louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01616914: Subclinical Delirium and Clinical Outcome
Official title: Delirium and Clinical Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: delirium
outcome
Lead sponsor: Jinhua Central Hospital
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients enter ICU GCS \> 10 RASS \> -2 No dementia

Brief summary: Delirium has been associated with clinical outcomes in critical care setting. However, its subclinical form has not been investigated. The investigators aimed to establish the association of subclinical delirium with outcome.

Detailed description: Delirium has been associated with clinical outcome in critical care setting. This syndrome has been associated with longer length of stay in ICU and hospital, longer duration of mechanical ventilation and higher mortality rate. however, its subclinical form has not been investigated. The subclinical syndrome is defined by CAM-ICU, in which several features of delirium are fulfilled but the diagnostic criteria are not fulfilled. The investigators aimed to establish the association of subclinical delirium with outcome.

Eligibility criteria: Inclusion Criteria:

* patients enter ICU
* GCS \> 10
* RASS \> -2

Exclusion Criteria:

* unable to cooperate
* coma

Primary outcomes:
measure: mortality
timeFrame: during hospital stay(60 days)
Secondary outcomes:
measure: duration of mechanical ventilation
timeFrame: 60 days
measure: length of stay in ICU and hospital
timeFrame: 60 days after enrollment
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Jinhua central hospital
state: Zhejiang
Study officials:
affiliation: Jinhua Central Hospital
name: Zhongheng Zhang, MM
role: STUDY_CHAIR
References:
citation: van den Boogaard M, Pickkers P, Slooter AJ, Kuiper MA, Spronk PE, van der Voort PH, van der Hoeven JG, Donders R, van Achterberg T, Schoonhoven L. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study. BMJ. 2012 Feb 9;344:e420. doi: 10.1136/bmj.e420.
citation: van den Boogaard M, Schoonhoven L, van der Hoeven JG, van Achterberg T, Pickkers P. Incidence and short-term consequences of delirium in critically ill patients: A prospective observational cohort study. Int J Nurs Stud. 2012 Jul;49(7):775-83. doi: 10.1016/j.ijnurstu.2011.11.016. Epub 2011 Dec 22.
citation: Tomasi CD, Grandi C, Salluh J, Soares M, Giombelli VR, Cascaes S, Macedo RC, de Souza Constantino L, Biff D, Ritter C, Dal Pizzol F. Comparison of CAM-ICU and ICDSC for the detection of delirium in critically ill patients focusing on relevant clinical outcomes. J Crit Care. 2012 Apr;27(2):212-7. doi: 10.1016/j.jcrc.2011.05.015. Epub 2011 Jul 6.
Clinical trial NCT06672614: Postexercise Hot-Water Immersion on Exercise Performance in Hypoxia
Official title: Effect of Five Days of Postexercise Hot-Water Immersion on Exercise Performance in Hypoxia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heat Exposure
Exercise Training
Lead sponsor: Nipissing University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
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 determine the effect of 5 days post-exercise hot water immersion on exercise performance at simulated altitude.

Detailed description: Human performance is compromised at altitude due to a lower partial pressure of oxygen and subsequent reductions in the convective transport of oxygen to tissue. Long-term acclimation to attitude incurs physiological adaptations that result in a near return to sea-level performance; however, the time required (\~2 weeks) for such adaptations is often logistically challenging for athletes, military personnel or other individuals who reside at sea level. Recent research suggests that physiological acclimation to heat stress (i.e., heat acclimation) and altitude (i.e., hypoxia) share similar cellular adaptations, namely an up-regulation of Hypoxia-inducible factor 1 (HIF-1) and various heat shock proteins. Therefore, it is hypothesized that heat acclimation may provide physiological protection from reduced oxygen transport to the tissue and enhance performance at altitude. This cross-tolerance model is supported by traditional heat acclimation protocols (i.e., submaximal exercise in hot ambient temperature); however, it has not been tested with passive exposure to heat stress through post-exercise hot water immersion.

Eligibility criteria: Inclusion Criteria:

* Physically active (minimum of 90 minutes of moderate-intensity exercise per week)

Exclusion Criteria:

* Cardiovascular disease
* resident of \>1500 m above sea-level in the past year;
* history of fainting

Primary outcomes:
measure: Time-Trial Performance in hypoxia conditions
timeFrame: 30 minutes
Secondary outcomes:
measure: Pulse oxygen saturation during exercise
timeFrame: 30 minutes
measure: Skin temperature during exercise
timeFrame: 90 minutes
measure: Core temperature during exercise
timeFrame: 90 minutes
measure: Heart Rate during exercise
timeFrame: 90 minutes
Other outcomes:
Locations:
city: North Bay
country: Canada
facility: Nipissing University
state: Ontario
Study officials:
affiliation: Nipissing University
name: Geoffrey L Hartley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00228514: Dutch Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA). PET Sub Study
Official title: Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA) PET Sub Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rosuvastatin
Heart Failure
Positron Emission Tomography (PET)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At one site, patients participating in the Corona main study are asked to participate in the PET-substudy. Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed to study the effect of rosuvastatin in Chronic Heart Failure on myocardial perfusion (reserve)


Eligibility criteria: Inclusion Criteria:

* Patients fulfilling the in and exclusion criteria of the CORONA study and separate informed consent for participation in the sub study.

Exclusion Criteria:

* See above

Primary outcomes:
measure: To study the effect of rosuvastatin in Chronic Heart Failure on myocardial perfusion (reserve). Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed.
Secondary outcomes:
measure: To study the effect of rosuvastatin in Chronic Heart Failure on mismatch. Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca CV Medical Department
role: STUDY_DIRECTOR
References:
Clinical trial NCT05134155: A Pilot Study to Test the Acceptability and Feasibility of Relaxation Rooms to Help Reduce Occupational Stress Among Healthcare Workers
Official title: A Pilot Study to Test the Acceptability and Feasibility of Relaxation Rooms to Help Reduce Occupational Stress Among Healthcare Workers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn Out
Stress
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Well Living Lab, Inc.
First posted: 2021-11-24
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only clinicians at Mayo will be recruited as part of this study.

Brief summary: Test the acceptability and feasibility of a relaxation room to reduce work stress among clinicians and collect clinician-reported outcome data after using the relaxation room.

Detailed description: The plan is to pilot test a relaxation room to demonstrate its acceptability and feasibility in the hospital and collect clinician-centered outcomes. This study will inform the design of a future trial using this intervention.

Eligibility criteria: Inclusion Criteria:

* Clinician at Mayo working at St. Mary's hospital or the downtown Rochester campus during the study

Exclusion Criteria:

* Any physical condition that might prevent them from sitting for 20-30 minutes in the room
* Significant hearing loss that they would not be able to hear the audio stimuli
* Significant vision loss that they would not be able to see the visual stimuli

Primary outcomes:
measure: Acceptability
timeFrame: 12 months
Secondary outcomes:
measure: Recruitment
timeFrame: 12 months
measure: Room Usage
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Liselotte N Dyrbye, MD, MHPE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04697355: Effect of Naringenin and Beta Carotene on Energy Expenditure
Official title: Case Study to Evaluate the Safety and Effect on Energy Expenditure of Naringenin and Beta Carotene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Expenditure
Safety Issues
Glucose Metabolism
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case study in a single human subject
Primary purpose: OTHER

Brief summary: This study is designed to test the effects of the combination of naringenin (from an extract of sweet oranges) and beta carotene on energy expenditure and glucose metabolism in a single human subject.

Detailed description: The subject will be treated for 8 weeks with the combination of naringenin + beta carotene.

We will conduct the following assessments before the treatment and at the end of eight weeks.

1. Resting metabolic rate
2. Oral glucose tolerance test with glucose and insulin
3. Ambulatory blood pressure
4. Recording of adverse events
5. Body weight

Eligibility criteria: Inclusion Criteria:

* Fasting blood glucose \< 200mg/dL

Exclusion Criteria:

* Known allergy to citrus fruits

Primary outcomes:
measure: Energy expenditure
timeFrame: Five hours
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Eight weeks
Secondary outcomes:
measure: Glucose metabolism
timeFrame: Three hours
measure: Blood pressure
timeFrame: 24 hours
measure: Body weight
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank L Greenway, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murugesan N, Woodard K, Ramaraju R, Greenway FL, Coulter AA, Rebello CJ. Naringenin Increases Insulin Sensitivity and Metabolic Rate: A Case Study. J Med Food. 2020 Mar;23(3):343-348. doi: 10.1089/jmf.2019.0216. Epub 2019 Oct 31.
Clinical trial NCT01605955: Fingertip Pulse Oximeter Clinical Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SPO2
Keywords: SPO2
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-05-25
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers who consent to induced hypoxia and arterial blood sampling as part of the experimental procedure

Brief summary: The purpose of this study is to validate the SpO2 accuracy of pulse oximeter equipment in comparison to "gold-standard" measurements of blood SaO2 by a CO-oximeter


Eligibility criteria: Inclusion Criteria:

* Subjects participate in the study on a voluntary basis
* All subjects should be in good health at the time of the study. Unless specified otherwise in the protocol, the following values could be applied: COHb\<3 %, MetHb\<2 %, ctHb\>10 g/dl;
* Inclusion criteria should serve the purpose of the study

Exclusion Criteria:

* Smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels, unless specific dyshaemoglobins are called for in the study protocol.
* Individuals subject to conditions that result in elevated levels of methaemoglobin, unless specific dyshaemoglobins are called for in the study protocol.
* Subjects who would be placed at undue medical risk associated with any procedures called for in the protocol (e.g. arterial cannulation or hypoxia).
* Age: young person and that of more than 50 years old.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00469755: Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne
Official title: A Comparison of Differin® Gel, 0.1% vs. Tazorac® Cream, 0.1% vs. Differin® Gel, 0.1% 6-week Treatment Switched to Tazorac® Cream, 0.1% 6-week Treatment in Patients With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-05-04
Enrollment: 302
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream

Detailed description: Same as above.

Eligibility criteria: Inclusion Criteria:

* Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face
* Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

* Subjects with more than 3 nodulo-cystic lesions

Primary outcomes:
measure: Efficacy - total lesion counts
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety - tolerability assessments and adverse event reporting
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Detroit
country: United States
facility: Henry Ford Medical Center-Dept. of Dermatology
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Brooklyn
country: United States
facility: State University of New York Downstate Medical Center-Dept. of Dermatology
state: New York
city: Cincinnati
country: United States
facility: Dermatology Research Associates
state: Ohio
city: Portland
country: United States
facility: Phoebe Rich, MD & Associates
state: Oregon
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center Center-Div. of Dermatology
state: Pennsylvania
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Bryan
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Carrollton
country: United States
facility: Stephens & Associates
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01552655: Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT
Official title: Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Recurrent
Keywords: Dual-time PET/CT
Breast cancer recurrence
Bone scintigraphy
CT thorax upper abdomen
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to elucidate the value of dual-time-point PET/CT in the recurrence of breast cancer and to determine whether the method is better than the modalities used in the standard work up.

150 patients with suspected breast cancer recurrence will be included. All patients will undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After completion of the examinations the early and the late PET/CT scan will be compared with each other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained, the presence of recurrence will be verified with additional imaging follow-up to ensure the highest possible confidence. Sensitivity, specificity, accuracy, negative and positive predictive value (NPV/PPV) will be calculated for each modality (incl. early and late PET/CT).


Eligibility criteria: Inclusion Criteria:

* Clinical suspected recurrence of breast cancer
* Blood glucose level less than 8,0 mmol/L

Exclusion Criteria:

* Disqualified patients
* Other malignancies
* \< 18 years
* \< 50 kg
* \> 90 kg
* Pregnant or lactating
* Patients with permanent address outside of the Region of Southern Denmark
* Estimated inability to collaborate

Primary outcomes:
measure: Diagnostic value of dual-time point 18FDG PET/CT in recurrent breast cancer
timeFrame: 2 years
Secondary outcomes:
measure: Diagnostic value of early and late 18FDG PET/CT respectively in recurrent breast cancer
timeFrame: 2 years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Nuclear Medicine, Odense University Hospital
state: Funen
Study officials:
affiliation: Dept. Nuclear Medicine, Odense University Hospital
name: Malene Hildebrandt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vogsen M, Geneser S, Rasmussen ML, Horder M, Hildebrandt MG. Learning from patient involvement in a clinical study analyzing PET/CT in women with advanced breast cancer. Res Involv Engagem. 2020 Jan 6;6:1. doi: 10.1186/s40900-019-0174-y. eCollection 2020.
citation: Baun C, Falch K, Gerke O, Hansen J, Nguyen T, Alavi A, Hoilund-Carlsen PF, Hildebrandt MG. Quantification of FDG-PET/CT with delayed imaging in patients with newly diagnosed recurrent breast cancer. BMC Med Imaging. 2018 May 9;18(1):11. doi: 10.1186/s12880-018-0254-8.
Clinical trial NCT02999555: Novel Evaluation of Aspirated Follicular Fluid
Official title: Presence and Quantification of Inflammatory Cytokines, Dendritic Cells, Vasorin and Soluble Flt1 in Aspirated Follicular Fluid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovary Inflammation
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Weizmann Institute of Science
First posted: 2016-12-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A molecular study of follicular fluid aspirated from ovarian follicles during routine in vitro fertilization treatment, after the eggs were identified and separated.

Detailed description: Ovarian stimulation is a routine part of in vitro fertilization treatment: this process involves an inflammatory response in the developing follicles. We still do not completely understand the complex interactions leading to the maturation of the egg and the multiple interactions of the egg with its supporting cells. In this study we will assess follicular fluid, letf over after the eggs were identified and separated, for the presence of inflammatory mediators, dendritic cells , vasorin and soluble Flt1. The presence and quantification of these factors, as well as their correlation with the size of the aspirated follicle is the focus of this study.

Eligibility criteria: Inclusion Criteria:

* All women going through a fertility/ fertility preservation indicated egg retrieval in the in vitro fertilization (IVF) unit in 'Meir medical center',
* Patients' informed consent

Exclusion Criteria:

* Patients refusing to take part in the study

Primary outcomes:
measure: Soluble Vasorin levels
timeFrame: 24 hours post egg retrieval
measure: Soluble Flt 1 levels
timeFrame: 24 hours post egg retrieval
measure: Dendritic cells quantification
timeFrame: 24 hours post egg retrieval
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Tel Aviv University
name: MEIR medical center REB committee REB committee
role: STUDY_CHAIR
References:
citation: Wulff C, Wiegand SJ, Saunders PT, Scobie GA, Fraser HM. Angiogenesis during follicular development in the primate and its inhibition by treatment with truncated Flt-1-Fc (vascular endothelial growth factor Trap(A40)). Endocrinology. 2001 Jul;142(7):3244-54. doi: 10.1210/endo.142.7.8258.
citation: Gruemmer R, Motejlek K, Berghaus D, Weich HA, Neulen J. Regulation of soluble vascular endothelial growth factor receptor (sFlt-1/sVEGFR-1) expression and release in endothelial cells by human follicular fluid and granulosa cells. Reprod Biol Endocrinol. 2005 Oct 25;3:57. doi: 10.1186/1477-7827-3-57.
Clinical trial NCT02354755: The Effect of Temperature on Anesthesia and Surgical Resident's Ability to Perform Clinical and Cognitive Tasks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Providers
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians in training (Anesthesiology/surgery residents, fellows and certified registered nurse anesthetists.

Brief summary: The purpose of the current study is to examine whether changes in intraoperative ambient temperature has in impact on the clinical performance of the physicians in training which include Anesthesiology and Surgical residents, fellows and certified nurse anesthetists (CRNA). Reaction times will be measured via a 10-minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device.


Eligibility criteria: Inclusion Criteria:

* CRNA or surgery or anesthesiology resident fellow in ongoing surgery case

Exclusion Criteria:

* unwilling to participate
* any clinical circumstance that precludes participation

Primary outcomes:
measure: Psychomotor vigilance test
timeFrame: 10 minutes
Secondary outcomes:
measure: SurveyMonkey Questionairre
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
References: