louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03429660: French Adult Primary Immune Thrombocytopenia
Official title: French Adult Primary Immune Thrombocytopenia: a pHarmacoepidemiological Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombocytopenia
Keywords: Disease epidemiology
Risk assessment
Drug utilisation study
Effectiveness evaluation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of patient registred in national administrative french database

Brief summary: Primary immune thrombocytopenia (ITP) is rare. First-line treatment is corticotherapy. Then, several second-line treatments (SLT) are available: splenectomy, off-label rituximab and thrombopoietin-receptor agonists since 2009. The compared efficacy and safety on clinical events in the long-term are unknown. The main objective of the FAITH study is to build the cohort of all treated adult persistent (≥3 months) primary ITP patients in France, to assess the benefit-to-risk ratio of SLT in real-life practice. Data source is the database of French Health Insurance System (SNIIRAM) which covers the entire French population. It collects demographic, chronic disease, hospitalization and drug dispensing data. All patients with ITP were extracted from 2009 to 2012, and then every year for 10 years. The investigator will build the cohort from raw data. Outcomes (death, hospitalization, drug dispensing) will be compared according to SLT, with controls from the general population and untreated patients.


Eligibility criteria: Inclusion Criteria:

* Incident case of immune thrombocytopenia or control patient

Exclusion Criteria:

* Patient not registered in the database between 2009 and 2012

Primary outcomes:
measure: Exposition or non exposition to available immune thrombocytopenia persistent
timeFrame: up to 10 years
Secondary outcomes:
measure: Mortality as assessed date of death collected in the database
timeFrame: Each year until 10 years
measure: Number of hospitalization for bleeding in the database
timeFrame: Each year until 10 years
measure: Safety of treatment for infections
timeFrame: Each year until 10 years
measure: Safety of treatment for cardio-vascular events
timeFrame: Each year until 10 years
measure: Safety of treatment for thrombo-embolic events
timeFrame: Each year until 10 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Maryse LAPEYRE-MESTRE, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01768260: Effect of EECP on Anterior Ischemic Optic Neuropathy
Official title: Study of the Effect of EECP on Anterior Ischemic Optic Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Ischemic Optic Neuropathy
Keywords: visual acuity
artery flow velocity
Enhanced External Counterpulsation
Ischemic
Optic Neuropathy
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Enhanced External Counterpulsation(EECP) therapy may promote the recovery of visual function by improving the blood perfusion of eyes. The present study aims to investigate the effect of EECP on Anterior Ischemic Optic Neuropathy.

Detailed description: Patients with Anterior Ischemic Optic Neuropathy are randomized into two groups: one group receive standard medical treatment for ischemic optic neuropathy, the other group plus EECP therapy besides standard medical treatment.

Eligibility criteria: Inclusion Criteria:

* ischemic optic neuropathy
* within 1 month

Exclusion Criteria:

* Hemorrhagic disease
* thrombophlebitis or infection lesions
* severe hypertensive patients
* Atrial fibrillation
* Aortic regurgitation

Primary outcomes:
measure: visual acuity
timeFrame: 7 weeks
Secondary outcomes:
measure: Ophthalmic artery blood flow velocity
timeFrame: 7 weeks
Other outcomes:
measure: Central retinal artery flow velocity
timeFrame: 7 weeks
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat- sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital of Sun Yat-sen University
name: Yan Zhang, Professor
role: STUDY_DIRECTOR
References:
citation: Werner D, Michalk F, Harazny J, Hugo C, Daniel WG, Michelson G. Accelerated reperfusion of poorly perfused retinal areas in central retinal artery occlusion and branch retinal artery occlusion after a short treatment with enhanced external counterpulsation. Retina. 2004 Aug;24(4):541-7. doi: 10.1097/00006982-200408000-00006.
Clinical trial NCT01727960: The Effect of Education on Decreasing the Prevalence and Severity of Neck and Shoulder Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Korean
Male
Adolescents
Keywords: Education
Neck pain
Shoulder pain
Prevalence
Associated factors
Students
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 1302
Sex: MALE
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: students from two academic high schools in the city of Seoul 912 students ranging in age from participated.

Brief summary: Neck and shoulder pain (NSP) is fairly common among high school students in Korea. Presumably, the high prevalence of NSP in Korean adolescents is a consequence of an inappropriate static position for a prolonged period of time. We suspect that proper education and posture correction for Korean adolescents may decrease the prevalence or severity of NSP. Although several studies have focused on the etiology of NSP during adolescence, few studies have addressed the management or prevention of NSP in adolescents, despite its high prevalence in this age group. The aims of this prospective study was to identify the effects of education, in terms of recognition of this issue and posture correction, on prevalence and severity of NSP in Korean adolescents


Eligibility criteria: Inclusion Criteria:

* high school students

Exclusion Criteria:

* deny to participate

Primary outcomes:
measure: NRS score of neck and shoulder pain
timeFrame: 3 months later
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 3 months later
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang Univsrsity Hospital
Study officials:
References:
Clinical trial NCT03866291: ESBL in Patients Returning to Sweden With Traveller's Diarrhoea
Official title: ESBL-producing Enterobacteriaceae in Patients With Traveller's Diarrhoea- a Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotic Resistant Infection
Antibiotic Resistant Strain
Traveler's Diarrhea
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 305
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Travellers of all ages

Brief summary: Patients with traveller's diarrhoea frequently harbour Extended Spectrum Betalactamase (ESBL)-producing Enterobacteriaceae (EPE) returning from EPE-endemic areas.

This study investigates to what extent travellers returning to Sweden with traveller's diarrhoea carry ESBL in their stool. The isolates are examined further according to species, phenotype, antibiogram and whole genome sequencing.

Detailed description: Samples sent to the department of clinical microbiology in Lund, Sweden for culture of salmonella, shigella, yersinia or campylobacter are also cultured selectively for ESBL.

All patients are contacted by mail with the results. ESBL-positive patients are invited to submit further faecal cultures and blood samples during one year follow up time, to investigate how long the patient is colonized with ESBL.

Eligibility criteria: Inclusion Criteria:

* Travellers diarrhoea
* foreign traveller

Exclusion Criteria:

* foreign traveller but no symptoms

Primary outcomes:
measure: Proportion ESBL-colonized after one year.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Oskar Ljungquist
state: Skåne
Study officials:
affiliation: Lunds Universitet
name: Oskar Ljungquist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ljungquist O, Camporeale A, Nematzadeh S, Giske CG, Resman F, Riesbeck K, Tham J. A Cross-Sectional Cohort Study of Extended-Spectrum-Beta-Lactamase-Producing Enterobacterales in Patients with Traveler's Diarrhea. Antimicrob Agents Chemother. 2020 Nov 17;64(12):e01585-20. doi: 10.1128/AAC.01585-20. Print 2020 Nov 17.
Clinical trial NCT01639391: Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study
Official title: Creation of a Bank of Fibroblast From Patients With Amyotrophic Lateral Sclerosis: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2012-07-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Patients with ALS will be included in the reference center for ALS in hospital La Pitié Salpêtrière, Paris.

The study proposes to investigate the pathophysiology of ALS by setting up a fibroblast bank for studying molecular, cellular and genetic parameters of the pathology.

iPS (induced pluripotent stem cells) and then differentiated cells will be generated.

The pathophysiology of ALS will be studied on the 3 types of cells (fibroblasts, iPS, differentiated cells).


Eligibility criteria: Inclusion Criteria:

* patients over 18 years old
* ALS sporadic or familial or unknown

Exclusion Criteria:

* known cutaneous disease not allowing the biopsy
* platelets less than 10 000/m3
* suspected or known xylocain allergy

Primary outcomes:
measure: Success of fibroblast culture, amplification, and freezing pellets
timeFrame: 2 months
Secondary outcomes:
measure: Induced pluripotent Stem Cells generation success
timeFrame: 2 years
measure: neurones, motoneurones, glial cells obtention from fibroblasts or iPS
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre référent maladies rares SLA
Study officials:
affiliation: hôpital La Pitié Salpêtrière, Paris
name: Lucette Lacomblez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Pasteur
name: Delphine Bohl, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01372891: Urine Adiponectin Concentration in Prediction of Contrast Induced Nephropathy
Official title: Urine Total Adiponectin and Its Isoforms Concentration in Prediction of Percutaneous Coronary Interventions Contrast Induced Nephropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Ischemia
Keywords: Contrast Induced Nephropathy
percutaneous coronary interventions
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-06-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study enrolls a group of patients\> 18 who have ST elevation myocardial infarction (STEMI) undergoing primary PCI.

Brief summary: The present study is to determine the ability of urinary total adiponectin and its isoforms excretion in the prediction of contrast induced nephropathy (CIN) in the patients undergoing PCI.

Detailed description: Contrast induced nephropathy (CIN) is a severe complication after percutaneous coronary intervention (PCI). CIN is responsible for approximately genic renal insufficiency and is the third cause of hospital-acquired renal failure and the injury of endothelial of renal tubule is responsible for the CIN. However markers reliably identifying CIN in the patients undergoing PCI are rare. Adiponectin is a 30-kDa adipocyte-derived vasoactive peptide closely linked to components of the metabolic syndrome. Recent study demonstrates that the quantification of urinary adiponectin excretion appears to be an independent indicator of vascular damage potentially identifying an increased risk for vascular events. Therefore, the investigators presume that the adiponectin excretion may predict the incidence of the CIN. The present study is to determine the ability of urinary total adiponectin and its isoforms excretion in the prediction of CIN in the patients undergoing PCI.

Eligibility criteria: Inclusion Criteria:

* All patients \> 18 of age who are undergoing elective PCI and are able to give informed consent are eligible for study.

Exclusion Criteria:

* The end-stage renal failure
* The patients who are relieving dialysis

Primary outcomes:
measure: increase in SCr 0.5 mg/dL(44.2 mol/L) from baseline
timeFrame: 3 days
Secondary outcomes:
measure: a 25% increase in SCr from baseline
timeFrame: 3 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT04395391: Home Usability Study of the SARS-CoV-2 (COVID-19) Test
Official title: Usability Study of Home Collection and Mailing With SARS-CoV-2 Test Specimen Collection Materials (2020-06)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Sample Collection
Human Factors Study
Nasal Swab
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2020-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of varying education levels, age, and health status. Subjects will be employees of Exact Sciences. Subjects are considered enrolled when they provide informed consent.

Brief summary: The primary objective is to determine the usability of the SARS-CoV-2 Specimen Collection Materials for at-home collection and mailing of sample to the testing laboratory.

Detailed description: This study is a prospective observational human factors usability study designed to evaluate the Instructions For Use (IFU) in the SARS-CoV-2 Specimen Collection Materials based on the successful completion of self-collection of a nasal swab sample, which includes a valid SARS-CoV-2 test result.

Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent

Exclusion Criteria:

* Prior medical or laboratory training
* Prior experience with COVID-19 specimen self-collection
* Prior SARS-CoV-2 testing

Primary outcomes:
measure: Valid SARS-CoV-2 Test
timeFrame: Subjects are assessed at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Exact Sciences
state: Wisconsin
Study officials:
References:
Clinical trial NCT05259891: eegCap Application in Paediatrics wiTh redUced GCS in REsus
Official title: CAPTURE:eegCap Application in Paediatrics wiTh redUced GCS in REsus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Status Epilepticus
Altered Level of Consciousness
Non-epileptic Seizures
Epilepsy
Encephalopathy
Keywords: EEG
Emergency Department
Paediatrics
Reduced Glasgow Coma Scale (GCS)
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 176
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is all children between 0 years and 15 years and 11 months who present to the Resuscitation room of the Emergency Department of Cork University Hospital. Children can have underlying co-morbidities ( eg neurodisability, epilepsy) or be their first time presenting to a hospital.

Brief summary: Children frequently present with altered or reduced consciousness levels to emergency departments. By using EEG monitoring, subclinical seizure activity may be detected, leading to earlier pharmacological intervention and improved outcomes. Post-ictal phases that may be interpreted as seizure activity may become less over-treated. A feasibility study will ascertain if EEG monitoring can be applied successfully in this cohort, within a specified time period, obtaining minimum artefact (defined as \< 25% artefact). EEG recordings will not be used to guide clinical management during this feasibility study.

Detailed description: See study protocol attached

Eligibility criteria: Inclusion Criteria:

Children between 0 and 15 years and 11 months who present to Resuscitation Room, ED, CUH with a Glasgow Coma Scale (GCS) \< 11 or, a reduction in baseline GCS in the case of children with significant neurodisability at baseline

Exclusion Criteria:

* Polytrauma
* Open head wounds
* Unstable airway or requirement for bag and mask ventilation, where cap application would affect clinical management

Primary outcomes:
measure: The percentage of children who had EEG monitoring applied within twenty minutes and obtainment of an interpretable EEG recording with less than 25% artefact.
timeFrame: Anticipated 12 month study period
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital (CUH)
state: Munster
Study officials:
affiliation: UCC and INFANT Centre
name: Deirdre Murray
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00201591: Training at Different Intensities in Coronary Artery Disease -Effects on Myocardial Function
Official title: Which Training Intensity is Most Effective in Improving Myocardial Function in Patients With Coronary Artery Disease?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Exercise training
Intensity
Randomized
echocardiography
Aerobic Exercise
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-09-20
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigated if aerobic endurance exercise of different intensity has different impact on the physical capacity and myocardial function in patients with coronary artery disease. Patients with stable CAD trained for 10 weeks, and oxygen consumption and myocardial function were measured before and after this period. Patients were randomly assigned to each exercise group.

Detailed description: Peak oxygen consumption was measured by gas-analysis. Myocardial function was measured by echocardiography. Exercise was performed on treadmills under close supervision of an exercise physiologist. Patients had to complete over 70% of sessions to be included in analysis. Three sessions were scheduled every week. Heart rate (HR) was about 85 % of max HR in the high intensity group, and about 65 % in the moderate intensity group.

Eligibility criteria: Inclusion Criteria:

* stable coronary artery disease
* over 4 months since cardiovascular event

Exclusion Criteria:

* heart failure
* inability to exercise

Primary outcomes:
measure: Peak oxygen consumption
Secondary outcomes:
measure: Quality of life
measure: Myocardial function measured by echocardiography
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Dept. of Circulation and Medical Imaging, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Stig A Slørdahl, Prof
role: STUDY_CHAIR
References:
citation: Amundsen BH, Rognmo O, Hatlen-Rebhan G, Slordahl SA. High-intensity aerobic exercise improves diastolic function in coronary artery disease. Scand Cardiovasc J. 2008 Apr;42(2):110-7. doi: 10.1080/14017430701744477.
Clinical trial NCT06847191: NE3107 in Adults With Neurological Symptoms of Long COVID
Official title: A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of Bezisterim (NE3107) in Adults With Long COVID
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Long COVID
Keywords: COVID-19
Neurocognition
Fatigue
Post-exertional malaise
Sleep
SARS-CoV-2
Brain fog
Lead sponsor: BioVie Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Long COVID is a condition where debilitating symptoms can persist for months after a COVID-19 infection. This study aims to evaluate the effects of NE3107 on several neurological symptoms reported in people with Long COVID including difficulty concentrating or remembering things ("brain fog") and fatigue.

Researchers will compare NE3107 to a placebo (a look-alike substance that contains no drug) to see if NE3107 works to treat neurocognitive and fatigue symptoms of long COVID.

Participants will:

* Take NE3107 or a placebo twice daily for 84 days
* Visit the clinic 5 times for checkups and tests and have a follow up phone call


Eligibility criteria: Inclusion Criteria:

* 18 years to 64 years of age
* diagnosed with Long COVID with symptoms of fatigue and brain fog for at least 3 months
* agree to use birth control measures
* provide voluntary consent
* willing to allow blood collection
* pass all screening tests and procedures

Exclusion Criteria:

* has received a COVID-19 vaccination within 30 days
* previous admission to the intensive care unit for COVID-19
* medical history of major mental or physical illness prior to COVID-19 infection

Primary outcomes:
measure: Change in performance on the Cogstate Cognition battery
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Clinical Trial Site
state: California
city: Jacksonville
country: United States
facility: Clinical Trial Site
state: Florida
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Silver Spring
country: United States
facility: Clinical Trial Site
state: Maryland
city: Farmington Hills
country: United States
facility: Clinical Trial Site
state: Michigan
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
Study officials:
References: