louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00855569: Hemostatic Textile to Control Bleeding at Donor Graft Sites
Official title: Use of a HemostaticTextile (StasilonTM) to Control Bleeding at Skin Graft Donor Sites (Randomized, Single-Blind)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Keywords: allografting
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the UNC Jaycee Burn Center

Brief summary: The rationale underlying the study is that donor site bleeding is common and often problematic when presenting to the burn surgeon or staff. Frequently, gauze wound dressings are not sufficiently hemostatic to control a donor site bleed thereby leading to administration of vasoconstrictive agents and repeated application of wound dressing/pressure. The hemostatic textile Stasilon™ has proven superior to gauze in reducing bleeding from anesthetized pigs undergoing standardized surgically-induced trauma. Also, observational case reports have noted cessation of bleeding in a limited number of human patients with difficult to control bleeds.


Eligibility criteria: Inclusion Criteria:

* \>/= 18 years old
* burn injury requiring allografting from donor site

Exclusion Criteria:

* \< 18 years
* unable to give consent due to mental or emotional instability

Primary outcomes:
measure: To compare the efficacy of a new hemostatic textile named Stasilon™ against standard wound dressings in controlling burn patient donor graft site bleeding.
timeFrame: At the time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Jaycee Burn Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Preston Rich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03109769: The Effect of Using Mobile Applications for Improving Oral Hygiene
Official title: The Effect of Using Mobile Applications for Improving Oral Hygiene in Patients With Orthodontic Fixed Appliances: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to investigate the effect of the use of mobile phone application sending reminders to patients with orthodontic fixed appliances on oral hygiene.

Detailed description: Subjects were randomized into two groups, the first group received a mobile application that sends active reminders notifications of oral hygiene. The second group received verbal oral hygiene instructions during their regular visits to the orthodontics clinics.

Eligibility criteria: Inclusion Criteria:

1. Participants were having orthodontic fixed appliance treatment.
2. Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.
3. Participants were willing to comply with given oral hygiene instructions.

Primary outcomes:
measure: Change in Plaque Index
timeFrame: At baseline and after 4 weeks.
measure: Change in Gingival Index
timeFrame: At baseline and after 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Riyadh Colleges of Dentistry and Pharmacy
name: Omar H AlKadhi, BDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alkadhi OH, Zahid MN, Almanea RS, Althaqeb HK, Alharbi TH, Ajwa NM. The effect of using mobile applications for improving oral hygiene in patients with orthodontic fixed appliances: a randomised controlled trial. J Orthod. 2017 Sep;44(3):157-163. doi: 10.1080/14653125.2017.1346746. Epub 2017 Jul 13.
Clinical trial NCT06621069: The Effect of Long-term Use of Bisphosphonates on Femur Morphology
Official title: The Effect of Long-term Use of Bisphosphonates on Femur Morphology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Knee Osteoarthristis
Keywords: bisphosphonates
atypical femur fracture
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients are mostly from Zhejiang Province

Brief summary: Recent studies have shown that bone modeling can occur throughout life, suggesting bone has a persistent ability of adapting structure to loading. Some bone medications have a significant effect on the process of bone modeling based on histological studies. Bisphosphonates (BP), a classical anti-resorption drug which impacts the process of bone turnover, is related with atypical femur fractures while the mechanism is unclear. Several hypotheses are considered competitive. Among them, increased femur bowing is associated with atypical femoral fractures. However, it remains doubtful whether long-term BP use increases femur bowing. Thus, the investigators design this retrospective cohort study.

Detailed description: If the participants meet the Inclusion Criteria, the investigators will collect the baseline characteristics of patients including age, gender, body mass index (BMI), as well as characteristics of BMD by dual-energy X-ray absorptiometry (DXA), BP treatment (type of drugs, duration before baseline). The primary outcome was femoral lateral bowing (FLB), femoral neck shaft angle (FNSA), and hip knee shaft angle (HKSA) from the frontal plane in standing radiographs of the lower limbs.

Eligibility criteria: Inclusion Criteria:

* standing radiographs of the lower limb

Exclusion Criteria:

* non-standard lower limbs X-ray , rheumatoid arthritis, tumor of the femur， congenital anomalies of the lower extremity

Primary outcomes:
measure: femoral lateral bowing
timeFrame: through study completion, an average of 8 years
Secondary outcomes:
measure: femoral neck shaft angle (FNSA)
timeFrame: through study completion, an average of 8 year
measure: hip knee shaft angle
timeFrame: through study completion, an average of 8 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 1. Department of Orthopedics Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
state: Zhejiang
Study officials:
References:
Clinical trial NCT02163369: The Use of Aromatherapy for Symptom Management
Official title: The Use of Aromatherapy for Symptom Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nausea, Vomiting and Anxiety Associated With Medical Oncology Patients
Lead sponsor: Central DuPage Hospital
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to introduce the use of aromatherapy/essential oils to medical oncology patients at Central DuPage Hospital to assess their perceived effectiveness to relieve symptoms of nausea or vomiting and/or anxiety.

Peppermint oil will be used for nausea/vomiting and lavender oil will be used for anxiety. This study will involve administration of aromatherapy to a convenience sample of patients, who will then be asked to complete a brief questionnaire. The questionnaire will involve a simple likert scale to measure efficacy (in the opinion of the patient) and simple multiple-choice questions to determine patients' likeliness to use aromatherapy again.


Eligibility criteria: Inclusion Criteria:

* Adult hospitalized medical oncology patients admitted to Central DuPage Hospital.
* Age 18 years or greater.
* Able to understand and speak English.
* Women of non-childbearing potential or with childbearing potential with a negative pregnancy test documented during the hospital stay.
* Able to understand concept of aromatherapy for treatment of distressing symptoms.

Exclusion Criteria:

* Prisoners.
* Non-English speaking patients.
* Under the age of 18.
* Unable to comprehend the concept of aromatherapy.
* Severe cognitive impairment.
* Not experiencing the symptoms of nausea, vomiting or anxiety.
* Women with child-bearing potential who have not had a negative pregnancy test during the hospital stay.
* Patients with known allergy to lavender or peppermint.

Primary outcomes:
measure: Post Intervention Patient Interview Form
timeFrame: 24hrs post aromatherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
Study officials:
affiliation: Central DuPage Hospital
name: Mary Lyons, MSN, APN/CNS, RN-BC, ONC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01846169: Study to Improve Healthy Eating for At-Risk Older Adults
Official title: Healthy Eating for At-Risk Older Adults (HERO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biometrics
Keywords: food insecurity
older adults
nutrition
food deliveries
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 101
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This application, funded by the American Association of Retired Persons(AARP) Foundation, is to implement the Healthy Eating for at Risk Older Adults (HERO) initiative. This initiative will address barriers of affordability, and reduced mobility by providing older adults with nutritious foods that are usually difficult to purchase due to high cost; delivering needed foods to individuals in their homes; tailoring food delivery frequency based on level of food insecurity; and offering basic nutrition education.


Eligibility criteria: Inclusion Criteria:

* 55 years old or older
* if member of Boston Medical Center's Elders Living at Home Program: Not currently homeless and expect to live at current residence or in the area for next 6 months
* if NOT member of Boston Medical Center's Elders Living at Home Program: Not currently homeless, live at public housing development, and plan to live there for at least next 6 months
* Able to understand, speak and read English

Exclusion Criteria:

* Follows a special diet that cannot be accommodated, as ascertained by clinical judgment of the nurse.

Primary outcomes:
measure: body composition
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
measure: weight
timeFrame: 6 months
measure: blood pressure
timeFrame: 6 months
measure: blood glucose
timeFrame: 6 months
Secondary outcomes:
measure: nutritional risk
timeFrame: 6 months
measure: food insecurity
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Eileen O'Brien
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04955769: Body Image, Self-stigma, Intuitive Eating and Exercise Behavior in Overweight and Obese
Official title: Investigation of Body Image, Self-stigma, Intuitive Eating and Exercise Behavior in Overweight and Obese
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overweight and Obesity
Keywords: Intuitive Eating
Body Image
Self-Stigma
Exercise Behavior
Overweight and Obesity
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese individuals between the ages of 18-65 will be included in the study.

Brief summary: This study, it was aimed to investigate the relationship between body image, self-stigma, intuitive eating and exercise attitude levels, which are thought to be effective on the mental well-being of overweight and obese individuals. For this purpose, the Body Image Scale, Intuitive Eating Scale-2, Exercise Stages of Change Scale-Short Form and Decisional Balance Scale in Exercise will be used to assess overweight and obese individuals. 100 people will be included in the study.


Eligibility criteria: Inclusion Criteria:

* Individuals aged between 18-65
* BMI ≥30 kg/m2,
* No surgical operation in the last 6 months

Exclusion Criteria:

* Musculoskeletal disorders or systemic diseases that may prevent exercise
* The presence of psychiatric or neurological disease affecting cooperation and cognitive functions
* Presence of acute pain
* Heart pain
* Presence of previous myocardial infarction, subjective heart failure, uncontrolled diabetes and hypertension

Primary outcomes:
measure: Body Image Scale
timeFrame: Baseline
measure: Intuitive Eating Scale-2
timeFrame: Baseline
Secondary outcomes:
measure: Exercise Stages of Change Scale-Short Form
timeFrame: Baseline
measure: Decisional Balance Scale in Exercise
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: DiyeTat-Beslenme ve Danışmanlık
state: Kadıköy
Study officials:
affiliation: Istanbul Universitesi-Cerrahpasa
name: Nur Elçin Boyacıoğlu, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04641169: Concordance AUTOFEVG
Official title: Evaluation of the Ejection Fraction of the Left Ventricle Ejection Fraction (LVEF) by a New Automatic Evaluation Tool in a Pocket Ultrasound Device: Study of Concordance With the Estimated by Cardiac Magnetic Reasoning Imaging (MRI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Echocardiography
Medicine, Emergency
Technology Assessment, Biomedical
Heart Diseases
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Clinical ultrasound has become essential in emergency medicine. The guidelines are to use of echocardiography in specific contexts: dyspnea, hypotension or chest pain. The evaluation of left ventricle ejection fraction (LVEF) is one of the basic objectives of echocardiography. The reference assessment in emergency medicine is visual assessment. It suffers from poor inter-observer reproducibility. Pocket ultrasound scanners seem to meet the constraints of point-of-care ultrasound. A new tool is available on a pocket ultrasound device: the automatic evaluation of LVEF. Its interest could be to have a better inter-observer reproducibility than visual evaluation.


Eligibility criteria: Inclusion criteria:

* Patient over 18 years of age
* Management in the investigator centre
* Admitted for dyspnea or hypotension or chest pain

Exclusion criteria:

* Age \< 18 years
* Patient not benefiting from a social security system
* Patient deprived of liberty
* Patient under the protection of justice, under guardianship or curatorship
* Patient refusing to participate in the study
* Inability to provide the patient with informed information

Primary outcomes:
measure: evaluate the interobserver reproducibility
timeFrame: Day 0
Secondary outcomes:
measure: Assess the interobserver reproducibility of visual LVEF
timeFrame: day 0
measure: Interobserver reproducibility of the visual LVEF measurement;
timeFrame: Day 0
measure: Evaluate the intraobserver reproducibility of the automatic LVEF measurement
timeFrame: Day 0
measure: Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination.
timeFrame: Day 0
measure: Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination considering image quality
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Xavier Bobbia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05204069: Screening for 3-D Visual Disorders in Preschool Children
Official title: Screening for 3-D Visual Disorders in Preschool Children, VISION Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Strabismus
Anisometropia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 95
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation.

Detailed description: Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Methodology: The "Association Française de Strabologie et d'Ophtalmologie Pédiatrique" AFSOP proposed criteria based on a 3-dimensions visual screening to assess whether or not a child presents risk factors of amblyopia such as ametropia, strabismus and anisometropia. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation. Expected results: We assume that a vision screening operated with the AFSOP 3 dimension screening recommendations and conducted by paramedical actors such as orthoptists will prove more sensitive and easier to implement on a national scale.

Eligibility criteria: Inclusion Criteria:

* Children aged 3 to 4 years
* Enrolled in kindergarten in the first section
* In the 19th district of Paris
* Who should benefit from visual screening via the school medical service

Exclusion Criteria:

* Children who do not speak French
* Children who are physically or cognitively unable to participate in the screening

Primary outcomes:
measure: Screening for 3-dimensional visual disorders
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Emmanuel BUI-QUOC, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00628069: The Effect of Bench-model Training in Cognitive Learning in the Operating Room
Official title: The Effect of Bench-model Training in Cognitive Learning in the Operating Room
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sensitivity Training Groups
Keywords: Orthopedics
bone fixation
Lead sponsor: The Physicians' Services Incorporated Foundation
Sponsor class: OTHER
First posted: 2008-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents enrolled in first or second year from a variety of divisions.

Brief summary: Based on the motor learning theories, it is hypothesized that bench-model training will allow junior residents to be more interactive than trainees lacking similar active hands-on training.


Eligibility criteria: Inclusion Criteria:

* Students enrolled in first or second year of their residency from a variety of division

Exclusion Criteria:

* Residents from higher year

Primary outcomes:
measure: The primary objective of the study is to show that bench model testing not only improves the technical skill of the student but that it also influences the student's ability to learn the didactic information and decision-making.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Khalid Syed, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02821169: Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain
Official title: Impact of Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain in the Setting of Endoscopic Sinonasal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: sinus surgery
sphenopalatin ganglion
ropivacaine
local anesthesia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endoscopic sinus surgery (ESS) is a prevalent surgical procedure. It is required in many chronic rhinosinusitis for whom the medical treatment failed. In order to improve the postoperative management of patients treated with ESS, we aim to assess the analgesic action of local injection of ropivacaine in the nasal fossa.

Detailed description: A prospective randomized double blind placebo controlled study was designed. Local injection of ropivacaine or placebo was conducted at the end of the surgical procedure in both nasal fossa through endoscopic view in the sphenopalatine region.

Pain was measured in the postoperative course with visual analogic scale in the recovery room and the rhinologic department.

Eligibility criteria: Inclusion Criteria:

* patients requiring endoscopic sinus surgery
* ASA score 1 or 2
* patients with health care insurance
* approved consent

Exclusion Criteria:

* any sinonasal malignant tumor
* renal failure, hepatic disorder, respiratory deficiency, cardiovascular diseases
* neurologic disorders
* alcohol or drugs addiction
* preoperative facial pain from an extranasal origin
* coagulation disorders
* antidepressive treatment

Primary outcomes:
measure: Visual analog scale
timeFrame: at the 2 postoperative hours
Secondary outcomes:
measure: Analgesics consumption orally
timeFrame: during the 7 days post-surgery
measure: Administration of analgesics by parenteral route
timeFrame: at the 2 postoperative hours
measure: Visual analog scale for the intensity postoperative pain
timeFrame: at the 4 and at the 6 postoperative hours
measure: Visual analog scale for the during postoperative pain
timeFrame: At Morning and evening between the 1 and 7 days post surgery
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Goeffrey Mortuaire, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morisse M, Rysman B, Szymanski C, Fackeure R, Mouawad F, Mortuaire G. A randomized placebo-controlled trial assessing sphenopalatine ganglion block in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2021 Sep;11(9):1384-1386. doi: 10.1002/alr.22804. Epub 2021 May 19. No abstract available.