louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06285513: Cardiovascular Metabolic Remodeling in Shock
Official title: Metabolic Remodeling Assessment During Severe Cardiovascular Dysfunction in Shock
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Shock
Keywords: Metabolic remodelling
Shock states
Cardiovascular dysfunction
Metabolomics
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalised in intensive care for shock, treated with a vasoactive or ionotropic amine, undergoing invasive mechanical ventilation for less than 24 hours

Brief summary: The aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved.

Detailed description: To do this, the investigators chose to carry out an in-depth study of the different metabolic pathways, using metabolomic analysis of plasma, targeting the cardiovascular metabolism of patients admitted to intensive care for septic and non-septic shocks.

Eligibility criteria: Inclusion Criteria:

* Patient aged between 18 and 75.
* Patient admitted to intensive care for shock treated with a vasoactive or inotropic amine (adrenaline, dobutamine or noradrenaline).Patient undergoing invasive mechanical ventilation for less than 24 hours (or admitted to intensive care for less than 24 hours if the patient arrived intubated) and for a foreseeable duration of ventilation of at least 48 hours.
* Patient, or relative if the patient is not competent, who has read and understood the information letter and does not object to participation in the research, or emergency procedure in the absence of a relative.
* Urine or blood pregnancy test if a sample is taken as part of routine negative care (if woman of childbearing age).

Exclusion Criteria:

* Moribund patient (death expected within \< 24 hours) and/or decision to limit or stop treatment on admission to intensive care.
* Pregnant, parturient or breast-feeding woman.
* Patient not suitable for enteral calorie intake. Patient with a history of: advanced chronic renal failure ; advanced chronic liver failure.
* Incapacitated patient of full age (under guardianship, curatorship) or deprived of liberty by court order.
* Patient already taking part in an interventional study.

Primary outcomes:
measure: Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock
timeFrame: Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: University Hospital of Rouen
Study officials:
affiliation: University Hospital of Rouen, France
name: Grégoire JOLLY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02277613: A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
Official title: A Phase 2 Prospective, Randomized, Double-blind, Sham-controlled, Parallel-group, Multi-center Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Attack
NSTEMI
Keywords: stem cells
Lead sponsor: Healios K.K.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-10-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).


Eligibility criteria: Inclusion Criteria:

* Subjects of either gender, 18-85 years of age, inclusive
* Diagnosis of non-ST elevation myocardial infarction (NSTEMI)
* Left Ventricular Ejection Fraction (LVEF) between ≥ 25 and ≤ 45%

Exclusion Criteria:

* Previous Coronary Artery Bypass Graft (CABG)
* Previous autologous, allogeneic bone marrow or peripheral stem cell transplant
* Previous solid organ transplant
* Anticipated need for additional planned coronary revascularization procedure(s)
* Hemodynamic instability
* Mechanical complications of the index acute myocardial infarction

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: 30 days
measure: To assess the effects of AMI MultiStem therapy on cardiac function
timeFrame: Day 120
Secondary outcomes:
measure: To assess the effects of AMI MultiStem therapy on cardiac function
timeFrame: Day 365
measure: To assess the incidence of Major Adverse Cardiovascular Events (MACE)
timeFrame: Day 365
measure: Incidence and severity of adverse events
timeFrame: Day 365
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Clearwater
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Detroit
country: United States
state: Michigan
city: Akron
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Salt Lake City
country: United States
state: Utah
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Summa Health System
name: Marc Penn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04746313: Prevalence of Hyperprolactinemia in Systemic Scleroderma
Official title: Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sclerosis, Systemic
Scleroderma
Hyperprolactinemia
Keywords: Systemic sclerosis
Scleroderma
Prolactin
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Association pour la Formation et la Recherche en Médecine Interne (AFORMI)
First posted: 2021-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Scleroderma patients are from scheduled hospitalization Department of Internal Medicine and Clinical Immunology, CHU Lille Healthy subjects are from the French Blood Establishment (EFS) and matched to scleroderma patients on age (+/- 5 years) and sex

Brief summary: Systemic sclerosis is an autoimmune and inflammatory disease characterized primarily by fibrosis and vascular involvement. We know that the immune system is disrupted in systemic sclerosis, but there are probably other mechanisms to explain the disease, including deregulation of certain proteins such as prolactin


Eligibility criteria: Inclusion Criteria:

Scleroderma patients:

* man or woman over 18 years old
* with systemic sclerosis meeting ACR-EULAR 2013 criteria
* having given his no opposition
* being social insured

Healthy subjects:

* man or woman over 18 years old
* donation of blood to the EFS
* matched on age (+/- 5 years) and sex
* having given his no opposition

Exclusion Criteria:

* Man or woman under 18 years old
* Pregnant or breastfeeding women
* Receiving medical treatment inducing dysfunction of the hypothalamic pituitary axis
* Refusing or unable to give no objection

Primary outcomes:
measure: the prevalence of hyperprolactinemia in scleroderma patients
timeFrame: At 2 years
Secondary outcomes:
measure: the prevalence of hyperprolactinemia between scleroderma patients and healthy subjects matched by age and sex
timeFrame: At 2 years
measure: the associations between prolactin levels and clinical (scleroderma phenotype, visceral involvement) and biological (inflammation, antibodies, cytokines) manifestations in systemic sclerosis
timeFrame: At 2 years
measure: association between prolactin levels and biological markers of the immune system in scleroderma patients
timeFrame: At 2 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: David Launay, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05274113: Low Dose Dexamethasone for Distal Radius Fractures
Official title: Efficacy of Direct Versus Peripheral Low-Dose Adjuvant Dexamethasone on Duration and Rebound Pain in Regional Anesthesia for Distal Radius Fracture Fixation: A Prospective Randomized Controlled Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Post Operative Pain
Distal Radius Fracture
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The addition of the steroid dexamethasone to a single injection of local anesthetic has been shown to significantly prolong the duration of peripheral nerve blockade compared to local anesthetic alone. This allows for improved post-operative pain scores and reduces opioid use in the early post-operative period. However, the use of a steroid adjuvant in regional nerve blocks is generally not considered standard of care, and there is considerable variation among anesthesiologists regarding preferred formulations and the role of adjuvants in regional anesthesia. A recent study from our institution demonstrated the effectiveness of dexamethasone directly mixed with local anesthetic at multiple doses compared to placebo for upper extremity surgery. With this prospective randomized controlled blinded trial, we hope to definitively establish which method of adjuvant dexamethasone administration is superior in extending the effects of a brachial plexus nerve block.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 undergoing open reduction and internal fixation of a distal radius fracture less than 3 weeks from injury with a volar plate technique
* American Society of Anesthesiologists (ASA) levels 1 through 3 at time of surgery
* Opioid naïve patients

Exclusion Criteria:

* History of Drug/opioid/alcohol abuse
* Polytrauma patients
* History of inflammatory disorder, infection, dementia, psychiatric/neurological disorder, relevant drug/local anesthesia allergy, relevant chronic upper extremity pain (RSD, fibromyalgia, neuralgia, etc)
* Excessive BMI
* Pregnancy

Primary outcomes:
measure: Postoperative pain control
timeFrame: 72 hours
measure: Postoperative pain control #2 questionnaire
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06596213: Hepatitis Inequalities Study
Official title: Overcoming Inequalities in Health to Eliminate Hepatitis - Real-World Evidence from a Territory-Wide Cohort
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Hepatitis B
HEPATITIS C VIRUS CHRONIC INFECTION
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100000
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: From the Clinical Data Analysis and Reporting System (CDARS) from Hospital Authority

Brief summary: Health inequality in liver diseases including age, gender, ethnicity and socioeconomic status has been increasingly recognised and potentially hinder hepatitis elimination. Health inequality has significant impact to evaluate the impact diagnostic and treatment uptake rates of chronic viral hepatitis on risk of hepatocellular carcinoma (HCC), hepatic event and liver-related death in patients with chronic hepatitis B and/or C. To overcome the limitation of small prospective cohort study of limited recruitment period, retrieving information from the Clinical Data Analysis and Reporting System (CDARS) from Hospital Authority (HA) will be one of the best way to answer these questions.


Eligibility criteria: Inclusion Criteria:

* Patients will be eligible if they have any of these viral markers (HBeAg / HBsAg / HBV DNA / HCV RNA) and/or any of the following diagnosis codes (ICD-9 070-070.9; 348.3, 349.82, 456, 456.2, 456.8, 567.2, 567.8, 570, 571.2, 571.5, 571.6, 572.2, 572.3, 572.4, 789.5) checked or coded in any public hospitals or clinics from 1 January 2000 to 31 March 2024.

Exclusion Criteria:

* Patients with missing age, gender, ethnicity and socioeconomic status
* (Subgroup analysis for ethnicity and socioeconomic status) Patients with missing ethnicity and socioeconomic status
* Serious medical illnesses or malignancy with life expectancy \&lt;1 year

Primary outcomes:
measure: Safety
timeFrame: From 1 January 2000 to 31 March 2024
Secondary outcomes:
measure: Safety
timeFrame: From 1 January 2000 to 31 March 2024
Other outcomes:
Locations:
Study officials:
References:
citation: El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012 May;142(6):1264-1273.e1. doi: 10.1053/j.gastro.2011.12.061.
Clinical trial NCT01662713: Optical Frequency Domain Imaging for Non-melanoma Skin Cancers
Official title: Optical Frequency Domain Imaging for Non-melanoma Skin Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Melanoma Skin Cancer (NMSC)
Keywords: skin cancer
optical imaging
optical coherence tomography
optical frequency domain imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this research study is to find out if a non-invasive imaging device called Optical Frequency Domain Imaging (OFDI) can help doctors to see the tissue and blood vessels that are related to non-melanoma skin cancers. OFDI was designed to see microscopic details of your skin without needing to use any invasive techniques such as surgery or biopsy.

Detailed description: Non-melanoma skin cancer (NMSC) is the most common cancer in the United States, with more than 750,000 diagnosed patients treated every year. Its prevalence and incidence have significantly increased over the past two decades and it has been estimated that 20% of all Americans will develop this type of cancer during their lifetime (Neville et al., 2007). Biopsy and surgical resection of NMSC can result in tissue mutilation and scaring. Therefore, there is a need for new imaging technologies that can be used to non-invasively guide biopsy and surgery.

Optical Frequency Domain Imaging (OFDI) is a second-generation imaging implementation of optical coherence tomography (OCT) developed at the Wellman Center. OFDI provides high-resolution three-dimensional imaging in tissue. It uses an interferometric depth-sectioning technique and employs a near-infrared light source. Through analysis of phase information in the recorded signal. OFDI can detect blood vessels within tissues and tumors. Importantly, OFDI-based vascular imaging can be performed without the need for exogenous contrast agents, making it relatively easy to deploy in clinical settings.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects with Fitzpatrick skin type I-VI
2. Subjects with ages between 18 and 80 years of age
3. Presence of at least one NMSC lesion

Exclusion Criteria:

1. Subjects with active localized or systemic infections
2. Subjects participating in potentially confounding clinical studies of investigational therapies, either drug or device.
3. Subjects taking any topical/systemic chemotherapy or immunosuppressants
4. Subjects who are pregnant and/or breastfeeding
5. Subjects with tape adhesive allergies

Primary outcomes:
measure: Successful imaging of lesion
timeFrame: After completion of imaging session
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Benjamin Vakoc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06752213: Comparison of Manual Therapy and Auricular Vagus Nerve Stimulation in Chronic Low Back Pain
Official title: Comparison of Manual Therapy and Auricular Vagus Nerve Stimulation in Chronic Low Back Pain: A Crossover Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Pain
Keywords: pain
low back pain
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Especially in the elderly population, low back pain is a major health problem, causing great human costs, negatively affecting the quality of life and limiting the daily activities of individuals


Eligibility criteria: Inclusion criteria Patients aged 20-65 years with nonspecific chronic low back pain will be included in the study.

Exclusion criteria

* Cognitive impairment
* Severe osteoprosis
* Neurological deficit
* Being pregnant
* Operations on the lumbar region

Primary outcomes:
measure: Muscle Endurance Assessment
timeFrame: 6 weeks
measure: Autonomic Nervous System Assessment
timeFrame: 6 weeks
measure: Flamingo Balance Test
timeFrame: 6 weeks
measure: Modified Star Excursion Balance
timeFrame: 6 weeks
measure: Algometer
timeFrame: 6 weeks
measure: Visual Analog Scale (VAS)
timeFrame: 6 weeks
measure: Oswestry Disability Index (ODI)
timeFrame: 6 weeks
measure: Range of Motion and Mobility Assessment
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02589613: Glucose and Fructose Stimulated Brain Activity in Obese Subjects
Official title: Effects of Acute Glucose and Fructose Ingestion on Brain Activity in Obese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exploratory Behavior
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI. Administration of glucose as well as fructose is followed by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese humans.


Eligibility criteria: Inclusion Criteria:

* right-handed healthy males, no drugs, non-smoking

Exclusion Criteria:

* drug abuse, smoker, left-handed, claustrophobia

Primary outcomes:
measure: Functional magnetic resonance imaging (fMRI) in healthy, obese volunteers while they performed a working memory task: changes in cerebral blood flow
timeFrame: changes from baseline to one hour after treatment
Secondary outcomes:
measure: Changes in plasma insulin
timeFrame: changes from baseline to one hour after treatment
measure: Changes in plasma glucose
timeFrame: changes from baseline to one hour after treatment
measure: Changes in plasma GLP-1
timeFrame: changes from baseline to one hour after treatment
Other outcomes:
Locations:
Study officials:
affiliation: University of Basel
name: Christoph Beglinger, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05443113: Young Pectus Excavatum Patients and Genetic Defects
Official title: Early Onset Pectus Excavatum is More Likely to be Part of a Genetic Defect
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Disease
Pectus Excavatum
Children, Adult
Keywords: Pectus excavatum
Children
Gene
Syndrome
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 18
Sex: ALL
Minimum age (years): 0
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pectus excavatum aged younger than 11 years

Brief summary: In most pectus excavatum (PE) patients an underlying genetic defect is not found with molecular analysis, as a direct genetic link with PE has yet to be found and because potential underlying genetic disorders are quite rare. Only one-fifth of all PE cases are identified in the first decade of life and thus of congenital origin making younger PE patients a unique patient group. Therefore, the research question is; is early-onset pectus excavatum (PE) more likely to be part of a genetic defect than PE which became apparent during puberty or adolescence?

Detailed description: Importance: In most pectus excavatum (PE) patients an underlying genetic defect is not found with molecular analysis, as a direct genetic link with PE has yet to be found and because potential underlying genetic disorders are quite rare. Only one-fifth of all PE cases are identified in the first decade of life and thus of congenital origin making younger PE patients a unique patient group.

Objective: the investigators hypothesize that early-onset PE is more likely to be part of a genetic defect than PE which became apparent during puberty or adolescence.

Design: Cohort study Setting: Single center Participants: All pediatric PE patients aged younger than 11 years upon first visit of the outpatient clinic of the department of pediatric surgery at the Sophia Children's Hospital - Erasmus Medical Center between 2014 and 2020 were identified and informed consent was obtained for inclusion. Two clinical geneticists performed the anamnesis and physical examination. Molecular analysis was performed based on the differential diagnosis. All young PE patients which have been referred for genetic counseling already, were analyzed retrospectively.

Main Outcome: incidence of genetic defects

Eligibility criteria: Inclusion Criteria:

* Patients with pectus excavatum aged younger than 11 years upon first visit of our outpatient clinic

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of genetic variations
timeFrame: Baseline
Secondary outcomes:
measure: Evaluation checklist referral of a patient with pectus excavatum for genetic counseling
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: René M Wijnen
role: PRINCIPAL_INVESTIGATOR
References: