louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04497246: Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)
Official title: Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Subjects 65 years of age or older, having been hospitalized for COVID-19 within the CHU Brugmann Hospital
* People aged 18 or over, member of the nursing staff of the CHU Brugmann Hospital, having worked during COVID-19.

Brief summary: COVID-19 is an infectious disease caused by the last coronavirus discovered, called SARS-CoV-2. Symptoms encountered in COVID-19 are: cough, breathing difficulties (dyspnea, chest pain, etc.), pyrexia, anosmia (loss of smell) and/or dysgeusia (loss of taste), but also ENT symptoms (rhinitis type, odynophagia), headaches, asthenia, muscle pain, confusion and diarrhea. Infection with SARS-CoV-2 can also be asymptomatic. COVID-19 can be passed from person to person by respiratory droplets expelled when a person speaks, coughs or sneezes. The currently estimated incubation period ranges from 1 to 14 days, and most often this is around 5 days.

According to a literature review, there is strong evidence that COVID-19 has an impact on mental health (anxiety being the most common symptom) whether in the general population, healthcare workers or vulnerable populations. The objective of this project is to assess mental health and sleep disorders within two populations: elderly patients and nursing staff.


Eligibility criteria: Inclusion Criteria:

* Subjects 65 years of age or older, having been hospitalized for COVID-19 within the CHU Brugmann Hospital
* People aged 18 or over, member of the nursing staff of the CHU Brugmann Hospital, having worked during COVID-19.

Exclusion Criteria:

* Incoherent patients
* Severe presbycusis
* Oral expression impairment
* Insurmountable language barrier

Primary outcomes:
measure: Impact Event Scale-Revised (IES-R)
timeFrame: 15 minutes
measure: Generalised Anxiety Disorder-7 (GAD-7)
timeFrame: 15 minutes
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 15 minutes
measure: Insomnia severity index (ISI)
timeFrame: 15 minutes
Secondary outcomes:
measure: Demographic data
timeFrame: 1 year
measure: Hospitalization duration
timeFrame: 1 year
measure: ICU stay
timeFrame: 1 year
measure: Medical history
timeFrame: 1 year
measure: Alcohol consumption
timeFrame: 1 year
measure: Tobacco consumption
timeFrame: 1 year
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Sophie Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00879346: A Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets
Official title: A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
ADME
Healthy male volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-10
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Phase I, randomised, open label, 3-period crossover study in healthy male subjects to investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the safety and tolerability of AZD8931.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria:

* Use of any prescribed or non-prescribed medication (including analgesics, herbal remedies, vitamins and minerals) during the two weeks prior to the first administration of investigational product
* Administration of another investigational medicinal product in the 3 months before the start of dosing in this study
* Definite or suspected clinically relevant personal history of adverse drug reactions, or drug hypersensitivity

Primary outcomes:
measure: To investigate the effect of food on the pharmacokinetics of AZD8931 160mg oral dose
timeFrame: Multiple blood PK samples taken between predose to up to 5 days post last dose
Secondary outcomes:
measure: To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG
timeFrame: Maximus of 7 weeks (From time of consent to last visit including any follow-up)
Other outcomes:
Locations:
city: Alderley Park
country: United Kingdom
facility: Research Site
state: Cheshire
Study officials:
affiliation: AstraZeneca, Clinical Pharamcology Unit, Alderley Park
name: Emeline Ramos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Mary Stuart, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00268112: Resynchronization of Left Ventricular Contraction After Reimplantation of Anomalous Left Coronary Artery
Official title: Resynchronization of Left Ventricular Contraction After Re-implantation of Anomalous Left Coronary Artery From the Pulmonary Artery (ALCAPA) Evaluated by Tissue Doppler Imaging
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: pediatric
cardiac
ALCAPA
Tissue Doppler Imaging
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-22
Enrollment: 3
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac pediatric patients

Brief summary: Spontaneous resynchronization of dyskinetic segments of the left ventricle occurs after coronary bypass surgery in adults and has been shown in some children. It is, however, unknown what degree of dyskinesis is likely to be reversible in infants with ischemia from anomalous coronary arteries and what criteria would indicate that a resynchronization strategy of biventricular pacing might be needed.

These questions need data from quantitative serial tissue Doppler observations of patients from pre-operative to late post-operative follow-up.

Detailed description: We have previously studied, at Children's Healthcare of Atlanta, Egleston Hospital, 2 patients with ALCAPA and one other patient is currently enrolled in a prospective study after recent surgery, also at Children's Healthcare of Atlanta. We propose to study these 3 patients with this rare defect concurrently with their routine echocardiographic evaluations. Data will then be taken off-line for analysis.

Standard deviations of times to peak contraction velocity will be assessed for twelve cardiac segments. These will be reevaluated at follow up intervals after surgery on previously obtained echocardiograms. Those subjects in whom improvement of cardiac function, Left Ventricular Ejection Fraction (LVEF) and mitral regurgitation is seen will be compared to those in whom no improvement occurs.

Eligibility criteria: Inclusion Criteria:

* Re-implantation of an anomalous left coronary artery from the pulmonary artery

Exclusion Criteria:

* those patients who do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Sibley Heart Center Cardiology at Children's Healthcare of Atlanta
name: Derek A. Fyfe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00808912: Does Sildenafil Increase Exercise Performance in Air Pollution?
Official title: Decreased Pulmonary Artery Pressure by Oral Sildenafil Injection During Exercise in Air Pollution Increases Exercise Performance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Pulmonary Artery Pressure
Exercise Performance
Air Pollution
Keywords: phosphodiesterase
sildenafil
pulmonary hypertension
exercise performance
air pollution
Lead sponsor: Marywood University
Sponsor class: OTHER
First posted: 2008-12-16
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine if the ingestion of a standard dose of sildenafil enhances the athletic performance of competitive athletes when exercising in a high pollutant environment verses a low air pollutant environment.

Detailed description: This study will evaluate effects of sildenafil on exercise performance while breathing high levels of emission exhaust ultrafine and fine particulate matter. Exercise performance will be measured by work accumulation (total kJ) during a 6-min maximal effort cycle ergometer ride (CER) done immediately after 30 min cycling at 75% of 6 min mean watts determined from familiarization trial. Peak oxygen consumption, cardiac output, pulmonary artery pressure, diffusion capacity(DLco), and SaO2 will be determined for each trial. Blood and urine will be analyzed for sildenafil using LC/MS.

Eligibility criteria: Inclusion Criteria:

* non-asthmatic
* asthmatic
* active participants in endurance sports.

Exclusion Criteria:

* history of high blood pressure
* history of heart disease
* pulmonary arterial hypertension
* pulmonary emboli
* diagnosis of moderate to severe asthma (FEV1 \<75% predicted)
* pregnant or lactating

Primary outcomes:
measure: That a decrease in exercise performance subsequent to emissions particle inhalation will be blunted by oral ingestion of 50 mg sildenafil prior to a 6-min maximal accumulation test (total kJ)on a cycle ergometer.
timeFrame: Cycle ergometer testing will be done one hour after administration of sildenafil or matching placebo.
Secondary outcomes:
measure: That the decreased VO2 peak and decreased exercise performance from emissions inhalation will be the result of pulmonary hypertension causing decreased stroke volume.
timeFrame: Pulmonary artery pressure will be measured before and immediately post exercise.
measure: That plasma and urine sildenafil and metabolites will be measurable by liquid chromatography mass spectrometry (LC/MS) 6 h post ingestion.
timeFrame: Blood and urine samples will be collected at 1, 3, 1nd 6 hours post exercise testing.
Other outcomes:
Locations:
city: Scranton
country: United States
facility: Marywood University
state: Pennsylvania
Study officials:
affiliation: Marywood University
name: Kenneth W Rundell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02648412: Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation
Official title: Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients Under Ketamine Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anesthesia
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study was to describe the relationship between the intensity of a standardized tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine sedation.

After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured before and after each stimulation.


Eligibility criteria: Inclusion Criteria:

* Patient admitted to pediatric burns care unit
* Burnt skin area 5-40%
* Scheduled for a dressing change under ketamine sedation

Exclusion Criteria:

* Neurologic or ophthalmic disease

Primary outcomes:
measure: Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry
timeFrame: 30 seconds after each stimulation (6 stimulations per patient)
Secondary outcomes:
measure: Heart rate variation
timeFrame: 30 seconds after each stimulation
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'anesthesie Hopital Armand Trousseau
Study officials:
affiliation: University Hospital Armand Trousseau
name: Isabelle Constant, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05735912: EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)
Official title: Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Insulinoma
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this muticentre randomized controlled trial is to compare endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) with surgery for treatment of pancreatic insulinoma. The main questions it aims to answer are: 1) What is the safest treatment? 2) Is efficacy comparable? Patients will be randomized to undergo EUS-RFA or surgical resection. Researchers will compare the rate of adverse events and the clinical efficacy after the two treatments to see if EUS-RFA result safer and effective compare with surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Diagnosis of pancreatic insulinoma (38) (e.g., fasting test, insulin blood levels, C-peptide blood levels)
* Presence of a visible single pancreatic nodule on imaging (computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound).
* No evidence of distant localizations visualized at computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound
* Tumor ≤ 2cm
* Informed consent provided by the patient or closest relative.

Exclusion Criteria:

* G2 with Ki-67 \>5% on histological examination at EUS-guided biopsy samples (if performed)
* Distance between lesion and main pancreatic duct ≤ 1mm or upstream dilation of the main pancreatic duct
* Metastatic tumor at the time of diagnosis
* Multiple pancreatic nodules
* Diagnosis of multiple endocrine neoplasia type 1 according to guidelines
* Unfit for surgery or high-risk surgical patients
* Endoscopic ultrasound not feasible for surgical altered anatomy
* Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma
* Use of anticoagulants that cannot be discontinued
* International normalized ratio \>1.5 or platelet count \<50.000
* Pregnancy or breast feeding
* Failure to sign the patient's or closest relative's informed consent

Primary outcomes:
measure: Rate of adverse events
timeFrame: Up to 72 months
Secondary outcomes:
measure: Clinical effectiveness
timeFrame: Up to 72 months
measure: Evaluation of quality of life by questionnaire
timeFrame: Up to 72 months
measure: Length of hospital stay
timeFrame: Up to 72 months
measure: Recurrence
timeFrame: Up to 72 months
measure: Reintervention
timeFrame: Up to 72 months
measure: Pancreatic insufficiency
timeFrame: Up to 72 months
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University Hospital of Verona
Study officials:
References:
Clinical trial NCT00409812: A Study of the Effects of Sodium Citrate on Olfactory Thresholds
Official title: A Double Blinded Randomised Controlled Trial of the Effects of Sodium Citrate on Olfactory Thresholds
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anosmic and Hyposmic Patients
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2006-12-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The study will be undertaken at the ENT department of the Leicester Royal Infirmary and in a research laboratory at the University of Leicester and also in the ENT department at the West Suffolk Hospital. One hundred subjects will be recruited. Subjects will be invited to undergo a series of smell tests using graded concentrations of 4 odours in 120ml bottles (1). This test has been described and validated by our previous work (2). The test will be fully explained to the subject beforehand by the researcher who will test the patient. The subject will be started with the smallest concentration of each odour and will ascend through the bottles until they detect 2 in a row, at which point the weaker concentration of the odour will be taken as their threshold. They will have a threshold levels determined for the odours phenethyl alcohol (roses), mercaptan (gas), acetic acid (vinegar) and eucalyptol (menthol).

Then, the subject will undergo a sodium citrate nasal douche at a specific concentration or will douche with sterile water. There will be three concentrations used (3%, 6% and 9%) and a control solution (sterile water). Patients will be randomly allocated to one of the four groups using a coded bottle system. Both patient and tester will be blinded to the solution used as these will be made in the pharmacy and coded for anonymity - the code will be broken at the end of the trial. Subjects will then be retested with the bottles and threshold levels will be observed for the four odours at 15 minute intervals over 2 hours. The purpose of the repeated tests is to determine the length of the effect (if present) of the citrate on the olfactory ability of the patients.

(N.B. Sodium citrate is a licensed product for use in body cavities (e.g. stomach, bladder) and can be found in the British National Formulary - the concentrations proposed do not exceed those used elsewhere.)

1. Wudarski TJ, Doty RL. Comparison of detection threshold values determined using glass sniff bottles and plastic squeeze bottles.Percept Mot Skills. 2004 Feb;98(1):192-6
2. Gaskin J, Robinson A, Philpott CM, Goodenough P, Murty G. Are patients cross-sensitive to odours in parallel threshold tests? Chemical Senses 2006; in progress


Eligibility criteria: Inclusion Criteria:

* Anosmia
* Hyposmia

Exclusion Criteria:

* Under age of 18 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals, Leicester
name: Julian Gaskin, MBChB MRCSEd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005712: Self Management Education Asthma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Lung Diseases
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To evaluate the effects of a new statewide program to enhance identification, referral and provision of care to rural families of Hispanic children with moderately severe to severe asthma. Specifically, to determine if comprehensive medical care (CMC) plus an educational self-management program for rural Hispanic children and their families had an impact on asthma morbidity, as well as on cost and family adaptation.

Detailed description: BACKGROUND:

Because of New Mexico's large rural and heavily Hispanic population, it was an ideal setting to determine effective methods for case management, self-management educational programs and effective tertiary to primary care delivery collaboration.

The study was part of a demonstration and education initiative "Interventions for Control of Asthma Among Black and Hispanic Children" which was released by the NHLBI in June 1989.

DESIGN NARRATIVE:

A randomized block design was used with random assignment of subjects by county to treatment groups of 1. comprehensive medical care or standard tertiary care and education, or 2. CMC-Plus adding a structured self-management program--Open Airways/Respiro Abierto (developed and tested with support of NHLBI). CMC-Plus also received in home education and intervention from community based Hispanic family educators trained in an empowerment model of family intervention, in-home support, and education. Case management was provided by CMS; CMC and CMC-Plus were provided at the UNM-PPP in close collaboration with and transfer of care to the primary physician. Additional educational contact with primary care providers and emergency rooms were provided through the UNM Department of Family, Community \& Emergency Medicine which utilized the National Institutes of Health National Asthma Education Program's Guidelines for Step-Wise Care of Asthma. Asthma morbidity, cost of care, family adaptation and family satisfaction were evaluated using standardized instruments.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Clark D, Gollub R, Green WF, Harvey N, Murphy SJ, Samet JM. Asthma in Jemez Pueblo schoolchildren. Am J Respir Crit Care Med. 1995 May;151(5):1625-7. doi: 10.1164/ajrccm.151.5.7735623.