louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02400294: Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients
Official title: Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Mechanical Ventilation
Ventilator Associated Pneumonia Prevention
Toothbrushing
Oral Care
Keywords: Critical care
Mechanical ventilation
Ventilator associated pneumonia
Oral care
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 2030
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mechanically ventilated patients

Brief summary: Effect of toothbrushing in oral care of mechanically ventilated critically ill patients on prevention of ventilator associated pneumonia

Detailed description: Prospective, before and after study in 5 Intensive Care Units (ICUs) of a university hospital.

The before period (control phase, 6 months): standard oral care 3 times a day in every consecutive intubated patients in the participating ICUs The interphase period (1 month): formal training of all the nurses, physicians and residents on the use of toothbrushing during oral care The after period: (study phase, 6 months): standard oral care with tooth brushing 3 times a day in every consecutive intubated patients in the participating ICUs

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Intubated mechanically ventilated ICU patient
* Platelets count \>50G/L

Exclusion Criteria:

* Edentulous patients

Primary outcomes:
measure: Nosocomial ventilator associated pneumonia
timeFrame: at Day-28
Secondary outcomes:
measure: Tracheobronchitis
timeFrame: at Day-28
measure: ICU length of stay
timeFrame: at Day-90
measure: ICU mortality
timeFrame: at Day-90
measure: Hospital mortality
timeFrame: at Day-90
measure: Antibiotic free days
timeFrame: at Day-90
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Russel CHABANNE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ory J, Mourgues C, Raybaud E, Chabanne R, Jourdy JC, Belard F, Guerin R, Cosserant B, Faure JS, Calvet L, Pereira B, Guelon D, Traore O, Gerbaud L. Cost assessment of a new oral care program in the intensive care unit to prevent ventilator-associated pneumonia. Clin Oral Investig. 2018 Jun;22(5):1945-1951. doi: 10.1007/s00784-017-2289-6. Epub 2017 Nov 30.
Clinical trial NCT00746460: The Healthy Options Feasibility Study
Official title: The Effectiveness of CVD Risk Profiles When Used by Allied Health Care Providers (HCP) Within a "Groupe de Médecine de Famille": The Healthy Options Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Sedentary Lifestyle
Dyslipidemia
Hypertension
Cigarette Smoking
Diabetes
Keywords: primary prevention
patient knowledge
nurse
exercise
smoking cessation
weight loss
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that having health care providers other than physicians within a "Groupe de Médecine de Famille" conduct cardiovascular risk assessments and teach lifestyle interventions to primary prevention patients will increase the likelihood that patients will adopt and maintain healthy lifestyles. These objectives will be supported by providing subjects with a cardiovascular risk profile estimating the subject's risk of cardiovascular disease and teaching them how to use the resources related to lifestyle changes available on the www.myhealthcheckup.com Web site.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects 30-79 years of age without known cardiovascular disease but with one or more risk factors such as obesity, a sedentary lifestyle, dyslipidemia, hypertension, cigarette smoking, or diabetes
* Have provided informed consent
* Recent (past 6 months) fasting lipid profile results in the medical charts

Exclusion Criteria:

* Unable or unlikely to follow and/or complete study or evidence of uncooperative attitude
* Subject is not literate in either French or English
* Subject does not have easy and regular access to the Internet
* Exercise or weight loss are contra-indicated for medical reasons

Primary outcomes:
measure: Feasibility of using health care providers other than physicians within a GMF to conduct a CV risk assessment and intervention on primary prevention patients
timeFrame: 10 months
Secondary outcomes:
measure: Patient's CV risk factors and overall CV risk
timeFrame: 16 weeks
measure: Subject's adherence with lifestyle changes and prescribed medications
timeFrame: 16 weeks
measure: Satisfaction of the nurse
timeFrame: 10 months
measure: Satisfaction of the patient
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill Cardiovascular Health Improvement Program
state: Quebec
Study officials:
affiliation: McGill Cardiovascualr Health Improvement Program
name: Steven Grover, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02948660: A Promising Tool for Predicting Consciousness Evolution in Prolonged Disorders of Consciousness
Official title: EEG Dynamics Induced by Zolpidem Forecasts Consciousness Evolution in Prolonged Disorders of Consciousness and Quantification of EEG Reactivity Predicts Recovery of Consciousness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Disorder of Consciousness
Keywords: Prolonged disorders of consciousness
Zolpidem
EEG
Prognosis
Unresponsive wakefulness syndrome
Minimally conscious state
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou University of Chinese Medicine
name: University of Melbourne
name: Tianjin University
First posted: 2016-10-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The research contains two parts. Part 1: To explore whether EEG responses to zolpidem can assess consciousness circuit integrity and predict the evolution of consciousness in patients with prolonged disorders of consciousness; Part 2: To explore if quantitative EEG reactivity might predict the prognosis of disorders of consciousness.


Eligibility criteria: Inclusion Criteria:

* presence of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) on admission;
* time since onset \> 4 weeks;
* no history of neurodegenerative or psychiatric diseases.

Exclusion Criteria:

* allergic to zolpidem;
* currently receiving zolpidem or related benzodiazepines;
* diagnosed with seizure or status epilepticus.

Primary outcomes:
measure: The Coma Recovery Scale-Revised
timeFrame: Six months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Neurology, Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Department of Neurology, Xijing Hospital, Fourth Military Medical University
name: Wen Jiang, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01760460: A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1)
Official title: A Multicenter, 24-Week, Double-Blind, Randomized, Placebo-Controlled, Phase III Study With 28-Week Open Labeled Extension Period to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Japanese Patients With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-01-04
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with dyslipidemia when added to an existing statin-modifying therapy.


Eligibility criteria: Inclusion Criteria:

* If female, cannot be of reproductive potential
* Treatment with an appropriate, stable dose of statin ± other lipid modifying therapy for at least 6 weeks and who is not at LDL-C goal per their category in the Japan Atherosclerosis Society guidelines

Exclusion Criteria:

* Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
* Homozygous and heterozygous familial hypercholesterolemia
* Severe chronic heart failure
* Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months

Primary outcomes:
measure: Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
timeFrame: Baseline and Week 24
measure: Percentage of Participants who Experience at Least One Adverse Event (AE)
timeFrame: 64 weeks
Secondary outcomes:
measure: Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)
timeFrame: Baseline and Week 24
measure: Percent Change from Baseline in Non-HDL-C
timeFrame: Baseline and Week 24
measure: Percent Change from Baseline in Apolipoprotein B (Apo-B)
timeFrame: Baseline and Week 24
measure: Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
timeFrame: Baseline and Week 24
measure: Percent Change from Baseline in Lipoprotein(a) (Lp[a])
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
Study officials:
References:
citation: Teramoto T, Daida H, Ikewaki K, Arai H, Maeda Y, Nakagomi M, Shirakawa M, Watanabe Y, Kakikawa T, Numaguchi H, Johnson-Levonas AO, Blaustein RO. Lipid-modifying efficacy and tolerability of anacetrapib added to ongoing statin therapy in Japanese patients with dyslipidemia. Atherosclerosis. 2017 Jun;261:69-77. doi: 10.1016/j.atherosclerosis.2017.03.009. Epub 2017 Mar 10.
Clinical trial NCT01092260: Renal Function Measurements in Children
Official title: Glomerular Filtration Rate in Children - a Methodological Study With Iohexol Clearance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Function Disorder
Keywords: Glomerular Filtration Rate
Kidney disease
Child
Iohexol
Cystatin C
Measurement of kidney function in children
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2010-03-24
Enrollment: 96
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with clinical indication for measurement of renal function

Brief summary: The purpose of this study is to validate a feasible, safe and reliable iohexol plasma clearance method in routine monitoring of the renal function (GFR) in children.

Different parameters of renal function will be compared to the gold standard multiple sample points procedure of iohexol clearance.


Eligibility criteria: Inclusion Criteria:

* Age \< 18 years
* Clinical indication for measurement of glomerular filtration rate

Exclusion Criteria:

* Previous serious reaction on Iohexol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital, Bergen, Norway
name: Camilla Tondel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eide TT, Hufthammer KO, Brun A, Brackman D, Svarstad E, Tondel C. Accuracy of single intravenous access iohexol GFR in children is hampered by marker contamination. Sci Rep. 2021 Dec 1;11(1):23224. doi: 10.1038/s41598-021-02759-1.
citation: Salvador CL, Tondel C, Rowe AD, Bjerre A, Brun A, Brackman D, Morkrid L. Estimating glomerular filtration rate in children: evaluation of creatinine- and cystatin C-based equations. Pediatr Nephrol. 2019 Feb;34(2):301-311. doi: 10.1007/s00467-018-4067-3. Epub 2018 Aug 31.
citation: Tondel C, Salvador CL, Hufthammer KO, Bolann B, Brackman D, Bjerre A, Svarstad E, Brun A. Iohexol plasma clearance in children: validation of multiple formulas and single-point sampling times. Pediatr Nephrol. 2018 Apr;33(4):683-696. doi: 10.1007/s00467-017-3841-y. Epub 2017 Nov 13.
citation: Salvador CL, Tondel C, Rowe AD, Bjerre A, Brun A, Brackman D, Bolstad N, Morkrid L. Renal Function Influences Diagnostic Markers in Serum and Urine: A Study of Guanidinoacetate, Creatine, Human Epididymis Protein 4, and Neutrophil Gelatinase-Associated Lipocalin in Children. J Appl Lab Med. 2017 Nov 1;2(3):297-308. doi: 10.1373/jalm.2016.022145.
citation: Tondel C, Bolann B, Salvador CL, Brackman D, Bjerre A, Svarstad E, Brun A. Iohexol plasma clearance in children: validation of multiple formulas and two-point sampling times. Pediatr Nephrol. 2017 Feb;32(2):311-320. doi: 10.1007/s00467-016-3436-z. Epub 2016 Jul 1.
Clinical trial NCT03502460: Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation.
Official title: Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation (ORFALU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Lung ultrasonography
fluid administration
limitation
stroke volume variation
esophageal Doppler
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The possibility of exploring the lungs by lung ultrasound, a non-invasive tool, is becoming increasingly popular for anesthesiologists. Recently, Lichtenstein has described the FALLS protocol (Fluid Administration Limited by Lung Sonography) which uses the potential of pulmonary ultrasound to evaluate early pulmonary overload due to fluid administration at a subclinical stage. Indeed, fluid administration can generate a sub-clinical interstitial syndrome that can be detected by passing from a profile A to a profile B in lung ultrasound. The transition from a profile A to a profile B therefore corresponds to the transition from a state of preload dependent to a state of preload independence. However, this tool has not been studied in the operating room. The main objective of this study will be to study the correlation between pulmonary ultrasound and SV variation measured by esophageal Doppler during fluid administration in patients with haemodynamic optimisation in the operating room during digestive, urological, gynecological and orthopedic surgeries. The main expected result is the following: good correlation between the absence of increased SV in the esophageal Doppler and the appearance of a B-profile lung ultrasound fluid administration in the operating room.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 ans
* inclusion criteria:
* Patient having a digestive, urological, gynecological, vascular or orthopedic surgery
* Haemodynamic optimisation requiring titration of the fluid administration
* Informed consent signed

Exclusion Criteria:

* Non-consent
* Chronic pulmonary pathology: COPD with pulmonary emphysema, pulmonary fibrosis

Primary outcomes:
measure: Apparition of Lines B at Lung Ultrasonography
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
citation: Bar S, Yee C, Lichtenstein D, Sellier M, Leviel F, Abou Arab O, Marc J, Miclo M, Dupont H, Lorne E. Assessment of fluid unresponsiveness guided by lung ultrasound in abdominal surgery: a prospective cohort study. Sci Rep. 2022 Jan 25;12(1):1350. doi: 10.1038/s41598-022-05251-6.
Clinical trial NCT01911260: Weekly Zinc Chelate Supplementation on Children's Growth
Official title: Effect of Weekly Zinc Chelate Supplementation on Schoolchildren's Growth: a Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Short Stature
Keywords: Zinc
Growth
Child
Dietary Supplements
Randomized Controlled Trial
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 199
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to measure the effect of weekly zinc supplementation on schoolchildren with growth deficit or normal stature.

Detailed description: Zinc is an important micronutrient for humans. Trials with zinc have shown positive effects of supplementation on growth, but there is still a lack of results on schoolchildren population. This Randomized Double-Blind Controlled Trial was design to measure the effect of weekly zinc supplementation on schoolchildren with growth deficit and normal stature. Schoolchildren were allocated into two homogeneous groups named Growth Deficit (HAZ \< -1,5 Z-score), and Normal Stature (HAZ between -1,0 and ±1,0 Z-score) and were randomly assigned to compose two exposed and two control groups to receive a supplement of 30mg of zinc amino acid chelate or placebo individually once a week, during 12 weeks. Children's heights were measured at the end of supplementation period and again after 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD). For the Normal Stature group(NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.

Exclusion Criteria:

* Children of GD group were evaluated by a Pediatrician specialized in growth disorders with the objective of excluding any organic or genetic condition correlated with growth deficit.

Primary outcomes:
measure: Change in Height-for-Age Z-score (HAZ) From End of Supplementation to End of Follow-up Period.
timeFrame: Height-for-Age Z-score was measured at the End of Supplementation period and again at the End of Follow-up period, with a 12 weeks interval.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: José Augusto AC Taddei, MD, Dr PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01530360: Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants
Official title: Safeguarding the Brains of Our Smallest Children - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Premature Infants
Near-infrared Spectroscopy
Oximetry
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Elsass Foundation
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Medical University of Graz
name: Hospices Civils de Lyon
name: KU Leuven
name: University College Cork
name: University of Zurich
name: University of Milan
name: Universitair Medisch Centrum Utrecht
name: University of Witten/Herdecke
name: Uppsala University
name: Cambridge University Hospitals NHS Foundation Trust
name: Hospital Universitario La Paz
First posted: 2012-02-09
Enrollment: 10
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. The investigators developed a treatment guideline and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10 infants.


Eligibility criteria: Inclusion Criteria:

* gestational age at birth less than 28 completed weeks
* cerebral oximeter in place at 3 hours after birth

Exclusion Criteria:

* decision not to provide full life support

Primary outcomes:
measure: change of medical management elicited by cerebral oxygenation out of range
timeFrame: 0-72 hours of life
Secondary outcomes:
measure: Adverse device effects
timeFrame: 0-72 hours
measure: burden of hypo-and hyperoxia
timeFrame: 0-72 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Neonatology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Gorm Greisen, MD,DMSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greisen G, Leung T, Wolf M. Has the time come to use near-infrared spectroscopy as a routine clinical tool in preterm infants undergoing intensive care? Philos Trans A Math Phys Eng Sci. 2011 Nov 28;369(1955):4440-51. doi: 10.1098/rsta.2011.0261.
citation: Hyttel-Sorensen S, Austin T, van Bel F, Benders M, Claris O, Dempsey EM, Fumagalli M, Gluud C, Hagmann C, Hellstrom-Westas L, Lemmers P, Naulaers G, van Oeveren W, Pellicer A, Pichler G, Roll C, Stoy LS, Wolf M, Greisen G. Clinical use of cerebral oximetry in extremely preterm infants is feasible. Dan Med J. 2013 Jan;60(1):A4533.