louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05604118: Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin
Official title: Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Dysfunction Due to Aspirin
Keywords: platelets
phospholipids
aspirin
Lead sponsor: Cardiff University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Healthy volunteers (n = 28) were recruited from the workplace (14 male, 14 female; age range 20-50 years). Ethical approval, which included informed consent, was from Cardiff University, Schools of Medicine and Dentistry Research Ethics Committee (SMREC16/02). Following a 2-week period free from non-steroidal anti-inflammatory drugs (NSAIDs), peripheral blood was obtained and platelets isolated. Participants were commenced on aspirin 75 mg once daily for seven days and then provided a repeat blood sample. Following a 2-month period, participants were invited to repeat samples pre- and post-aspirin, and again a third time 2 months later.


Eligibility criteria: Inclusion Criteria:

* two-week washout period from any non-steroidal anti-inflammatory drugs (NSAIDs) use.
* Ability to take aspirin 75 mg once daily for seven days and sampled thereafter, before stopping the aspirin.
* Willingness to repeat this process after two months and four months of the initial sampling date.

Exclusion Criteria:

\* Recent NSAID use

Primary outcomes:
measure: Platelet EoxPL differences in amounts (ng) as measured by liquid chromatography with tandem mass spectrometry
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Sir Geraint Evans Cardiovascular Research Building
Study officials:
References:
Clinical trial NCT05498818: The Effects of Synaquell on Brain Function of Ice Hockey Players
Official title: The Effect of Synaquell on Objective Brain Function Measures in Youth Ice Hockey Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Ice Hockey
Cognitive Function
Cognition
Brain
Supplement
Contact Sport Athletes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 81
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth ice hockey players.

Detailed description: This randomized clinical trial will compare a brain health supplement (Synaquell) with placebo in both male and female ice hockey players over the course of an entire season. The repeated measure design will compare pre- and post-season objective brain health parameters, including quantitated EEG (Neurocatch), blood biomarkers and a rapid number naming test (King Devick).

Eligibility criteria: Inclusion Criteria:

* Fluent English speakers
* Medically cleared to play ice hockey

Exclusion Criteria:

* An allergy to the ingredients of SynaquellTM or the placebo
* Clinically documented hearing issues,
* In-ear hearing aid or cochlear implant
* Implanted pacemaker or defibrillator
* Metal or plastic implants in skull
* Lack of verbal fluency in the English language
* History of seizures
* Allergy to rubbing alcohol or EEG gel

Primary outcomes:
measure: Change in N100 Amplitude
timeFrame: Baseline, Postseason (approximately 6 months)
measure: Change in N100 Latency
timeFrame: Baseline, Postseason (approximately 6 months)
measure: Change in P300 Amplitude
timeFrame: Baseline, Postseason (approximately 6 months)
measure: Change in P300 Latency
timeFrame: Baseline, Postseason (approximately 6 months)
measure: Change in N400 Amplitude
timeFrame: Baseline, Postseason (approximately 6 months)
measure: Change in N400 Latency
timeFrame: Baseline, Postseason (approximately 6 months)
measure: Change in blood biomarker
timeFrame: Baseline, Postseason (approximately 6 months)
Secondary outcomes:
measure: Change in King-Devick Test (KDT) scores
timeFrame: Baseline, Postseason (approximately 6 months)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Stuart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01659918: Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 10 mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Asthma
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to montelukast or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute, Ltd.
name: Alan K Copa, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01190618: Surgical Outcomes of Vaginal Prolapse Repair With Elevate
Official title: Surgical Outcomes of Vaginal Prolapse Repair With the Elevate Prolapse Repair Kit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Prolapse
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2010-08-27
Enrollment: 417
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women having vaginal repair with Elevate prolapse repair kit

Brief summary: The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. .

Detailed description: The investigators hypothesize that the less invasive Elevate mesh results in a shorter operative time, lower blood loss, complications, postoperative pain and earlier discharge from the hospital.

Eligibility criteria: Inclusion Criteria:

* Women who have had a vaginal repair with Elevate prolapse repair kit

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Comparison of Outcomes
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Larry Sirls, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05969418: Deep Learning Optical Coherence Tomography (OCT) and OCT Angiography (OCTA) in NVC
Official title: Deep Learning OCT and OCTA Quantification in Neovascular Age Related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration Choroidal Neovascularization
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 50 years with diagnosis of neovascular macular degeneration. They did not present other ophthalmological disease

Brief summary: To evaluate the activity of neovascular macula degeneretion as assessed by SD-OCTand OCT-A using a split-person study design and deep-learning quantification.

Detailed description: Exudative neovascular macular degeneration is the primarily an age-related retinal condition The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features in order to choose the best therapy .

The study evaluates the changes in structural optical coherence tomography and optical coherence tomography angiography features in neovascular macular degeration patients undergoing ANTI-VEGF treatments using artificial intelligence.

Eligibility criteria: Inclusion Criteria: age older than 50 years

* diagnosis of neovascular macular degeneration
* absence of previous retinal surgery and congenital eye diseases.
* absence of errors of refraction
* absence of lens opacities
* absence of low-quality OCT and OCTA images

Exclusion Criteria:• age younger than 50 years

* previous retinal surgery and congenital eye diseases
* errors of refraction
* lens opacities
* low-quality OCT and OCTA images

Primary outcomes:
measure: The measurements of retinal and choriocapillary vessel density in patients with macular degeneration complicated by nvc
timeFrame: more than sixmonths
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University
Study officials:
affiliation: Federico II University
name: Ciro Costagliola, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04357418: Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives
Official title: Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives (ICOS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety State
COVID-19
Isolation, Social
Health Personnel Attitude
Keywords: anxiety
depression
anger
quarantine
health care workers
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is about hospital staff and close relatives

Brief summary: The purpose of the investigators is to study the psychological impact of the COVID-19 lockdown on the members of the Ville Evrard Hospital staff and their close relatives, and to identify potential lockdown conditions that could increase anxiety, anger and depressive symptoms in this population.


Eligibility criteria: Inclusion Criteria:

* For hospital staff: Adult members of the Ville Evrard Hospital staff (trainees or employees) willing to participate to at least one survey during the COVID lockdown.
* For close relatives: Adult relatives of the Ville Evrard Hospital staff members, living or not with them.

Exclusion Criteria:

* NONE

Primary outcomes:
measure: State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)
timeFrame: Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
measure: State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)
timeFrame: Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
Secondary outcomes:
measure: Visual numeric scales assessing anger and stress the ongoing week.
timeFrame: Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
measure: Visual numeric scales assessing anger and stress the ongoing week.
timeFrame: Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
measure: Beck Depression Inventory
timeFrame: Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
measure: Beck Depression Inventory
timeFrame: Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
Other outcomes:
Locations:
city: Neuilly-sur-Marne
country: France
facility: URC Ville Evrard
Study officials:
affiliation: CH Ville Evrard
name: Clemence ISAAC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Ville Evrard
name: Dominique JANUEL, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01748318: New Mexico Honey Wound Treatment Research Study
Official title: New Mexico Honey Wound Treatment Research Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Community-acquired Methicillin-resistant Staphylococcus Aureus Infection
Keywords: Community acquired MRSA
New Mexico Honey
Lead sponsor: Rankin, R. Stephen, M.D.
Sponsor class: INDIV
First posted: 2012-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a time of emerging bacteria that are resistant to antibiotics, honey offers an alternative that has potential to reduce the heavy reliance on pharmaceutical antibiotics. We will be evaluating the effectiveness of a locally produced New Mexico Honey against the standard of care Bactrim antibiotic on Community Acquired MRSA.

Detailed description: Locally grown New Mexico Honey will be utilized on abscess wounds of the trunk and extremities vs routine (Bactrim) antibiotic care to determine if NM Honey is effective treatment for Community Acquired MRSA 6 cm abscesses.

Eligibility criteria: Inclusion Criteria:

* Patients 16 years of age or older
* Abscess less than or equal to 6 cm in diameter on the extremity or trunk requiring incision and drainage
* Patient willing to try honey prepared dressing
* Patient able to return to office each day for 7 days for evaluation

Exclusion Criteria:

* Under the age of 16
* Abscess of face, scalp or genitals
* Diagnosed as a diabetic
* Allergic to bee pollen, honey or sulfa antibiotics
* Diagnosed with peripheral vascular disease
* Patient acknowledgement of current drug or alcohol abuse

Primary outcomes:
measure: Size of lesion at day 7
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Pinon Family Practice
state: New Mexico
Study officials:
name: R Stephen Rankin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03832218: Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies
Official title: Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitochondrial Diseases
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-02-06
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The major steps forward of the neurosciences in recent years have linked psychiatric diseases, neuropsychological symptoms and brain dysfunctions. The cerebral functioning requiring a big quantity of energy, mitochondria, essential organelles in the cellular energy processes, are at present considered as a way of research for big interest in neurology and in psychiatry. Thus, an increasing number of studies describe potential links between mitochondrial dysfunction and psychiatric symptomatology. The clinical symptomatology of children with mitochondrial cytopathy is varied. Well described neurologically and somatically, it is significantly less in its psychiatric aspects. However, psychiatric symptoms are frequently associated and this symptom has already been described in adult patients. The symptoms mainly include depressive and anxiety disorders, or even tables suggestive of psychotic disorders, which would precede the diagnosis of mitochondrial disease of 13 years on average.

Neuropsychological disorders refer to disorders of the higher functions following a cerebral anomaly (language, praxis, motricity, gnosis, visual spatial processing, memory, attention, intelligence, executive functions ...). Tests validated in French and adapted to children and adolescents can identify neuropsychological disorders in these populations.


Eligibility criteria: Inclusion Criteria:

* Child with mitochondrial cytopathy (defined by the presence of a mutation known to cause mitochondrial cytopathy or mitochondrial respiratory chain abnormality)
* Aged 6 to 17 years
* Beneficiary of a Social Security regime
* Parents sign consent

Exclusion Criteria:

* Child refusal to participate in the study
* Complete inability to complete questionnaires (e.g. non-communicating child)
* Child already included in intervention research modifying care

Primary outcomes:
measure: Prevalence of the psychiatric disorders in a population of children reached of mitochondrial disease
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Dr RIQUIN Elise
Study officials:
References:
Clinical trial NCT01966718: Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.
Official title: Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Joint pain
Repository corticotropin injection
Lead sponsor: Arthritis Treatment Center, Maryland
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 8
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: TREATMENT

Brief summary: It is hypothesized that repository corticotropin injection in combination with other biologic agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of rheumatoid arthritis for patients with disease that had inadequately responded to biologics previously.

Detailed description: Although there are many types of treatment for rheumatoid arthritis (RA) currently available, some patients have disease that is refractory to treatment and cannot achieve remission. The objective of this study is to assess the efficacy and safety of subcutaneous injections of repository corticotropin as an adjunct therapy in patients with active RA who have had an inadequate response to at least two biologic agents as well as a third agent they are currently receiving.

Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis of at least 2 years duration
* On at least third biologic with a different mechanism of action for at least 12 weeks
* Active disease as defined by at least 6 tender and 6 swollen joints
* Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at least 1.2 times the upper limit of normal
* Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for at least 4 weeks

Exclusion Criteria:

* Prior treatment with Acthar Gel
* History of intolerance or allergy to glucocorticoids
* Unstable diabetes
* Active infection

Primary outcomes:
measure: Change From Baseline in the Ritchey-Camp Articular Index
timeFrame: From baseline to week 16
measure: Change From Baseline in the 20-item Health Assessment Questionnaire Score
timeFrame: From baseline to week 16
Secondary outcomes:
measure: Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)
timeFrame: From baseline to week 16
measure: Change From Baseline in the C-Reactive Protein (CRP) Level
timeFrame: From baseline to week 16
Other outcomes:
Locations:
city: Frederick
country: United States
facility: Arthritis Treatment Center
state: Maryland
Study officials:
affiliation: Nathan Wei, MD dba Arthritis Treatment Center, Frederick, MD 21702 USA
name: Nathan Wei, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05388318: Weight Reduction and Cognitive Health: Pilot Study Testing a Prolonged Testing Prolonged Fasting Among Obese, Stressed Mid-life Adults
Official title: Weight Reduction and Cognitive Health: A Remote Randomized Controlled Pilot Study Testing a Prolonged Nightly Fasting Intervention Among Obese, Stressed Mid-life Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Midlife Obese Adults With Cognitive Decline
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 49
Sex: ALL
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with 2 groups (intervention and control).
Primary purpose: PREVENTION

Brief summary: Using a randomized controlled trial (RCT) design, we will test feasibility and outcomes following an remotely delivered, nationwide 8-week prolonged nightly fasting (PNF) intervention compared to an health education control (HEC) in 50 obese, stressed mid-life adults to explore outcomes related to cognitive function, metabolism and associated lifestyle behaviors.


Eligibility criteria: Inclusion Criteria:

* 40-59 years old
* experiencing memory loss
* BMI 30-45.9
* PSS-4 score ≥5
* access to smartphone, zoom, and wifi
* lives in United States

Exclusion Criteria:

* diabetes
* pregnant,
* neurological disorder
* eating disorder within last 20 years
* In current weight loss program
* previously had bariatric surgery
* works a night shit
* health condition not conducive to nightly fasting

Primary outcomes:
measure: Telephone Montreal Cognitive Assessment
timeFrame: 8 weeks
measure: Every Day Cognition-12
timeFrame: 8 weeks
Secondary outcomes:
measure: Perceived Stress Scale- 10
timeFrame: 8 weeks
measure: Rapid Eating Assessment for Participants
timeFrame: 8 weeks
measure: Creature of Habit Scale
timeFrame: 8 weeks
measure: Three-Factor Eating Questionnaire-Revised
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References: