louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03207737: Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury.
Official title: A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injuries
SCI
Telehealth
Mindfulness
Nutrition
Exercise
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Lakeshore Foundation
name: The Craig H. Neilsen Foundation
First posted: 2017-07-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine the effects of onsite and telehealth programs for individuals with spinal cord injury. The primary aim of this study is to compare the effectiveness of a blended 5-day onsite health promotion program followed by a 12-month telehealth package composed of exercise, nutrition, and mindfulness, to a 12-month telehealth-only package in individuals with spinal cord injury. The investigators hypothesize that the blended onsite and telehealth program will achieve better gains in fitness, dietary control, body composition, and pain management scores across a one-year period in comparison to the telehealth-only group. The secondary objective of this study is to examine changes in psychosocial mediators between the two groups to determine if key social cognitive theory constructs were significantly different between the two groups. The investigators hypothesize that the blended onsite and telehealth program will achieve better improvements in these outcomes compared to the telehealth only group.


Eligibility criteria: Inclusion Criteria:

* SCI ≥ 1 year post injury
* Able to use arms for exercise
* 18-60 years old
* Reliable access to the internet
* Ability to prepare own food, or have input into person responsible for food preparation
* Can provide own self-care.

Exclusion Criteria:

* Cognitive impairment
* Depression
* Poorly controlled blood pressure (SBP ˃ 159 or DBP ˃ 95 mm HG)
* Cardiovascular disease event within the past six months
* Severe pulmonary disease
* Renal failure
* Current use of insulin or sulfonylurea agents
* Current use of medications for psychosis or bipolar disorder
* Active pressure ulcers

Primary outcomes:
measure: Change in Warwick-Edinburgh Mental Well-Being Scale Score reflecting resilience
timeFrame: Change from baseline to 7 days post baseline to 1 year post baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lakeshore Foundation
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: James Rimmer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02661737: Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Volume s
Official title: A Multi-center, Prospective and Observational Study to Evaluate Long-term Safety and Biodegradability of Modified Sodium Hyaluronate Gel (YVOIRE Volume s) Injected for Correction of Nasolabial Folds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Correction of Nasolabial Folds
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2016-01-22
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject who receive hyaluronic acid filler into the nasolabial folds

Brief summary: To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.


Eligibility criteria: Inclusion Criteria:

1. Subjects whose age is over 18 years old and under 65 years old
2. Subjects whose WSRS grade is equal or greater than 2
3. Subjects must be willing and able to provide written informed consent form
4. Subjects who are scheduled to be treated with YVOIRE volumes for facial tissue augmentation to correct the nasolabial folds

Exclusion Criteria:

1. Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE volume s
2. Subjects who have received permanent implantation (silicone, PAAG, PMMA, CaHA etc) on the nasolabial folds
3. Subjects who have received nonpermanent aesthetic treatments, such as botulinum toxin injection or filler on the nasolabial folds within 9 months before screening
4. Subjects who have received face lifting or plastic surgery on face within 9 months before screening
5. Subjects who have received laser therapy on the nasolabial folds, chemical peeling or peeling on face within 3 months before the screening
6. Subjects who have any skin diseases (including inflammation and skin cancer) or infectious diseases on the injection sites
7. Subjects who tend to have hypertrophic scars
8. Subjects with a history of streptococcal disease, severe allergy or anaphylaxis or bleeding disorders.
9. Women in pregnancy or lactation

Primary outcomes:
measure: Incidence of Device-related Adverse Events
timeFrame: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06163937: Acute Effects of Fruit Juices Consumption on Postprandial Glycemic Responses and Satiety
Official title: Examining the Acute Effects of Two Different Fruit Juices (Orange Juice and Mixed Fruit Juice Consisted of Apple, Orange, Grape, and Pomegranate) on Postprandial Glycemic Responses and Satiety in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Abnormality of Glucose Tolerance
Appetitive Behavior
Keywords: blood glucose
fruit juice
glycemic index
glycemic load
satiety
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
Collaborators: name: Institute of Technology and Agricultural Products
First posted: 2023-12-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study investigated the acute effects of two fruit juices on postprandial glycemic responses and satiety in healthy individuals

Detailed description: This study aimed to 1. Determine the glycemic index and glycemic load of two types of fruit juices (orange juice and mixed fruit juice consisted of apple, orange, grape, and pomegranate) and 2. Investigate the effects of these two fruit juices on postprandial glycemic responses and satiety in healthy individuals

Eligibility criteria: Inclusion Criteria:

* healthy
* non-smoking
* non-diabetic and normotensive men and women
* body mass index between 18.5 and 25 kg/m2

Exclusion Criteria:

* severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* gastrointestinal disorders
* pregnancy
* lactation
* competitive sports
* alcohol abuse
* drug dependency

Primary outcomes:
measure: Glycemic index
timeFrame: 2 hours
measure: Capillary blood glucose responses
timeFrame: 2 hours
Secondary outcomes:
measure: Subjective appetite ratings
timeFrame: 2 hours
measure: Blood pressure
timeFrame: 2 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
state: Attica
city: Athens
country: Greece
facility: Agricultural University of Athens
Study officials:
affiliation: Agricultural University of Athens
name: Emilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05481437: A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma
Official title: Specified Drug Use Surveillance for ADCETRIS Intravenous Infusion 50 mg -Untreated CD30 Positive Hodgkin Lymphoma (Pediatric)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hodgkin Lymphoma
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-08-01
Enrollment: 8
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.

Brief summary: This study is a survey in Japan of Brentuximab Vedotin used to treat children or teenagers with Hodgkin lymphoma (HL). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from Brentuximab Vedotin especially myelosupression, peripheral neuropathy, and lung disorder.

During the study, pediatric participants with HL will take Brentuximab Vedotin injection and AVD treatment (doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine) according to their clinic's standard practice. The study doctors will check for side effects from Brentuximab Vedotin for 26 weeks.


Eligibility criteria: Inclusion Criteria:

1. Treatment-naive participants
2. CD30 positive participants
3. Participants treated with the study drug in combination with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD).
4. Participants aged \< 18 years at the start of this drug.

Exclusion Criteria:

Participants with contraindications to the study drug.

Primary outcomes:
measure: Percentage of Participants who Experienced Myelosuppression
timeFrame: Up to 26 Weeks
measure: Percentage of Participants who Experienced Peripheral Neuropathy
timeFrame: Up to 26 Weeks
measure: Percentage of Participants who Experienced Lung Disorder
timeFrame: Up to 26 Weeks
Secondary outcomes:
measure: Percentage of Participants with Adverse Event (AE) Leading to Brentuximab Vedotin Discontinuation, Serious Adverse Event (SAE), and Grade 3 or Higher Adverse Event (AE)
timeFrame: Up to 26 Weeks
measure: Percentage of Participants Who Achieve or Maintain Any Best Response
timeFrame: Up to 26 Weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02864537: Self-management of Anticoagulation Treatment
Official title: Comparison Between Conventional Anticoagulation Treatment and Self-management of Anticoagulation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Venous Thromboembolism
Artificial Heart Valve
Keywords: warfarin
self-management
Conventional management
Training
TTR
Complications
Quality of life
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway.

Detailed description: Patients (n=132) on anticoagulant treatment with warfarin participated in a 21 weeks training program where they learned how to analyse International Normalised Ratio (INR) using the point-of-care instrument CoaguChek®XS and dose warfarin. The patients had to display their skills through a test before considered self-managing. They continued to measure INR weekly for two years. All INR values during the training program and self-control period were collected. In addition, the patients were told to notify if they had any complications during this period. INR values and complications two years before enrolment was collected from INR cards and/or their general practioner. The participant filled in a quality of life-questioner at enrolment and after two years of self-management.

Eligibility criteria: Inclusion Criteria:

* On life-long oral anticoagulation therapy
* Judged to be qualified for patient self-management anticoagulation treatment by their GP
* Motivated to follow the training program

Exclusion Criteria:

* Drug abuse
* Liver disease

Primary outcomes:
measure: Change in Time in therapeutic range (TTR)
timeFrame: From two years before enrolment until two years of self management
Secondary outcomes:
measure: Change in number of complications
timeFrame: From two years before enrolment until two years of self management
measure: Quality of life (QoL)
timeFrame: Baseline before training and after two years with self-management
Other outcomes:
Locations:
Study officials:
affiliation: University of Bergen
name: Una Ø Sølvik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01591837: A Study to Assess the Immunogenicity and Safety of CSL's 2012/2013 Formulation of Enzira® Vaccine in Healthy Volunteers
Official title: A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2012/2013 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged 18 to 59 Years) and 'Older Adults' (Aged 60 Years or Older)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or older.


Eligibility criteria: Inclusion Criteria:

* Males or females aged 18 years or older at the time of vaccination.
* Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Exclusion Criteria:

* Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
* Clinical signs of an active infection.
* A clinically significant medical condition.
* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
* Females who are pregnant or lactating.

Primary outcomes:
measure: The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
timeFrame: Approximately 21 days after vaccination
measure: The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
timeFrame: Approximately 21 days after vaccination
measure: The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
timeFrame: Approximately 21 days after vaccination
Secondary outcomes:
measure: Frequency and Intensity of Any Solicited Adverse Events (AEs).
timeFrame: During the 4 days after vaccination (Day 0 plus 3 days)
measure: Frequency of Any Unsolicited AEs.
timeFrame: After vaccination until the end of the study; approximately 21 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Study Site
Study officials:
affiliation: Seqirus
name: Clinical Director Vaccines
role: STUDY_DIRECTOR
References:
Clinical trial NCT01143337: Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis
Official title: A Multicenter Randomized, Double-blind, Placebo-controlled Study of MP-435 in Combination With MTX in Patients With Rheumatoid Arthritis - Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2010-06-14
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the Efficacy, Safety, and Pharmacokinetics of MP-435 administered for 12 weeks in subjects with rheumatoid arthritis (RA) on stable doses of Methotrexate.


Eligibility criteria: Inclusion Criteria:

* Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987) for at least 6 months.
* Subjects who inadequately response for stable dose of MTX.

Exclusion Criteria:

* Patients with Class IV functional activity by the Steinbrocker's scale.
* Patients who have received a biological agent in the past.
* Patients who have other rheumatic diseases, or who have other diseases with joint symptoms.
* Patients with severe or uncontrolled endocrine, psychiatric, cardiac, hematological, pulmonary, hepatic, kidney, gastrointestinal, or thyroid disease.

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response
timeFrame: Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)
Secondary outcomes:
measure: Percentage of Participants Achieving ACR 50 Response
timeFrame: Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)
measure: Percentage of Participants Achieving American College of Rheumatology 70 (ACR 70) Response
timeFrame: Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)
measure: Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components
timeFrame: LOCF (Week 12 or discontinuation time)
measure: Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components
timeFrame: LOCF (Week 12 or discontinuation time)
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Investigational site
Study officials:
References:
Clinical trial NCT02261337: Is Gait Speed and Sarcopenia Prognostic in Chronic Respiratory Disease?
Official title: Do Gait Speed and Markers of Sarcopenia Predict Prognosis in Patients With Chronic Respiratory Disease?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease and Allied Conditions
Keywords: Sarcopenia
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2014-10-10
Enrollment: 565
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: Any patient with chronic respiratory disease. The cohort will be recruited from Harefield hospital.

Brief summary: This study aims to assess usual walking speed (4-metre gait speed) and markers of sarcopenia predict mortality in patients with chronic respiratory disease.


Eligibility criteria: Inclusion Criteria:

* All patients with chronic respiratory disease who are able to complete the assessments.

Exclusion Criteria:

* Significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation).
* Any patient whom the Chief Investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease).

Primary outcomes:
measure: Number of participant deaths
timeFrame: 1 year
Secondary outcomes:
measure: Number of participant deaths
timeFrame: 2 years and 5 years
measure: Number of exacerbations as defined by a worsening of symptoms that warrant a change in medication.
timeFrame: 1 and 2 years
measure: Number of hospital admissions
timeFrame: 1 and 2 years
measure: Number of patients admitted to a nursing home
timeFrame: 2 and 5 years
measure: Number of hospital bed days
timeFrame: 1 and 2 years
Other outcomes:
Locations:
city: Harefield
country: United Kingdom
facility: Harefield hospital
state: Middlesex
Study officials:
affiliation: NIHR Respiratory Biomedical Research Unit Royal Brompton & Harefield NHS Foundation Trust
name: William DC Man, FRCP PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06960837: Ultrasound Simulation Case-based Workshop Implementation and Impact Assessment
Official title: Ultrasound Simulation Case-based Workshop Implementation and Impact Assessment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Point-of-care Ultrasound
Simulation Training
Medical Education in Emergency Ultrasound
Keywords: point-of-care ultrasound
simulation training
medical education
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a prospective cohort study implementing a point-of-care ultrasound (POCUS) simulation case-based workshop in emergency (EM) physicians at different training levels as an educational and competency-based assessment tool. The investigators incorporate elements of Miller's pyramid (second and third levels of "knows how" and "shows how") and the latter part of Kern's six step model framework for curriculum development (intervention implementation and student assessment, program evaluation, and feedback). The investigators will compare pre-/post-workshop knowledge and post-OSCE (Objective Structured Clinical Exam) technical skills scores. The investigators will also collect demographic data on baseline POCUS scans completed, training level, interest in ultrasound fellowship, monthly performed clinical POCUS scans, etc. The standardized simulation cases for EM POCUS training can then be generalized for use at any program globally to improve clinical training and patient care.


Eligibility criteria: Inclusion Criteria:

* Emergency medicine physicians

Exclusion Criteria:

* Emergency medicine nurses
* Emergency medicine technicians
* Advanced practice providers (APPs)

Primary outcomes:
measure: Change in knowledge exam score
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Ultrasound Competency Assessment Tool (UCAT) score
timeFrame: 12 months
measure: Number of POCUS (point-of-care ultrasound) exams performed per participant
timeFrame: 12 months
measure: Change in quality assurance score
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Rebecca G Theophanous, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
References: