louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03002610: Presenting Summary Information From Cochrane Systematic Reviews to Physicians
Official title: Presenting Summary Information From Cochrane Systematic Reviews to Physicians: Protocol for Research of Infographics Presentation vs. Plain Language Summary
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
Collaborators: name: University of Liverpool
First posted: 2016-12-26
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to evaluate the efficacy of infographics, compared to standard PLS and scientific abstract format, in presenting information, in terms of understanding and remembering research results by physicians.

Detailed description: The investigators will conduct a randomized controlled trial (RCT) with three different formats of the same systematic review summary (Infographics, PLS, scientific abstract). The content of these three formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation in plain language, plain language only, and text with scientific abbreviations. The interventions will be delivered online in January 2016, with physicians who are currently working at Clinical Hospital Split. The trial will be preformed online, and it will be voluntary and anonymous. The survey will consist of 5 parts, in the following order: 1) one format of the summary (randomly assigned), 2) health numeracy, 3) demographic data 4) comprehension test of the information given in the summary, and 5) user friendliness of information and overall satisfaction with the given summary assessed by survey.

Eligibility criteria: Inclusion Criteria:

* physicians who are working at Clinical Hospital Split

Exclusion Criteria:

* none

Primary outcomes:
measure: Understanding of the Content of Summary Format
timeFrame: One month (30 days)
Secondary outcomes:
measure: Reading Experience
timeFrame: One month (30 days)
measure: User Friendliness
timeFrame: One month (30 days)
Other outcomes:
measure: Health Numeracy
timeFrame: One month (30 days)
Locations:
city: Split
country: Croatia
facility: University of Split
Study officials:
affiliation: Researcher
name: Ivan Buljan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osborn CY, Wallston KA, Shpigel A, Cavanaugh K, Kripalani S, Rothman RL. Development and validation of the General Health Numeracy Test (GHNT). Patient Educ Couns. 2013 Jun;91(3):350-6. doi: 10.1016/j.pec.2013.01.001. Epub 2013 Feb 21.
Clinical trial NCT00285610: Early Exposure to Lead and Adult Antisocial Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lead Poisoning
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2006-02-02
Enrollment: 225
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: Pregnant women were recruited from four prenatal clinics in Cincinnati, Ohio if they resided in areas of the city with a high concentration of older, lead-contaminated housing

Brief summary: Prior research indicates a link between early lead exposure and risk for delinquent behavior. In this study, we follow a large birth cohort from the Cincinnati Lead Study into early adulthood to determine whether this increased risk persists. Outcome measures include official arrest records, diagnoses of Substance Abuse Disorder and Antisocial Personality Disorder, self-report of delinquent behavior, and a psychopathy scale. Predictors include pre-natal and post-natal blood lead levels. Multivariate statistical methods will control for potential confounders/covariates.


Eligibility criteria: Inclusion Criteria: (1) Part of original CLS birth cohort -

Exclusion Criteria: (1) Moved out of geographic area

-

Primary outcomes:
measure: Lead Exposure and Antisocial Behavior
timeFrame: Prenatal (1-2 trimester) and postnatal on a quarterly and bi-annual basis (until 6.5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: M. Douglas Ris, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449410: Silent Cerebrovascular Lesion and Cognitive Decline Prevention by Cholesterol Lowering in Elderly AF Patients
Official title: Silent Cerebrovascular Lesion and Cognitive Decline Prevention in Atrial Fibrillation by Intensive Cholesterol Lowering in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Neuropsychology
Magnetic Resonance Imaging
Inflammation
Hemostasis
Keywords: Atrial Fibrillation
elderly
cholesterol lowering
neurocognitive function
cerebrovascular lesion
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Schering-Plough
First posted: 2007-03-20
Enrollment: 35
Sex: ALL
Minimum age (years): 68
Maximum age (years): 82
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In elderly patients with atrial fibrillation (AF) the presence of silent brain infarcts and neurocognitive deficit is high despite adequate treatment with oral anticoagulation. Atherosclerosis is considered to be a chronic inflammatory disease and thrombosis and inflammation are strongly correlated. Atrial fibrillation is linked with increased levels of inflammatory markers and intensive cholesterol lowering has proven to reduce inflammation. In a prospective double-blind randomized pilot-study we want to test the hypothesis, that addition of intensive cholesterol lowering treatment besides adequate oral anticoagulation will reduce cerebrovascular lesions and will be beneficial for neurocognitive status in elderly AF patients.


Eligibility criteria: Inclusion Criteria:

* Elderly patients (\>68 and \<82 years) with atrial fibrillation and adequate oral anticoagulation therapy and cholesterol levels between 4,5 mmol/l and 7 mmol/l

Exclusion Criteria:

* Indication for cholesterol lowering treatment according to Dutch CBO-cholesterol guidelines (2004)

Primary outcomes:
measure: Neurocognitive function
measure: Cerebrovascular lesions on MRI
Secondary outcomes:
measure: Level of inflammatory markers
measure: Level of hemostatic markers
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Gheorghe AM Pop
Study officials:
affiliation: UMCN Radboud
name: Janet Kuilenburg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMCN Radboud
name: Gheorghe AM Pop, MD PhD
role: STUDY_DIRECTOR
References:
citation: Lappegard KT, Pop-Purceleanu M, van Heerde W, Sexton J, Tendolkar I, Pop G. Improved neurocognitive functions correlate with reduced inflammatory burden in atrial fibrillation patients treated with intensive cholesterol lowering therapy. J Neuroinflammation. 2013 Jun 28;10:78. doi: 10.1186/1742-2094-10-78.
Clinical trial NCT06651710: Zynamite® in Cognition and Mood in University Students
Official title: Effects of Zynamite® on Cognitive Function and Mood in University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: University Student
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study examines the effects of a single dose of ZynS on cognitive function (memory, concentration, attention, and mental agility) in college students and will test the efficacy of this treatment on mood (anger, fatigue, vigor, agreeableness, tension, and depression).


Eligibility criteria: Inclusion Criteria:

* Be an active undergraduate or graduate student
* Be between 18 and 25 years of age
* Be healthy and free of any relevant medical condition or disease.

Exclusion Criteria:

* Suffer from chronic diseases such as asthma, type 1 diabetes, thyroid diseases (such as hypothyroidism or hyperthyroidism), autoimmune disorders (such as Crohn's disease) and psychiatric conditions such as anxiety disorders, major depression, eating disorders (anorexia, bulimia), attention deficit hyperactivity disorder (ADHD), among others; ii) Pregnancy or breastfeeding.
* Known intolerance, hypersensitivity or allergies to any of the ingredients of the products under investigation;
* Intestinal absorption problems, as well as learning difficulties, dyslexia, eye problems or color blindness;
* Intake of psychoactive substances or medications that may influence the results of the study, such as consuming \>500 mg of caffeine per day (\>6 cups of 150 ml filtered coffee) and/or alcohol;
* Having comprehension or communication difficulties that prevent full understanding of the informed consent or effective participation in the study, such as autism spectrum disorders, aphasia, or intellectual disability.

Primary outcomes:
measure: del POMS (Profile Of Mood States)
timeFrame: Up to fourteen days
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Up to fourteen days
measure: Trail Making Test (TMT)
timeFrame: Up to fourteen days
measure: The Digit Symbol Substitution Test (DSST)
timeFrame: Up to fourteen days
measure: Stroop Color and Word Test
timeFrame: Up to fourteen days
Secondary outcomes:
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: University of Atlántico Medio
Study officials:
References:
Clinical trial NCT05409781: Prevalence of May-Thurner Syndrome in 1st-degree Relatives of Symptomatic Patients
Official title: Prevalence of May-Thurner Syndrome in 1st-degree Relatives of Symptomatic Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: May-Thurner Syndrome
Lead sponsor: University Hospital of Limerick
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 50
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: The pathogenesis of MTS is largely unknown and whilst the condition is known to be more prevalent in females, familial risk factors are largely unknown. To our knowledge, no studies have previously assessed the prevalence of MTS in relatives of those with the condition.

Brief summary: The aim is to assess the prevalence of May-Thurner syndrome in 1st-degree relatives of previously identified symptomatic patients.

Detailed description: May-Thurner syndrome (MTS) is a condition characterised by compression of the left common iliac vein by the right common iliac artery and the anterior spine of the 5th lumbar vertebrae. Previously thought to be a rare condition, the prevalence of MTS is thought to be underreported. MTS can lead to significant morbidity in the form of chronic venous insufficiency, venous ulceration, lower limb swelling, venous claudication, deep-vein thrombosis, varicose veins, pelvic congestion syndrome, chronic pelvic pain and chronic post-thrombotic syndrome. It is a known risk factor for development of venous incompetence and varicose veins in adolescents and young adults. Furthermore, it is known to be an a causative factor in the development of "unprovoked" DVT in younger patients, however data on the risk of development of DVT in MTS patients has to date, been unavailable.

The pathogenesis of MTS is largely unknown and whilst the condition is known to be more prevalent in females, familial risk factors are largely unknown. To date, no studies have previously assessed the prevalence of MTS in relatives of those with the condition.

Eligibility criteria: Inclusion Criteria:

* Informed consent, first degree relative with symptomatic May-Thurner syndrome

Exclusion Criteria:

* Those who not give informed consent to be contacted or to be scanned.

Primary outcomes:
measure: Prevalence Assessment
timeFrame: 1 year
Secondary outcomes:
measure: Venous Competence Assessment
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03912181: Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes
Official title: Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes From a 10 Year Follow-up Linking Datasets Between Patient Medical Records and Patient Claims: the ESTHYM Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Familial Chylomicronemia Syndrome
Multifactorial Chylomicronemia Syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients male or female at least 18 years old having genetically documented familial or multifactorial chylomicronaemia syndrome.

Brief summary: A retrospective, systematic study of reimbursed healthcare costs over a 10 year period in patients suffering from Familial Chylomicronaemia Syndromes (FCS) or Multifactorial Chylomicronaemia Syndromes (MCS) in order to establish the relative healthcare burden of both syndromes by linking the Hospices Civils de Lyon (HCL) registry of FCS or MCS patients and data obtained from FCS or MCS patients followed in Paris, Nantes and Lyon to the French National Health System (NHS) healthcare claims database, the Système National d'Information Inter-Régimes de l'Assurance Maladie (SNIIR-AM).

A probabilistic approach will be used to link databases. This linkage will be based on the following variables: age, gender, date of discharge of any hospitalization, date of any imaging procedure.

This study will help to describe, in real life, the management of severe hyperglyceridaemia in France. In addition, the descriptive results will help obtain a better understanding of the patients suffering from this disease, the burden of the disease and the healthcare consumption linked to this disease. Even if this consumption of care has been relatively unexplored until this point, it is not negligible. The potential of merging genomics and claims data for cardiovascular research could help to identify ways to optimize disease


Eligibility criteria: Inclusion Criteria:

* genetically documented FCS
* genetically documented MCS

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of Acute Pancreatitis, Ischemic Cardiovascular Disease and any additional co-morbidity
timeFrame: 2006-2016 (10 year follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Philippe Moulin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belhassen M, Van Ganse E, Nolin M, Berard M, Bada H, Bruckert E, Krempf M, Rebours V, Valero R, Moulin P. 10-Year Comparative Follow-up of Familial versus Multifactorial Chylomicronemia Syndromes. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1332-e1342. doi: 10.1210/clinem/dgaa838.
Clinical trial NCT00055081: The Impact of Family CTI on Homeless Children
Official title: The Impact of Family CTI on Homeless Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: Homeless Persons
Lead sponsor: Nathan Kline Institute for Psychiatric Research
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-02-20
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine how services and housing provided for homeless families affect the mental health and behavior of homeless children over time.

Detailed description: This study is a supplement to a parent study which concentrates on the outcomes of homeless mothers who are provided with services and housing. This study will focus on the effects of housing and services on children, who may be the major beneficiaries of such assistance.

Participants are randomly assigned to either receive services and permanent housing or to remain in a homeless shelter without additional assistance. Children and their parents are interviewed separately 3, 9, and 15 months after study entry. The teachers of participating children are surveyed twice during the study.

Eligibility criteria: Inclusion Criteria:

* Enrollment in the parent study
* Homeless and living at a shelter with mother/maternal guardian at the time of study enrollment

Primary outcomes:
measure: Internalizing, externalizing, school outcomes
timeFrame: 18 months post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Orangeburg
country: United States
facility: The Nathan S. Kline Institute for Psychiatric Research
state: New York
Study officials:
affiliation: The Nathan S. Kline Institute for Psychiatric Research
name: Judith A Samuels, MBA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04415281: Photobiomodulation for the Management of Temporomandibular Disorder Pain
Official title: Photobiomodulation for the Management of Temporomandibular Disorder Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain Related to TMD
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2020-06-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for TMD pain. Also, we propose to determine if PBM-induced changes in inflammation contribute to PBM's analgesic effects. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.


Eligibility criteria: Inclusion Criteria:

* Provides a signed and dated informed consent form
* Is at least 18 years of age (male or female and any race or ethnicity)
* Meets diagnostic criteria for TMD, ( Masticatory Muscle Disorders, 1A: Myalgia)
* Has experienced facial pain for at least 3 months
* At Screening and Baseline Visit (Visit 0), reports an average pain intensity rating over the past week of ≥ 30 on a numerical rating scale (0-100)

Exclusion Criteria:

* Starting a new daily prescription medication for the management of pain within 30 days prior to treatment session;
* Use of any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 2 weeks prior to the CATI;
* Starting occlusal appliance therapy within 30 days prior to CATI; d) history of facial trauma or orofacial surgery within 6 weeks prior to CATI;
* Active orthodontic treatment;
* Psychiatric hospitalization within one year prior to screening.
* Has known hypersensitivity to laser therapy.
* Currently being treated with chemotherapy or radiation therapy
* Has been treated with another investigational drug or treatment within 30 days prior to the Screening and Baseline Visit
* Is pregnant or nursing
* Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

Primary outcomes:
measure: Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable
timeFrame: Through study completion; an average of 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Margarete Ribeiro-Dasilva, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01720381: OptiScanner Versus Standard Blood Glucose Monitoring
Official title: Manual vs. Automated moNitoring Accuracy of GlucosE II (MANAGE II)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Keywords: monitoring
blood glucose
intensive care unit
Lead sponsor: OptiScan Biomedical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Erasme University Hospital
First posted: 2012-11-02
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to the intensive care unit (ICU) of Erasme University Hospital in Brussels, Belgium.

Brief summary: The study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in critically ill patients when compared to a reference YSI 2300 STAT Plus and the Gem 3000, the reference standard for Erasme University Hospital.


Eligibility criteria: Inclusion Criteria:

* Signed Informed consent.
* Age ≥ 18 years.
* Admitted to the ICU of Erasme University Hospital.
* Expected ICU stay of ≥ 3 days at the time of enrollment (as judged by the Principle Investigator).
* APACHE II score of ≥ 10, within the first 24 hours of ICU admission.
* Existing central venous catheter + arterial catheter.
* No participation in any other investigational interventional study while enrolled in this study.
* Hyperglycemia (BG \> 150 mg/dl) at the time of admission.

Exclusion Criteria:

* Pregnancy.

Primary outcomes:
measure: Glucose Prediction error
timeFrame: 1 year
Secondary outcomes:
measure: Clarke Error Grid analysis
timeFrame: 1 year
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme University Hospital
Study officials:
affiliation: Erasme University Hospital
name: Jean-Charles Preiser, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Righy Shinotsuka C, Brasseur A, Fagnoul D, So T, Vincent JL, Preiser JC. Manual versus Automated moNitoring Accuracy of GlucosE II (MANAGE II). Crit Care. 2016 Nov 25;20(1):380. doi: 10.1186/s13054-016-1547-3.