louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00554138: The Effect of Rosuvastatin on Adenosine Metabolism
Official title: Rosuvastatin Augments Dipyridamole Induced Vasodilation by Increased Adenosine Receptor Stimulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenosine Metabolism
Keywords: rosuvastatin
dipyridamole
caffeine
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to show whether rosuvastatin influences adenosine metabolism. Therefore we will determine whether rosuvasatin increases dipyridamole-induced vasodilation by increased adenosine receptor stimulation.


Eligibility criteria: Inclusion Criteria:

* age 18 - 50 years
* Signed informed consent

Exclusion Criteria:

* hypertension
* hypercholesterolemia
* diabetes Mellitus
* alanine aminotransferase \> 90 U/L
* creatinine Kinase \> 440 U/L
* cardiovascular disease
* GFR \< 80 ml/min

Primary outcomes:
measure: forearm vasodilatory response to dipyridamole
timeFrame: 7 days
Secondary outcomes:
measure: lipid profile
timeFrame: 7-10 days
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Centre Dep. Pharmacology-Toxicology
name: Gerard Rongen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Meijer P, Oyen WJ, Dekker D, van den Broek PH, Wouters CW, Boerman OC, Scheffer GJ, Smits P, Rongen GA. Rosuvastatin increases extracellular adenosine formation in humans in vivo: a new perspective on cardiovascular protection. Arterioscler Thromb Vasc Biol. 2009 Jun;29(6):963-8. doi: 10.1161/ATVBAHA.108.179622. Epub 2009 Apr 9.
Clinical trial NCT02293538: Formula Identification (FID) 114657 in Contact Lens Wearers
Official title: Evaluation of a Lubricant Eye Drop on Tear Lipid Layer Thickness in Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: Symptoms of Contact Lens Related Discomfort
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-11-18
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.


Eligibility criteria: Inclusion Criteria:

* Must sign the informed consent form.
* Stable, tear lipid layer thickness ≤ 75 nm without contact lenses.
* Successfully wearing bi-weekly or monthly replacement soft contact lenses in both eyes for a minimum of 5 days/week during the past 2 months prior to Visit 1.
* Vision correctable to 20/25 Snellen (feet) or better at distance with habitual contact lenses at Visit 1.
* Willing to wear lenses 5 days a week, 8 hours a day for at least 2 days during the study.
* Demonstrate symptoms of contact lens discomfort.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Routinely sleeping in lenses.
* Any active eye inflammation or condition that contraindicates contact lens wear.
* Any systemic diseases that could prevent successful contact lens wear.
* Use of systemic or ocular medications that contraindicate lens wear.
* Fit with only 1 contact lens.
* Unwilling to discontinue the use of cosmetics (such as eyeliner, mascara, or eye shadow) or facial creams on or around the eyelids on Day 1 and Day 14 of the study.
* Women of childbearing potential who are currently pregnant, test positive for pregnancy at Screening visit, breast feeding, or unwilling to use adequate birth control throughout the study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1
timeFrame: Day 1, after 2 hours of lens wear
Secondary outcomes:
measure: Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14
timeFrame: Baseline (Day 0), Day 14
measure: Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses
timeFrame: Baseline (Day 0), Day 14
measure: Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14
timeFrame: Baseline (Day 0), Day 14
measure: Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14
timeFrame: Day 14, after 2 hours of lens wear
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, Pharmaceuticals, Global Medical Affairs
role: STUDY_DIRECTOR
References:
Clinical trial NCT03419338: Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone
Official title: Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone: a Clinical, Histologic and Histomorphometric Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus
Keywords: Maxillary Sinus
Sinus lifting
Bone graft
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. For that, it will be compared the tomographic bone gain 6 months after surgery between a group that received inorganic bovine bone alone (n=8) and a group that received inorganic bovine bone associated with NFB (n=8).

Detailed description: The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. It will be recruited for this study individuals 25-60 years of age, both genders, presenting a missing tooth at an upper premolar or molar region with 2-9 mm of remaining bone between alveolar ridge crest and sinus floor and the existence of an edentulous ridge or at least one tooth condemned to extraction. Sinus will be treated by NFB mixed to inorganic bovine bone - IBB (test; n= 8) or IBB (control; n= 8). The volume of bone tissue will be evaluated by computerized tomography obtained at baseline examination and 6 months after surgery. After this period, biopsies of hard tissue will be obtained during implant placement for histologic and histomorphometric analysis.

Eligibility criteria: Inclusion Criteria:

• Presenting a distance between alveolar crest and maxillary sinus of 2 to 9 millimeters.

Exclusion Criteria:

* History of periodontal surgery at the area on the last 12 months
* Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based, contraceptives, steroids)
* Pregnant
* Smokers
* Diabetics
* History of head and neck radiotherapy

Primary outcomes:
measure: Bone height measured in millimeters using the panoramic radiography reconstructions
timeFrame: Six months
Secondary outcomes:
measure: Descriptive histologic analysis of biopsy samples performed by two trained and previously calibrated examiners
timeFrame: Six months
measure: Quantitative histologic analysis of biopsy samples using Leahy et al. (2013) score
timeFrame: Six months
measure: Histomorfometric analysis of biopsy samples using percentage of different tissues evaluated at ImageJ
timeFrame: Six months
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry - University of Sao Paulo
state: SP
Study officials:
affiliation: Bauru School of Dentistry - University of Sao Paulo
name: Adriana CP Sant'Ana, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03501238: Interaction of Salivary Proteins and Polyphenols
Official title: Interaction and Modulation of Salivary Proteins With Repeat Exposure to Polyphenols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Diet Modification
Taste, Altered
Saliva Altered
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Participants will be chosen through an initial sensory test to find high and low-perceivers of astringency. Selected participants will drink a chocolate milk or milk substitute beverage for one week each with washout weeks in between. At the end of each week participants will taste and rate multiple beverages for their astringency and other sensory properties. Participants will provide saliva samples weekly for proteomic analysis and (potentially) analysis of polyphenols. Participants will also be asked to provide a 24 hour dietary recall once per week. Data will be analyzed to determine if there is a relationship between polyphenol exposure, astringency ratings, and salivary protein composition.


Eligibility criteria: Inclusion Criteria:

* High or low perceivers of astringency (from initial screening)

Exclusion Criteria:

* Current smokers (within 30 days), dairy/nut/cocoa allergies, piercings in mouth, mid-range perceiver of astringency, issues with taste, smell, swallowing or choking.

Primary outcomes:
measure: Relative salivary proteins in saliva
timeFrame: 1 year
Secondary outcomes:
measure: Subject Diets
timeFrame: 8 months
measure: Chocolate milk flavor ratings
timeFrame: 8 months
measure: Chocolate milk substitute flavor ratings
timeFrame: 8 months
measure: Chocolate milk substitute with gelatin flavor ratings
timeFrame: 8 months
measure: Polyphenol content in saliva samples
timeFrame: 8 months
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
Clinical trial NCT00004838: Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lead Poisoning
Keywords: environmental/toxic disorders
lead poisoning
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Nationwide Children's Hospital
First posted: 2000-02-25
Enrollment: 175
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.

Detailed description: PROTOCOL OUTLINE: This is randomized study. Patients are randomized to receive succimer in addition to standard treatment (arm I) or standard treatment only (arm II).

Succimer is administered orally 3 times a day for 7 days, then twice daily for 19 days. Patients may receive up to 3 courses.

Standard treatment consists of a medical history and physical examination, environmental assessment with modification to reduce lead exposure, dietary modifications to decrease lead absorption, the use of a daily multivitamin and mineral supplement with iron, developmental screening and intervention, and frequent follow up of lead levels.

If blood lead level rises above 45 mcg/dL, patient receives succimer regardless of treatment arm originally assigned.

Patients are followed every 3-4 weeks for 2 months, then every 3 months for 6 months, and then every 6 months thereafter.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Asymptomatic children with confirmed venous blood lead of at least 20 mcg/dL and less than 45 mcg/dL Children with blood lead of 45 mcg/dL or greater are not randomized in this study since they probably will receive succimer regardless of being enrolled in this study --Patient Characteristics-- Other: No contraindications to the use of succimer (i.e., allergy or a lack of lead safe environment in which to live during chelation)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Children's Hospital
name: Marcel J. Casavant
role: STUDY_CHAIR
References:
citation: The Treatment of Lead-exposed Children (TLC) trial: design and recruitment for a study of the effect of oral chelation on growth and development in toddlers. Paediatr Perinat Epidemiol. 1998 Jul;12(3):313-33. doi: 10.1046/j.1365-3016.1998.00122.x.
Clinical trial NCT02168738: Investigation of Docosahexaenoic Acid (DHA) Metabolic Pathway in Human by Using 13C Labeled Molecules
Official title: Bioavailability of DHA-TG (Docosahexaenoic Triglyceride), DHA-PC (Docosahexaenoic Phosphatidylcholine) and AcedoPC (1-acetyl-2-docosahexaenoic-glycerophosphocholine) in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Keywords: nutrition
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 4
Sex: MALE
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare three lipidic forms of DHA in their metabolic pathway in human by using 13C labeled molecules.

The circulating form of DHA plays a major role in his cerebral incorporation. The aim of this research is to confirm that some lipidic forms are best carriers for the cerebral incorporation in studying 13C-DHA distribution in plasma lipids and blood cells.


Eligibility criteria: Inclusion Criteria:

* Healthy male
* Aged of 60 to 70 years
* Body Mass Index of 20 to 30 kg/m2
* Glycaemic and lipid parameters normal

Exclusion Criteria:

* Smokers more than ten cigarettes/day
* Medical history of personal or family dyslipidemia
* Medication that could interfere with lipid metabolism

Primary outcomes:
measure: Concentration of 13C-DHA in red blood cells
timeFrame: At Day 1
Secondary outcomes:
measure: Concentration of 13C-DHA in plasma lipids
timeFrame: At Day 1
measure: Concentration of 13C-DHA in platelets
timeFrame: At Day 1
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes, 165 chemin du Grand Revoyet,
Study officials:
References:
Clinical trial NCT05235308: Predictive Factors on the Results of Epidural Adhesiolysis in Patient With Chronic Spinal Pain
Official title: Predictive Factors on the Results of Percutaneous Epidural Adhesiolysis in Patient With Chronic Spinal Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Chronic
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 193
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 presenting with low back or leg pain who have not had positive responsive to the conservative treatments or procedures, such as epidural steroid injections.

Brief summary: The primary aim of this exploratory study was to determine the demographic, clinical, and technical factors associated with treatment outcome, to create a better select treatment candidates.


Eligibility criteria: Inclusion Criteria:

* patients in whom percutaneous epidural lysis of adhesions was performed

Exclusion Criteria:

* nonadhesiolytic procedure
* lack of follow-up
* incomplete outcome data

Primary outcomes:
measure: pain intensity
timeFrame: baseline to 12 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training and Research Hospital
Study officials:
References:
Clinical trial NCT02970708: Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia
Official title: Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia in Chinese Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amblyopia, Anisometropic
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 176
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating anisometropic amblyopia.

Detailed description: A total of 176 children with anisometropic amblyopia, aged 4 to 13 years, will randomize to receive patching or Eyetronix Flicker Glasses treatment in a 1:1 ratio.Eyetronix Flicker Glasses, a lightweight spectacle frame with liquid crystal lenses that provide direct square-wave alternating occlusion, will be used at a pre-programmed temporal frequency. Patching is a traditional treatment of amblyopia. The best corrected visual acuity, contrast sensitivity, binocular function,visual evoked potential and functional MRI will be measured at baseline and follow-up visits to assess the improvement of amblyopia.Feedback information from the questionnaires will be used to evaluate the compliance and adverse effects.

Eligibility criteria: Inclusion Criteria:

1. aged from 4 to 13 years old
2. the best corrected visual acuity in the amblyopic eye is no more than 0.1logMAR, with two lines or more of difference between the two eyes
3. anisometropia is defined as an inter-ocular spherical refractive error difference of 1.00 D or more or a cylindrical difference of 1.50 D or more.
4. no amblyopia treatment one month prior to the study except refractive correction.
5. myopia is less than -6.00D or hyperopia is less than +9.00D, strabismus was less than 20 prism diopters
6. willing to participate in this study and be able to follow up on time

Exclusion Criteria:

1. ocular disease and other disease that have an influence on the visual acuity
2. history of ocular surgery that have an influence on the visual acuity
3. the patient is receiving other amblyopia treatment except refractive correction
4. a family or personal history of seizures
5. the patient is using some medicine that may have an influence on visual acuity

Primary outcomes:
measure: best corrected visual acuity
timeFrame: 6 months
Secondary outcomes:
measure: stereocuity
timeFrame: 6 months
measure: contrast sensitivity function
timeFrame: 6 months
measure: visual evoked potential
timeFrame: 6 months
measure: functional MRI
timeFrame: 6 months
measure: best corrected visual acuity
timeFrame: a year and a half
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02533908: Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children
Official title: Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children: A Prospective, Randomized, Double-blind, Placebo-controlled, Monocentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inhalation of Nitrous Oxide
Opioid Analgesic Adverse Reaction
Pain
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 402
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for analgosedation for short and painful procedures in children.

Detailed description: Nitrous oxide 70% (N20 70%) combined with 30% oxygen meets many criteria of an ideal pain medication for procedural analgosedation in children. At the emergency department of the Children's Hospital of Zurich, Switzerland, N20 70% is regularly used for short and painful orthopaedic procedures, mostly for reduction of dislocated forearm or finger fractures. The analgesic efficacy of N20 70% still remains controversial. Therefore, all children who are eligible for N20 70% receive additionally either fentanyl or placebo intranasal and then their behavior, level of sedation and adverse events are measured during the painful procedure. The hypothesis is that a combination of N20 70% and fentanyl intranasal is not significant better than N20 70% combined with basic analgetics.

Eligibility criteria: Inclusion Criteria:

* indication for nitrous oxide 70% application
* boys/girls aged 2-16 years
* informed consent

Exclusion Criteria:

* due to language barrier no sufficient communication possible to explain the study
* incompatibility to Fentanyl Sintetica
* incompatibility to morphinomimetics

Primary outcomes:
measure: Analgesic efficacy of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal using the FLACC score
timeFrame: up to 18 months
Secondary outcomes:
measure: adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Children's Hospital
Study officials:
affiliation: University Children's Hospital of Zurich
name: Michelle Seiler
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seiler M, Staubli G, Landolt MA. Combined nitrous oxide 70% with intranasal fentanyl for procedural analgosedation in children: a prospective, randomised, double-blind, placebo-controlled trial. Emerg Med J. 2019 Mar;36(3):142-147. doi: 10.1136/emermed-2018-207892. Epub 2019 Jan 10.
Clinical trial NCT01080508: Spirometry in Esophageal Intubation
Official title: Analysis of the Spirometry Pattern in Esophageal Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Intubation
Keywords: pressure pattern
esophageal and tracheal ventilation.
esophageal intubation.
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2010-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA I \& II patients

Brief summary: The primary objective of the study is to describe the pressure patterns during esophageal and tracheal ventilation and to validate the diagnostic algorithm.


Eligibility criteria: Inclusion Criteria:

* Patients, requiring total anesthesia for a surgical procedure where the use of the easytube could be indicated.

Exclusion Criteria:

* ASA III
* Expected difficulty for oral intubation.
* Expected operation time \>3 hours

Primary outcomes:
measure: Determination of the sensitivity and specificity of the algorithm to detect esophageal intubation.
timeFrame: during intubation
Secondary outcomes:
measure: Pressure pattern of ventilation in esophageal and tracheal ventilation.
timeFrame: during intubation
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen, University of Groningen, the Netherlands
Study officials:
affiliation: University Medical Center Groningen
name: Alain F kalmar, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalmar AF, Absalom A, Monsieurs KG. A novel method to detect accidental oesophageal intubation based on ventilation pressure waveforms. Resuscitation. 2012 Feb;83(2):177-82. doi: 10.1016/j.resuscitation.2011.10.009. Epub 2011 Oct 30.