cyrilzakka/clinical-trials huggingface dataset:
Cannabis Edibles Packaging Imagery Experiment

The purpose of this study is to assess differences in perceptions of product appeal, harm, and subsequent willingness to try cannabis edibles products with/without packaging imagery.

Cannabis edibles are rapidly leading the legal recreational cannabis market. Cannabis edibles present health harms that are not typical of smoked marijuana, including accidental overconsumption of high levels of Tetrahydrocannabinol (THC) . Product packaging plays an important role in influencing perceptions of a product's appeal and potential harm. This experiment will assign participants to view real cannabis edibles packaging edited with one of four images commonly found on real cannabis edibles products, and ask a series of questions to assess perceptions of product appeal and harm. One group of participants will serve as the control and will see the same cannabis edibles packaging without any imagery.

Eligibility Criteria:
Inclusion Criteria:

* US resident
* Aged 18-65, inclusive
* Up to 13% of participants will be those who identify as Black/African American
* Up to 16% of participants will be those who identify as Hispanic
* Approximately 50% of participants will be past year cannabis users
* Was not a participant on the anteceding experiment, Cannabis Edibles Packaging Descriptors Experiment

Exclusion Criteria:

* Does not currently reside in the United States
* Younger than 18 or older than 65
* Does not provide information regarding history of cannabis use
* Otherwise eligible but demographic and/or user group quotas have been met
* Was a participant on the anteceding experiment, Cannabis Edibles Packaging Descriptors Experiment
Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years

The purpose of this post-marketing study is to assess the safety of Comirnaty monovalent XBB.1.5. for booster vaccination children ages 6 months though 4 years under actual use medical practice.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 4 years at the time of the booster vaccination (4th dose) who (or whose representative) gave written consent to take part in the study.

Exclusion Criteria:

-There are no exclusion criteria for this study.
High Flow Oxygen Therapy in Patients Undergoing Bronchoscopy Under Sedation

A reduction of peripheral oxygen saturation (SpO2) commonly occurs during bronchoscopy and may be associated with both respiratory and cardiac adverse events. The type of breathing assistance that should be delivered to patients, in order to treat and/or to prevent acute respiratory failure, during or after bronchoscopy, is not universally standardized; studies comparing the impact of different respiratory supports on patient's outcome and on hospital resource use are very few. the risk of respiratory failure rises according to the type of procedure (i.e., increased risk with broncho-alveolar lavage and trans-bronchial lung biopsy) and to the use of sedative drugs. Conventional oxygen therapy with nasal cannula, continuous positive airway pressure and non-invasive ventilation are commonly applied during endoscopic procedures. High flow oxygen therapy (HFOT) is a relatively novel device, still under-used in the context of interventional pulmonology, providing an humidified air-oxygen blend up to 60 L/min. HFOT has been reported to be effective for the treatment of both hypoxemic and hypercapnic respiratory failure. The investigators hypothesize that HFOT could be feasible and safe in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* pH ≥7.30 e PaCO2 \>45 mmHg and/or
* PaO2/FiO2 \<300 mmHg o SpO2 \<90 percent on room air
* Patient at risk of respiratory failure (COPD III-IV GOLD stage; OSAS; restrictive lung and chest wall diseases; cardiac failure)

Exclusion Criteria:

* Need of laryngeal mask and/or
* Patients on NIV for \>16 hrs/day and/or
* pH \<7.30 and/or
* Tracheostomy and/or
* Recent (\<3 months) facial trauma and/or
* Hemodynamic instability and/or
* High risk of aspiration and/or
* Lacerated trachea
Patient-Portal vs Text-based Hypertension Monitoring Among Black Medicaid/Medicare Patients

The coronavirus disease 2019 (COVID-19) pandemic has uprooted conventional health care delivery for routine ambulatory care, requiring health systems to rapidly adopt telemedicine capabilities. The digital divide, has been well documented with lower rates of technology and broadband adoption among racial/ethnic minorities. Additionally, Black patients suffer a disproportionate burden of hypertension and cardiovascular disease. This study will implement a text-based home hypertension monitoring program among Black Medicaid patients with hypertension and cardiovascular disease (CVD) and compare its uptake to the currently available blood pressure monitoring program using the patient portal that is integrated into the electronic health record (EHR).


Eligibility Criteria:
Inclusion Criteria:

* Self-identified Black race
* Medicaid or Medicare insurance
* Hypertension
* Cardiovascular disease or presence of at least 1 cardiovascular risk factor
* Seen for in-person consultation at the Heart and Vascular clinic at the Hospital of the University of Pennsylvania

Exclusion Criteria:

* Does not speak English
* Already owns a BP cuff
* Does not have internet access or a phone 15 with texting capabilities
Effects of Genetic Variations in the Response to Brazil Nut Supplementation

This study investigates the effect of genetic variations after supplementation with Brazil nuts in healthy Brazilians. Briefly, all the participants will consume one nut a day for 2 months and will stop the intake for more 2 months. Five blood sampling collection will be performed in one month interval, starting at baseline and ending at 2 months without intervention.

Brazil nuts are the richest source of selenium in nature, a micronutrient that has essential functions in human physiology.

Selenium status can be measured by the quantification of biomarkers in the blood. Previous studies have shown that genetic polymorphisms can affect Se status and modulate risk for chronic diseases. In this study, five biomarkers will be quantified in the blood, before and after supplementation with Brazil nuts. The genetic variants will be used to stratify the biomarkers and multivariate linear regressions will be used to explore the influence of the polymorphisms on concentrations of the biomarkers .

Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 60 years; not taking vitamin and minerals supplements, not taking antiinflammatory, not having chronic diseases

Exclusion Criteria:

* athletes, excessive alcohol consumption, being obese, having cancer, cardiovascular disease, diabetes and hypo or hyperthyroidism
Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis

Growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. Especially those who were under additional treatment with glucocorticoids for high disease activity. The hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. In a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. Additionally, we are interested in bone density development in those treated with growth hormone.

Growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. Especially those who were under additional treatment with glucocorticoids for high disease activity. This is the case in patients with a polyarticular and a systemic form of juvenile idiopathic arthritis. The permanent consequence is short stature at final height. Up to 30% of these patients will have a final height below the 3rd percentile, even after discontinuation of glucocorticoid treatment. The hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. In a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. From safety aspects we were interested in the effect of growth hormone on the disease activity. Additionally, we are interested in bone density development in those treated with growth hormone up to final height.

Eligibility Criteria:
Inclusion Criteria:

* Polyarticular or systemic juvenile idiopathic arthritis,
* Growth velocity below the 25th percentile and or short stature ,
* Treatment with glucocorticoids for at least the previous 6 months before inclusion,
* Prepubertal stage,
* Bone age below 10 in girls and 12 in boys,
* Growth hormone levels after stimulation with clonidine or arginine above 10 ng/ml

Exclusion Criteria:

* Previous treatment with growth hormone,
* Endocrinopathy,
* Additional chronic disease beside juvenile idiopathic arthritis,
* Malignant disase,
* Chromosomal aberration or othe syndromal disease,
* Previous treatment with Oxandrolone,
* Small for gestational age,
* Elevated fasting glucose level
Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are moderately anxious, anxious or very anxious during their radiotherapy treatment.

45 patients will be randomized into the following arms:

* Arm A (standard): relaxation with music listening during radiotherapy treatment
* Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment

For the study each patient will be followed during 2 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at the time of enrollment into the study.
2. Patient with localized or metastatic solid malignant tumor.
3. Patient being followed for the cancer pathology at IUCT-O and to receive, for the first time in the follow-up, treatment by radiotherapy (radiotherapy treatment should not have been initiated prior to inclusion in the study).
4. Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy.
5. Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion).
6. ECOG patient ≤ 2.
7. Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
8. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Patient doesn't understand the French language.
2. Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment.
3. Patient with hearing problems.
4. Pregnant or breastfeeding women.
5. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
6. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls

Stroke is major public health issue. The investigators recommend post-stroke patients to practice physical activity. Nevertheless, the recommendations are not widely respected due to the intensity of exercises. Oxygen consumption is a parameter to assess the intensity of physical activity. in this sense, we want to measure the oxygen consumption during various walking tasks compared to healthy controls.

Stroke is defined as an interruption of blood circulation in the brain. The treatments are in first time medical in emergency. Then, the patient will start his rehabilitation with several contributors. At this time, it will recommend physical activity to patients. Regardless of the all benefits of physical activity, it will help patient to avoid a second stroke. The investigators have the recommendations of the high authority of health in physical activity for stroke population. It recommends to practice around 20 to 60 minutes daily of physical activity with moderate effort intensity. Oxygen consumption is a parameter of effort intensity of physical activity measured in ml O2/kg/min. Currently, the investigators have the compendium of physical activity (PA). it allows us to classify PA according to effort intensity. And so, an activity with a moderate effort intensity is an activity between 3 and 5.9 metabolic equivalent task (MET). Note that 1 MET is 3.5 ml/O2/Kg. Nevertheless, this compendium does not correspond to post-stroke individuals. As consequences, Low intensity exercise as described in guidelines might be at a moderate intensity level for stroke survivors. Hence, the investigators want to assess the oxygen consumption of post-stroke individuals during various walking tasks and compare it to healthy controls.

Eligibility Criteria:
Inclusion Criteria:

Common to both groups:

* Age \>=18 years
* Able to give consent
* Not under guardianship or curatorship
* Enrolled in the French social security system

Specific to the cerebrovascular accident Group:

* Stroke confirmed by brain imaging
* Able to walk stairs without human assistance (modified Functional Ambulation Classification \>= 6)

Healthy Group Specific:

- Individuals matched to stroke individuals on age sex and BMI.

Exclusion Criteria:

Cerebrovascular accident group - Severe cognitive impairment (MoCA \< 18)

Common to both groups:

- Presence of contraindication to physical activity: unstable diabetes, unstable hypertension, unstable angina, intra-cardiac thrombus.
Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus

With this design, this study hypothesizes that; (i) ICG-PDT would produce superior clinical, microbiological, and immune-inflammatory outcomes as compared to RSD and (ii) ICG-PDT would produce equal efficacy among different forms of diabetes as produced in non-diabetic subjects and that diabetes mellitus would not produce negative impact on the therapeutic outcomes of ICG-PDT. Therefore, the aim of this randomized controlled clinical trial was to evaluate the efficacy of ICG-mediated aPDT in the treatment of stage III grade C periodontitis among patients with prediabetes, T2DM and non-diabetic subjects.


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥30 years
2. clinically diagnosed with mild to moderate periodontitis
3. self-reported type-2 DM for ≥2 years confirmed by a physician with HbA1c levels ≥6.5%
4. patients who complied with the treatment protocol.

Exclusion Criteria:

(i) pregnancy and lactation (ii) who had taken antibiotics in the previous 3 months (iii) who had undergone periodontal therapy or any decontamination treatment in their oral cavity in the previous 6 months (iv) former/current smokers (v) failure to provide a signed informed consent.
Assessment of Posture, Balance, Gait Disorders in Patients With Fibromyalgia

The study aims to determine the posture, balance and gait disorders objectively in patients with fibromyalgia (FM) and to investigate their relationships with disease-related parameters.

After being informed about study and potential risks, all participants giving written informed consent will undergo screening period determine eligibility for study entry. The participants who met the eligibility recruitments will get into the assessment.

The study will include 100 participants aged between 18-65 years and without any disease or orthopedic disorder that can cause posture, balance and gait disorders: 50 female patients who met the ACR (American College of Rheumatology) 2016 FM diagnostic criteria and 50 pain-free females.

Researcher will record sociodemographic data of all participants and disease duration of patients with FM. The researcher will evaluate disease activity by Fibromyalgia Impact Questionnaire, sleep quality by Pittsburgh Sleep Quality Index and fatigue severity by Fatigue Severity Scale in FM group.

In both groups the researcher will use; DIERS formetric 3D/4D video-rasterstereography (Diers International GmbH, Schlangenbad, Germany) device for the posture analyze, HUR SmartBalance BTG4 system (Hur Labs, Kokkola, Finland) for postural balance control and limits of stability measurements, Zebris FDM type 3 (Zebris Medical GmbH, Germany) gait analysis system for measuring spatio-temporal gait parameters.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Fibromyalgia according to ACR 2016 diagnostic criteria
* Signing written informed consent to participate in the study

Exclusion Criteria:

* Rheumatological, neurological and/or psychiatric diseases that may cause balance and gait disorders (cerebrovascular accident sequelae, Parkinson's, myasthenia gravis, polyneuropathy, rheumatoid arthritis, ankylosing spondylitis, major depression)
* Other diseases that cause balance and other gait disorders (history of major trauma to the lower extremity, and/or orthosis users, those who have had spinal and/or lower extremity surgery)
* Orthopedic disorders that may cause limitation in joint range of motion and/or loss of motor muscle strength
* Those who cannot take commands due to cognitive dysfunction
* Vestibular and/or cerebellar disorders
* Abnormal ophthalmic/optometric disorder (vision disorders)
* Pregnancy
* Serious cardiac disease, malignancy and renal failure
Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis

Multiple Sclerosis (MS) is inflammatory, demyelinating and autoimmune disease of the central nervous system. It is usually seen with relapses and genetic and environmental factors play a role in the etiology. Neurological symptoms seen in MS restrict the patient's daily activity and social role participation. Mobility problems and fatigue are the most important reasons of role limitations and decreased quality of life. The importance of exercise training in disease management has been emphasized in recent years. However, few studies have investigated the effects of task-oriented trainings on symptoms of the disease. The aim of this sudy is to investigate the effects of task-oriented training additional to combined exercise training on functional capacity, mobility, balance, fatigue and quality of life in patients with MS.


Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis diagnosis
* Expanded Disability Status Scale \> 5,5
* No cognitive problems
* No relapses in the last 3 months
* No other neurological or chronic disease

Exclusion Criteria:

* Relapse during the intervention
* Exercise intolerance
Mental Health Intervention for Elderly Abuse Victims

There is no current elder abuse service that systematically assesses and provides services to address the mental health needs of older adult abuse victims. The proposed study will investigate the efficacy of a skill-based, mental health intervention to help treat elder abuse victims, bolster mental health outcomes, and improve detection of symptomatology in future screenings.

Despite increasing recognition of the epidemic of elder abuse, we continue to face barriers helping abuse victims access and use elder abuse resolution services. In addition, many victims suffer from concurrent mental health problems that prevent them from taking the necessary steps to protect themselves. The proposed study will introduce a tailored intervention, built on an evidence-based approach (Problem Solving Therapy), to be delivered through a sustainable mental health program embedded in elder abuse services. The proposed psychotherapy is a brief 8-session weekly intervention that combines problem-solving therapy, anxiety management, and psycho education developed specifically for this population by this team.

The objectives of the project are to: identify the mental health needs of elder abuse victims, provide the mental health treatment, assess the impact of the treatment, and facilitate conditions which will sustain the mental health program.

Eligibility Criteria:
Inclusion Criteria:

* Client of the New York City Department for the Aging's (DFTA) Elderly Crime Victims Resource Center
* Score of 10 or higher on the Patient Health Questionnaire (PHQ-9) or Generalized Anxiety Disorder 7-item scale (GAD-7)

Exclusion Criteria:

* Co-morbid psychiatric disorder other than unipolar non-psychotic major depression that prevents participation in depression and anxiety screening
* Inability to speak or understand English
* Cognitive impairment that prevents participation in screening, as determined by screening social worker
A Study to Examine the Efficacy of the Arthritis Self Management Program

This study will examine the efficacy of the Arthritis Self Managemnet Program (ASMP)and determine changes in health resource utilization after completeing the ASMP program.

This study will provide an analysis of the efficacy of the Arthritis Self Management Program (ASMP) using both patient administered questionnaires as well as the health utilization data maintained within the administrative databases at Alberta Health and Wellness. This study will also provide other information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information as it is recorded in administrative databases, will include a control group and will adjust for potential confounding variables such as sex, age, body mass index (BMI) and stage of disease.

Eligibility Criteria:
Inclusion Criteria:

* OA of the hip and/or knee
* Patient is 18 years of age and over

Exclusion Criteria:

* a concurrent systemic inflammatory disease
* Patient has previously participated in an arthritis self management educational program
* Patient is awaiting total hip or total knee replacement surgery patient has a medical co-morbidity that would render the patient to participate fully in the study procedures, including terminal conditions such as chronic obstructive pulmonary disease, end stage renal disease, heart failure, malignancy with anticipated life expectancy of equal to or less than 2 years
* Patient has been diagnosed with senile dementia or Alzheimer's disease