louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01823263: Metabolic and Cognitive Parameters Following Partial Sleep Deprivation
Official title: Metabolic and Cognitive Effects of Sleep Deprivation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Deprivation
Sleep
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether partial sleep deprivation, as compared with normal sleep, influences certain metabolic and cognitive parameters, related to food intake, hunger and memory functions, when participants are shielded from external time cues.

Detailed description: It is predicted that partial sleep deprivation negatively affects the hormonal status, e.g. upregulating ghrelin and other hunger-promoting hunger hormones, while showing impaired memory functions. It is also predicted that participants will tend to increase their desired portion sizes after partial sleep deprivation, compared with after a normal night's sleep.

Eligibility criteria: Inclusion Criteria:

* Male
* Age 20-28y
* Healthy (self-reported) and not on medication
* Non-smoking
* Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported and verified by sleep diaries)
* Normal dietary habits (regular meal pattern with daily breakfast)

Exclusion Criteria:

* Major illness
* Taking any serious medications
* Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
* Any dietary issues with the food items provided
* A history of endocrine, neurological or psychiatric disorders
* Shift work in the previous 3 months
* Travel over several time zones within the previous two months

Primary outcomes:
measure: Memory tasks
timeFrame: Change in memory performance between learning (at 2230 hours in NS and PSD condition) before going to sleep, and at 0800 and 0930 hours (following PSD or NS)
Secondary outcomes:
measure: Circulating hormone levels
timeFrame: Change in circulating hormone levels and other metabolism-linked and neurodegeneration-associated molecules at 0730, 0830, 0910, 0925, 0940, 1010, 1040, 1105, and 1150 hours following the respective nighttime intervention and after the interference task
measure: Intake task
timeFrame: Change in intake at around 1200 hours, following the respective nighttime intervention (NS or PSD)
measure: Working memory function task
timeFrame: Change in memory performance at 0800 hours and after the interference task again at 0930 hours (between and following PSD or NS)
measure: Portion Size Task
timeFrame: Change in selected portion size from baseline (at 0800 hours following the nighttime intervention), to one hour later, i.e. after an interference task
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of Neuroscience, Uppsala University
Study officials:
affiliation: Department of Neuroscience, Uppsala University
name: Christian Benedict, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05859763: 99mTc-HFAPI SPECT/CT in Pulmonary Fibrosis
Official title: 99mTc-Labeled FAPI SPECT Imaging in Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Fibrosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This prospective study will investigate the potential usefulness of 99mTc labeled FAPI SPECT/CT in the diagnosis, treatment response assessment, and follow-up of pulmonary fibrosis.

Detailed description: Idiopathic pulmonary fibrosis refers to a specific form of chronic fibrous interstitial pneumonia that occurs spontaneously, limited to the lung, and shows features of usual interstitial pneumonia on high resolution computed tomography and histological examination. Radionuclide labeled FAPI has been developed as a new tracer for tumor and inflammatory lesions imaging. Recent studies have shown that FAPI PET/CT imaging is a promising new imaging method for pulmonary fibrosis. HFAPI is obtained by conjugating 99mTc-chelator moiety (6-hydrazinonicotinamide, HYNIC) with FAP targeting moiety. The aim of this study is to investigate the location and extent of 99mTc labeled FAPI tracer (99mTc-HFAPI) in normal and fibrotic lung tissue of patients with pulmonary fibrosis, and to explore the clinical significance of 99mTc-HFAPI SPECT/CT in the diagnosis, treatment response evaluation and follow-up of pulmonary fibrosis.

Eligibility criteria: Inclusion Criteria:

* suspected or confirmed pulmonary fibrosis patients;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against FAPI
* any medical conditions that are considered by the investigator to be likely to seriously interfere with study compliance

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: through study completion, an average of 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
state: Dongcheng
Study officials:
References:
Clinical trial NCT00329563: Pilot Community Clinical Study of Hypothermia in Cardiac Arrest
Official title: Pilot Community Clinical Study of Hypothermia in Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cardiac Arrest
Keywords: Cardiac Arrest
Hypothermia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Medic One Foundation
First posted: 2006-05-24
Enrollment: 125
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 overall goal of this study is to determine the feasibility of initiating hypothermia in cardiac arrest patients as soon as possible in the field. In this pilot study we will randomize 125 patients after return of spontaneous circulation (ROSC) to hypothermia with rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV sedation and muscle paralysis or to standard of care following ROSC. The primary objectives of this study will be to determine whether temperature of 33-34oC can be achieved and maintained using this strategy. The primary outcome measures will include: temperature changes of the patients at time of admission to the hospital. Secondary analysis will include determining if the proportion of patients discharged from the hospital is increased in the group receiving hypothermia. If this initial pilot study can demonstrate feasibility in achieving and maintaining hypothermia, a larger randomized clinical trial to test the hypothesis that hypothermia initiation in the field will increase the proportion of patients surviving following cardiac arrest will be planned.


Eligibility criteria: Inclusion Criteria:

* Resuscitated out-of-hospital cardiac arrest defined as having a palpable pulse comatose IV access Intubated

Exclusion Criteria:

* age less than 18 traumatic cause of cardiac arrest

Primary outcomes:
measure: Temperature difference between first field temperature and hospital arrival temperature
timeFrame: less than 60 minutes
Secondary outcomes:
measure: Survival to discharge from hospital
timeFrame: Between 2 -30 days
measure: Awakening in the hospital
timeFrame: between 2-30 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Francis Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06712563: Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
Official title: Pooled Analysis of Multi-country, Open-label Single-arm, Non-interventional, Multi-center, Cohort Studies of Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2024-12-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD who are new initiators of BGF enrolled in several planned and on-going prospective, non-interventional single-arm studies. Eligible patients for the individual studies are those with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation. Only patients that have signed an informed consent form (ICF) allowing the secondary use of their data will be eligible for the CHOROS pooled analysis.

Brief summary: The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation
* Enrolled in on-going single-arm studies
* Provided consent for secondary use of data

Exclusion Criteria:

* Did not provide consent for secondary use of data

Primary outcomes:
measure: COPD Assessment Test (CAT)
timeFrame: 12 weeks
Secondary outcomes:
measure: COPD Assessment Test
timeFrame: 4 weeks
measure: COPD Assessment Test
timeFrame: 52 weeks
measure: COPD Assessment Test Responder Rate
timeFrame: 12 weeks
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: 12 weeks and 52 weeks
measure: Annual rate of COPD exacerbations
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Michael F Pollack, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02100163: Virtual Reality Pain Control Orthopedic Trauma
Official title: Controling Pain After Orthopedic Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma/Injury Problem
Keywords: Ortho trauma. Virtual Reality. Pain. Anxiety
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
First posted: 2014-03-31
Enrollment: 211
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The treatment of postoperative pain after severe trauma is poorly understood, and it can lead to chronic pain, opiate drug addiction and elevated health care costs. The proposed project will be a randomized controlled trial to evaluate an innovative methodology for delivering clinical hypnosis (virtual reality hypnosis) for pain control as well as a more time-honored delivery system that uses audio recordings. The goal will be to reduce postoperative pain in a sample of patients hospitalized for the care of severe orthopedic trauma and other types trauma. This proposal will test innovative and low-risk approaches to reducing postoperative trauma pain that are designed to reduce pain, anxiety and other complications after surgery. The findings have the potential not only to reduce pain and suffering in patients who have suffered severe trauma but could be applicable to the millions of people who have surgery every year. Reducing addictive opiate-based medication and health care costs are both potential outcomes from this project.


Eligibility criteria: Inclusion Criteria:

* Compliant and able to complete questionnaires
* English speaking
* Hospitalization for trauma orthopedic injuries
* No history of psychiatric disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* 18 years of age or older

Exclusion Criteria:

* Not capable of filling out study measures
* Evidence of a traumatic brain injury or any other
* Cognitive deficits that would impact decisional capacity to consent for the
* study or complete measures
* History of psychiatric disorder as evidenced in the RN and MD admission notes
* Unable to communicate verbally
* Extreme susceptibility to motion sickness
* Seizure history
* Non-English speaking
* In isolation for infections such as Clostridium difficile

Primary outcomes:
measure: Graphic Rating Scale (GRS) pain and anxiety Questionnaire
timeFrame: up to 10 days
Secondary outcomes:
measure: Tellegen Absorption Scale
timeFrame: 1 day (Once in the hospital)
Other outcomes:
measure: The Short Stanford Hypnotizability Scale (SSHS)
timeFrame: 1 day (Once in the hospital)
measure: SF-36
timeFrame: 1 day (Once in the hospital)
measure: Brief Symptom Inventory
timeFrame: 1 day (Once in the hospital)
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: David R. Patterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00406263: Comparison of Scheimpflug Photos of the Crystalline Lens in Patients Who Have Undergone Vitrectomy Surgery and Controls
Official title: Comparison of Scheimpflug Photos of the Crystalline Lens in Patients Who Have Undergone Vitrectony Surgery and Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nuclear Sclerotic Cataract
Keywords: nuclear sclerotic cataract
cataract
Lead sponsor: Barnes Retina Institute
Sponsor class: OTHER
First posted: 2006-12-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing vitrectony surgery and controls

Brief summary: Progression of nuclear sclerotic cataract after pars plana vitrectomy has been recognized for many years The mechanism for the rapid progression of nuclear sclerotic cataract remains unclear. The objective of this trial is to evaluate and compare the level and progression of cataract advancement in controls versus eyes that have undergone 20-gauge pars plana vitrectomy and 25-gauge pars plana vitrectomy.

Detailed description: Approximately 105 patients will be recruited to obtain 35 control eyes that have not had pars plana vitrectomy and 35 eyes who will have undergone 20-gauge pars plana vitrectomy and 35 eyes will have undergone 25-gauge pars plana vitrectomy. Scheimpflug crystalline lens photographs will be taken for evaluation of level and progression of cataract development.

Eligibility criteria: Inclusion Criteria:

* phakic eyes of patients that are scheduled to undergo pars plana vitrectomy,
* controls will be phakic eyes of patients that have not undergone andy kind of intraocular surgery,
* age 18 and older

Exclusion Criteria:

* any eye that is pseudophakic,
* has had previous vitreoretinal surgery,
* has had previous intravitreal injection,
* previous intraocular inflammatory condition such as uveitis,
* previous irradiation,
* any patient with a history of ocular malignancy,
* history of infectious intraocular condition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Barnes Retina Institute
state: Missouri
Study officials:
affiliation: Barnes Retina Institute
name: Nancy M Holekamp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05831163: Analyzing Clinical Research Participation of Patients With Spinal Cord Injury
Official title: A Review of Clinical Trial Experiences and Trends From Spinal Cord Injury Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injuries
spinal cord injury
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are actively considering involvement in an observational spinal cord injury clinical trial, but have not yet completed enrollment and registration.

Brief summary: The percentages of participants in clinical studies haven't always been perfectly representative of a particular group.

This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for spinal cord injury.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future spinal cord injury research.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Ability to understand and the willingness to sign a written informed consent document.
* Diagnosis of spinal cord injury

Exclusion Criteria:

* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Inability to provide written informed consent

Primary outcomes:
measure: Rate of patients who decide to enroll in a spinal cord injury clinical study.
timeFrame: 3 months
measure: Number of spinal cord injury study participants who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Duan R, Qu M, Yuan Y, Lin M, Liu T, Huang W, Gao J, Zhang M, Yu X. Clinical Benefit of Rehabilitation Training in Spinal Cord Injury: A Systematic Review and Meta-Analysis. Spine (Phila Pa 1976). 2021 Mar 15;46(6):E398-E410. doi: 10.1097/BRS.0000000000003789.
citation: Yamazaki K, Kawabori M, Seki T, Houkin K. Clinical Trials of Stem Cell Treatment for Spinal Cord Injury. Int J Mol Sci. 2020 Jun 2;21(11):3994. doi: 10.3390/ijms21113994.
citation: Kim YH, Ha KY, Kim SI. Spinal Cord Injury and Related Clinical Trials. Clin Orthop Surg. 2017 Mar;9(1):1-9. doi: 10.4055/cios.2017.9.1.1. Epub 2017 Feb 13.
Clinical trial NCT01264263: Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes
Official title: Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Dyslipidemia
Keywords: cIMT
hs CRP (C-reactive protein)
DM (Diabetic Mellitus)
Korea
Corelation between cIMT (carotid intima media thickness)
Cardio Vascular risk in Diabetic Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 181
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 360 patients who has diabetic mellitus with dyslipidemia

Brief summary: This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean diabetic patients with atherosclerosis. Total 360 patients will be enrolled through 6 sites.

Detailed description: MC MD

Eligibility criteria: Inclusion Criteria:

* patients with Diabetic Mellitus
* patients with dyslipidemia

Exclusion Criteria:

* patients who have established cardiovascular disease
* patient using NSAID

Primary outcomes:
measure: Measurement of intima media thickness, visit 1
timeFrame: Visit 1
measure: Measurement of intima media thickness, visit 2
timeFrame: Visit 2
Secondary outcomes:
measure: hs-C-Reactive Protein, visit 1
timeFrame: Visit 1
measure: hs-C-Reactive Protein, visit 2
timeFrame: Visit 2
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Research Site
city: Koyang
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Hanyang University
name: Dongsun Kim
role: STUDY_CHAIR
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: Eunkyung Hong
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeoido Saint Mary's Hospital
name: Hyunsang Kwon
role: PRINCIPAL_INVESTIGATOR
affiliation: Ilsan-Paik Hospital
name: Dongjoon Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Hospital
name: Sungjin Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: Singon Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong EG, Ohn JH, Lee SJ, Kwon HS, Kim SG, Kim DJ, Kim DS. Clinical implications of carotid artery intima media thickness assessment on cardiovascular risk stratification in hyperlipidemic Korean adults with diabetes: the ALTO study. BMC Cardiovasc Disord. 2015 Oct 6;15:114. doi: 10.1186/s12872-015-0109-y.
Clinical trial NCT00264563: "Iatrogenesis Imperfecta"- Extent and Characteristic in NICU in Israel.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iatrogenesis in NICU
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-12-13
Enrollment: 750
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ifants admitted to NICU during the study period

Brief summary: Iatrogenesis is inevitable in the NICUs.

Detailed description: In the first 3 months of the study we will document Iatrogenic events in 3 NICUs in Israel without informing the medical and nursing staff. In the second 3 months of the study we will try to draw the attention of the medical and nursing staff that we are documenting iatogenesis, and we will assess wether this intervention will decrease the events of Iatrogenesis.

Eligibility criteria: Inclusion Criteria:All infants in NICU -

Exclusion Criteria:None

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa ans Ashkelon
country: Israel
facility: Bnai Zion Medical Center, Rambam Medical Center, Barzilay Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Senior Neonatologist
name: Amir Kugelman
role: PRINCIPAL_INVESTIGATOR
References: