louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04972214: The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome
Official title: The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbial Colonization
Keywords: intestinal microbiota
very preterm infant
breast milk
preterm formula
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very preterm infants born before 32 gestational weeks and admitted to the NICU of CHA Bundang Medical Center

Brief summary: This study aims to examine the factors associated with preterm infant's intestinal microbiota depending on feeding type (breast milk or preterm formula)

Detailed description: The gut microbiome has been increasingly found to affect human health. Feeding plays an important role in determining the composition and diversity of the neonatal gut microbiome. Preterm infants are at a high risk of gut microbiota disruption and dysbiosis because of physiological immaturity and environmental factors. In preterm infants, breast milk has been associated with improved growth and cognitive development and a reduced risk of necrotizing enterocolitis and late onset sepsis.

The objective of study is to determine the impact of feeding type on gut microbiome of very preterm infants admitted in a neonatal intensive care unit (NICU). Meconium and the additional 2 fecal samples will be collected from preterm infants. Fecal samples will be collected every 14 days, during 28 days, from diapers into sterile tubes. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.

The type of infant feeding (breast milk or preterm formula) is recorded daily to classify the type of infant feeding received during the 14 days prior to each fecal sample collection.

Eligibility criteria: Inclusion Criteria:

- Very preterm infants (\< 32 weeks gestational age) admitted in the NICU of CHA Bundang Medical Center within the first 24 hours after birth

Exclusion Criteria:

* Parents refuse to participate/sign informed consent
* Major congenital anomalies

Primary outcomes:
measure: intestinal microbiome composition according to the type of feeding
timeFrame: within 24 hours after birth
measure: intestinal microbiome composition according to the type of feeding
timeFrame: 2 weeks after birth
measure: intestinal microbiome composition according to the type of feeding
timeFrame: 4 weeks after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical center
state: Gyeonggi-do
Study officials:
affiliation: CHA Bundang Medical Center
name: Hye-Rim Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05446714: Evaluation of the Effect of Three Types of Rapid Maxillary Expanders (Conventional, Hybrid and MSE)
Official title: Evaluation of Three Types of Rapid Maxillary Expanders (Conventional, Hybrid, And MSE) on Maxilla in Adolescent A Randomized Clinical Trial - CBCT Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Maxillary Retrusion
Nasal Airway Obstruction
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2022-07-07
Enrollment: 54
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study: To compare radiographically the morphometric changes in the nasal airway after using three types of rapid maxillary expansion (RME) conventional hyrax (CH), hybrid hyrax (HH) and maxillary skeletal expander (MSE) using cone beam computed tomography (CBCT).

Detailed description: Abstract Aim of the study: To compare radiographically the morphometric changes in the nasal airway after using three types of rapid maxillary expansion (RME) conventional hyrax (CH), hybrid hyrax (HH) and maxillary skeletal expander (MSE) using cone beam computed tomography (CBCT).

Material and Methods: A total sample of thirty CBCT of patients presented with constricted maxilla with mean age of 14±3Y was randomized in to three groups. Group 1 CH, group 2 HH and group 3 MSE.

CBCT records were taken before(T1) and after six months (T2) of RME; the Airway was segmented and quantified using software (version 5.3.4.39USA).

Eligibility criteria: Inclusion Criteria:

* Patients suffering maxillary collapse with a skeletal background
* Patients with unilateral or bilateral posterior crossbite.
* Patients with reduced or average anterior face height.
* Patients with no periodontal disease.
* Patients with good oral hygiene and general health.
* No systemic diseases that may affect bone quality or interfere with orthodontic treatment.
* Patients with erupted maxillary permanent first molars and premolars.
* Patients with no previous orthodontic treatment.

Exclusion Criteria:

* previous treatment
* syndromes
* cleft lip and palate

Primary outcomes:
measure: Molar Distance:
timeFrame: 6 months
Secondary outcomes:
measure: Molar Inclination
timeFrame: 6 months
measure: Maxillary Width
timeFrame: 6 months
measure: Temporomandibular Joint
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo
Study officials:
affiliation: Al-Azhar University
name: Shendy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gracco A, Malaguti A, Lombardo L, Mazzoli A, Raffaeli R. Palatal volume following rapid maxillary expansion in mixed dentition. Angle Orthod. 2010 Jan;80(1):153-9. doi: 10.2319/010407-7.1.
citation: Lagravere MO, Major PW, Flores-Mir C. Long-term skeletal changes with rapid maxillary expansion: a systematic review. Angle Orthod. 2005 Nov;75(6):1046-52. doi: 10.1043/0003-3219(2005)75[1046:LSCWRM]2.0.CO;2.
Clinical trial NCT02529514: Usage of Baclofen for Sleep Improvement After Cardiac Surgery
Official title: Usage of Baclofen for Sleep Improvement After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Sleep
Keywords: Baclofen
Cardiac Surgery
Polysomnography
Intensive Care Units
Sleep
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.

Detailed description: This is a prospective randomized single-blind study involving patients adults admitted to the University Hospital of Liege for a scheduled heart surgery.

The study is based on the oral administration of baclofen (or placebo) the evening Bedrooms (10 pm). This administration begins the day before surgery and ends 5th day after. Sleep is evaluated by various questionnaires at baseline, during the protocol and the end. In addition, a 24 polysomnography is performed the day after surgery.

Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgery

Exclusion Criteria:

* Haemodynamic instability
* Epilepsy
* Psychotic disturbances
* Acute / Chronic respiratory failure
* Morbid obesity (BMI \> 45 kg/m2)
* Sleep apnea (treated)
* Severe hepatic or renal failure
* Patient refusal

Primary outcomes:
measure: Polysomnography (quantity & quality of sleep)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
Study officials:
affiliation: Soins intensifs généraux
name: Pierre Damas, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05948514: Complications Related to Vascular Access Devices in Home Parenteral Nutrition Patients
Official title: Venous Thromboembolism and Infections Associated With Three Vascular Access Devices in Home Parenteral Nutrition : a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Access Complication
Keywords: central venous access device
catheter-related complications
venous thromboembolism
catheter-related bloodstream infection
peripherally inserted central catheters
home parenteral nutrition
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 300
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: patients receiving HPN

Brief summary: Central vascular access devices are required for home parenteral nutrition (HPN). There is few data available concerning their complications in adult HPN patients, and the potential link between venous thromboembolism and catheter infection is not well established.

The aim of this prospective cohort study is to compare the incidence rate of catheter related complications among 3 types of central vascular access: peripherally inserted central catheters; tunneled catheters and port-a-cath devices, in adults patients on HPN; describe the risk factors, and identify a potential link between venous thromboembolism and infection.

More than 300 patients will be consecutively enrolled and followed up from the time of catheter insertion until its removal. Venous complication (identify by an ultrasound examination if deep vein thrombosis is suspected), infection related to catheter and mechanical complications will be analyzed. The incidence of complications will be expressed per 1000 catheters-day and or as a percentage of total catheter.


Eligibility criteria: Inclusion Criteria:

* adult patients
* having a catheter insertion during the study periode
* at the unit of vascular access of Lyon Sud Hospital
* for parenteral nutrition
* from July 1st, 2017 to June 30, 2020

Exclusion Criteria:

* catheter inserted in intensive care unit
* for other treatment (chemotherapy, antibiotic)

Primary outcomes:
measure: Rate of (incidence) symptomatic venous thromboembolism, catheter related infection, and mechanical complications related to central venous access device
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud-Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT02980614: 4D Velocity Mapping of the Heart in rTOF Patients
Official title: Cardiac 4D MR Velocity Mapping in Repaired Tetralogy of Fallot Patients: Evaluation of Pulmonary Regurgitant Fraction and Ventricular Volume
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Magnetic Resonance Imaging
Tetralogy of Fallot
Keywords: phase-contrast MRI
blood flow
velocity mapping
Quantitative MRI
Cardiac imaging
Tetralogy of Fallot
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence.

Detailed description: MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence. The objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D MR-flow in repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery tree (PA flow =LeftPA flow +RightPA flow ? ).

Eligibility criteria: Inclusion Criteria:

* Tetralogy of Fallot patients
* referred for clinical MRI examination
* ≥ 15 years

Exclusion Criteria:

* Anyone with a classic contraindication to MRI
* Severe obesity
* Gadolinium chelate allergy
* \< 15 years
* counter-indication to MRI examination
* vulnerable person

Primary outcomes:
measure: Regurgitant fraction comparison
timeFrame: Day 0
Secondary outcomes:
measure: Right ventricular volume
timeFrame: Day 0
measure: Pulmonary arteries flows
timeFrame: Day 0
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Cedric Renard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06563414: A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa (DEB)
Official title: A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa (DEB)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epidermolysis Bullosa Dystrophica
Epidermolysis Bullosa Dystrophica, Recessive
Epidermolysis Bullosa Dystrophica Dominans
Keywords: Dystrophic Epidermolysis Bullosa
DEB
Corneal Abrasions
Lead sponsor: Krystal Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-20
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Dystrophic Epidermolysis Bullosa, aged 6 months or older.

Brief summary: This study is a non-interventional, observational study that will evaluate the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB).

Detailed description: The objective of this study is to characterize the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB). Patients will be followed via remote weekly symptom diaries and monthly questionnaires to assess corneal abrasion symptoms, frequency, and duration.

Eligibility criteria: Inclusion Criteria:

1. The subject or their respective legal guardian must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent/Assent Form and must be able to and willing to follow study procedures and instructions.
2. Age 6 months or older at time of Informed Consent/Assent.
3. Prior genetic diagnosis of DEB due to mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

Primary outcomes:
measure: Corneal abrasion frequency
timeFrame: Baseline through up to 1 year
Secondary outcomes:
measure: Epidermolysis Bullosa Eye Disease Index Symptom Score
timeFrame: Baseline through up to 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Krystal Biotech
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02009514: Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients
Official title: Glucose Control During Glucose Containing And Glucose Free Hemodialysate Evaluated By Continuous Glucose Monitoring In Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End-Stage Kidney Disease
Type 2 Diabetes Mellitus
Keywords: Hemodialysis
Continuous glucose monitoring
Hypoglycemia
Hyperglycemia
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
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 investigate differences in glycemia

* during the whole hemodialysis day and the whole freeday
* during hemodialysis, during the evening and the night after hemodialysis and at the same time intervals during the freeday in an unselected type 2 diabetic patient group using both glucose-containing and glucose-free dialysate.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetic patient
* undergoing stable intermittent thrice weekly hemodialysis for at least one month

Exclusion Criteria:

* None

Primary outcomes:
measure: Glucose below 4.0 mmol/l
timeFrame: In the end of a two week period
Secondary outcomes:
measure: Glucose below 4.0 mmol/l during specified time intervals
timeFrame: In the end of a two-week period
Other outcomes:
measure: Mean glucose
timeFrame: In the end of a two-week period
measure: Mean glucose during specified time intervals
timeFrame: In the end of a two-week period
measure: Glucose above 10.0 mmol/l
timeFrame: In the end of a two-week period
measure: Glucose above 10.0 mmol/l during specified time intervals
timeFrame: In the end of a two-week period
measure: Standard deviation of glucose
timeFrame: In the end of a two-week period
measure: Standard deviation of glucose during specified time intervals
timeFrame: In the end of a two-week period
Locations:
Study officials:
affiliation: Tampere University Hospital
name: Pasi I Nevalainen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03587714: Prevalence of Hepatitis c Virus Infection Among Rheumatological Patients
Official title: Prevalence of Hepatitis c Virus Infection Among Rheumatological Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All rheumatologic and other muscloskeletal diseased patients attending Rheumatology clinic Assuit university hospital

Brief summary: Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases.

Detailed description: Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases.

This study aims at detecting the prevalence of subclinical HCV infection in different rheumatologic disease groups in Egypt.

Consecutive patients with different rheumatologic diseases from seven- geographically different- rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection. Patients' serum samples were screened for the presence of anti-HCV antibodies. Patients with positive serology were further evaluated for the presence of HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with different rheumatologic diseases from seven- geographically different- rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection

Exclusion Criteria:

* pregnancy and end organ failure

Primary outcomes:
measure: HCV RT-PCR
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut governorate
Study officials:
affiliation: Assiut University
name: Manal Hassanien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00937014: Assessment of Growth of Infants Fed a New Formula
Official title: Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition
Keywords: infant formula
growth
weight
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2009-07-10
Enrollment: 180
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.


Eligibility criteria: Inclusion Criteria:

* Healthy newborn infant
* Full-term (\>37 weeks gestation)
* Birth weight between \> 2500 and \< 4500 g
* Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment
* Tolerating a cows milk based formula for at least 3 days
* Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information
* Informed consent signed (Parent/Legal representative)
* Parent/Caregiver has a working freezer
* Lives within 45 minutes of a study site

Exclusion Criteria:

* Congenital illness or malformation that may affect infant feeding and/or normal growth
* Suspected or known allergy to cow's milk protein
* Significant pre-natal and/or post-natal disease
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
* Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment
* Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
* Infant currently participating in another clinical study
* Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol

Primary outcomes:
measure: Mean weight gain
timeFrame: 4 months
Secondary outcomes:
measure: anthropometry, tolerance, morbidity, blood tests
timeFrame: 9 months
Other outcomes:
Locations:
city: Newburgh
country: United States
facility: Pedia Research, LLC
state: Indiana
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: University of Maryland School of Medicine, Department of Pediatrics
name: Susan Feigelman, MD
role: PRINCIPAL_INVESTIGATOR
References: