community pharmacies participating in the project
* pharmacy staff in community pharmacies participating in the project

Exclusion Criteria:

* unable to understand and read English

Primary outcomes:
measure: Experience with vaccination
timeFrame: within 15 minutes after vaccination
Secondary outcomes:
measure: Fear
timeFrame: within 15 minutes after vaccination
measure: Pain
timeFrame: within 15 minutes after vaccination
measure: Dizziness
timeFrame: within 15 minutes after vaccination
measure: Fainting
timeFrame: within 15 minutes after vaccination
measure: Utilization of coping strategies during vaccination
timeFrame: within 5 minutes of vaccination
measure: CARD satisfaction survey
timeFrame: within 15 minutes of vaccination
measure: Implementation success of CARD
timeFrame: within 3 months of vaccination clinics
measure: Attitudes about vaccination
timeFrame: within 3 months of vaccination clinics
measure: Vaccination behaviours
timeFrame: within 3 months of vaccination clinics
measure: Vaccine interaction survey
timeFrame: within 5 minutes of vaccination
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Anna Taddio
state: Ontario
Study officials:
affiliation: University of Toronto
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03935503: COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR
Official title: COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR FOR SEXUAL, SENSORY, LIFE QUALITY AND URINARY FUNCTIONS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Keywords: Quality of life
Inguinal Hernia
Lichtenstein repair
Sexual Function
Total Extraperitoneal Repair
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SEXUAL ACTIVE

Brief summary: The superiority of laparoscopic inguinal hernia surgery over open surgery has been shown in many high patient-numbered studies with early return to work, less pain and good cosmetic results. The aim of this study is to determine the differences between two different methods in terms of sexual, sensory, quality of life and urinary results.

Detailed description: Between July 2017 and January 2018, 42 sexually active male patients were randomized with Laparoscopic Total Extraperitoneal (TEP) method and Lichtenstein (LCH) method and repair of inguinal hernia. Patients were evaluated preoperatively, at 1 month and 6 months postoperatively, International Sexual Function Index (IFIF), International Prostatic Symptom Score, SF-36 Quality of Life Scale, Visual Analog Pain Scale, Beck Depression Scale, Inguinal Region Discrimination Test ( DT), DN4 Neuropathic Pain Survey, Uroflowmetry and FSH, LH, Total Testosterone levels were evaluated.

Eligibility criteria: Inclusion Criteria:

* Unilateral inguinal hernia (diagnosed by physical examination or imaging)
* Sexual Active
* Male gender
* aged between 18 and 65
* ASA 1-2
* EHS Classification (Primary, lateral or medial, 1 and 2)

Exclusion Criteria:

* Patients with previous abdominal and inguinal hernia surgery
* ASA 3-4
* Sexually inactive
* Emergency patients (Etrangule inguinal hernia)

Primary outcomes:
measure: International Sexual Function Index (IFIF)
timeFrame: UP TO 6 MONTHS
measure: International Prostatic Symptom Score
timeFrame: UP TO 6 MONTHS
measure: SF-36 Quality of Life Scale
timeFrame: UP TO 6 MONTHS
measure: Visual Analog Pain Scale
timeFrame: UP TO 6 MONTHS
measure: Beck Depression Scale
timeFrame: UP TO 6 MONTHS
measure: Inguinal Region Discrimination Test ( DT)
timeFrame: UP TO 6 MONTHS
measure: DN4 Neuropathic Pain Survey
timeFrame: UP TO 6 MONTHS
measure: Uroflowmetry test for urination
timeFrame: UP TO 6 MONTHS
measure: Follicle Stimulating Hormone levels
timeFrame: UP TO 6 MONTHS
measure: Luteinising Hormone levels
timeFrame: UP TO 6 MONTHS
measure: Total Testosterone levels
timeFrame: UP TO 6 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatih Sultan Mehmet Research and Training Hospital
Study officials:
References:
Clinical trial NCT03237403: Hospital Orientation Since SAMU Regulation Centre Call
Official title: Study of Association Between Clinical Criteria Collected at the SAMU Regulation Centre Call and the Hospital Orientation of Patients With Suspected Sepsis State
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: Sepsis
Adults
Pre hospital settings
Triage
Hospital orientation
Outcome
Lead sponsor: Hôpital Necker-Enfants Malades
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects calling the SAMU regulation centre call with a clinical suspected sepsis history

Brief summary: Specify the association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call in patients with suspected sepsis and their hospital orientation: emergency department or intensive care unit

Detailed description: Anonymous, descriptive, longitudinal, resting study searching an association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call for patients with suspected sepsis and their subsequent hospital orientation

Eligibility criteria: Inclusion Criteria:

* adults (age\>18years)
* patients with suspected sepsis state at the regulation SAMU centre call

Exclusion Criteria: minor (age\<18years)

Primary outcomes:
measure: Hospital Admission Service
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP Necker Enfants Malades
Study officials:
affiliation: APHP Necker Enfants Malades SAMU 75
name: Romain Jouffroy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03578003: Morning Bright Light to Improve Sleep Quality in Veterans
Official title: Morning Bright Light to Improve Sleep Quality in Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Injuries, Traumatic
Post-traumatic Stress Disorder
Keywords: Sleep
Bright Light
Lead sponsor: Portland VA Medical Center
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2018-07-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the principal complicating factors associated with traumatic brain injury (TBI) is sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders). Morning bright light therapy (MBLT) has been shown to improve sleep quality in a variety of conditions, but little has been done investigating the utility of MBLT in improving sleep in Veterans with TBI. This proposal aims to determine the effect of MBLT on sleep quality in Veterans with TBI. Veterans with and without TBI will be recruited from the VA Portland Health Care System. Baseline questionnaires and 7 days of actigraphy will be collected prior to engaging in 60 minutes of MBLT daily for 4 weeks, during which actigraphy will also be collected continuously. Post-MBLT questionnaire data will be collected, and follow-up questionnaire data will be collected at 3 months post-MBLT.


Eligibility criteria: Inclusion Criteria:

* Veterans

Exclusion Criteria:

* History of bipolar disorder
* History of macular degeneration
* Non-English speaking
* Decisionally impaired
* Currently using a light box

Primary outcomes:
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline; after 4 weeks of intervention; and 2 months after the end of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
Study officials:
affiliation: Portland VA Medical Center
name: Miranda M Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elliott JE, McBride AA, Balba NM, Thomas SV, Pattinson CL, Morasco BJ, Wilkerson A, Gill JM, Lim MM. Feasibility and preliminary efficacy for morning bright light therapy to improve sleep and plasma biomarkers in US Veterans with TBI. A prospective, open-label, single-arm trial. PLoS One. 2022 Apr 14;17(4):e0262955. doi: 10.1371/journal.pone.0262955. eCollection 2022.
Clinical trial NCT01919203: the Effective Bolus Dose of Remifentanil for Laryngeal Mask Airway (LMA) Insertion in Children
Official title: the Effective Bolus Dose of Remifentanil for Laryngeal Mask Airway (LMA) Insertion in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Complication
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2013-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This research attempts to find the optimum dose of remifentanil that can prevent the unnecessary responses such as coughing, gagging, and movement when LMA is inserted during sevoflurane induction in pediatric patients.

Detailed description: Anaesthesia is induced by inhalation with 3% sevoflurane. A predetermined bolus dose of remifentanil is injected over 30 seconds. The LMA is attempted 60 seconds after bolus administration. The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status 1 or 2
* undergoing short elective surgery(i.e Strabismus surgery, Entropion surgery, Inguinal hernia surgery, etc) under general anesthesia

Exclusion Criteria:

* suspected difficult airways
* respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
* body mass index \> 30 kg/m2
* allergies to the study drugs
* a history of gastric reflux

Primary outcomes:
measure: patients's response to the LMA insertion
timeFrame: 2 minutes after LMA insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Nam gu
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
state: Daegu
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
name: sangjin park, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00766103: The Effects of PaCO2 Levels on Cerebral Metabolism and Perfusion During Induced Hypothermia.
Official title: The Effects of PaCO2 Levels on Cerebral Metabolism and Perfusion During Induced Hypothermia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Metabolism and Perfusion
Keywords: Cerebral metabolism, perfusion, induced hypothermia
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2008-10-03
Enrollment: 8
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: Incidence of hypo- and hypercarbia during induced hypothermia after cardiac arrest is high. The original report from HACA-group reported that hypothermia treated patients had improved survival and neurological outcome. Suprisingly, in that trial normocarbia was not achieved even though the aim was set for ventilatory support as normoventilation. This study aims to investigate the effects of mild hypo- and hypercarbia on cerebral perfusion (blood flow, intracranial pressure) and metabolism (microdialysate metabolites). We hypothesize that uncontrolled ventilatory suppport may render the patients in risk of exacerbation of neuronal damage, conversely, further improvement in outcome may be achieved with succesfull ventilatory management. We intend to enroll 10 out-of-hospital cardiac arrest patients succesfully resuscitated and subsequently treated with controlled hypothermia for 24 hours. The patients in need of anticoagulation are excluded. We plan to induce mild hypocarbia and hypercarbia during and after induced hypothermia. Metabolic and perfusion data are collected with clinically used methods such as transcranial doppler, intracranial pressure measurement, near infrared spectroscopy, jugular bulb, intracerebral microdialysis).


Eligibility criteria: Inclusion Criteria:

succesfull resuscitation of out of hospital cardiac arrest, primary rhytm shockable

Exclusion Criteria:

* known coagulopathy, need of anticoagulation therapy, need of interventional cardiological procedures

Primary outcomes:
measure: surrogate physiological endpoints
timeFrame: 60minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Critical Care Medicine Research Group/ department of intensive care
state: Pirkanmaa
Study officials:
References:
Clinical trial NCT04553003: Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
Official title: Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Drug-induced Liver Injury
Keywords: glucocorticosteroid
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of DILI
2. RUCAM score≥6 and with liver histology
3. Meet any of the following conditions:

   1. TBIL ≥ 10 fold ULN ;
   2. TBIL ≥ 5 fold ULN and serum AST or ALT ≥ 20 fold ULN

Exclusion Criteria:

1. An chronic onset (≥6 months)
2. Other liver diseases, such as autoimmune liver diseases, viral hepatitis, etc
3. with contraindications of glucocorticoid

Primary outcomes:
measure: percentage of patients that AST or ALT decline 25% at day 4
timeFrame: Change from Baseline ALT and AST at day4
Secondary outcomes:
measure: percentage of patients that AST or ALT decline 50% at day 8
timeFrame: Change from Baseline ALT and AST at day8
measure: the time needed when TBIL decline 50%
timeFrame: up to 2 weeks
measure: incidence of side effects
timeFrame: up to 2 years
measure: relapse rate in 12 months after drug withdrawal
timeFrame: 12 months after drug withdrawal
measure: mortality in 12 months after drug withdrawal
timeFrame: 12 months after drug withdrawal
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT01815203: Caffein Consumption and Response Inhibition
Official title: Does Caffeine Consumption Improve Response Inhibition to Food Cues?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Obesity
Keywords: Caffeine effects
Inhibitory control
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2013-03-20
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: With the abundance of energy-dense foods that are designed for ease of consumption in the current environment, it is of importance to better understand the factors that may undermine the control of energy intake at healthy levels.

One of the factors that is potentially important in response inhibition is caffeine.

The aim is to assess the direct effects of caffeine on response inhibition, using a No Go/Go-task. We will also assess whether the presentation of food cues, i.e. as words or as pictures, modulate response inhibition different in restrained vs. non-restrained eaters.

Detailed description: In a blinded, randomized cross-over design, participants will receive either a capsule with caffeine or placebo at two separate occasions whereupon study tasks will be performed.

Eligibility criteria: Inclusion Criteria:

* Only males
* 18 ≤ 35 years
* Healthy (self rated)
* Used to drink caffeine
* Used to eat breakfast regularly (≥ 5 times a week).
* Non-smokers

Exclusion Criteria:

* BMI outside the range of 18,5 ≤ 25
* hypersensitivity for the ingredients of the foods under study
* being a vegan or vegetarian. Participants reported not using products that are artificially sweetened, nor sugar in coffee and/or tea
* Presence of any chronically disease and/or treatment with medication

Primary outcomes:
measure: Inhibition control
timeFrame: 20 min
Secondary outcomes:
measure: Food test
timeFrame: 20 min
Other outcomes:
measure: Blood sample
timeFrame: 5 min (1 sample)
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Pleunie Hogenkamp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05151003: Epidemiology of In-hospital Acute Kidney Injury
Official title: Analysis of In-hospital Acute Kidney Injury Epidemiology, Treatment and Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Dialysis; Complications
Chronic Kidney Diseases
Lead sponsor: Universita degli Studi di Genova
Sponsor class: OTHER
Collaborators: name: Ospedale Policlinico San Martino
First posted: 2021-12-09
Enrollment: 60000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to Policlinico Universitario San Martino, Genova, Italy (including those with COVID-19).

Brief summary: Retrospective observational study to investigate acute kidney injury (AKI) epidemiology and outcomes in patients hospitalized in University Hospital San Martino, Genova, Italy.

Detailed description: A retrospective observational study was designed to investigate acute kidney injury (AKI) epidemiology and outcome in patients hospitalized in University Hospital San Martino, Genova, Italy.

All data will be extracted from the hospital electronic database. The investigators will evaluate demographic, clinical and laboratory data, including age, sex, serum creatinine (sCr), sodium and electrolytes, intensive care unit (ICU) admission, length of hospital stay, death, comorbidities and primary diagnosis codes at the hospital discharge (using International Classification of Diseases-ICD-9- codes).

The investigators will include also patients affected by Coronavirus disease 19 (COVID-19).

The primary endpoint will be to describe AKI epidemiology, secondary endpoints will be to evaluate AKI-related risk factors and clinical outcomes, such as length of stay and mortality.

Moreover, the investigators will describe the differences in the outcome and treatments of AKI patients in the medical wards and ICU.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to University Hospital San Martino, Italy
* We'll include also patients affected by Coronavirus disease 19 (COVID-19).

Exclusion Criteria:

* Hemodialysis patients

Primary outcomes:
measure: Acute Kidney Injury incidence
timeFrame: Collection of retrospective data from 2016
measure: Acute Kidney Injury severity
timeFrame: Collection of retrospective data from 2016
Secondary outcomes:
measure: Mortality in Acute Kidney Injury patients
timeFrame: Collection of retrospective data from 2016
measure: Creatinine clearance after discharge
timeFrame: Collection of retrospective data from 2016
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS Policlinico San Martino
Study officials:
affiliation: University of Genova, Italy
name: Pasquale Esposito, Prof
role: PRINCIPAL_INVESTIGATOR
References: