louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06699953: Characterizing the EEG Signature of Fentanyl and Its Association With Drug Liking
Official title: Characterizing the EEG Signature of Fentanyl and Its Association With Drug Liking
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Activity Related to Opioid Administration
Brain Activity Related to Drug Liking
Keywords: opioid crisis
neuroscience
EEG
drug liking
fentanyl
anesthesia
general anesthesia
opioids
analgesia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients scheduled for general surgical procedures under general anesthesia

Brief summary: The goal of this study is to characterize an electroencephalogram (EEG) biomarker for fentanyl and understand where this signal is coming from in the brain. The investigators also aim to understand how this EEG biomarker is connected to patient perception to drug liking.


Eligibility criteria: Inclusion Criteria:

1. 18 years old or above (male and female)
2. American Society of Anesthesiologists (ASA) physical status classification of I, II or III
3. Candidates scheduled for general surgical procedures under general anesthesia and receive fentanyl for surgery

Exclusion Criteria:

1. Craniofacial abnormalities
2. Known or suspected difficult intubation or mask ventilation
3. Known or suspected need for rapid sequence induction and intubation
4. Body mass index above 45 kg/m2
5. Allergies to fentanyl
6. History of obstructive sleep apnea requiring CPAP
7. History of obstructive or restrictive lung disease
8. Opiate use within 24 hours
9. History of opiate abuse within the last 3 years
10. Known or suspected severe chronic pain condition that require use of opiates or limit daily activities
11. MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body

Primary outcomes:
measure: Source Localization of Fentanyl EEG Signature
timeFrame: 15 minutes prior to surgery
Secondary outcomes:
measure: Relationship Between Fentanyl EEG Signature and Fentanyl Effect Site Concentration
timeFrame: 15 minutes prior to surgery
measure: Relationship Between Visual Analog Scale Liking Rating and Fentanyl EEG Signature
timeFrame: 15 minutes before the surgery
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital
state: California
Study officials:
References:
citation: Balanza GA, Bharadwaj KM, Mullen AC, Beck AM, Work EC, McGovern FJ, Houle TT, Eric TP, Purdon PL. An electroencephalogram biomarker of fentanyl drug effects. PNAS Nexus. 2022 Aug 30;1(4):pgac158. doi: 10.1093/pnasnexus/pgac158. eCollection 2022 Sep.
Clinical trial NCT03954353: Effect of Cholesterol Level on Postoperative Acute Kidney Injury of Non-cardiac Surgeries
Official title: Effect of Cholesterol Level on Postoperative Acute Kidney Injury of Non-cardiac Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 78888
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults (age ≥ 18 years old) who underwent elective non-cardiac surgery from January 1, 2012, to December 31, 2017.

Brief summary: Preoperative serum cholesterol level may influence occurrence of postoperative acute kidney injury of cardiac surgeries. However, the effect of Preoperative serum cholesterol level for non cardiac surgery remains unknown. This study aimed to explore the effect in non-cardiac surgical population.


Eligibility criteria: Inclusion Criteria:

adults elective non-cardiac surgery

Exclusion Criteria:

cardiac surgeries kidney surgeries obstetric surgeries local infiltration anesthesia perioperative data missing

Primary outcomes:
measure: post-operative acute kidney injury within 30 days in the hospital
timeFrame: 30 days postoperatively in hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: First hospital Peking University
state: Beijing
Study officials:
References:
citation: Zhou Y, Yang HY, Zhang HL, Zhu XJ. High-density lipoprotein cholesterol concentration and acute kidney injury after noncardiac surgery. BMC Nephrol. 2020 Apr 25;21(1):149. doi: 10.1186/s12882-020-01808-7.
Clinical trial NCT01896453: Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design
Official title: Treatment of Chronic Non-specific Low Back Pain With Brain and Peripheral Electrical Stimulation: a Factorial, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Low Back Pain
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of brain and peripheral electrical stimulation on chronic non-specific low back pain patients.


Eligibility criteria: Inclusion Criteria:

* Males and females aged \> 18 years and \<65 years
* Complaining of back pain for more than three months
* Presence of a chronic pain measurable with the number rating scale (NRS 0-10) not less than 4 during a 1 week daily NRS monitoring
* Seeking care for low back pain

Exclusion Criteria:

* Previous surgery on the spine, spondylolisthesis
* Previous treatment with TENS \<6 months
* Previous treatment with tDCS
* Disc herniation with nerve compression
* Neurological, psychiatric and rheumatologic diseases
* Impaired sensibility
* Use of pacemakers or other implanted devices
* Pregnancy

Primary outcomes:
measure: Pain intensity
timeFrame: Four weeks after randomization
Secondary outcomes:
measure: Disability
timeFrame: 4 weeks, 3 and 6 months after randomization.
measure: Quality of pain
timeFrame: 4 weeks, 3 and 6 months after randomization.
measure: Global perceived effect (GPE)
timeFrame: 4 weeks, 3 and 6 months after randomization.
measure: Pain intensity
timeFrame: 3 and 6 months after randomization
Other outcomes:
measure: Anxiety
timeFrame: 4 weeks, 3 and 6 months after randomization.
measure: Depression
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Satisfaction with care
timeFrame: 4 weeks after randomization
Locations:
city: São Paulo
country: Brazil
facility: School of Physiotherapy - University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Fuad A Hazime, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Silvia MA João, PT
role: STUDY_CHAIR
References:
citation: Hazime FA, de Freitas DG, Monteiro RL, Maretto RL, Carvalho NA, Hasue RH, Joao SM. Analgesic efficacy of cerebral and peripheral electrical stimulation in chronic nonspecific low back pain: a randomized, double-blind, factorial clinical trial. BMC Musculoskelet Disord. 2015 Jan 31;16(1):7. doi: 10.1186/s12891-015-0461-1.
Clinical trial NCT01770951: A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
Official title: A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atypical Hemolytic Uremic Syndrome (aHUS)
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients of any age who have been diagnosed with aHUS.

Brief summary: The objective of this retrospective trial is to assess safety and efficacy of eculizumab in aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients of any age who have been diagnosed with aHUS.
2. Received at least one dose of eculizumab for the treatment of aHUS between 2007 and 2009 outside of an Alexion sponsored controlled clinical trial.

Exclusion Criteria:

1. Patients who have participated or are currently participating in a controlled clinical trial of eculizumab

Primary outcomes:
measure: Overall safety and tolerability of eculizumab based on Adverse Events of Special Interest/Adverse Drug Reactions and Additional Adverse Events.
timeFrame: Through 26 weeks
Secondary outcomes:
measure: Assess eculizumab treatment affect based on change in laboratory parameters (platelets, hemoglobin, LDH and parameters associated with renal function and intravascular hemolysis) and reduction of thrombotic microangiopathy (TMA).
timeFrame: Through 26 weeks
Other outcomes:
Locations:
city: Dunwoody
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Portland
country: United States
state: Maine
city: Boston
country: United States
state: Massachusetts
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Corpus Christi
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Appleton
country: United States
state: Wisconsin
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Montreal
country: Canada
state: Quebec
city: Caen
country: France
city: Le Kremlin Bicetre
country: France
city: Paris
country: France
city: Berlin
country: Germany
city: Heidelberg
country: Germany
city: Amsterdam
country: Netherlands
city: Barcelona
country: Spain
city: Bern
country: Switzerland
Study officials:
References:
Clinical trial NCT05422651: Observational Study About In-patients Admitted With Fever
Official title: Characteristic, Diagnosis and Prognosis of Patients Admitted With Fever in Department of Infectious Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fever
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the age of 14-90, who were admitted to Department of Infectious Diseases because of fever with/without other symptoms were all elligible for this observational study.

Brief summary: Fever is a common symptom in patients with infectious diseases. This study hopes to understand the epidemiological characteristics of patients hospitalized due to fever through observational research, including: clinical characteristics, etiology of fever and prognosis after treatment. So as to further search for biochemical or other serological indicators to predict the diagnosis and prognosis of infectious fever and non-infectious fever, and try to establish relevant prediction models.

Detailed description: This study mainly prospectively analyze the clinical data of patients with fever with/without other symptoms admitted to the department of infectious diseases, Xiangya Hospital of Central South University, to analyze the epidemiological characteristics, diagnosis and prognosis of these patients. This is an observational study. All subjects will receive the currently recognized routine test of fever according to their disease and corresponding etiological treatment if needed. The researchers will collect various clinical examination indexes of the subjects in the process of diagnosis and treatment, including but not limited to white blood cells, C-reactive protein, Procalcitonin, ferritin, blood culture, therapeutic drugs, etc. Etiology and prognosis of patients will be recorded. Blood samples, urine and stool samples of all subjects will be taken after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects. All subjects will sign informed consent.

Eligibility criteria: Inclusion Criteria:

* all patients admitted to department of infectious diseases because of fever

Exclusion Criteria:

* patents who refuse to sign informed consent

Primary outcomes:
measure: Length of fever
timeFrame: 1 month after admission
Secondary outcomes:
measure: Fever associated mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Infectious Disease, Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Yan Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02012751: Nevus Doctor Clinical Decision Support
Official title: Nevus Doctor Clinical Decision Support Program for Pigmented Skin Lesions and Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nevus
Melanoma
Keywords: Computer-assisted diagnosis
General practice
Dermatoscopy
Melanoma
Nevus
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
name: The Research Council of Norway
First posted: 2013-12-16
Enrollment: 49
Sex: ALL
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 "Nevus doctor" is a dermatoscopy based computer decision support tool to assist general practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the program "Nevus doctor" is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious PSLs that need biopsy or referral to specialist health care for further assessment. The aim of this study is to investigate the diagnostic performance of the decision support tool in a primary care setting in Norway. We hypothesize that the diagnostic accuracy of the computer program "Nevus doctor" is better than the performance of the GPs.

Detailed description: In the trial GPs examine patients who attend a primary health care center. A given PSL is first assessed clinically by the GP and afterwards photographed. A clinical photograph as well as a dermatoscopic photograph is taken, the latter using a dermatoscope attached to the lens of the camera. The dermatoscopic image is then processed by the computer program. The performance of "Nevus doctor" is compared with the GPs' assessment. A dermatologist reviews all cases based on the clinical and dermatoscopic photographs and this assessment serves as the reference standard.

Eligibility criteria: Inclusion Criteria:

* Pigmented skin lesion

Exclusion Criteria:

-

Primary outcomes:
measure: Number of correct test results
timeFrame: Up to 2 weeks from enrollment
Secondary outcomes:
measure: Patterns regarding false test results
timeFrame: Up to 2 weeks from enrollment
Other outcomes:
measure: User-friendliness
timeFrame: 6-8 months after enrollment
Locations:
city: Kirkenes
country: Norway
facility: Kirkenes Legesenter
state: Finnmark
Study officials:
affiliation: University Hospital North-Norway
name: Thomas R Schopf, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05115851: Short Term Effects of Anodal Cerebellar vs Anodal Cerebral Transcranial Direct Current Stimulation in Stroke Patients
Official title: Short Term Effects of Anodal Cerebellar Transcranial Direct Current Stimulation vs Anodal Cerebral Transcranial Direct Current Stimulation on Balance, Mobility and Cognition in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Anodal Cerebral
Anodal Cerebellar
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of anodal cerebellar Transcranial Direct Current Stimulation (tDCS) vs anodal cerebral tDCS on balance, mobility and cognition in stroke patients in stroke patients


Eligibility criteria: Inclusion Criteria:

* ability to give written consent.
* Able to walk unassisted
* Functional status allowing the participants to participate in the balance training.
* Score 6 or above on Johns Hopkins fall risk assessment tool

Exclusion Criteria:

* Neurological diseases, such as Parkinson, Alzheimer
* Any history of psychological illnesses
* Receipt of electrotherapy that might affect the nervous system in the two weeks prior to the study
* Cerebellar disorders
* use of any sedative medicines in the two days prior to the study
* any symptoms of amnesia and depression;
* Memory disorders with scores below 21 on the Mini Mental Status Examination test
* Any signs of severe motor disorders in the lower extremity which cause any movement limitation or deformity
* Any signs of radiculopathy or root lumbar spinal cord involvement
* Any visual or auditory impairment, or vertigo reports
* Use of a heart rate regulator
* Any structural deformities in the lower extremities or the spine
* Any abnormalities in the vestibular system
* History of recent fracture
* Inability to move without assistance

Primary outcomes:
measure: Changes from the base line, Berg balance scale
timeFrame: Day 3
measure: Timed Up and Go test
timeFrame: Day 3
measure: Balance Evaluation Systems Test
timeFrame: Day 3
Secondary outcomes:
measure: Montreal cognitive Scale
timeFrame: Day 3
measure: Mini mental state examination (MMSE)
timeFrame: Day 3
measure: Johns Hopkins fall risk assessment Tool
timeFrame: Day 3
measure: Timed 25-Foot Walk test
timeFrame: Day 3
measure: 6 min walk test: Distance (meters)
timeFrame: Day 3
measure: tDCS Adverse Effects Questionnaire
timeFrame: Day 3
Other outcomes:
Locations:
city: Gujrāt
country: Pakistan
facility: Akbar Hospital, Gujrat
state: Punjab
Study officials:
affiliation: Riphah International University
name: Arshad Nawaz Malik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06110351: Acute Clinical Outcomes of Hemorrhagic Myocardial Infarction
Official title: Acute Clinical Outcomes of Hemorrhagic Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary PCI STEMI patients having post-PCI biomarkers

Brief summary: Acute clinical outcomes 1. Mortality 2. Arrhythmia 3. Readmission 4. CVA 5. ADHF


Eligibility criteria: Inclusion Criteria:

1. 18-85 years of age
2. Primary PCI
3. Post-PCI cardiac biomarker labs

Primary outcomes:
measure: Mortality
timeFrame: 30-days and 6 months
Secondary outcomes:
measure: Acute heart failure
timeFrame: 30-days and 6 months
measure: Arrhythmia
timeFrame: 30-days and 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Methodist Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT00597051: Study of 3 Doses of ARD-0403 in Testosterone Deficient Men
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Centre Study of the Pharmacokinetics and Tolerability of 3 Different Doses of ARD-0403 in Testosterone Deficient Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism
Lead sponsor: Ardana Bioscience Ltd
Sponsor class: INDUSTRY
First posted: 2008-01-17
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which dose, if any, results in testosterone levels within the normal range for men.


Eligibility criteria: Inclusion Criteria:

* Testosterone deficiency
* Normal BMI

Exclusion Criteria:

* Previous treatment with testosterone replacement therapy within 4 weeks
* Moderate-severe benign prostatic hypertrophy, or prostatic cancer
* Haematocrit \>50%

Primary outcomes:
measure: Pharmacokinetic
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Republican Endocrinology Center Hospital
Study officials:
affiliation: Republican Endocrinology Center Hospital, Minsk, Republic of Belarus
name: Tatiana Mokhort, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02398851: TacTIC- Trans-disciplinary Chronic Disease Continuity of Care Model
Official title: TacTIC- Trans-disciplinary Chronic Disease Continuity of Care Model
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Disease
Geriatrics
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall aim of this study is to create a trans-disciplinary chronic disease continuity of care model with health information technology, utilizing mobile devices such as tablets, iPads and smartphones.

Detailed description: This study aims to explore if a trans-disciplinary chronic disease continuity of care model with integrated technology (mobile devices such as tablets, iPads and smartphones) to standard practice (patient-centered, coordinated care model without the integration of technology) will results in a reduction in 30-day readmission rate in adult patients.

Eligibility criteria: Inclusion Criteria:

* Adult patients on a 43 bed medical surgical unit
* Adult patients on 44 bed geriatric unit

Exclusion Criteria:

* Adult patients admitted and not diagnosed with chronic disease
* Patients who are transferred between Intervention and non-Intervention unit
* Patients who refuse
* Patients with delirium, dementia and altered mental status
* Patients who cannot read and write in any language
* Patients in the intervention group who cannot use mobile technology

Primary outcomes:
measure: Reduction in the 30-day readmission rates in adult patients who receive care in a trans-disciplinary chronic disease continuity of care model integrated with technology (mobile devices such as tablets, iPads and smartphones).
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Julius Gardin, MD
role: PRINCIPAL_INVESTIGATOR
References: