louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04442477: Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
Official title: Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Ability, General
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2020-06-22
Enrollment: 116
Sex: ALL
Minimum age (years): 64
Maximum age (years): 68
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who previously consumed study formula through one year of age in MJN Project 6027.

Brief summary: This is a follow-up study of a multi-center, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5 years of age and health outcomes through 5.5 years of age in participants who received one of two staged study formulas through one year of age.


Eligibility criteria: Inclusion Criteria:

* Participant who previously consumed study formula through one year of age in MJN Project 6027
* 5.5 years of age (i.e. when child turns 5 years and 6 months old ± 2 months) at Visit 1
* Signed informed consent obtained for child's participation in the study

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)
timeFrame: At 5.5 years of age
Secondary outcomes:
measure: Dimensional Change Card Sort (DCCS)
timeFrame: At 5.5 years of age
measure: Stroop Task
timeFrame: At 5.5 years of age
measure: Functional Near Infrared Spectroscopy (fNIRS)
timeFrame: At 5.5 years of age
measure: Child Behavior Checklist (CBCL)
timeFrame: At 5.5 years of age
measure: Body weight
timeFrame: At 5.5 years of age
measure: Body height
timeFrame: At 5.5 year of age
measure: Health history outcomes
timeFrame: At 5.5 years of age
Other outcomes:
Locations:
city: Anhui
country: China
facility: Fuyang Fifth People's Hospital
Study officials:
affiliation: Shanghai Children's Medical Center
name: Fei Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Mead Johnson/RB
name: Steven Wu, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00932477: Safety and Tolerability of Artificial Tears in Dry Eye Subjects
Official title: Safety and Tolerability of Artificial Tears in Dry Eye Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.


Eligibility criteria: Inclusion Criteria:

* Mild, moderate or severe symptoms of dry eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Contact lens wear
* Participation in another clinical study

Primary outcomes:
measure: Tolerability Questionnaire Mean Scores at 1 Week
timeFrame: 1 Week
Secondary outcomes:
measure: Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week
timeFrame: 1 Week
measure: Best-Corrected Visual Acuity (BCVA) Status at 1 Week
timeFrame: 1 Week
measure: The Number of Ophthalmic Adverse Events at 1 Week
timeFrame: 1 Week
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04668677: Return to Work and Functional Results of French Soldiers After Anterior Cruciate Ligament Reconstruction
Official title: Return to Work and Functional Results of French Soldiers After Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Rupture
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of military personnel who underwent first-line ACL reconstruction surgery in a military hospital (military training hospital Bégin or military training hospital Percy) between January 2014 and May 2019.

Brief summary: The return to work in the military population after surgical reconstruction of the anterior cruciate ligament (ACL) has been poorly investigated within the French armed forces. Only American studies are available and show that this surgery has a significant impact on the operational capacity of soldiers.

ACL rupture is extremely frequent in active populations. This pathology has already been extensively explored in at-risk populations, particularly in sports. Most studies show that the resumption of sport is greatly affected by this pathology.

Furthermore, an over-risk (10 times greater incidence of ACL rupture) in the military has been demonstrated.


Eligibility criteria: Inclusion Criteria:

* Military personnel who underwent first-line ACL reconstruction surgery between January 2014 and May 2019

Exclusion Criteria:

* People who have had ACL reconstruction surgery after initial failure
* People with a multiligamentous knee condition

Primary outcomes:
measure: Percentage of participants who regained their professional competence one year after anterior cruciate ligament (ACL) reconstruction surgery.
timeFrame: 1 year after anterior cruciate ligament (ACL) reconstruction surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
Study officials:
References:
Clinical trial NCT00718653: Effects of Antioxidants on Human Macular Pigments
Official title: Effects of Antioxidants on Human Macular Pigments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Health
Keywords: Macular pigment, lutein, green tea extract, antioxidant
Lead sponsor: National Eye Institute (NEI)
Sponsor class: NIH
First posted: 2008-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Age-related macular degeneration (AMD) is the leading cause of blindness in the United States. Low dietary intake or low blood levels of lutein and zeaxanthin, which are the only pigments found in the macular region of the human retina, has been associated with an increased risk for AMD. We have reported that the dietary supplementation of lutein and zeaxanthin can increase the macular pigments (MP) of the eye. MP effectively absorbs blue light as well as quenches reactive oxygen species (ROS). Green tea polyphenols are also effective scavenger of ROS in vitro.

Our goal is to elucidate how to effectively increase MP by physiologic levels of antioxidant supplementation. We hypothesize that lutein and tea polyphenols protect the macula of the eye by increasing MP carotenoids effectively through an antioxidant mechanism.


Eligibility criteria: Inclusion Criteria:

* Normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting
* non-smokers

Exclusion Criteria:

* A history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders
* Exogenous hormone users
* weighing greater than 20% above or below the NHANES median standard
* subjects with serum lutein/zeaxanthin concentrations that are more than 150 % of median of normal population (as previously reported in NHANES III at same age group)
* early age related macular degeneration, cataract, or glaucoma except for those with age appropriate progression of the eye status.

Primary outcomes:
measure: macular pigments, Plasma lutein concentrations
timeFrame: Every month - baseline, 1, 2, 3, & 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Kyung-Jin Yeum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li L, Duker JS, Yoshida Y, Niki E, Rasmussen H, Russell RM, Yeum KJ. Oxidative stress and antioxidant status in older adults with early cataract. Eye (Lond). 2009 Jun;23(6):1464-8. doi: 10.1038/eye.2008.281. Epub 2008 Sep 19.
Clinical trial NCT02932553: BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease
Official title: BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease: Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Angina Pectoris, Variant
Keywords: bioresorbable vascular scaffold
variant angina
moderate coronary artery disease
vasospastic angina
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold) implantation with optimal medical therapy can improve the outcome of patients with variant angina and moderate coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* Age 19 and more
* Vasospastic angina diagnosed by provocation test including ergonovine provocation coronary angiography or ergonovine echocardiogram
* No-ischemia producing moderate coronary artery disease(stenosis\>50%, FFR\>0.8)

Exclusion Criteria:

* Ischemic coronary lesion
* Organic heart disease associated with myocardial ischemia or sudden cardiac death
* History of percutaneous coronary intervention
* Cerebrovascular diseases or peripheral disease
* NYHA III and IV
* Cardiac pacemaker or implantable defibrillator
* Pregnancy or breast feeding
* Life expectancy less than 2 years

Primary outcomes:
measure: Composite of all cause death, myocardial infarction, and angina-related hospitalization
timeFrame: 2year
Secondary outcomes:
measure: Variant angina
timeFrame: 2year
measure: All cause death
timeFrame: 2year
measure: Cardiac death
timeFrame: 2year
measure: Repeat revascularization
timeFrame: 2year
measure: Scaffold thrombosis
timeFrame: 2year
measure: Myocardial infarction
timeFrame: 2year
measure: Stroke
timeFrame: 2year
measure: Angina-related hospitalization
timeFrame: 2year
measure: Composite event of death or myocardial infarction
timeFrame: 2year
measure: Composite event of cardiac death or myocardial infarction
timeFrame: 2year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT05090553: Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques
Official title: Cutibacterium Acnes Colonization on Intervertebral Discs of Patients With Low Back Pain: Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Back Pain, Low
Degenerative Disc Disease
Lead sponsor: Gaffree & Guinle Universitary Hospital
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2021-10-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to identify metabolites present in intervertebral discs colonized by C. acnes from patients with low back pain and degenerative disc disease, correlating them with their clinical, radiological and demographic profiles.


Eligibility criteria: Inclusion Criteria:

* low back pain lasting longer than 3 months;
* MRI findings of degenerative lumbar discopathy (DDL) performed less than 6 months after inclusion in the study;
* indication for open surgical treatment, with isolated microdiscectomy or associated with lumbar arthrodesis;
* failure of conservative treatment for at least 6 weeks and/or progressive neurological deficit

Exclusion Criteria:

* History of open lumbar spine surgery at any stage of life;
* presence of chemotherapy or pulse therapy with corticoids;
* patients with immune deficiency;
* patients undergoing previous intradiscal therapies (nucleotomy or discography);
* patients undergoing previous endoscopic surgery;
* patients with a history of previous spinal infection treated with antibiotics in the 6 months prior to inclusion in the study;
* use of antibiotics in the 2 months prior to the surgical procedure

Primary outcomes:
measure: Incidence of C. acnes on intervertebral disc
timeFrame: Up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Gaffrée e Guinle
Study officials:
References:
Clinical trial NCT02304653: Acute Appendicitis: The Influence of C-reactive Protein and Leucocytes on Clinical Decision-making
Official title: Acute Appendicitis: The Influence of C-reactive Protein and Leucocytes on Clinical Decision-making
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Council for Independent Research
First posted: 2014-12-02
Enrollment: 226
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute abdominal pain with the suspicion of acute appendicitis

Brief summary: Aim: To investigate if the results of CRP and leucocytes had any positive or negative influence on the surgeon's decision-making when handling patients with suspected AA.

Detailed description: A prospective observational cohort study including patients (≥15 years of age) admitted on suspicion of AA. The surgeons were instructed to perform their physical examination and register whether they found the patient more or less than 50% likely to have AA. Thereafter, the surgeons had to assess the blood results and reevaluate their diagnosis. The surgeon's diagnosis before and after was compared to the final diagnosis defined by surgical findings or follow up. Gold standard was any degree of appendicitis on histology.

Eligibility criteria: Acutae abdominal pain Suspect for acute appendicites

Primary outcomes:
measure: Change in diagnosis
timeFrame: Two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital, surgical department A
Study officials:
affiliation: Head of surgical eserach unit
name: Niels Qvist, Professor
role: STUDY_DIRECTOR
References:
citation: Tind S, Qvist N. Acute Appendicitis: A Weak Concordance Between Perioperative Diagnosis, Pathology and Peritoneal Fluid Cultivation. World J Surg. 2017 Jan;41(1):70-74. doi: 10.1007/s00268-016-3686-8.
citation: Tind S, Lassen AT, Zimmerman-Nielsen E, Qvist N. C-reactive protein and white blood cell count do not improve clinical decision-making in acute appendicitis. Dan Med J. 2015 Dec;62(12):A5167.
Clinical trial NCT02295553: Ketamine and Propofol for Upper Endoscopy
Official title: Co-administration of Ketamine and Propofol for Upper Endoscopy in Children: a Dose-finding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Ketamine
Propofol
Children
Pediatrics
Upper endoscopy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 56
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the dose-response relationship of ketamine in combination with propofol.

Detailed description: Direct visualization of the esophagus, stomach and small intestine is performed using a scope that is inserted while the patient is under under deep sedation or general anesthesia. The most common method of providing general anesthesia for upper endoscopy is intravenous administration of medications such as propofol, often in combination with other medications such as fentanyl, midazolam, remifentanil or ketamine. One study found that the combination of propofol and ketamine provides better conditions (less patient movement, more stable heart and breathing) but more side effects afterwards compared to propofol and fentanyl.

Eligibility criteria: Inclusion Criteria:

* Age 3-13 years
* Receiving general anesthesia for upper endoscopy

Exclusion Criteria:

* Known or possible difficult airway
* BMI \> 35
* Weight \< 10 kg
* Sedative premedication required
* Known contraindication to ketamine or propofol

Primary outcomes:
measure: Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's Esophagus
timeFrame: This outcome is measured at the time of insertion of the endoscope into the esophagus.
Secondary outcomes:
measure: Duration of Apnea After Propofol Administration
timeFrame: This outcome will be measured after propofol is administered until the end of the procedure.
measure: Incidence of Adverse Respiratory Events During the Procedure
timeFrame: From induction of anesthesia until endoscopy procedure is complete
measure: Incidence of Side Effects and Complications During the Recovery Period
timeFrame: From the time procedure is complete until discharge from hospital with an average time of 1 hour.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jason Hayes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayes J, Matava C, Pehora C, El-Beheiry H, Jarvis S, Finkelstein Y. Determination of the median effective dose of propofol in combination with different doses of ketamine during gastro-duodenoscopy in children: a randomised controlled trial. Br J Anaesth. 2018 Aug;121(2):453-461. doi: 10.1016/j.bja.2018.03.037. Epub 2018 Jun 5.
Clinical trial NCT03429153: Management of Infectious Endocarditis as Part of a Multidisciplinary Consensus Meeting
Official title: Impact of Setting up a Multidisciplinary Consensus Meeting in the Prognosis and Management of Infectious Endocarditis at Strasbourg University Hospital.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endocarditis
Keywords: endocarditis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Diagnosis of confirmed Infectious Endocarditis
* Medical and / or surgical care at Strasbourg University Hospital between January 2007 and June 2018

Brief summary: New ESC 2015 recommendations with encouragement to set up a Multidisciplinary Consultation Meeting to discuss the medical and surgical management of endocarditis, set up at Strasbourg University Hospital in October 2016: Impact and benefits


Eligibility criteria: Inclusion Criteria:

* Age over 18 18 years at diagnosis
* Diagnosis of confirmed Infectious Endocarditis
* Medical and / or surgical care at Strasbourg University Hospital between January 2007 and June 2018

Exclusion Criteria:

- Refusal to participate in the study

Primary outcomes:
measure: Mortality rate
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Maladies Infectieuses et Tropicales
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Xavier ARGEMI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01294553: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010
Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of Avandamet® Administered in Korean Diabetic Patients According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 717
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type II diabets mellitus patients prescribed rosiglitazone/metformin in general hospital

Brief summary: An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information

Detailed description: An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information

Eligibility criteria: Inclusion criteria

* Subjects administered with rosiglitazone/metformin as an adjunct to diet and exercise for the treatment of type2 diabetes mellitus
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
* Subjects administered with rosiglitazone/metformin following the locally approved prescribing information

Exclusion criteria

* Subjects with previous history of hypersensitivity to rosiglitazone and/or metformin or any other ingredient
* Subjects with previous history of lactic acidosis, renal disease or renal dysfunction, hepatic dysfunction, cardiogenic shock, heart failure, myocardial infarction, pulmonary infarction and any other status with stomach upset
* Subjects with type 1 diabetes mellitus
* Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
* Subjects with severe infection, pre/post surgery, severe trauma
* Subjects with malnutrition, inanition, emaciation, pituitary insufficiency, adrenal insufficiency
* Subjects undergoing radiologic studies involving intravascular administration of iodinated contrast materials

Primary outcomes:
measure: Number of Participants With an Adverse Event
timeFrame: 41.4 weeks
Secondary outcomes:
measure: Number of Participants With a Serious Adverse Event
timeFrame: 41.4 weeks
measure: Number of Participants With the Indicated Unexpected Adverse Events
timeFrame: 41.4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: