cyrilzakka/clinical-trials huggingface dataset:
Effect of Artronat on the Quality of Life of Patient With Osteoarthritis

The purpose of this study is to determine whether the nutritional supplement ARTRONAT improves the quality of life of patients with osteoarthritis.

Osteoarthritis is a degenerative disease that greatly impairs the quality of life of patients. A nutritional supplement may help, in association with the normal treatment of osteoarthritis, improving the quality of life of such patients, in reducing pain and/or improving join flexibility.

Eligibility Criteria:
Inclusion Criteria:

* age 40-75 years
* BMI 18.5-30
* osteoarthritis type II or III

Exclusion Criteria:

* osteoarthritis type I or IV
* allergy to one of the component of the supplement
* blood pressure \> 14/8
* history of knee surgery
Aerosol Deposition in Asthmatic Obese Women Using Heliox

BACKGROUND: The aim of this study was to assess pulmonary deposition and distribution of radio-aerosol in obese and normal women, using 2-D planar scintigraphy. METHODS: after inhaling an aerosol of technetium labeled diethylenetriamine penteacetic acid (99mTc - DTPA) with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml using a vibrating mesh inhaler.

BACKGROUND: Obese asthmatics are difficult to treat effectively, worse asthma control, and do not respond as well to standard therapy as lean asthmatic. Medical aerosols an important route of drug delivery in asthma, but narrowing in the airway cause by the obesity, can provoke turbulence and the effectiveness of the treatment could be compromise.

AIM: To assess pulmonary deposition, distribution of radio-aerosol and analyze upper way dimension in obese and normal weight women, using 2-D planar scintigraphyand and computed tomography. METHODS: 20 obese women, 10 asthmatics and 10 non-asthmatics took part of the first part of the study. Anthropometric and clinical assessments were carried out, than lung function was performed. After randomization of the sequence of gas (sequence 1- oxygen and heliox; sequence 2-heliox and heliox) that would be used to inhale an aerosol with technetium labeled diethylenetriamine penteacetic acid (99mTc - DTPA) with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml using a vibrating mesh inhaler. All patients inhaled two times with one week of washout between then to eliminate risk of residual trace radiation and to avoid the possibility of bias.

Eligibility Criteria:
Inclusion Criteria:

* Were women with Body mass Index (BMI) ≥30kg/m2 for obese and BMI =18.5 - 24.9 kg/m2 for the control group
* Age between 18 to 60 years old
* With and without moderate to severe asthma
* Positive response to bronchodilator (improvement in FEV1 and/or FVC of at least 12% and 200ml).

Exclusion Criteria:

* Were women with active pulmonary disease other than asthma
* Neuromuscular diseases
* Smokers and those incapable of performing procedures were excluded.
Coronary Physiology Testing in Acute Coronary Syndromes

This is an interventional, prospective, multicenter study (5 IRCCS hospitals belonging to the Italian Cardiology Network) in patients with STEMI treated with successful primary PCI to assess the ability of coronary physiology parameters measured soon after recanalization to predict myocardial tissue characterization assessed with cardiac magnetic resonance (CMR) within a week of the acute event. Furthermore, patients will be followed up for a period of 12 months to assess the incidence of major adverse cardiovascular events (death, death from cardiovascular causes, re-infarction, new coronary revascularization interventions, development of heart failure) based on their stratification according to coronary physiology parameters.

In the present study the investigators will enroll consecutive patients with STEMI acute myocardial infarction treated with successful primary PCI, to assess the ability of coronary physiology parameters, i.e. coronary flow reserve (CFR) and index of microvascular resistance (IMR) measured after recanalization to predict myocardial tissue characterization (MVO, MSI, IS, T2-rt, T1-rt and ECV) assessed with contrast CMR within a week of the acute event. Furthermore, the relationship between left ventricular end-diastolic pressure and of coronary physiology parameters will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with STEMI (defined according to ESC Guidelines 2017), with symptom onset within 12 hours (Class I), or between 12 and 48 hours (Class IIa), (1) successfully treated with primary PCI. (1)

Exclusion Criteria:

1. Patients with previous myocardial infarction in the territory of the infarct-related artery;
2. Patients with previous coronary artery bypass grafting;
3. Patients with cardiogenic shock at presentation;
4. Patients with need for mechanical support of the circulation;
5. Patients with known severe aortic stenosis / insufficiency;
6. Patients with known cardiomyopathy;
7. Patients with malignant neoplasm or systemic pathology with a "quoad vitam" prognosis of less than 1 year;
8. Patients affected by known active infectious diseases;
9. Women who are pregnant or breastfeeding;
10. Patients who are unable to express valid informed consent upon enrollment;
11. Patients with hypersensitivity to the active ingredients used for the study of coronary physiology (nitrates and adenosine);
12. Patients with specific contraindications to cardiac magnetic resonance imaging, including:

    * Patients with allergies and / or with other specific contraindications to the use of paramagnetic contrast media (gadolinium), including chronic renal failure with glomerular filtrate (eGFR) \<30 mL / min;
    * Patients with non-resonance-compatible devices or who have undergone previous surgical interventions with placement of non-resonance-compatible vascular clips;
    * Claustrophobic patients.
The Effect of a Nutrient Dense Food on the Skin CarotenoidLevels of School Age Children

Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks significantly increased skin carotenoid levels as compared to children who consumed a placebo juice. A naturally carotenoid-rich baked product, potentially marketable as a healthy breakfast food alternative, was developed by Utah State University researchers.

Objective: To determine the effect and response of a carotenoid-rich baked product on change in skin carotenoid levels among children.

Design: A six week randomized controlled trial. Participants/setting: Participants were children age 5-18 during March-June, 2015 living in Cache County, UT (n=46). Intervention: Children were randomly assigned to one of two groups: treatment (n=23) with a high carotenoid baked food or control (n=25) who consumed a baked food with no carotenoids. Children were asked to eat the designated portion of the assigned food once a day for six weeks. Skin carotenoid levels were measured every two weeks by a BioPhotonic scanner and reported in Raman intensity counts. Participants were asked to maintain their diet and completed a food frequency questionnaire at Baseline, Week 3, and Week 6. Uneaten portions of the food were returned to clinic, counted, and recorded.

Main outcome measures: Change in skin carotenoid levels as measured in Raman counts over 6 weeks.

Statistical analysis performed: Repeated-measures ANOVA was used to assess the group differences in Raman counts.


Eligibility Criteria:
Inclusion Criteria:

* Skin carotenoid levels 11,000-33,000 Raman intensity counts
* Age 5-18 years
* Willing to attend 7 clinic visits
* Willing to eat designated food each day for 6 weeks

Exclusion Criteria:

* Illness in two weeks before study began
* Chronic disease such as asthma, rheumatoid arthritis, type 1 diabetes
* Skin carotenoid levels \<11,000 and \>33,000 Raman intensity counts
* Consumption of high carotenoid supplements
* Use of topical self-tanning lotion
Motivators and Barriers for Physical Activity in Patients With Minor Stroke

The aim of this study is to investigate motivators and barriers for physical activity in patients discharged from hospital for a minor stroke or TIA. The study has a qualitative research design and will be conducted by focus group interviews.

Little is known about motivators and barriers for physical activity after hospital discharge for patients with a minor stroke or TIA. These patients have few and temporary symptoms and are therefore discharged early from the hospital or seen in a outpatient TIA clinic. Standard treatment are preventive medication and advice on self-managed lifestyle changes. Occurrence of one ischemic stroke or TIA predisposes to further ischemic strokes and patients are at risk of developing cognitive deficits or vascular dementia over time unless multiple preventive measures are taken including physical activity. The purpose is to investigate motivators and barriers for physical activity after hospital discharge by focus-group interviewing this potential fragile group of patients. The research team want to facilitate the patients to be physically active and thereby prevent a recurrent stroke and slow the progression of vascular diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic stroke or transient ischemic attack (TIA) without the need of a re-habilitation plan, but needs an exercise plan in order to prevent a recurrent stroke
* Patients who have participated in ≤ 1 hour of vigorous intensity activity on weekly basis within the last 3 months
* Patients able to speak, read, and understand Danish
* Patients ≥ 18 years of age and able to give informed consent

Exclusion Criteria:

* Patients with previous large artery stroke with sequelae preventing aerobic exercise in groups
* Symptoms or comorbidities preventing aerobic exercise in groups
* Dyspnoea caused by heart or lung diseases (e.g. chronic obstructive pulmonary disease (COPD))
* Aphasia or dementia interfering with participation in aerobic groups exercise
* Patients with Intermittent claudication/vascular claudication
Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome

The purpose of this study is to find out if the bacteria present in the nose or sinuses of people with seasonal allergies changes during their allergy season. Another purpose of this study is to see if the bacteria present in the nose and sinuses of non-allergic people are the same as allergic people before the allergy season and if it changes during the season. Many bacteria are difficult to grow in the laboratory so the investigators are using analysis of DNA (the genetic material in cells) of the bacteria in the nose and sinus to find them. The investigators will be testing DNA of the bacteria only and not of the human subjects taking part in this study. This research is being done to help us understand how allergy affects bacteria in the nose and sinuses.


Eligibility Criteria:
Inclusion Criteria

1. Males and females between 18 and 55 years of age.
2. History of tree and/or grass allergic rhinitis for at least 2 years (allergic subjects) or no allergy history at all (normal controls).
3. For allergic subjects, a positive skin test to trees and/or grass antigen within prior 12 months. For non-allergic subjects, negative skin tests to common allergens in the Chicago area.

Exclusion Criteria

1. Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
2. Use of nasal steroids, antihistamines in the last 4 weeks.
3. Upper respiratory infection, sinusitis less than 2 weeks before screening.
4. Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
5. Participation in other investigational therapy in the last 30 days.
6. Any systemic disorder or medication interfering with the study.
7. Undergoing allergen desensitization therapy.
8. Not willing to give informed consent
9. Inability to understand the nature and requirements of the study, or to comply with the study procedures.
10. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Assessment of Psychological State of Mothers of Diabetic Children Aged 5 and Under (in Terms of Depression, Stress, Coping , Anxiety, Fear of Hypoglycemia) and Influencing Factors of This Psychological State

The incidence of type one diabetes is still rising, especially in children under 5 years old. Mothers often are the primary caregivers of these children. To take care of a young child with diabetes is a great responsibility and mothers must be constantly vigilant. This study aims to assess the psychological state of these mothers (in term of depression, anxiety, stress, coping, fear of hypoglycemia) and factors which influence this state.


Eligibility Criteria:
Inclusion Criteria:

* Mother of diabetic child aged 5 and under, followed-up in Pediatrics Department of Besançon University Hospital.

Exclusion Criteria:

* Mother of diabetic child older than 5 years old
Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma

This study will use PET/MRI in patients with adenocarcinoma of the pancreas to identify hidden metastatic disease or identify patients with borderline or locally advanced disease.

Patients will receive a PET/MRI scan within 6 weeks of their standard of care imaging. There is no maximum number of scans for research. The number of scans depends on each patient's treatment plan.

Eligibility Criteria:
Inclusion Criteria:

* Presence of suspicious lesion of the pancreas consistent with pancreatic adenocarcinoma. Cytological confirmation is not required.
* Patients preparing to receive therapy for pancreas cancer, including patients enrolled in NCT01413022
* Patient must be 18 years or older
* Patient must have a life expectancy of more than 6 months and performance status of 2 or less
* Patient must be able to understand and willing to sign an approved written informed consent document
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the length of the study
* Patients enrolled in the Clinical trials.gov# NCT01413022 trial must meet both studies eligibility criteria.

Exclusion Criteria:

* Patient must not have had prior resection for pancreatic adenocarcinoma.
* Patient must not have a history of other malignancy less than or equal to 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix
* Patient must not be unable to receive a PET-MRI scan due to renal function, allergy or other problem with receiving or tolerating an MRI scan, etc. All patients will fill out a standard MRI screening form.
* Patients must not have a blood glucose of greater than or equal to 200mg/dL at the time of PET-MRI or if a patient is diabetic and glucose is not controlled. At the discretion of the PI and the authorized user and with their approval prior to 2-\[18\]fluoro-2-deoxy-D-glucose (FDG) injection, patients with blood glucose ≥ 200 mg/dL may participate in the study.
* Patient must not be pregnant and/or breast feeding
A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)

This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study designed to evaluate the safety, pharmacokinetic (PK), and exploratory activity of topically-applied NS2 dermatologic cream administered once-daily (QD) to subjects with ichthyosis secondary to Sjögren- Larsson Syndrome (SLS).

NS2 is expected to trap fatty aldehydes that are pathogenic in SLS patients, and thereby diminish the lipid-aldehyde adduct formation that likely results in ichthyosis associated with SLS, and potentially reduce the mild dermal inflammation characteristic of SLS.


Eligibility Criteria:
Inclusion Criteria:

* Genetically-confirmed diagnosis of SLS
* Active ichthyosis on the lower extremities that is determined to be at least moderate severity

Exclusion Criteria:

* Evidence of an active infection
* Currently receiving immunosuppressive therapy, including intermittent or low-dose corticosteroids and is not able or willing to suspend from 2 weeks before and during the study
* Currently receiving systemic or topical retinoids, other topically applied drugs, or other supplements that could interfere with dermatologic examination findings
* Received an investigational systemic or topically administered drug within 30 days before screening
Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

This project includes a parallel group randomized controlled trial comparing two psychological treatments: 1) Exposure-based Family Therapy (IE) vs. 2) Family Based Therapy (FBT) for low weight eating disorders with 12 month follow-up. Primary outcomes are expected body weight and clinical impairment. Three mechanisms of change (Autonomous Eating, Non-Judgmental Body Awareness, and Extinction Learning) will be examined in a process mediation models of change.

A total of 120 individuals with Anorexia Nervosa ages 12-18 will be enrolled to either 20 sessions of outpatient Exposure-based Family Therapy (IE) or Family Based Therapy (FBT). The aims of the study are to test the comparative efficacy and primary mechanisms of change after 6 months of treatment and at one year post-treatment and to explore the mediators and moderators of the primary outcomes at these endpoints. All recruitment and study procedures will take place through the Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai. Assessments will take place at 2-, 4-, 6-, 12-, and 18-months following baseline.

Eligibility Criteria:
Inclusion Criteria:

* Aged 12-18
* Speak English
* Permission from pediatrician or equivalent to receive outpatient care
* Clinically significant restriction of food intake by EDA-5 or evidence of persistent food avoidance from patient or guardians
* Evidence of the inability to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories

Exclusion Criteria:

* Comorbid psychotic or bipolar disorder
* Active suicidal ideation
* Current substance dependence
* Psychiatric medication initiated or dosage changes \<2 weeks from baseline
* Major medical illness (e.g., diabetes mellitus, Crohn's disease, etc.)
The Effect of Trabeculectomy & Ex-PRESS Glaucoma Drainage Implant on the Corneal Biomechanical Properties

This study aims to look into the change of the corneal biomechanical properties in patients undergoing insertion of the Ex-PRESS mini shunt or trabeculectomy for medically uncontrolled glaucoma

The patients in the study were divided into two groups. In group 1 the patients had the Ex-PRESS mini shunt inserted in the operated eye and in group 2 the patients underwent standard trabeculectomy.

The corneal biomechanical properties were measured with the Ocular Response Analyzer before surgery and at 1, 6 and 12 months after surgery. The corneal biomechanical properties measured were the Corneal Hysteresis (CH) and the Corneal Resistance Factor (CRF).

The change of the CH and CRF was compared in each group before and after surgery (at the aforementioned predetermined time points) and between the two groups.

The intraocular pressure was also measured with the Goldmann applanation tonometer at the same time points and the change was compared before and after surgery in each group and between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Average Intraocular pressure \> 24 mmHg on at least 2 occasions 1 month before surgery
* Congenital glaucoma

Exclusion Criteria:

* Previous ocular trauma
* Previous ocular surgery other than phacoemulsification
* Previous disease of the ocular surface
Accuracy of Needle Placement Into The Subacromial Space of The Shoulder

This study attempts to determine the most accurate route for injection of the subacromial bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the routes of injection is used. It has not been determined if one route is superior, or if all routes are equal in delivering medication into the subacromial bursa, which sits on top of the rotator cuff tendons.

Patients with a diagnosis of rotator cuff tendonitis, having failed other non-operative measures, are offered an injection of steroid and local anesthetic to relieve their pain. This is standard treatment. In this study, patients are prospectively randomized to receive their injection by one of the three commonly used routes: anterior, posterior, or lateral. Accuracy of the injection is determined by including a small amount of contrast dye in the injection which will make the injection visible on post-injection radiographs.

Eligibility Criteria:
Inclusion Criteria:

* rotator cuff tendinitis

Exclusion Criteria:

* diabetes
* allergy to contrast dye
* renal disease
* pregnancy
* frozen shoulder
Get Out of Your Head 2.0: Evaluation of an Online Prevention Campaign and Updated Website for Men

The primary objective of this study is to evaluate the perceptions and evaluations of men with suicidal thoughts, regarding the new "Get Out of Your Head" campaign and the updated website. The findings will inform potential adjustments to enhance the campaign and website as needed.

In a previous study (BUN: B6702024000090) the authors focused on identifying these barriers and needs among adult men experiencing suicidal thoughts and their healthcare providers. Findings from this needs assessment suggest that men with suicidal ideation often perceive a lower need for help and hold attitudes that inhibit help-seeking and sustained engagement in care. These attitudes appear closely linked to societal gender norms around emotional openness, self-reliance, and the perceived responsibility to provide for a family. Furthermore, men experiencing suicidal thoughts expressed a desire for information on certain topics that may currently be unavailable.

To address these gaps, a new awareness campaign is being developed, alongside updates to the existing "Get out of your head" website (original: www.komuitjekop.be), incorporating necessary information. The campaign and website updates are being shaped through a participatory co-creation process involving men with a history of suicidal thoughts to ensure relevance and leverage their experiential knowledge (BUN: B6702024000420). In this approach, men with lived experience are central to the decisions on the design and content of the tools. Additionally, input from experts in healthcare and masculinity, as well as international research, is being integrated.

Once the campaign is developed and the website (www.komuitjekop.be) is updated, the authors aim to evaluate how these resources are perceived by men with suicidal thoughts to further refine these suicide prevention efforts.

The primary objective of the current study is to evaluate the perceptions and evaluations of men with suicidal thoughts, regarding the new "Get Out of Your Head" campaign and the updated website. The findings will inform potential adjustments to enhance the campaign and website as needed.

Eligibility Criteria:
Inclusion Criteria:

* Men (≥ 18y/o)
* Experienced suicidal thoughts in the past three year
* Access to a smartphone, tablet, or computer with internet connection
* Proficiency in Dutch

Exclusion Criteria:

* Does not meet the specified inclusion criteria.