louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02048683: A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients
Official title: A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ICU Patients With Indication of Sedation
Keywords: Pharmacokinetics
Sevoflurane
Burn
Sedation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.

Detailed description: Prospective clinical study in ICU with sedated ventilated patients with sevoflurane with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride) comparing burn and non burn ICU patients

Eligibility criteria: Inclusion Criteria:

* Adult patients ventilated requiring invasive procedure in ICU

  * Stable respiratory and hemodynamic conditions
  * Consent of patients or family
  * Arterial line
  * Burn patients : burn area between 20 and 50% (3rd degree) OR non burn patients

Exclusion Criteria:

* BMI \<30

  * Sevoflurane anaphylaxia

Primary outcomes:
measure: Determination of plasmatic concentrations of sevoflurane
timeFrame: at 5min, 15 min, 60 min and just before the end of sedation.
Secondary outcomes:
measure: Determination of plasmatic concentrations of HFIP and fluoride
timeFrame: at 5min, 15 min, 60 min and just before the end of sedation. And 5min, 10 min, 30 min, 60 min and 120 min after the end of sedation
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perbet S, Bourdeaux D, Lenoire A, Biboulet C, Pereira B, Sadoune M, Plaud B, Launay JM, Bazin JE, Sautou V, Mebazaa A, Houze P, Constantin JM, Legrand M; PRONOBURN group. Sevoflurane for procedural sedation in critically ill patients: A pharmacokinetic comparative study between burn and non-burn patients. Anaesth Crit Care Pain Med. 2018 Dec;37(6):551-556. doi: 10.1016/j.accpm.2018.02.001. Epub 2018 Feb 15.
Clinical trial NCT04408183: GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)
Official title: Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: SARS-CoV 2
Infection
Keywords: COVID-19
Lead sponsor: GeneOne Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-29
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This clinical trial will evaluate the safety, tolerability and effectiveness of topical GLS-1200 nasal spray to reduce the incidence of confirmed, symptomatic SARS-CoV-2 infection.

Detailed description: This Phase II randomized, placebo-controlled, double-blind study will assess whether topical GLS-1200 applied via nasal spray atomizer is well-tolerated and can reduce the incidence of confirmed SARS-CoV-2 infection. Subjects will be randomized to either the GLS-1200 or placebo group in a 2:1 ratio with a target enrollment of 225 subjects. Subjects will self-administer study drug three times daily for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Able to provide informed consent
* Able and willing to comply with study procedures
* Able and willing to utilize an approved form of pregnancy prevention for women of child bearing potential through to the end of treatment

Exclusion Criteria:

* Know allergy to quinine, quinidine, or mefloquine
* Confirmed prior positive test for SARS-CoV-2
* Treatment within the past 2 weeks with chloroquine, hydroxychloroquine, or remdesivir
* Pregnancy or documentation of pregnancy by pre-treatment urine test or breast feeding or plans to become pregnant during the course of the study

Primary outcomes:
measure: Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0
timeFrame: 4 weeks of treatment
measure: Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group
timeFrame: 4 weeks of treatment
Secondary outcomes:
measure: Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome.
timeFrame: 4 weeks of treatment
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Sinus and Nasal Specialists of Louisiana
state: Louisiana
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Conroe
country: United States
facility: Conroe Willis Medical Reasearch
state: Texas
Study officials:
References:
Clinical trial NCT06768983: Fatigue Reduction in Chronic Kidney Disease (CKD)
Official title: A Pilot Trial of Strategies to Reduce Fatigue for People With Chronic Kidney Disease (CKD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Fatigue
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this pilot trial, investigators will pilot test a cognitive behavioral intervention for acceptability and proof of concept for a larger future trial to be submitted for federal funding. This is a one-group design with qualitative and quantitative data collection integrated into the intervention.


Eligibility criteria: Inclusion Criteria:

* Interest in participating in a fatigue study
* Age ≥18 years old
* Estimated glomerular filtration rate (eGFR) 15-44 mL/min/1.73 m2
* Ability and willingness to provide informed consent
* Ability to speak English
* Ability to walk
* Ability to join remote study sessions via WebEx

Exclusion Criteria:

* Current involvement in an activity/exercise program
* High likelihood of a kidney transplant within 6 months (assessed via the medical record)
* Any safety concerns about increased walking (assessed via the medical record)

Primary outcomes:
measure: Session Adherence
timeFrame: Up to Week 12
Secondary outcomes:
measure: Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score
timeFrame: Baseline, Week 6
measure: Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score
timeFrame: Baseline, Week 12
measure: Change in Dialysis Symptom Index (DSI) Score
timeFrame: Baseline, Week 6
measure: Change in Dialysis Symptom Index (DSI) Score
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Daniel Cukor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02105883: The Effect of Identification Badge on Situation Awareness During High Fidelity Simulation
Official title: The Effect of Identification Badge on Situation Awareness During High Fidelity Simulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Simulation
Awareness
Reality Testing
Residency
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Centre d'apprentissage des attitudes et des habiletés cliniques (CAAHC)
First posted: 2014-04-07
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate if the use of identification badge (role and place) during high-fidelity simulation as an impact on situation awareness.

Detailed description: High-fidelity simulation is well recognized as an educational tool. Mr. Issenberg completed a review(2005) that determined features of high-fidelity simulation training that lead to effective learning. It this review, it is mentioned that the validity of the simulator (realism) is essential to help learners to increase their skills and sharpen their responses. It is essential to get and maintain engagement during high-fidelity simulation and it pass by an increase in realism and situation awareness. The purpose of this study is to evaluate if the use of identification badge (physical and conceptual realism) during high-fidelity simulation as an impact on situation awareness and engagement.

Eligibility criteria: Inclusion Criteria:

* anesthesiology residents (university of montreal) who participate to simulation course on crisis resources management

Exclusion Criteria:

* none

Primary outcomes:
measure: Situation awareness
timeFrame: 2 days
Secondary outcomes:
measure: Subject's engagement in high-fidelity simulation
timeFrame: 2 days
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CAAHC
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Issam Tanoubi, MD
role: STUDY_DIRECTOR
affiliation: Université de Montréal
name: Marie-Eve Belanger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01329783: EuroSIDA As An External Comparator To MOTIVATE Trials
Official title: Incidence And Risk Factors For Acquired Immune Deficiency Syndrome (AIDS) Defining And Non-AIDS Defining Malignancies, And Other AIDS Defining Illnesses In The EuroSIDA Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
AIDS
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Copenhagen HIV Programme
name: Pfizer
First posted: 2011-04-06
Enrollment: 1181
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patient aged over 16 at baseline.
* Viral Load (VL) \> 5000 copies/ml at baseline (and measured in 6 months prior to baseline).
* No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline.
* \> 3 months exposure (sequential or cumulative) to at least 3 of the following;
* Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI)
* Non-nucleoside reverse transcriptase inhibitor (NNNRTI)
* Protease Inhibitor (PI )
* Enfuvirtide

Brief summary: Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort. The rates of specific clinical adverse events in this identified patient population will be compared with the rates of these events in the participants of the MOTIVATE trials.

Detailed description: All patients in EuroSIDA cohort that meet the entry criteria of MOTIVATE trials are included without any sampling.

Eligibility criteria: Inclusion Criteria:

* Patient aged over 16 at baseline.
* Viral Load (VL) \> 5000 copies/ml at baseline (and measured in 6 months prior to baseline).
* No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline.
* \> 3 months exposure (sequential or cumulative) to at least 3 of the following;
* Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI)
* Non-nucleoside reverse transcriptase inhibitor (NNNRTI)
* Protease Inhibitor (PI )
* Enfuvirtide

Exclusion Criteria:

None

Primary outcomes:
measure: Malignancy
timeFrame: Median follow up of 3 years
measure: Opportunistic infection
timeFrame: Median follow up of 3 years
measure: Myocardial infarction
timeFrame: Median follow up of 3 years
measure: All cause death
timeFrame: Median follow up of 3 years
measure: Liver related death
timeFrame: Median follow up of 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06395883: Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease
Official title: Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease - the BOOGIE Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoporosis
Osteoporosis, Steroid Induced
Inflammatory Rheumatism
Keywords: Bone turnover
Bone turnover markers
Glucocorticoids
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: Vestre Viken Hospital Trust
name: Hormone Laboratory, Aker University Hospital, Oslo, Norway
First posted: 2024-05-02
Enrollment: 160
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of rheumatoid arthritis or spondyloarthritis or psoriatic arthritis

Brief summary: Bone turnover markers (BTMs) are recommended as an important tool in follow-up of osteoporosis treatment. However, there is a lack of knowledge in the reliability of BTMs during and after glucocorticoid treatment. Glucocorticoids suppresses BTMs during treatment with at least 30% and, moreover, glucocorticoids increase the risk of fractures. Patients with an inflammatory joint disease are at increased risk of osteoporosis, and disease flares are often treated with glucocorticoids, which in turn can lead to loss in reliability of the BTMs in patients who also are on osteoporosis treatment.

There is a need of more knowledge on BTM changes during and after glucocorticoid treatment for optimized patientcare, reduced risk of side effects and reduced health economic costs.


Eligibility criteria: Inclusion Criteria:

* diagnosis of inflammatory rheumatic joint disease
* indication of disease modifying treatment initiation with or without glucocorticoids OR
* stable DMARD treatment with parenteral glucocorticoid injection

Exclusion Criteria:

* known osteoporosis or osteoporosis treatment
* women during the transitory phase
* oestrogen treatment
* any fracture within the last year
* chronic glucocorticoid treatment
* glucocorticoid treatment within the last year prior to inclusion
* active cancer
* kidney failure

Primary outcomes:
measure: P1NP level 3 months after glucocorticoid termination
timeFrame: september 2024 til december 2025
Secondary outcomes:
measure: P1NP level 6 months after glucocorticoid termination
timeFrame: september 2024 til december 2025
measure: CTX1 level 3 and 6 months after glucocorticoid termination
timeFrame: september 2024 til december 2025
measure: P1NP and CTX1 dynamic until 6 months after treatment of inflammation without glucocorticoids
timeFrame: september 2024 til december 2025
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00665483: Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a Pollen and Dust Mite Mixture.
Official title: Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a 6-grass Pollen Mixture, House Dust Mite (Dermatophagoides Pteronyssinus), Birch Pollen, and Mugwort Pollen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type I Allergy
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2008-04-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: Multicenter Skin Prick Test


Eligibility criteria: Inclusion Criteria:

* anamnesis referring to suspicion of an IgE-mediated allergy
* positive Skin Prick Test in the medical history to at least one of the investigational allergens with an existing anamnesis

Exclusion Criteria:

* serious chronic diseases
* Other perennial allergies

Primary outcomes:
measure: Optimal trade-off between sensitivity and specificity
timeFrame: December 2007 - December 2008
Secondary outcomes:
measure: Evaluation of the documentation of adverse events
timeFrame: January - December 2008
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
state: Hessen
Study officials:
affiliation: Klinikum Darmstadt
name: Nicola Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00136383: Comparing Paroxetine and Duloxetine on Cardiovascular Measures
Official title: A Study of the Effects of Paroxetine vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depressive Symptoms
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This double-blind placebo-controlled trial is designed to test and to compare the cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients with depressive symptoms.

Detailed description: This double-blind placebo-controlled study will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine than paroxetine in outpatients with major depressive disorder. We will also examine the relationship between changes in heart rate variability to the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug.

Eligibility criteria: Inclusion Criteria:

* Depressive symptoms
* Ages 20-60
* In good medical health and not pregnant

Exclusion Criteria:

* Bipolar disorder
* Schizophrenia or other psychotic disorder
* Alcohol or other substance abuse within the last 3 months
* Cognitive impairment
* History of attempted suicide in the past 2 months and who score 4 or more on the suicide item of the MADRS

Primary outcomes:
measure: R-R interval change with deep breathing
measure: Respiratory sinus arrhythmia
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
measure: Hospital Anxiety and Depression Scale
measure: Spielberger State-Trait Anxiety Inventory
measure: Connor-Davidson Resilience Scale
measure: Norepinephrine receptor occupancy
measure: Serotonin receptor occupancy
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Wei Zhang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03100383: Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain
Official title: Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain in Women With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Gain
Eating Behavior
Keywords: gestational diabetes
Type2 Diabetes
Lead sponsor: Materno-Perinatal Hospital of the State of Mexico
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 57
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in puerperium with known T2DM or GDM diagnosed at the hospital were invited to participate in the study.

Brief summary: To assess the association of the number of medical nutrition therapy (MNT) consultations and eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) with GWG in women with type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM).

Detailed description: Women in puerperium with known T2DM or GDM diagnosed at the hospital were invited to participate in the study. Gestational diabetes was diagnosed with a 75-g oral glucose tolerance test. Weight (kg) and height (m) were measured using a mechanical column scale (SECA).

The specific dimensions of eating behavior were measured through the 18-item Three-Factor Eating Questionnaire-18 (TFEQ-18).

The Medical Nutrition Therapy (MNT) was offered every 2-4 weeks. This therapy consists of providing a food plan with the following recommendations: limiting carbohydrate intake to 35-45% of total calories calculated as 30 kcal/kg based on pregestational BMI for an ideal weight .

We evaluated the effect of MNT on GWG using a multiple linear regression model

Eligibility criteria: Inclusion Criteria:

* Women in puerperium with known T2DM or GDM diagnosed at the hospital.

Exclusion Criteria:

* Women with a twin or other multiple pregnancy, type 1 diabetes mellitus (T1DM), or intolerance to carbohydrates, and those with additional diseases (hypertensive disorders of pregnancy, hyper- or hypothyroidism, lupus, kidney or liver disease).

Primary outcomes:
measure: Gestational Weight Gain (GWG).
timeFrame: 9 months
Secondary outcomes:
measure: Eating behavior
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
name: Hugo Mendieta Zerón, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180583: Vision II: Evaluation of GALILEO Intravascular Radiotherapy System
Official title: Vision II: Non Randomized French Evaluation of GALILEO Intravascular Radiotherapy System in Patients With de Novo Coronary Arteries Lesions by Restenosis on Angioplasty or Restenosis on Endoprosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system

Detailed description: The purpose of this study is to evaluate the cardiac events (MACE) and adverse extra cardiac events at 6 month follow up and up to 24 months for the patients treated with Galileo system

Eligibility criteria: Inclusion Criteria:

* Patient with angor, patients with only one de novo lesion. Target zone must be \< 52 mm, artery section must be \< 3,7mm and \> 2,25 mm

Exclusion Criteria:

* Vessel with extremely tortuous proximal segment, lesion with angulous segments (\>90°) Unstable ventricular arrhythmia, dialysis, MI within the last 72 hours etc...

Primary outcomes:
measure: MACE
timeFrame: 6 months
Secondary outcomes:
measure: All adverse cardiac or extra cardiac events
timeFrame: 24-month
Other outcomes:
Locations:
city: Rouen
country: France
facility: Clinique St. Hilaire
Study officials:
affiliation: Clinique St Hilaire, Rouen, France
name: Jacques BERLAND, MD
role: PRINCIPAL_INVESTIGATOR
References: