louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03741621: Viscosity of Fibre Predicts Cholesterol-lowering in Healthy Individuals
Official title: Viscosity Rather Than Quality of Dietary Fibre Predicts Cholesterol-lowering Effect in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lipidemia
Healthy
Keywords: dietary fibre
Viscosity
lipids
Healthy
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Kellogg Company
name: University of Toronto
First posted: 2018-11-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the role of fibre viscosity (low, medium, high) in lowering cholesterol in healthy individuals


Eligibility criteria: Inclusion Criteria:

-healthy individuals

Exclusion Criteria:

* regular alcohol consumption
* regular smoking

Primary outcomes:
measure: change in LDL cholesterol
timeFrame: change from baseline after 21 days, relative to control
Secondary outcomes:
measure: change in total cholesterol
timeFrame: change from baseline after 21 days, relative to control
measure: change in triglycerides
timeFrame: change from baseline after 21 days, relative to control
measure: change in HDL cholesterol
timeFrame: change from baseline after 21 days, relative to control
measure: change in apolipoprotein B
timeFrame: change from baseline after 21 days, relative to control
measure: change in apolipoprotein A-1
timeFrame: change from baseline after 21 days, relative to control
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04018521: Use of Parent Connectors in First Episode Psychosis (FEP)
Official title: Use of Parent Connectors in First Episode Psychosis (FEP)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: First Episode Psychosis (FEP)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study proposes to adapt an evidence based peer parent navigator (PPN) intervention, called Parent Connectors, in which trained and supervised PPNs deliver weekly telephone-based support for six to nine months to parents or caregivers of all newly enrolled youth or young adults (Y/YA) in FEP services. This PPN model will be used to enhance the delivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY). This research project has potential to add value to the CSC model through the inclusion of a feasible, low burden intervention that may improve family participation in services and Y/YA outcomes. Using random assignment, this study will examine the feasibility and preliminary impact of an accelerator strategy-the inclusion of peer parent navigators or PPNs-in CSC teams.


Eligibility criteria: Inclusion Criteria:

* Parents or caregivers of all newlyenrolled youth or young adults (Y/YA) in FEP services

Exclusion Criteria:

* NA

Primary outcomes:
measure: Family Empowerment Scale (FES)
timeFrame: 9 Months
measure: Patient Activation Measure (PAM)
timeFrame: 9 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03302221: Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound
Official title: Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound in Patients Undergoing Video-assisted Thoracic Surgery With Different Kinds of Anaesthesia Management
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Lung Cancer
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Doppler Ultrasonography Assessed Vascular Changes
Primary purpose: TREATMENT

Brief summary: The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management.

Detailed description: The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management. The patients in this trial were visited during the entire operation and just before leaving the post-anaesthesia care unit. Velocity-associated data related to pulsed-wave Doppler ultrasound and the consumption of phenylephrine were collected.

Eligibility criteria: Inclusion Criteria:

1. ethnic Chinese;
2. age, 18 to 65 years old;
3. American Society of Anaesthesiologists (ASA) physical status I or II;
4. required VATS for lung surgery and one lung ventilation .

Exclusion Criteria:

body mass index exceeding 30 kg/m2; Patients with a history of hypertension, diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study.

Patients with arrhythmias or implanted cardiac pacemakers were excluded. Patients with diseases of the central or peripheral nervous system were excluded.

Patients taking medications affecting the autonomic nervous system, such as b-blockers and calcium channel blockers

Primary outcomes:
measure: The Change of end-diastolic velocity
timeFrame: baseline and 10 minutes after induction
Secondary outcomes:
measure: pulsed-wave Doppler ultrasound
timeFrame: before leaving the PACU, up to 5 minutes
measure: intraoperative consumption of phenylephrine
timeFrame: through study completion, an average of 3 hours
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Department of Anesthesiology
name: Hong Ma, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04755621: The Effect Of Core Stability Training In Temporomandibular Disorders
Official title: The Effect Of Core Stability Training on Pain, Function and Quality of Life in Individuals With Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Keywords: core stability
pain
quality of life
function
temporomandibular disorder
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: This study is to investigate the effect of Core stability training on pain, function, quality of life, sleep quality, body posture, foot posture, oral habits and kinesiophobia in individuals with temporomandibular disorder.

Materials and Methods: The study included 40 people over the age of 18, who were diagnosed with temporomandibular disorder from the dentist.


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18-55, diagnosed with temporomandibular disease by a dentist

Exclusion Criteria:

* Having received another treatment for TMR other than the use of night plate in the last 6 months
* Having a disease that can cause facial pain such as sinusitis, migraine, tension headache, trigeminal neuralgia
* Skeletal system fractures

Primary outcomes:
measure: Posture
timeFrame: 6 weeks
measure: Sleep Quality
timeFrame: 6 weeks
measure: Kinesiophobia
timeFrame: 6 weeks
measure: Oral Habits
timeFrame: 6 weeks
measure: Jaw Function
timeFrame: 6 weeks
Secondary outcomes:
measure: Foot Posture
timeFrame: 6 weeks
measure: Graded Pain
timeFrame: 6 weeks
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: University and Health Sciences Physical Therapy and Rehabilitation
state: Uskudar
Study officials:
affiliation: University of Health Sciences, Physical Therapy and Rehabilitation
name: Emre Serdar Atalay, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06019221: Pediatric Relapsing Polychondritis : Diagnosis and Management in a French Retrospective Study
Official title: Pediatric Relapsing Polychondritis : Diagnosis and Management in a French Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Relapsing Polychondritis
Keywords: Polychondritis
Relapsing Polychondritis
Pediatric Relapsing Polychondritis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor subject aged 1 to 17 years having atrophic polychondritis

Brief summary: The incidence in pediatrics is very low (about 3.5 per million per year according to a 2015 study) and therefore the data on the pathology very poor, especially on the therapeutic level.

Without appropriate treatment, the disabling sequelae, even involving the vital prognosis, are significant. However, in paediatrics, therapeutic habits have been extrapolated from adult data and lack precision.

Existing treatments are almost composed of immunomodulatory and/or immunosuppressive treatments. Different therapeutic lines have been introduced over the years and a better understanding of the pathology. More recently, biotherapies have been introduced in this pathology, but data on their effectiveness remain limited. Data on the evolution under therapy in children are thus still poor.

Complications related to the pathology that can jeopardize the vital prognosis and the response to treatment for this pathology deserve to be studied in order to be known and if possible avoided.

The aim of the study is to describe French practices and compare the lines of treatment proposed for juvenile atrophic polychondritis.


Eligibility criteria: Inclusion criteria:

* Minor subject aged 1 to 17 years
* Diagnosis of atrophic polychondritis between 01/01/2008 to 31/12/2022.
* Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject (or his parents) having expressed his (their) opposition to participating in the study
* Associated pathologies that cannot be related to the diagnosis of atrophic polychondritis and whose prognosis can lead to biases in the efficacy and/or complications related to treatments.

Primary outcomes:
measure: Therapeutic effectiveness of the various treatments proposed depending on the degree of initial clinical involvement
timeFrame: Files analysed retrospectively from from January 01, 2008 to December 31, 2022 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie 1 - CHU de Strasbourg - France
Study officials:
affiliation: University Hospitals of Strasbourg
name: Ariane ZALOSZYC, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02827721: Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Obstructive Ventilation Disorder
Pulmonary Emphysema
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with indication for routine lung function testing

Brief summary: Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of COPD.


Eligibility criteria: Inclusion Criteria:

* known or suspected COPD
* known or suspected obstructive ventilation disorder
* pulmonary healthy controls

Exclusion Criteria:

* pregnancy
* inability to participate

Primary outcomes:
measure: lung clearance index (LCI) as determined by multiple breath washout
timeFrame: 30 minutes
measure: airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry
timeFrame: 30 minutes
Secondary outcomes:
measure: repeatability of lung clearance index (LCI)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Center Mannheim
Study officials:
References:
Clinical trial NCT04668521: Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
Official title: Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adnexal Mass
Germline BRCA1 Gene Mutation
Germline BRCA2 Gene Mutation
Hereditary Breast and Ovarian Cancer
Lead sponsor: Aspira Women's Health
Sponsor class: INDUSTRY
First posted: 2020-12-16
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with or without a pelvic mass.

Brief summary: The objective of this project is to validate a next-generation assay that utilizes both the protein biomarkers of our already established ovarian cancer risk assessment combined with a molecular profile in both germline and early somatic detection.


Eligibility criteria: Key inclusion criteria:

* Female subject
* 18 years of age or older

Cohort A specific inclusion criteria:

• Diagnosed with a pelvic mass

Cohort B specific inclusion criteria:

* Diagnosed with a pelvic mass
* Undergoing genetic testing through our commercial offering

Cohort C specific inclusion criteria:

• Subject must not have an identifiable adnexal mass and may, or may not, have a family history or a known familial genetic abnormality (germ line or identified in family cancer i.e. somatic DNA mutation) associated with ovarian cancer.

Exclusion Criteria:

* n/a

Primary outcomes:
measure: OVA360
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Silvana Franco
state: Texas
Study officials:
affiliation: Aspira Women's Health
name: Todd Pappas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03220321: Pink and White Esthetic Scores of Polymer-infiltrated-ceramic-network and Lithium Disilicate Implant Hybrid Abutment Crowns
Official title: Pink and White Esthetic Scores of Polymer-infiltrated-ceramic-network and Lithium Disilicate Implant Hybrid Abutment Crowns: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implants
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of polymer-infiltrated-ceramic-network hybrid ceramic on pink and white esthetics in comparison with lithium disilicate.

The research hypothesis is that there will be comparable clinical performance results between polymer-infiltrated-ceramic-network and lithium disilicate hybrid abutment crowns.


Eligibility criteria: Inclusion Criteria:

* Literate, capable of reading and signing the informed consent document
* Healthy, free from or with controlled systemic disease
* With acceptable oral health to support implant restorations
* With good bone quality and quantity
* Cooperative, accepting follow up and maintenance sessions
* Having single missing tooth in esthetic zone

Exclusion Criteria:

* Under 18 years old
* Illiterate, unable of comprehending or signing the informed consent document
* Unhealthy with uncontrolled systemic disease
* Pregnancy
* With unfavorable oral state that might affect implant procedure and restoration
* Uncooperative, not willing to return for follow up visits

Primary outcomes:
measure: Pink Esthetic Score (PES)
timeFrame: 6 months
measure: White Esthetic Score (WES)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05297721: Nurses' Level of Knowledge on Skin Tears: A Cross-Sectional Study
Official title: Determination of Nurses' Level of Knowledge on Skin Tears in Acute Care Hospitals: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nurse's Role
Wound
Knowledge, Attitudes, Practice
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 384
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all nurses working in acute care hospitals in Turkey.

Brief summary: Skin tears (ST) are one of the skin integrity problems encountered in healthcare settings with rates equal to or greater than pressure injuries. However, the importance of this problem has been emphasized in the literature in recent years. This study was conducted to determine the knowledge level of nurses about ST.

Detailed description: The population of the study consisted of all nurses working in acute care hospitals in Turkey.

The sample size of the study was calculated as 384 nurses. The data of the study were collected in the form of online and paper-based surveys (an introductory information form and the Skin Tear Knowledge Assessment Instrumen)

Eligibility criteria: Inclusion Criteria:

* were employed as a nurse for at least 1 year
* cared for patients aged 65 and over
* agreed to participate in the study

Exclusion Criteria:

• nurses who filled in the data collection tools incompletely

Primary outcomes:
measure: Skin Tear Knowledge Assessment Instrument
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri City Hospital
state: Melikgazi
Study officials:
References:
Clinical trial NCT01063621: Extended Long-Term Safety Study of KW-6500
Official title: Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection at Home in Patients With Parkinson's Disease)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a extended long-term safety study in Parkinson's disease patients who have motor response complications on levodopa therapy and completed 12 weeks administrations of KW-6500 in 6500-004 study. The safety and efficacy of long-term subcutaneous self-injections of KW-6500 are evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients who have given written informed consent
* Patients who have completed the 6500-004 study

Primary outcomes:
measure: Adverse events and related adverse events
timeFrame: From first administration of study drug through Study Week 52
Secondary outcomes:
measure: Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in UPDRS part III, response ratio, and UPDRS part II score
timeFrame: From first administration of study drug through Study Week 52
Other outcomes:
Locations:
city: Toon
country: Japan
state: Ehime
Study officials:
References:
Clinical trial NCT05231421: A Focus Group Study to Explore Smoking Triggers and Acceptability of Just-in-time Adaptive Intervent
Official title: A Focus Group Study to Explore Smoking Triggers and Acceptability of Just-in-time Adaptive Interventions (JITAI) for Smoking Cessation Among Low-income Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Smoking Cessation
Smoking Behaviors
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2022-02-09
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will recruit low-income current smokers

Brief summary: This research intends to identify common smoking triggers and barriers to quitting smoking; understand useful and effective strategies for smoking cessation; and explore the feasibility and acceptability of mobile phone-based interventions among low-income smokers.

Detailed description: This research intends to identify common smoking triggers and barriers to quitting smoking; understand useful and effective strategies for smoking cessation; and explore the feasibility and acceptability of mobile phone-based interventions among low-income smokers.

Specific research questions of this research project are:

1. What are the common smoking triggers and barriers to quitting smoking for low-income smokers?
2. What are the preferred and useful smoking cessation strategies based on low-income smokers quitting experience?
3. What is the feasibility and acceptability of using a) text messages, b) virtual reality programs, and c) just-in-time adaptive smoking cessation interventions among low-income smokers?

Eligibility criteria: Inclusion criteria:

1. between 18 and 89 years old
2. current smokers
3. reside in Denver Metropolitan Area
4. have a personal cell phone
5. have a household income at or lower than 200% of the federal poverty level; and
6. ability to read and speak English or Spanish (since a large proportion of the low-SES population in Denver are Spanish speakers).

Exclusion criteria:

1. Unable to provide informed consent;
2. age ≥ 89 years;
3. unable to speak or understand English, or Spanish.

Primary outcomes:
measure: Use focus group discussion to identify barriers faced by low-income smokers
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Colorado Research Center
state: Colorado
Study officials:
affiliation: Colorado Research Center
name: Shuo Zhou
role: PRINCIPAL_INVESTIGATOR
References: