louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05238428: Understanding and Overcoming the Racial/Ethnic Inequalities in COVID-19 Vaccination Acceptance
Official title: Mind the Vaccination Gap: Understanding and Overcoming the Racial/Ethnic Inequalities in COVID-19 Vaccination Acceptance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Refusal
Keywords: COVID-19 vaccination acceptance
vaccine hesitancy
trust
health inequality
racial/ethnicity
Lead sponsor: University of Essex
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Department of Health and Social Care
name: Kingston University
First posted: 2022-02-14
Enrollment: 4039
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In a 4 x 4 experimental design, the investigators will manipulate the content of the vaccination invitation message in within-subject and the message source in between-subjects. Each participant will hence read four versions of the COVID-19 booster vaccination invitation message sent by one of the four possible sources.
Primary purpose: TREATMENT

Brief summary: With the constant threat of new epidemic waves and the emergence of variants, COVID-19 resilience can only be attained when a sufficient level of immunity is achieved. Yet, in the US and the UK, COVID-19 vaccination campaigns have failed to secure consistent vaccination acceptance in racial/ethnic minority communities. Despite racial/ethnic minorities being more at risk from COVID-19, they are less vaccinated than the White majority. The investigators propose that current vaccination invitation messages are deemed less trustworthy by racial/ethnic minorities than the White majority and that this might partly explain reduced vaccination acceptance. To provide causal evidence of the role of trust and actionable insights, the investigators will experimentally assess the benefits of new invitation messages to receive the COVID-19 booster dose in large, racially/ethnically diverse samples in the US and the UK. Results will evidence how to increase message and source trustworthiness to foster trust and vaccination acceptance across racial/ethnic groups.


Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

* if participants complete the study in less than 5 minutes
* if participants complete the study without paying attention (as indicated by their answers to two attention check questions)

Primary outcomes:
measure: Trust perception
timeFrame: immediately after intervention
measure: Vaccination appointment booking
timeFrame: immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Qualtrics. The data is gathered via an online platform.
Study officials:
affiliation: University of Essex
name: Marie Juanchich, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05360628: Evaluation of PK and Safety of D-0120 and Allopurinol
Official title: A Phase I, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic Interactions Between D-0120 and Allopurinol in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: D0120 Allopurinol
Primary purpose: OTHER

Brief summary: Evaluation of safety and PK interaction between D-0120 and Alopurinol in healthy adult subjects


Eligibility criteria: Inclusion Criteria:

* Healthy subjects between the ages of 18-55
* Required evaluation by Investigator for screening and enrollment
* Agreement and compliance with the study and follow-up procedures

Exclusion Criteria:

* Significant medical history or current comorbidly determined by the Investigator.
* Pregnant or nursing women

Primary outcomes:
measure: Type, incidence, severity and attribution of AEs.
timeFrame: 14 days
measure: Plasma concentration of D-0120 and Allopurinol
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical
state: Wisconsin
Study officials:
References:
Clinical trial NCT03517228: Pilot Trial of the Robotic Uterine Manipulator
Official title: Pilot Trial of the Robotic Uterine Manipulator
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gynecologic Surgery
Keywords: Robotic Uterine Manipulator
18-173
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Northwell Health
First posted: 2018-05-07
Enrollment: 28
Sex: FEMALE
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 test a robotic uterine manipulator system called the Barakat Automated Uterine Manipulator (BAUM), which will assist the surgeon in moving and positioning the uterus during a hysterectomy. This new device will allow the surgeon to control the movements of the robotic arm directly instead of giving verbal instructions to a staff member. The BAUM has never been used during surgeries before this trial. Overall, the study goal is to determine whether the use of this robotic uterine manipulator system can be safely used in the operating room while improving surgeon control during the procedure.


Eligibility criteria: Inclusion Criteria:

* Female participant must be scheduled for a total laparoscopic or robotic-assisted hysterectomy for a gynecologic condition
* Female participants must be 18 years of age or older

Exclusion Criteria:

* Female participant is not eligible if the surgeon does not plan to use a uterine manipulator

Primary outcomes:
measure: the Number of Intraoperative Complications Attributed to the Robotic Manipulator.
timeFrame: 25- 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mario Leitao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03566628: Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography
Official title: Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Angiography
Shivering
Keywords: Cerebral Angiography
Shivering
Anaesthesia
Warmed solutions
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: Hospital Carlos Van Buren
First posted: 2018-06-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates whether the use of warmed solutions during cerebral angiography reduces the incidence of post-anaesthetic shivering. Half of participants will receive pre-warmed (39ºC) isotonic saline, while the other half receives the same solution at room temperature.

Detailed description: Shivering is a physiologic reaction aimed at raising body temperature that is very common amongst patients undergoing cerebral angiographies. The use of pre-warmed solutions during the procedure may reduce the incidence of shivering amongst these patients. In this triple-blind randomised trial, a consecutive sample of participants receiving total intravenous anaesthesia (TIVA) and undergoing cerebral angiography will be allocated to receive a warmed (39ºC) solution of up to 500cc of isotonic saline or the same solution, but at room temperature. Patients requiring sedation, those expected to require mechanical ventilation after the procedure, those with diminished consciousness (Glasgow Coma Scale \<15 pts) and patients not wishing to participate will be excluded from the study. The primary endpoint for this study is the incidence of shivering up to 60 minutes after the procedure is completed. Shivering will be assessed using a validated scale by operators unaware of treament allocation. All analyses will be undertaken by a statistician that will not participate of the clinical assessment of included patients.

Eligibility criteria: Inclusion Criteria:

* Patients receiving TIVA
* Patients undergoing cerebral angiography

Exclusion Criteria:

* Glasgow Coma Scale \<15 points prior to procedure
* Expected need of mechanical ventilation after procedure completion
* Use of sedatives
* Refusal to participate

Primary outcomes:
measure: Postprocedural Shivering
timeFrame: up to 60 minutes
Secondary outcomes:
measure: Shivering severity
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Valparaiso
country: Chile
facility: Hospital Carlos Van Buren
Study officials:
affiliation: Hospital Carlos Van Buren
name: Nathalie Lopez, MD
role: STUDY_DIRECTOR
affiliation: Universidad de Valparaiso
name: Alvaro Silva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Andrés Bello
name: Felipe Martinez, M.D; M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03348228: Effect of Hydroxycitrate on Urine Chemistry
Official title: Effect of Hydroxycitrate on Urine Chemistry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrolithiasis
Keywords: Hydroxycitrate Supplements
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hydroxycitrate (HCA) is a compound extracted from the fruit, Garcinia Cambogia. Hydroxycitrate supplements are available over the counter and are primarily promoted as a weight loss supplement. There has been recent evidence that hydroxycitrate is a potent inhibitor of calcium oxalate crystal growth and can lead to the dissolution of the crystals. The purpose of this research study is to study the effect of Hydroxycitrate (HCA) supplements on HCA urinary excretion and on urine chemistries in kidney stone formers and normal subjects.


Eligibility criteria: Inclusion Criteria:

Stone formers group:

* Established diagnosis of recurrent calcium stone formers
* Ages between 18 and 80
* Subjects must be able to read and follow instructions clearly and able to do 24 hour urine collections.
* Subjects must be voluntarily willing and able to sign an informed consent form.

Control Group:

* In addition to b, c and d above, subjects must not have any known kidney disease or family history of renal stones. Inclusion would be based on information provided by participants.

Exclusion Criteria:

-

Primary outcomes:
measure: changes in urinary excretion of citrate
timeFrame: 7 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03692728: Increased Risk of ADHD Among Children With Bilateral Congenital Cataracts
Official title: Increased Risk of Attention Deficit Hyperactivity Disorder Among Children With Bilateral Congenital Cataracts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Cataract
Keywords: congenital cataract
attention deficit hyperactivity disorder
Conners'Parent Rating Scale-48
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 262
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital-based

Brief summary: In this study, the investigators conducted a cross-sectional, face-to-face investigation to evaluate the behavioral and psychological disorders and the risk of ADHD among children with bilateral congenital cataracts using the Conners'Parent Rating Scale (CPRS) questionnaire, an assessment tool for screening ADHD that obtains parental reports of childhood behavioral problems in research and clinical settings.15-17 Age-matched children with normal vision and the Chinese urban norm were used as controls.


Eligibility criteria: Inclusion Criteria:

* CC children and NV children aged 3-8 years presenting to the Zhognshan Ophthalmic Center between July and December 2016.

Exclusion Criteria:

* Patients complicated with systemic manifestations, such as Lowe syndrome, Marfan syndrome, and Down syndrome, were excluded.

Primary outcomes:
measure: Risk of ADHD
timeFrame: 2016.7-12
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05066828: Conventional One-piece Versus Two-piece Magnet-retained Obturators
Official title: Patient Satisfaction of Conventional One-piece Versus Two-piece Magnet-retained Obturators for Patients With Complete Edentulism: A Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Evaluation of patients' satisfaction with conventional one-piece obturators versus two pieces magnet -retained obturators in completely edentulous patient maxillectomy cases.

Detailed description: Ten completely edentulous participants with hemimaxillectomy (8 males and 2 females) were selected in an across over study. Participants received conventional obturator one piece and two pieces obturator connecting by magnet attachment in alternate periods (sequences A-B and B-A), and outcomes were assessed after 1 week,3 months, and 6 months Evaluation included Obturator Functioning Scale(OFS) and Oral Health Impact Profile for edentulous people (OHIP-EDENT ). One way ANOVA test and Multivariate analysis of variance with a general linear model with repeated measure was used to test the impact of the group, time, and order on each of the studied scores (α=.05).

Eligibility criteria: Inclusion Criteria:

- completely edentulous participants with hemimaxillectomy mouth opening is not less than 25 mm and intact soft palate

Exclusion Criteria:

* exposed to radiotherpy

Primary outcomes:
measure: patient satisfaction
timeFrame: 1 week to 6 months
Secondary outcomes:
measure: patient satisfaction
timeFrame: 1 week to 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT02925728: Nutritional Intake of "Finger-food" on Elderly People in Seniors's Resident
Official title: Nutritional Intake of "Finger-food" on Elderly People in Seniors's Resident
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritive Value
Keywords: Finger-Food
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The undernourishment and the prevention of its risk at the elderly person in seniors's resident represent a major issue in public health. The diagnosis of undernourishment and its risk are systematically recommended in these structures where the nutrition of these people is a problem because often inappropriate for their capacities of prehension and consequently for their nutritional needs. One of the solutions to remedy can be found in the " finger-food ".

The study FIFO ("Finger-Food") suggests verifying the hypothesis which the finger-food would allow to increase the nutritional intake of the resident who have disorders of the prehension and\\or requiring a nutritional stimulation and\\or require an help to the preparation of the meal.


Eligibility criteria: Inclusion Criteria:

* Residents institutionalized in seniors's resident for 3 months at least
* Residents in disability to feed single-handedly because of cognitive and/or physical disorders
* Having at least use of a hand
* Do not opposing the participation in the study or information and not opposition of the family / close to confidence / legal guardian in case of resident in incapacity to understand (senility, insanity)

Exclusion Criteria:

* Confined to bed
* Specific diets (without residue, allergen, ...)
* Enteral nutrition
* Absence motricity of 2 hands

Primary outcomes:
measure: Quantitative Measure of Ingesta
timeFrame: Monthly: From date of finger-food's implementation until the date of the end of the study (assessed up to 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Departemental Vendée
Study officials:
References:
Clinical trial NCT03508128: Evaluation of EMI in Patients With Micra Leadless Pacemaker
Official title: Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electromagnetic Interference
Lead sponsor: Edward-Elmhurst Health System
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Micra leadless pacemakers implanted at Edward-Elmhurst Healthcare since May 2016 who then required a surgical procedure.

Brief summary: Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).

Detailed description: Patients with pacemakers have a potential risk of EMI from sources including electrosurgery which can cause oversensing, pacing inhibition and device reset. There is limited data on surgical EMI in Medtronic Micra leadless pacemakers. The goal of this study is to evaluate for surgical EMI in subjects with leadless pacemakers.

Subjects with Micra leadless pacemakers requiring surgery will have procedure records reviewed for type of procedure and use of electrosurgery. Next postoperative device interrogation will be reviewed for evidence of EMI. EMI will be evaluated by review of sensing integrity counter, heart rate histograms and device reset.

Eligibility criteria: Inclusion criteria:

* subjects with an implanted Micra pacemaker who required a surgical procedure

Exclusion Criteria:

* no Micra pacemaker

Primary outcomes:
measure: EMI
timeFrame: up to 6 months next postop interrogation
Secondary outcomes:
measure: Device reset
timeFrame: up to 6 months next postop interrogation
Other outcomes:
Locations:
city: Naperville
country: United States
facility: EdwardElmhurst Healthcare
state: Illinois
Study officials:
affiliation: Edward-Elmhurst Health
name: Janet Gifford, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06078228: Prediction of Hypotension During Induction of General Anesthesia
Official title: Assessment of Ultrasonographic Carotid Artery Corrected Flow Time and Internal Jugular Vein Collapsibility Index in Prediction of Hypotension During Induction of General Anesthesia
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patient undergoing elective surgeries.

Brief summary: Post induction hypotension is closely related to postoperative complications. Patients are at high risk of hypotension due to preexisting hypovolemia and the vasodilatory effects of induction agents. Ultrasonographic measurement of the Carotid artery corrected flow time and internal jugular vein collapsibility index may predict post induction hypotension.

Detailed description: * Type of Study: Observational Prospective Cohort Design.
* Study Setting and ethical consideration: The approval of the Scientific Research Ethics Committee of the Faculty of Medicine, Ain Shams University will be obtained before starting work on the study. This study will be conducted in operating theatres of Ain Shams University Hospitals. Informed written consents to participate will be obtained from the patients.
* Study Period: One year (October 2023-October 2024)
* Study Population: Adult patient undergoing elective surgeries.

Eligibility criteria: Inclusion Criteria:

* 1- Patients of American Society of Anesthesiologists (ASA) physical status I to II of both genders.

  2- Aged 18-65 years. 3- Elective surgeries under general anesthesia. 4- BMI less than 40.

Exclusion Criteria:

* Patients with

  1. Renal diseases.
  2. Hepatic diseases.
  3. ASA scores of 3-4.
  4. The presence of a left ventricular ejection fraction less than 50%.
  5. Age under 18 years old.
  6. Patient refusal.
  7. Coronary heart disease.
  8. Cardiac disease including cardiomyopathy and mild to severe valve disease.
  9. Pulmonary hypertension.
  10. Peripheral arterial disease.
  11. Preoperative cervical vascular ultrasound abnormalities including plaque, stenosis and anatomical variation.
  12. Any previous neck surgery or trauma.

Primary outcomes:
measure: the predictive value of the carotid Ftc for prediction of hypotension.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbassia
Study officials:
affiliation: Ain Shams University
name: Marina George, MD candidate
role: PRINCIPAL_INVESTIGATOR
References: