louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00904774: Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants
Official title: Polymorphisms of Genes Controlling Alveolar Development and Risk of Bronchopulmonary Dysplasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchopulmonary Dysplasia
Keywords: bronchopulmonary dysplasia
neonates
lung development
prematurity
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2009-05-20
Enrollment: 800
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature neonates

Brief summary: Despite considerable obstetric and neonatal advances in the care of very low birth weight (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of surviving infants, and new ways for combatting this disease must be found. BPD appears to result from arrested lung development, but its etiology has not yet been fully established. Besides the role of the exposure of the immature lung to injurious factors in the development of BPD, a genetic susceptibility for BPD in preterm infants was recently evidenced. Taking advantage of new genomic technologies, the objective of the investigators' project is to identify predisposing human genetic variants through:

1. a genome-wide association (GWA) study in VLBW neonates,
2. a candidate-gene association study, including selection of single nucleotide polymorphisms (SNPs) found in (a) and
3. functional studies of any SNP found to be convincingly associated with BPD in (a) and (b).


Eligibility criteria: Inclusion Criteria:

* Gestational age \< 28 weeks
* Inborn birth
* Prophylactic administration of surfactant in the delivery room
* Written informed consent obtained from parents

Exclusion Criteria:

* Gestational age of 28 weeks or more
* Outborn birth
* No prophylactic administration of surfactant in the delivery room
* Congenital malformation
* Absence of written informed consent obtained from parents

Primary outcomes:
measure: bronchopulmonary dysplasia
timeFrame: 36 weeks of postconceptional age
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal
Study officials:
References:
citation: Hadchouel A, Decobert F, Franco-Montoya ML, Halphen I, Jarreau PH, Boucherat O, Martin E, Benachi A, Amselem S, Bourbon J, Danan C, Delacourt C. Matrix metalloproteinase gene polymorphisms and bronchopulmonary dysplasia: identification of MMP16 as a new player in lung development. PLoS One. 2008 Sep 11;3(9):e3188. doi: 10.1371/journal.pone.0003188.
Clinical trial NCT02983474: Korea Surgical Quality Improvement Program
Official title: Development of Cholecystectomy Complication Predictive Model for Developing the Surgical Quality Improvement Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholecystectomy
Lead sponsor: National Evidence-Based Healthcare Collaborating Agency
Sponsor class: OTHER_GOV
First posted: 2016-12-06
Enrollment: 3000
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: patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or cholelithiasis

Brief summary: The member of National Evidence-based Healthcare Collaborating Agency and the planning committee of Korean Association of hepato-biliary pancreatic Surgery established the protocol of Korean Surgical Quality Improvement Program (KSQIP) with verifying variables of American College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP and National Clinical Database (NCD) of Japan; demographics, preoperative information, laboratory values, operation finding, general occurrences, postoperative occurrences, and follow-up data to develop post cholecystectomy complication risk model.

The 50 surgeons from 20 hospitals have decided to participated in the primary prospective study to apply KSQIP to cholecystectomy. The investigators developed web-based database system (http://www.ksqip.org/gb) and surgical clinical reviewer of each hospital will fill out the case report form. Finally, the investigators will provide a risk-adjusted surgical risk calculator and feedback system for reducing complication.


Eligibility criteria: Inclusion Criteria:

* Patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or cholelithiasis

Exclusion Criteria:

* Under 18 age
* Who underwent other abdominal surgery simultaneously
* Gallbladder Cancer, cholangiocarcinoma
* Who did not agree with participation

Primary outcomes:
measure: Composite of bile leakage and iatrogenic duct injury
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03151174: Effects of Vitamin D Supplementation on Strength, Bone Density, and Injury Risk in Collegiate Athletes
Official title: Vitamin D, Strength, and Bone Density in Collegiate Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vitamin D Deficiency
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will either receive placebo, 5000IU, or 10000IU per day of Vitamin D for 8-12 weeks.
Primary purpose: PREVENTION

Brief summary: The goal of this study is to determine whether Vitamin D supplementation improves strength and bone density, and reduces the risk of injury in collegiate athletes.

Detailed description: Vitamin D is a hormone that is important for bone and muscle health. As such, not having enough vitamin D in your body is associated with increased risk of injury and reduced health and athletic performance. It is often recommended that individuals who have low levels of vitamin D take vitamin D supplements. However, the effects of vitamin D supplementation on health and strength gains in collegiate athletes are not known. The goal of this study is to determine whether vitamin D supplementation increases strength and bone density, while reducing the risk of injury in collegiate athletes. Fasting vitamin D concentrations will be measured and athletes will be supplemented daily with Vitamin D for 8-12 weeks. The amount of supplementation will depend on whether the athlete is categorized as sufficient (\>30ng/ml), insufficient (20-35ng/ml), or deficient (\<20ng/ml). Vitamin D concentrations, strength, bone density, and injury risk will be assessed before and after the intervention period.

Eligibility criteria: Inclusion Criteria:

* athlete for a sanctioned Virginia Tech sport

Exclusion Criteria:

* pregnant or trying to become pregnant, currently taking vitamin D (\>600IU/day), calcium (\>1000mg/dl), taking any performance enhancing supplements (example, creatine), or any other medication or nutritional supplements that might influence the study variables, cardiac or thyroid problems, have diabetes, or epilepsy

Primary outcomes:
measure: Strength
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Femur Bone Density
timeFrame: Up to 12 weeks
measure: Spine Bone Density
timeFrame: Up to 12 weeks
measure: Injury Occurence
timeFrame: Every week for up to 12 weeks
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Virginia Tech
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Matthew Hulver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00972374: Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhegmatogenous Macula-off Retinal Detachment
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.


Eligibility criteria: Inclusion Criteria:

* The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology)
* The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
* The repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure
* The visual acuity score must be between 20/50 and 20/320 in the study eye

Exclusion Criteria:

* Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
* Anticipated need for ocular surgery during the 12-month study period
* Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide)
* Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
* Any infectious condition in the study eye

Primary outcomes:
measure: Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Month 3
Secondary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Month 3
Other outcomes:
measure: Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit
timeFrame: 12 Months
Locations:
city: Abilene
country: United States
state: Texas
city: New Delhi
country: India
city: Tel Aviv
country: Israel
city: Seoul
country: Korea, Republic of
city: Makati
country: Philippines
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03698474: Comparison of Different Low Volume Solutions Prior to Colonoscopy
Official title: Comparison of Efficiency and Tolerance of Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate and Oral Sulfate Solution Before Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Lead sponsor: Tomas Bata Hospital, Czech Republic
Sponsor class: OTHER
Collaborators: name: Faculty Hospital Kralovske Vinohrady
First posted: 2018-10-09
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study evaluates the head -to-head efficacy and tolerability of low volume preparations prior to colonoscopy

Detailed description: Aim of the study: To compare the efficacy and tolerance of sodium picosulphate/magnesium citrate, polyethylene glycol/ascorbic acid and oral sulfate formula in a single or split dose regimen prior to colonoscopy

Eligibility criteria: Inclusion Criteria:

* subjects referred to diagnostic or therapeutic colonoscopy

Exclusion Criteria:

* known or suspected bowel obstruction
* active bowel inflammation
* pregnancy
* prior bowel resection
* any presence of serious medical conditions ( cardiac, renal, liver disease)
* inability to obtain valid data from subject
* active bowel bleeding

Primary outcomes:
measure: Satisfactory bowel preparation quality (Aronchick score 1-2)
timeFrame: one day
Secondary outcomes:
measure: Bowel preparation tolerance assessed by Visual Analogue Scale (VAS)
timeFrame: one day
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
Study officials:
affiliation: KNTB Zlin
name: Vladimir Kojecky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05774574: Physiological and Appetitive Effects of CBD Supplementation
Official title: Physiological and Appetitive Effects of Four Weeks of 60 mg/Day CBD Supplementation in an Adult Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Appetitive Behavior
Adverse Effect
Metabolic Health
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: Bridge Farm Nurseries Limited, Spalding, UK
First posted: 2023-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: CBD may affect metabolic control and energy intake. However, there is currently little data regarding these specific outcomes in humans. Therefore, this study will investigate whether four weeks of supplementation with 60 mg/day CBD affects energy intake at a single meal, and or fasting blood-based markers of appetite regulation and metabolic health. Healthy, adult volunteers will be assigned to placebo or CBD supplementation, in a randomized controlled trial, comparing changes in outcomes across the supplementation period between groups.


Eligibility criteria: Exclusion Criteria:

* No history of any substance abuse
* Have used tobacco regularly (\>2x in a week) within the past 6 months
* Are suffering from any condition that may affect study outcomes
* Currently use any prescription or over-the-counter medications (except for hormonal contraception and simple painkillers)
* Have given a standard blood donation within 30 days of screening
* Are currently pregnant or lactating
* Are allergic/intolerant to any ingredients in food items we provide during the study (relevant allergens: oats, milk)

Inclusion Criteria:

* Males and females, aged 18-50, who do not meet the exclusion criteria

Primary outcomes:
measure: Energy Intake
timeFrame: Baseline and after 4 weeks supplementation
Secondary outcomes:
measure: CBD
timeFrame: Baseline and after 4 weeks supplementation
measure: Liver transaminases
timeFrame: Baseline and after 4 weeks supplementation
measure: Hormones implicated in appetite regulation
timeFrame: Baseline and after 4 weeks supplementation
measure: Lipoproteins
timeFrame: Baseline and after 4 weeks supplementation
measure: Glucose
timeFrame: Baseline and after 4 weeks supplementation
measure: Triglycerides
timeFrame: Baseline and after 4 weeks supplementation
measure: Insulin
timeFrame: Baseline and after 4 weeks supplementation
measure: Subjective appetite (hunger, fullness, desire to eat)
timeFrame: Baseline and after 4 weeks supplementation
measure: self-reported adverse events
timeFrame: During 4 weeks supplementation
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
References:
Clinical trial NCT02571374: Symbiotics to Prevent Postoperative Infection in Colorectal Cancer
Official title: Change in Incidence of Surgical Site Infection After Resection of Colorectal Cancer Between Patients Receiving a Symbiotic Compound and Patients Receiving a Placebo.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Surgical Site Infection
Keywords: symbiotic
colorectal cancer
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. The researchers will compare incidence of surgical site infection between the study groups.

Detailed description: This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be randomly selected to receive either a symbiotic formulation or placebo during the perioperative period. The researchers will compare incidence of surgical site infection, detected by clinical examination and complementary tests (CT scans, X-rays, microbiological and hematological tests) between the study groups.

Eligibility criteria: Inclusion Criteria:

* Adults between 18 and 85 years old;
* Colorectal cancer patients.
* Ability to understand and signing the informed consent

Exclusion Criteria:

* Pregnancy (early diagnosis)
* Reduced intellectual level that could prevent proper understanding of the objectives of the study
* Patients with rectal cancer undergoing neoadjuvant treatment (chemotherapy and radiotherapy)
* Use of products with prebiotic, probiotic and / or symbiotic function or fiber module; by more than 3x a week
* Refusal to participate and / or to sign the Consent Form Free and Clear

Primary outcomes:
measure: Number of participants with colorectal cancer on symbiotic to prevent postoperative infection
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Aline Taborda, ms
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06584474: THE EFFECT OF NEBULIZED AZITHROMYCIN AS THERAPY FOR BRONCHOPULMONARY DYSPLASIA
Official title: THE EFFECT OF NEBULIZED AZITHROMYCIN AS AN ADJUVANT PREVENTIVE THERAPY FOR BRONCHOPULMONARY DYSPLASIA IN PRETERM INFANTS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bronchopulmonary Dysplasia
Premature
Ventilation, Mechanical
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the effectiveness of nebulized azithromycin therapy in prevention of BPD in very low birth weight preterm infants when compared with placebo.


Eligibility criteria: Inclusion Criteria:

1. Gestational age less than 32 weeks and birth weight less than 1500 g.
2. Infants who are still in need of respiratory support at day 7 of life (intubated, or by non-invasive mechanical ventilation, including CPAP and high-flow nasal cannula, or any form of oxygen therapy).

Exclusion Criteria:

* Gestational age ≥ 32 weeks.
* Newborns with congenital cyanotic heart diseases.
* Obvious major congenital malformations, known syndromes or chromosomal anomalies.
* Infants with signs compatible with the diagnosis of necrotizing enterocolitis (NEC) in the first week of life.
* Current use of steroids.

Primary outcomes:
measure: Development of BPD (bronchopulmonary dysplasia)
timeFrame: 28 days of life and/or 36 weeks postmenstrual age
measure: Lung Ultrasound assessment
timeFrame: 14 days postnatal age.
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
References:
Clinical trial NCT00471874: Study Evaluating Health Related Utility in Rheumatoid Arthritis
Official title: An Observational Study to Examine the Relationship Between Rheumatoid Arthritis Disease Severity and Health Related Utility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study is to determine in Australia what effect rheumatoid arthritis has on quality of life, and also to determine the costs that are associated with having rheumatoid arthritis.

Detailed description: At a routine visit to the clinic, patients will be asked to answer questions about their symptoms, have a routine examination by the doctor, fill out a questionnaire that will ask questions about them, about their arthritis, about how it affects their well being and quality of life, and about treatment and costs. The questionnaire will take them about 30 minutes to complete. A blood test may also be required.

This ends the patient's involvement with the study.

Eligibility criteria: Inclusion Criteria:

* Male or female patient with clinically defined rheumatoid arthritis diagnosed for at least 3 months
* Age 18 years or older
* Ability to complete the study documents in English

Exclusion Criteria:

· Current participation in a blinded trial of an investigational treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
state: New South Wales
city: Wollongong
country: Australia
state: New South Wales
city: Maroochydore
country: Australia
state: Queensland
city: Malvern
country: Australia
state: Victoria
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Australia, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00753974: Cardiovascular Biorepository
Official title: Cardiovascular Biorepository
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cardiovascular Diseases
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2008-09-17
Enrollment: 10000
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: • All patients undergoing cardiovascular surgery/procedure at the University of Kentucky who are at least 18 years of age

Brief summary: Use biospecimens procured from patients and organ donors to improve understanding of molecular, cellular, and tissue-level processes produced by cardiovascular disease and therapeutic interventions

Detailed description: This is a prospective evaluation of patients undergoing cardiovascular procedures at the University of Kentucky Medical Center.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing cardiovascular surgery/procedure at the University of Kentucky who are at least 18 years of age

Primary outcomes:
measure: Use biospecimens procured from patients and organ donors to improve understanding of molecular, cellular, and tissue-level processes produced by cardiovascular disease and therapeutic interventions.
timeFrame: 6/26/2008 - 6/9/2030
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky, Department of Internal Medicine, Division of Cardiovascular Medicine
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Kenneth S Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: