cyrilzakka/clinical-trials huggingface dataset:
A 3-month Cycle of Weekly Montreal Museum of Fine Arts Tours

Social isolation in older community-members living in urban areas and its possible reduction through a 3-month cycle of weekly museum tours.

Social isolation is a major problem for the Canadian society because of its: (1) high prevalence in the older population (30% in individuals aged 65 and over, which represents 1.5 million individuals), (2) association with a wide range of mental and physical health problems and (3) increased use of health and social services. Museum art-based activities have demonstrated benefits on an individual's sense of social inclusion, their well-being, their quality of life and physical frailty. Few studies have examined the effects of the participation in museum art-based activities in older community members experiencing social isolation. In 2019, the team conducted an experimental pilot study comprised of pre-post intervention, single arm, prospective and a longitudinal follow-up. This experiment indicated that a 3-month cycle of weekly visits to the Montreal Museum of Fine Arts (MMFA) in the form of a guided tour may improve the social inclusion of socially isolated older adults. We hypothesize that it is possible to reproduce these previous positive results using a mixed methods approach that combines: (1) a qualitative phase comprised of observation of the guided tours; semi-structured interviews, focus groups and an analysis of relevant organizational documents; (2) a quantitative phase based on a randomized clinical trial (RCT). Over a two-year period, we will examine whether and how a 3-month cycle of weekly MMFA tours may (1) improve social inclusion, well-being and quality of life, and (2) reduce frailty in older community members, living in Montreal, who are experiencing social isolation. The study includes the participation of community workers who work with socially isolated older Montrealers, members of this community, as well as museum works and administrators. Our research will not only include information on how the museum experience has affected older adults. It will incorporate feedback from all of these participants leading to an evaluation of the program offered by the museum to better serve the future needs and desires of this population. It will also benefit the participating organizations.

Eligibility Criteria:
Inclusion Criteria:

1. Being 65 years and over
2. Having an Internet access with an electronic device (i.e.; laptop, computer, smartphone, tablet) at the participant's place of living as the repetitive assessments for this study will be performed on the web platform of the Centre of Excellence on Longevity of McGill University
3. Understanding and writing the language of the recruitment centre (i.e., French or English)
4. Life expectancy estimated over 3 months as the duration of the follow-up is 3 months

Exclusion Criteria:

1. Concomitant participation to another clinical trial,
2. Having participated to a participatory art-based activity of the MMFA,
3. Not speaking the language of the study.
Efficacy of Group Exercise Program in Older People With Nonspecific Low Back Pain

The main objective of the study is to assess the feasibility of a randomized clinical trial that investigates the effects of an 8-week group exercise program on pain, disability, fear of falling, overall impression of recovery, frequency of falls and level of physical activity in elderly people with nonspecific low back pain.

The main objective of the study is to assess the feasibility of a randomized clinical trial that investigates the effects of an 8-week group exercise program on pain, disability, fear of falling, overall impression of recovery, frequency of falls and level of physical activity in elderly people with nonspecific low back pain. The evaluation of feasibility will be related to: (1) blinding the evaluator to allocate the groups; (2) eligibility and recruitment rates; (3) acceptability of random allocation to a group; (4) possible contamination between groups; (5) adherence to treatment; (6) satisfaction with the treatment; and (7) difficulty in understanding the information provided by the physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Older people aged 60 years old or over who have nonspecific LBP, defined as pain below the costal margin and above the lower gluteal folds, with or without referred leg pain for at least 3 months.
* Disability with score 4/24 in Roland-Morris Disability Questionnaire or higher and persistent back pain of pain 3/10 or higher.

Exclusion Criteria:

* Suspected or confirmed serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder);
* Radiculopathy (i.e. presence of 2 of the 3 following criteria: strength, reflex or sensation alterations compatible with lumbosacral nerve root compression);
* Previous history of spinal surgery; scheduled for major surgery during the study or at the follow up period;
* Any of the contraindications to exercise listed on page 103 of the American College of Sports Medicine (ACSM) guidelines.
"Acrylic Vs. Metal Palatal Coverage in Complete Dentures: Patient-Reported Outcomes"

Conventional dentures can be uncomfortable and limit oral functionality due to the polished surfaces covering the palate and rugae areas. A randomized crossover clinical trial was conducted to compare patients' satisfaction and oral health-related quality of life when using dentures with an acrylic or metal palate. The study aimed to determine whether an acrylic palate would provide better sensory feedback and improved oral function. Participants wore each denture and completed a questionnaire. The study's results have implications for the design of complete dentures, as they highlight the importance of considering patient experiences and feedback when selecting materials. By prioritizing patient satisfaction and oral health-related quality of life, dental professionals can enhance denture treatments' effectiveness and improve patients' quality of life.

Conventional dentures have long been criticized for their discomfort and limitations in oral functionality, primarily attributed to the polished surfaces covering the palate and rugae areas. To address these concerns, a rigorous randomized crossover clinical trial was meticulously conducted to compare the subjective experiences of patients wearing dentures with either an acrylic or metal palate.

The primary objective of this study was to evaluate patients' satisfaction and oral health-related quality of life while wearing dentures with different palate materials. Specifically, researchers sought to ascertain whether the use of an acrylic palate could offer superior sensory feedback and enhance overall oral function compared to traditional metal palates.

Participants enrolled in the study were required to wear both types of dentures consecutively and subsequently complete a comprehensive questionnaire designed to capture their subjective experiences and perceptions. The questionnaire encompassed various aspects, including comfort, ease of speech, ability to chew and swallow, and overall satisfaction with the dentures.

Eligibility Criteria:
Eligibility Minimum Age: 45 Years Maximum Age: 80 Years Sex: All Gender-Based Inclusion: No Accepts Healthy Volunteers: Yes (if completely edentolous)

Inclusion Criteria:

* Patients seeking a set of conventional maxillary and mandibular complete dentures at the University of Jordan Hospital, either for the first time or as a replacement for previous dentures
* Patients aged between 45 and 80 years old
* Completely edentulous for at least 3 months
* Patients who approved and consented to participation

Exclusion Criteria:

- Patients with severe underlying medical conditions, including: Neuromuscular dysfunction, Auditory problems, Mental conditions, Oral pathology, Xerostomia, Tied tongue condition

- Patients who met the inclusion criteria but failed to sign a consent form
Studying Genes for Barrett's Esophagus in Brothers and Sisters

RATIONALE: Learning about how often heartburn and other risk factors occur in brothers and sisters and other family members of patients with Barrett's esophagus may help identify other individuals at risk and identify genes for Barrett's esophagus.

PURPOSE: This clinical trial is studying genes for Barrett's esophagus in brothers and sisters.

OBJECTIVES:

Primary

* To investigate the familial incidence of heartburn and Barrett's esophagus in first and second degree relatives of patients with Barrett's esophagus in the United Kingdom.
* To determine susceptibility genes for Barrett's esophagus in affected sibling pairs.
* To examine gene-environment interactions, such as smoking, alcohol, and Helicobacter pylori status, on familial susceptibility to heartburn and Barrett's esophagus.

Secondary

* To compare the mortality from esophageal adenocarcinoma in family members with heartburn and Barrett's esophagus with deaths from other causes.

OUTLINE: This is a multicenter study.

Patients complete a family history questionnaire. Epidemiological data is also collected about environmental exposures, such as smoking and alcohol history. Any siblings or other living family members affected by heartburn identified from this survey are then contacted to validate their symptoms/diagnoses and to collect other relevant epidemiological data. Family members with heartburn are offered a screening endoscopy for the presence of Barrett's esophagus. In the absence of an endoscopy, a symptom nomogram predictive for the presence of Barrett's esophagus is used.

Patients and their siblings, as well as any other willing family member (affected or non-affected) are asked to have a blood sample (EDTA tube for genetic analysis and a serum sample for Helicobacter pylori status) taken by their physician. Genomic DNA is extracted from lymphocytes and a genome-wide scan is performed using a standard marker set. A computer program is used to verify sibling relationships. Individuals not found to be full siblings are excluded from subsequent analyses. Maximum likelihood score (MLS) and the nonparametric linkage score (NPL) is used to estimate the degree of linkage.

All study participants are flagged with the National Health Service (NHS) Central Register to ascertain the future mortality from esophageal adenocarcinoma compared with deaths from other causes.

PROJECTED ACCRUAL: A total of 200 sibling pairs will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Sibling pairs will be recruited either from the United Kingdom National Barrett's Oesophagus Registry (UKBOR) of patients with Barrett's esophagus from 37 centers OR from National Health Service hospitals

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Do Treatments for Smoking Cessation Affect Alcohol Drinking?

The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated.

Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior.

Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.


Eligibility Criteria:
Inclusion Criteria:

* 21 years old or older
* Able to read and write in English
* Smokers, non-daily smokers, and non-smokers
* Heavy Drinkers and/or meet criteria for alcohol use disorders

Exclusion Criteria:

* Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
* Significant hepatocellular injury
* Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
* Women who are pregnant or nursing
* Suicidal, homicidal, or evidence of severe mental illness
* Prescription of any psychotropic drug in the 30 days prior to study enrollment
* Blood donation within the past 8 weeks
* Individuals who are seeking treatment for drinking or smoking or who have attempted to quit drinking or smoking within the past 3 months
* Specific exclusions for administration of bupropion not specified above including: having taken monoamine inhibitors in the past six weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology
* Known allergy to varenicline or taking H2blockers
* Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
* Subjects likely to exhibit clinically significant alcohol withdrawal during the study
Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health

Therefore, the present study is designed to contribute to the body of literature by investigating the effect of 12-weeks of lutein supplementation on multiple parameters of skin health and appearance in healthy women.

This is a randomized, double-blind, placebo-controlled, parallel twelve-week study of the performance of an oral test product to evaluate the effects of twelve weeks of lutein supplementation on skin health and appearance in healthy women. A seven-day washout period will precede the evaluation period. The subjects in each cohort will use consume one softgel of their assigned test product (treatment or placebo) daily in the morning with breakfast for 12 weeks. Changes in skin condition and appearance as well as blood chemistry will be assessed using results from expert visual grading, instrumental assessments, skin and blood assays and subjective questionnaire responses. Subjects will be recruited during the winter season to account for seasonal variations of skin parameters.

Evaluation points will occur pre-application (Baseline; Week 0) and after 42 and 84 days of use (D42, D84; Week 6, Week 12). Data will be collected on the following outcomes:

1. Skin Hydration 2. Skin texture/smoothness 2. Reduction of facial fine lines and wrinkles 3. Skin elasticity and firmness 4. Sagging skin, dry skin, skin tone, appearance from expert clinical grading and subjective questionnaire responses.

6. Skin hydration 7. Skin collagen 8. Skin lipid content. 9. Skin Carotenoids

Eligibility Criteria:
Inclusion Criteria:

1. Females in good health, and between the ages of 30 and 65 years old
2. Fitzpatrick Skin Type I-V
3. Mild to moderate loss of skin elasticity, wrinkles (global) and rough skin texture
4. Able to read, understand and sign an informed consent form
5. Willing and able to follow all study directions, attend study visits as scheduled and willing to accept the restrictions of the study
6. Willing and able to maintain regular diet, exercise, hydration, and sleep patterns throughout the study

Exclusion Criteria:

1. Participating in any other clinical study
2. Acute or chronic disease or medical condition
3. Unreliable or unlikely to be available for the duration of the study
4. Routine use of tanning bed(s)
5. History of abnormal response to sunshine
6. Current usage of medications with contraindication of enhancing sun exposure, or medications for skin conditions.
7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.
8. Immunocompromised subjects
9. Subject has a history of unconventional sleep patterns
10. Started Hormone Replacement Therapy within the last three months
11. Using oral contraception for less than three months
12. Known to be pregnant, lactating or planning to become pregnant within six months
13. Unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function
WISE ARIC: Retinal Photography in Women With Chest Pain

The purposes of this study are:

* To correlate the severity of retinal arteriolar narrowing and other microvascular changes, as determined from retinal photographs and video imaging, to measures of coronary microvascular function in women evaluated for chest pain.
* To evaluate measures of vascular compliance with applanation tonometry and photoplethysmography using a nasal alar probe.

Women who meet study eligibility criteria and provide written informed consent will have a baseline physical exam, including measurements of heart rate, blood pressure, weight. Medical history will be updated, specifically cardiovascular events (hospitalizations, procedures) since last contact and current medications. Patients will be scheduled for retinal photography. Those who are currently being screened and qualify for EWISE or other ancillary studies will have retinal photography scheduled as close to the index CFR as possible and prior to receiving randomized therapy.

The retinal photography will follow a standardized written protocol.

For the second protocol, 100 patients will be scheduled for an appointment in the Eye clinic where they will meet the Women's Ischemic Syndrome Evaluation (WISE)/Atherosclerosis Risk in Communities (ARIC) staff and complete the baseline information and have a brief physical examination. They will then have provocative testing completed with retinal imaging.

Eligibility Criteria:
Inclusion Criteria:

* Women who participated in or are being screened for the WISE or EWISE or any ancillary studies
* Willing to provide written informed consent
* Have recorded measurements of coronary flow reserve, with or without obstructive coronary disease

Exclusion Criteria:

* Unwilling to complete study required procedures
* Contraindication to adenosine
CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

How health-related information is communicated affects what is understood and might influence how people make decisions and how confident they feel in participating in clinical shared decision-making.

The CICERO trial will compare three different communication tools providing information on fictional interventions for a common medical problem (i.e. social anxiety disorder) both in terms of how well interventions work (benefit) and also possible harms associated (risk). The three communication tools ("Summary of Findings table", "Kilim plot", and "Vitruvian plot") differ in how they present information: exclusively written, primarily written and partially graphical, or mixed written and visual. Each participant will be asked to go through one clinical scenario.

The investigators will ask participants to familiarise themselves with the tool they have been allocated to (either a plot or a table) and then answer some validated questionnaires to measure how useful and efficient the communication strategy was.

The entire study occurs online in a single study session (about 20 minutes).

The results of the CICERO trial will inform how to communicate research findings to the general population, facilitating their implementation in clinical shared decision-making.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 65 years (inclusive)
Frontal EEG in OHCA Feasibility Study

This study aims to optimize the treatment of out-of-hospital cardiac arrest (OHCA) by focusing on neurological outcomes through Bispectral Index (BIS) monitoring. It will evaluate the feasibility of BIS monitoring in the prehospital phase, assess the need for sedation based on BIS values, and examine the timing of interventions in ICU (intensive care unit) settings to identify irreversible Hypoxic-Ischemic Brain Injury (HIBI).

The research project is designed to contribute to the low survival discharge rates of OHCA patients in Europe, which is currently around 8%.

Objectives:

1. To assess the feasibility of BIS monitoring in the prehospital environment during CPR and ROSC.
2. To determine the optimal mean BIS cut-off value after ROSC (Return of Spontaneous Circulation) during the prehospital phase.
3. To assess BIS and etCO2 values in OHCA patients under evaluation of CPR quality.
4. To understand the sedation needs based on BIS values.
5. To identify the timing of interventions in the ICU that signify irreversible HIBI.

Phases:

* Phase 1: The initial focus is assessing BIS and etCO2 values in OHCA patients receiving CPR.
* Phase 2: We will investigate whether patients with higher mean BIS values (\>25) require earlier and more sedation than those with lower BIS values.
* Phase 3: This phase will examine ICU interventions and their timing to ascertain which patients are at risk of suffering from irreversible HIBI.

Methodology:

The project will utilize prehospital and ICU settings for a multidisciplinary approach, integrating cardiological, neurological, and anesthesiological perspectives. A pilot phase of 5 patients will be conducted initially to fine-tune the protocol and address any technical issues with the equipment.

Timeline:

The study will span approximately 14 months, starting with patient recruitment, data collection, and analysis and ending with the publication of results.

This project aims to provide critical insights into the feasibility and effectiveness of BIS monitoring in improving neurological outcomes for OHCA patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* In out-of-hospital cardiac arrest (OHCA)

Exclusion Criteria:

* BIS application non-possible (for example, due to massive facial trauma)
* No ALS (Advanced Life Support) performed
* Clear signs of death
* Sustained ROSC (\>5 minutes after CPR with signs of life) on the arrival of the emergency physician
Autologous Micrografts From the Palatal Mucosa for Periodontal Regeneration

Some research studies have demonstrated that autologous micrografts made out of different oral tissues may enhance tissue regeneration. The primary aim of this study is to evaluate the clinical performance of a combined approach using an autologous micrograft derived from the palatal mucosa with an alloplastic scaffold for periodontal regeneration of intrabony defects in terms of clinical attachment level gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill) compared to a scaffold alone. Moreover, this study aims to compare early wound healing and patient-reported outcome measures between the two groups.


Eligibility Criteria:
Patients selected for the study should fulfil the following inclusion criteria:

* Affected from stage III-IV periodontitis.
* Completed non-surgical periodontal therapy.
* FMPS \<15% at 3-month re-evaluation.
* FMBS \<15% at 3-month re-evaluation.
* At least one site with an interproximal intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, extending to the lingual/palatal side as assessed by preoperative bone sounding.
* Intrasurgically, the defect has to present a non-supporting anatomy (1-2 residual walls in its most coronal portion), requiring flap elevation on both buccal and oral side for its accessibility.
* Signed informed consent.

Exclusion criteria:

* Compromised general health which contraindicates the study procedures (ASA III-VI patients).
* Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulatory drugs (e.g., cyclosporine), and high-dose oral contraceptives.
* Current smokers (self-reported), users of chewing tobacco, and drug/alcohol abusers.
* Pregnant or nursing women.
* Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
* Very large and wide defects that required the use of membrane.