louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02058186: Effect of Oral Vitamin D Supplement on Atopic Dermatitis; A Clinical Trial With Staphylococcus Aureus Colonization Determination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis, vitamin D supplementation, cathelicidin, Staphylococcus aureus colonization, SCORAD score
Lead sponsor: Srinakharinwirot University
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Background: Increase in skin colonization of Staphylococcus aureus (S. aureus) in atopic dermatitis patients (AD) resulted from the reduction of cathelicidin production in these patients plays the important role in pathogenesis of this disease. Recently in vivo study has showed that vitamin D can stimulate cathelicidin production. Oral supplement of vitamin D might be beneficial in atopic dermatitis.

Objective: To determine the effect of oral vitamin D supplement on clinical impact including skin colonization of S. aureus in atopic dermatitis patients.


Eligibility criteria: Inclusion Criteria:

* Eligible criteria included patients with mild to moderate atopic dermatitis by SCORAD (Scoring for Atopic Dermatitis) score criteria1,17,18, age between 1-18 years old. All patients had been advised to take normal, dietary product and their activities. They had been advised to discontinue at least 4 weeks of oral corticosteroid, at least 2 weeks of topical corticosteroid or topical calcineurin inhibitor application and at least 6 months of vitamin supplement prior to starting the protocol

Exclusion Criteria:

* The exclusion criteria were to coexisting skin infection on top with AD lesions, known case of primary or secondary immune-compromised host, hepatic or renal disease, those taking vitamin D or nutraceutical supplementation, those continues taking with antibiotics, corticosteroid, immunosuppressive agents, anti-epileptic drugs, thiazide diuretics, proton-pump inhibitors, histamine 2-receptor antagonists at the time of enrollment. Patients who used topical antiseptic or antibiotic products during study period were also excluded. Patients who developed worsening of AD with flare-up of clinical manifestation or SCORAD greater than 40, secondary infection on-top tested lesions were excluded from data analysis.

Primary outcomes:
measure: SCORAD score
timeFrame: May - August 2012 (3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Skin Center, Srinakharinwirot University
Study officials:
References:
citation: Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Clinical trial NCT05708586: Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures
Official title: Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Pain
Keywords: Virtual reality
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 66
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate that the use of a virtual reality experience can decrease child and caregiver anxiety and pain for simple orthopaedic office procedures.


Eligibility criteria: Inclusion Criteria for pediatric patient:

* Undergoing cast removal, pin removal, or suture removal in study affiliated clinic
* Less than 17 years old

Exclusion Criteria for pediatric patient:

* History of seizures
* Pregnant, have preexisting binocular vision abnormalities or psychiatric disorders, or suffer from a heart condition or other serious medical condition
* Patients can't have implanted medical devices including cardiac pacemakers, hearing aids and defibrillators

There is no minimum or maximum age for the Caretakers/Parents.

Primary outcomes:
measure: Child Pain Score
timeFrame: Up to 24 hours following procedure
measure: Child Anxiety (7 Years Old and Older)
timeFrame: Up to 24 hours following procedure
measure: Child Anxiety (Younger Than 7 Years Old)
timeFrame: Up to 24 hours following procedure
Secondary outcomes:
measure: Parental Anxiety
timeFrame: Up to 24 hours following procedure
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Noelle Whyte, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06732986: Does the Structure of the Tendon Relate to the Temporal, Kinetic and Kinematic Jump Variables? Athletes Vs. Non Athletes
Official title: Does the Structure of the Tendon Relate to the Temporal, Kinetic and Kinematic Jump Variables? Athletes Vs. Non Athletes: an Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vertical Jump
Patellar Tendon
Achilles Tendon
Keywords: Vertical jump
Jump performance
Patellar tendon
Tendon structure
UTC
Achilles tendon
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for this study consisted of young adults aged 18 to 35, of both sexes, including volleyball athletes and non-athletes.

Brief summary: The goal of this observational study is to investigate the relationship between temporal, kinetic, and kinematic jump variables and patellar and Achilles tendons' structure in athletes and non-athletes. The main research questions are:

Does the structure of the patellar and Achilles tendons relate to the temporal, kinetic, and kinematic jump variables? Does the relationship between these variables differ between athletes and non-athletes? To answer these questions, researchers will compare the two groups to determine if the relationships between the variables are similar. Participants will undergo a UTC (Ultrasound Tissue Characterization) scan of the patellar and Achilles tendons and perform five jumps: a countermovement jump, a single-leg countermovement jump on each leg and a single-leg horizontal jump on each leg.


Eligibility criteria: Inclusion Criteria for the Athletes Group:

1. Being a volleyball athlete competing in the 1st or 2nd division of the portuguese national championship;
2. Participating in training and games for more than 20 hours per week.

Exclusion Criteria for the Athletes Group:

1. Presence of any musculoskeletal, neurological, cardiorespiratory, or metabolic condition that affects jumping performance;
2. Absence from competition due to injury or illness in the last two weeks;
3. History of tendon rupture;
4. Previous tendon surgery;
5. Diagnosis of patellar tendinopathy in the last 12 months.

Exclusion Criteria for the Non-Athletes Group:

1. Presence of any musculoskeletal, neurological, cardiorespiratory, or metabolic condition that affects jumping performance;
2. Absence from competition due to injury or illness in the last two weeks;
3. History of tendon rupture;
4. Previous tendon surgery;
5. Diagnosis of patellar tendinopathy in the last 12 months;
6. Previous participation in a jumping sport.

Primary outcomes:
measure: Tendon Structure
timeFrame: Baseline
measure: Jump Variables
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior de Saúde do Instituto Politécnico do Porto
Study officials:
References:
Clinical trial NCT01699386: Growth of Infants Fed an Elemental Medical Food
Official title: Growth of Infants Fed an Elemental Medical Food
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 213
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.


Eligibility criteria: Inclusion Criteria:

* Singleton, healthy infant
* Gestational age of 37 to 42 weeks
* Birth weight of 2500 grams or greater
* Age between birth and 9 days of age
* Parents agree to not administer mineral or vitamin supplements during the study period
* Parents agree to feed study formula exclusively for the duration of the study

Exclusion Criteria:

* Maternal, fetal or perinatal history which may have adverse effects on growth
* Multiple birth

Primary outcomes:
measure: Weight
timeFrame: 14 days of age to 112 days of age
Secondary outcomes:
measure: Anthropometric Measurements
timeFrame: 14 days of age to 112 days of age
measure: GI Tolerance
timeFrame: At visits 14 and 28
measure: Lab Measurement
timeFrame: At 112 day visit
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: T&W Research
state: Arkansas
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: Abbott Nutrition
name: Marlene W Borschel, PhD, RD
role: STUDY_CHAIR
References:
citation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
Clinical trial NCT00768586: Analysis of the Early Development of the Visual Function in Extreme Premature Infants Under 28th Weeks of Gestation
Official title: Analysis of the Early Development of the Visual Function in Extreme Premature Infants Under 28th Weeks of Gestation. - A Prospective Study to Identify Normal Values of Flash Visual Evoked Potentials in This Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vision
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 23
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants between the 23-29th week of gestation are included.

Brief summary: The aim of this study is to collect data on the early visual development of extreme premature infants. The method is the measurement of flash visual evoked potentials and the study population includes premature infants under the 28th weeks of gestation, who have normal cranial ultrasound examinations, normal aEEG, no clinical neurological symptoms and who have a normal ophthalmological status.

fVEP measurements were recorded from the first week of life every second week until term.

The fVEP recordings were performed in active sleep, in stable premature infants, who were continuously monitored. The Nihon Kohden Neuropack 8 was used, the stimulus frequency was 0,5 Hz, artefact free averages were analyzed.

The measurements were analyzed according to the presence and absence of known waveforms, their latencies and amplitudes. Longitudinal analysis was performed to analyse the effect of extrauterine visual development on fVEP with growing gestational ages.


Eligibility criteria: Inclusion Criteria:

* All premature infants under the 29th week of gestation entering our ward.

Exclusion Criteria:

* Infants with intracranial abnormalities, cerebral malformations, neurological symptoms or known eye pathology.

Primary outcomes:
measure: Latency and Amplitude of Visual Evoked Potential waveforms measured in the first week of life than every second week prospectively until term.
timeFrame: Until term
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Pediatrics, Neonatology
Study officials:
affiliation: MUV
name: Manfred Weninger, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02578186: Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness
Official title: Randomized, Double-Blind, Placebo-Controlled, Crossover, In-home Study to Assess the Efficacy of Diphenhydramine Hydrochloride in Subjects With Occasional Sleeplessness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Occasional Sleeplessness
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2015-10-16
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The present study was conducted to investigate the impact of diphenhydramine hydrochloride on the ability to initiate sleep.

Detailed description: Diphenhydramine hydrochloride (herein referred to as diphenhydramine) is an antihistamine of the ethanolamine classes with known sleep-inducing properties and is approved by the Food \& Drug Administration to reduce the time to sleep onset in individuals having difficulty falling asleep. The goal of the study is to investigate diphenhydramine versus placebo with regard to several sleep parameters, including time to sleep onset, in healthy adult subjects suffering from occasional sleeplessness.

Eligibility criteria: Inclusion Criteria:

* be male or female subjects, ≥18 years of age to 55 years of age, who report that they are currently experiencing occasional sleeplessness characterized by difficulty initiating sleep (ie, taking ≥30 minutes to fall asleep) on average 2-4 times per week for less than 1 month;
* be in good general health without clinically significant disease (no previously diagnosed sleep disorders);
* if female, have a negative screening pregnancy test and agree to be on approved methods of birth control throughout the study

Exclusion Criteria:

* have a clinically significant illness within 30 days of Screening;
* are taking medication that could interfere with the study medication;
* have been under a clinician's care for insomnia treatment and control within the past year or has a history of insomnia or is currently taking prescription medications for insomnia;
* are currently taking medications known to effect sleep function;
* have current or past history of serious, severe or unstable physical or psychiatric illness;
* have current diagnosis of severe urinary retention;
* have current diagnosis of untreated narrow angle glaucoma;
* had participated in a clinical drug study or used an investigational new drug during the previous 30 days;
* have any clinically significant or abnormal finding in physical examination, vital signs, ECG, or clinical laboratory tests that may affect the subject's safety or outcome of the study;

Primary outcomes:
measure: Mean Latency to Persistent Sleep
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06821386: N-Care Project: Enhancing Asian-Pacific Collaboration
Official title: N-Care Project: Enhancing Asian-Pacific Collaboration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Whole Genome Sequencing
Genetic Disease
Critical Care, Intensive Care
Nanopore Sequencing
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 70
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants or newborns under 18 months of age admitted to the ICU with a high suspicion of a genetic disease.

Brief summary: Through Asian-Pacific multinational collaboration, we aim to utilize third-generation genome sequencing to rapidly diagnose genetic diseases in critically ill infants and young children, achieving the goal of early diagnosis for targeted treatment.

Detailed description: A group of individuals with specific characteristics was selected. Genetic studies were arranged for participants who provided their consent.

Eligibility criteria: Inclusion Criteria:

1. Age: infant/newborn less than 18 months
2. Admitted to intensive care unit
3. At least one of the following conditions A. Specific anomaly highly suggestive of a genetic etiology

   * Multiple birth defects
   * Single major malformation that required intervention (surgery or medication)
   * Significantly abnormal EKG
   * Significant hypotonia

B. Children with high-risk stratification on assessment of a Brief Resolved Unexplained Event (BRUE) with any of the following:

* Recurrent severe infection events
* Recurrent or prolonged seizures
* Unexplained cardiopulmonary resuscitation (CPR)
* Suspect inborn error of metabolism

Exclusion Criteria:

1. Infants with a definitive non-genetic diagnosis: ex as below A. An infection with normal response to therapy B. Isolated prematurity C. Transient hypoglycemia D. Isolated unconjugated hyperbilirubinemia E. Isolated Transient Neonatal Tachypnea F. Those where the clinical course can be explained without genetic testing
2. Confirmed genetic diagnosis explains illness
3. Lack of consent: Families who do not consent to genetic testing or data sharing.
4. Infants without sufficient DNA sample quality/quantity: Where the quality or quantity of the DNA sample is inadequate for sequencing.

Primary outcomes:
measure: Positive yield rate
timeFrame: 9 days after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01647386: Pilot Study Using Radiostereometric Analysis (RSA) to Evaluate the Fixation of the Tibial Components in the DePuy M.B.T. Revision Knee System
Official title: Pilot Study Using Radiostereometric Analysis (RSA) to Evaluate the Fixation of the Tibial Components in the DePuy M.B.T. Revision Knee System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Revision Total Knee Replacement
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2012-07-23
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Failed primary TKR

Brief summary: Motivated by the growing number of revision total knee arthroplasty (TKAs) and the interest among surgeons to quantify the effectiveness of specific implant designs, the goal of the current project is to use Radiostereometric Analysis (RSA) to provide conclusive and clinically relevant results on fixation of the tibial component with the DePuy M.B.T. Revision TKA system using Metaphyseal Sleeves.

Does the tibial component of the M.B.T. Revision Knee System achieve adequate fixation to the underlying bone (proximal tibia) as measured by migration? • Null Hypothesis: The maximum total point motion (MTPM) value of migration of the M.B.T. Revision Knee System component between postoperative years one and two does not exceed 0.2 mm indicating adequate long-term fixation at the bone-implant interface.

• Alternative Hypothesis: The MTPM value of migration of the M.B.T. Revision Knee System component between postoperative years one and two does exceed 0.2 mm indicating inadequate long-term fixation at the bone-implant interface.

b) In what proportion of patients is adequate fixation achieved?


Eligibility criteria: Inclusion Criteria:

* Revision TKA is indicated and it is the opinion of the investigator that the PFC Sigma M.B.T. Tibial component with metaphyseal sleeves and a stem is a suitable treatment
* Contained bone defects in the proximal tibia that allow for contiguous contact between metaphyseal sleeves and cortical bone
* Use of tibial stem
* Ability to give informed consent

Exclusion Criteria:

* Revision TKA due to infection
* Patellar revision only
* Polyethylene liner exchange only
* Revision requiring hinged TKA
* Uncontained defects in the proximal tibia that preclude contiguous contact between metaphyseal sleeves and cortical bone

Primary outcomes:
measure: Implant Migration
timeFrame: 2 years
Secondary outcomes:
measure: BMD
timeFrame: 2 years
Other outcomes:
measure: Health outcome questionnaire
timeFrame: 2 years
Locations:
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Michael Dunbar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01452386: Modified Functional Magnetic Stimulation Treatment for Constipation Improvement
Official title: Modified Functional Magnetic Stimulation Treatment for Constipation Improvement
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Constipation
Keywords: Constipation
Stimulation Treatment
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: constipation patients

Brief summary: To prove the modify functional magnetic stimulation could improve constipation.

Detailed description: 1. Permission： Any agent without effecting gastrointestinal motility or defecation is allowed.
2. Inhibition： From test day to the next day(48 hours),it's not allowed to take any medication treatment which might affect digestive system or excretory system.

Eligibility criteria: Inclusion Criteria:

* Patients who age between 20\~60 years old and have suffered from chronic constipation for more than 6 months will be enrolled in this study.

Exclusion Criteria:

* Patients with implantation chip of brain
* Patients with implantation of pacemaker
* Patients with heart transplantation
* Patients are embedded electronic and Life support products.
* People who have be implanted metal、electronic devices、artificial joints or fixator.
* Patients with hemiplegia
* Patients with peripheral neuritis
* Patients with Prostate abnormalities
* Patients with Pregnancy
* Patients with Fever
* Patients with Injure
* Patients with Heart disease
* Patients with Consciousness disturbance
* Patients with Organic constipation
* Patients with Kidney stone
* Patients with Ureteric calculus

Primary outcomes:
measure: To improve bowel movement by the modify functional magnetic stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Fat-Moon Suk
role: PRINCIPAL_INVESTIGATOR
References: