louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06662279: Hyrax Vs. Invisalign Palatal Expander Clinical Study
Official title: Hyrax Vs. Invisalign Palatal Expander Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malocclusions
Narrow Maxilla
Narrow Maxillary Arch
Crowding
Lead sponsor: Align Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.


Eligibility criteria: Inclusion Criteria:

* Subject ages 6-11 years old
* Subject must need maxillary expansion
* Subjects must have erupted dentition in the area of the primary molars or permanent premolars and the first permanent molar

Exclusion Criteria:

* Subjects with palatal exostosis/surface aberration/ cleft palate
* Subject's dentition not compatible with device or allergy to device materials
* Subject with active caries, periodontal disease, TMD

Primary outcomes:
measure: width of palate after expansion
timeFrame: from enrollment to study completion, approximately 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Orange Coast Orthodontics
state: California
city: Warner Robins
country: United States
facility: Spillers Orthodontics
state: Georgia
city: Naperville
country: United States
facility: Innovative Orthodontic Centers
state: Illinois
city: Chevy Chase
country: United States
facility: The Orthodontic Studio
state: Maryland
Study officials:
References:
Clinical trial NCT03370679: The Prognostic Significance of Premature Ventricular Complexes in Patients Without Structural Heart Disease
Official title: The Prognostic Significance of Premature Ventricular Complexes in Patients Without Structural Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Ventricular Complexes Multiple
Premature Ventricular Contraction
Keywords: Premature
Ventricular
Complexes
Beats
Prognosis
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Premature Ventricular Complexes treated at Three major hospitals in the Stockholm area (Danderyd Hospital, Karolinska Hospital and Södersjukhuset Hospital)

Brief summary: With this project the investigators aim to investigate whether premature ventricular complexes (PVC) have a prognostic significance in persons without structural heart disease. Further the investigators look at the possible connection between PVC-morphology and clinical outcome and investigate whether advanced cardiac imaging-methods may identify subtle signs of heart disease in PVC-patients with normal findings at echocardiography.

Detailed description: The PULSE project consists of four different studies:

* in study one the investigators include patients who are evaluated because of PVCs and have no signs of structural heart disease at echocardiography and exercise test. The investigators follow them (average follow-up time 3,5 years) to investigate if they have a higher mortality och cardiovascular morbidity than standard population
* in study two the investigators carry out a sub-group analysis of the population in study one to assess whether PVC:s different sites of origin (morphology) are related to the clinical outcome
* in study three the investigators include persons with a high PVC-burden (at least 10 000 PVC:s/day) and normal echocardiography. The included subjects undergo magnetic resonance (MR) to investigate whether it can identify signs of heart disease where standard echocardiography cannot

Eligibility criteria: Inclusion Criteria:

- Diagnosed with Premature Ventricular Complexes at Three major Hospitals in Stockholm, Sweden

Exclusion Criteria:

* History of Myocardial Infarction
* Undergone coronary arterty bypass grafting (CABG)
* Finding of Heart Failure at echocardiography
* Direct or indirect findings of coronary ischaemia at exercise test, coronary angiography or other equivalent examination

Primary outcomes:
measure: Mortality
timeFrame: Average follow-up time 3,5 years
Secondary outcomes:
measure: Cardiovascular morbidity
timeFrame: Average follow-up time 3,5 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Hjärtkliniken Danderyds Sjukhus
Study officials:
affiliation: Karolinska Institutet - Danderyd Hospital
name: Raffaele Scorza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03678779: Snack It Up for Parents: Interventions to Improve Children's Snacks
Official title: Snack It Up for Parents: Interventions to Improve Children's Snacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Snacking
Keywords: child nutrition
nutrition education
parent intervention
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Newman's Own Foundation
name: Stop & Shop Supermarket Company
name: Soccer4Success/America SCORES
First posted: 2018-09-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Influencing children's snacking habits has the potential to reap long-term rewards, yet few studies have focused on helping parents to provide healthier snacks for their children. The study tested the feasibility and preliminary effectiveness of parent interventions to improve snacks for children ages 8-12.

Detailed description: Objective. Influencing children's snacking habits has the potential to reap long-term rewards, yet few studies have focused on helping parents to provide healthier snacks for their children. The study tested the feasibility and preliminary effectiveness of parent interventions to improve snacks for children ages 8-12.

Methods. Parents of children enrolled in an out-of-school-time soccer program in a low-income school district (n 16) were recruited. A comparison of 3 randomly-assigned interventions was conducted: 4 parents received grocery store gift cards (Incentive); 7 received nutrition education videos with tip sheets (Education); and 5 received both (Combined). The interventions were assessed qualitatively by interviewing parents and quantitatively to determine motivation (psychosocial survey) and children's snack quality (web-based 24-hour recall).

Eligibility criteria: Inclusion Criteria:

* 18 year and older
* Must have a child enrolled in one of three designated soccer sites of the study and must agree to let their child take the online 24 hour recall (ASA24)
* Must have a child 7 years or older participating on a soccer team
* Must frequently buy groceries from Stop \& Shop (only if recruited for a study arms that involves grocery coupons)
* Must be literate in English or Spanish.

Exclusion Criteria:

* Failure to provide informed consent

Primary outcomes:
measure: snack quality by on-line 24-hour dietary recall (ASA24)
timeFrame: 6 weeks
Secondary outcomes:
measure: Intrinsic motivation by adapted Intrinsic Motivation Inventory
timeFrame: 6 weeks
measure: Decisional balance by the Mainvil Decisional Balance Scale
timeFrame: 6 weeks
measure: Self-efficacy by questions adapted NCI Food Attitudes and Behaviors Survey
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06459479: Conversational AI Study
Official title: Conversational Artificial Intelligence Simulations to Improve Non-Technical Skills Among Anesthesiology Trainees: A Prospective, Mixed-Methods Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Medical Education
Keywords: artificial intelligence
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, collaborative, mixed-methods study which includes anesthesiology trainees receiving one active intervention - a conversational artificial intelligence (CAI) simulation. The goal is to explore the capability of AI to provide high-fidelity simulations that can ultimately improve how healthcare professionals handle difficult conversations such as disclosing medical errors or mistakes.


Eligibility criteria: Inclusion Criteria:

* Hospital providers, including nurses, physician assistants, physicians, physician trainees, and other healthcare workers at Lucile Packard Children's Hospital (LPCH) and affiliated facilities who communicate with patients daily will be included

Exclusion Criteria:

* Participants with reported severe motion sickness
* Nausea
* Seizure disorder
* Currently using chronotropic heart medications, such as β blockers

Primary outcomes:
measure: Evaluate acceptance of Conversational Artificial Intelligence Simulations using Guided Discussion Interview Question Guide
timeFrame: Before simulation
Secondary outcomes:
measure: Evaluation of Conversational Artificial Intelligence Simulations usability via the System Usability Scale (SUS)
timeFrame: Immediately after simulation
measure: Evaluation of Conversational Artificial Intelligence Simulations usability via the User Experience Questionnaire (UEQ-S).
timeFrame: Immediately after simulation
measure: Evaluation of the reliability of AI quantitative assessment of non-technical performance compared to expert human assessors
timeFrame: immediately after simulation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02798679: Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity
Official title: Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiotoxicity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive participants with breast cancer or lymphoma scheduled to receive anthracycline-based chemotherapy or trastuzumab.

Brief summary: The purpose of this study is to determine whether pre-existing cardiac fibrosis is a predictor of cancer treatment-related cardiotoxicity.


Eligibility criteria: Inclusion Criteria:

* Stage I-III breast cancer or lymphoma with a \>2 year life expectancy
* A treatment plan that includes anthracyclines and/or trastuzumab
* Age \>45 years
* Able to hold breath for 10 seconds
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Refusal or inability to provide informed consent
* Known heart failure or LVEF \<50%
* Heart rate over 100 bpm
* Renal dysfunction with GFR \<30 mL/min/1.73m2
* Participants with pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
* Symptomatic claustrophobia
* Plans to move within 24 months of enrollment

Primary outcomes:
measure: Cardiotoxicity assessed clinically or by cardiac MRI
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Chetan Shenoy, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07008079: Flapless Mini-incision Implant Surgery
Official title: Flapless Mini-incision Implant Surgery vs Conventional Flap or Flapless Implant Surgery: A Prospective, Randomized, Single Blind, Clinical and Radiographic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: IMPLANTATION
Dental Implant
Dental Implant Placement
Peri-Implant Tissues
Keywords: flapless surgery
mini-incision surgery
peri-implant soft tissue
dental implant
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: King Saud University
First posted: 2025-06-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluate the clinical efficacy of the flapless mini-incision method compared to conventional flap and flapless punch methods


Eligibility criteria: Inclusion Criteria:

* Adult patients with adequate bone height and width at the site of implant 120 placement, and good quality bone to support a primary stability of at least 30 Ncm and D2 bone quality according to Lekholm and Zarb classification), based on preoperative radiographic assessment
* Clinical evidence of optimal periodontal health with no active periodontal disease in adjacent teeth
* No history of systemic illnesses that could affect bone health and wound heal- ing (e.g. uncontrolled diabetes mellitus, osteoporosis, renal osteodystrophy...etc.)
* No history of or requirement for bone grafting and augmentation at the implant site
* Willingness to participate in the study and attend prescribed follow-up appointments

Exclusion Criteria:

* Patients with history of radiation therapy for head and neck cancer
* Patients with history of allergy and hypersensitivity to local anesthetic agents, and biomaterials used in dental implants
* Pregnant women and lactating mothers
* History of smoking (\>2 cigarettes per day)
* Patients under treatment with anti-resorptive or anti-neoplastic medication such as bisphosphonates, chemotherapeutic agents, and monoclonal antibodies (e.g. Denosumab

Primary outcomes:
measure: Pain score
timeFrame: 18 months postoperatively
Secondary outcomes:
measure: Soft-tissue healing
timeFrame: 18 months postoperatively
measure: Radiographic bone level
timeFrame: 18 months postoperatively
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
References:
Clinical trial NCT01113879: Exercise as an Adjuvant to Aphasia Therapy
Official title: Exercise as an Adjuvant to Aphasia Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: rehabilitation
aphasia
exercise
BDNF
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Brooks Rehabilitation
First posted: 2010-04-30
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study used a single-subject, multiple-baseline design across behaviors. Following assessment and baseline procedures, participants completed 2 therapy periods: Block 1 was aphasia therapy alone, and Block 2 was aphasia therapy plus aerobic exercise or stretching.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities than patients who do not participate in aerobic activity.

Detailed description: The objective of this research project is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities with treatment than patients who do not participate in aerobic activity. As secondary objectives, we will determine if there is a direct relationship between either brain efficiency or increases in Brain Derived Neurotrophic Factor (BDNF) after exercise and higher learning rates in aphasia.

Eligibility criteria: Inclusion Criteria:

* Post-stroke aphasia
* at least 6 months post-stroke
* at least minimally intact auditory verbal comprehension
* pre-morbidly right handed
* native English speaker

Exclusion Criteria:

* contraindications for fMRI (metal implants, claustrophobia)
* inability to pass an exercise tolerance test
* significant depression
* uncorrected hearing or vision problems
* severe apraxia of speech
* regularly perform 20 minutes of cardiovascular exercise 3 times per week

Primary outcomes:
measure: Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means
timeFrame: administered before and after each of two, two week aphasia therapy blocks
Secondary outcomes:
measure: Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise
timeFrame: six samples collected over a 16 week period
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
city: Jacksonville
country: United States
facility: Brooks Rehabilitation Clinical Research Center
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System
name: Stacy M. Harnish, PhD CCC/SLP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harnish SM, Rodriguez AD, Blackett DS, Gregory C, Seeds L, Boatright JH, Crosson B. Aerobic Exercise as an Adjuvant to Aphasia Therapy: Theory, Preliminary Findings, and Future Directions. Clin Ther. 2018 Jan;40(1):35-48.e6. doi: 10.1016/j.clinthera.2017.12.002. Epub 2017 Dec 23.
Clinical trial NCT06846879: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Hospitalizations
Official title: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Hospitalizations: Validation of an Algorithm Based on Computerized Hospital Databases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Quality of Care
Evaluation
Emergency Department
Appropriateness
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 240000
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: All patients aged 18 years and over who arrived at participating centres between 1 January 2023 and 31 December 2024.

Brief summary: The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.

Detailed description: The information normally recorded in the Emergency Department medical record will be used, as well as the available clinical and administrative databases. For reasons of feasibility, the investigators will also restrict the analysis to patients coming to the Emergency Department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.

Eligibility criteria: Inclusion Criteria:

All patients aged 18 years and over who arrived at participating centres between 1 January 2023 and 31 December 2024.

Exclusion Criteria:

All patients under 18 years of age arriving at participating centers between January 1, 2023 and December 31, 2024 and all patients arriving at participating centers outside the time frame January 1, 2023 - December 31, 2024.

Primary outcomes:
measure: Qualitative validation and first refinement of the classification algorithm
timeFrame: From August 2025 to November 2025
measure: Quantitative validation and second refinement of the classification algorithm
timeFrame: From September 2025 to October 2026
measure: Application of the algorithm to all eligible patients
timeFrame: From November 2026 to Dicember 2026
measure: Feasibility of assessing the appropriateness of discharge from the emergency room
timeFrame: From November 2026 to June 2027
Secondary outcomes:
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: Ospedale San Luigi Gonzaga
Study officials:
References:
Clinical trial NCT01671579: Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease
Official title: Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Sm. Bowel Crohn Disease.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2012-08-23
Enrollment: 33
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To establish the accuracy of bowel ultrasound in the follow-up of known (previously diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance imaging technology used to obtain detailed images of the small bowel) as the reference standard.

Detailed description: 25-30% of individuals with Crohn disease present during childhood or adolescence, and the incidence is rising. MRE (magnetic resonance enterography) is considered the standard of care for imaging of pediatric small bowel Crohn's disease. Bowel ultrasound is an emerging technology for bowel assessment and offers several advantages over MRE, including lower cost, shorter exam time, and lack of need for sedation and contrast materials and bowel medication. The researchers goal is to assess the accuracy of bowel ultrasound in the follow-up of known pediatric small bowel Crohn disease using MRE and the reference standard.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or younger
* Subjects with known small bowel Crohn disease undergoing a clinically ordered imaging follow-up with MR enterography.

Exclusion Criteria:

* Subjects with suspected or newly diagnosed Crohn disease
* Subject who have the following in their body may not undergo MRE imaging:

  * Metal chips/shrapnel
  * Surgical clips
  * Artificial joints
  * Metallic bone plates
  * Prosthetic devices
  * Heart pacemakers
  * Clips in or around the eye balls
  * artificial heart valves
  * Bullet fragments
  * Chemotherapy or insulin pumps

Primary outcomes:
measure: Follow-up of known small bowel Crohn disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jonathan R. Dillman
role: PRINCIPAL_INVESTIGATOR
References: