louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02725944: Prediction and Detection of Occult Atrial Fibrillation in Patients After Acute Cryptogenic Stroke and TIA
Official title: Prediction and Detection of Occult Atrial Fibrillation in Patients After Acute Cryptogenic Stroke and Transient Ischemic Attack
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Stroke
Atrial Fibrillation
Keywords: Cryptogenic stroke
Occult paroxysmal atrial fibrillation
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 251
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: 250 participants of both sexes included at Akershus University Hospital, Norway, within two weeks after diagnosed with cryptogenic stroke and/or TIA.

Brief summary: PROACTIA is a prospective, event-driven observational study. It aims to propose a composite scoring system in order to evaluate the risk of paroxysmal atrial fibrillation (PAF) in patients after acute cryptogenic stroke and transient ischemic attack (TIA).

Detailed description: It will be enrolled 250 participants of both sexes within two weeks after diagnosed cryptogenic stroke and/or TIA at Akershus University Hospital, Oslo area, Norway.

Evaluation of participants' comorbidity with CHADS2-VASc score, ECG, Holter ECG, echocardiography, detection of biochemical cardiac markers and screening for obstructive sleep apnea syndrome will be performed. All participants will be monitored with a continuous cardiac rhythm during one year by implantation of implantable cardiac rhythm monitors (ICRM). All patients without high bleeding risk will get prescribed oral anticoagulants (OAC) after detection of PAF.

A biobank will be established in order to store the sampled biological material.

Eligibility criteria: Inclusion Criteria:

- Patients diagnosed with cryptogenic stroke and/or TIA, in accordance to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification.

Exclusion Criteria:

* Patients with known or newly detected AF on initial examination including 24 h Holter ECG.
* Patients on oral anticoagulants (OAC) for non-AF indications.
* Patients with strong contraindications for OAC, even if the presence of underlying AF is detected.
* Patients with atrial- or ventricular thrombi, or atheromas of the aortic arch greater than 4 mm, detected by transesophageal echocardiography.
* Patients unable to sign the informed consent or with a life expectancy due to comorbidities of less than two years.

Primary outcomes:
measure: Detection of paroxysmal atrial fibrillation
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Loreta Skrebelyte-Strøm
state: Akershus
Study officials:
References:
citation: Skrebelyte-Strom L, Ronning OM, Dahl FA, Steine K, Kjekshus H. Prediction of occult atrial fibrillation in patients after cryptogenic stroke and transient ischaemic attack: PROACTIA. Europace. 2022 Dec 9;24(12):1881-1888. doi: 10.1093/europace/euac092.
Clinical trial NCT00668044: Ciprofloxacin on Burned Patients
Official title: A Population Pharmacokinetics Study of Plasma Levels of Ciprofloxacin Following a Regimen of Repeated Dose I.V. Administration (400 mg TID) on Burn Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burns
Bacterial Infections
Keywords: Ciprofloxacin regimen in compromised patients
Ciprofloxacin
Burned patients
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a non randomised, multi center, italian study performed in burn patients receiving an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study was to validate a pharmacokinetics model useful to verify if a standard dose regimen of ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead is over or under dosed.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe burnt patients defined as burning of 20 to 60% of total body surface according to rule of nine, II deep degree and III degree according to Full-Thickness Burn model,
* Hospitalization for burning injury since at least 72h during hyper metabolic phase
* Active infections microbiological confirmed
* Signed informed consent

Exclusion Criteria:

* Pregnant or lactating female patients
* Previous history of tendinopathy
* Knowing syndrome of QTc prolongation
* Impairment renal function
* Hepatic insufficiency
* Convulsion
* Limited life expectancy

Primary outcomes:
measure: Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model
timeFrame: >72 h post injury, 48h and 120 h after treatment
Secondary outcomes:
measure: Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio
timeFrame: >72 h post injury, 48h and 120 h after treatment
Other outcomes:
Locations:
city: Cesena
country: Italy
state: Forlì
city: Catania
country: Italy
city: Genova
country: Italy
city: Genova
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Roma
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06895044: Evolution of Ocular Growth in Myopic Children: A Prospective Cohort Study
Official title: Evolution of Ocular Growth in Myopic Children: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myopia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2025-03-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 6 to 17 years at inclusion, diagnosed with myopia (refractive error of -0.5 D or less in spherical equivalent in at least one eye)

Brief summary: Myopia and high myopia are the leading causes of visual impairment and blindness worldwide. The total number of myopic people globally was estimated to be 2.6 billion in 2020, and it could reach 4.8 billion by 2050 unless preventive interventions are implemented.

Strategies to slow the progression of myopia, such as contact lenses, orthokeratology, atropine, and increased time spent outdoors, have shown promising results, although evidence varies depending on the method. However, most research has been conducted in Asia, and there are few studies on ocular growth in myopic children in Europe. Meanwhile, the prevalence of myopia is also increasing significantly in Europe, particularly in France.

Understanding the growth of the myopic eye in European children is crucial. Cohort studies of myopic children are scarce and do not always include high-quality imaging. A cohort of myopic children with prospective collection of the best retinal and corneal images, along with ophthalmological exams to detail and model the growth of the myopic eye, will provide valuable insights to enhance our understanding of ocular growth and its inter-individual variability.


Eligibility criteria: Inclusion Criteria:

* Myopia in at least one eye, defined as a refractive error in spherical equivalent ≤ -0.50 diopters (autorefraction under cycloplegia)
* Affiliated or beneficiary of a social security system
* Explicit consent from a holder of parental authority

Exclusion Criteria:

* Presence of trauma in both eyes
* Presence of inflammatory conditions in both eyes
* History of intraocular surgery (cataract, filtering surgery, intra-vitreal surgery) in both eyes
* Patient benefiting from legal protection measures

Primary outcomes:
measure: axial length
timeFrame: Year 5
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschild
Study officials:
References:
Clinical trial NCT03195244: Aquatic Therapy and Autism Spectrum Disorders
Official title: Aquatic Therapy and Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: aquatic therapy, hydrotherapy
Lead sponsor: Panhandle Eye Group, LLP
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of one-on-one versus group-based aquatic therapy on the social interactions, behaviors and physical activities of children with autism spectrum disorders (ASDs).


Eligibility criteria: Eligibility criteria:

* DSM-V diagnosis of Autism Spectrum Disorder or DSM-IV diagnosis of Asperger's syndrome or high functioning atypical autism or pervasive development disorder - not otherwise specified or else the typical clinical findings and suspicion of an ASD
* Treatment naïve to prior aquatic therapy

Exclusion criteria:

* Not willing to undergo an investigational treatment
* Unable to cooperate well enough to safely participate in aquatic therapy under the protocol guidelines
* Known allergies to pool chemicals
* Other significant co-morbidities which may include (but is not limited to): severe cerebral palsy with low motor function, advanced pulmonary disease, home oxygen requirement, spina bifida with low motor function, permanent feeding tubes, poorly controlled seizure disorder, chronic indwelling urinary catheters or any condition causing severe cognitive impairment

Primary outcomes:
measure: Change in PedsQL Score
timeFrame: Baseline and 10 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Amarillo
country: United States
facility: Turn Center
state: Texas
Study officials:
References:
Clinical trial NCT04616144: Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
Official title: Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hyperopia
High Astigmatism
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Miopic Group Hyperopic Group
Primary purpose: TREATMENT

Brief summary: The refractive combination of high hyperopia with high astigmatism is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition. The method used at the EYE Hospital Pristina using fresh lenticule implantation by ReLex-SMILE is safe and effective method. Fresh Corneal Implantation is a safe treatment for hyperopia with high astigmatism comparing with refractive IOL implantation (loss of accommodation, endophthalmitis). Its primary objective is to increase visual acuity, accommodation process, patient satisfaction which makes patient to enjoy a happier life. We believe this study will be the future of refractive surgery for treating high hyperopia.

Detailed description: This study is to investigate the effect of fresh corneal lenticule implantation as allogenic implant that will be taken from myopic patients to implant in hyperopic patients with high astigmatism using VisuMax Femtosecond laser - Smile module surgery with primary objective to assess (increase) visual acuity (far, intermediate, near vision) and secondary objective to stabilize (decrease) high astigmatism by reducing K-values.

Eligibility criteria: Inclusion Criteria:

* patients with high spherical hyperopia over + 4.5 D
* astigmatism over + 3 cyl.
* corneal thickness minimum 450 µm and maximum 550 µm.

Exclusion Criteria:

* corneal thickness over 550 µm
* history of glaucoma
* retinal detachment
* cataract
* history of ocular inflammation.

Primary outcomes:
measure: Increase of visual acuity, accommodation process
timeFrame: 12 months
Secondary outcomes:
measure: Decrease of high hyperopic astigmatism
timeFrame: 12 months
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
References:
Clinical trial NCT03401944: Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.
Official title: Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wasting;Muscle(S)
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates effects related to muscle protein metabolism at provision of Total Parenteral nutrition.

Detailed description: Randomized study investigating alterations in muscle protein metabolism at provision of parenteral nutrition. The study uses a genomic/transcriptomic/proteomic approach to evaluate factors related to activation of skeletal muscle protein synthesis. Patients scheduled for major gastrointestinal surgery are included. Muscle specimens are collected during surgery.

Eligibility criteria: Inclusion Criteria:

* Major gastrointestinal surgery
* Assumed need of post-operative artificial nutrition.

Exclusion Criteria:

* Insulin dependent diabetes
* Steroid medication

Primary outcomes:
measure: Muscle protein metabolism
timeFrame: Single evaluation point at 12-14 hours following the start of overnight infusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Department of Surgery
Study officials:
affiliation: Department of Surgery, University of Gothenburg
name: Kent Lundholm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00917644: Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet
Official title: An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: Bioqeuivalence, Pharmacokinetics, Atorvastatin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
* Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Secondary outcomes:
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
measure: Plasma Elimination Half-life (t1/2)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02404740: Noninvasive Intracranial Pressure and Hydrocephalus Patients
Official title: Continuous Noninvasive Estimation of Intracranial Pressure to Assess Ventriculoperitoneal Shunt Malfunction in Patients With Hydrocephalus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Keywords: VP shunted
Normal intracranial pathology
patients
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 163
Sex: ALL
Minimum age (years): 31
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VP shunted patient, Normal intracranial pathology patient

Brief summary: Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus are typically treated with a shunt in order to reduce ICP. At times the shunt can malfunction. We believe that our algorithm will help identify when a hydrocephalus patient's shunt has malfunctioned.

Detailed description: A malfunctioning ventriculoperitoneal (VP) shunt will typically cause a rise in intracranial pressure, which can be difficult to identify without costly imaging. Novel, state-of-the art machine learning techniques can be leveraged to develop an algorithm that noninvasively estimates intracranial pressure. The resulting algorithm will accurately determine the presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus.

Eligibility criteria: Inclusion Criteria:

1. Age: 31 days - 35 years
2. Patients seen at Children's Hospital Colorado Neurosurgery clinic, Emergency Department or on an inpatient service
3. Either hydrocephalus patients with a VP shunt in place (with or without suspicion of VP shunt malfunction), or patients with no known intracranial pathology.

Exclusion Criteria:

1. Pregnant patients
2. Incarcerated patients
3. Patients who object at any time to participating in the study.

Primary outcomes:
measure: The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Childrens Hospital Colorado
name: Steve Moulton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02130440: Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic Rhinitis
Official title: Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: nasal obstruction
sneezing
itching
rhinorrhea
respiratory infections
wheezing
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe.

Detailed description: The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe. The primary objective is to assess whether the treatment with nasal spray based resveratrol is able to improve the allergic rhinitis symptoms during the two months of treatment. The secondary aim is to evaluate if the resveratrol nasal spray is able to reduce respiratory infections and wheezing episodes.

Eligibility criteria: Inclusion Criteria:

* Children of both sexes, ranging in age from 4 to 17 years
* History of seasonal allergic rhinitis, mild, moderate or severe, defined according to the ARIA guidelines in 2010, documented by recurrent episodes in the previous year and confirmed by a positive skin test results
* Written informed consent from at least one parent or a legal representative

Exclusion Criteria:

* Lack of informed consent in writing by at least one parent or a legal representative
* Concomitant disorders, such as infection of the upper (sinusitis, etc..) or lower respiratory tract, nasal surgery in the last year, abnormalities of the respiratory tract, immune diseases
* Use of antihistamines, nasal or systemic corticosteroids, leukotriene modifiers, cromolyn sodium, in the last six weeks

Primary outcomes:
measure: Nasal symptom severity
timeFrame: two years
Secondary outcomes:
measure: Cough
timeFrame: two years
measure: Wheezing
timeFrame: two year
measure: Albuterol use
timeFrame: two years
measure: Fever
timeFrame: two years
measure: School absences
timeFrame: two years
measure: Antihistamines use
timeFrame: two years
measure: Emergency visits
timeFrame: two years
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Second University of Naples
Study officials:
References:
citation: Miraglia Del Giudice M, Maiello N, Capristo C, Alterio E, Capasso M, Perrone L, Ciprandi G. Resveratrol plus carboxymethyl-beta-glucan reduces nasal symptoms in children with pollen-induced allergic rhinitis. Curr Med Res Opin. 2014 Oct;30(10):1931-5. doi: 10.1185/03007995.2014.938731. Epub 2014 Jul 7.