cyrilzakka/clinical-trials huggingface dataset:
A Digitally-Supported Shared Decision Making Approach for Coronary Artery Disease Patients During Cardiac Rehabilitation

Investigating the role of shared-decision making in cardiac rehabilitation

The clinical study is a prospective double-arm, randomized controlled trial to study the user experience of the approach with the supporting applications, and the impact on patients' quality of life, physical activity, perception of rehabilitation and engagement in the decision making process.

Eligibility Criteria:
Inclusion Criteria:

* Have a history of coronary artery disease with or without intervention (PCI/CABG/conservative)
* Be clinically stable without inducible ischemia or high risk ventricular arrhythmia, confirmed by the last available maximal ergospirometry test
* Recently having started cardiac rehabilitation in Jessa Hospital Hasselt
* Age ≥18 years
* Willing and physically able to follow a technology-supported shared decision making program and other study procedures in a three months follow-up period
* Show evidence of a personally signed and dated informed consent, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study
* Possession of and/or able to use an Android based smartphone
* Possession of internet connectivity
* Dutch speaking and understanding

Exclusion Criteria:

* • Orthopedic, neurologic or any other pathologic condition which makes the patient physically unable to follow a technology-supported shared decision making program

  * Planned interventional procedure or surgery in the next three months
  * Pregnant females
  * Present cardiovascular complaints
  * Participation in other cardiac rehabilitation program trials, focusing on exercise outcome
  * Current or recent participation in other technology-supported programs, even when not directly targeting exercise capacity
  * Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than three months based on investigators judgement
Predictive Value of the Global Limb Anatomic Staging System (GLASS) in Patients With Critical Limb-threatening Ischemia

The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) proposes the Global Limb Anatomic Staging System (GLASS), a new angiographic scoring system to quantify the anatomic severity of infrainguinal disease in CLTI patients. However, GLASS validation still needs to be completed, and the infrapopliteal (IP) target artery pathway (TAP) was easily influenced by the procedures. Thus the IP target artery could be selected either as the least diseased artery based on angiography or prospectively based on the angiosome concept. So the investigators aim to evaluate its correlation with clinical outcomes after revascularization.

The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) recommends using the Global Limb Anatomic Staging System (GLASS) to assess the severity of infrainguinal disease in CLTI patients. GLASS staging involves scoring the femoropopliteal (FP) and infrapopliteal (IP) segments separately. For IP segment scoring, the target artery path (TAP) is identified by the clinician based on either the least diseased or the recanalized IP path. However, this approach may lead to diverse GLASS staging results, especially for simple lesions below the knee. Additionally, the current version of GLASS does not account for multivessel IP revascularization, which may introduce subjective bias if a physician chooses different IP targets during multiple revascularization procedures.

In order to improve our understanding of the current staging system, the investigators will establish a prospective registry that collects data on conservative patients who have Chronic Limb-Threatening Ischemia (CLTI) and undergo endovascular therapy for infrainguinal lesions. To evaluate the stage of the lesions, the investigators will use two distinct IP scoring techniques. One approach will be based on the least disease IP path as identified by the pre-interventional angiogram, while the second technique will be based on the recanalized IP path preferred by the clinician. This scoring will be carried out by experienced physicians and the results will be recorded in an electronic database. Then the correlation between the major adverse limb events (such as clinical-driven target limb revascularization, major amputation, and all-cause death) with the patient's Wound, Ischemia, foot Infection (WIFI) classification, GLASS anatomic staging, calcification severity, and modified Society for Vascular Surgery (SVS) run-off score will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of chronic limb-threatening ischemia (CLTI)
2. Undergo endovascular therapy for infrainguinal lesions

Exclusion Criteria:

1. Pregnant women or female patients with potential childbearing
2. Patients who have acute limb thromboembolism or require thrombectomy during the procedure
3. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
4. Patients with known allergy to contrast media
Effectiveness of Two Water-Based Potassium Oxalate Desensitizers

This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent to participate in the study
* Be at least 18 years of age
* Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
* Agree to refrain from participating in any other oral/dental product studies for the duration of the study
* Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
* Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
* Agree to comply with study/product usage instructions; and
* Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening

Exclusion Criteria:

* Gross oral neglect or urgent dental treatment needs
* Severe periodontal disease and/or generalized mobility
* Active treatment for periodontitis
* Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
* Self-reported pregnancy or nursing
High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes

Diabetes/ prediabetes is a substantial problem in India not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of importance for the prevention of other diseases. It is not clear if a high protein calorie diet in the Indian population associated with a heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dysmetabolic state etc. could, besides lifestyle factors, be related to diet, or interaction between the two. The analysis of whole blood transcriptomes and plasma metabolomics profiles may be a potentially useful tool for the assessment of metabolic health status. The proposed study is the first to perform a detailed gene expression profiling with the use of next-generation sequencing technology to assess the differences in molecular mechanisms in the peripheral blood of subjects with prediabetes.

This study will be conducted at the outpatient department of the National Diabetes, Obesity and Cholesterol Foundation (N-DOC), Diabetes Foundation (India) (DFI)and Fortis-C-DOC, Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, New Delhi, India.

Experimental Protocol: In this study, a total of 60 subjects with pre-diabetes and 60 age and body mass index, and gender-matched controls (age 18-40 years) will be recruited. They will be randomized to an equicaloric normal diet (carbohydrates 60%, protein 15%, and fat 25%) or a high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods. All assessments as done on day 1 will be repeated at day 60.

Eligibility Criteria:
Exclusion Criteria:

* Acute infections and advanced end-organ damage.
* History of hepatitis or pancreatitis, abnormal liver and renal function tests.
* Recent (\<3 months) changes in weight (≥5%) and/or weight changing medications.
* Subjects with metallic implants, pacemaker leads, radioactive seeds or surgical staples in the body.

Inclusion Criteria

Cases:

* Age 18 to 50 years. Subjects with pre-diabetes on oral glucose tolerance test (OGTT)
* Fasting blood glucose≥100mg/dl and \<126 mg/dl or 2-h plasma glucose ≥140mg/dl and \<200mg/dl (after ingestion of 75 grams of anhydrous oral glucose) or both.

Controls:

* Age 18 to 50 years. Normoglycemia by OGTT
* Fasting blood glucose \<100mg/dl and 2-h plasma glucose \<140mg/dl (after ingestion of 75 gram of anhydrous oral glucose).
Screening Of Adult urBan pOpulation To diAgnose Heart Failure

Screening Of adult urBan pOpulation To diAgnose Heart Failure (SOBOTA-HF) is a cross-sectional prevalence study in a representative sample of Murska Sobota residents aged 55 years or more. Individuals will be invited to participate in a screening with NT-proBNP. All subjects with NT-proBNP ≥ 125 pg/mL will be invited for a diagnostic visit that will include history and physical examination, electrocardiogram, echocardiography, ankle brachial index, pulmonary function tests, body composition measurement, physical performance tests and questionnaires. To validate the screening procedure, a control group (NT-proBNP \< 125 pg/mL) will undergo same diagnostic evaluation. An external center will validate echodardiography exams and the HF diagnosis will be adjudicated within an independent HF expert panel. Overall and age specific HF prevalence will be calculated in individuals ≥ 55 years and extrapolated to the whole population.


Eligibility Criteria:
Inclusion Criteria:

* age \>55
* living in Murska Sobota
* part of representative sample as selected by Statistical Office of the Republic of Slovenia

Exclusion Criteria:

NONE.
Communicating Smoking Risks Through Graphic Warning Labels

Smoking is the largest preventable health risk in the U.S. The Family Smoking Prevention and Tobacco Control Act of 2010 mandated the placement of larger pictorial warnings on cigarette packs as well as nine new statements of smoking risks. This trial tests the effectiveness of the warnings proposed by the Food and Drug Administration by providing cigarettes with the proposed labels to 320 smokers across two sites (Philadelphia, PA and Columbus, OH). In addition, the trial tests the effects of different warning label components.


Eligibility Criteria:
Inclusion Criteria:

* smoke between 5 and 40 cigarettes per day and 100 in lifetime
* Not currently trying to quit
* between 18 and 65 years of age

Exclusion Criteria:

* smokes 120's or roll-your own or noncommercial cigarettes
* pregnant or breastfeeding
* history of substance abuse past 5 years
* more than 25 standard alcohol drinks per week
* use of other nicotine products, such as cigars, nicotine gum
* current treatment for copd, cancer, pulmonary disease, alcohol/drug dependence
* current treatment for a psychiatric condition
* physical/visual/mental impairment that prevents reading from a computer screen
* not US resident
* unable to read English
* English not main language
* other member of household in study
* friend who smokes in study
* unable to attend weekly appointments between 9 am and 6 pm Monday-Friday
* unable to use hand-held computer to enter daily mood ratings
Reliability of MRI and Ultrasound in Cervical Epidural Needle Depth Estimation

This study aims to evaluate the reliability of magnetic resonance imaging (MRI) and ultrasound (USG) in predicting needle depth during cervical epidural injections, compared to fluoroscopy. The goal is to identify alternative imaging methods that reduce radiation exposure while maintaining procedural accuracy and patient safety.

Cervical epidural steroid injections (CESI) are commonly used to manage chronic neck and radicular pain. Accurate needle placement is critical for the success and safety of the procedure. Fluoroscopy is the standard method for guiding the needle; however, it exposes patients and clinicians to ionizing radiation.

This study compares pre-procedural MRI and USG measurements of needle depth with fluoroscopy-guided needle depth during CESI.

Primary Objective: Assess the agreement between MRI, USG, and fluoroscopy measurements of needle depth using intraclass correlation coefficients (ICC) within a ±0.3 cm tolerance.

Secondary Objectives: Evaluate the correlation between fluoroscopic lateral imaging frequency and radiation exposure.

The study is a methodological observational study conducted at Ankara Etlik City Hospital, involving adult patients undergoing CESI. Data will be collected retrospectively and prospectively for eligible participants.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years, Diagnosed with chronic cervical pain, Referred for cervical epidural steroid injection, Patients capable of providing informed consent.

Exclusion Criteria:

Age \< 18 years, Pregnancy or breastfeeding, History of coagulation disorders or use of anticoagulants, Severe systemic infections or local infections at the injection site, Known allergy to steroids or local anesthetics, Uncontrolled diabetes mellitus, Patients with spinal tumors or significant spinal deformities, Previous cervical spine surgery, Cognitive impairment preventing informed consent or follow-up participation.
NUTS for the Prevention of Cardiovascular Disease in Chinese Adults

This study evaluates the feasibility of walnuts supplementation among population of high CVD risks over a period of 6 months. 70 participants will be controls receiving non-edible gifts. 70 participants will be given 30 grams of walnuts everyday and 70 participants will be given 60 grams of walnuts a day.

Increased consumption of nuts improves the levels of lipid risk factors associated with cardiovascular disease and consistently relates to lower risk of cardiovascular disease (CVD) in prospective cohort studies. The estimates of health effects and potential population benefits of increased consumption of nuts are based mostly on observational data and there remains considerable uncertainty about whether higher intake of nuts will actually reduce cardiovascular outcomes. To address this uncertainty will require a well-conducted, adequately powered, large-scale, randomised control trial that tests the causal relationship between nut intake and the risk of cardiovascular diseases.

We hereby designed a 6-month walnut supplementation trial in a rural area of China with high rates of CVD, to obtain data to support and help to refine the design of a future long-term large RCT testing the effect of nut supplementation on CVD risk. The main objectives of the current trial are to assess the acceptability and adherence to two different doses of walnut supplementation (30 and 60 grams per day). The exploratory objectives are to determine the effects of walnut supplementation on cardiovascular risk factors including blood lipids, fasting glucose, and body weight.

Eligibility Criteria:
Inclusion Criteria:

1. A history of CVD, defined on the basis of a prior hospitalisation for a myocardial infarction or stroke, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (with or without stenting), peripheral revascularization (angioplasty or surgery), symptomatic with documented hemodynamically-significant carotid or peripheral vascular disease, or amputation secondary to vascular disease, OR
2. Male aged \>60 years, or female aged\>65 years, AND

With at least two of the following risk factors:

1. Type 2 diabetes requiring treatment with at least two oral anti-hyperglycaemic agents and/or insulin
2. Systolic blood pressure \> 140 mmHg while on one or more antihypertensive agents
3. Current daily smoking
4. Dyslipidaemia defined as HDL-cholesterol\<1.0mmol/L or LDL-cholesterol\>6.0mmol/L
5. Micro or macro albuminuria

Exclusion Criteria:

1. Allergic to nuts (history of food allergy with hypersensitivity to any of the components of nuts)
2. Other serious medical condition that prevents nut consumption (e.g. digestive disease with fat intolerance)
3. Any medical condition thought to limit survival to less than 1 year
4. Difficulty with consuming nuts (e.g. dental health issues that prevent chewing walnuts)
5. Unwilling to consume nuts
Longitudinal Study of Bone Mineral Density in Survivors of Solid Pediatric Cancers

Specific subgroups of children who survive treatment for childhood malignancies have been shown to develop relative osteopenia following chemotherapy and are felt to be at risk for developing osteoporosis later in life due to their inability to reach peak bone mass during childhood. Based upon an earlier study in our department, the investigators reported conclusive evidence that approximately half of survivors of pediatric solid malignancies are at risk for these problems. However, the proportion of patients in our population that showed osteopenia/osteoporosis was lower than that in other similar cross-sectional studies in solid tumors such as osteosarcoma. The main difference between our report and the osteosarcoma study was duration of follow-up, with ours being shorter. Longer follow-up may prove that a larger proportion of our patients are affected. The purpose is to perform a longitudinal follow-up study of bone mineral density using dual-energy X-ray absorptiometry (DXA) in adult survivors of solid pediatric tumors that were previously studied as subjects in our original cross-sectional study. The primary hypothesis is that the proportion of pediatric solid cancer survivors with significantly lower bone mineral density (BMD) compared to established age group controls will be increased with the additional time that has elapsed since the original study despite the fact that the patients are young and would not normally be expected to have osteopenia/osteoporosis at this age.

AS ABOVE

Eligibility Criteria:
Inclusion criteria:

* The 38 patients from the SUNY Upstate Medical Center Pediatric Oncology Long-term Survivor Clinic who were subjects in the original Georg Fund supported study will comprise the patient population if they are locatable and willing to participate.
* Patients must be less than 40 years of age to participate.

Exclusion criteria:

* Patients who have received interval treatment for Acute Lymphocytic Leukemia (ALL) and those who have received subsequent cranial irradiation or total body irradiation (groups already known to be at high risk for osteoporosis) will be excluded. These would have had to have occurred in the interval since the original study, as these were also exclusion criteria for that study. In addition, any patient who received interval non-autologous bone marrow transplant will be excluded, as these patients may have graft versus host disease (also known to be associated with osteopenia).
Use of PET-CT in the Management of Crohn's Disease

Crohn's disease (CD) is an autoimmune disorder which affects over 700,000 people in the U.S. The disease can vary in severity and multiple drug classes are available to the disease depending on disease severity and complications. Our purpose will be to study how PET-CT scans can be used to better manage Crohn's Disease.

Crohn's disease (CD) is a gastrointestinal autoimmune disease thought to result from exposure to luminal antigen. This exposure then results in a robust Th1 mediated immune response which is not downregulated, resulting in intestinal tissue injury. Crohn's disease most commonly involves the distal small intestine, a site that can be difficult to visualize given its central location within the gastrointestinal tract.

A substantial proportion of patients do not respond to any of the standard therapies. Over 40% of patients do not respond to an initial anti-TNF (biologic) agent and approximately 10% per year lose their response to these drugs. There is no standard definition of what constitutes a patient who has primary biologic failure.

Disease activity is measured by indices such as the Crohn's Disease Activity Index (CDAI). The CDAI includes a combination of clinical criteria and lab values. However, the CDAI is limited by reliance on subjective criteria, limiting the score's use as a valid measure of studying response to medical therapy. Clinically, reliance on CDAI can result in inappropriate continuation of an ineffective therapy resulting in worsening of underlying disease, and increasing risk of adverse reactions.

Small studies have demonstrated that PET scans may accurately quantify disease activity in Crohn's. We propose to study CD patients with active flares to assess for a correlation between PET activity and CDAI. Additionally, we will determine whether PET signal intensity is predictive of clinical response to therapy with biologic agents.

The study proposes to test the hypothesis that PET can be used to determine which CD patients with small bowel disease will be true responders (or nonresponders) to biologic therapy at week 12. The use of PET to determine response to biologic therapy in small bowel Crohn's disease would be novel.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn's disease
* CDAI1\>220
* Identification of small bowel disease based on an imaging study (CT scan, Abdominal ultrasound, MRI), colonoscopy, or histopathology 4. Need for initiation of biologic therapy to control disease process.

Exclusion Criteria:

* Abdominal surgery within 8 wks of study entry
* Change in dose of steroids or immunomodulators within 2wks of study entry
* Pregnancy
* Active bacterial infection or undrained abscess
* Any contraindications to initiation of AntiTNF therapy (i.e. latent tuberculosis).
Study of MDW Levels Predicting the Development of Sepsis in Hospitalized HIV-infected Patients and Correlation With Prognosis

Sepsis is a common and critical complication in HIV-infected patients and an important marker of high risk of patient death. The widely used diagnostic criteria for sepsis still have many deficiencies and do not allow for good prediction and timely determination of the onset of sepsis. In HIV-infected patients, abnormal activation of monocyte-macrophage is also a key mechanism in the development of their sepsis. Monocyte distribution width (MDW) is a marker of the degree of peripheral blood monocyte activation and has been recommended abroad for the early diagnosis of adult sepsis patients in emergency departments. However, in China, MDW has not been applied to the clinic yet, and the related studies are almost blank. Therefore, it is worthwhile to analyze the monocyte activation status of HIV-infected patients by MDW assay and thus predict the occurrence of sepsis.

This is a prospective observational study, and investigators intend to collect HIV-infected patients in our hospital within 1 year from the conduct of this study and hospitalized, after informed consent, for inclusion in the study. Investigators will collect clinical data, basic laboratory indicators, and test MDW levels of the patients and follow the patients until discharge or death.

Eligibility Criteria:
Inclusion Criteria:

* Positive ELISA test results for HIV-1 antibodies;
* Hospitalized patients; Voluntarily signing the patient's informed consent and being able to promise to be followed up;
* No plans to move away from the current trial site during the course of the trial.

Exclusion Criteria:

* Western Blot and/or HIV RNA assay confirmed as HIV negative;
* Women who are pregnant or breastfeeding;
* Current drug users;
* Persons with a history of alcohol abuse that cannot be terminated;
* Persons of non-Chinese nationality;
* Other patients who, in the judgment of the investigator, are deemed unsuitable for participation in this trial.