cyrilzakka/clinical-trials huggingface dataset:
Relationship of Epicardial Adiposity With Sedentary Time, Physical Activity and Performance in Hypertensives

Epicardial adipose tissue is associated with the development of cardiovascular disease and its increase is positively correlated with blood pressure elevation in hypertensive individuals. In the literature, being physically active has been shown to be effective in the treatment of hypertension and reduction of epicardial adipose tissue thickness. The aim of this study was to evaluate the relationship between epicardial adipose tissue thickness and sedentary time, physical activity level and physical performance in patients with hypertension. The study included 40 patients with hypertension. The physical and demographic characteristics of the participants were collected using a sociodemographic form. Waist/hip circumference was measured with tape measure and epicardial adipose tissue thickness with echocardiography device. Physical activity levels and sedentary time were recorded via IPAQ-7. Physical performance was determined using the 30-s sit-and-stand test. There is no previous study in the literature evaluating the relationship between epicardial adipose tissue thickness and sedentary time and physical activity levels in hypertensive patients. With this study, we aim to contribute to the literature by filling this deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being diagnosed with hypertension for at least 6 months
* Speaking Turkish
* to be able to read and write,
* To be between 18-65 years old

Exclusion Criteria:

* Severe valvular disease
* be heart failure
* being cardiomyopathy
* having chronic kidney disease
* being thyroid diseases
* active infectious or inflammatory diseases
* serious psychiatric illnesses such as panic disorder or major depression
DNA-damage Pathways in Workers Exposed to Silica (Caesar Stone)

Silicosis is well-known occupational disease caused by free crystalline silica (silicon dioxide) and is marked by inflammation and pulmonary fibrosis. There are cumulative evidences that exposure to Caesar stone (quartz surface products that manufactured from up to 93% quartz, polymer resins and pigments) is particularly dangerous to exposed workers.

Goals: To examine correlation between disease and exposure to Caesar stone and genetic differences regarding genes involved in oxidative stress to understand Genetic susceptibility

It is a sub-study of "DNA-damage biomarkers to monitor and early detect health impairment in workers exposed to Silica (Caesar Stone)" study. Study participants would be recruited during two years of the study. They will be asked to come to a single visit at Pulmonary Laboratory of Tel Aviv Medical Center. During the meeting, participants will be given a precise explanation about the tests they will perform and after signing the informed consent will perform following tests:

1. Induced sputum (IS)
2. Exhaled Breath Condensate
3. Pulmonary function tests (PFTs)
4. Participants will be asked to complete occupational questionnaire

Genetic studies (DNA) will be done from peripheral blood samples (20 ml) to study differences in Heme oxygenase 1 (HO-1) gene sequencing between participants with evidences of clinically definite silicosis according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines and participants without evidences of clinically definite silicosis.DNA samples will be obtained and coded in the same day of a participant visit and after collecting reasonable amount of samples examination of genes of interest will be done.Analysis of data will be done after the completion of data collection and laboratory tests.

Each sample will be given specific code to protect confidentiality of participants. Blood samples, test results and the code key will be kept in different places and only few research staff will have the accessibility to genetic information. In any case employers or any other persons that not included in research staff will not have any accessibility to this information. In this study genetic analysis is not connected to gender, nationality or any other social feature.

Eligibility Criteria:
Inclusion Criteria:

1. male
2. 18-70 years old
3. At least six months of professional exposure to Caesar stone

Exclusion Criteria:

1. Other occupational exposure (welding of any kind)
2. Chronic Obstructive Pulmonary Disease (COPD), tuberculosis, asthma, autoimmune disease in healthy exposed workers
3. Interstitial lung disease in exposed workers with clinically approved silicosis
Incidence of Perioperative Hypothermia in Adults

Perioperative hypothermia is associated with many complications, including surgical site infections, delayed wound healing, coagulopathy, prolonged hospital and intensive care unit length of stay. Perioperative close monitoring of the body temperature is important, and this is recommended by many clinical practice guidelines. In this study the investigators aimed to detect the incidence of perioperative hypothermia in adult patients in the operating room, and to detect the possible associated risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Any elective operation
* ASA I-III physical status

Exclusion Criteria:

* Emergency operations
* ASA IV-V physical status
* Open heart surgeries
The Effects of Fractional Carbon Dioxide (CO2) Laser Treatment Prior to Wound Closure

The purpose of this study is to determine if fractional carbon dioxide laser treatment of a fresh wound at the time of surgery, decreases scar formation. Scar revision is commonly done at 6-10 weeks following surgery. Therefore, it may be more beneficial, for both the patient and physician, to perform scar revision at the time of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing skin cancer surgery
* Will have a straight-line incision
* Fluent in English
* Must reside in the Los Angeles vicinity for the duration of the study

Exclusion Criteria:

* Non-English speakers
* Pregnant or cognitively impaired subjects
Alive & Thrive Evaluation in Burkina Faso

The time between birth and age 24 months provides a unique opportunity to impact the long-term health and development of children through improved infant and young child feeding practices. In Burkina Faso, the prevalence of exclusive breastfeeding is currently around 25% in infants younger than six months.

The purpose of this study is to evaluate whether the Alive \& Thrive intervention package, consisting of interpersonal counselling and community mobilisation activities, can increase the exclusive breastfeeding rate among infants younger than six months to at least 50% using a cluster randomised design.


Eligibility Criteria:
Inclusion Criteria:

* Gives informed consent
* Being aged from 15 to 49 years old (women of reproductive age)
* Has at least one infant less than 12 months old who is currently alive and lives with her.
the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels

In this study the investigators investigate the effect of a red rice product on plasma lipids in a sample of physicians and/or their family members.

After a baseline measurement of cholesterol, HDL, LDL and TG, participants are randomised to receive a commercially available red rice product or placebo. After a period of 8 weeks, lipid levels are measured again.


Eligibility Criteria:
Inclusion Criteria:

* total fasting cholesterol \> 200mg/dl
Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.

This single arm study is designed to evaluate the safety and tolerability of a personalized treatment in adults with metastatic colorectal cancer by first analyzing the expression of tumor-associated antigens and then treating the patients with a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD)-based immunotherapy. pLADD is based on the attenuated form of Listeria monocytogenes that has been genetically modified to reduce its ability to cause disease, while maintaining its ability to stimulate a potent immune response. pLADD is manufactured using patient-specific antigens and is therefore individualized to each patient.

Eligibility Criteria:
Inclusion Criteria:

* metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)
* able to provide adequate tumor tissue from at least 1 accessible tumor site
* completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening
* on maintenance standard-of-care chemotherapies or on treatment holiday
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* adequate organ function
* progression of disease at the time of Enrollment

Exclusion Criteria:

* BRAF V600E mutation
* known allergy to both penicillin and sulfa drugs
* implanted devices that cannot be easily removed
* immunodeficiency, immune compromised state or receiving immunosuppressive therapy
Reinforcing Effects of Marijuana and Opioids

The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-50
* Experience with marijuana and opioids
* General good health
* Willing to live at the University of Kentucky Hospital (research unit) for approx. 6.5 weeks (meals are provided,

Exclusion Criteria:

* Significant medical complications/conditions
Prospective Comparison of Oral Intubation Via - Ambu® Aura Gain™ vs Slotted Guedel Tubus

The study has to show that an intubation with the AuraGain Laryngeal mask could bring the same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18
* ASA 1 -2
* Surgery of the shoulder, elbow, hand, hip, knee or foot
* Signed consent form

Exclusion Criteria:

* Patients with expected difficulties regarding to the intubation
* Patients with diseases / anatomical changes in the area of the pharynx, the larynx, the trachea, the esophagus or the stomach
* Not sober
* Increased risk of aspiration
* BMI \> 35 kg/m2
* Acute disease which could affect the suitability of the anesthesia
* Patients in which the use of a laryngeal mask is contraindicated or otherwise not possible
* Patients with a disease which prevents an accurate examination of the patients (eg neuromuscular, mentally, metabolic disease)
* Drug abuse in the recent past
* Legal incompetence
Phenotype Correlates Genotype of Inherited Retina Dystrophies, Retinitis Pigmentosa, Con>Rod Dystrophies.

Patients with retina dystrophies (retinitis pigmentosa, cone\>rods dystrophies, Usher and syndromic) will be correlated with genotype and validate inheritance mode by segregation analysis.

Patients with retina dystrophies (retinitis pigmentosa, cone\>rods dystrophies, Usher and syndromic, etc.) will be correlated with genotype and validate inheritance mode by segregation analysis. Ocular exam of proband, parents and two unaffected siblings is needed, retina analysis, autofluorescence and ocular coherence tomography (OCT) are needed as well as family map. Blood samples 10ml max blood extraction will be sent and genotype will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of inherited retina dystrophy or retinitis pigmentosa
2. Must be able to perform all study tests.
3. Must be able to visit every year.

Exclusion Criteria:

1) Not willing to visit every year.
Outcomes of a Small Process Group on Medical Students' Grit, Resilience, and Stress

The incidence of burnout and mental ill-health begins very early in medical school and continues to be high throughout training. Medical students are under high amounts of stress, which often becomes chronic, and can lead to both physical and psychological issues as a student, resident, and physician. Chronic stress and burnout in medical students are not a new phenomenon, but recent research has highlighted the worsening mental health of medical students, with as high as three-quarters of students reporting mental ill-health. It is vital that ways are found to reduce burnout and assist in improving the mental health of medical students. This quasi-experimental study aimed to assess the effect of a small process group vs. a control group of preclinical medical students on their stress, resilience, and grit.

The investigators assessed the effects of a year-long small process group intervention, led by a psychiatrist, which aimed to improve self-awareness, mindfulness, and resilience in first and second-year medical students. Students self-selected into the process group, and the same number were randomly recruited as controls from the rest of the preclinical student body. The psychiatrist who led the groups was blinded to student participation in the study. Students in the process and control groups were surveyed with the Perceived Stress Scale, the Connor-Davidson Resilience Scale, and the Grit Scale in September 2022, and again after nine months and 25 sessions, in May 2023, after the academic year. Statistical analysis was done with R Studio. Bandura's theory of self-efficacy was used to conceptualize the study. Recruitment was done by email, as was data collection. The intervention included guided exploration of the psychodynamic process, group dynamic theory, cognitive behavioral therapy, dialectical behavioral therapy, boundaries, and empathy.

Eligibility Criteria:
Inclusion Criteria:

1. The participant must be an enrolled student at the College of Osteopathic Medicine of the Pacific-NW
2. Participant must be in their first or second year of medical school
3. Participant must be at least 18 years of age
4. Participant must self-select into either the intervention group or control group
5. Participant must sign informed consent

Exclusion Criteria:

1. Data will be excluded if a student goes on a LOA during the course of the year
2. Data will be excluded if a student does not attend a minimum of 12 out of 25 small group sessions
3. Student does not give informed consent
4. Student withdraws consent at any time
Natural History of Peripheral Arterial Disease

The Veterans Administration Patient Study examined the progression of peripheral arterial disease (PAD) in patients with large vessel PAD or isolated small vessel PAD. The Community Follow-up Study following subjects with and without PAD from a previous cohort to determine subsequent coronary heart disease and cardiovascular disease morbidity and mortality.

BACKGROUND:

Peripheral arterial disease is a common condition, particularly in the elderly, but is the least frequently studied and the least well understood of the major atherosclerotic diseases.

DESIGN NARRATIVE:

Veterans Administration Patient Study: The progression of PAD was followed in patients diagnosed at the San Diego VA Medical Center from July 1984 to June 1989. Four non-invasive tests used in the initial diagnosis were repeated after a five year interval. The tests included segmental blood pressure flow velocity by Doppler ultrasound, post-occlusive reactive hyperemia, and pulse reappearance time. Risk factors examined for related to PAD included cigarette smoking, alcohol consumption, lipids and lipoproteins, blood pressure, fasting plasma glucose, diabetes history, immunoglobulin E, and creatinine. The degree of concordance between PAD and carotid disease was evaluated using phonoangiography.

Community Follow-up Study: The study was conducted in a cohort first examined for PAD in 1978-1981 and followed for morbidity and mortality.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB)

This study will evaluate the treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with Vibegron for the treatment of OAB in the context of real-world clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of overactive bladder (OAB) with or without urgency urinary incontinence
* Symptoms of OAB for at least 3 months prior to the Baseline Visit
* Willing and able to complete electronic patient-reported outcomes questionnaires monthly for a minimum of 1 year
* Previous exposure to anticholinergics or mirabegron monotherapy and/or mirabegron plus solifenacin combination therapy prior to initiation of vibegron

Exclusion Criteria:

* Any contraindication to the use of vibegron per the United States label
* History of OAB treatment with botulinum toxin A; sacral neuromodulation; percutaneous tibial nerve stimulation; external beam radiation therapy; urinary stents within the last 6 months; pelvic or lower urinary tract surgery within the last 6 months; and urethral catheterizations within the last 3 months prior to the Baseline Visit
* History of mixed incontinence where stress incontinence is the predominant form (as determined by the investigator)
* Participants at risk of urinary retention (as determined by the investigator)
* Neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
* Pregnant or breastfeeding or plans to do so during the study
* Use of vibegron prior to the Baseline Visit either prescribed or in a previous vibegron clinical trial where the participant was on vibegron
* Anyone who, at the discretion of the investigator, is not suitable for treatment with a beta 3 agonist for OAB for any reason
Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \[SIAC\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
* Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
* Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (SPC)
* HbA1c, 7.0-11.0 % (both inclusive)
* Body Mass Index (BMI), 25.0-37.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Metformin contraindication according to local practice
* Thiazolidinedione (TZD) treatment within previous 3 months prior to Visit 1
* Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
* Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products

The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product.

The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product. To accomplish this, a randomized, double-blinded, placebo controlled, crossover study design will be used, in order to determine the different effects of a variety of fibre-enriched pudding products on markers of type 2 diabetes and satiety response, versus low-fibre control puddings.

Eligibility Criteria:
Inclusion Criteria:

* Men/Women
* Age 18-70 years
* CANRISK Questionnaire score ≥21 (brief questionnaire that identifies risk of diabetes)
* BMI ≥25 and \<40 kg/m2
* Prior use of acetaminophen

Exclusion Criteria:

* Smokers
* Food allergies or any life-threatening allergy (food or otherwise)
* Acetaminophen allergy
* Gastrointestinal conditions or illnesses (Including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD))
* Serious major medical condition (i.e. renal, liver)
* Pregnant or breastfeeding
* Food Neophobia Scale score between 30 and 54 (Food Neophobia Scale is a questionnaire which is intended to screen out individuals who are unsure of consuming new products)
* TFEQ-CR \>16 (TFEQ is a questionnaire to screen for restrained eaters)
* Alcohol consumption\>4 drinks/sitting
* Medication or natural health products (NHPs) used for diabetes (glycemic control)
* Medication or NHPs contraindicated with acetaminophen
* Recent or intended significant weight loss or gain (i.e. \>4 kg in previous 3 months)
Cyanotic Heart Disease and Thrombosis

The purpose of the study is to examine previously examined patients with cyanotic congenital heart disease to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago.

Patients with cyanotic congenital heart disease have reduced oxygen content in their blood due to abnormal connection between the heart's right and left sides. The reduced oxygenation of the blood affects several organs of the body and a common complications to the disease is blood clots. Despite the patients are young and do not have typical risk factors, previous studies have shown, that they have a very high prevalence of thrombosis in the lungs and brain.

The reason for the increased prevalence of blood clots is not known. A previous study investigated the prevalence of blood clots systematically in patients with cyanotic congenital heart disease and found that approximately 30-40% of the patients had had a clot in the lung or brain. Thus, the study could not predict, when the patient had had a thrombotic event, and most of the patients did not previously had imaging performed. Therefore the aim of this study is to re-examine previously examined cyanotic patients regardless of previous medical history, to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cyanotic congenital heart disease who have previously participated in the study 'cyanotic congenital heart disease: Hemostatic abnormalities and clinical manifestations' (H-KF-2006-4068).
* Clinically stable

Exclusion Criteria:

* Patients who are not guardians for themselves (not adult).
* Age \<18 years.