louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04376242: Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge
Official title: The Utilization of Virtual Reality Technology Versus Standard of Care During Pediatric Oral Food Challenge: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Food Allergy in Children
Food Allergy
Keywords: food allergy
oral food challenge
virtual reality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 57
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care of utilizing existing technologies that are currently more common in food allergy research treatment and clinics (i.e. television and patients' personal electronic devices) for decreasing levels anxiety and fear in pediatric patients undergoing oral food challenge (OFC) and their caregivers.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 5 and 17
* Willing to participate in both the VR and standard of care technology conditions
* Able to consent or have parental consent
* Undergoing at least two Oral Food Challenges within the window of recruitment at the Sean N. Parker Center

Exclusion Criteria:

* People who do not consent
* Significant Cognitive Impairment
* History of Severe Motion Sickness
* Current Nausea
* Seizures
* Visual Problems
* Non-English Speaking
* Patients who clinically unstable or requires urgent/emergent intervention
* ASA class 4 or higher

Primary outcomes:
measure: Change in Children's Fear Scale Score Before and After OFC dosing
timeFrame: measurements occur at single time points before and after each food challenge with approximately 4-6 hours between measurements. Thus 4 discrete measurements will be taken over two food challenges which will occur approximately one week apart.
measure: Change in Childhood Anxiety Meter Score Before and After OFC dosing
timeFrame: Before and after each evaluation (approximately 4-6 hours between measurements at each visit, with visits approximately 1 week apart)
Secondary outcomes:
measure: Level of Immersion after OFC
timeFrame: After each evaluation (approximately 1 week apart)
measure: Level of satisfaction - participant, caregiver and provider
timeFrame: After each evaluation (approximately 1 week apart)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Sayantani Sindher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00794742: Antimicrobial Resistance of Bacteria in Burn Patients
Official title: Analyzing the Antimicrobial Resistance Profile of Bacterial Isolates Obtained From Severely Burned Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Keywords: Burn
Antimicrobial
Bacteria
Resistance
Biofilm
Pathogen
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2008-11-20
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with open,unhealed,burn wounds

Brief summary: The purpose of this study is to test the resistance of pathogenic bacteria in infected tissues of burn patients to various antimicrobials and enzyme debriders.

Detailed description: Bacteria that is present in infected burn wounds will be isolated and identified. The isolates will be tested for resistance to commercially available antimicrobials.

Eligibility criteria: Inclusion Criteria:

* Males and females of any age
* Have open, unhealed wounds(s) that will be cultured per standard of care
* Subject or authorized representative provide informed consent

Exclusion Criteria:

* Informed consent not provided or able to be obtained

Primary outcomes:
measure: Types of bacteria
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: University Medical Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: John Griswold, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04017442: Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery
Official title: Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postpartum Pain
Postpartum Depression
Opioid Consumption
Keywords: Postpartum depression
Postpartum anxiety
Postpartum opioids
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, prospective, randomized
Primary purpose: TREATMENT

Brief summary: Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.

Detailed description: After obtaining consent, women presenting to the labor floor at Mount Sinai Hospital will be randomized into two groups, intervention and placebo. Baseline demographic data and surveys in regards to postpartum depression, anxiety, breastfeed willingness and pain scores will be obtained. After delivery of the baby patients will either receive 2mg preservative free morphine or saline via the epidural catheter prior to its removal. The study team will then record pain and recovery scores, as well as follow up screens to the aforementioned endpoints. The study will end at the 6 week postpartum visit with the patient's obstetrician.

Eligibility criteria: Inclusion Criteria:

* Pregnant women in labor

Exclusion Criteria:

* Not a candidate for neuraxial anesthesia
* Patient refusal
* Allergy to morphine
* Patients with chronic pain syndromes

Primary outcomes:
measure: Opioid Consumption in MME
timeFrame: within 24 hours of delivery
Secondary outcomes:
measure: Pain Score
timeFrame: at 24 hours
measure: Obstetric Quality of Recovery Score (OBSQ10)
timeFrame: 24 hours
measure: Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10
timeFrame: up to 6 weeks
measure: Number of Participants With Exclusive Breast Feeding
timeFrame: 1 week
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Daniel Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.
Clinical trial NCT01150942: Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea
Official title: A Multi-center, Active-control, Randomized, Double-blind Phase 3 Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine 'KD-287(JEIMMUGEN INJ.) in Korean Healthy Children Aged 12~23 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Keywords: JEV
vero cell
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Hospital
name: Gachon University Gil Medical Center
name: Inha University Hospital
name: Inje University
name: Korea Cancer Center Hospital
name: Samsung Medical Center
name: The Catholic University of Korea
name: Ewha Womans University
name: Wonju Severance Christian Hospital
name: Kyunghee University Medical Center
First posted: 2010-06-25
Enrollment: 205
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12\~23 months

Detailed description: To compare the Vero cell-derived inactivated Japanese encephalitis(JE) vaccine 'KD-287(JEIMMUGEN INJ.)' with the mouse brain-derived inactivated JE vaccine in terms of the immunogenicity and safety, in Korean healthy children aged 12\~23 months

Eligibility criteria: Inclusion Criteria:

* Healthy children aged 12-23 months
* Written informed consent

Exclusion Criteria:

* History of documented HIV
* Known or suspected impairment of immunologic function
* History of serious chronic disease
* Received any JE vaccine prior to enrollment

Primary outcomes:
measure: immunogenicity
timeFrame: pre-dose, after 3rd vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hoan Jong Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yun KW, Lee HJ, Kang JH, Eun BW, Kim YJ, Kim KH, Kim NH, Hong YJ, Kim DH, Kim HM, Cha SH. Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC(R)) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial. BMC Infect Dis. 2015 Jan 8;15:7. doi: 10.1186/s12879-014-0744-4.
Clinical trial NCT04728542: ORIGIN® vs. VANGUARD® PS Observational Study
Official title: A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthroplasty
Replacement
Knee
Keywords: Arthroplasty
Knee
Prosthesis
Lead sponsor: Symbios Orthopedie SA
Sponsor class: INDUSTRY
First posted: 2021-01-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-inflammatory degenerative and inflammatory knee joint disease

Brief summary: The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.

Detailed description: This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study with 140 subjects with 2 years follow-up.

Eligibility criteria: Inclusion/exclusion criteria

Primary outcomes:
measure: Forgotten Joint Score
timeFrame: Preoperative, 1 year, and 2 years visits
measure: The Self-Administered Patient Satisfaction Scale
timeFrame: Preoperative, 1 year, and 2 years visits
Secondary outcomes:
measure: Oxford Knee Score (OKS)
timeFrame: Preoperative, 1 year, and 2 years visits
measure: EQ-5D-5L
timeFrame: Preoperative, 1 year, and 2 years visits
measure: Knee Society clinical rating system (KSS) Objective Knee Indicators
timeFrame: Preoperative, 1 year, and 2 years visits
measure: Single Leg Stance test
timeFrame: Preoperative, 1 year, and 2 years visits
measure: Time Up & Go tests
timeFrame: Preoperative, 1 year, and 2 years visits
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center of Johannes Gutenberg-University Mainz
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Philippe Drees, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlson VR, Post ZD, Orozco FR, Davis DM, Lutz RW, Ong AC. When Does the Knee Feel Normal Again: A Cross-Sectional Study Assessing the Forgotten Joint Score in Patients After Total Knee Arthroplasty. J Arthroplasty. 2018 Mar;33(3):700-703. doi: 10.1016/j.arth.2017.09.063. Epub 2017 Oct 7.
citation: Wheatley B, Nappo K, Fisch J, Rego L, Shay M, Cannova C. Early outcomes of patient-specific posterior stabilized total knee arthroplasty implants. J Orthop. 2018 Dec 6;16(1):14-18. doi: 10.1016/j.jor.2018.11.003. eCollection 2019 Jan-Feb.
citation: Kahlenberg CA, Lyman S, Joseph AD, Chiu YF, Padgett DE. Comparison of patient-reported outcomes based on implant brand in total knee arthroplasty: a prospective cohort study. Bone Joint J. 2019 Jul;101-B(7_Supple_C):48-54. doi: 10.1302/0301-620X.101B7.BJJ-2018-1382.R1.
Clinical trial NCT01977742: Rest-exercise Transition Training to Improve Cardiac Vagal Tone
Official title: A Sudden Rest-exercise Transition Training to Improve Cardiac Vagal Tone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects Evaluated With Low Cardiac Vagal Tone
Lead sponsor: Clínica de Medicina do Exercício
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: to investigate the hypothetical additive value of a sudden rest-exercise training over the cardiac vagal of cardiac patients in a supervised exercise program.

Detailed description: Allocating in the admission for a supervised exercise program all subjects evaluated with low cardiac vagal tone (cardiac vagal index ≤ 1,30), it is expected that from a sample of almost 150 subjects (all over 18 years-old, ranging mostly from 40 to 50), we will compare 50 subjects that adhered to the supervised exercise program ( more than 65% of expected presence). Patients with pacemaker on unable to exercise in the bicycle will be excluded from the study, as well as those who does not adhere to at least more than 65% of the expected presence in the supervised exercise program.

All the sample will be randomized to performed 8 weeks of a specific sudden rest-exercise training and after 8 weeks will discontinue the protocol, or will do the opposite ( 8 weeks of no specific protocol, followed by 8 weeks of specific sudden rest-exercise training). The cardiac vagal will be evaluated at every 8 weeks to measure the cardiac vagal index between both phases. During all the time, all clients will perform aerobic, strength and flexibility exercises as part of the supervised exercise program.

Eligibility criteria: Inclusion Criteria:

* cardiac vagal index ≤ 1,30

Exclusion Criteria:

* pacemaker
* low adherence
* cognitive/physical impairment

Primary outcomes:
measure: Supervised exercise program and rest-exercise transition training to improve cardiac vagal tone
timeFrame: 16 weeks
Secondary outcomes:
measure: Longitudinal effects of supervised exercise program and rest-exercise transition training to improve cardiac vagal tone
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Gama Filho University
name: Claudio Gil S Araujo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01161342: Nutritional Status Among Older Adults. Risk Factors and Consequences of Malnutrition
Official title: Nutritional Status Among Older Adults. Risk Factors and Consequences of Malnutrition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: Malnutrition
Aged
Aged 80 and over
Prevalence
Mortality
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Social Affairs, Sweden
First posted: 2010-07-13
Enrollment: 1771
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The included sample comprised 1771 patients 65 years and older, consecutively admitted during fifteen months to two internal medicine wards (n = 706), two surgical wards (n = 681), and one orthopaedic ward (n = 384) at the Central hospital in Västerås, Sweden.

Brief summary: The aim of the study is to estimate the prevalence of malnutrition among older adults admitted to hospital and to analyse predictive factors for malnutrition. Further, the aim was to analyse the association between nutritional status and all-cause and cause-specific mortality.

The hypothesis is that malnourished patients have a higher mortality then well-nourished patients after three years.

Detailed description: The baseline survey was a cross-sectional study of 1771 patients aged ≥65 years who were admitted to hospital. Nutritional status was assessed using the MNA instrument, and possible risk factors associated with malnutrition were recorded during the hospital stay. All-cause mortality was followed up after median 3.5 years s in a cohort study of 1767 participants. Cause-specific mortality was followed up after median 4.7 years in a cohort of 1767 participants. Previous dietary intake in middle-aged and older adults was recorded at basline in 725 participants, who had their nutritional status assessed with the MNA when admitted to hospital 10 years later.

Eligibility criteria: Inclusion Criteria:

* Patients 65 years or older

Exclusion Criteria:

* unable to communicate and no relative could anwer the questions (n = 356)
* receiving palliative care (n = 44)
* impossible to measure height or weight (n = 22)
* miscellanious (n = 71)

Primary outcomes:
measure: Nutritional status according to the screening instrument Mini Nutritional Assessment (MNA)
timeFrame: 30 minutes
measure: All-cause mortality
timeFrame: All-cause mortality was analyzed after median 3.5 years.
measure: Cause-specific mortality
timeFrame: Cause-specific mortality was analyzed after median 4.7 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Center for Clinical research, the County Council of Vestmanland/Uppsala University, Sweden
name: Leif Bergkvist, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03009942: Biochemical Mediators After Implant Loading
Official title: Nitric Oxide and Arginase Levels in Peri-Implant Tissues After Delayed Loading
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implant Loading
Keywords: nitric oxide
arginase
loading
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty patients with one or more implants restored with fixed crown prostheses

Brief summary: This study evaluates the nitric oxide and arginase levels in patients with dental implants. Peri-implant sulcular fluid and saliva samples were collected after loading of the implants

Detailed description: Nitric oxide (NO) metabolism is associated with the clinical inflammatory state of peri-implant tissues and also affected by the mechanic stimulus. Therefore, The NO content of PISF reflects two different measures and can serve as an indicator of peri-implant soft tissue inflammation and/or bone response to force application and loading Arginase may reduce NO production by depleting the common substrate. Thus, increased salivary arginase activities detected in periodontitis patients may cause decreased NO synthesis and lead to a decrease in the antibacterial property of saliva.

Eligibility criteria: Inclusion Criteria:

* Patients with ≥ 20 teeth, no systemic diseases that could affect bone metabolism, no smoking habits, and had one or more implants

Primary outcomes:
measure: Biochemical parameters (nitric oxide and arginase) in periimplant sulcular fluid and saliva
timeFrame: Baseline and 1, 3 and 6 months after implant loading
Secondary outcomes:
measure: Plaque index
timeFrame: Baseline and 1, 3 and 6 months after implant loading
measure: Gingival index
timeFrame: Baseline and 1, 3 and 6 months after implant loading
measure: Probing depth
timeFrame: Baseline and 1, 3 and 6 months after implant loading
measure: Bleeding on probing
timeFrame: Baseline and 1, 3 and 6 months after implant loading
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04400370: Point of Care Ultrasound to Evaluate Diaphragmatic Function in Children Undergoing Thoracic Surgery
Official title: Point of Care Ultrasound to Evaluate Diaphragmatic Function in Children Undergoing Thoracic Surgery: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm Dysfunction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 75
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients under 7 years undergoing lung resection

Brief summary: In children undergoing pulmonary resection, the diaphragm function is evaluated using ultrasound before and after surgery to evaluate the incidence of diaphragm dysfunction after pulmonary resection. In addition, we examine if there is a relationship between diaphragmatic dysfunction and pulmonary complications, including postoperative lung atelectasis.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients under 7 years undergoing lung resection

Exclusion Criteria:

* Asthma
* Myopathy or neuropathy

Primary outcomes:
measure: Changes in diaphragmatic thickness
timeFrame: 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
measure: Changes in diaphragm thickening fraction
timeFrame: 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
measure: Changes in the length of diaphragmatic tidal excursion
timeFrame: 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References: