cyrilzakka/clinical-trials huggingface dataset:
DeStress for Health: Partnering With Granville and Vance Counties to Reduce Stress and Cancer Risk (Part 2)

The purpose of this research study is to determine whether a positive psychology intervention paired with a health behavior intervention is successful in decreasing perceived stress and increasing positive affect in residents of Vance and Granville County.The program will consist of 4 in person / zoom sessions that are based on empirically supported PPWB components including Optimism, Gratitude, Mindfulness and Positive Savoring to improve behavioral self-regulation towards health-related goals with an additional class five as a check in that will be used for survey completion. Specifically, principal investigator will provide participants with instruction on positive psychology exercises that can do on their own and counseling around increased fruit and vegetable intake, physical activity and smoking cessation. Participants will then be asked to create a SMART goal to work on each week of the program for one of the behaviors. Research staff will conduct surveys with participants at baseline and at end of program. Feasibility and acceptability measures of the intervention will be collected at the end of the program. Research team will also collect informal feedback from participants at the end of each of the class sessions. Classes will be delivered in person and broadcasted via zoom via a password protected zoom link. Participant who choose to remain remote and participate via Zoom will be mailed binders of study materials with information on who to call if participants have questions. Participants who attend live events will receive their materials in person. Pre- and post-intervention surveys will be sent to participants via email. This is Part 2 of study (NCT03776890)


Eligibility Criteria:
Inclusion Criteria:

* Live in Granville or Vance Counties;
* \>18 years old;
* Interested in participating a stress reduction study
* Speak English

Exclusion Criteria:

* Does Not Live in Granville or Vance Counties
* Under 18 years of age
* Not interested in participating in a stress reduction study
* does not speak English
An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)

This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (according to local legislation)
* Chronic hepatitis C
* Treatment with long-acting interferon plus ribavirin
* Quantifiable HCV RNA before initiation of treatment
* No contra-indications to long-acting interferon and ribavirin therapy as detailed in the label

Exclusion Criteria:

* End stage renal disease
* Major organ transplantation
* Concomitant therapy with telbivudine
* Pregnant or breast-feeding females
* Male partners of pregnant females
Redirecting Immune, Lipid and Metabolic Drivers of Early Cardiovascular Disease: The RESET Cohort Study

Project RESET is a Singapore National Medical Research Council Large Collaborative Grant funded program that brings together a nationwide community of cardiovascular, metabolic, and digital health researchers, as well as clinicians across primary and tertiary care to study the immune, lipid and metabolic drivers of early cardiovascular disease. RESET incorporates a nested randomised controlled trials (RCT) to test the use of a combined digital wearable and AI-human symbiotic lifestyle intervention to halt or reverse the progression of early disease.


Eligibility Criteria:
Inclusion Criteria:

* 40-70 years old
* ASCVD (atherosclerotic cardiovascular disease) score of 5% and higher

Exclusion Criteria:

* Previous major cardiovascular disease (myocardial infarction, heart failure, ischemic stroke)
* Limited life expectancy
* Other ongoing unstable medical conditions
* Pregnant women
Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab

Patients with diabetic macular edema who were switched to aflibercept after having been treated with bevacizumab or ranibizumab were retrospectively reviewed to assess for visual acuity and anatomic outcomes.


Eligibility Criteria:
Inclusion Criteria: Those patients with diabetic macular edema switched to aflibercept from bevacizumab and/or ranibizumab -

Exclusion Criteria: None

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Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms

The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).

This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150 subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites. There will be no prospective control group. Subjects diagnosed with infrarenal abdominal aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months post-implantation. In addition, annual follow-up visits out to 5 years will be conducted.

The primary goal of this study is to gather safety and effectiveness data on the Treovance device. A maximum of 150 endovascular subjects will be required to fulfill the U.S. Phase II requirements. The data from this study will be submitted to the FDA and used to support approval in the U.S.

There are two primary objectives, efficacy and safety of the Treovance Stent-Graft in subjects with infrarenal aortic aneurysms:

* Primary Efficacy will be evaluated by successful aneurysm treatment 12 months post-implant
* Primary Safety will be assessed by composite major adverse event (MAE) rate at 30-days

Secondary objectives involve assessment of major device-related events and major morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement
* Subject must have an infrarenal AAA that is \> 4.5 cm in diameter for males, or \> 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months

Exclusion Criteria:

* Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
* Subject has had a prior AAA repair (endovascular or surgical)
* Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure
Intermountain Risk Score and Trauma

The investigators hypothesize that a risk score composed of age, sex, and the components of commonly ordered laboratory panels will be predictive of mortality in trauma patients, and will help improve clinicians' ability to make more accurate mortality predictions at the time of admission.


Eligibility Criteria:
Inclusion Criteria:

* Patient presents to Intermountain Medical Center as a Level I or Level II trauma activation.
* Age ≥18

Exclusion Criteria:

* Patients who are not admitted to the hospital

  1. Patients who expire in the Emergency Department
  2. Patients who are discharged to home from the Emergency Department
* Patients who do not have a complete blood count and basic metabolic profile drawn in the Emergency Department as part of routine clinical care.
* Patients who enter the hospital as "trauma consults." These patients have traumatic injuries, and are often admitted to the trauma service, but the severity of their trauma is not thought to warrant trauma team activation.
Development of New Diagnostic Tools in Capsule Endoscopy

Patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the procedure, while reducing reading time by physicians.

Capsule endoscopy is a minimally-invasive diagnostic procedure based on the ingestion (or endoscopic delivery) of a miniaturized biocompatible, camera. Capsules capture tenths of thousands images of the digestive tract. Reading the captured images and reporting is long, tedious, and at risk of errors when the reader's attention is disturbed. Artificial intelligence is expected to alleviate these limitations, by both improving diagnostic performances of capsule endoscopy while reducing reading time.

Any patient in whom a capsule endoscopy examination is performed as part of routine care will be invited to participate to the study. Their de-identified images and videos will be extracted, thus allowing the creation of several databases for training, tuning and testing technological bricks of artificial intelligence. Basic clinical data will be collected (age, gender, indication for capsule endoscopy, type of device, ingestion or delivery of capsule). Images and videos will be characterized centrally and consensually by a panel of 3 expert readers, according to their level of relevance in relation to the type and indication of capsule endoscopy.

The various, developed technological bricks will aim to automatically detect and characterize anatomical landmarks and abnormal findings, and to quote the intestine cleanliness.

Assessment of diagnostic performance and reading time will be performed within a few months or up to five years, for each technological brick, individually and then combined, according to their stepwise development.

Eligibility Criteria:
Inclusion Criteria:

- Any patient in whom a capsule endoscopy examination is performed as part of routine care.

Exclusion Criteria:

- Opposition to the use of images and videos from daily, routine care for research purposes.
Evaluation of Fats on Postprandial Glucose Control

The purpose of this study is examine the effect of different fat types on postprandial glucose control in patients with type 1 diabetes.

Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals.

The investigators hypothesize that, despite identical carbohydrate content,the lunches higher in saturated fat will lead to more postprandial hyperglycemia than the lunch containing minimal fat and the lunch high in monounsaturated fat.

The hypothesis is that from time points 0-180 minute area under the curve for Lunches A, B, C, and D will be the same, whereas from time points 180-360 minutes for Lunch B and D will be greater than that of Lunch A and C.

Subjects for this study will be adults with type 1 diabetes who use insulin pump in their diabetes self-management. Prior to admission the the clinical research center the basal rates and insulin-to-carbohydrate ratio of the subjects will be optimized using standard clinical procedures.

Subjects will be admitted to the clinical research center in mid-morning following a light breakfast at home. Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals. Blood samples for measurement of plasma glucose and insulin levels will be drawn for the subsequent 6 hours. We hypothesize that postprandial glucose levels 3-6 hours after start of the meal will be higher following lunches B and D, compared to lunches A and C.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18-75 years) with type 1 diabetes \> 3 years.
* On insulin pump therapy.
* A1c \< 8.5%.

Exclusion Criteria:

* History or symptoms suggestive of gastric dysmotility, celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion.
* Eating disorder.
* Diet allergies.
* Special diet restrictions, such as vegan or any nut allergy.
* Medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan).
* High-titre insulin autoantibodies with delayed insulin kinetics.
* Women who are breast feeding, pregnant, or wanting to become pregnant.
Efficiency of Physiotherapy Treatments for Low Back Pain in Women.

Aim: To evaluate and compare the effectiveness of a combined treatment of TENS or Elec-tromagnetic and Back School with the effectiveness of only the Back School treatment.

Design: Single-blind experimental prospective study of clinic intervention. Setting: Physiotherapy and Speech Therapy Unit at the Cambrils Slight Hospital. Spain.

Population: 96 women (50-85 years) with chronic low back pathology. Methods: Subjects were divided into three randomized groups: Back School (group 1), TENS with Back School (group 2), and Magnetic therapy with Back School (group 3). They have re-ceived 20 sessions of treatment. The intensity of pain (EVA Scale) and the quality of life (Oswestry Scale) were measured, at the beginning and at the end of the treatment and after three and six months. Anthropometric and physical activity variables were collected.


Eligibility Criteria:
Inclusion Criteria:

* Women between 50 and 85 years.
* Chronic LBP condition for at least three months ago.
* Patient's agreement by signing the consent.

Exclusion Criteria:

* Cardiac pacemaker carriers.
* Patients with parts of osteosynthesis and / or prostheses.
* Patients with a not well balanced medical condition.
* Patients with TENS at home and / or having completed physiotherapy during the last three months.
* Patients with skin infectious diseases or skin lesions and / or areas of hypoesthesia.
* Patients with malignant tumours.
* Patients who received any spinal injection during the last six weeks.
* Patients who participate or have participated in a study in the last three months
TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry: Dutch National Registry for Patients With Moderate-to-severe Atopic Eczema on Photo- or Systemic Therapies

The TREAT NL (TREatment of ATopic eczema, the Netherlands) registry is a national registry for children and adults with moderate-to-severe atopic eczema aiming to gather data on their prescribed photo- and systemic immunomodulating therapies. Atopic eczema is a common, chronic, itchy, inflammatory skin disease that can have a major impact on the quality of life of patients and their immediate surroundings.

Serious atopic eczema patients are treated by means of photo- or systemic immunomodulating therapy. Of these mostly off-label applied therapies, there is insufficient evidence on the short and long term for their effectiveness, safety and cost-effectiveness. Moreover, good comparative research and real-life data are lacking. With the arrival of new expensive treatments it is crucial to get insight into these treatments in order to improve quality of care.

By means of a prospective registry these data can be collected and help to obtain information for clinical practice, for answering research questions, for reducing costs and implementing the results by guidelines and decision aids.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a diagnosis of atopic eczema, based on the U.K. working party's diagnostic criteria;
* Starts with any type of phototherapy (e.g. UVB) or systemic immunomodulating therapy (e.g. cyclosporin, systemic glucocorticosteroids, azathioprine, methotrexate, mycophenolic acid, dupilumab);
* Has voluntarily signed and dated an informed consent prior to any study related procedure or has a legal representative to do so and is willing to comply with the requirements of this study protocol.

Exclusion Criteria:

* Patient uses only (systemic) antibiotics or antihistamines;
* Patient starts with systemic immunomodulating therapy for another indication than atopic eczema;
* Insufficient understanding of the study by the patient or parent/legal representative.
The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-induced Metabolic Syndrome

Almost all of antipsychotics can induce metabolic syndrome,Genetic factors play a key role in the development of metabolic syndrome,TCF7L2 and SLC30A8 are strongestly correlated with metabolic syndrome.Moreover,Antipsychotics have an effect on the expression of TCF7L2 and SLC30A8 genes.It indicates the variations of TCF7L2 and SLC30A8 play an important part in the development of antipsychotics-induced metabolic syndrome.

* In this study, we will determine the effect of olanzapine on the expression of TCF7L2 and SLC30A8.
* The relationship of the polymorphism of TCF7L2 and SLC30A8 with antipsychotic-induced metabolic syndrome in schizophrenia patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of first episode schizophrenia
* Must be able to swallow tablets
* Take only one antipsychotics

Exclusion Criteria:

* liver or renal or cardiovascular diseases
* pregnant or lactating women
* drug and alcohol dependence
Optimized Peak VO2 in Predicting Advanced HF

The ability and timely selection of severe heart failure (HF) patients for cardiac transplantation and advanced HF therapy is challenging. Peak VO2 by cardiopulmonary exercise test (CPET) was used for transplant listing. This study aimed to reassess the prognostic significance of peak VO2 and to compare that with the Heart Failure Survival Score in the current optimized novel guideline-directed medical therapy (GDMT).

Investigators retrospectively collected acute HF patients discharged alive from the hospital. Investigators divided participants into more-GDMT (≥2 kinds) and few-GDMT (\<2 kinds) groups and compared the prognostic significance of peak VO2 and HFSS for combined all-cause mortality and urgent cardiac transplantation.

Eligibility Criteria:
Inclusion Criteria:

* acute HF patients with reduced ejection fraction (left ventricular ejection fraction, LVEF \<=40%) and discharged alive from the hospital
* patients with age \>= 20 years of age
* patients who performed cardiopulmonary exercise test (CPET) within one month after discharge
* patients with serum B-type natriuretic peptide (BNP) level \>100 pg/mL.

Exclusion Criteria:

* patients with estimated survival time \< 6 months
* patients who could not tolerate exercise test due to muscular-skeletal disorder or other reason
* patients who had severe valvular heart disease.
Choroidal Thickness in Optic Neuropathy

This study plans to learn more about the thickness of the choroid in patients with optic neuropathy. The choroid is a layer of blood vessels that supplies oxygen and nourishment to the outer layers of the retina. Patients are being asked to be in this research study because they have optic neuropathy and are receiving care at the University of Colorado Hospital.


Eligibility Criteria:
Inclusion criteria:

* age greater than 18 years,
* diagnosis of optic neuropathy,
* willing and able to sign an informed consent.

Exclusion criteria:

* steroid use within the past 4 weeks,
* inability to cooperate with optical coherence tomography (OCT) testing,
* relevant ocular comorbidities in the affected or unaffected eye, such as

  * glaucoma,
  * uveitis,
  * optic nerve hypoplasia,
  * age related macular degeneration,
  * refractive error greater than 5 spherical diopters.
Resistance Training in Intradialysis Patients

Dialysis patients usually have peripheral muscle weakness due to metabolic disturbances (increased protein catabolism) and fatigue. This muscle weakness may decrease functional capacity and quality of life. It also serves to increase cardiovascular risk factors in these end stage renal disease patients. Peripheral muscle strength training shall combat physical inactivity during dialysis. In the investigators trial, the investigators hypothesis that peripheral muscle training might regulate protein catabolic rate,renal functions, cardiovascular risk factors, improve functional capacity and quality of life in endstage renal disease patients undergoing dialysis.

End stage renal failure patients undergoing dialysis have profound muscle wasting, reduced functional capacity and quality of life due to uremia, steroids, frequent dialysis and fatigue. During dialysis, physical inactivity further deteriorates the patient's functional capacity. Aerobic or strength training may combat this physical inactivity. It may also improve the functional capacity and quality of life. Recent studies have claimed the benefits of resistance exercises in improving functional capacity. But they have not documented effects on kidney function (electrolyte and urea kinetics) and muscle wasting (protein catabolic rate). In our trial, we attempt to study the effects of resistance training in improvement of renal function and muscle wasting apart from functional capacity and quality of life in dialysis patients

Eligibility Criteria:
Inclusion Criteria:

* Must have end stage renal disease (diagnosed and the stage graded by nephrologist or the intensivist concerned) for more than 6 months and dialysis for at least 3 months (the impact of exercise training can be easily assessed)
* Must be between the ages of 30 - 60 years of age/ both genders.
* Must be able to understand the purpose of exercise testing and resistance training.

Exclusion Criteria:

* Those with acute nephritic syndrome and hematuria \< 2 months.
* Those with profound anemia and blood transfusion \< 2 months
* Those underwent renal transplantation \< 6 months.
* Those receiving/ received cytotoxic drugs - amiloride, azathioprine/ aspirin (antiplatelets)\< 2 months
* Those with coagulation disorders or under anticoagulants \< 4 months.
* Those underwent recent cardiac surgeries and with recent unstable cardiac failures
* Those with recent cerebrovascular accidents \< 6 months
* Those have recent urinary tract infections, Renal and bladder carcinomas \< 2 months
* Those with absolute contraindications for resistance exercise training (as per American College of Sports Medicine.
Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy

Hormone responsive breast cancer is common and costly. Long-term adjuvant endocrine therapy (AET) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated with physical and emotional concerns. I propose to evaluate the feasibility and preliminary effectiveness of a behavioral intervention to facilitate problem identification, provide education, coaching for breast cancer survivors with symptoms while on AET. Therefore, the intervention intends to empower women to engage in better self-care and seek out resources they need, which, in turn, will lead to better symptom management.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50.
* Nonmetastatic bread cancer survivors reporting being bothered by 1 or more symptoms related to their treatment with AET (for \> 0 months and \< 6 months).
* Possess a household or cell telephone.
* Ability to provide informed consent.

Exclusion Criteria:

* Clinically significant cognitive impairment.
* Communication barrier limiting ability to participate in telephone assessments.