louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05536856: Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo
Official title: Development and Clinical Evaluation of Topical 5-Fluorouracil Effervescent Powder Formulation in the Treatment of Vitiligo
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Vitiligo
Topical Fluorouracil
Effervescent Mixture
Keywords: Vitiligo
Fluorouracil
Effervescent powder
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A novel approach for 5-Fluorouracil delivery based on a solid effervescent formulation is proposed . 5-Fluorouracil is water soluble (\~50mg/ml) and therefore has been used for the development of novel topical formulations including nano and microparticles intended for skin targeting. After hydration 5-Fluorouracil could form a complex, a suspension or even be formulated to generate effervescence. In effervescent technology, gas bubbles occur from the liquid after chemical reaction between alkali salts and organic acids (mainly citric or tartaric. Due to liberation in CO2 gas, the dissolution of drug in water is enhanced. The aim of this study is the development and clinical evaluation of topical 5-florouracil effervescent powder formulation in the treatment of vitiligo.


Eligibility criteria: Inclusion Criteria:

* Patients who will be diagnosed as localized stable vitiligo.
* Age older than 10 years
* Stability of lesions for a duration of at least 1 year.
* Patients who didn't receive treatment for vitiligo in the previous 6 weeks before starting the study.
* Patients who agreed to join the study and signed written consent and continued till the end of the follow up period

Exclusion Criteria:

* Patients with vitiligo patches on mucous membrane,
* Patients with Koebner phenomenon,
* Other uncontrolled systemic illnesses
* Patients receiving any systemic or topical treatment for vitiligo

Primary outcomes:
measure: Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Facualty of Pharmacy, Al Azhar University
Study officials:
References:
Clinical trial NCT03354156: The Effect of Statin Treatment on Trained Innate Immunity
Official title: Effect of Statins on Epigenetic Reprogramming of Monocytes in Patients With Elevated Levels of LDL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: AIDS Malignancy Consortium
name: Erasmus Medical Center
First posted: 2017-11-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the outpatient clinics of the Radboudumc, AMC, or Erasmus MC, with LDL cholesterol levels \>4.9 mmol/l, who will treated with statins according to current guidelines, will be will be selected.

Brief summary: The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming, in particular trimethylation of lysine 4 at histone 3 (H3K4me3).

In this study, the investigators aim to investigate the immunophenotype of circulating monocytes in patients with elevated LDL cholesterol levels and the effect of statins on this phenotype.

Detailed description: The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming, in particular trimethylation of lysine 4 at histone 3 (H3K4me3).

The main objective is to study whether circulating monocytes of patients with elevated levels of LDL have a phenotype of trained innate immunity compared to control patients. Subsequently the investigators will study the effect of treatment with statins on the increased inflammatory response and epigenetic changes of the innate immune system.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Elevated LDL levels (\>4.9 mmol/l)
* Decision made by treating physician to initiate statin treatment

Exclusion Criteria:

* previous cardiovascular events.

Primary outcomes:
measure: Cytokine production capacity
timeFrame: baseline
Secondary outcomes:
measure: Cytokine production capacity
timeFrame: Three months after start of statin treatment
measure: Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.
timeFrame: baseline
measure: Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.
timeFrame: Three months after start of statin treatment
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
Study officials:
References:
Clinical trial NCT06416956: Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants
Official title: Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infant,Premature
Caffeine
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 30
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will be inpatients on the Newborn Care Unit and born prematurely (before 37 weeks gestation)

Brief summary: This study investigates how brain activity and breathing changes in premature babies when their dose of caffeine treatment is changed or stopped. The study will assess premature babies receiving caffeine treatment as part of their clinical care. Brain activity will be recorded just before caffeine dose is changed and again two days afterwards. Breathing and other 'vital signs' (breathing rate, heart rate, oxygen saturation) will be recorded from the baby's monitor between the recordings of brain activity and for up to two weeks afterwards.


Eligibility criteria: Inclusion Criteria:

* Born to a mother aged 16 or over
* Admitted to the Newborn Care Unit, John Radcliffe Hospital
* Born prematurely (before 37 weeks' gestation)
* Parent given informed written consent
* Receiving caffeine citrate

Exclusion Criteria:

* Known chromosomal abnormality or life-threatening congenital abnormality
* Severe hypoxic insult at birth
* Intraventricular haemorrhage grade III or IV or other severe neurological pathology

Primary outcomes:
measure: Respiration
timeFrame: From baseline to two days later
measure: Brain activity
timeFrame: From baseline to two days later
Secondary outcomes:
measure: Heart rate
timeFrame: From baseline to two days later
measure: Oxygen saturation
timeFrame: From baseline to two days later
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Newborn Care Unit, John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Caroline Hartley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01734356: Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells
Official title: Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inherited Arrhythmias and Valvulopathies
Keywords: iPS
fibroblast
arrhythmias
valvulopathies
electrophysiology
genetics
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: The recent developments of research on iPS (induced pluripotent stem) cells lead to the establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with genetic and cellular characteristics of the donors. These cells represent a biological material more readily available to identify the pathophysiological mechanisms involved in the diseases of BrS or ERS patients, which will lead to the identification of genetic markers.


Eligibility criteria: Inclusion criteria:

* Patient with a family history of inherited arrhythmia or valvulopathy
* Age : 22-60 yo.
* patient no confine to bed
* Male or female
* Written consent
* Patient affiliated to the French social security

Exclusion criteria:

* Pregnant woman
* Patient under 22 yo or adults under guardianship
* Indication against local anesthesia
* Anticoagulant treatment
* Absence or positivity of HIV, HBV, HCV serology

Primary outcomes:
measure: Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient
Secondary outcomes:
measure: Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes UH
name: Vincent PROBST
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02240056: Brain fMRT In Takotsubo Cardiomyopathy
Official title: Pilot Study: Central Nervous System and Hormonal Changes In Takotsubo Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Takotsubo Cardiomyopathy
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 55
Sex: FEMALE
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women with TTC or NSTEMI / STEMI aged below 90 years

Brief summary: Certain cardiac and neurologic diseases influence each other via a still poorly understood "brain-heart axis". Subarachnoidal bleedings are well known to cause ECG alterations resembling those of myocardial infarction, along with a reduction of systolic myocardial function ("neurogenic stunned myocardium"). Alterations of the right insula region by a stroke or intracranial hemorrhage go along with a sympathetic activation (increased circulating catecholamine levels, tachycardia, arterial hypertension). In contrast, alterations of the left insula region often cause vagal reactions such as bradycardia, arterial hypotension. Takotsubo cardiomyopathy (TTC) is a just recently recognised subform of heart attacks, often caused by psychological or physical stress (death of a beloved one, divorce, job loss, infection, preoperative state). In more than 90% of cases, TTC affects postmenopausal women.

Functional MRT enables imaging of activated brain regions, either without ("resting state") or with specific stimuli. The investigators speculate that there is a specific involvement of the insula region during TTC.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal females aged below 90 years
* Informed written consent
* TTC or NSTEMI / STEMI undergoing coronary angiography within 24 hours of symptom onset

Exclusion Criteria:

* Delayed coronary angiography (\> 24 hours after symptom onset)
* Inability to perform rsfMRT within the first 72 hours after coronary angiography
* Inability to communicate in German language
* Contraindications for a MRT examination (including pacemaker, implantable cardioverter-defibrillator, mechanical heart valves, claustrophobia, severe adipositas)
* Drug addiction, under guardianship
* Inability to stick to the follow up examination

Primary outcomes:
measure: Changes in brain functional MRT (resting state, paradigma) in postmenopausal females suffering from TTC as compared to NSTEMI / STEMI postmenopausal female patients
timeFrame: Within the first 72h after diagnosis and after 4-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tirol
Study officials:
affiliation: Medical University Innsbruck
name: Wolfgang Dichtl, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03381456: Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia
Official title: Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dystonia, Primary
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 patient with dystonia and 10 healthy subject paired by sex and age.
Primary purpose: TREATMENT

Brief summary: Cortical excitability depends on inhibitory mechanisms efficiency among which long latency intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic stimulation (TMS). Some recent evidences suggest that LICI may be one of the mechanisms by which the motor comment is adapted to the ongoing motor task with LICI strength being dependent on task complexity. In writer cramp and musician cramp, two forms of dystonia, the cortical excitability is not correctly modulated in some complex gestures. the hypothesis is that this task dependent perturbation of excitability in writer cramp could be due to a lack of LICI efficiency.


Eligibility criteria: Inclusion Criteria:

* Patient with hand dystonia : writers cramp
* Subject affiliated to social security regimen.

For healthy volunteers :

* Healthy volunteer without neurological disorders based on sensorimotor examination.
* Subject affiliated to social security regimen.

Exclusion Criteria :

* Subject unable to receive informed consent (dementia).
* Contraindication to Transcranial Magnetic Stimulation(TMS) (epilepsia, intracranial metalic foreign object, hearing device, cochlear implant).
* Patient using a psychotrope treatment.
* Patient under guardianship or curatorship.
* Pregnant or nursing women.
* Patient with a cardiac stimulator.

For healthy volunteers only :

• Abnormal neurological evaluation based on sensorimotor examination or neurological history ( epilepsy, stroke ; brain or spinal cord surgery ; history of neurological disease affective sensitive and motor control)

Primary outcomes:
measure: long-interval intracortical inhibition (LICI) level
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Philippe Derambure, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01859156: End-Tidal Carbon Dioxide as a Measure of Carboxyhemoglobin in Carbon Monoxide Poisoning
Official title: End-Tidal Carbon Dioxide as a Measure of Carboxyhemoglobin in Carbon Monoxide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carbon Monoxide Exposure
Keywords: Carbon Monoxide
Carboxyhemoglobin
End-tidal carbon dioxide
Capnography
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency department at an urban county hospital.

Brief summary: The purpose of this study is to determine whether a relationship exists between EtCO2 and carboxyhemoglobin levels in carbon monoxide exposure. Our hypothesis is that a liner relationship exists between EtCO2 and carboxyhemoglobin in carbon monoxide poisoning.


Eligibility criteria: Inclusion Criteria:

* Carbon monoxide exposure

Exclusion Criteria:

* Less than 18 years old
* Suicide attempt
* Unable to provide informed consent
* Pregnant

Primary outcomes:
measure: EtCO2
timeFrame: Immediately upon study enrollment, an average time of 30 minutes post arrival to the hospital.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: James R Miner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01263756: Autism Spectrum Disorders (ASD) Driving Study
Official title: A Study of the Driving Performance of Individuals With Autism Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: Driving
Autism Spectrum Disorders
ASD
Attention Deficits
Adults
Adolescents
Pervasive Developmental Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
First posted: 2010-12-21
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and adults, ages 16-50, with Autism Spectrum Disorders.

Brief summary: The proposed pilot study will begin to assess whether driving impairments are included in the functional deficits associated with Autism Spectrum Disorders (ASDs). This will be completed by obtaining data on velocity, collision risk, and visual attention of subjects with ASDs who drive in a simulator. The study includes 2-3 visits for the screening period (approximately 6 hours of assessments) and one driving simulation visit (approximately 2.5 hours). The investigators expect to enroll 20 adolescents and adults (ages 16-50, inclusive) who have been identified as having an ASD from a prior diagnosis or participation in community conferences for individuals with ASDs.


Eligibility criteria: Inclusion Criteria:

* Male and female patients, aged 16-50 years
* Identification as having ASD from a prior diagnosis or participation in community conferences for individuals with ASD

Exclusion Criteria:

* Major sensorimotor handicaps (e.g. deafness, blindness)
* Inadequate command of the English language
* Individuals who have never held a valid driver's license
* Mental retardation (IQ \< 80)

Primary outcomes:
measure: Simulated driving performance of adolescents and adults with ASDs.
timeFrame: one-time observation (3 hour assessment)
Secondary outcomes:
measure: Questionnaire measures of driving history and behavior of adolescents and adults with ASDs.
timeFrame: one-time assessment (2-6 hour screening visit)
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Biederman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00243256: Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2005-10-21
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate if supplementation with vitamin D in doses of 20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as compared to placebo during 1 year.

Detailed description: We will include 450 obese subjects that will be devided in 3 groups: 40.000IU cholecalciferol per week, 20.000 IU cholecalciferol per week, and placebo. All subjects will be given 500 mg calcium per day. There will be visits every tird month. In addition to weight reduction, we will also evaluate the calcium metabolism (blood test and urin samples), insulin sensitivity, muscle strenght, blood pressure and depression.

Eligibility criteria: Inclusion Criteria:

* BMI 30 - 40
* serum calcium \< 2.55 mmol/L

Exclusion Criteria:

* serious diseases
* reduced kidney function
* renal stone disease
* using psychopharmaca
* using drugs for weight reduction

Primary outcomes:
measure: Body Weight
measure: Body composition
measure: Measures of calcium metabolism
measure: Insulin sensitivity
measure: Muscle strength
measure: Depression score
measure: Blood pressure
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Clinical Research Unit, University Hospital of North Norway
Study officials:
affiliation: University of Tromsø, Tromsø, Norway
name: Rolf Jorde, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jorde R, Sneve M, Torjesen PA, Figenschau Y, Hansen JB, Grimnes G. No significant effect on bone mineral density by high doses of vitamin D3 given to overweight subjects for one year. Nutr J. 2010 Jan 7;9:1. doi: 10.1186/1475-2891-9-1.