louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05901662: Older Volunteers' Competence Training
Official title: Older Volunteers' Competence Training for Community-based Long-term Care Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volunteers
Keywords: knowledge and skills
motivation
self-efficacy
satisfaction
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 162
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project was aimed to evaluate the effectiveness of the competence training program in improving the knowledge and skills of volunteer work, the motivation for volunteering, self-efficacy, and satisfaction with volunteer work among older volunteers.

Detailed description: A cluster-randomized controlled trial was conducted to test the effects of a 3-month comprehensive competence training program in improving the knowledge and skills of volunteer work, the motivation for volunteering, self-efficacy, and satisfaction with volunteer work among older volunteers. Using convenience sampling, 10 senior activity centers with 162 older volunteers were recruited and cluster-randomized to the intervention group (5 centers) or wait-list comparison group (5 centers). The intervention group received a 3-hour weekly course training session in four consecutive weeks and provided services to community-dwelling older adults for two months; the comparison group provided their routine services at senior activity centers. Data were collected at baseline, one month, and three months into the study.

Eligibility criteria: Inclusion Criteria:

* older adults age ≥ 65
* able to read and write in Chinese
* being a volunteer at the senior activity center for at least 1 month

Exclusion Criteria:

* illiterate

Primary outcomes:
measure: knowledge and skills of volunteer work
timeFrame: 3 months
Secondary outcomes:
measure: motivation for volunteering
timeFrame: 3 months
measure: self-efficacy
timeFrame: 3 months
measure: satisfaction with volunteer work
timeFrame: 3 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University, Taiwan
name: Kuei-Min Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04206462: Investigation of Oxidative Markers and Antioxidant Defense in Female Patients With Osteoarthritis
Official title: Investigation of Oxidative Markers and Antioxidant Defense in Female Patients With Osteoarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with osteoarthritis

Brief summary: Osteoarthritis has a multifactorial etiology: aging, genetic, sex, weight, alimentation, injuries, infections etc. The objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats). Also, the oxidative-antioxidative balance will be evaluated by determining markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde.

Detailed description: A total of 300 patients with osteoarthritis will be included in the study. The objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats). Also, the weight and height of each patient will be assessed and the patients will be included in 4 classes based on the body mass index: underweight, normal weight, overweight and obese. The type of physical activity will also be noted and the oxidative-antioxidative balance will be evaluated by determining serum markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde. Correlation between eating behaviour, body mass index and oxidative stress markers will be made.

Eligibility criteria: Inclusion Criteria:

* osteoarthritis
* signed informed consent

Exclusion Criteria:

* drugs or foods with antioxidant effects
* lack of judgement
* refuse to participate

Primary outcomes:
measure: serum concentration of oxidative stress markers
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj Napoca
country: Romania
facility: Clinical Rehabilitation Hospital
Study officials:
affiliation: University of Medicine and Pharmacy Iuliu Hatieganu
name: Rodica A Ungur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05444062: Quebec Lung Cancer Screening PLUS Trial
Official title: Quebec Lung Cancer Screening PLUS Trial - a Randomized Controlled Trial of an Educational Intervention for Untreated Chronic Obstructive Pulmonary Disease (COPD) and/or Cardiovascular Disease (CVD) Identified During Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Coronary Artery Calcification
Keywords: COPD
Coronary Artery Calcification
Lung cancer screening
Undiagnosed disease
Educational intervention
Medication adherence
Untreated disease
Statins
Inhalers
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 330
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Does an educational intervention for untreated COPD and cardiovascular disease which is integrated in an existing lung cancer screening program improve guideline concordant medication adherence at 12 months


Eligibility criteria: Inclusion Criteria:

* Patient screened for lung cancer as part of the Quebec Lung Cancer Demonstration project by low dose CT scan of the chest.
* Cardiovascular aim: mild to severe CAC identified on low dose CT, not on guideline recommended lipid-lowering therapy.
* COPD aim: diagnosed with COPD, symptomatic (mMRC \>=1 or CAT\>= 10) and untreated, or not on first line guideline recommended therapy for COPD.

Exclusion Criteria:

* Any participant with a high suspicion of lung cancer, defined as Lung-RADS (Lung Imaging Reporting and Data System) 3 or 4, as this is an inopportune time to initiate new medical therapies.
* Cardiovascular aim: Absent CAC, known clinical atherosclerosis, known former heart surgery, Diabetes Mellitus.
* COPD aim: asymptomatic, or already on appropriate first line COPD therapy.

Primary outcomes:
measure: Guideline concordant statin therapy 1 year following the first low dose CT scan.
timeFrame: 1 year post CT
measure: Guideline concordant inhaler therapy 1 year following the first low dose CT scan
timeFrame: 1 year post CT
Secondary outcomes:
measure: Medication possession ratio (MPR) - Aim 1
timeFrame: 1 year post CT
measure: Medication possession ratio (MPR) - Aim 2
timeFrame: 1 year post CT
measure: COPD Symptoms
timeFrame: Baseline, 6 months post intervention, 12 months post intervention
measure: Quality of life using SF-36 questionnaire
timeFrame: Baseline, 12 months post intervention
measure: Patient satisfaction with communication and decision making
timeFrame: 3 months post intervention
measure: Health Care Utilisation
timeFrame: 1 year post intervention
measure: Absenteeism and presenteeism
timeFrame: baseline
measure: Health literacy
timeFrame: baseline
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
References:
Clinical trial NCT04695262: EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors
Official title: EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Subepithelial Tumors
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with subepithelial gastrointestinal tumors

Brief summary: The differentiation among the Gastrointestinal Subepithelial Tumors (SETs) represents a clinical challenge. Endoscopic Ultrasound (EUS) alone may be ineffective in differentiating SETs subtypes, and tissue sampling of these lesions may be technically difficult. EUS Elastography (EUS-E) has been applied to many gastrointestinal diseases, providing a qualitative/semi-quantitative stiffness analysis, but only few studies have examined the role of EUS-E in the diagnosis of SETs. In addition, the use of contrast agents has improved the diagnostic performance of the EUS, especially in the differentiation between GISTs and other gastrointestinal SETs.

The aim of the study is to examine the performance of EUS-E and Contrast Enhanced-EUS (CE-EUS) in distinguishing among different gastrointestinal SETs subtypes. EUS patterns of different techniques will be compared to the final diagnosis gained by the analysis of histopatological specimens (surgical resection or EUS-FNB) or imaging/clinical follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients with GI SETs scheduled for EUS-FNB
* Patients with age \> 18 but \<85 years

Exclusion Criteria:

* Patients with GI SETs \<15mm
* severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma
* severe cardiopulmonary diseases and severe chronic kidney disease defined as glomerular filtration rate (GFR) \< 15 ml/min
* known allergic disposition to SonoVue®
* pregnancy

Primary outcomes:
measure: EUS-E accuracy in terms of qualitative and quantitative elastography
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
Study officials:
References:
Clinical trial NCT02877862: Mobile Phone Technology to Increase Genetic Counseling
Official title: Mobile Phone Technology to Increase Genetic Counseling for Women With Ovarian Cancer and Their Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This innovative project seeks to harness mobile phone technology as a means to take preventive health care to a new level among ovarian cancer survivors. Using the Fogg Behavioral Model, developed from the concept of persuasive technology, this study proposes to develop the Mobile Application for Genetic Information on Cancer (mAGIC) intervention to motivate ovarian cancer survivors to undergo genetic counseling. The overall study objective is to develop and assess the feasibility and effectiveness of a theory-based intervention aimed to encourage ovarian cancer survivors to receive genetic counseling

Detailed description: This project seeks to harness mobile phone technology as a means to take preventive health care to a new level among ovarian cancer survivors. Using the Fogg Behavioral Model31 (FBM), developed from the concept of persuasive technology, this study proposes to develop the Mobile Application for Genetic Information on Cancer (mAGIC) week-long intervention to motivate ovarian cancer survivors to undergo genetic counseling.

Eligibility criteria: Inclusion Criteria:

* Woman diagnosed with ovarian, primary peritoneal or fallopian tube cancer
* 18 years old or older
* At least a fifth grade education
* Able to read and write in English
* Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

• Known major psychiatric or neurological diagnosis

Primary outcomes:
measure: Uptake of cancer genetic counseling
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Melissa Geller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vogel RI, Niendorf K, Petzel S, Lee H, Teoh D, Blaes AH, Argenta P, Rivard C, Winterhoff B, Lee HY, Geller MA. A patient-centered mobile health application to motivate use of genetic counseling among women with ovarian cancer: A pilot randomized controlled trial. Gynecol Oncol. 2019 Apr;153(1):100-107. doi: 10.1016/j.ygyno.2019.01.019. Epub 2019 Feb 1.
Clinical trial NCT02677662: Longitudinal Acute Air Pollution Systemic Effects
Official title: Longitudinal Acute Air Pollution Systemic Effects (LAPSE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Diesel exhaust
Oxidative stress
Systemic inflammation
Air pollution
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2016-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Air pollution continues to be a key global issue with many governments focusing great attention on air quality legislation because of its harmful environmental and health impacts. Whilst there is much that remains unknown about the mechanisms underlying the negative health effects of air pollution, it is generally acknowledged that air pollution exposure leads to an increase in cardiovascular, cerebrovascular and respiratory mortality and morbidity. The current study will investigate systemic effects during a 72 hour period after a controlled diesel exhaust exposure.

Detailed description: Exposure to air pollution (both indoor and outdoor sources) contributes to the premature deaths of 7 million people each year, primarily linked to cardiovascular and respiratory conditions. Within the complex mixture which air pollution comprises, combustion derived particulate matter (PM) has been suggested as one of the most harmful components to the cardiopulmonary system. In urban areas PM derived from combustion originates largely from diesel vehicles.

Numerous experimental chamber studies have demonstrated respiratory as well as cardiovascular dysfunctions after the inhalation of diesel exhaust. Many of these dysfunctions are driven by inflammation and oxidative stress. There is much less knowledge concerning the systemic effects of diesel exhaust exposure, and especially over longer time courses than 24 hours.

The investigators aim to investigate the time course of systemic effects (such as markers of inflammation, cardiovascular dysfunction, and oxidative stress) in blood and urine samples taken after a diesel exhaust exposure. The effects of exercise or rest in an experimental chamber exposure will also be investigated.

Eligibility criteria: Inclusion Criteria:

* Normal clinical examination
* Normal EKG
* Normal routine blood tests
* Normal lung function
* Normal skinprick test

Exclusion Criteria:

* Cardiovascular disease
* Diabetes Mellitus
* Asthma and/or allergy
* Smoking

Primary outcomes:
measure: Inflammatory biomarkers
timeFrame: 72 hours
Secondary outcomes:
measure: Oxidative stress markers
timeFrame: 72 hours
measure: Cardiovascular biomarkers
timeFrame: 72 hours
measure: Metabolomics
timeFrame: 72 hours
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Umeå University
name: Jenny Bosson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00475462: The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope, Vasovagal
Keywords: Metoprolol and Syncope
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2007-05-21
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study to evaluate the effectiveness of metoprolol versus conventional treatment in the prevention of syncope recurrence in children and adolescents.

Detailed description: Syncope is often a frustrating clinical problem seen in pediatric patients. Most pediatric syncope is benign, and vasovagal syncope (VVS) is the most common type of syncope seen in children . The diagnosis of VVS is established by history, often confirmed by tilt tests. A wide range of drugs has been proposed for VVS , with β-adrenergic blocking agents being first-line therapy. However, clinical studies have shown conflicting results in terms of therapy effectiveness. β-blockers have been claimed to be effective for 60% to 100% of young patients in many uncontrolled studies but not in most short- and long-term controlled studies . Sheldon et al., in a recent multicenter, double-blinded, placebo-controlled, randomized study of adult patients, reported that metoprolol was not effective in preventing VVS. To our knowledge, no pediatric randomized controlled trials with long-term follow-up have demonstrated the efficacy of β-blockers for the prevention of syncope.

Eligibility criteria: Inclusion Criteria:

* Children with a history of syncope were included if they had had at least three syncopal episodes per year and had a positive head-up tilt test result.

Exclusion Criteria:

* Patients were excluded if they had:

  * Other causes of syncope;
  * Cardiovascular and/or systemic disease;
  * Systolic blood pressure \>130 mm Hg or diastolic blood pressure \>90 mm Hg； or
  * History of asthma, impaired liver function, Ⅱ to Ⅲ degrees of atrioventricular block, sinus bradycardia \< 40 beats/min, or other contraindications for β-blockers.

Primary outcomes:
measure: Our primary outcome variable was recurrence of syncope.
timeFrame: The primary endpoint was recurrence of syncope within 2 weeks after beginning therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University First Hospital
name: Junbao DU, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04314362: Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
Official title: A Single-center, Vehicle-controlled, Study to Evaluate Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Azura Ophthalmics
Sponsor class: INDUSTRY
Collaborators: name: The University of New South Wales
First posted: 2020-03-19
Enrollment: 32
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: Single-center, single-masked (the individual(s) performing efficacy and safety measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized study.

Detailed description: Randomized study with 6 visits. For all dose groups a screening visit will be followed by a baseline visit 14 days later (qualification period). At the end of the qualification period patients who still exhibit signs of Meibomian Gland Dysfunction (MGD) at the baseline visit will be enrolled into a 3-month treatment period. At the baseline (Day 0) visit, patients will be randomly assigned to receive either AZR-MD-001 ointment/semi-solid drug or AZR-MD-001 vehicle twice-weekly.

Eligibility criteria: Inclusion Criteria:

* Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit
* Reported dry eye signs and symptoms within the past 3 months:

Ocular Surface Disease Index (OSDI) score ≥ 13; TBUT \< 10 seconds in both eyes

Exclusion Criteria:

* Uncontrolled ocular disease (except for MGD) or uncontrolled systemic disease
* Patient has glaucoma or ocular hypertension as demonstrated by an intraocular pressure (IOP) in either eye at screening of ≥24 mm Hg determined by Goldman applanation tonometry or has planned insertion/removal of glaucoma filtration shunts/devices during the study
* Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or corneal integrity
* Recent (within the past 3 months of the baseline visit) ocular surgery, trauma, herpes, or recurrent inflammation
* Contact lens use anticipated during the study

Primary outcomes:
measure: Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS)
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Fiona Stapleton
state: New South Wales
Study officials:
References: