cyrilzakka/clinical-trials huggingface dataset:
Enteral Nutrition After Pancreaticoduodenectomy

Pancreaticoduodenectomy (PD) is the treatment of choice for resectable periampullary cancer. PD is still associated with a relatively a high incidence of delayed gastric emptying. And, there are no acknowledged strategies to avoid DGE. Several feeding strategies have been investigated to cope with this problem. However, there is still no consensus concerning the best nutrition support method after pancreaticoduodenectomy. The purpose of this study is to determine the effect of nutrition support methods on DGE after pancreaticoduodenectomy: early enteral nutrition or total parenteral nutrition.

Patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group), or Saline administration (Saline group), or oral intake only (Natural control). The EN group will receive standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The Saline group will receive saline administered through a nasojejunal tube beginning from the 1st postoperative day. Oral intake will not be restricted in all three group.


Eligibility Criteria:
Inclusion Criteria:

Patients underwent selective pancreaticoduodenectomy Patients ≥18 years old and ≤80 years old Having given written informed consent

Exclusion Criteria:

Previous gastric resection or intestinal reconstruction Preoperative complete parenteral or enteral feeding ASA score ≥4 Pregnant women Severe malnutrition Patient who cannot give written informed consent.
Comparison of Dyslipidemia Among Diabetics Versus Non Diabetics in Haemodialysis Patients

* How dyslipidemia common among Diabetic and non- Diabetic Haemodialysis patients.
* How differ dyslipidemia types among Diabetic and non- Diabetic in Haemodialysis patients. (Qualitative difference).

Diabetes mellitus (DM) is a metabolic disease , a consequence of defects in insulin action, secretion, or both, and there are complications associated with it, such as nephropathy, retinopathy, neuropathy, cardiovascular complications ,cerebrovascular and peripheral arterial disease. Diabetic nephropathy, which occurs in about one third of type 2 diabetic patients, is the most common factor leading to end-stage renal disease (ESRD) . A very common metabolic abnormality associated with diabetes is dyslipidemia, which is characterized by a spectrum of quantitative and qualitative changes in lipids and lipoproteinsSeveral previous studies have pursued linking blood glucose levels to serum lipid activities. The etiology of dyslipidemia appears to be centered on the increased large TAG-rich very low-density lipoprotein-cholesterol (VLDL-C) and its impaired clearance. American diabetic association (ADA) defines dyslipidemia as hypercholesterolemia ≥200 mg/dl of serum total cholesterol, hypertriglyceridemia ≥150 mg/dl of serum triglyceride, reduced high density lipoprotein cholesterol (HDL-C) \<40 mg/dl for men and \<50 mg/dl for women, elevated low density lipoprotein cholesterol (LDL-C) ≥70 mg/dl and high TC to HDL-C ratio of ≥4.5. Normal plasma lipids and lipoprotein metabolism is critical for cellular cholesterol homeostasis and protection against atherosclerosis, renal disease and other complication . A study found that people with high blood pressure and overweight or obesity have a higher risk of developing dyslipidemia ,Early detection and effective control of blood lipid levels can reduce the morbidity and mortality of CVD in patients with DM. Therefore, it is important to determine the factors associated with dyslipidemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 60 years.
* Patients undergoing regular conventional Haemodialysis for more than 6 months

Exclusion Criteria:

* Peritoneal Dialysis
* Haemodiafilteration
* Acute Kidney Injury
* Nephrotic syndrome
* Hypothyroidism
* Familial hypertriglyceridemia.
* Acute pancreatitis
* Connective tissue disease.
* Decompensated liver disease
* Active malignancy.
FIT (Fast Infarction Treatment): Complete Revascularization During Primary Percutaneous Coronary Intervention (PCI) Can be Achieved Safely With an Improved Clinical Outcome During the Indexed Hospitalization.

Few reports described outcomes of complete compared with infarct related artery (IRA) only revascularization in patients with ST elevation myocardial infarction (STEMI) and multivessel coronary disease (CAD).

The purpose of this study is to determine outcome (death, myocardial infarction, target vessel failure) of 180 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty.

Before the first angioplasty patients are randomized to 2 different strategies: 1) culprit vessel angioplasty only, 2) staged revascularization.


Eligibility Criteria:
Inclusion Criteria:

* myocardial acute infarction
* prolonged chest pain (\>20 minute) started less \<12 hours before arrive in hospital
* ST segment elevation of \>1mm in \>2 contiguous leads
* new left bundle branch block
* diameter of the coronary suitable of angioplasty \>2mm
* the patients agrees to the study protocol and provides a written consensus
* two or more coronary suitable for angioplasty

Exclusion Criteria:

* refused written consensus
* hypersensitivity or contraindication to any of the following medications: heparin bivalirudin aspirin prasugrel stainless steel
* history of bleeding
* cardiogenic shock (PA \< 90mmHg)
* chronic total occlusion in the second lesion
* TIMI Flow \< II in the culprit lesion
* recent pregnancy
* history of intra-cerebral major hemorrhagic stroke
* an elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment life expectancy \<1 year
Systems Science Approaches to Improve Access to Healthier Foods: The FRESH Trial

Working with independently owned restaurants, a common source of calorie-rich, nutrient-poor foods in predominantly minority, low-income urban neighborhoods, has the potential to improve dietary quality, and contribute to cancer prevention. This study uses systems science approaches to improve access to healthier foods in independently owned restaurants by: 1) testing the effects of a novel intervention called FRESH (Focus on Restaurant Engagement to Strengthen Health) on dietary quality, health indicators and other outcomes in African American and Latin communities, and 2) developing a system dynamics model to allow stakeholders to virtually test FRESH strategies in their own communities. The resulting restaurant intervention simulation model offers potential cost savings from avoided trial-and-error testing, and will support community-based cancer prevention.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18-75 years)
* Regular restaurant customer (e.g., visits the specified restaurant at least 1x/week)
* Live in a household of at least 2 persons (criterion intended to provide a more stable sample, and to reduce loss to follow-up)
* Current resident of study neighborhood

Exclusion Criteria:

* Anticipate moving out of Baltimore or District of Columbia metropolitan area in the next 18 months
* Pregnant (due to changes in diet, weight and body composition)
Exercise Habit & MPAC

The limitations of applying social cognitive models to understand physical activity (PA) have led to the emergence of several new PA models within the past decade. The Multi-Process Action Control (M-PAC) is a comprehensive PA model that proposes intention is established from outcome expectations, perceived capability, and opportunity, then the success of translating this to behavior depends on affective judgments and behavioral-regulation. Over time, M-PAC proposes that behavior is can become maintained through the formation of identity and habit. The purpose of this study was to investigate the trajectory of change of these M-PAC constructs across time in a randomized controlled trial. Participants (n=85) were inactive new gym members and were randomized into a control (n=41) or intervention (n=44) group. The intervention group attended a workshop and received a booster phone call follow-up at week four. Measures for both groups included accelerometry and M-PAC at baseline and eight week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* adults 18-65
* new gym members
* exercising \< 150 minutes/week at a moderate to vigorous level

Exclusion Criteria:

* not affiliated with a gym or recreation center
* exercising \> 150 minutes/week at a moderate to vigorous level
* clinical health conditions (assessed by the PAR-Q)
An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy

This study was an extension to study MA21573 \[NCT00750880\], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was \> 500 individuals.


Eligibility Criteria:
Inclusion Criteria:

- patients who completed the 24-week MA21573 core study, had at least a moderate response based on EULAR definition criteria and no adverse events (AEs), serious adverse events (SAEs) or conditions that led to unacceptable risk of continued treatment.

Exclusion Criteria:

-as for MA21573.
Radiotherapy Combined With Tislelizumab and Irinotecan in MSS/pMMR Recurrence and Metastatic Colorectal Cancer

Explore the efficacy of radiotherapy combined with Tislelizumab and irinotecan in MSS/pMMR inoperable recurrent and metastatic colorectal cancer patients; To evaluate the safety and tolerability of radiotherapy combined with Tislelizumab and irinotecan in MSS/pMMR inoperable recurrent and metastatic colorectal cancer; To evaluate the radiosensitization effects of Tslelizumab and irinotecan;


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary signing of informed consent;
2. Aged 18-70 years old, regardless of gender;
3. Histologically confirmed as inoperable recurrent or metastatic colorectal adenocarcinoma;
4. Previously received oxaliplatin and fluorouracil based chemotherapy; No previous treatment with irinotecan;
5. NGS sequencing or immunohistochemistry prompts MSS/pMMR
6. At least one measurable lesion;
7. Palliative radiotherapy is required for clinical evaluation (except radiotherapy for bone or brain metastasis);
8. ECOG scores 0-2;
9. Expected survival ≥ 6 months;
10. The organ function of the patient was normal within 7 days before treatment, and the function of important organs met certain requirements.

Exclusion Criteria:

1. Pregnant or breastfeeding women;
2. There were primary lesions or metastases in the radiation field and had received radiotherapy before;
3. Previously received PD-1, PD-L1 or PD-L2 for any indication;
4. Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ;
5. If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance;
6. Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months;
7. Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases;
8. Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC)≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP).
Animal and Plant Proteins and Glucose Metabolism

The goal of this proposal is to determine the effect of a high protein diet in which the increase in protein intake is derived from different sources (animal vs plant and protein-rich whole foods vs protein isolates) on: i) liver and muscle insulin sensitivity; ii) the metabolic response to a meal, and iii) 24-h plasma concentration profiles of glucose, glucoregulatory hormones, and protein-derived metabolites purported to cause metabolic dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* age: ≥21 and ≤70 years;
* BMI: \>24.5 and \<32.5 kg/m2;
* habitual protein intake \<0.9 g/kg/day (assessed on 2 weekdays and 2 weekend days by using the HealthWatch 360 app); and
* weight stable (i.e., ≤3% change) and untrained (≤150 min of structured exercise/week) for at least 2 months before entering the study.

Exclusion Criteria:

* prediabetes or type 2 diabetes;
* evidence of chronic kidney disease by medical history or laboratory tests (glomerular filtration rate \<60 ml/min/1.73 m2 or an albumin to creatinine ratio in urine ≥30 mg/g);
* vegetarians or vegans;
* intolerance or allergies to ingredients in the metabolic meal or intervention diet;
* take dietary supplements (e.g., pre- and probiotics, fiber, fish oil) or medications known to affect our study outcomes;
* received antibiotic or antifungal treatment (which affect the microbiome and therefore microbial metabolite production) 2 months before entering the study;
* consume tobacco products or excessive alcohol (women: \>14 drinks/week; men: \>21 drinks/week);
* evidence of significant organ system dysfunction or diseases (e.g., cirrhosis), and
* unwilling or unable to provide informed consent.
Third Eye Panoramic Device Feasibility Evaluation

This study will evaluate the feasibility of using the Third Eye Panoramic device in conjunction with standard colonoscopes in a clinical setting.

Patients will undergo a colonoscopy procedure during which the study device will provide video imaging of areas of the colon that are difficult to evaluate with the colonoscope alone.

The utility of the device will be assessed from the impressions of the investigators and from telephone follow-up with subjects to assess for post-procedural complications.

The purpose of this study is to evaluate the feasibility of using the Third Eye Panoramic device along with a standard colonoscope as a means of enhancing the ability of endoscopists to view areas that are hidden from the view of the colonoscope.

Colonoscopy is generally agreed to be the best method for detecting and removing cancers and pre-cancerous adenomas in the colon. However, numerous studies have demonstrated that from 22% to over 40% of adenomas are missed during standard colonoscopy. More importantly, 12% of large adenomas (at least 1 cm) are missed even by expert endoscopists using meticulous technique with the best available equipment, and these large adenomas are the ones that are most likely to transform into cancer.

Factors such as quality of bowel cleansing and time spent examining the colonic mucosa have been shown to affect miss rates. However, comparison with the results of CT colonography has shown that 2/3 of missed adenomas are located behind folds in the wall of the colon, in areas that are very difficult to see with a standard forward-viewing colonoscope.

When clipped onto the tip of a standard colonoscope, the Third Eye Panoramic device provides two additional miniature video cameras and light sources that offer views to the left side and right side of the colonoscope's tip. These lateral views complement the forward view of the colonoscope's camera to result in a "panoramic" view of over 300°. This extreme wide-angle view allows the endoscopist to examine the areas located behind folds.

In this study, each subject will undergo a colonoscopy procedure utilizing the Third Eye Panoramic device along with a standard colonoscope.

The investigators will evaluate issues related to usability and safety based on their experience and impressions, with telephone follow-up with subjects to assess for any post-procedural complications.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup.
2. The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

1. Patients \>75 years of age;
2. Patients with a history of colonic resection;
3. Patients with suspected chronic stricture potentially precluding complete colonoscopy;
4. Patients with diverticulitis or toxic megacolon;
5. Patients with a history of radiation therapy to abdomen or pelvis;
6. Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Coginitve and Physical Functions in Geriatric İndividuals

The aim of this study is to investigate the relationship between cognitive functions with physical performance, grip strength, walking speed, mobility, and frailty in geriatric individuals.

Decline in cognitive function and decline in physical performance are generally associated with advanced age. Cognitive dysfunction is a natural consequence of ageing and is an important factor in maintaining quality of life and independence. Investigating the relationship between cognition, physical performance, mobility, and frailty has become a challenging issue in recent years. However, there is a need to further clarify the direction of this cognitive-motor link.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer healthy geriatric individuals aged 65 years and over
* Able to walk independently

Exclusion Criteria:

* Without neurological and rheumatological diseases,
* Without acute musculoskeletal problems in the lower extremities
A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment

This clinical trial studies the use of a quality of life intervention called Y-AMBIENT to help young African American with stage I-III breast cancer manage daily life. Y-AMBIENT is a four-month, telephone-based intervention that includes three themed education sessions with three follow-up sessions, written materials, and videos. The Y-AMBIENT intervention may improve quality of life and other health-related outcomes in young African American breast cancer survivors.

PRIMARY OBJECTIVES:

I. Evaluate feasibility and acceptability of Y-AMBIENT and enhanced usual care among young African American breast cancer survivors.

II. Explore the degree to which the Y-AMBIENT versus (vs.) enhanced usual care affects preliminary health-related outcomes among young African American (AA survivors).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (Y-AMBIENT): Patients receive three themed education sessions over 1 hour each, written materials, and videos at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss how they are doing and discuss any concerns that they are still managing at months 2, 3, and 4.

ARM II (ENHANCED USUAL CARE): Patients receive usual care at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss their chemotherapy regimen at months 2, 3, and 4.

After completion of study, patients are followed up at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Biologically born women
* Self-identify as AA
* Are aged 18 to 44 years on study entry
* Are diagnosed with breast cancer stage I-III
* Are in treatment with chemotherapy and/or radiation for stage I-III breast cancer at study entry
* Are English- speaking
* Have telephone and internet access

Exclusion Criteria:

* Participation in formal survivorship navigation programs because they are associated with improved health- related outcomes, which could be a confounder
The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease

The investigators hypothesize that circulating tumor cells (CTC) will be observed in patients with muscle-invasive or metastatic bladder cancer and that CTC will become undetectable, at least transiently, in a fraction of patients after treatment. To investigate this hypothesis, investigators will assess the levels of CTCs both before and after treatment. The feasibility and potential value of fluorescent in situ hybridization (FISH) in the CTCs will be assessed.

The measurement of circulating tumor cells is pursued in several cancers including breast and prostate cancer. The number of cells measured in these cancers has been shown to be prognostic. There is little information on the presence or importance of circulating tumor cells in bladder cancer. This trial is designed to determine if patients with advanced bladder cancer have circulating tumor cells and if these circulating cells are affected by treatment of the cancer.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of transitional cell carcinoma of the urothelium of at least T2-4, Nx, Mx stage. Mixed histologies will be allowed (e.g. squamous differentiation) as long as a transitional cell component is present.
* Clinical plans for surgery (with or without chemotherapy), radiation therapy, or chemotherapy.
* Participants must not have any condition which in the investigator's opinion may compromise the feasibility of completing the study.
* Subject must be 18 years of age or older
* Subject must be willing to have up to 4 peripheral blood samples obtained over a 6 month period of study.
* Prior therapies for bladder cancer will be allowed if patient currently has muscle-invasive or metastatic bladder cancer despite the previous treatments.
* Predicted life expectancy of \> 12 weeks.

Exclusion Criteria:

* Subjects who are unwilling or unable to comply with the study guidelines as determined by the principal investigator.
A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis

Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.


Eligibility Criteria:
Inclusion Criteria:

* medial tibiofemoral OA defined as definitive osteophytes and joint space narrowing in the medial compartment, as confirmed with radiographs
* history of knee pain longer than 6 months
* average self-reported knee pain of at least 3 out of 10 (using an 11-point numerical rating scale with terminal descriptors of 0 = "no pain" and 10 = "worst pain imaginable") over the 6 months prior to baseline testing
* pain in the same foot/feet as the painful knee(s)
* ability to communicate in English
* show an immediate biomechanical response to the insoles. This final eligibility criterion will be determined from an in-person biomechanical assessment after participants have passed all previous eligibility screening.

Exclusion Criteria:

* radiographic evidence of more lateral tibiofemoral OA than medial
* knee surgery or intra-articular injection within the previous 6 months
* current or recent (within 6 months) corticosteroid use for any reason
* presence of a systemic arthritic condition
* history of knee joint replacement or tibial osteotomy
* any other condition affecting lower limb function
* current usage of shoe-worn insoles, or planning to acquire footwear modifications in the next 6 months
* any previous experience with insoles that resulted in increased lower limb pain or a self- or clinician-initiated termination of use.